bluuebunny/crossref_metadata_2025_split huggingface dataset:
Neoplasm Reports in Food and Drug Administration Adverse Event Reporting System Following Angiotensin Receptor Blocker Recalls
Authors: Cohen Sedgh Robert , Moon Jungyeon , Jackevicius Cynthia A. 
Published: August 2021

Background:
A worldwide voluntary recall of valsartan in July 2018 due to the potential carcinogen N-nitrosodimethylamine received extensive media and public attention. This was followed by more Food and Drug Administration (FDA) recalls regarding other contaminated ARB (angiotensin receptor blocker) products. Our study investigated the association between the FDA recalls and ARB neoplasm adverse events (AEs) reported to the FDA adverse event reporting system.

Methods:

In this cross-sectional study, data were retrospectively collected from the FDA adverse event reporting system database from January 2015 to December 2019. Reporting odds ratios (RORs) were estimated to detect signals of association between ARBs (valsartan, irbesartan, and losartan) and reported neoplasm AEs using negative (amoxicillin and sertraline) and positive (omeprazole and ranitidine) control exposures. The χ
2
was used to compare categorical variables.

Results:

A total of 2 181 524 AEs, including 10 461 nonmetastatic neoplasm AEs were analyzed. Monthly RORs (95% CI) of valsartan-associated neoplasms versus controls (ROR*: valsartan/negative exposures; ROR†: valsartan/omeprazole; and ROR‡: valsartan/ranitidine) showed the highest signals after the recall date in July 2018 (7.64 [4.78–12.19]*; 4.77 [3.36–6.79]†; 4.13 [2.50–6.84]‡) and August 2018 (7.87 [5.19–11.94]*; 5.65 [4.12–7.75]†; and 7.20 [4.46–11.63]‡). In contrast, the highest cancer signals for the irbesartan and losartan recalls detected in March 2019 (4.80*; 4.06†; and 3.38‡) and April 2019 (3.63*; 3.69†; and 2.52‡) respectively, were lower. One-year postrecall reported neoplasm AEs were ≈2-fold higher for valsartan than irbesartan (OR, 1.77 [95% CI, 1.47–2.13],
P
<0.0001) and losartan (OR, 2.07 [95% CI, 1.85–2.32],
P
<0.0001). Although all ARBs had the same nitrosamine contamination, we found 1-year postrecall versus prerecall cancer signals for valsartan were 3-fold higher versus control exposures, while the changes in RORs for irbesartan and losartan were only 20-30% higher.

Conclusions:
Significantly more postrecall neoplasms were reported for valsartan, with higher valsartan-associated cancer signals compared with irbesartan and losartan, although they all contained the same carcinogenic contaminant. Extensive media coverage of the FDA valsartan recall may have alarmed patients and generated these abrupt, biologically infeasible cancer signals.
atg7
-Based Autophagy Activation Reverses Doxorubicin-Induced Cardiotoxicity
Authors: Wang Yong , Lu Xiaoguang , Wang Xiaoping , Qiu Qi , Zhu Ping , Ma Lin , Ma Xiao , Herrmann Joerg , Lin Xueying , Wang Wei , Xu Xiaolei 
Published: August 2021

Rationale:
Anthracycline-induced cardiotoxicity (AIC) is a major side effect that limits the use of anthracyclines as effective chemotherapeutics. No mechanism-based therapy is available when cardiac function deteriorates.

Objective:
We aim to elucidate the dynamic autophagic defects in AIC and to identify a mechanism-based therapy via both genetic and pharmacological studies.

Method and Results:

Through phenotyping an adult AIC zebrafish model, we detected a biphasic response in autophagy: activation in the early stage and suppression in the later phase that is characterized by a decline in cardiac function. We conducted conditional genetic studies with
atg7
, which encodes a rate-limiting autophagy core protein, and found that
atg7
overexpression leads to therapeutic effects in the late phase but deleterious effects in the early phase of adult AIC. We then assessed the therapeutic effects of 37 Food and Drug Administration–approved autophagy activators using an embryonic AIC zebrafish model and identified spironolactone, pravastatin, and minoxidil as top-ranking drugs. We demonstrated the therapeutic efficacy of these Food and Drug Administration–approved autophagy activators in the adult AIC model and confirmed that these drugs exert therapeutic effects in the late phase but not in the early AIC phase. Finally, we demonstrated that the time-dependent therapeutic effects are conserved in a mouse AIC model and that spironolactone and rapamycin activated autophagy in an Atg7-dependent fashion.

Conclusions:
Our findings suggest that atg7-based autophagy activation is an effective therapeutic avenue to reversing the decline in cardiac function in AIC, highlighting the time-dependent nature of autophagy-based therapy.
Regime Stability and the Persistence of Traditional Practices
Authors: Poyker Michael 
Published: August 2021

Abstract
I examine why the harmful tradition of female genital mutilation (FGM) persists in certain countries but in others it has been eradicated. People are more willing to abandon their traditions if they are confident that the government is durable enough to set up long-term replacements for them. Using a country-ethnicity panel data set spanning 23 countries from 1970 to 2013 and artificial partition of African ethnic groups by national borders, I show that a one-standard-deviation larger increase in political regime durability leads to a 0.1-standard-deviation larger decline in the share of newly circumcised women, conditional on the presence of an anti-FGM government policy.
Skill Versus Voice in Local Development
Authors: Casey Katherine , Glennerster Rachel , Miguel Edward , Voors Maarten 
Published: August 2021

AbstractWhere the state is weak, traditional authorities control the local provision of public goods. These leaders come from an older, less educated generation and often rule in an authoritarian and exclusionary fashion. This means the skills of community members may not be leveraged in policymaking. We experimentally evaluate two solutions to this problem in Sierra Leone: one encourages delegation to higher-skill individuals, and a second fosters broader inclusion in decision making. In a real-world infrastructure grants competition, a public nudge to delegate led to better outcomes than the default of chiefly control, whereas attempts to boost participation were largely ineffective.
Valuing Domestic Transport Infrastructure: A View from the Route Choice of Exporters
Authors: Fan Jingting , Lu Yi , Luo Wenlan 
Published: August 2021

Abstract
A key input to quantitative evaluations of transport infrastructure projects is their impact on transport costs. We propose a new method of estimating this impact relying on widely accessible customs data: by using the route choice of exporters. We combine our method with a spatial equilibrium model to study the effects of the massive expressway construction in China between 1999 and 2010. We find transport costs are 20% lower on expressways than on regular roads. The expressways construction increases aggregate exports by 10% and domestic trade by 14%. It generates 5.1% welfare gains, implying a 150% net return to investment.
Bootstrap Inference for Quantile Treatment Effects in Randomized Experiments with Matched Pairs
Authors: Jiang Liang , Liu Xiaobin , Phillips Peter C. B. , Zhang Yichong 
Published: August 2021

Abstract
This paper examines methods of inference concerning quantile treatment effects (QTEs) in randomized experiments with matched-pairs designs (MPDs). Standard multiplier bootstrap inference fails to capture the negative dependence of observations within each pair and is therefore conservative. Analytical inference involves estimating multiple functional quantities that require several tuning parameters. Instead, this paper proposes two bootstrap methods that can consistently approximate the limit distribution of the original QTE estimator and lessen the burden of tuning parameter choice. Most especially, the inverse propensity score weighted multiplier bootstrap can be implemented without knowledge of pair identities.
Long-Term Care Hospitals: A Case Study in Waste
Authors: Einav Liran , Finkelstein Amy , Mahoney Neale 
Published: August 2021

AbstractThere is substantial waste in U.S. healthcare but little consensus on how to combat it. We identify one source of waste: long-term care hospitals (LTCHs). Using the entry of LTCHs into hospital markets in an event study design, we find that most LTCH patients would have counterfactually received care at Skilled Nursing Facilities—facilities that provide medically similar care but are paid significantly less—and that substitution to LTCHs leaves patients unaffected or worse off on all dimensions we can objectively measure. Our results imply Medicare could save about $4.6 billion per year by not allowing discharge to LTCHs.
The Effects of Career and Technical Education: Evidence from the Connecticut Technical High School System
Authors: Brunner Eric J. , Dougherty Shaun M. , Ross Stephen L. 
Published: August 2021

Abstract
We examine the effect of attending stand-alone technical high schools in Connecticut using regression discontinuity. Male students are 10 percentage points more likely to graduate from high school and have half a semester less time enrolled in college. Male students have 32% higher average quarterly earnings. Earnings effects may in part reflect general skills: male students have higher attendance rates and test scores, industry fixed effects explain less than one-third of earnings gains, and large earnings gains persist past traditional college going years. Attending a technical high school does not affect the outcomes of female students.
The Missionaries of Africa and the Rwandan Genocide
Authors: Denis Philippe 
Published: August 2021

Abstract
On the basis of documentary evidence, this paper examines the position of the Missionaries of Africa, also known as White Fathers, in political and ethnic matters during the buildup to the genocide in Rwanda, the genocide itself, and the postgenocide period. It argues that the Missionaries of Africa responded to the genocide in different ways. Some, especially those who returned to Rwanda after 1994, recognised the errors done by the church and tried to restart their ministry on a new foundation. However, many, particularly in Belgium, the country from where half of them originated, adopted a more defensive attitude. They subscribed, explicitly or not, to the double genocide theory according to which the crimes of the Rwandan Patriotic Front equalled or even surpassed those of the Rwandan authorities and the militias during the genocide. On the whole, the General Council of the congregation in Rome reacted to the Rwandan situation in a nonpartisan manner.
Neoadjuvant Radiotherapy is Associated With Improved Pathologic Outcomes and Survival in Resected Stage II-III Pancreatic Adenocarcinoma Treated With Multiagent Neoadjuvant Chemotherapy in the Modern Era
Authors: Hue Jonathan J. , Dorth Jennifer , Sugumar Kavin , Hardacre Jeffrey M. , Ammori John B. , Rothermel Luke D. , Saltzman Joel , Mohamed Amr , Selfridge Jennifer E. , Bajor David , Winter Jordan M. , Ocuin Lee M. 
Published: August 2021

Background Neoadjuvant chemotherapy (CT) is being utilized more frequently in patients diagnosed with localized pancreatic cancer. The role of additional neoadjuvant radiotherapy (RT) remains undefined. We explored outcomes associated with neoadjuvant RT in the modern era. Methods The National Cancer Database (2010-2017) was queried for patients with clinical stage II-III pancreatic adenocarcinoma who received neoadjuvant multiagent systemic CT +/− RT. Demographics, pathologic outcomes, postoperative outcomes, and overall survival were compared. Results A total of 5245 patients were included, of whom 3123 received CT and 1941 received CT + RT. Use of RT decreased over the 8-year study period. On multivariable analysis, treatment at academic facilities (odds ratio (OR) = 1.52, P < .001) and clinical T4 tumors (OR = 1.68, P < .001) were independently associated with receipt of RT. Patients treated with CT + RT had a higher frequency of ypT0-T2 tumors (35.8% vs. 22.7%) and a lower rate of ypT3-T4 tumors (57.3% vs. 72.8%; P < .001), lower rate of node-positive disease (36.6% vs. 59.8%, P < .001), and margin-positive resections (13.8% vs. 20.2%, P < .001), but slightly higher 90-day postoperative mortality (4.9% vs. 3.6%, P = .04). Neoadjuvant chemotherapy+ RT was associated with longer overall survival (32.7 vs. 29.8 months, P = .008), and remained independently associated with survival on multivariable analysis (HR = .85, P < .001). Discussion In patients with stage II-III pancreatic adenocarcinoma, the addition of neoadjuvant RT to multiagent neoadjuvant CT may be associated with increased rates of node-negative and margin-negative resection, as well as improved overall survival.
Open Hemorrhoidectomy With Ligasure™ Under Local or Spinal Anesthesia: A Comparative Study
Authors: Feo Claudio F. , Ninniri Chiara , Tanda Cinzia , Deiana Giulia , Porcu Alberto 
Published: August 2021

Background There is increasing evidence that many anorectal surgical procedures may be performed under local anesthesia. The aim of the present study was to evaluate the safety and efficacy of local anesthesia in the outpatient clinic vs spinal anesthesia in the operating room for open hemorrhoidectomy. Methods Sixty-two patients with grade III or IV hemorrhoids underwent open hemorrhoidectomy with LigaSure™ between 2018 and 2020. Of them, 32 procedures were performed in the operating room under spinal anesthesia with hyperbaric bupivacaine and other 30 procedures were undertaken in the outpatient clinic under local anesthesia with ropivacaine. Results There were no significant differences regarding age, gender, American Society of Anesthesiologists class, and Goligher’s grade in between groups. No significant differences were observed in postoperative pain score (P = .85), perioperative complications (P = .51), and reoperation rate (P = .96). No recurrences and no differences in patients’ satisfaction degree (P = .76) were documented at long-term follow-up in both study groups. Discussion Our results suggest that open hemorrhoidectomy with LigaSure™ performed in selected patients under local anesthesia in the outpatient clinic is a well-tolerated, safe, and effective procedure.
Predicting the risk of postoperative acute kidney injury: development and assessment of a novel predictive nomogram
Authors: Wu Yukun , Chen Junxing , Luo Cheng , Chen Lingwu , Huang Bin 
Published: August 2021

Objective This study aimed to establish and internally verify the risk nomogram of postoperative acute kidney injury (AKI) in patients with renal cell carcinoma. Methods We retrospectively collected data from 559 patients with renal cell carcinoma from June 2016 to May 2019 and established a prediction model. Twenty-six clinical variables were examined by least absolute shrinkage and selection operator regression analysis, and variables related to postoperative AKI were determined. The prediction model was established by multiple logistic regression analysis. Decision curve analysis was conducted to evaluate the nomogram. Results Independent predictors of postoperative AKI were smoking, hypertension, surgical time, blood glucose, blood uric acid, alanine aminotransferase, estimated glomerular filtration rate, and radical nephrectomy. The C index of the nomogram was 0.825 (0.790–0.860) and 0.814 was still obtained in the internal validation. The nomogram had better clinical benefit when the intervention was decided at the threshold probabilities of >4% and <79% for patients and doctors, respectively. Conclusions This novel postoperative AKI nomogram incorporating smoking, hypertension, the surgical time, blood glucose, blood uric acid, alanine aminotransferase, the estimated glomerular filtration rate, and radical nephrectomy is convenient for facilitating the individual postoperative risk prediction of AKI in patients with renal cell carcinoma.
Phacoemulsification and dexamethasone intravitreal implant in diabetic patients: A combined approach
Authors: Montrone Lucrezia , Macinagrossa Giancarlo 
Published: August 2021

Purpose: To analyse the morpho-functional outcomes of dexamethasone intravitreal implant (Ozurdex) injected after lens surgery in diabetic patients with coexisting cataract and macular oedema. Methods: This is a non-randomized, perspective, single-group study on 17 eyes with a diagnosis of cataract and early and advanced diabetic macular oedema. All eyes underwent combined phacoemulsification and Ozurdex injection at the end of surgery and morpho-functional outcomes were analysed in 3 months follow-up. Results: Foveal thickness decreased significantly from 349.6 ± 19.8 (95% CI) at baseline to 310.7 ± 17.5 (95% CI) 90 days after surgery ( p < 0.01). Mean BCVA (LogMAR) improved significantly from 0.38 ± 0.08 (95% CI) at baseline to 0.15 ± 0.06 (95% CI) after 90 days ( p < 0.01). Any ocular or systemic complications were observed during follow-up. Conclusions: Dexamethasone intravitreal implant combined with phacoemulsification may be safe and effective to improve morpho-functional outcomes in diabetic patients with coexisting cataract and macular oedema.
Yiddish–Slavic language contact in multilingual songs: Describing deliberate code-switching
Authors: Verschik Anna 
Published: August 2021

Aims and objectives/purposes/research questions: The aim of the article is to describe what language contact phenomena are present. The research questions are as follows: (a) what types of code-switching (CS) are at work; (b) is there any preference for any particular type of CS; and (c) what Jewish (seemingly) monolingual songs in Slavic languages can tell us about contact varieties of Slavic used by Jews. Design/methodology/approach: Collecting texts of Yiddish–Slavic and Jewish folk songs in Slavic languages; and qualitative analysis of CS and structural change. Data and analysis: Sixty-two Slavic–Yiddish texts were chosen from Jewish songs’ collections and CS instances analysed. Findings/conclusions: Both insertions and alternations are present but alternations are preferred. There is an asymmetry between Yiddish insertions into Slavic (nouns) and Slavic insertions into Yiddish (all parts of speech). Alternations may be just renditions of the same meaning in another language but most often they play the same role as in naturalistic speech described in the literature on multilingual communication (change of topic, addressee, etc.). Originality: Previous research on multilingual Jewish songs concentrated on the choice of languages and interpretation of the symbolic role that each language plays but not structural analysis of multilingual texts. Significance/implications: Now that some tendencies are identified, it remains to be seen whether naturalistic Yiddish–Slavic speech exhibits the same patterns of CS.
Prevention of EAE by tolerogenic vaccination with PEGylated antigenic peptides
Authors: Pfeil Jennifer , Simonetti Mario , Lauer Uta , von Thülen Bianca , Durek Pawel , Poulsen Christina , Pawlowska Justyna , Kröger Matthias , Krähmer Ralf , Leenders Frank , Hoffmann Ute , Hamann Alf 
Published: August 2021

Background: Therapeutic treatment options for chronic autoimmune disorders such as multiple sclerosis (MS) rely largely on the use of non-specific immunosuppressive drugs, which are not able to cure the disease. Presently, approaches to induce antigen-specific tolerance as a therapeutic approach; for example, by peptide-based tolerogenic ‘inverse’ vaccines have regained great interest. We have previously shown that coupling of peptides to carriers can enhance their capacity to induce regulatory T cells in vivo. Method: In this present study, we investigated whether the tolerogenic potential of immunodominant myelin T-cell epitopes can be improved by conjugation to the synthetic carrier polyethylene glycol (PEG) in an experimental autoimmune encephalomyelitis (EAE) mouse model for chronic MS (MOG C57BL/6). Results: Preventive administration of the PEGylated antigenic peptide could strongly suppress the development of EAE, accompanied by reduced immune cell infiltration in the central nervous system (CNS). Depletion of regulatory T cells (Tregs) abrogated the protective effect indicating that Tregs play a crucial role in induction of antigen-specific tolerance in EAE. Treatment during the acute phase of disease was safe and did not induce immune activation. However, treatment at the peak of disease did not affect the disease course, suggesting that either induction of Tregs does not occur in the highly inflamed situation, or that the immune system is refractory to regulation in this condition. Conclusion: PEGylation of antigenic peptides is an effective and feasible strategy to improve tolerogenic (Treg-inducing) peptide-based vaccines, but application for immunotherapy of overt disease might require modifications or combination therapies that simultaneously suppress effector mechanisms.
Participant views and experiences of sexual health research: The Contraception Choices online trial
Authors: Bailey Julia V , Bennett Kirsty F , Gubijev Anasztazia , Shawe Jill , Stephenson Judith 
Published: August 2021

Background Online sexual health research can be convenient, efficient and low cost, but there are debates about the adequacy of online informed consent, privacy, and the acceptability of different methods of follow-up. Objectives To explore women's views and experiences of the Contraception Choices feasibility trial procedures and the place of digital interventions for contraception decision making. Methods We analysed data from two sources: (1) Qualitative interviews. Eighteen interviews were conducted with women who had taken part in the Contraception Choices pre-trial feasibility study, to evaluate recruitment and online trial procedures. (2) Free-text comments. Women in the main Contraception Choices randomised controlled trial were followed up at 3 and 6 months, and asked ‘Please tell us what you liked or disliked about the website’ and ‘Has being in the study had any good or bad effects on your life?’ A total of 387 and 414 comments were made at 3 and 6 months respectively. Data were analysed thematically. Results Participants liked being involved in a study about contraception, although recruitment from an abortion clinic was less acceptable than in other sexual health settings. Women found the trial procedures straightforward, and expressed no major concerns about online self-registration, informed consent or online data collection. Online survey questions about contraception and fertility were acceptable, and participants liked the convenience of being followed up by email or text. Conclusions Participants appreciated the advantages of the online research design and did not express concerns about consent or privacy. Women would welcome digital interventions for contraception in a variety of settings.