bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of 6-Week Use of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness
Authors: Tidey Jennifer W , Colby Suzanne M , Denlinger-Apte Rachel L , Goodwin Christine , Cioe Patricia A , Cassidy Rachel N , Swift Robert M , Lindgren Bruce R , Rubin Nathan , Murphy Sharon E , Hecht Stephen S , Hatsukami Dorothy K , Donny Eric C 
Published: August 2019

Abstract

Introduction
The US Food and Drug Administration is considering implementing a reduced-nicotine standard for cigarettes. Given the high rate of smoking among people with serious mental illness (SMI), it is important to examine the responses of these smokers to very low nicotine content (VLNC) cigarettes.

Methods
This trial compared the effects of VLNC (0.4 mg nicotine/g tobacco) and normal nicotine content cigarettes (15.8 mg/g) over a 6-week period in non-treatment-seeking smokers with schizophrenia, schizoaffective disorder, or bipolar disorder (n = 58). Linear regression was used to examine the effects of cigarette condition on cigarettes per day, subjective responses, nicotine and tobacco toxicant exposure, craving, withdrawal symptoms, and psychiatric symptoms.

Results
At week 6, participants in the VLNC condition smoked fewer cigarettes per day, had lower breath carbon monoxide levels, lower craving scores, and rated their study cigarettes lower in satisfaction, reward, enjoyment, and craving reduction than those in the normal nicotine content condition (ps &lt; .05). Week 6 psychiatric and extrapyramidal symptoms did not differ by condition, except for scores on a measure of parkinsonism, which were lower in the VLNC condition (p &lt; .05). There were no differences across conditions on total nicotine exposure, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, withdrawal symptoms, or responses to abstinence.

Conclusions
These results suggest that a reduced-nicotine standard for cigarettes would reduce smoking among smokers with SMI. However, the lack of effect on total nicotine exposure indicates VLNC noncompliance, suggesting that smokers with SMI may respond to a reduced-nicotine standard by substituting alternative forms of nicotine.

Implications
Results from this trial suggest that a reduced-nicotine standard for cigarettes would reduce smoking rates and smoke exposure in smokers with SMI, without increasing psychiatric symptoms. However, noncompliance with VLNC cigarettes was observed, suggesting that these smokers might respond to a reduced-nicotine standard by substituting alternative forms of nicotine.
Examining Age as a Potential Moderator of Response to Reduced Nicotine Content Cigarettes in Vulnerable Populations
Authors: Davis Danielle R , Parker Maria A , Villanti Andrea C , Streck Joanna M , Priest Jeff S , Tidey Jennifer W , Gaalema Diann E , Sigmon Stacey C , Heil Sarah H , Higgins Stephen T 
Published: August 2019

Abstract

Introduction
Young adults (aged 18–24 years) have a higher smoking prevalence than younger and older age groups and young adulthood is an important developmental period during which long-term behavior patterns like cigarette smoking are established. The aim of the current study was to examine how young adult smokers with additional vulnerabilities to smoking respond to reduced nicotine content cigarettes.

Methods
This is a secondary analysis of a double-blind, within-subject experiment conducted with 169 cigarette smokers recruited from populations with comorbid psychiatric conditions or socioeconomic disadvantage assessing acute effects of research cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g). Participants were dichotomized by chronological age (18–24 vs. ≥25 years). Across 14 laboratory sessions effects of nicotine content were examined on measures of relative reinforcing efficacy (Cigarette Purchase Task [CPT] and Concurrent Choice testing), subjective effects, craving/withdrawal, and smoking topography. Repeated measures analysis of variances were used to examine potential moderating effects of age.

Results
Young adults exhibited lower demand for reduced nicotine content cigarettes than older adults across three of five CPT indices (ps &lt; .05). No differences by age were observed on other measures of reinforcing efficacy, subjective effects, craving/withdrawal, or smoking topography where effects generally decreased as an orderly function of decreasing nicotine content (ps &lt;.05).

Conclusion
Overall, these findings suggest that reducing the nicotine content of cigarettes would decrease the addiction potential of cigarette smoking in young adult smokers as much or perhaps more than older adult smokers from populations at increased vulnerability to smoking, addiction, and smoking-related health consequences.

Implications
Reducing the nicotine content in cigarettes to lower addiction potential of smoking has been proposed as a means to improve overall population health. It is imperative to examine how young adults may respond to a nicotine reduction policy. We saw minimal evidence that age moderates acute response and where there was evidence it was in the direction of reduced nicotine content cigarettes having less addictive potential among young versus older adults (eg, steeper decreases in demand for very low nicotine content cigarettes among young versus older adults). Overall, a nicotine reduction policy has the potential to reduce smoking across age groups.
Increasing Quit Attempts by Transitioning to Very Low Nicotine Content Cigarettes Versus Reducing Number of Cigarettes Per Day: A Secondary Analysis of an Exploratory Randomized Trial
Authors: Klemperer Elias M , Hughes John R , Callas Peter W 
Published: August 2019

Abstract

Introduction
The Food and Drug Administration (FDA) has proposed reducing nicotine with very low nicotine content (VLNC) cigarettes. In contrast, reducing nicotine by reducing number of cigarettes per day (CPD) is common. Our prior findings demonstrate that VLNC cigarettes decreased dependence more and were more acceptable than reducing CPD. This secondary analysis explored which reduction strategy increased quit attempts (QA), self-efficacy, or intention to quit more.

Methods
This is a secondary analysis of 68 adult daily smokers not ready to quit randomized to smoke VLNC cigarettes versus reduce CPD over 5 weeks. All participants smoked study cigarettes with nicotine yield similar to most commercial cigarettes ad lib for 1 week (baseline). Participants were then randomized to gradually reduce to 70%, 35%, 15%, and 3% of baseline nicotine over 4 weeks by either (1) transitioning to lower nicotine VLNC cigarettes or (2) reducing the number of full nicotine CPD. All participants received nicotine patches to aid reduction. We assessed (1) QAs using nightly and weekly self-reports, (2) Velicer’s Self-Efficacy to Quit measure weekly, and (3) the Intention-to-Quit Ladder nightly.

Results
More CPD (41%) than VLNC (17%) participants made any QA (odds ratio = 3.4, 95% confidence interval = 1.1, 10.5). There was no difference in QAs ≥24 h. Self-efficacy increased for VLNC but not CPD participants (interaction: F = 3.7, p &lt; .01). The condition by time interaction for intention-to-quit was not significant.

Conclusions
Reducing number of CPD increased QAs more than reducing nicotine via switching to VLNC cigarettes. The lack of difference in longer QAs suggests replication tests are needed.

Implications
Reducing the frequency of smoking behavior (ie, CPD) could be a more effective strategy to increase QAs than reducing the magnitude of nicotine in each cigarette (ie, VLNC) per se.
Emergent Polymyxin Resistance: End of an Era?
Authors: Li Zekun , Cao Yuping , Yi Lingxian , Liu Jian-Hua , Yang Qiwen 
Published: August 2019

AbstractUntil recently, the polymyxin antibiotics were used sparingly due to dose limiting toxicities. However, the lack of therapeutic alternatives for infections caused by highly resistant Gram-negative bacteria has led to the increased use of the polymyxins. Unfortunately, the world has witnessed increased rates of polymyxin resistance in the last decade, which is likely in part due to its irrational use in human and veterinary medicine. The spread of polymyxin resistance has been aided by the dissemination of the transferable polymyxin-resistance gene, mcr, in humans and the environment. The mortality of colistin-resistant bacteria (CoRB) infections varies in different reports. However, poor clinical outcome was associated with prior colistin treatment, illness severity, complications, and multidrug resistance. Detection of polymyxin resistance in the clinic is possible through multiple robust and practical tests, including broth microdilution susceptibility testing, chromogenic agar testing, and molecular biology assays. There are multiple risk factors that increase a person’s risk for infection with a polymyxin-resistant bacteria, including age, prior colistin treatment, hospitalization, and ventilator support. For patients that are determined to be infected by polymyxin-resistant bacteria, various antibiotic treatment options currently exist. The rising trend of polymyxin resistance threatens patient care and warrants effective control.
Minimum Inhibitory Concentration Distribution of Fluconazole Against Cryptococcus Species and the Fluconazole Exposure Prediction Model
Authors: Chesdachai Supavit , Rajasingham Radha , Nicol Melanie R , Meya David B , Bongomin Felix , Abassi Mahsa , Skipper Caleb , Kwizera Richard , Rhein Joshua , Boulware David R 
Published: August 2019

AbstractBackgroundFluconazole is lifesaving for treatment and prevention of cryptococcosis; however, optimal dosing is unknown. Initial fluconazole doses of 100 mg to 2000 mg/day have been used. Prevalence of fluconazole nonsusceptible Cryptococcus is increasing over time, risking the efficacy of long-established standard dosing. Based on current minimum inhibitory concentration (MIC) distribution, we modeled fluconazole concentrations and area under the curve (AUC) relative to MIC to propose a rational fluconazole dosing strategy.MethodWe conducted a systematic review using the MEDLINE database for reports of fluconazole MIC distribution against clinical Cryptococcus isolates. Then, we utilized fluconazole concentrations from 92 Ugandans who received fluconazole 800mg/day coupled with fluconazole’s known pharmacokinetics to predict plasma fluconazole concentrations for doses ranging from 100 mg to 2000 mg via linear regression. The fluconazole AUC above MIC ratio were calculated using Monte Carlo simulation and using the MIC distribution elucidated during the systemic review.ResultsWe summarized 21 studies with 11 049 clinical Cryptococcus isolates. Minimum inihibitory concentrations were normally distributed with a geometric mean of 3.4 µg/mL, median (MIC50) of 4 µg/mL, and 90th percentile (MIC90) of 16 µg/mL. The median MIC50 trended upwards from 4 µg/mL in 2000–2012 to 8 µg/mL in 2014–2018. Predicted subtherapeutic fluconazole concentrations (below MIC) would occur in 40% with 100 mg, 21% with 200 mg, and 9% with 400 mg. The AUC:MIC ratio &gt;100 would occur in 53% for 400 mg, 74% for 800 mg, 83% for 1200 mg, and 88% for 1600 mg.ConclusionsCurrently recommended fluconazole doses may be inadequate for cryptococcosis. Further clinical studies are needed for rational fluconazole dose selection.
Ceftriaxone+Sulbactam+Disodium EDTA Versus Meropenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: PLEA, a Double-Blind, Randomized Noninferiority Trial
Authors: Mir Mohd Amin , Chaudhary Saransh , Payasi Anurag , Sood Rajeev , Mavuduru Ravimohan S , Shameem Mohd 
Published: August 2019

Abstract

Background
CSE is a novel combination of ceftriaxone, sulbactam, and disodium ethylenediaminetetraacetic acid (EDTA) with activity against multidrug-resistant Gram-negative pathogens.

Methods
Adult patients aged ≥18 years with a diagnosis of complicated urinary tract infections (cUTIs), including acute pyelonephritis (AP), were randomized 1:1 to receive either intravenous CSE (1000 mg ceftriaxone/500 mg sulbactam/37 mg disodium EDTA) every 12 hours or intravenous meropenem (1000 mg) every 8 hours for up to 14 days. The primary objective was to show the noninferiority of CSE to meropenem at the test-of-cure visit (8–12 days after the end of therapy), with a noninferiority margin of 10%.

Results
Of 230 randomized patients, 74 of 143 and 69 of 143 were treated with CSE and meropenem, respectively. Of these, 98% were ceftriaxone nonsusceptible and 83% were ESBL-positive at baseline. Noninferiority of CSE to meropenem was demonstrated for both the US Food and Drug Administration-defined coprimary endpoints of (1) symptomatic resolution at test-of-cure (71 of 74 [95.9%] patients vs 62 of 69 [89.9%]; treatment difference, 6%; 95% confidence interval [CI] −2.6% to 16%) and (2) symptomatic resolution as well as microbiological eradication at test-of-cure (70 of 74 [94.6%] vs 60 of 69 [87.0%]; treatment difference, 7.6%; 95% CI, −2.0% to 18.4%). Microbiological eradication at test-of-cure (European Medical Agency’s primary endpoint) was observed in 70 of 74 (94.6%) vs 61 of 69 (88.4%) (treatment difference, 6.2%; 95% CI, −3.2% to 16.6%) patients treated with CSE and meropenem, respectively. Safety profile of CSE was consistent with that of ceftriaxone alone.

Conclusions
The results support the use of CSE as a carbapenem-sparing treatment for patients suffering from cUTI/AP caused by resistant Gram-negative pathogens.
Resistance in Patients Failing Integrase Strand Transfer Inhibitors: A Call to Replace Raltegravir With Dolutegravir in Third-Line Treatment in South Africa
Authors: Steegen Kim , Van Zyl Gert , Letsoalo Esrom , Claassen Mathilda , Hans Lucia , Carmona Sergio 
Published: August 2019

Abstract
Data on integrase resistance patterns in low- and middle-income countries (LMICs) is scarce. We assessed genotypic drug resistance in 43 patients with virological failure on integrase strand transfer inhibitors (INSTIs) containing regimens as part of the third-line treatment program in South Africa. Of the raltegravir (RAL)-exposed patients 20 of 34 (59%) had ≥1 major INSTI mutation, including 2 (6%) with dolutegravir (DTG) cross-resistance. Dolutegravir resistance was detected in 1 of 4 DTG-exposed patients. Replacing RAL with DTG may reduce the risk of INSTI mutations. We recommend DTG drug resistance monitoring when DTG is introduced at a larger scale in LMICs.
The Changing Partisanship of the South and Its Impact on National Politics
Authors: Bullock Charles S. , MacManus Susan A. , Mayer Jeremy D. , Rozell Mark J. 
Published: August 2019

Abstract
For generations many assumed that Democratic hegemony in the South would last forever. Civil rights and the national Democratic Party’s move to the left reconfigured partisan competition in the South. By the 1970s, the South became a crucial battleground in the election of the president and Republican gains in the region started to trickle down to statewide elections and eventually to local offices. The realignment of the southern electorate looked complete by the 2000s with near GOP control of the region, but recent elections have shown some swing back to the Democrats in several Growth States.
New York Sybarite Conquers the South
Authors: Bullock Charles S. , MacManus Susan A. , Mayer Jeremy D. , Rozell Mark J. 
Published: August 2019

Abstract
Donald Trump, the thrice married and publicly philandering Manhattan resident who had recently been pro-choice and pro-gun control, won the Republican nomination and the presidency in 2016 in part through his very strong showing among Southern white voters. How he managed to do that is the story of this chapter. Trump appealed to Southern white racial resentment, as well as to the anti-immigration fervor particularly evident in the low growth “stagnant” Southern states such as Alabama and Mississippi. But what was really remarkable is how he won the GOP nomination by doing well in all regions. The Republican Party has become unified around a largely Southern conception of conservatism: deeply religious, pro-military, and less concerned with free trade. In the general election, by contrast, regional polarization intensified in 2016. In both elections, Trump’s path to victory required him to do well among Southern whites, which he ably did.
An Epistemological Critique
Authors: Spannaus Nathan 
Published: August 2019

Abstract
The main premise of Qursawi’s reformism is that any action or belief must be based on the most certain sources of religious knowledge—Qur’an and sound hadith—to the exclusion of anything not conforming to them. He took aim at taqlid, the widespread reliance upon which obscured any position’s basis and obliged adherence to ulama’s interpretations rather than scripture. The “scaffolding” of postclassical scholarship limited scholars’ autonomy to engage directly with scripture in order to preclude divergent and incorrect positions, but Qursawi saw it as allowing error to spread unchecked, and he criticized ulama for failing as religious interpreters and guides for the community. Since they could not be relied upon necessarily, he argued therefore that any position must be verified through tahqiq to ensure scriptural and logical correctness.
Prior Record and the Risk of Recidivism
Authors: Frase Richard S. , Roberts Julian V. 
Published: August 2019

Abstract
It is generally assumed that prior convictions provide a useful proxy for the offender’s risk of committing further crimes, and as a general proposition that assumption is well supported by research. But as this chapter shows, there is much less research on how well particular prior record formulas predict recidivism risk. This chapter identifies the elements of guidelines criminal history scores that appear to be designed to measure risk, reviews the limited research assessing the accuracy of criminal history scores and score components as predictors of subsequent offending, and examines the closeness of fit between predicted increases in risk, as the criminal history score rises, and the increments in sentence severity that are prescribed by grid-based guidelines systems. The chapter also argues against the use of rigid prior record enhancement formulas, and in favor of giving judges power to adjust sentences to take into account case-specific variations in recidivism risk.
The Effects of Prior Convictions on Sentence Severity
Authors: Frase Richard S. , Roberts Julian V. , Hester Rhys 
Published: August 2019

Abstract
This chapter explores the degree to which a higher criminal history score increases the severity of recommended and imposed sentences in U.S. guidelines systems. The impact of criminal history on sentence severity is measured in several ways. One set of measures assesses the extent to which a high criminal history score translates into increased sentencing severity—by causing the offender to be recommended for immediate commitment to prison, and/or by increasing the duration of the recommended prison or other custodial sentence. Other measures of prior record enhancement magnitude relate to the criminal history formula itself—the components of the score and the way in which each component is weighted. These rules determine how quickly offenders acquire a high score, triggering the most severe impacts, and they also determine which offenders are most likely to receive high scores. The chapter concludes with proposals for regulating the magnitude of prior record enhancements.
Impacts of Criminal History Enhancements on Prison Bed Needs and Costs
Authors: Frase Richard S. , Roberts Julian V. , Hester Rhys 
Published: August 2019

Abstract
This chapter shows how sentencing data can be used to quantify the substantial fiscal impacts of high-magnitude criminal history enhancements, overall and with respect to the problematic aspects of those enhancements identified and discussed in previous chapters. It uses data from Minnesota and several other states as examples because of the excellent sentencing data available for those states. The chapter first examines the total fiscal impact (added bed needs and costs) that results from the sentence-enhancing effects of criminal history on prison commitment and prison duration decisions. It then quantifies the fiscal impacts of the identified problematic aspects of prior record enhancements: disproportionately severe prison durations imposed on high history offenders, imprisonment of nonviolent offenders recommended for prison solely because of their elevated criminal history scores, imprisonment of aging offenders who are recommended for prison due to their high history scores, and racially disparate sentences that result from criminal history enhancements.
The Not-So-New Southern Racism
Authors: Maxwell Angie , Shields Todd 
Published: August 2019

Abstract
During and after the Civil Rights Movement, GOP leaders capitalized on white racial angst to attract southern white voters. However, in order to do so without alienating Republicans nationwide, the GOP utilized coded language as an end-around of public displays of prejudice and championed an “us vs. them” cosmology. The decline of overt, Old-Fashioned Racism seemed positive, but the decline masked the persistence of white supremacist attitudes so dominant in the South. Since whiteness functions as a vantage point, supremacy can be maintained as long as the gap between whites and an “other” is also maintained. When denigrating minorities publicly was no longer socially acceptable, the GOP manufactured a host of increasingly threatening “others.” These common enemies catalyzed both an elevation of and a clinging to whiteness, which, in turn, preserved the “not-so-new” racial hierarchy key to southern white voters that only relative measures of racial animus can expose.
The Myth of the Gender Gap
Authors: Maxwell Angie , Shields Todd 
Published: August 2019

Abstract
Taking their cue from anti-feminist leader Phyllis Schlafly, the GOP celebrated traditional gender roles and demonized feminism as part of a Long Southern Strategy. The Republican Party dropped the Equal Rights Amendment from its platform in 1980, which many feminists believed would cost the party women voters. When the gender gap emerged during the next election cycle with more women than men voting for Democrats, a myth took hold. However, the gender gap is not universal because anti-feminism and Modern Sexism remain deeply burrowed into southern white identity where they have been reinforced religiously and politicized continually by the GOP. When geography and identity are brought to bear on the myth of the gender gap, it looks remarkably different. Where it does not disappear completely, it is reversed, with southern white women proving more conservative than southern white men and dramatically more so than white American women as a whole.
The Not-So-New Southern Religion
Authors: Maxwell Angie , Shields Todd 
Published: August 2019

Abstract
In an effort to win southern white voters, the GOP embraced the old southern religion turning the church faithful into the party loyal. They did so because in many parts of the South, the church remains the central institution defining, organizing, and politicizing its surrounding community. A “sacred canopy” drapes over the region, where there is a common cosmology that is intractable from southern white identity, including its reverence for white supremacy and patriarchy. In general, as a block, white southerners were more evangelical, Protestant, fundamentalist, and moralist than the rest of the country. The not-so-new southern religiosity satisfies an appetite for certainty, conformity, and even social status. As a means to solidify southern white support, the Long Southern Strategy framed southern white Christianity as under attack and cast the GOP as its protector, the price of which is increased cultural defensiveness, anxiety, fear, and distrust.