bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prevalence and Factors Associated With Clozapine-Related Constipation
Authors: Chougule Amitkumar , Praharaj Samir Kumar , Bhat Shripathy M. , Sharma P.S. V.N. 
Published: December 2017

Abstract

Background
Despite being a very effective treatment for resistant schizophrenia and bipolar disorder, use of clozapine is limited by adverse effects. Constipation is a common but potentially life-threatening adverse effect of clozapine that is understudied. The objective was to study the prevalence and factors associated with constipation in those receiving clozapine compared with control subjects.

Methods
Fifty patients in age group of 18 to 55 years receiving clozapine were compared with 50 patients in the same age group receiving medications other than clozapine. Presence of constipation was ascertained using the World Gastroenterology Organization Practice Guidelines definition. The severity of constipation was assessed using Constipation Assessment Scale and Bristol Stool Form Scale, and anticholinergic burden was assessed using Anticholinergic Burden Scale.

Results
Among clozapine-treated patients, 28 (56%) had constipation as compared with 11 (22%) in the control subjects (P < 0.001); the odds of developing constipation was 4.5 (95% confidence interval, 1.9–10.8). Kaplan-Meier survival analysis showed median time to onset of constipation in clozapine-treated patients was 60 days (SE, 13.1 days; 95% confidence interval, 34.3–85.7 days) and median dose of clozapine was 300 mg/d (interquartile range, 312 mg/d). Clozapine group had high Constipation Assessment Scale scores (P = 0.005, Cohen d = 1.17) and higher prevalence of types 1 and 2 Bristol stool types (Fisher exact P = 0.005, Cramer V = 0.59).

Conclusions
Constipation was prevalent in more than half of patients receiving clozapine, which was severe and took longer time for recovery. Limitations include using a hospital-based sample and that dietary habits and lifestyle factors were not studied.
Efficacy and Acceptability of Cariprazine in Acute Exacerbation of Schizophrenia
Authors: Zhao Ming-jun , Qin Bin , Wang Jin-bao , Zhang Yan-ping , Zhao Jian-ting , Mao Ya-ge , Zhang Xiang-yang , Zhang Rui-ling 
Published: December 2017

Abstract

Purpose
The purpose of this study was to assess the efficacy and acceptability of cariprazine treatment in acute exacerbation of schizophrenia.

Methods
This review included randomized controlled trials of patients with acute exacerbation of schizophrenia in relation to efficacy and acceptability. The efficacy outcomes were assessed by pooling standardized mean differences (SMDs) calculated from the difference in the reduction in the mean of the Positive and Negative Syndrome Scale (PANSS) total score, PANSS positive and negative scores, and response rate. The primary acceptability outcomes were determined by pooling the risk ratios (RRs) of discontinuation for any reason, the incidence of serious adverse events, and treatment emergent events.

Findings
Four randomized controlled trials consisting of 1843 patients met all inclusion and exclusion criteria. Efficacy analysis showed significant positive effects in relation to cariprazine therapy (SMD: −0.37, P < 0.00001 for PANSS total score change; SMD: −0.32, P < 0.00001 for PANSS positive score change; SMD: −0.32, P < 0.0001 for PANSS negative score change; RR, 1.41; 95% confidence interval [CI], 1.19–1.67; P < 0.0001 for response rate). For primary acceptability outcomes, less patients taking cariprazine discontinued treatment for any reason compared with patients receiving placebo (RR, 0.90; 95% CI, 0.78–1.04; P = 0.16). Significantly less patients on cariprazine had serious adverse events during the double-blind treatment period compared with patients taking placebo (RR, 0.55; 95% CI, 0.34–0.89; P = 0.01). Significantly more patients on cariprazine had treatment emergent events compared with those receiving placebo (RR, 1.10; 95% CI, 1.03–1.18; P = 0.006).

Implications
Results suggest that cariprazine may be an effective and acceptable treatment for schizophrenia and future research is warranted.
Improving the Clinical Pharmacologic Assessment of Abuse Potential
Authors: Sellers Edward M. 
Published: December 2017

Abstract

Purpose
This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance.

Procedures
The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk.

Findings
The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system–active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development.

Conclusions
If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.
Psychometric Evaluation of the Chinese Respiratory Distress Observation Scale on Critically Ill Patients With Cardiopulmonary Diseases
Authors: CHAN Ya-Hsiang , WU Hua-Shan , YEN Chih-Ching , CAMPBELL Margaret L. 
Published: December 2017

ABSTRACT

Background:
Respiratory distress is a common and distressing experience that strikes most critically ill patients with cardiopulmonary diseases. Now, most dyspnea assessment tools rely on patient’s self-report. Only one instrument, the Respiratory Distress Observation Scale (RDOS), is valid for assessing respiratory distress when the patient cannot provide a dyspnea self-report.

Purpose:
The aims of this study were to develop the Chinese version of RDOS through two-way translation and examine its reliability and validity.

Methods:
The first step was the translation and back-translation to establish the Chinese RDOS and examine the semantic equivalence between the back-translation version and the original one. The second step was the psychometric testing of the Chinese RDOS including internal reliability, interrater reliability, concurrent validity, convergent validity, and content and construct validity.

Results:
The Chinese RDOS was reported with an internal consistency (Cronbach’s α value) of .73, an interobserver reliability of .97, and a content validity index of .97. In the conscious critically ill patients, significant correlations were found between the Chinese RDOS and Spielberger State Anxiety Inventory scores or Dyspnea Vertical Visual Analog Scale scores (r = .69 and r = .76, respectively; p < .001). In the unconscious critically ill patients, there was a significantly positive correlation between the Chinese RDOS scores and fraction of inspiration O2 (r = .26, p < .05) and a significantly negative correlation between the Chinese RDOS scores and saturation peripheral oxygen (SpO2; r = −.42, p = .001). In addition, it also could effectively identify the dyspnea differences between the first and last days in the intensive care units (p < .001).

Conclusions:
The Chinese RDOS showed good reliability and validity in conscious critically ill patients. The assessment with the Chinese RDOS could be completed within a short period no matter whether the assessor has nursing background in respiratory care or not. It could help the professionals systematically manage and track the change of respiratory distress in patients.
Testing the Psychometric Properties of the Postpartum Sleep Quality Scale in Turkish Women
Authors: BOZ İlkay , SELVI Nida 
Published: December 2017

ABSTRACT

Background:
Postpartum sleeplessness has been observed to be an important health problem in Turkey. However, no scale is currently available to evaluate quality of sleep in Turkish postpartum women.

Purpose:
The aim of this study was to test the validity and reliability of the Turkish Postpartum Sleep Quality Scale (T-PSQS).

Methods:
The sample of this methodological study surveyed 100 women during their first 2 postpartum weeks. Data were obtained using a personal characteristics form and the PSQS. The PSQS is a 5-point scale ranging from 0 to 4. The validity of the PSQS was tested using content validity index and confirmatory and exploratory factor analyses, and the reliability of the scale was tested using Cronbach’s alpha.

Results:
The opinions of eight experts were canvassed to test the validity of the T-PSQS. The content validity index showed that the scale had high validity (.92). The factor analysis that was conducted to test the construct validity of the scale indicated that the scale was composed of three factors with eigenvalues over 1.00 and that the total Cronbach’s alpha coefficient was .88. The Cronbach’s alpha for the subscales “Infant night care-related daytime dysfunction,” “ Physical symptoms-related sleep inefficiency,” and “Sleep quality or sleep” were .82, .86, and .80, respectively.

Conclusions:
Content validity, construct validity, and reliability analyses of the T-PSQS revealed that the scale may be used to measure postpartum sleeplessness levels and sleep quality in Turkish women.
The Relationship Between Childhood Trauma and Poor Sleep Health in Adulthood
Authors: Brindle Ryan C. , Cribbet Matthew R. , Samuelsson Laura B. , Gao Chenlu , Frank Ellen , Krafty Robert T. , Thayer Julian F. , Buysse Daniel J. , Hall Martica H. 
Published: December 2017

ABSTRACT

Objective
Childhood trauma has been related to adverse behavioral, mental, and health outcomes later in life. Sleep may be a potential mechanism through which childhood trauma is related to adverse health. The current retrospective study aimed to characterize the relationship between childhood trauma exposure and sleep health, a novel multidimensional measure of sleep.

Methods
Participants (N = 161; mean [standard deviation] age = 59.85 [9.06] years; 67.7% female) retrospectively reported trauma exposure using the Trauma History Questionnaire. Childhood trauma was defined as the number of reported traumatic events before 18 years of age. Trauma exposure after 18 years of age and across the life-span was also recorded. Sleep health was derived both from diary- and actigraphy-assessed measures of sleep regularity, timing, efficiency, and duration, subjective sleep satisfaction, and daytime sleepiness from the Epworth Sleepiness Scale. The relationships between childhood trauma exposure and sleep health were examined using hierarchical linear regression, controlling for relevant covariates.

Results
In unadjusted models, a greater number of childhood trauma exposures were associated with poorer diary- and actigraphy-measured sleep health in adulthood. After adjustment for current stress, depression history, and other sociodemographic covariates, greater childhood trauma remained significantly associated with poorer sleep health (diary: β = −0.20, ΔR
2 = 0.032; actigraphy: β = −0.19, ΔR
2 = 0.027). Trauma exposure after 18 years of age and across the life-span did not relate to diary- or actigraphy-based sleep health.

Conclusions
Childhood trauma may affect sleep health in adulthood. These findings align with the growing body of evidence linking childhood trauma to adverse health outcomes later in life.
Child and Adult Socioeconomic Status and the Cortisol Response to Acute Stress: Evidence From the Multi-Ethnic Study of Atherosclerosis
Authors: Lê-Scherban Félice , Brenner Allison B. , Hicken Margaret T. , Needham Belinda L. , Seeman Teresa , Sloan Richard P. , Wang Xu , Diez Roux Ana V. 
Published: December 2017

ABSTRACT

Objective
A long-hypothesized pathway through which low socioeconomic status (SES) harms health is through dysregulation of the physiologic stress response systems. No previous studies have tested this hypothesis by investigating cortisol reactivity and recovery to acute stress in relation to SES at different times in the life course in adults. Alteration of the cortisol response to an acute stressor could signal dysregulation of the hypothalamic-pituitary-adrenal axis and has been associated with chronic illness.

Methods
We used data on 997 adults 54 years or older from a multiethnic, multisite United States study to examine associations between life course SES and cortisol response to a laboratory stress challenge. Informed by life course theory, we hypothesized that lower child and adult SES would be associated with lower reactivity (i.e., smaller increase in cortisol) and a slower recovery rate (i.e., slower rate of decline in cortisol after the challenge).

Results
In demographics-adjusted multilevel piecewise linear regression models, low child and adult SES were associated with a 19% (95% CI = 4%–50%) and 27% (7%–55%) slower recovery rate compared with high child and adult SES, respectively. Compared with participants with stable high SES, those with stable low SES had a 48% (16%–70%) slower recovery rate. Differences in reactivity by SES were small.

Conclusions
Our results support the hypothesis that low SES throughout life affects the hypothalamic-pituitary-adrenal axis and in turn the ability to recover from exposure to acute stressors. This mechanism can help explain how socioeconomic disparities contribute to disparities in chronic disease.
Quantifying Dental Office–Originating Adverse Events: The Dental Practice Study Methods
Authors: Tokede Oluwabunmi , Walji Muhammad , Ramoni Rachel , Rindal Donald B. , Worley Donald , Hebballi Nutan , Kumar Krishna , van Strien Claire , Chen Mengxia , Navat-Pelli Shaked , Liu Hongchun , Etolue Jini , Yansane Alfa , Obadan-Udoh Enihomo , Easterday Casey , Enstad Chris , Kane Sheryl , Rush William , Kalenderian Elsbeth 
Published: December 2017

Background
Preventable medical errors in hospital settings are the third leading cause of deaths in the United States. However, less is known about harm that occurs in patients in outpatient settings, where the majority of care is delivered. We do not know the likelihood that a patient sitting in a dentist chair will experience harm. Additionally, we do not know if patients of certain race, age, sex, or socioeconomic status disproportionately experience iatrogenic harm.

Methods
We initiated the Dental Practice Study (DPS) with the aim of determining the frequency and types of adverse events (AEs) that occur in dentistry on the basis of retrospective chart audit. This article discusses the 6-month pilot phase of the DPS during which we explored the feasibility and efficiency of our multistaged review process to detect AEs.

Results
At sites 1, 2, and 3, respectively, 2 reviewers abstracted 21, 11, and 23 probable AEs, respectively, from the 100 patient charts audited per site. At site 2, a third reviewer audited the same 100 charts and found only 1 additional probable AE. Of the total 56 probable AEs (from 300 charts), the expert panel confirmed 9 AE cases. This equals 3 AEs per 100 patients per year. Patients who experienced an AE tended to be male and older and to have undergone more procedures within the study year.

Conclusions
This article presents an overview of the DPS. It describes the methods used and summarizes the results of its pilot phase. To minimize threats to dental patient safety, a starting point is to understand their basic epidemiology, both in terms of their frequency and the extent to which they affect different populations.
Short-term Automated Quantification of Radiologic Changes in the Characterization of Idiopathic Pulmonary Fibrosis Versus Nonspecific Interstitial Pneumonia and Prediction of Long-term Survival
Authors: De Giacomi Federica , Raghunath Sushravya , Karwoski Ronald , Bartholmai Brian J. , Moua Teng 
Published: December 2017

Purpose:
Fibrotic interstitial lung diseases presenting with nonspecific and overlapping radiologic findings may be difficult to diagnose without surgical biopsy. We hypothesized that baseline quantifiable radiologic features and their short-term interval change may be predictive of underlying histologic diagnosis as well as long-term survival in idiopathic pulmonary fibrosis (IPF) presenting without honeycombing versus nonspecific interstitial pneumonia (NSIP).

Materials and Methods:
Forty biopsy-confirmed IPF and 20 biopsy-confirmed NSIP patients with available high-resolution chest computed tomography 4 to 24 months apart were studied. CALIPER software was used for the automated characterization and quantification of radiologic findings.

Results:
IPF subjects were older (66 vs. 48; P<0.0001) with lower diffusion capacity for carbon monoxide and higher volumes of baseline reticulation (193 vs. 83 mL; P<0.0001). Over the interval period, compared with NSIP, IPF patients experienced greater functional decline (forced vital capacity, −6.3% vs. −1.7%; P=0.02) and radiologic progression, as noted by greater increase in reticulation volume (24 vs. 1.74 mL; P=0.048), and decrease in normal (−220 vs. −37.7 mL; P=0.045) and total lung volumes (−198 vs. 58.1 mL; P=0.03). Older age, male gender, higher reticulation volumes at baseline, and greater interval decrease in normal lung volumes were predictive of IPF. Both baseline and short-term changes in quantitative radiologic findings were predictive of mortality.

Conclusions:
Baseline quantitative radiologic findings and assessment of short-term disease progression may help characterize underlying IPF versus NSIP in those with difficult to differentiate clinicoradiologic presentations. Our study supports the possible utility of assessing serial quantifiable high-resolution chest computed tomographic findings for disease differentiation in these 2 entities.
Soluble Epoxide Hydrolase Plays a Vital Role in Angiotensin II-Induced Lung Injury in Mice
Authors: Tao Wei , Li Ping-Song , Xu Gang , Luo Yi , Shu Yu-Sheng , Tao Yong-Zhong , Yang Liu-Qing 
Published: December 2017

ABSTRACT

Background:
Angiotensin II plays a vital role in the pathogenesis of acute respiratory distress syndrome (ARDS). However, its mechanism is not well defined. Angiotensin II upregulates the expression of soluble epoxide hydrolase (sEH; Ephx2). sEH is suggested as a potential pharmacologic target for ARDS. The present study investigates whether the sEH is involved in the angiotensin II-triggered pulmonary inflammation and edema using an angiotensin II-induced lung injury animal model.

Methods:
Lung injury was induced by angiotensin II intratracheally instillation in wild-type or Ephx2 deficient mice.

Results:
sEH activities were markedly increased in wild-type mice treated with angiotensin II. Angiotensin II markedly increased the levels of tumor necrosis factor-α and interleukin-1β in bronchoalveolar lavage fluid, worsened alveolar capillary protein leak and lung histological alterations, and elevated activity of activator protein-1 and nuclear factor-κB. However, these changes were significantly improved in Ephx2 deficient mice. Moreover, Losartan, an angiotensin II receptor 1 antagonist, abolished the sEH induction and improved mortality.

Conclusions:
Angiotensin II-induced lung injury was improved in sEH gene deleted mice. The angiotensin II-triggered pulmonary inflammation is mediated, at least in part, through the sEH.
Development of Noninvasive in Vivo Approach to Assess Vascular Permeability in Inflammation Using Fluorescence Imaging
Authors: Shimazui Takashi , Nakada Taka-aki , Fujimura Lisa , Sakamoto Akemi , Hatano Masahiko , Oda Shigeto 
Published: December 2017

ABSTRACT

Introduction:

In vivo fluorescence imaging can quantify vascular permeability without requiring sacrifice of animals. However, use of this noninvasive approach for vascular permeability assessment in remote organ injury caused by systemic inflammatory disease has not been reported.

Methods:
Evans blue (EB) and Genhance 750 fluorescent dye were mixed and injected into mice. The lung as a remote organ and the footpad as a noninvasive observational site were assessed in a cecal ligation and puncture (CLP)-induced systemic inflammation mouse model and compared with sham and hydrocortisone pretreated (CLP + HC) mouse models. Extraction of EB in harvested tissues was assessed as a conventional indicator of vascular permeability. Fluorescent intensities in the footpad or harvested lung were assessed and their correlation was analyzed to investigate this novel, noninvasive approach for estimation of lung vascular permeability.

Results:
Fluorescent intensity in the footpad and harvested lung in the CLP group was significantly higher than in the other groups (footpad, sham vs. CLP, P < 0.0001; CLP vs. CLP + HC, P = 0.0004; sham vs. CLP + HC, P = 0.058; lung, sham vs. CLP, P < 0.0001; CLP vs. CLP + HC, P < 0.0001; sham vs. CLP + HC, P = 0.060). The fluorescent intensity in the footpad was strongly correlated with that in the lung (r = 0.95).

Conclusions:
This fluorescent technique may be useful for vascular permeability assessment based on EB quantification. Footpad fluorescent intensity was strongly correlated with that in the lung, and may be a suitable indicator in noninvasive estimation of lung vascular permeability.
The genus
Gennadas
(Benthesicymidae: Decapoda): morphology of copulatory characters, phylogeny and coevolution of genital structures
Authors: Vereshchaka Alexander L. , Lunina Anastasia A. , Olesen Jørgen 
Published: December 2017

Species within
Gennadas
differ from each other largely only in male (petasma) and female (thelycum) copulatory characters, which were restudied in scanning electron microscopy and used as a basis for phylogenetic analyses. Twenty-six petasma characters and 49 thelycum characters were identified. All 16 recognized species of
Gennadas
and
Aristaeomorpha foliacea
(outgroup) were included as terminals. Four robust monophyletic clades were retrieved, described and diagnosed as new species groups. The thelycum characters had greater impact on tree topology and supported deeper nodes than did the petasma characters. We hypothesize that features of the thelycum evolved first followed by aspects of the petasma. Relatively more conservative characters include parts of the sternites of the thelycum and of the petasma, while the scuti and protuberances on the thelycum and the shape and subdivisions of the petasma lobes are evolutionarily plastic. We identified two groups of copulatory characters, which are likely coupled functionally and interlinked evolutionarily: (i) the external part of the petasma and the posterior part of the thelycum and (ii) the internal part of the petasma and anterior part of the thelycum. We reconstruct possible mating position during copulation for each of the new species groups presented here. We also present an updated key to genera of Benthesicymidae and key to species of
Gennadas
.