bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of vitamin D supplementation during pregnancy on mid-to-late gestational blood pressure in a randomized controlled trial in Bangladesh
Authors: Subramanian Anita , Korsiak Jill , Murphy Kellie E. , Al Mahmud Abdullah , Roth Daniel E. , Gernand Alison D. 
Published: August 2020

Objective:
To examine the dose-dependent effect of maternal vitamin D during pregnancy on blood pressure from mid-to-late gestation within the context of a randomized, placebo-controlled trial of vitamin D supplementation in Bangladesh (n = 1298).

Methods:
Healthy women without hypertension were enrolled at 17–24 weeks gestation and randomized to one of four vitamin D doses during pregnancy: placebo, 4200, 16 800 or 28 000 IU/week. This substudy examined 1257 women with blood pressure measured at enrollment with at least one other timepoint (measurements included at 24 weeks, 30 weeks, and weekly from 36 weeks until delivery). Effects of vitamin D on SBP or DBP were analyzed using mixed-effects models.

Results:
Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI) mmHg: SBP = 2.3 (0.9–3.7); DBP = 1.9 (0.7–3.0)]. The differences in changes in SBP and DBP between vitamin D groups and placebo across intervals were small (P > 0.10), but the difference for 28 000 IU/week versus placebo was the highest from 30 to 36 weeks [SBP 0.2 (−0.1 to 0.5) and DBP 0.2 (−0.0 to 0.4) mmHg].

Conclusion:
Vitamin D supplementation starting mid-pregnancy did not affect SBP or DBP until late gestation, and then only at the highest dose. These results do not support the clinical use of vitamin D in pregnancy to lower maternal blood pressure.
A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)
Authors: García Feijoó Julián , Denis Philippe , Hirneiß Christoph , Aptel Florent , Perucho González Lucía , Hussain Zubair , Lorenz Katrin , Pfeiffer Norbert 
Published: August 2020

Precis:
In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma.

Purpose:
This study evaluates the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627) for surgical treatment of primary open-angle glaucoma in patients refractory to topical hypotensive medications.

Methods:
In a prospective, interventional, single-arm, multicenter, European study (STAR-II), MINIject was successfully implanted in a stand-alone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal IOP ≤21 and >5 mm Hg with ≥20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361.

Results:
At the 6-month follow-up, the primary endpoint was fulfilled, with 75.9% of patients reaching prospectively defined success. The mean IOP was reduced by 40.2% (9.9 mm Hg) to 14.7±6.0 mm Hg at 6 months from 24.6±3.8 mm Hg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% from 2.9±1.2 at baseline to 1.0±1.3. Furthermore, 79.3% of the patients had mean IOP ≤18 mm Hg, 82.8% achieved a ≥20% IOP reduction, and 55.2% were medication free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion, and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density.

Conclusion:
Ab-interno supraciliary surgical implantation using MINIject DO627 in a stand-alone procedure significantly lowers IOP by 40% at the 6-month follow-up, while reducing the need for IOP-lowering medication.
Medically Attended Outpatient Coronavirus Infections in Ecuadorean Children During the 20 Months Preceding Countrywide Lockdown Related to the SARS-CoV-2 Pandemic of 2020
Authors: Sippy Rachel , Prado Esteban Ortiz , Pizarro Fajardo Freddy , Hidalgo Iván , Aguilar Guillermo Victoriano , Bonville Cynthia A. , Aponte Cinthya Cueva , Gómez Mariuxi Salazar , Aponte Jorge Luis Carrillo , Cordova Mercy Borbor , Polo Gladys Rincón , Suryadevara Manika , Domachowske Joseph B. 
Published: August 2020

Background:
Human coronaviruses (HCoVs) cause respiratory tract infections during childhood manifesting as common colds, bronchiolitis, croup and pneumonia. In temperate geographies, HCoV activity peaks between December and March. The epidemiology and manifestations of HCoV infections have not been previously reported from Ecuador.

Methods:
Children <5 years who presented with ≥2 symptoms consistent with an acute respiratory tract infection were eligible for enrollment. After obtaining informed consent, demographic data and details regarding the acute illness were recorded. Secretions collected with a nasopharyngeal swab underwent diagnostic testing using multiplex polymerase chain reaction.

Results:
A total of 850 subjects were enrolled. A total of 677 (80%) tested positive for at least 1 pathogen, including 49 (7.2%) who tested positive for ≥1 HCoV type. HCoV-NL63 was the most frequent type detected (39%), followed by HCoV-OC43 (27%), 229E (22%) and HKU1 (12%). Nearly all subjects who tested positive for HCoV had nasal congestion or secretions (47/49; 96%). The most frequent syndromic diagnosis was common cold (41%), followed by bronchiolitis (27%). We found no association between the infecting HCoV type and subject’s syndromic diagnosis (P > 0.05) or anatomic location of infection (upper vs. lower respiratory tract; P > 0.05). The 2018–2019 peak HCoV activity occurred from October to November; the 2019–2020 peak occurred from January to February.

Conclusions:
HCoVs were detected in ~7% of outpatient Ecuadorean children <5 years of age with symptoms of acute respiratory tract infection. The most frequently detected HCoV types, and the period of peak HCoV activity differed for the 2018–2019 and 2019–2020 seasons.
Identification of neural and psychophysical predictors of headache reduction after cognitive behavioral therapy in adolescents with migraine
Authors: Nahman-Averbuch Hadas , Schneider Victor J. , Chamberlin Leigh Ann , Kroon Van Diest Ashley M. , Peugh James L. , Lee Gregory R. , Radhakrishnan Rupa , Hershey Andrew D. , Powers Scott W. , Coghill Robert C. , King Christopher D. 
Published: August 2020

Abstract
Cognitive behavioral therapy (CBT) is a psychological intervention that involves development of coping strategies to reduce the experience of pain. Although CBT is a promising intervention to reduce headache days in patients with migraine, it may not be effective for all patients. Thus, there is a need to identify markers that could predict which patients will respond to CBT. We aimed to determine whether baseline brain function and amygdalar connectivity, assessed by functional magnetic resonance imaging, or pain modulation capacities, assessed by the conditioned pain modulation (CPM) response, can predict a reduction in headache days after CBT in adolescents with migraine. Patients with migraine (n = 20; age range 10-17 years) completed 8 weekly CBT sessions. The CPM response was examined in the trapezius and the leg. Headache days significantly decreased after CBT (P < 0.001). Greater functional connectivity before CBT between the right amygdala and frontal gyrus, anterior cingulate cortex, and precentral gyrus was related to greater headache reduction after CBT. Greater reduction in headache days after CBT was related with less efficient CPM response before CBT at the trapezius (r = −0.492, P = 0.028) but not at the leg. This study found that headache reduction after CBT was related to right amygdala connectivity with frontal and sensorimotor regions at baseline as well as baseline pain modulation capacities. These findings suggest that individual differences in brain function and pain modulation can be associated with clinical improvements and help with determination of CBT responsiveness.
Employers’ Role in Employee Health
Authors: Pfeffer Jeffrey , Vilendrer Stacie , Joseph Grace , Kim Jason , Singer Sara J. 
Published: August 2020

Objective:
Employers affect the health of employees and their families through work environments and employee benefits. We sought to understand employer decisions around those topics.

Methods:
Interviews with 21 executives from diverse, purposely-sampled, progressive companies with transcripts analyzed using inductive and deductive methods.

Results:
Companies often viewed keeping employees healthy primarily as a means to profitability rather than an end in itself and rationalized stressful workplaces as necessary and non-changeable. Many possible actions including job redesign and changing benefits administrators were seen as infeasible. Even large, resource-rich organizations were strikingly non-agentic.

Conclusions:
Companies seem less committed to the goal of increasing employee health than they claim or than they should be, given the significant relationship between employee health and economic performance, and see external and internal barriers to improving health that are often self-created.
Nurses’ Mental Health During the Covid-19 Outbreak
Authors: Sampaio Francisco , Sequeira Carlos , Teixeira Laetitia 
Published: August 2020

Objective:
To describe nurses’ mental health status during the Covid-19 outbreak and to explore the factors that might accentuate the negative consequences on their mental health.

Methods:
We conducted an online survey to evaluate demographic variables, working conditions, family dynamics, and mental health variables in nurses working in healthcare settings, in Portugal, during the Covid-19 outbreak.

Results:
Portuguese nurses presented higher depression, anxiety and stress levels, when compared to the Portuguese general population, during the outbreak. Overall, nurses who did not consider the quantity and quality of personal protective equipment as adequate presented significantly higher levels of depression, anxiety, and stress.

Conclusions:
Our results suggest that nurses’ mental health status seems to be particularly affected by the Covid-19 outbreak and that some modifiable elements might accentuate the impacts on their mental health.
Early Experience With Telemedicine in Patients Undergoing Otologic/Neurotologic Procedures
Authors: Shapiro Scott B. , Lipschitz Noga , Kemper Nathan , Zuccarello Mario , Breen Joseph T. , Pensak Myles L. , Samy Ravi N. 
Published: August 2020

Objective:
Compare outcomes for patients who were seen via telemedicine visits after otology/neurotology surgical procedures with those who were seen in traditional office visits.

Study Design:
Retrospective case review.

Setting:
Tertiary care academic medical center.

Patients:
Inclusion criteria were patients who underwent otologic/neurotologic surgery and were seen in at least one telemedicine visit for postoperative care.

Intervention (s):
Telemedicine visit for postoperative care.

Main Outcome Measure (s):
Comparison of the number of patient calls, unplanned visits, and delayed complications between telemedicine patients and controls matched for age, procedure, and American Society of Anesthesiologists (ASA) status.

Results:
Eighteen patients were seen in telemedicine visits postoperatively after the following otologic/neurotologic surgical procedures: cochlear implant surgery (10), vestibular schwannoma resection (4), combined middle fossa and transmastoid cerebrospinal fluid (CSF) leak repair (2), middle fossa repair of superior canal dehiscence (1), and stapedectomy (1). All telehealth visits were for the second postoperative visit. The mean number of patient calls after surgery was 2.3 for the telemedicine group and 1.9 for matched controls which was not a statistically significant difference (p = 0.466). Both groups each had two patients who went to the emergency room, with one in each group being admitted. There was one delayed complication in the control group.

Conclusion:
Our preliminary experience suggests telemedicine may be used safely in caring for patients after otologic/neurotologic surgery, though it may be associated with more patient phone calls. Further study and experience, including assessing patient satisfaction, will clarify the future role of telemedicine in otology and neurotology.
Case Report: Long-term Structural and Functional Effects of Ethambutol Optic Neuropathy
Authors: Addy Laura K. , Harrison Wendy W. 
Published: August 2020

SIGNIFICANCE
This case report demonstrates reduction in the retinal nerve fiber layer (RNFL) thickness and an abnormal electroretinogram after toxic optic neuropathy from ethambutol, more than 1 year after improvements in visual acuity (VA) and visual fields (VFs) were seen. Although many studies have described complications of ethambutol, continuing reduction in RNFL thickness 2 years after discontinuation has not been described elsewhere.

PURPOSE
It is well known that ethambutol can cause optic nerve toxicity, visual impairment, and VF loss. Visual acuity can be regained after stopping the drug; however, the amount and time frame are variable. There are few data on long-term follow-up of these cases to direct clinicians how to proceed once VA has stabilized. Here we present a case with 2 years of follow-up for a patient with ethambutol toxicity, showing the condition change even after VA becomes normal.

CASE REPORT
A 61-year-old man presented shortly after discontinuing ethambutol for Mycobacterium avium complex. Visual acuity values were 20/70 in the right eye and 20/125 in the left eye with cecocentral VF scotomas. Optical coherence tomography showed normal RNFL. Visual-evoked potentials were significantly reduced and delayed. Over the course of 2 years, the patient became asymptomatic as VA and VF returned to normal and visual-evoked potential improved. However, the optical coherence tomography RNFL was reduced from each visit to the next, and the electroretinogram showed decreased scotopic and photopic amplitudes.

CONCLUSIONS
Signs of ethambutol toxicity may remain or worsen years after discontinuation, even in the absence of patient symptoms and with normal VA and VF.
Three Cases of Karoshi Without the Typical Pathomorphological Features of Cardiovascular/Cerebrovascular Disease
Authors: Miao Qi , Li Jing , Pan Yu-Peng , Yu Yan-Geng , Zhang Fu , Xiao Ning , Li Dong-Ri 
Published: August 2020

Abstract
Karoshi is a term used to describe unexplained sudden death associated with overwork and has become a serious public health issue in China. Cases have occurred in physicians, university professors, engineers in high-tech companies, and blue-collar workers. The mechanisms associated with death by overwork are very complex. According to most researchers, karoshi is considered to be caused by an excessive workload that induces deterioration of underlying hypertension or atherosclerosis. These conditions inevitably lead to death from cardiovascular or cerebrovascular diseases. However, in our own experience, we have found that in some cases, the victims of karoshi were in a chronic state of overwork but without a history of cardiovascular or cerebrovascular diseases. In support of this, we have found that even autopsies have revealed few positive findings except for cardiac hypertrophy. In this article, we report 3 typical cases of karoshi but without the typical pathomorphological features of cardiovascular or cerebrovascular disease.
Characteristics of Patients With Congenital Heart Disease Requiring ICU Admission From Japanese Emergency Departments*
Authors: Haga Taiki 
Published: August 2020

Objectives:
To evaluate the characteristics of patients with congenital heart disease requiring ICU admission from emergency departments and determine the associations between the reasons for emergency department visits and specific congenital heart disease types or cardiac procedures.

Design:
Retrospective observational study using data from a Japanese multicenter database.

Setting:
Twelve PICUs and 11 general ICUs in Japan.

Patients:
All patients requiring ICU admission from an emergency department during 2013–2018, divided into two groups: with congenital heart disease and without congenital heart disease groups.

Interventions:
None for this analysis.

Measurements and Main Results:
Of the 297 patients with congenital heart disease (9.2% of a total of 3,240 patients), more than half had moderate-to-high complexity congenital heart disease; most of them were pediatric patients who had visited specialized congenital heart disease centers. All the patients’ clinical outcomes were similar. Regarding the reasons for emergency department admission, seizure was significantly associated with a single ventricle anatomy (odds ratio, 3.3; 95% CI, 1.1–10.0), post-Glenn shunt placement (odds ratio, 5.6; 95% CI, 1.1–29.4), and a Fontan-type operation status (odds ratio, 6.3; 95% CI, 1.5–25.5). Sepsis and gastrointestinal bleeding were associated with asplenia (odds ratio, 21.1; 95% CI, 4.3–104 and odds ratio, 21.0; 95% CI, 3.1–141, respectively); gastrointestinal bleeding was also associated with systemic-to-pulmonary artery shunt placement (odds ratio, 18.8; 95% CI, 2.8–125) and a Fontan-type operation status (odds ratio, 17.0; 95% CI, 2.6–112). Arrhythmia was associated with a single ventricle anatomy (odds ratio, 21.0; 95% CI, 3.1–141), systemic-to-pulmonary artery shunt placement (odds ratio, 18.8; 95% CI, 2.8–125), and a Fontan-type operation status (odds ratio, 17.0; 95% CI, 2.6–112).

Conclusions:
Classification of the reasons for emergency department admission by congenital heart disease type and surgical stage may guide clinicians in the selection of appropriate treatments in such settings.
Point-of-Care Ultrasound to Assess Gastric Content in Pediatric Emergency Department Procedural Sedation Patients
Authors: Moake Matthew M. , Presley Bradley C. , Hill Jeanne G. , Wolf Bethany J. , Kane Ian D. , Busch Carrie E. , Jackson Benjamin F. 
Published: August 2020

ObjectivesThere is debate regarding the timing of procedural sedation and analgesia (PSA) in relation to fasting status. Point-of-care ultrasound (POCUS) provides the ability to measure gastric content and is being used as a surrogate for aspiration risk in anesthesia. We sought to evaluate the gastric content of pediatric emergency department (PED) patients undergoing PSA using POCUS.MethodsWe performed a prospective observational study using a convenience sample of pediatric patients undergoing PSA between July 1, 2018, and June 30, 2019. Following a brief history, gastric content was measured using POCUS in both supine and right lateral decubitus positions at 2-hour intervals until the time of PSA. Qualitative content and calculated volume were classified based on the Perlas Model of anesthesia “Risk” assessment.ResultsNinety-three patients were enrolled with 61.3% male and mean age of 6.5 years. Gastric content was determined in 92 patients. There were 79.3% that had “high risk” content at the time of PSA, with a median fasting time of 6.25 hours and no serious adverse events. Fasting duration had a weak to moderate ability to predict “risk” category (area under the curve = 0.73), with no patient (n = 17) who underwent multiple evaluations awaiting PSA progressing from “high” to “low risk.”ConclusionsThe majority of PED patients undergoing PSA at our institution had “high risk” gastric content with no clinically significant change occurring during serial evaluations. This calls into question the utility of delaying PSA based upon fasting status and lends support to a more comprehensive risk-benefit approach when planning pediatric PSA.
Efficacy, pharmacokinetics and neurocognitive performance of dual, NRTI-sparing antiretroviral therapy in acute HIV-infection
Authors: Gay Cynthia L. , Neo Dayna T. , Devanathan Aaron S. , Kuruc Joann D. , McGee Kara S. , Schmitz John L. , Sebastian Joe , Shaheen Nicholas J. , Ferrari Guido , McKellar Mehri , Fiscus Susan A. , Hicks Charles B. , Robertson Kevin , Kashuba Angela D.M. , Eron Joseph J. , Margolis David M. 
Published: August 2020

Objectives:
The aim of this study was to evaluate penetration of antiretrovirals into compartments and efficacy of a dual, NRTI-sparing regimen in acute HIV infection (AHI).

Design:
Single-arm, open-label pilot study of participants with AHI initiating ritonavir-boosted darunavir 800 mg once daily and etravirine 400 mg once daily or 200 mg twice daily within 30 days of AHI diagnosis.

Methods:
Efficacy was defined as HIV RNA less than 200 copies/ml by week 24. Optional sub-studies included pharmacokinetics analysis from genital fluids (weeks 0–4, 12, 48), cerebrospinal fluid (CSF) (weeks 2–4, 24 and 48) and endoscopic biopsies (weeks 4–12 and 36–48). Neuropsychological performance was assessed at weeks 0, 24 and 48.

Results:
Fifteen AHI participants were enrolled. Twelve (80%) participants achieved HIV RNA less than 200 copies/ml by week 24. Among 12 participants retained through week 48, nine (75%) remained suppressed to less than 50 copies/ml. The median time from ART initiation to suppression less than 200 and less than 50 copies/ml was 59 and 86 days, respectively. The penetration ratios for etravirine and darunavir in gut associated lymphoid tissue were 19.2 and 3.05, respectively. Most AHI participants achieving viral suppression experienced neurocognitive improvement. Of the three participants without overall improvement in neurocognitive functioning as measured by impairment ratings (more than two tests below 1 SD), two had virologic failure.

Conclusion:
NRTI-sparing ART started during AHI resulted in rapid viral suppression similar to NRTI-based regimens. More novel and compact two-drug treatments for AHI should be considered. Early institution of ART during AHI appears to improve overall neurocognitive function and may reduce the risk of subsequent neurocognitive impairment.

ClinicalTrials.gov:
NCT00855413