bluuebunny/crossref_metadata_2025_split huggingface dataset:
The effect of Tai Chi training on the dual-tasking performance of stroke survivors: a randomized controlled trial
Authors: Chan Wing Nga , Tsang William Wai-Nam 
Published: May 2018

Objective: To compare the effect of Tai Chi training with conventional exercise on dual-tasking performance among stroke survivors. Design: An assessor-blinded, randomized controlled trial. Subjects: Community-dwelling stroke survivors. Setting: Community centers and university. Interventions: Subjects in the Tai Chi group and the conventional exercise group were trained with the corresponding exercises for 12 weeks (1 hour/session, 2/week). No training was given to the controls. Main measures: An auditory Stroop test, a turning-while-walking test, and a dual-tasking condition that combined the two tests were conducted at baseline, after the intervention, and one month later. Results: Forty-seven subjects were randomized into Tai Chi group ( n = 15), conventional exercise group ( n = 17), or control group ( n = 15). There was no significant difference in the outcome measures among the three groups after the intervention and at the one month follow-up assessment. Within-group comparisons showed improvements in dual-tasking performance after Tai Chi training and further improvement during the follow-up period (composite score on the auditory Stroop test: pre-assessment: 73.1 ± 27.6, post-assessment: 89.9 ± 23.4, follow-up assessment: 91.7 ± 26.9; completion time of the turning-while-walking test: pre-assessment: 17.7 ± 6.9 seconds, post-assessment: 15.6 ± 5.2 seconds, follow-up assessment: 14.9 ± 4.9 seconds). Conclusion: Tai Chi training does not have superior effect on dual-tasking performance compared with conventional exercise among stroke survivors. Further studies with larger sample size, longer training, and follow-up periods are needed.
Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers
Authors: de Hoon Jan , Van Hecken Anne , Vandermeulen Corinne , Herbots Marissa , Kubo Yumi , Lee Ed , Eisele Osa , Vargas Gabriel , Gabriel Kristin 
Published: May 2018

Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg. Blood pressure was measured pre-dose and at prespecified times post-dose. The primary endpoint was individual time-weighted averages of mean arterial pressure, measured from 0 hours to 2.5 hours after the first dose of sumatriptan. Pharmacokinetic parameters for sumatriptan were evaluated by calculating geometric mean ratios (erenumab and sumatriptan/placebo and sumatriptan). Adverse events and anti-erenumab antibodies were also evaluated. Results A total of 34 subjects were randomized and included in the analysis. Least squares mean (standard error) time-weighted averages of mean arterial pressure were 87.4 (1.0) mmHg for the placebo and sumatriptan group and 87.4 (1.2) mmHg for the erenumab and sumatriptan group. Mean difference in mean arterial pressure between groups was −0.04 mmHg (90% confidence interval: −2.2, 2.1). Geometric mean ratio estimates for maximum plasma concentration of sumatriptan was 0.95 (90% confidence interval: 0.82, 1.09), area under the plasma concentration–time curve (AUC) from time 0 to 6 hours was 0.98 (90% confidence interval: 0.93, 1.03), and AUC from time 0 to infinity was 1.00 (90% confidence interval: 0.96, 1.05). No clinically relevant safety findings for co-administration of sumatriptan and erenumab were identified. Conclusion Co-administration of erenumab and sumatriptan had no additional effect on resting blood pressure or on pharmacokinetics of sumatriptan. Trial registration: ClinicalTrials.gov, NCT02741310.
Off-Hours Admissions and Mortality in PICU Without 24-Hour Onsite Intensivist Coverage
Authors: Thabet Farah Chedly , alHaffaf Faisal Ahmed , Bougmiza Iheb Mohamed , Bafaqih Hend Ali , Chehab May Said , alMohaimeed Sulaiman Abdulkareem 
Published: May 2018

Objective: To evaluate whether the off-hours admission has any effect on risk-adjusted mortality and length of stay for nonelective patients admitted to a pediatric intensive care unit (PICU) without 24-hour in-house intensivist coverage. Design: Prospective cohort study. Setting: A 34-bed tertiary PICU. Patients: All consecutive nonelective patients aged 0 to 14 years admitted from January 2012 to June 2015. Measurements and Main Results: A total of 1254 patients were nonelectively admitted to the PICU. They were categorized according to time of PICU admission as either office hours (07:30 to 16:30 from Sunday to Thursday and whenever an intensivist is present in the ICU) or off-hours (16:30 to 07:30, Friday and Saturday and public holidays). Standardized mortality rates (SMRs) of patients admitted during off-hours were compared to SMRs of patients admitted during office hours using Pediatric Risk of Mortality (PRISM2) score. Multivariate logistic regression was used to assess the effect of time of admission on outcome after adjustment for severity of illness using the PRISM2. The mortality observed in the office-hours group was 9.4% and in the off-hours group was 8.1%. The PRISM2-based SMR was 0.83 (95% confidence interval [CI]: 0.43-1.47) for the office-hours group and 0.68 (95% CI: 0.34-1.36) for the off-hours group. No significant differences in length of ICU stay or duration of mechanical ventilation were observed between patients admitted during off-hours and those admitted during office hours. In the logistic regression model, off-hours admission was not significantly associated with a higher mortality (odds ratio: 0.85, 95% CI: 0.57-1.27; P = .44). Conclusions: The absence of an in-house intensivist during off-hours is not associated with an increase in mortality, length of ICU stay, or duration of mechanical ventilation for patients admitted to our pediatric ICU.
Social Support for Breastfeeding in the Era of mHealth: A Content Analysis
Authors: Schindler-Ruwisch Jennifer M. , Roess Amira , Robert Rebecca C. , Napolitano Melissa A. , Chiang Shawn 
Published: May 2018

Background: Several barriers to successful breastfeeding exist, including a lack of support from peers or professionals. With the emergence of mobile health (mHealth) tools to provide additional breastfeeding support, a more thorough review of social support resources was needed. Research Aim: The aim of this study was to determine mHealth breastfeeding support resources and characterize the type of social support they provide. Methods: A content analysis of mHealth programs ( n = 65), including text messaging ( n = 12) and mobile applications ( n = 53), was conducted on the basis of searches of the iTunes and Google Play stores ( n = 50) and PubMed, the Cumulative Index of Nursing and Allied Health, and American Business Information/INFORM Complete Plus ( n = 15). Results were then dual-coded for key characteristics and types of support provided. Results: Thirty-eight apps (76%) were free to users, 14 (28%) were offered in a variety of languages, and 47 (94%) provided informational support. The mobile applications were targeted largely to postpartum women, focused on breastfeeding duration, and included troubleshooting information. Mobile applications often included media components ( n = 12 [24%]); few were tailored or personalized ( n = 5 [10%]) and interactive ( n = 15 [30%]). Text-messaging programs were available in a variety of countries ( n = 7 [58%]) and provided mostly informational support ( n = 5 [42%]), were pro-breastfeeding ( n = 12 [100%]), were targeted to both pregnant and postpartum women ( n = 6 [50%]), focused on both breastfeeding initiation and duration ( n = 9 [75%]), and had two-way interactivity ( n = 6 [50%]) and personalization ( n = 5 [42%]). Conclusions: Although freely available mobile applications and text-messaging programs exist, with potential for wide reach, the majority provide only informational support. These programs would benefit from additional study of their usefulness.
Revision Lingual Frenotomy Improves Patient-Reported Breastfeeding Outcomes: A Prospective Cohort Study
Authors: Ghaheri Bobak A. , Cole Melissa , Mace Jess C. 
Published: May 2018

Background: Lingual frenotomy improves patient-reported outcome measures, including infant reflux and maternal nipple pain, and prolongs the nursing relationship; however, many mother–infant dyads continue to experience breastfeeding difficulty despite having had a frenotomy. Research aim: The aim of this study was to determine how incomplete release of the tethered lingual frenulum may result in persistent breastfeeding difficulties. Methods: A one-group, observational, prospective cohort study was conducted. The sample consisted of breastfeeding mother–infant (0-9 months of age) dyads ( N = 54) after the mothers self-elected completion lingual frenotomy and/or maxillary labial frenectomy following prior lingual frenotomy performed elsewhere. Participants completed surveys preoperatively, 1-week postoperatively, and 1-month postoperatively consisting of the Breastfeeding Self-Efficacy Scale–Short-Form (BSES-SF), Visual Analog Scale (VAS) for nipple pain severity, and the Revised Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R). Results: Significant postoperative improvements were reported between mean preoperative scores compared with 1-week and 1-month scores of the BSES-SF, F(2) = 41.2, p < .001; the I-GERQ-R, F(2) = 22.7, p < .001; and VAS pain scale, F(2) = 46.1, p < .001. Conclusion: We demonstrated that besides nipple pain, measures of infant reflux symptoms and maternal breastfeeding self-confidence can improve following full release of the lingual frenulum. Additionally, a patient population was identified that could benefit from increased scrutiny of infant tongue function when initial frenotomy fails to improve breastfeeding symptoms.
Employment in Schools in India
Authors: Jain Chandan 
Published: May 2018

In the present article, we highlight the role that schools play in the Indian labour market. Using data from two rounds of the National Sample Survey, we provide estimates for the number of individuals employed in schools and the share of schools in the overall labour force in the country. We find that the share of schools in the overall labour force has increased between 2004–2005 and 2011–2012. Further, we also analyse the differences in these estimates across regions and gender as well. We find that despite the decline in female labour force in rural areas, number of females employed in schools in rural areas has increased over time. Additionally, we find that schools constituted the largest share in the overall female labour force employed in the services sector in the country. JEL: I20, J21
Innovative Surgical Treatment of Severe Cherubism
Authors: Son Ji H. , Marshall Danielle C. , Valiathan Manish , Otteson Todd , Ferretti Gerald , Grigorian Paula A. , Rosen Carol , Becker Devra , Rowe David , Soltanian Hooman , Lakin Gregory 
Published: May 2018

Background: Cherubism is an autosomal dominant syndrome characterized by excessive bilateral maxillomandibular bony degeneration and fibrous tissue hyperplasia. Conservative management is the preferred treatment as cherubism has a self-limiting course. Functional or emotional disturbances may, however, demand surgical intervention. We report a patient who underwent surgical intervention. Method/Description: He had significant enlargement of lower cheeks and bilateral lower lid scleral show. On computed tomography of the face, the patient had significant fibrous tissue involving bilateral maxilla and mandible. The mandibular tumor was excised. Given normal inferior border, bilateral sagittal split osteotomy was performed to infracture and inset the outer cortex. During the procedure, patient required blood transfusion intraoperatively, so the maxillary portion of the procedure was delayed until 6 months later. For the maxilla, bilateral transconjunctival approach was used to resect parts of the orbital floors that were concave, resulting in 1 × 2 cm defects bilaterally which were reconstructed using resorbable plates. Then the anterior maxillary tumor was excised. Results: The patient and his parents were satisfied with his appearance after surgery. The patient was noted to have improvement in contour and decreased scleral show. He has most recently followed up 15 months after the initial surgery. There were no long-term complications. Conclusions: Severity of cherubism influences the type of surgical intervention. The present case is innovative because this is the first reported case of recontouring orbital floors with resorbable plates and infracturing of the mandible using sagittal split osteotomies for surgical treatment of cherubism.
Determining Success or Failure After Foot and Ankle Surgery Using Patient Acceptable Symptom State (PASS) and Patient Reported Outcome Information System (PROMIS)
Authors: Anderson Michael R. , Baumhauer Judith F. , DiGiovanni Benedict F. , Flemister Sam , Ketz John P. , Oh Irvin , Houck Jeffrey R. 
Published: May 2018

Background: As the role of generic patient-reported outcomes (PROs) expands, important questions remain about their interpretation. In particular, how the Patient Reported Outcome Measurement Instrumentation System (PROMIS) t score values correlate with the patients’ perception of success or failure (S/F) of their surgery is unknown. The purposes of this study were to characterize the association of PROMIS t scores, the patients’ perception of their symptoms (patient acceptable symptom state [PASS]), and determination of S/F after surgery. Methods: This retrospective cohort study contacted patients after the 4 most common foot and ankle surgeries at a tertiary academic medical center (n = 88). Patient outcome as determined by phone interviews included PASS and patients’ judgment of whether their surgery was a S/F. Assessment also included PROMIS physical function (PF), pain interference (PI), and depression (D) scales. The association between S/F and PASS outcomes was evaluated by chi-square analysis. A 2-way analysis of variance (ANOVA) evaluated the ability of PROMIS to discriminate PASS and/or S/F outcomes. Receiver operator curve (ROC) analysis was used to evaluate the ability of pre- (n = 63) and postoperative (n = 88) PROMIS scores to predict patient outcomes (S/F and PASS). Finally, the proportion of individuals classified by the identified thresholds were evaluated using chi-square analysis. Results: There was a strong association between PASS and S/F after surgery (chi-square <0.01). Two-way ANOVA demonstrated that PROMIS t scores discriminate whether patients experienced positive or negative outcome for PASS ( P < .001) and S/F ( P < .001). The ROC analysis showed significant accuracy (area under the curve > 0.7) for postoperative but not preoperative PROMIS t scores in determining patient outcome for both PASS and S/F. The proportion of patients classified by applying the ROC analysis thresholds using PROMIS varied from 43.0% to 58.8 % for PASS and S/F. Conclusions: Patients who found their symptoms and activity at a satisfactory level (ie, PASS yes) also considered their surgery a success. However, patients who did not consider their symptoms and activity at a satisfactory level did not consistently consider their surgery a failure. PROMIS t scores for physical function and pain demonstrated the ability to discriminate and accurately predict patient outcome after foot and ankle surgery for 43.0% to 58.8% of participants. These data improve the clinical utility of PROMIS scales by suggesting thresholds for positive and negative patient outcomes independent of other factors. Level of Evidence: II, prospective comparative series.
Lenstar® LS 900 vs Pentacam®-AXL: Comparative study of ocular biometric measurements and intraocular lens power calculation
Authors: Pereira Joana Maria Mendes , Neves Arminda , Alfaiate Pedro , Santos Mónica , Aragão Henrique , Sousa João C 
Published: May 2018

Purpose: Comparison of biometric measurements and calculation of intraocular lens with a new biometer (Pentacam®-AXL, Oculus, Germany) and a reference biometer (Lenstar LS 900®, Haag-Streit AG, Switzerland), in order to assess the agreement between these two devices. Setting: Centro Hospitalar de Leiria, Portugal Materials and methods: Prospective, institutional study, in which measurements of axial length, anterior chamber depth from the corneal epithelium and endothelium to the anterior surface of the lens (anterior chamber depth ext and anterior chamber depth int), central corneal thickness and keratometry readings of the flattest and steepest meridians (K1 and K2) were obtained with the two systems. Intraocular lens calculation was also performed, using the Haigis, SRK/T and HofferQ formulas. Results: The study sample included 136 eyes of 79 patients. Of these, 42 were women and 37 were men. Statistically significant differences were found (p < 0.05, paired T test) in K1, K2 and central corneal thickness between the 2 biometers. Intraocular lens calculation with the Lenstar® and the Pentacam® with Haigis, SRK/T and HofferQ formulas showed statistically significant differences (p < 0.05 Paired T test). Conclusion: Axial length measurements obtained with the Pentacam® and Lenstar® appear to be interchangeable, while measurements of anterior chamber depth, K1 and K2, and central corneal thickness do not appear to be interchangeable between different devices. Statistically significant differences were found in the calculation of intraocular lenses in all formulas used.
The impact of intravascular ultrasound on outcomes of endovascular repair of blunt traumatic aortic injury
Authors: Etheridge James C , Ahanchi S Sadie , Dexter David J , Cain Brandon C , Collins Jay N , Panneton Jean M 
Published: May 2018

Introduction Endovascular repair has become first-line therapy for traumatic aortic injury. Proper endograft sizing is critical to outcomes following traumatic aortic injury repair; however, the adequacy of standard imaging modalities for this purpose remains uncertain. We assessed the impact of intravascular ultrasound on outcomes of endovascular traumatic aortic injury repair. Methods A retrospective review was conducted for all traumatic aortic injury patients from 2005 to 2015. Primary endpoints were 30-day aortic-related complications (aortic-related mortality, stroke, and spinal cord ischemia) and late device-related complications (collapse, migration, endoleak, and reintervention) over the duration of follow-up. Aortic measurements were calculated from three-dimensional-reconstructed computerized tomography studies and intravascular ultrasound images. Aortic remodeling was quantified by volume change between initial and first follow-up computerized tomography scans. Results Twenty-five patients were included (mean age 41, 72% male). Intravascular ultrasound was used in 14 patients. No differences in demographics or injury characteristics were observed between intravascular ultrasound and non-intravascular ultrasound patients. Proximal neck diameter was 1.2 mm greater on intraoperative intravascular ultrasound than initial computerized tomography imaging ( P = .048). Endograft oversizing in relation to initial computerized tomography was 25% in intravascular ultrasound patients versus 9% in non-intravascular ultrasound patients ( P = .001). No significant differences in aortic-related complications were noted. Device-related complications occurred more frequently in the non-intravascular ultrasound group at a mean follow-up of 252 days (36.4% vs. 0%, P = .026). Aortic remodeling rate was 4.41 cm3/day in the intravascular ultrasound group versus 2.34 cm3/day in the non-intravascular ultrasound group ( P = .256). Conclusions Intravascular ultrasound significantly impacts endograft sizing and was associated with decreased device-related complications following endovascular traumatic aortic injury repair.
A novel technique to visualize true lumen in endovascular treatment of the occlusive carotid dissection and the usefulness of external–internal carotid collateral channel
Authors: Murata Keiji , Yamauchi Shigeru , Kaneshiro Yuta , Urano Yumiko , Yamagata Keishi , Takami Toshihiro 
Published: May 2018

Background Dissection of the internal carotid artery (ICA) can cause occlusion or severe stenosis and is known to be one of the major causes of ischemic stroke in the young. Endovascular treatment is one of the useful options for carotid dissections, but passing the guidewire through the occlusion (lesion-cross) and confirmation of the true lumen are sometimes difficult. Case presentation A 40-year-old right-handed man complaining of dysarthria and gait disturbance consulted our hospital. Magnetic resonance imaging and angiography revealed right ICA dissection. Because of worsening symptoms with conservative treatment, we performed endovascular treatment. Prior to the lesion-cross, a microcatheter was navigated to the third segment of the internal maxillary artery and a balloon-guiding catheter was navigated to the proximal ICA. Under balloon occlusion of the ICA, superselective angiography via the ipsilateral maxillary artery and slow evacuation from the balloon-guiding catheter were performed. Thereafter, the course of the true lumen was clearly visualized, and we were able to navigate another microcatheter without difficulty. Subsequently, angioplasty and stent placement were successfully accomplished. Conclusion We presented a case of ICA dissection and demonstrated a novel technique for a safe lesion-cross for occlusive ICA dissection.
Biosimilars and federal preemption in the USA
Authors: Bousquet Jeffrey R 
Published: May 2018

Summary This article reports on the recent decision by the Court of Appeals for the Federal Circuit (“Federal Circuit”) in Amgen v. Sandoz on remand from the U.S. Supreme Court. The Supreme Court held that a biosimilar applicant cannot be compelled under federal law to provide a copy of its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”) as required by the Biologics Price Competition and Innovation Act (“BPCIA”). The Supreme Court remanded the case to the Federal Circuit to determine whether there was any remedy under California state law available to Amgen, and if so, whether such remedy is preempted by the BPCIA. The Federal Circuit held that the BPCIA preempts state law remedies for a biosimilar applicant’s failure to comply with the BPCIA. This article also briefly discusses three other recent cases involving situations where the biosimilar applicant initiates the BPCIA information exchange process but provides only partial or no manufacturing information to the RPS or fails to complete the process by opting out at some later stage of the process.