bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: Findings from the Phase 3 trials (SAMURAI and SPARTAN)
Authors: Loo Li Shen , Plato Brian , Turner Ira , Case Michael , Raskin Joel , dowsett sherie , Krege John 
Published: July 2019

Abstract
Background

We studied the efficacy and safety of a second dose of lasmiditan for acute treatment of migraine.

Methods

SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies in which individuals with migraine were randomized to oral lasmiditan 50mg (SPARTAN only), 100mg, 200mg, or placebo. Study drug was to be taken within 4 hours (h) of onset of a migraine attack (moderate or severe pain). A second dose of study drug was provided for rescue (patient not pain-free at 2h and took a second dose 2-24h post-first dose) or recurrence (patient pain-free at 2h, but experienced recurrence of mild, moderate, or severe migraine pain and took a second dose 2-24h after first dose). Randomization to second dose occurred at baseline; patients originally assigned lasmiditan were randomized to the same lasmiditan dose or placebo (2:1 ratio), and those originally assigned placebo received placebo. Data from SAMURAI and SPARTAN were pooled for efficacy and safety assessment of a second dose of lasmiditan.

Results

The proportion of patients taking a second dose was lower with lasmiditan versus placebo, and decreased with increasing lasmiditan dose; the majority who took a second dose did so for rescue. In patients taking lasmiditan as first dose, outcomes (pain free, most bothersome symptom [MBS] free) at 2h after a second dose for rescue were similar whether the second dose was lasmiditan or placebo (p>0.05 in all cases). In patients taking lasmiditan for first dose, outcomes at 2h after a second dose for recurrence were as follows: lasmiditan pooled versus placebo - pain free, 50% vs 32% (p>0.05); MBS free, 71% vs 41% (p=0.02); pain relief, 77% vs 52% (p=0.03). In patients whose first dose was lasmiditan, the incidence of treatment emergent adverse events (TEAEs) reported after the second dose was similar whether second dose was lasmiditan or placebo.

Conclusions

A second dose of lasmiditan showed some evidence of efficacy when taken for headache recurrence. There was no clear benefit of a second dose of lasmiditan for rescue treatment. The incidences of TEAEs were similar whether the second dose was lasmiditan or placebo.
The tidal volume challenge improves the reliability of dynamic preload indices during robot-assisted laparoscopic surgery in the Trendelenburg position with lung-protective ventilation
Authors: Jun Joo-Hyun , Chung Rack Kyung , Baik Hee Jung , Chung Mi Hwa , Hyeon Joon-Sang , Lee Young-Goo , Park Sung-Ho 
Published: July 2019

Abstract
Background: The reliability of pulse pressure variation (PPV) and stroke volume variation (SVV) is controversial under pneumoperitoneum. In addition, the usefulness of these indices is being called into question with the increasing adoption of lung-protective ventilation using low tidal volume (VT) in surgical patients. A recent study indicated that changes in PPV or SVV obtained by transiently increasing VT (VT challenge) accurately predicted fluid responsiveness even in critically ill patients receiving low VT. We evaluated whether the changes in PPV and SVV induced by a VT challenge predicted fluid responsiveness during pneumoperitoneum.
Methods: We performed an interventional prospective study in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. PPV, SVV, and the stroke volume index (SVI) were measured at a VT of 6 mL/kg and 3 minutes after increasing the VT to 8 mL/kg. The VT was reduced to 6 mL/kg, and measurements were performed before and 5 minutes after volume expansion (infusing 6% hydroxyethyl starch 6 ml/kg over 10 minutes). Fluid responsiveness was defined as ≥ 15% increase in the SVI.
Results: Twenty-four of the 38 patients enrolled in the study were responders. In the receiver operating characteristic curve analysis, an increase in PPV > 1% after the VT challenge showed excellent predictive capability for fluid responsiveness, with an area under the curve (AUC) of 0.95 [95% confidence interval (CI), 0.83–0.99, P < 0.0001; sensitivity 92%, specificity 86%]. An increase in SVV > 2% after the VT challenge predicted fluid responsiveness, but showed only fair predictive capability, with an AUC of 0.76 (95% CI, 0.60–0.89, P < 0.0006; sensitivity 46%, specificity 100%). The augmented values of PPV and SVV following VT challenge also showed the improved predictability of fluid responsiveness compared to PPV and SVV values (as measured by VT) of 6 ml/kg.
Conclusions: The change in PPV following the VT challenge has excellent reliability in predicting fluid responsiveness in our surgical population. The change in SVV and augmented values of PPV and SVV following this test are also reliable.
ANTIBIOGRAMS AND RISK FACTORS OF SALMONELLA ISOLATES FROM LAYING HENS AND EGGS IN JIMMA TOWN, SOUTH WESTERN ETHIOPIA
Authors: Taddese Diriba , Tolosa Tadele , Deresa Benti , lakow Matios , Olani Abebe , Shumi Eshetu 
Published: July 2019

Abstract
Objectives

Salmonella is the most important causes of foodborne illness especially from poultry and poultry products. So the aim of this study was to carryout phenotypic characterization, antimicrobials susceptibility pattern and risk factors of salmonella isolates from farms and markets eggs, cloacae swabs of chickens and stool of egg collectors. A cross-sectional study was conducted from January 2018 to September 2018. Samples were, processed; salmonella was isolated, Phenotypically identified by OmniLog and antimicrobials susceptibility were carried out.

Result

Over all; 11(2.65%) of salmonella enterica were phenotipically characterized out of 415 samples from farms egg content (n=83), farms eggshell (n=83), cloacae (n=83), market eggshell (n=83) and market egg contents (n=83) with 2.4%, 0%, 2.4%, 4.8% and 3.6% prevalence, respectively. Out of isolates, 8(72.72%) displayed multidrug resistance. All isolates showed susceptibility to Gentamicin, Kanamycin and Streptomycin. Lack of separating cracked eggs, washing hand, eggs stay longer unsold, and mixing excreta with feed were associated risk factors for salmonella presence (p-value<0.05). The presence of drug resistant salmonella enterica within egg/and chicken can pose serious health problem. Good hygienic practices are important to reduce risk factors of salmonella contamination.
Knowledge and practice of immediate new-born care among midwives in central zone public health Facilities, Tigray, Ethiopia: cross sectional study.
Authors: Gebru Tesfay Tsegay , Murugan Rajalakshmi , Abrha Alem Gebremariam , Goyteom Mekonnen Haftom 
Published: July 2019

Abstract
Objective

The objective of this study was to assess knowledge and practice of immediate newborn care among midwives in governmental health facilities of central zone of Tigray regional state, 2016.

Results

The mean age of the study participants was 34.1 years. Majority of the participants (83%) were diploma midwives. The score of knowledge of participants on immediate newborn care was 17.7% good and 25.2% poor. More than half (52.4%) of midwives practiced immediate newborn care. Midwives working in health center have 82% lower odds of newborn care compared to those working in hospital (p=0.000, OR=0.18 (0.07, 0.43).
PET-CT Standard uptake value predict bevacizumab-containing chemotherapy response and prognosis for unresectable colorectal cancer liver metastasis
Authors: Lv Yang , Feng QingYang , Tang WenTao , Xu YuQiu , Lin SongBin , Mao YiHao , Zheng Peng , Yang LiangLiang , He GuoDong , Xu JianMin 
Published: July 2019

Abstract
Background: Standard uptake value (SUV) of PET-CT is an indicator of tumor metabolic response. In this paper, we aim to explore the clinical value of SUV on the unresectable colorectal cancer liver metastasis (CRLM) patients receiving bevacizumab-containing chemotherapy.
Method: This study was performed retrospectively. A total of 185 CRLM patients between April 2011 to December 2015 with complete clinical data were included in this study. All the enrolled patients were assigned into two treatment cohorts (bevacizumab plus first-line chemotherapy cohort and chemotherapy only cohort). A blindly, independent radiologist evaluated images for RECIST and morphologic response. All clinical variables, and various PET/CT parameters were statistically compared with progression-free survival (PFS) and overall survival (OS). Primary and Metastatic tumor SUV were selected for analysis.
Results: Among the 185 patients, 101 patients received first line chemotherapy plus bevacizumab (beva cohort), 84 patients only received first-line chemotherapy (CMT cohort). Baseline characteristics of two cohorts showed no statistical difference (P>0.05). Primary SUV level was correlated with primary tumor size, while metastatic SUV was statistically correlated with metastatic tumor number and tumor size (P=0.000). Primary lesion, metastatic lesion SUV and elevation of SUV demonstrated prognostic role for OS (P<0.05). SUV gap were statistically associated with optimal response in bevacizumab cohort (P=0.03) and no-PD status in chemotherapy cohort (P=0.019), respectively. After multivariate analysis, elevated SUV is an independent risk factor for OS (P=0.000). Besides, elevation of SUV between metastatic and primary lesion can be a predictive factor for bevacizumab survival benefit.
Conclusion: PET-CT scan is important for CRLM patients. Our study demonstrated that an elevation of SUV was a better prognostic and predictive marker for CRLM patients.
Relationship of possible biomarkers with malignancy of thymic tumors: a meta-analysis
Authors: Zeng Huilan , Yang Weilin , Xu Bo , Zou Jianyong , Su Chunhua , Zhong Beilong , Zhu Haoshuai , Chen Zhenguang 
Published: July 2019

Abstract
Introduction

Role of biomarkers for promotion of tumor proliferation (BPTPs) and for promotion of apoptosis (BPAs) in thymic malignant tumors is still unclear. The purpose of this study was to evaluate the relationship between BPTPs and/or BPAs and malignancy of thymic malignant tumors.

Materials and Methods

Studies on thymic malignant tumors and biomarkers were searched in PubMed, ISI Web of Knowledge, and Embase databases, and all statistical analyses were conducted using Review Manager.

Results

Twelve articles related to biomarkers and thymic malignant tumors were selected and analyzed. A relationship between BPAs and Masaoka stage was demonstrated for four markers, included 138 stage I/II patients and 74 stage III/IV patients, and BPAs were significantly correlated with high Masaoka staging (P = 0.005). We further found a relationship between BPAs and degree of malignancy for four markers, included 176 thymoma patients and 36 thymic carcinoma patients, and BPAs were significantly correlated with thymic carcinoma (P = 0.010). In addition, a relationship between BPTP and Masaoka staging was demonstrated for eight markers, included 374 patients with stage I/II and 282 patients with stage III/IV, and BPTPs were significantly correlated with high Masaoka staging (P < 0.001). We also found BPTPs were significantly correlated with thymic carcinoma (P < 0.001).

Conclusion

These findings show that high levels of BPTPs or BPAs are more closely related to thymic carcinoma and Masaoka stage III/IV, suggesting that BPTPs and BPAs may play an important role in the occurrence and development of thymic malignant tumors.
Effect of lymph node dissection on stage-specific survival in patients with upper urinary tract urothelial carcinoma treated with nephroureterectomy.
Authors: Zhai Ting-Shuai , Jin Liang , Zhou Zhen , Liu Xiang , Liu Huan , Feng Li-Ming , Chen Wei , Lu Jing-Yi , Yao Xu-Dong , Ye Lin 
Published: July 2019

Abstract
Objectives To estimate the stage-specific impact of lymph node dissection (LND) on survival for upper urinary tract urothelial carcinoma (UTUC) patients treated with nephroureterectomy (NU).
Methods Overall, 7278 UTUC patients undergoing NU within the SEER database from 2004 to 2015 were identified. Kaplan-Meier plots illustrated overall survival (OS) and cancer-specific survival (CSS) rates according to LND status. Multivariable Cox regression analyses assessed the effect of LND on OS and CSS rates stratified by pathological tumor stage.
Results LND was performed in 26.9% of patients, and in 18.6, 23.3, 31.2 and 45.9% for pT1, pT2, pT3 and pT4 patients, respectively (P < 0.001). In multivariable Cox regression analyses, LND was associated with a higher OS or CSS in UTUC patients with pT3 and pT4 disease (all P < 0.05), but failed to achieve independent predictor status in patients with pT1 and pT2 disease (all P > 0.05). LND with 1 to 3 regional lymph nodes removed was prone to a higher OS or CSS only in pT4 compared to no LND (both P < 0.01). LND with 4 or more regional lymph nodes removed predisposed to a higher OS or CSS in pT3 or pT4 (all P < 0.05).
Conclusion LND was more frequently performed in locally advanced UTUC patients. The beneficial effect of LND especially LND with 4 or more regional lymph nodes removed on survival was more significant in these patients than those with pT1 or pT2 disease. LND at UN should always be contemplated, regardless of tumor stage.
Using the serum lactate dehydrogenase level to predict prognosis in the patients with soft tissue sarcoma: a retrospective case-control study
Authors: Fujibuchi Taketsugu , Miyawaki Joji , Kidani Teruki , Imai Hiroshi , Miura Hiromasa 
Published: July 2019

Abstract
Background
Several studies have reported the prognostic factors for soft tissue sarcoma. Although serum lactate dehydrogenase (LDH) levels are reportedly associated with poor prognosis in several cancers, its role in sarcomas, especially in non-small-round cell sarcomas, remains unclear. This study aimed to evaluate the correlation between the clinical features, prognosis, and serum LDH level in soft tissue sarcoma.
Methods
A total of 67 patients with primary soft tissue sarcoma diagnosed between 2003 and 2014 were retrospectively reviewed. The serum LDH level at the first visit was stratified as >253 IU/L vs. ≤253 IU/L according to the standard values at our institution. The correlation between the stratified serum LDH level and clinical characteristics and the survival according to clinical characteristics including the serum LDH level were analyzed.
Results
A total of 15 patients showed high serum LDH level at the first visit. The presence of metastasis was significantly correlated with high serum LDH level (p = 0.010). In patients of all histologic types and even in those with non-small-round cell sarcoma without distant metastasis, the disease-specific survival was significantly worse in patients with high serum LDH level than those with normal serum LDH level (p < 0.001 and p = 0.018, respectively).
Conclusion
Elevated serum LDH level was found to be correlated with the presence of metastatic lesion. Moreover, in all soft tissue sarcomas and even in non-small-round cell sarcoma, high LDH level was one of the predictive factors for poor prognosis. Serum LDH level appeared to be associated with tumor cell activity and metastatic potential.
Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial
Authors: Wang Wenwen , Ma Xiangyi , Zhang Wei , Li Zhiying , Wang Yan , Yu Zhiying , Zhang Chunlian , Hong Li , Luo Ruoyu , Xing Hui , Wang Wuliang , Yue Qingfen , Wei Jia , Zhang Minli , Wang Shixuan 
Published: July 2019

Abstract
Background: To preserve fertility or integrity of organs was on the rise for the most women with adenomyosis. Adenomyomectomy is now a widely applied conservative surgery, however relapse is a serious problem after operation. Postoperative treatment, such as gonadotropin-releasing hormone agonist (GnRHa) has been suggested to result in reducing the recurrence rate in patients. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy of GnRHa for decreasing the postoperative recurrence rate.
Method/Design：Relapse after conservative surgery combined with Triptorelin Acetate versus conservative surgery only in women with focal adenomyosis is a multicenter, prospective, randomized controlled trial. The primary outcome is relapse accessed with Visual Analogue Scale (VRS) and Numeric Rating Scale (NRS), Pictorial blood loss assessment chart (PBAC) score and the size of uterus and lesion are measured by two/three-dimensional color doppler ultrasonography (2D/3D-CDUS) or magnetic resonance imaging (MRI). The secondary outcomes include quality of life, clinical pregnancy, ovarian reserve, and adverse events, assessing by Short Form (36) Health Survey and Female Sexual Function index, serum follicle-stimulating hormone, estradiol levels and anti-muellerian hormone and so on. All these indexes are measured at 3, 6, 12, 18, 24, 30, 36 months after conservative surgery.
Discussion：The result of this large multicenter randomized trial will provide evidence for one of the strategies of long-term management in focal adenomyosis after conservative operation.
Successful implementation of ChicaEducation system for Oncology Residency Standardized Training
Authors: Yao Quan , Wu Hong , Zou Lian , Lan Haitao , Luo Shuchun , Lu Shun , Li Xianfu , Lang Jinyi , Xu Chuan 
Published: July 2019

Abstract
The ability to access knowledge and skills of radiation oncology is fundamental for oncology residency standardized training. This study evaluates whether or not the ChicaEducation system for oncology residency standardized training contributes to training radiation oncology medical students. As a virtual reality system for radiotherapy training, ChicaEducation system was successfully implemented. We compared the ChicaEducation system training module with a traditional training module. Whether the integration of ChicaEducation into medical teaching was intended to enhance students’ autonomic learning and comprehensive analysis were also evaluated. The integration of ChicaEducation system into oncology residency standardized training was valuable compared to traditional training methods and could improve radiation oncology medical students’ perceptions and understanding. ChicaEducation system training module was positive and could enhance radiation oncology medical students’ level of confidence in radiation oncology. The role of ChicaEducation system training module in delivering an efficient quantity of oncology medical education was ascertained because of its ability to visualize conceptual information within a simulated clinical environment. ChicaEducation system may alleviate economic burdens in some hospitals and be used for training for doctors in rural areas.
Do USMLE Steps and ITE Results Predict Performance in the American Board of Internal Medicine Certifying Exam?
Authors: Rayamajhi Supratik , Dhakal Prajwal , Wang Ling , Rai Manoj P , Shrotriya Shiva 
Published: July 2019

Abstract
Objective

To evaluate if United States Medical Licensing Examination (USMLE) Step 1, USMLE Step 2, USMLE Step 3, and residency third-year in-service training exam (ITE) results predict performance of Internal Medicine (IM) residents in American Board of Internal Medicine Certifying Exam (ABIM-CE).

Methods

A retrospective review of USMLE Step 1, USMLE Step 2, USMLE Step 3 scores, residency third year ITE and ABIM-CE of IM residents at Michigan State University from 2004 through 2017 was conducted. Pearson correlation coefficient and two sample t-tests were used to assess the relationship between various scores and pass or fail results in ABIM-CE.

Results

Among 114 MD residents included in the study; 92% (n=105) passed the ABIM-CE. There was a significant correlation of passing ABIM-CE with USMLE Step 1 (OR 1.042; 95% CI 1.004- 1.082), Step 2 (OR 1.043; 95% CI 1.004-1.085) and Step 3 (OR 1.046; 95% CI 1.004- 1.089) independently, with the combined odds of all USMLE exams being 1.044 (p=0.031). Increase in ITE percentage increased the likelihood of passing ABIM-CE (OR 1.28, 95% CI 1.160-1.419). The increase in the gap was associated with decreased chances of passing ABIM-CE (OR 0.774; 95% CI 0.670-0.893). All residents who failed ABIM-CE had Step 1 scores <220. Among 31 residents with Step 2 score <220, 20% (n=6) failed ABIM. Similarly, 9% of residents with USMLE Step 3 score less than 220 failed ABIM-CE; all residents who failed had scores less than 220. The probability curve predicted that the chance of passing ABIM- CE was around 80% with USMLE scores greater than 200 and increased to almost 100% with USMLE scores of 250 or more.

Conclusion

There is a strong correlation between ABIM-CE results with scores of USMLE Steps and third-year ITE. Thus, performance in these exams may identify the internal medicine residents who might need more help in ABIM-CE. This helps the residents as well as the program to plan and implement various measures to improve the pass rate.
SPS-neutralization in tissue samples for efficacy testing of antimicrobial peptides
Authors: Dijksteel Gabrielle , Nibbering Peter , Ulrich Magda , Middelkoop Esther , Boekema Bouke 
Published: July 2019

Abstract
Background
Accurate determination of the efficacy of antimicrobial agents requires neutralization of residual antimicrobial activity in the samples before microbiological assessment of the number of surviving bacteria. Sodium polyanethol sulfonate (SPS) is a known neutralizer for the antimicrobial activity of aminoglycosides and polymyxins. In this study, we evaluated the ability of SPS to neutralize residual antimicrobial activity of antimicrobial peptides [SAAP-148 and pexiganan; 1% (wt/v) in PBS], antibiotics [mupirocin (Bactroban) and fusidic acid (Fucidin) in ointments; 2% (wt/wt))] and disinfectants [2% (wt/wt) silver sulfadiazine cream (SSD) and 0.5% (v/v) chlorhexidine in 70% alcohol].

Methods
Homogenates of human skin models that were exposed to various antimicrobial agents for 1 h were pipetted on top of Methicillin-resistant Staphylococcus aureus (MRSA) on agar plates to demonstrate the presence of residual antimicrobial activity in tissue samples.
To determine the efficacy of SPS in neutralization, various antimicrobial agents were mixed with PBS, 0.05%, 0.1%, 0.5% or 1% (wt/v) SPS in PBS. Subsequently, 10^5 colony forming units (CFU) MRSA were added to the mixtures and these were incubated for 30 min to determine the antimicrobial effect.
Ex vivo excision wound models were inoculated with 10^5 CFU MRSA for 1 h and exposed to SAAP-148, pexiganan, chlorhexidine or PBS for 1 h to study the effect of SPS-neutralization on the bacterial killing of these antimicrobials.
To quantify the number of surviving bacteria, 10-fold serial dilutions of the homogenates were cultured overnight on agar plates.

Results
All tested antimicrobials displayed residual activity in tissue samples, resulting in a lower recovery of surviving bacteria on agar. SPS concentrations at ≥0.05% (wt/v) were able to neutralize the antimicrobial activity of SAAP-148, pexiganan and chlorhexidine, resulting in the complete recovery of bacteria. However, SPS did not neutralize the activity of SSD, Bactroban and Fucidin. Finally, SPS-neutralization in ex vivo efficacy tests of SAAP-148 (p<0.001), pexiganan (p<0.05) and chlorhexidine (p<0.01) resulted in at least 10-fold higher numbers of MRSA compared to control samples without SPS-neutralization.

Conclusion
SPS can be used for the neutralization of residual activity of different antimicrobials, including SAAP-148, pexiganan and chlorhexidine and this prevents an overestimation of their efficacy.