bluuebunny/crossref_metadata_2025_split huggingface dataset:
Vietnamese Women Entrepreneurs’ Motivations, Challenges, and Success Factors
Authors: Nguyen Hoang Anh , Phuong Tam To , Le Thuy Thi Bich , Vo Linh Phuong 
Published: February 2020

The Problem According to the Mastercard Index of Women Entrepreneurs, 31.3% of businesses in Vietnam are owned by women, placing Vietnam at the sixth out of the 53 surveyed economies. Despite the prevalence of female entrepreneurship in Vietnam, little is known about the motivations, challenges, and success factors of those occupying this vibrant sector of the Vietnamese economy. Greater knowledge of how women entrepreneurs perceive themselves and the Vietnamese business environment could stimulate greater support for their personal and career development. The Solution This study aims to explore Vietnamese women entrepreneurs’ motivations, challenges, and success factors. This qualitative research study provides (a) a brief introduction to the business context and the role of women entrepreneurs in Vietnam; (b) findings on Vietnamese women motivation for to starting and running business, as well as the challenges they face, and factors contributing to their success; and (c) recommendations for government policies, business communities, and the development of female entrepreneurs in Vietnam. As few research studies on women business owners in Vietnam are available, this empirical study can contribute to more effective practice and further research on this cohort in Vietnam. The Stakeholders Recommendations provided in this study will help governmental policymakers, business communities, and female entrepreneurs in Vietnam.
Estimated costs of pivotal trials for U.S. Food and Drug Administration–approved cancer drugs, 2015–2017
Authors: Hsiue Emily Han-Chung , Moore Thomas J , Alexander G Caleb 
Published: February 2020

Background: Pivotal clinical trials provide critical evidence to regulators regarding a product’s suitability for marketing approval. The objectives of this study are (1) to characterize select features of trials for oncology products approved by the U.S. Food and Drug Administration between 2015 and 2017; and (2) to quantify the costs of these trials and how such costs varied based on trial characteristics. Methods: We identified novel oncology therapeutic drugs, and their respective pivotal trials, approved between 2015 and 2017 using annual summary reports from the Food and Drug Administration. Cost estimates for each pivotal trial were calculated using IQVIA’s CostPro, a clinical trial cost estimating tool based on executed contracts between pharmaceutical manufacturers and contract research organizations. Measures of drug and trial characteristics included trial design, end point, patient enrollment, and regulatory pathway. We also performed sensitivity analyses that varied assumptions regarding how efficiently each trial was conducted. Results: A total of 39 pivotal clinical trials provided the basis for Food and Drug Administration approval of 30 new oncology drugs from 2015 to 2017. Among these trials, primary end points were objective response rate in 20 (51.3%), progression-free survival in 13 (33.3%), and overall survival in 6 (15.4%). Twenty trials (51.3%) were single-arm studies. The median estimated cost of oncology pivotal trials was $31.7 million (interquartile range = $17.0–$60.4 million). Trials with objective response rate as primary end point had a median estimate of $17.7 million (interquartile range = $11.9–$27.1 million), compared with trials examining progression-free survival ($42.3 million, interquartile range = $34.6–$101.2 million) or overall survival ($79.4 million, interquartile range = $56.9–$97.7 million) (p < 0.001). Estimated costs for single-arm trials ($17.7 million, interquartile range = $11.9–$23.7 million) were less than for trials with a placebo-controlled ($56.7 million, interquartile range = $40.9–$103.9 million) or active control arm ($67.6 million, IQR = $35.5–$93.5 million) (p < 0.001). Conclusions: Relative to the estimated costs of drug development, the costs of these oncology pivotal trials were modest, with trials that produced more valuable scientific information costing more than their counterparts.
Adjuvant Chemotherapy with Chinese Herbal Medicine Formulas Versus Placebo in Patients with Lung Adenocarcinoma after Radical Surgery: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Authors: Wang Qin , Jiao Lijing , Wang Shengfei , Chen Peiqi , Bi Ling , Zhou Di , Yao Jialin , Li Jiaqi , Wang Liyu , Chen Zhiwei , Jia Yingjie , Zhang Ziwen , Shen Weisheng , Zhu Weirong , Xu Jianfang , Gao Yong , Xu Ling , Gong Yabin 
Published: February 2020

Abstract
Background
The toxicity and side effects caused by adjuvant chemotherapy (ACT) after radical surgery for lung adenocarcinoma (LAC) lead to early termination frequently. This study was conducted to provide an objective basis for the effect of Chinese herbal medicine formulas (CHMFs) combined with chemotherapy in reducing toxicity and enhancing efficacy of ACT.

Method
From February 17th, 2012 to March 20th, 2015, 233 patients from 7 hospitals diagnosed with LAC in IB~IIIA stage were randomly assigned into ACT + CHMF group (116 patients) and ACT + placebo group (117 patients). CHMF was taken orally until the end of chemotherapy. Chemotherapy-related toxic, side effects were investigated as the primary outcome. Disease-free survival (DFS) and overall survival (OS) were used as the secondary outcome.

Results
At one week following chemotherapy, the incidence of dry mouth, diarrhea and thrombocytopenia significantly decreased in CHMF group (P = 0.017, P = 0.033, P = 0.019, respectively). At two weeks following chemotherapy, fatigue and diarrhea were more obvious in the placebo group (P = 0.028, P = 0.025, respectively). In addition, patients in the CHMF group showed an increase in median DFS from 37.1 to 51.5 months compared with placebo group although there was no statistical significance (P = 0.16). In the stage IB subgroup, the CHMF group had a significantly better DFS (HR (95% CI) = 0.53 (0.28–0.99), P = 0.046). There was no significant difference in OS between the groups (P = 0.72).

Conclusion
For patients with LAC, ACT combined with CHMF after radical surgery can prolong the DFS time especially in the early stage, and reduces the chemotherapy-related toxic and side effects.

Trial Registration
NCT 01441752. Registered 14 July, 2011.
Taste disorder in facial onset sensory and motor neuronopathy: a case report
Authors: Ohashi Nobuhiko , Nonami Jin , Kodaira Minori , Yoshida Kunihiro , Sekijima Yoshiki 
Published: February 2020

AbstractBackgroundTaste disorder is a common symptom in the general population. Several studies have shown that patients with neurological disorders, such as amyotrophic lateral sclerosis and Parkinson’s disease, develop taste disturbance. Facial onset sensory and motor neuronopathy (FOSMN) is a rare disease characterized by sensory disturbance and weakness spreading from the face to the limbs caudally. We describe a patient with FOSMN who showed taste disorder as the sole initial symptom.Case presentationA 49-year-old man who smoked cigarettes developed taste disturbance. Despite using zinc supplements, an herbal medication, and an ointment, his taste disorder worsened. 4 years later, a tingling feeling emerged at the tip of his tongue and gradually spread to his entire lips. At 55 years of age, he showed difficulty in swallowing, followed by facial paresthesia, muscle atrophy, and weakness in the face and upper limbs without apparent upper motor neuron sign. Cessation of smoking did not improve his taste disturbance, and he was unable to discriminate different tastes on the entire tongue. In an electrogustometric study, electrical stimulation did not induce any type of taste sensation. Blink reflex showed delayed or diminished R2 responses. Needle electromyography revealed severe chronic neurogenic changes in the tongue and masseter muscles. Mild chronic neurogenic changes were also observed in the limbs. In the thoracic paraspinal muscles, active neurogenic changes were detected. Findings of hematological and cerebrospinal fluid analyses, and magnetic resonance images of the brain and spinal cord were unremarkable. One cycle of intravenous immunoglobulin therapy did not improve his symptoms. We diagnosed him as having FOSMN with the sole initial symptom of taste disorder. Nine years after the onset of taste disorder, he developed impaired sensation of touch in the right upper limb and required tube feeding and ventilator support.ConclusionTaste disorder can be the initial manifestation of FOSMN and might involve the solitary nucleus.
A potential risk factor of total knee arthroplasty: an infected Baker’s cyst – a case report
Authors: Lee Byung-Ill , Seo Jong-Hyeon , Kim Yong-Beom , Seo Gi-Won 
Published: February 2020

Abstract
Background
In adults, Baker’s cyst development is attributable principally to secondary alterations after degenerative changes. The latter changes often accompany osteoarthritis, and we frequently encounter patients with Baker’s cysts seeking total knee arthroplasty (TKA). Baker’s cysts are not usually subject to extensive preoperative evaluation because the cysts often disappear naturally after surgery, unaccompanied by any adverse symptoms.

Case presentation
A 63-year-old woman presented with moderate pain in the left knee joint that had developed 1 year ago. Posterior knee pain was aggravated on maximum knee flexion. Three months previously, a popliteal mass had become palpable and the patient had undergone needle mass aspiration twice in a local orthopedic hospital, but the mass had recurred. We initially considered TKA for her severe degenerative osteoarthritis. However, we decided to perform only arthroscopic debridement and cyst excision because the patient was experienced severe pain only on maximal knee flexion, and did not want TKA. Pus gushed from the torn cyst during the operation. We diagnosed an infected Baker’s cyst. The patient was treated with a first-generation cephalosporin postoperatively.

Conclusions
A Baker’s cyst that was aspirated and still causes symptoms with altered blood tests needs to be evaluated accurately before TKA.
Differential effects of Chinese high-fat dietary habits on lipid metabolism: mechanisms and health implications
Authors: Yan Sisi , Zhou Huijuan , Liu Shuiping , Wang Ji , Zeng Yu , Matias Froilan Bernard , Wen Lixin 
Published: February 2020

Abstract
Background
The traditional Chinese diet blends lard with vegetable oil, keeping the fatty acid balance intake ratio of saturated fatty acids, monounsaturated fatty acids, and polyunsaturated fatty acids at nearly 1:1:1. However, the effects of a mixture of lard and vegetable oil on lipid metabolism have never been researched. In the present study, by simulating Chinese high-fat dietary habits, we explored the effects of a mixture of lard and vegetable oil on lipid metabolism.

Methods
We randomly assigned 50 male C57BL/6 J mice to 5 groups (10 in each group) and fed them lard, sunflower oil (SFO), soybean oil (SBO), lard blended with sunflower oil (L-SFO), or lard blended with soybean oil (L-SBO) for 12 weeks.

Results
We found that the final body weights of mice in the lard group were significantly higher than those of mice in the SFO and SBO groups. Body fat rate and volume of fat cell of the lard group were significantly higher than those of the SFO, SBO, and L-SBO groups. Liver triglyceride level of the lard group increased significantly compared to the other groups. Although body fat rate and liver triglyceride level in the SBO and SFO groups decreased compared to those in the other groups, the high-density lipoprotein cholesterol/low-density lipoprotein cholesterol ratio were also significantly decreased in the SBO and SFO groups.

Conclusions
We found that a lard diet induced accumulation of body fat, liver and serum lipids, which can increase the risk of obesity, non-alcoholic fatty acid liver disease, and atherosclerosis. The vegetable oil diet resulted in cholesterol metabolism disorders even though it did not lead to obesity. The mixed oil diet induced body fat accumulation, but did not cause lipid accumulation in the liver and serum. Thus, differential oil/fat diets have an impact on differential aspects in mouse lipid metabolism.

Graphical abstract
The effectiveness of different down-regulating protocols on in vitro fertilization-embryo transfer in endometriosis: a meta-analysis
Authors: Cao Xue , Chang Hong-yang , Xu Jun-yan , Zheng Yi , Xiang Yun-gai , Xiao Bing , Geng Xu-jing , Ni Li-li , Chu Xi-ying , Tao Shi-bo , He Yan , Mao Gen-hong 
Published: February 2020

Abstract
Background
To investigate the effectiveness of the GnRH-a ultra-long protocol, GnRH-a long protocol, and GnRH-a short protocol used in in vitro fertilization-embryo transfer (IVF-ET) in infertile women with endometriosis.

Methods
We searched PubMed, Embase, Web of Science, Cochrane Library, Elsevier Science Direct, OA Library, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, China Science and Technology Journal database, and the China Biology Medicine disc for randomized controlled trials (RCTs) and observational studies (non-RCTs) to evaluate the efficacy of the GnRH-a ultra-long protocol, GnRH-a long protocol, and GnRH-a short protocol in IVF-ET in infertile patients with endometriosis.

Results
A total of 21 studies in compliance with the standard literature were included, and RCT and non-RCT studies were analyzed separately. This meta-analysis showed that the GnRH-a ultra-long protocol could improve the clinical pregnancy rate of infertile patients in RCT studies, especially in patients with stages III–IV endometriosis (RR = 2.04, 95% CI: 1.37~3.04, P < 0.05). However, subgroup analysis found the different down-regulation protocols provided no significant difference in improving clinical outcomes in patients with endometriosis in the non-RCT studies.

Conclusion
This study suggests that the GnRH-a ultra-long protocol can improve the clinical pregnancy rate of the patients with stages III–IV endometriosis in RCT studies. Although it is generally believed that the results of RCT are more reliable, the conclusions of the non-RCT studies cannot be easily neglect, which let us draw conclusions more cautious.
Successful pregnancy after prenatal diagnosis by NGS for a carrier of complex chromosome rearrangements
Authors: Ou Jian , Yang Chuanchun , Cui Xiaoli , Chen Chuan , Ye Suyan , Zhang Cai , Wang Kai , Chen Jianguo , Zhang Qin , Qian Chunfeng , Fang Guangguang , Zhang Wenyong 
Published: February 2020

Abstract
Background
The study is aimed to provide prediction for fertility risk in the setting of assisted reproduction for a woman with complex chromosomal rearrangements (CCRs).

Methods
We implemented a robust approach, which combined whole-genome low-coverage mate-pair sequencing (WGL-MPS), junction-spanning PCR and preimplantation genetic testing for aneuploidy (PGT-A) method to provide accurate chromosome breakpoint junctional sequences in the embryo selection process in the setting of assisted reproduction for a couple with recurrent abortions due to CCRs.

Result
WGL-MPS was applied to a female carrying CCRs which consisted of 9 breakpoints and 1 cryptic deletion related to fertility risks. Sequencing data provided crucial information for designing junction-spanning PCR and PGT-A process, which was performed on the 11 embryos cultivated. One embryo was considered qualified for transplanting, which carried the exact same CCRs as the female carrier, whose phenotype was normal. The amniotic fluid was also investigated by WGL-MPS and karyotyping at 19 weeks’ gestation, which verified the results that the baby carried the same CCRs. A healthy baby was born at 39 weeks’ gestation by vaginal delivery.

Conclusion(s)
Our study illustrates the WGL-MPS approach combining with junction-spanning PCR and PGT-A is a powerful and practical method in the setting of assisted reproduction for couples with recurrent miscarriage due to chromosomal abnormalities, especially CCRs carriers.
Pharmacodynamic material basis of traditional Chinese medicine based on biomacromolecules: a review
Authors: Zhang Wen-Jin , Wang Sheng , Kang Chuan-zhi , Lv Chao-geng , Zhou Li , Huang Lu-Qi , Guo Lan-Ping 
Published: February 2020

AbstractBiomacromolecules, the first components of bioactive substances in traditional Chinese medicines (TCM) have wide bioactivity-related efficacy but have not yet been fully appreciated compared to small molecule components. The present review brings a novel and systemic point of view to deepen the understanding of the pharmacodynamic material basis of TCM based on biomacromolecules (polysaccharides, proteins and nucleic acids). Biomacromolecules have been, are and will have considerable roles in the efficacy of Chinese medicine, as evidenced by the number of biological activities related to traditional clinical efficacy. The direct and indirect mechanisms of biomacromolecules are further accounted for in a variety of neurotransmitters, hormones, and immune substances to maintain immune function in both sensitive and stable equilibrium. The biological functions of biomacromolecules have been elaborated on in regard to their roles in the process of plant growth and development to the relationship between primary metabolism and secondary metabolism and to the indispensable role of polysaccharides, proteins, and nucleic acids in the quality formation of TCM. Understanding the functional properties and mechanisms of biological macromolecules will help to demystify the drug properties and health benefits of TCM.
Live birth rate comparison of three controlled ovarian stimulation protocols for in vitro fertilization-embryo transfer in patients with diminished ovarian reserve after endometrioma cystectomy: a retrospective study
Authors: Zhao Feiyan , Lan Yonglian , Chen Tong , Xin Zhimin , Liang Yu , Li Ying , Wang Shuyu , Zhang Jun , Yang Xiaokui 
Published: February 2020

Abstract
Background
Women with endometriosis and previous cystectomy may respond less well to gonadotropin stimulation, which results in fewer oocytes retrieved and poor pregnancy outcomes. Choosing an appropriate protocol for such populations is essential. This study involved an analysis of the effect of different controlled ovarian stimulation (COS) protocols on the clinical outcomes of in vitro fertilization-embryo transfer (IVF-ET) in women with diminished ovarian reserve (DOR) who underwent ovarian endometrioma cystectomy.

Methods
A total of 342 patients that underwent IVF-ET treatment at the Beijing Obstetrics and Gynecology Hospital from January 1, 2013 to April 30, 2018 were included in this retrospective study. The patients were distributed into three groups according to the COS protocols, namely prolonged GnRH-agonist (Group A, n = 113), GnRH-antagonist (Group B, n = 121), and long GnRH-agonist (Group C, n = 108). The clinical and laboratory parameters of the three protocols were analyzed and a logistic regression of clinical pregnancy and live births was conducted.

Results
There were no significant differences in the age, infertility duration, basic follicle stimulation hormone (FSH), luteinizing hormone (LH), or estradiol (E2) levels as well as other baseline characteristics among groups (P > 0.05). The total gonadotrophin (Gn) dosage and duration tended to be less in the GnRH-antagonist group than in the others (P < 0.05). No significant differences were found in the implantation rate and clinical pregnancy rate among the groups, but the prolonged GnRH-agonist group showed the highest rates. In addition, no significant differences were present in the number of retrieved oocytes, oocyte fertilization rate, embryo utilization rate, live birth rate, abortion rate, ectopic pregnancy rate, or multiple pregnancy rate in the three groups (P > 0.05). Age had a significant effect on both clinical pregnancy and live birth.

Conclusion
For those DOR patients who had undergone ovarian endometriosis cystectomy, the prolonged GnRH-agonist protocol may achieve better clinical IVF-ET outcomes, but there were no significant differences from the other groups. The GnRH-antagonist protocol may reduce the cost and time of drug treatment. Age should be considered for its influence on pregnancy outcome. However, a larger sample size may be needed for further study.
Racial disparities in pre-operative pain, function and disease activity for patients with rheumatoid arthritis undergoing Total knee or Total hip Arthroplasty: a New York based study
Authors: Hirsch J. , Mehta B. , Finik J. , Navarro-Millan I. , Brantner C. , Mirza S. , Figgie M. , Parks M. , Russell L. , Orange D. , Goodman S. 
Published: February 2020

Abstract
Background
Black and Hispanic patients with osteoarthritis have more pain and worse function than Whites at the time of arthroplasty. Whether this is true for patients with rheumatoid arthritis (RA) is unknown.

Methods
This cross-sectional study used data on RA patients acquired between October 2013 and November 2018 prior to elective total knee (TKA) or hip arthroplasty (THA). Pain, function, and disease activity were assessed using the visual analogue scale (VAS), the Multidimensional Health Assessment Questionnaire (MDHAQ), and the Disease Activity Score (DAS28-ESR). We linked the cases to census tracts using geocoding to determine the community poverty level. Race, education, income, insurance and medications were collected via self-report. Using multivariable linear and logistic models we examined whether minority status predicted pain, function and RA disease activity at the time of arthroplasty.

Results
Thirty seven (23%) of the 164 patients were Black or Hispanic (minorities). The MDHAQ and DAS28-ESR were not significantly worse while VAS pain score was significantly worse in minority patients (p = 0.03). There was no significant difference in education between the groups. Insurance varied significantly; 29% of minority patients had Medicaid vs. 0% of Whites (p < 0.0001). In the multivariable analyses minority status was not significantly associated with DAS28-ESR [p = 0.66], MDHAQ [p = 0.26], or VAS pain [p = 0.18].

Conclusions
For Black and/or Hispanic patients with RA undergoing THA or TKA at a high-volume specialty hospital, unlike Black or Hispanic patients with osteoarthritis (OA), there was no association with worse pain, function, or RA disease activity at the time of elective arthroplasty.
Effect of Plasma Exchange in Thyroid Storm With Consideration of Its Distribution Into the Extravascular Space
Authors: Shinohara Mai , Uchida Toyoyoshi , Funayama Takashi , Watanabe Mika , Kusaoi Makio , Yamaji Ken , Tamura Naoto , Goto Hiromasa , Satoh Hiroaki , Watada Hirotaka 
Published: February 2020

Abstract
Plasma exchange (PE), which directly removes some plasma thyroid hormones, is a treatment option for thyroid storm. However, the effect of PE has not been accurately assessed yet. Here we assessed the effect of PE in a patient with thyroid storm while taking into consideration the distribution of thyroid hormones in the extravascular space. A 51-year-old woman with thyroid storm underwent 2 PE procedures at our hospital. By measuring changes in thyroid hormone levels in plasma, fresh frozen plasma (FFP) used, and waste fluid during each 2.5-hour PE procedure, we calculated the efficiency of thyroid hormone removal based on the hypothesis that total thyroid hormone content before and after PE is the same. During the patient’s first PE procedure, the estimated thyroxine (T4) balance in the extravascular space (ΔX) was −70 μg, which corresponds to approximately 19% of T4 in the waste fluid. During the second PE procedure, ΔX was −131 μg, which corresponds to approximately 52% of T4 in the waste fluid. These data indicated that the source of removed T4 during PE varies. The amount of T4 removed from the extravascular space should be taken into account during assessment of the effect of PE in thyroid storm.