bluuebunny/crossref_metadata_2025_split huggingface dataset:
Combination Cisplatin-Epirubicin-Paclitaxel Therapy for Metastatic Extramammary Paget's Disease
Authors: Hirai Ikuko , Tanese Keiji , Nakamura Yoshio , Ishii Maki , Kawakami Yutaka , Funakoshi Takeru 
Published: March 2019

Abstract
Extramammary Paget's disease (EMPD) is a rare cutaneous adenocarcinoma that clinicopathologically resembles breast cancer. The prognosis of metastatic EMPD is poor. Although several chemotherapies have been tried, the effects are temporary; better drugs and combinations are required.
In the present study, we retrospectively analyze the efficacy and safety of combination of cisplatin, epirubicin, and paclitaxel in five metastatic EMPD cases. The efficacy was better than that for previously reported regimens: 80% partial responses, including two patients who were refractory to taxane- and/or platinum-based regimens. In terms of safety, four patients who were able to continue treatment exhibited acceptable tolerability.
This is the first regimen to combine taxane and anthracycline. When treating breast cancer, anthracycline is regarded as the key cytotoxic agent, and anthracycline in combination with taxane constitutes a key chemotherapeutic regimen. Given our results, we speculate both drugs are critical chemotherapeutic agents for the treatment of metastatic EMPD.
Efficacy and Safety of Tenapanor in Patients with Hyperphosphatemia Receiving Maintenance Hemodialysis: A Randomized Phase 3 Trial
Authors: Block Geoffrey A. , Rosenbaum David P. , Yan Andrew , Chertow Glenn M. 
Published: March 2019

Significance Statement
Phosphate binders are currently the only medications available to reduce elevated serum phosphate in patients with ESRD receiving hemodialysis. Tenapanor, a minimally absorbed inhibitor of gastrointestinal sodium/hydrogen exchanger 3 (NHE3), acts via a non–phosphate-binding mechanism, reducing paracellular phosphate transport in the intestine. The authors found that tenapanor significantly lowered elevated serum phosphate in patients receiving hemodialysis, resulting in a mean reduction of 1.0–1.2 mg/dl over 8 weeks. Tenapanor also showed a significant benefit over placebo in patients rerandomized to either continue tenapanor treatment or receive a placebo for 4 weeks. Adverse effects were largely limited to softening of stool and more frequent bowel movements. By targeting paracellular phosphate transport’s substantial contribution to net phosphate absorption in the gut, tenapanor has the potential to improve management of mineral bone disorder in CKD.

Background
Guidelines recommend reducing elevated serum phosphate in patients with CKD. Tenapanor, a minimally absorbed inhibitor of gastrointestinal sodium/hydrogen exchanger 3 (NHE3), reduces paracellular phosphate transport.

Methods
In this phase 3 randomized, double-blind trial, we randomly assigned patients with hyperphosphatemia receiving maintenance hemodialysis to receive twice-daily oral tenapanor (3, 10, or 30 mg [the latter down-titrated, if needed]) for 8 weeks. Patients were then rerandomized 1:1 to receive either their previously assigned dose or placebo for a 4-week ‘withdrawal’ period. We measured serum phosphate levels over the course of the trial. The primary end point was mean change in serum phosphate over the 4-week withdrawal period for the tenapanor group (using pooled data) versus the placebo group.

Results
Of 219 patients randomized, 152 completed both study phases. During the initial 8-week treatment period, all three treatment groups experienced significant decreases in mean serum phosphate (reductions of 1.00, 1.02, and 1.19 mg/dl, corresponding to the 3, 10, and 30 mg [down-titrated] dose groups, respectively). Tenapanor also showed a significant benefit over placebo during the withdrawal period, with a mean increase of 0.85 mg/dl in the placebo group versus a mean increase of 0.02 mg/dl in the pooled tenapanor group. Adverse events were largely limited to softened stool and a modest increase in bowel movement frequency, resulting from increased stool sodium and water content, stemming from tenapanor’s mechanism of action.

Conclusions
Tenapanor significantly reduced elevated serum phosphate in patients with hyperphosphatemia receiving maintenance hemodialysis. Adverse effects were limited to those induced by its known mechanism of action, which increases stool sodium and water content.
Twin pregnancy in the unicornuate uterus and non-communicating rudimentary horn: A case report
Authors: Hafizi Leili , Ghomian Nayereh 
Published: March 2019

Background: A unicornuate uterus is present in 0.1% of the general population. This müllerian anomaly carries significant obstetrical risk including abortion, preterm delivery, and rudimentary horn ruptures.
Case: The patient is a 24-yr-old primigravida with 12-wk gestational age and a twin pregnancy in the unicornuate uterus and non-communicating rudimentary horn. One fetus in the unicornuate uterus and other in the rudimentary horn that was ruptured. In urgent laparotomy rudimentary horn and fallopian tube excised. Pregnancy in the unicornuate uterus was continued and at 38-wk gestational age, cesarean section due to premature rupture of the membrane was performed and then normal fetus was delivered.
Conclusion: Twin pregnancy in a unicornuate uterus and rudimentary horn is a rare condition that carries a considerable risk to the mother. There is a need for increased awareness of this rare condition to prevent maternal morbidity and mortality.
Key words: Twin pregnancy, Uterus, Mullerian ducts.
Evaluation of orally disintegrating tablets (ODTs) containing microspheres with losartan potassium
Authors: Sarecka-Hujar Beata , Łyczak Karol , Balwierz Radosław , Jankowski Andrzej 
Published: March 2019

WprowadzenieUkłady wielokompartmentowe, w których dawka substancji leczniczej jest rozdzielona między nośniki (liposomy, mikrosfery, mikrokapsułki, nanokapsułki), otwierają nowe możliwości w uzyskaniu przedłużonego lub kontrolowanego uwalniania substancji leczniczej. Mikrosfery to monolityczne, porowate lub gładkie cząstki sferyczne
o wielkości 1–500 µm, w których substancja lecznicza jest zawieszona, inkorporowana, rzadziej emulgowana w matrycy polimerowej. Celem pracy było sporządzenie mikrosfer zawierających losartan potasu i Eudragit L 100-55 jako matrycę polimerową, a następnie tabletek rozpadających się w jamie ustnej (<i>orally disintegrating tablets</i> – ODTs) z otrzymanymi mikrosferami.MetodyMikrosfery o stosunku lek : polimer 1 : 1 i 1 : 2 otrzymano metodą suszenia rozpyłowego w następujących warunkach: temperatura na wlocie 150°C, wydajność aspiratora 80% oraz wydajność pompy 10%. Morfologia i wielkość mikrosfer oceniana była mikroskopowo. Tabletki zawierające mikrosfery z losartanem wykonano metodą tabletkowania bezpośredniego. Otrzymane ODTs oceniano zgodnie z wymogami Farmakopei Polskiej X (FPX) dla tej postaci leku. Analizę statystyczną przeprowadzono za pomocą programu Statistica 10.1.WynikiOtrzymane ODTs spełniały normy wyglądu, wielkości i jednolitości masy. Czas rozpadu ODTs nie przekraczał wymaganych 3 min. W przypadku analizy uwalniania losartanu dla mikrosfer o stosunku lek : polimer 1 : 1 w 0,1 M roztworu kwasu solnego (HCl) maksymalna ilość substancji czynnej (21%) uwolniła się w 60 minucie. Po 120 min proces kontynuowano w sztucznym soku jelitowym (pH = 6,8), w którym losartan uwolnił się całkowicie w czasie 270 min. W przypadku mikrosfer 1 : 2 w 0,1 M HCl maksymalna ilość losartanu (36%) uwolniła się w 90 minucie, a dalsze uwalnianie w sztucznym soku jelitowym wykazało uwolnienie 99,43% substancji czynnej w czasie 300 min.WnioskiModelowe mikrosfery z losartanem potasu mogą być wykorzystane jako pośrednia postać leku do stworzenia ODTs.
Resident Surgical Skills Web-Based Evaluation
Authors: Van Heest Ann E. , Agel Julie , Ames S. Elizabeth , Asghar Ferhan A. , Harrast John J. , Marsh J. Lawrence , Patt Joshua C. , Sterling Robert S. , Peabody Terrance D. 
Published: March 2019

Background:
Evaluation of surgical skill competency is necessary as graduate medical education moves toward a competency-based curriculum. This study by the American Board of Orthopaedic Surgery (ABOS) and the Council of Orthopaedic Residency Directors (CORD) compares 2 web-based evaluation tools that assess the level of autonomy that is demonstrated by residents during surgical procedures in the operating room as measured by faculty.

Methods:
Two hundred and ninety-four residents from 16 orthopaedic surgery residency programs were evaluated by 370 faculty using 2 web-based evaluation tools in a crossover design in which residents requested faculty review of their surgical skills before starting a case. One thousand, one hundred and fifty Ottawa Surgical Competency Operating Room Evaluation (O-Score) assessments, which included a 9-question evaluation of 8 steps of the surgical procedure, were compared with 1,186 P-score evaluations, which included a single-question summative evaluation. Twenty-five different surgical procedures were evaluated.

Results:
There were no significant differences in rates of resident requests or faculty completion of the 2 scores. The most common surgical procedures that were assessed were total knee arthroplasty (n = 254, 11%), carpal tunnel release (n = 191, 8%), open reduction and internal fixation (ORIF) of stable hip fractures (n = 170, 7%), ORIF of simple ankle fractures (n = 169, 7%), and total hip arthroplasty (n = 166, 7%). Both instruments disclosed significant differences in competency among entry, intermediate, and advanced-level residents. The findings support the construct validity of the evaluation method. The survey results indicated that >70% of the faculty were confident that use of either the P-score or the O-score allowed them to distinguish a resident who can perform the surgery independently from one who needs additional training.

Conclusions:
This research has led to the modification of the O-score and the P-score into a combined OP-score instrument. The ABOS envisions that the OP-score instrument can be used with an expanded number of surgical procedures as a required element of residency training in the near future.

Clinical Relevance:
This study allows the profession of orthopaedic surgery education to take a leadership role in the measurement of competence for surgical skills for orthopaedic surgeons in residency training, an important clinically relevant topic to the practice of orthopaedic surgery.
Prediction of Complications, Readmission, and Revision Surgery Based on Duration of Preoperative Opioid Use
Authors: Jain Nikhil , Brock John L. , Malik Azeem Tariq , Phillips Frank M. , Khan Safdar N. 
Published: March 2019

Background:
Preoperative opioid use results in adverse outcomes and higher costs after elective surgery. However, duration thresholds for higher risk are not entirely known. Therefore, the purpose of our study was to determine the number and duration of preoperative opioid prescriptions in order to estimate the risk of postoperative adverse events after major joint replacement and lumbar fusion.

Methods:
National insurance claims data (2007 to September 30, 2015) were used to identify primary total knee arthroplasties (TKAs), total hip arthroplasties (THAs), and 1 or 2-level posterior lumbar fusions (PLFs) performed for degenerative disease. The effect of preoperative opioid burden (naive, ≤3 months, >3 to 6 months, >6 months but stopped 3 months before surgery, and >6 months of continuous use) on the risks of various adverse outcomes was studied using Cox proportional hazards analysis with adjustment for demographic and clinical covariates.

Results:
A total of 58,082 patients stratified into 3 cohorts of 32,667 with TKA, 14,734 with THA, and 10,681 with 1 or 2-level PLF were included for this analysis. A duration of preoperative opioids of >3 months was associated with a higher risk of 90-day emergency department (ED) visits for all causes and readmission after TKA. Preoperative opioid prescription for >6 months was associated with a higher risk of all-cause and pain-related ED visits, wound dehiscence/infection, and hospital readmission within 90 days as well as revision surgery within 1 year after TKA, THA, and PLF. Stopping the opioid prescription 3 months preoperatively for chronic users resulted in a significant reduction in the risk of adverse outcomes, with the greatest impact seen after THA and PLF.

Conclusions:
Patients with a preoperative opioid prescription for up to 3 months before a major arthroplasty or a 1 or 2-level lumbar fusion had a similar risk of adverse outcomes as opioid-naive patients. While >6 months of opioid use was associated with a higher risk of adverse outcomes, a 3-month prescription-free period before the surgery appeared to mitigate this risk for chronic users.

Level of Evidence:
Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Occurrence and characteristics of perfluoroalkyl substances (PFASs) in electroplating industrial wastewater
Authors: Jiawei Tang , Yizhen Zhang , Jiajun Sun , Xuelu Shi , Chao Sun , Chunhui Zhang 
Published: March 2019

Abstract
The potential negative effects of perfluoroalkyl substances (PFASs) discharged into aquatic environments are drawing increasing attention. However, little research has been undertaken on PFASs in wastewater from electroplating industrial parks. In this study, the concentration profiles and geographical distribution of 11 PFASs were analyzed in water samples collected from different production workshops and an artificial landscaped lake. The total concentrations of PFASs (Σ11PFASs) at various points in the production drainage system range from 229.5 to 5410.6 ng/L, and are mainly contributed by nickel plating, pickling, and the cyanide bright silver plating procedure, which correspond to cyanide-containing and acid-alkali wastewater conditioning tanks. Wastewater treatment by oxidation and precipitation removed 52.6% and 20% of PFASs, respectively. Σ11PFASs in effluents is about 538 ng/L, which consists of perfluorooctanoic acid (PFOA, 430.5 ng/L), followed by perfluorooctane sulfonate (PFOS, 35.27 ng/L), perfluorohexane sulfonate (PFHxS, 28.05 ng/L), and perfluorohexanoic acid (PFHxA, 18.3 ng/L). Principal component analysis suggests that the Σ11PFASs in electroplating wastewater is very high and short-chain (C4–C8) PFASs have high detection and contribution rates. As a result, much attention should be paid to the increase in short-chain substitution effects and pollution around the factory area.
Association of CYP2D6*10 (c. 100 C>T) Genotype with Z-END Concentration in Patients with Breast Cancer Receiving Tamoxifen Therapy in Indonesian Population
Authors: Yenny  , Panigoro Sonar S. , Purwanto Denni J. , Hidayat Adi , Louisa Melva , Andalusia Rizka , Setiabudy Rianto 
Published: March 2019

Background:
Tamoxifen (TAM) is a frequently used hormonal prodrug for patients with
breast cancer that needs to be activated by cytochrome P450 2D6 (CYP2D6) into Zusammen-endoxifen
(Z-END).

Objective:
The purpose of the study was to determine the association between CYP2D6*10
(c.100C>T) genotype and attainment of the plasma steady-state Z-END minimal threshold concentration
(MTC) in Indonesian women with breast cancer.

Methods:
A cross-sectional study was performed in 125 ambulatory patients with breast cancer
consuming TAM at 20 mg/day for at least 4 months. The frequency distribution of CYP2D6*10
(c.100C>T) genotypes (C/C: wild type; C/T: heterozygous mutant; T/T: homozygous mutant) was
detected using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP),
the results of which were subsequently confirmed by sequencing. The genotypes were categorized
into plasma Z- END concentrations of <5.9 ng/mL and ≥5.9 ng/mL, which were measured using
ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS).

Results:
Percentages of C/C, CT, and T/T genotypes were 22.4%, 29.6%, and 48.8%, respectively.
Median (25-75%) Z-END concentrations in C/C, C/T, and T/T genotypes were 9.58 (0.7-6.0), 9.86
(0.7-26.6), and 3.76 (0.9-26.6) ng/mL, respectively. Statistical analysis showed a significant difference
in median Z-END concentration between patients with T/T genotype and those with C/C or C/T
genotypes (p<0.001). There was a significant association between CYP2D6*10 (c.100C>T) genotypes
and attainment of plasma steady-state Z-END MTC (p<0.001).

Conclusion:
There was a significant association between CYP2D6*10 (c.100C>T) and attainment of
plasma steady-state Z-END MTC in Indonesian breast cancer patients receiving TAM at a dose of 20
mg/day.
The Design of an Integrated Crude Oil Distillation Column with Submerged Combustion Technology
Authors: Mamudu Angela O. , Okonkwo Ebenezer , Okocha Stephen I. , Okoro Emeka E. , Elehinafe Francis , Igwilo Kevin 
Published: March 2019

Objective:
Generally, Petroleum refineries are put in place to convert or refine unprocessed crude oil into more useful products using both physical separation and chemical conversion processes. Albeit, different refining unit are subsets of the physical separation category. The atmospheric and vacuum distillation unit seems to be more prominent. Conventionally, the crude atmospheric residue cannot be further heated in an atmospheric condition due to: coke formation, pipes plugging, thermal cracking and straining of the furnace. A vacuum distillation column is therefore required.

Methods:
This study, therefore, focuses on the limitations, “over straining of the furnace to provide the necessary heat” and “non-reliance on the additional re-boiler since it only acts as a heat exchanger”. An integrated distillation column with a capacity of 10,000 barrel per day was therefore designed for the concurrent production of all distillate cuts.

Results:
This was achieved through the introduction of a submerged combustion zone at the stripping section of the column where Naphtha was utilized as the source of fuel. Verification of this approach was also conducted using Autodesk invention software and a finite element analysis tool to evaluate both thermal and computational fluid analysis impact. Overall, all derived distilled products met the American Society for Testing and Material Standard Table 6.
Psychopharmacological Options in the Multidisciplinary and Multidimensional Treatment of Eating Disorders
Authors: Milano Walter , Capasso Anna 
Published: March 2019

Eating Disorders (ED) are a syndrome characterized by persistent alteration of eating behavior and the conditions that cause insufficient ingestion and/or adsorption of foods. There are three different ED diseases: Anorexia Nervosa (AN), Bulimia Nervosa (BN) and Binge Eating Disorders (BED). ED are complex conditions that arise from a combination of long-standing behavioral, emotional, psychological, interpersonal, and social factors. A common trait to all EDs is the incongruous diet, often based on arbitrary parameters, disconnected from physiological needs, with a strong alteration of the sensations of hunger and satiety, to which variations in weight, body composition, health status and quality of life of patients occur. Although EDs are relatively frequent psychiatric disorders in the general population, especially in adolescent and juvenile age groups, evidence based on the scientific evidence of the efficacy of the pharmacological treatment of EDAs remains modest. The currently available international guidelines related to the pharmacological treatment of EDs are currently few and not always adequately informative, as they are affected by the lack of studies on the subject. As a further consequence of this it is not surprising that, with the sole exception of fluoxetine for the treatment of Bulimia Nervosa (BN) symptoms, no psychopharmaceutical has been authorized by national and international regulators for the treatment of ED.This narrative review focuses on the advantages and limitations of drugs used in the treatment of ED.
La familia Sarcoscyphaceae (Pezizales, Ascomycota) en México
Authors: Ortega-López Ismael , Valenzuela Ricardo , Gay-González Alfonso Daniel , Lara-Chávez Ma. Blanca Nieves , López-Villegas Edgar Oliver , Raymundo Tania 
Published: March 2019

Antecedentes y Objetivos: La Familia Sarcoscyphaceae es la quinta más numerosa del orden Pezizales con 102 especies; se caracteriza por presentar apotecios de colores rojos a anaranjados brillantes, debido a la presencia de pigmentos carotenoides y ascas suboperculadas con esporas lisas u ornamentadas, principalmente con estrías longitudinales vistas al microscopio óptico. El objetivo del presente estudio es realizar una revisión taxonómica de la familia Sarcoscyphaceae en México, basada en caracteres morfológicos macro y microscópicos y observación de las esporas al MEB para separar las especies.Métodos: Los especímenes estudiados fueron recolectados entre 2013 y 2018; además, se revisaron los que están depositados en la colección de hongos del herbario ENCB. Los ejemplares fueron estudiados, descritos y determinados de acuerdo a las técnicas tradicionales en micología. Por otro lado, se analizó el habito de crecimiento y tipo de vegetación donde se desarrollan las especies, de acuerdo al habitat donde crecen las aquí descritas.Resultados clave: Se determinaron 18 especies de Sarcoscyphaceae en México, de las cuales Geodina guanacastensis, Nanoscypha pulchra, Phillipsia olivacea y Sarcoscypha austriaca se citan por primera vez para el país. De acuerdo al habitat, las especies de esta familia se asociaron principalmente a los bosques tropicales caducifolios y perennifolios, mientras que el hábito lignícola de 16 especies fue el dominante.Conclusiones: La familia Sarcoscyphaceae se encuentra bien representada en México, siendo una de las mejores estudiadas del Orden Pezizales en el Phylum Ascomycota. La familia presenta una distribución destacadamente tropical con más de 60% de las especies localizadas en bosques tropicales caducifolios y perennifolios. Las especies de zonas templadas presentan distribución restringida y una mayor especificidad por el hospedero, en la mayoría de los casos, coníferas.