bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development And Validation of a LC-MS Compatible Method for Quantification of Degradation Impurities of Clofazimine Using UHPLC
Authors: Surya Narayana Murty Nagulakonda Naga Veera Venkata Sri , Bhattacharjee Akash , Krishnamurthy Tatikonda , Rao Muguda Ravi Prasada , Rao Gollapalli Nageswara 
Published: March 2019

Background:Clofazimine has antibacterial and leprostatic properties, which has its use in Multidrug Therapy (MDT) of leprosy. As per the FDA guidance for industry, each NDA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product. However, it was noticed that no stability indicating method is available in the literature for the estimation of degradation impurities of Clofazimine.Objective:Objective of the proposed work is to develop and validate a rapid, specific, linear, robust, accurate and sensitive Ultra High-Performance Liquid Chromatography (UHPLC) method with LC-MS compatible mobile phase for the quantification of degradation impurities of Clofazimine in a pharmaceutical dosage form (topical gel 0.5% w/w).Methods:Ultra High-Performance Liquid Chromatography equipped with PDA and Tunable UV (TUV) detector at a wavelength of 284 nm, stationary phase with a fused core particle technology, LC-MS compatible mobile phase was employed in this study. Gradient elution was employed for ensuring the selectivity of degradation impurities and clofazimine. This method was validated in accordance with ICH Q2 guidelines. This is the first reported Ultra High-Performance Liquid Chromatography method for estimation of degradation impurities of clofazimine.Results:The method showed good linearity over the range of 0.25 -1.5μg/ml of clofazimine. All the validation parameters were within the acceptance criteria. The product is found to degrade in the acid and peroxide degradation condition. The major degradant impurities are eluted at relative retention times of 0.35, 0.89 and 0.95. The developed method successfully separated the degradation products of clofazimine and able to quantitate accurately in its formulation.Conclusion:To date, there is no UHPLC method for determination of degradation impurities of clofazimine. in pharmaceutical dosage forms. Being a specific, linear, accurate and robust method, this would help in determining the chemical stability of drug product during the product development as well as in the shelf life of the drug product.
Satisfaction with Orthodontic Care Provided in a University Orthodontic Clinic
Authors: Lyros Ioannis , Elpida Pavi , Tsolakis Apostolos I. , Margarita Makou , John Kyriopoulos 
Published: March 2019

Objective:
To evaluate patients’ satisfaction with their orthodontic care at the Department of Orthodontics of University of Athens.

Materials and Methods:

The study sample comprised of 100 individuals whose orthodontic treatment had been completed during the period May to October 2010. A questionnaire was designed and piloted before the telephone interviews were carried out. Questions concerned socio-demographic characteristics, reason for seeking care at the Dental School, level of satisfaction with treatment outcome, fees paid for treatment, and various aspects of organisation of care provision, assessed on 1-very dissatisfied to 5-very satisfied Likert type items.

Results:
Satisfaction score was particularly high as far as treatment outcome (53% were “very satisfied” and 31% were “satisfied”), dentist’s response to an emergency (81% were “very satisfied”), and personnel’s behavior at initial examination (81% were “very satisfied”) were concerned. Factors appearing to require improvement were the waiting time from initial examination to the beginning of treatment, the waiting room and the duration of treatment. Overall satisfaction was found to be significantly associated with total duration of treatment, fees paid by patients, treatment outcome, the behaviour of personnel who conducted first clinical examination, and dentist’s response to an emergency. Overall satisfaction was confirmed as the vast majority of patients (97%) would recommend the Orthodontic Clinic.

Conclusion:
While the Orthodontics Clinic enjoys overall highly satisfied patients, there is scope for improvement of organizational aspects of care provision like the waiting time between the initial examination and the beginning of treatment, the waiting room and the duration of treatment.
Prevalencia de la cirugía de control de daños en pacientes diagnosticados con trauma abdominal y toracoabdominal en el Hospital Traumatológico Dr. Ney Arias Lora; Período enero 2014-diciembre 2015, Santo Domingo, República Dominicana
Authors: Soto Alejandro , González Violeta , Ramírez Elizabeth , De Jesús Manuel , Mejía Sang Miguel , Guzmán Pérez Laura 
Published: March 2019

Objetivo: determinar la prevalencia de la cirugía de con­trol de daños y el impacto sobre la recuperación de los pacientes con trauma abdominal y toracoabdominal.
Materiales y métodos: Se realizó una investigación de tipo observacional, descriptiva y transversal, con informa­ción retrospectiva, donde se revisaron los expedientes de 32 pacientes diagnosticados con trauma abdominal o to­racoabdominal, a los que se les haya realizado la cirugía de control de daños en el Hospital Traumatológico Dr. Ney Arias Lora, en el período enero 2014-diciembre 2015.
Resultados y discusión: El 59% (n=19) de los pacien­tes tenían entre 15-30 años. El 81% (n=26) eran del sexo masculino. El 53% (n=17) presentó trauma cerrado de abdomen, mientras que 44% (n=14) presentó el accidente de vehículo de motor como causa de traumatismo. En los hallazgos quirúrgicos un 31% (n=10) presentó la lesión hepática AAST Grado IV. El 66% (n=21) de los casos no presentó complicaciones, y un 16% (n=5) presentó alte­raciones hemodinámicas. La tasa de mortalidad durante o después de la realización de dicho procedimiento fue de 0.0317 x 1000, lo cual también puede ser expresado como proporción de mortalidad de 32%.
Conclusiones: los jóvenes y adultos del sexo masculino son los más propensos a sufrir accidentes de cualquier tipo, convirtiéndolos en candidatos para la realización de cirugía de control de daños. Se infiere que la mayoría de la población estuvo expuesta a accidentes de vehículo de motor, transformándose éste, en un factor de riesgo para desarrollar trauma cerrado de abdomen.
Síndrome de Turner y embarazo espontáneo: presentación de dos casos
Authors: Carvajal Martínez Francisco , Borges Carcases Danexy , Ávila Baltazar Yisel , Burgos Cabrera Alicia , Piz Ramos Yuraimi 
Published: March 2019

Introducción: El Síndrome de Turner constituye la única monosomía completa compatible con la vida. Se produce por la no disyunción meiótica o mitótica de los cromosomas, con expresión variable, que se presenta en el sexo femenino y en el que es extraordinariamente infrecuente el embarazo espontáneo.
Objetivo: Describir dos casos clínicos con diagnóstico de Síndrome de Turner que lograron embarazo espontáneo.
Presentación de los casos clínicos:
Caso 1: Paciente femenina que a los 9 años de edad cronológica es remitida al Departamento de Endocrinología Pediátrica del Instituto Nacional de Endocrinología, por presentar retraso del crecimiento y desarrollo, donde a través de las manifestaciones clínicas y de los exámenes complementarios realizados, se le diagnosticó un Síndrome de Turner 45X/46XX. Recibió tratamiento con hormona de crecimiento biosintética y hormonas sexuales; logrando embarazo espontáneo a los 23 años de edad, y actualmente, tiene una hija de un año y medio.
Caso 2: Paciente femenina que a los de 9.4 años de edad cronológica es remitida al Departamento de Endocrinología Pediátrica del Instituto Nacional de Endocrinología por presentar retraso del crecimiento y desarrollo, donde a través de las manifestaciones clínicas y de los exámenes complementarios realizados, se le diagnosticó un Síndrome de Turner 45X. Recibió tratamiento con hormona de crecimiento biosintética, presentó menarquía espontánea a los 13 años con ciclos menstruales regulares; logró gestación espontánea a los 20 años, interrumpiendo el mismo por decisión personal.
Conclusiones: El embarazo en el Síndrome de Turner es infrecuente. Existe solo una publicación nacional, y muy pocas internacionales, de pacientes con esta afección que logren gestación espontánea. Se plantea que puede existir una línea celular a nivel de ovarios y útero que permite el desarrollo folicular y así lograr la fecundación. En la actualidad las expectativas de fertilidad con este síndrome han cambiado en los últimos años, gracias a los tratamientos de reproducción asistida.
Germinoma pineal como causa de panhipopituitarismo: reporte de un caso
Authors: Lantigua Güichardo Elianny Aimeé , H. Ang Kathleen 
Published: March 2019

Introducción: Los tumores de células germinales intracraneales constituyen un grupo infrecuente de neoplasias que afectan principalmente a la población pediátrica. Su presentación clínica varía en función de la localización y el tamaño del tumor. Las lesiones localizadas en la región pineal a menudo causan hidrocefalia obstructiva, mientras que las lesiones de localización supraselar, usualmente se asocian a disfunción del eje hipotálamo-hipofisario. Un tumor germinal de localización pineal que curse con endocrinopatías es una entidad extremadamente rara. Por tanto, reportamos el caso de un paciente masculino de 16 años de edad, con panhipopituitarismo secundario a un germinoma pineal.
Material y métodos: Este paciente fue referido al Departamento de Emergencias tras presentar hipernatremia en un análisis sanguíneo de rutina. Se presentó con polidipsia, poliuria y fatiga de un año de evolución. Las evaluaciones clínicas y pruebas de laboratorio reportaron diabetes insípida, panhipopituitarismo y hemianopsia bitemporal. El paciente recibió terapia de sustitución hormonal y tres meses después, la resonancia magnética de seguimiento reveló una masa en el área pineal que, a través de una posterior evaluación, fue diagnosticada como germinoma.
Conclusión: Luego de tratamiento con quimioterapia y radiación, hubo una resolución completa de la lesión. Sin embargo, no hubo mejoría clínica significativa y el paciente continúo necesitando terapia de reemplazo hormonal.
Tumor Neuroectodérmico Primitivo Supratentorial (TNEP): a propósito de un caso
Authors: Peña A. Chabela , Roa Batista Adriel , Fernández Josefina , Máquez Johanny , Martial Valentina 
Published: March 2019

Introducción: Los tumores neuroectodérmicos primitivos supratentoriales (TNEP) suponen el 2-3% de los tumores cerebrales infantiles. Se suelen presentar en la primera década de la vida, y están constituido por células neuroepiteliales indiferenciadas o poco diferenciadas, teniendo un comportamiento agresivo y rápida evolución.
Material y métodos: Se describe el caso de un lactante de 3 meses de edad, con diagnóstico inicial de meningitis bacteriana, manejado con antibioticoterapia. Al no evidenciarse evolución del cuadro, se realizan imágenes y pruebas imnunohistoquímicas que arrojan el diagnóstico de un TNEP localizado en región fronto-temporal derecha, de rápida progresión clínica hacia la muerte.
Conclusion: La acelerada evolución y la agresividad con la que se comportan estos tumores representa un alto nivel de mortalidad, su diagnóstico y tratamiento oportuno son vital para una evolución favorable del cuadro.
Casos de parálisis flácida aguda reportados para descartar polio en la República Dominicana entre 2001 y 2017: revisión de sus factores etiopatológicos
Authors: Santoni Juan , Garib Zacarias , Mancebo Pablo , Santoni Carlos , Grullón Patricia , Rodríguez Antolina 
Published: March 2019

Introducción: Tras 18 casos de poliomielitis descubiertos al final del 2000, en Constanza, el Ministerio de Salud Pública (MSP) y la Organización Panamericana de la Salud (OPS), comparten la responsabilidad de revisar, a los 60 días, todos los casos de Parálisis Flácidas Agudas (PFA). Para examinarlos se nombra un comité de pro­fesores (Tolentino, Mendoza, Santoni). Las entidades comprometidas habían publicado las características clí­nico-epidemiológicas del brote, mientras que J.Santoni y C.Santoni Williams publican su electromiografía. Para este artículo se revisa la literatura de etiopatogenias en la PFA y polio.
Métodos: Se citan 336 casos acompañados por encargados comunitarios, 188 varones, 148 hembras, edad promedio: 6.2 años. Se revisa: evolución, imágenes, analítica, cultivo viral en heces. Así mismo, diagnóstico y clasificación tras examen neurológico.
Resultados: Casos de poliomielitis (18), de 1 a 13 años: todos vacunados irregularmente. Citamos patología de membrana CD155 y del cañón neuronal. Describimos los casos de PFA en orden descendente; síndromes de Guillain-Barré (84), 10 de ellos Miller-Fisher; evolución moderada, 2 fallecidos. Se atribuye a mímica proteica de oligosacáridos. Casos de FPA que involucran a las cito­kinas; mielitis y encefalomielitis diseminada agudas (58); encefalitis, meningitis, cerebelitis (49); polineuritis/mono­neuritis (23); miopatías relacionadas a Estreptococias (25) con sus 6 Coreas por mímica proteica anti-lysogangliosi­do GM1; procesos entero virales (16), vasculitis con ACV escasos (11), tumores (10). Finalmente, encontramos 15 con exámenes asimétricos sospechosos de motoneurona lesionada, pero todos con cultivos fecales de poliovirus negativos; y 24 exámenes neurológicos normales, pero sin causa. Aceptamos 3 inasistencias.
Conclusión: Demostramos la ausencia de nuevos casos de polio y actualizamos la clasificación de las PFA. Revisando sus etiopatogenias las entendemos mejor.
The activeness, critical, and creative thinking skills of students in the Lesson Study-based inquiry and cooperative learning
Authors: Hasan Rusdi , Lukitasari Marheny , Utami Sri , Anizar Anizar 
Published: March 2019

The implementation of innovative learning and lesson study (LS) are potential to improve student thinking skills and activeness differently and mostly implemented separately. This study aimed to explore and compare the student critical and creative thinking skills as well as student activeness in the inquiry and cooperative models combined with LS-based learning practice. This was a descriptive quantitative study that was conducted at Islamic Senior High School 1 of Bengkulu. The sample was two classes consisted of 33 and 32 students each that conducted LS-inquiry and LS-cooperative learning. The essay test delivered to measure critical and creative thinking skills and observation sheet to measure student activeness. The data were analyzed by t-test to compare critical and creative thinking skills as well as the student activeness between the LS-inquiry and LS-cooperative classes. The result showed that LS-inquiry learning improved the student critical and creative thinking skills that significantly higher than LS-cooperative learning. The student activeness improved gradually as LS cycles during learning processes in either inquiry or cooperative learning, but no significant difference between these two learning models. It showed that inquiry learning plays a dominant influence in critical and creative thinking skills improvement, whereas LS in student activeness improvement otherwise.
Long-term Association of Depression Symptoms and Antidepressant Medication Use With Incident Cardiovascular Events in the Look AHEAD (Action for Health in Diabetes) Clinical Trial of Weight Loss in Type 2 Diabetes
Authors: Hazuda Helen P. , Gaussoin Sarah A. , Wing Rena R. , Yanovski Susan Z. , Johnson Karen C. , Coday Mace , Wadden Thomas A. , Horton Edward S. , Van Dorsten Brent , Knowler William C. ,   for The Look AHEAD Research Group
Published: March 2019

OBJECTIVE
To examine whether depression symptoms or antidepressant medication (ADM) use predicts the probability of cardiovascular events in overweight/obese individuals with type 2 diabetes.

RESEARCH DESIGN AND METHODS
Preplanned analyses of depression and incident cardiovascular disease (CVD) were performed in the Look AHEAD (Action for Health in Diabetes) weight loss trial after a median follow-up of 9.6 years. Depression symptoms, assessed with the Beck Depression Inventory (BDI), were analyzed both as a continuous and dichotomized variable (BDI score &lt;10 or ≥10). ADM use was coded from participants’ prescription medications. Four composite CVD outcomes were defined in the study protocol. Sex-stratified Cox proportional hazards models were adjusted for a range of baseline covariates.

RESULTS
Depression symptoms were only significantly associated with a composite secondary outcome comprising CVD death, nonfatal myocardial infarction, nonfatal stroke, hospitalized angina, congestive heart failure, peripheral vascular disease, coronary artery bypass graft, and carotid endarterectomy. Significant sex interactions were observed for BDI score and BDI score ≥10. BDI score was significantly associated with higher probability of this composite outcome in men but was not associated with the outcome in women. BDI score ≥10 was positively associated with this composite outcome in men but was negatively associated in women. Exploratory analysis identified a significant BDI ≥10 × ADM use interaction for this composite outcome that differed in men versus women. Men with both BDI score ≥10 and ADM use compared with those with neither had 60% higher probability of the outcome, whereas women with both compared with those with neither had 50% lower probability.

CONCLUSIONS
Sex differences in the association of depression symptoms and ADM use with incident CVD warrant further investigation.
Placental 11β-HSD2 and Cardiometabolic Health Indicators in Infancy
Authors: Chen Lu , Guilmette Julie , Luo Zhong-Cheng , Cloutier Anik , Wang Wen-Juan , Yang Meng-Nan , Fraser William D. , Dubois Josée , Nuyt Anne Monique 
Published: March 2019

OBJECTIVE
Fetal excessive exposure to glucocorticoids may program cardiometabolic risk. Placental 11 β-hydroxysteroid dehydrogenase 2 (11β-HSD2) serves as a barrier to prevent fetal overexposure to maternal glucocorticoids. It has not been explored whether placental 11β-HSD2 levels are associated with cardiometabolic health in postnatal life.

RESEARCH DESIGN AND METHODS
In a prospective birth cohort study of 246 mother-infant pairs, we measured placental 11β-HSD2 expression and maternal (32–35 weeks of gestation) and cord plasma cortisol concentrations. The primary outcomes were HOMA of insulin resistance (IR) and blood pressure (BP) in infants at age 1 year. Other outcomes included fasting insulin, HOMA β-cell function, carotid intima-media thickness, weight z score, and skinfold thickness (triceps and subscapular) at age 1 year.

RESULTS
Placental 11β-HSD2 expression was negatively correlated with HOMA-IR (r = −0.17, P = 0.021) and fasting insulin (r = −0.18, P = 0.017) and marginally negatively correlated with systolic BP (r = −0.16, P = 0.057) but was not correlated with HOMA of β-cell function, diastolic BP, carotid intima-media thickness, and skinfold thickness (all P &gt; 0.1) in infants at age 1 year. Cord plasma cortisol was negatively correlated to skinfold thickness (r = −0.20, P = 0007) but was not correlated with other outcomes at age 1 year. Maternal plasma cortisol was positively correlated with maximal carotid intima-media thickness (r = 0.20, P = 0.03) but was not correlated with other outcomes. Adjusting for maternal and infant characteristics, the associations were similar.

CONCLUSIONS
The study is the first to show that higher placental 11β-HSD2 expression is associated with lower IR in infancy. Independent cohort studies are required to confirm this novel finding.
Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program
Authors: Danne Thomas , Cariou Bertrand , Buse John B. , Garg Satish K. , Rosenstock Julio , Banks Phillip , Kushner Jake A. , McGuire Darren K. , Peters Anne L. , Sawhney Sangeeta , Strumph Paul 
Published: March 2019

OBJECTIVE
To evaluate effects of the dual sodium–glucose cotransporter (SGLT) 1 and SGLT2 inhibitor sotagliflozin in combination with insulin on glucose time in range (TIR) and glucose excursions, postprandial glucose (PPG), and other glycemic metrics in adults with type 1 diabetes using masked continuous glucose monitoring (CGM).

RESEARCH DESIGN AND METHODS
Data sets from the inTandem1 (clinical trial reg. no. NCT02384941) and inTandem2 (clinical trial reg. no. NCT02421510) double-blind randomized trials evaluating sotagliflozin versus placebo in adults with type 1 diabetes treated with optimized insulin were pooled for analyses of masked CGM data from a subset of participants in each trial. The pooled cohort included patients randomized to receive placebo (n = 93), sotagliflozin 200 mg (n = 89), or sotagliflozin 400 mg (n = 96). The primary outcome was change from baseline to week 24 in glucose TIR (3.9–10.0 mmol/L [70–180 mg/dL]). Secondary end points included time below and above the target range and 2-h PPG level assessed after a standardized mixed meal.

RESULTS
Mean percentage of glucose TIR/percentage time spent at &lt;3.9 mmol/L (&lt;70 mg/dL) during week 24 was 51.6%/5.9%, 57.8%/5.5%, and 64.2%/5.5% with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively, which corresponded to a placebo-adjusted change from a baseline of +5.4%/−0.3% (P = 0.026; +1.3/−0.1 h/day) for sotagliflozin 200 mg and +11.7%/−0.1% (P &lt; 0.001; +2.8/−0.02 h/day) for sotagliflozin 400 mg. Placebo-adjusted PPG reductions were 1.9 ± 0.7 mmol/L (35 ± 13 mg/dL; P = 0.004) and 2.8 ± 0.7 mmol/L (50 ± 13 mg/dL; P &lt; 0.001) with sotagliflozin 200 and 400 mg, respectively.

CONCLUSIONS
Combined with optimized insulin in type 1 diabetes, sotagliflozin significantly increased glucose TIR without increasing time spent at &lt;3.9 mmol/L and reduced PPG, thereby improving glycemic control.