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English to Spanish: Extract from a clinical trial protocol General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Landmark outcomes of a 70.6% response rate, 14-month progression-free survival (PFS) and 27-month median survival have been attained in Caucasian erlotinib-treated non-small-cell lung cancer patients harboring activating mutations in the epidermal growth factor receptor (EGFR) kinase domain. The L858R mutation had a detrimental effect on survival in comparison with the deletion in exon 19 (del 19). There were no differences in survival between patients receiving erlotinib as first- or second-line therapy, in contrast to findings in the erlotinib-sensitive PC9 cell line, containing the del 19, where prior exposure to platinum agents reduced erlotinib sensitivity fivefold. In a study of Asian patients (79% females and 93.6% never-smokers), a subgroup with EGFR mutations attained a response rate of 71.2% with gefitinib, compared to 47.3% with carboplatin-paclitaxel; PFS was longer in the gefitinib arm, while overall survival was around 23 months in both arms. Pooled data on Japanese EGFR-mutated patients also showed strikingly better response of PFS in patients receiving first-line gefitinib than in those receiving first-line chemotherapy, although overall survival was similar (27.7 vs 25.7 months).
Translation - Spanish En los pacientes de raza blanca que presentaban carcinoma broncopulmonar no microcítico con mutaciones activadoras en el dominio cinásico del receptor del factor de crecimiento epidérmico (EGFR) y que fueron tratados con erlotinib, se obtuvieron los siguientes resultados de referencia: una tasa de remisión del 70,6 %, un tiempo de supervivencia sin progresión (SSP) de 14 meses y una mediana de la supervivencia de 27 meses. A diferencia de la deldeleción del exón 19 (del 19), la mutación L858R tuvo un efecto perjudicial en el periodo de supervivencia de los pacientes. No se observaron diferencias en el tiempo de supervivencia entre los pacientes que recibieron erlotinib como tratamiento de primera línea y los que lo recibieron como tratamiento de segunda línea, a diferencia de los resultados obtenidos con la estirpe celular PC9 sensible al erlotinib que contiene del 19, donde la exposición previa a sustancias derivadas del platino redujo en 5 veces la sensibilidad al erlotinib. En un estudio con pacientes asiáticos en el que el 79 % de los participantes eran mujeres y el 93,6 % nunca habían fumado, en el subgrupo con mutaciones en el EGFR se obtuvo una tasa de remisión del 71,2 % en los pacientes que fueron tratados con gefitinib, mientras que la tasa de remisión en los pacientes que fueron tratados con carboplatino-paclitaxel fue del 47,3 %; el periodo de SSP fue más largo en el grupo de gefitinib y, en términos generales, el tiempo de supervivencia en ambos grupos fue de aproximadamente 23 meses. Los datos agrupados de los pacientes japoneses con mutaciones en el EGFR mostraron que la respuesta en cuanto al tiempo de SSP en los pacientes que recibieron gefitinib como tratamiento de primera línea fue sorprendentemente superior que la de los pacientes que recibieron quimioterapia como tratamiento de primera línea, aunque, en conjunto, el tiempo de supervivencia en ambos casos fue similar (27,7 meses frente a 25,7 meses).
English to Spanish: Extract from ICF General field: Medical Detailed field: Medical (general)
Source text - English ETHICAL ASPECTS
Study-Specific Design Considerations
Potential subjects or their legally-acceptable representative will be fully informed of the risks and requirements of the study and, during the study, subjects or their legally-acceptable representative will be given any new information that may affect their decision to continue participation. They or their legally-acceptable representative will be told that their consent to participate in the study is voluntary and may be withdrawn at any time with no reason given and without penalty or loss of benefits to which they would otherwise be entitled. Only subjects or their legally-acceptable representative who are fully able to understand the risks, benefits, and potential AEs of the study, and provide their consent voluntarily will be enrolled.
The total blood volume to be collected will be approximately 332.5 mL (336.5 mL first 30 subjects), will not exceed the ethically allowed maximum of 3 % of the total blood volume during a period of 4 weeks and should not exceed 1% at any single time, as per the pediatric guidelines related to Directive 2001/20/EC of the European Commission.
Translation - Spanish ASPECTOS ÉTICOS
Consideraciones específicas del diseño del estudio
Se le informará al posible participante, o a su representante legal, sobre todos los riesgos y los requisitos del estudio; del mismo modo, también se le comunicará cualquier información nueva que surja a lo largo del estudio y que pueda afectar su voluntad de seguir participando.
Se les comunicará que su consentimiento para participar en el estudio es voluntario, que lo puede revocar en cualquier momento sin tener que justificarse y sin que su decisión comporte penalización alguna ni menoscabo de las prestaciones que le corresponden. Solo se inscribirá a las personas que comprendan en su totalidad los riesgos, los efectos beneficiosos y los posibles acontecimientos adversos del estudio, y que den su consentimiento voluntariamente.
El volumen de sangre que se extraerá en total será 332,5 ml (336,5 ml a los primeros 30 participantes), no superará el volumen máximo que la ética permite en un periodo de cuatro semanas (3 % de la volemia), ni se extraerá en ningún momento más del 1 % del volumen total de sangre, de acuerdo con las recomendaciones en pediatría relacionadas con la directiva 2001/20/EC del Parlamento Europeo y del Consejo.
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Other - World Language Services
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Years of experience: 14. Registered at ProZ.com: Dec 2018. Became a member: Mar 2019.
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English to Spanish (Chartered Institute of Linguists) English to Spanish (Words Language Services, verified)
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I'm Doris Cueto Briceno, a medical translator and interpreter specializing in clinical trial documents. With a master's degree in medical translation and membership in the Chartered Institute of Linguists, I've dedicated myself to the field of medical translation, driven by a deep passion for languages and cultures. Over the years, I have successfully translated over 1000 clinical trial projects for major Clinical Research Organizations and various translation agencies, encompassing informed consent forms, clinical trial protocols, investigator brochures, and more.
My expertise isn't limited to clinical trials alone; I've also translated medical product descriptions, case studies, healthcare articles, and provided general translation services for certificates, websites, and marketing materials. I pride myself on delivering accurate, culturally sensitive translations that meet the specific needs of my clients, facilitating clear communication and understanding across language barriers.
Whether you're looking for a specialist in medical translation or need reliable translation services for your project, I'm here to offer my expertise and help you achieve your goals. Let's connect and see how we can work together to bridge language gaps in your medical communications.
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Member since Mar '19
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