Nov 7, 2018 21:02
5 yrs ago
7 viewers *
English term
Argentina
One-Month Clear
English to Spanish
Medical
Medical: Cardiology
Ensayo clínico
El término aparece en el título de un ensayo clínico.
Title: A Single Arm Study with *** in ONE- Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear
La descripción del objetivo del estudio es la siguiente:
The purpose of this study is to test the clinical safety of the *** stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month dual antiplatelet therapy (DAPT) treatment receiving reduced duration (one-month) of DAPT following stent implantation.
No encuentro un término médico específico para "one-month clear".
¡Muchas gracias!
Title: A Single Arm Study with *** in ONE- Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear
La descripción del objetivo del estudio es la siguiente:
The purpose of this study is to test the clinical safety of the *** stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month dual antiplatelet therapy (DAPT) treatment receiving reduced duration (one-month) of DAPT following stent implantation.
No encuentro un término médico específico para "one-month clear".
¡Muchas gracias!
Proposed translations
(Spanish)
| 3 | no presentaron eventos el primer meses |
Victor Muruet
|
| 3 | no aptos para [no recomendable] más de un mes de doble antiagregación |
Chema Nieto Castañón
|
Proposed translations
3 hrs
Victor Muruet
Native in Spanish
Works in field
NGOs tourism marketing patents since 97
Native in: Spanish (Variant: Mexican) 
Works in: English to Spanish, French to Spanish, Italian to Spanish
Related KudoZ points
:
4
Selected
no presentaron eventos el primer meses
encontré un estudio DAPT en español que inclupia la frase
"no presentaron eventos los 12 primeros meses"
no estoy 100% seguro pero ¿tal vez se refiera a eso? Seguiré buscando para ver si le damos al claco
"no presentaron eventos los 12 primeros meses"
no estoy 100% seguro pero ¿tal vez se refiera a eso? Seguiré buscando para ver si le damos al claco
4 KudoZ points awarded for this answer.
Comment: "¡Muchísimas gracias, Victor! El cliente acaba de confirmar tu opción. "One-month clear" hace referencia a la ausencia de eventos/acontecimientos al mes de la implantación del stent."
1 day 11 hrs
Chema Nieto Castañón
Spain
Spain
Native in Spanish
Specializes in field
Spain
Psychologist & Emergency Physician
Native in: Spanish (Variant: Standard-Spain) 
Works in: English to Spanish
Related KudoZ points
:
48
no aptos para [no recomendable] más de un mes de doble antiagregación
Aunque la expresión original es tal vez poco clara, se alude aquí a pacientes para los que está contraindicado el tratamiento con doble antiagregación (DAPT) durante más de un mes. Mientras que diversos estudios previos, incluido el propio Onyx ONE en el que se integra este (Onyx ONE Clear), evalúan los efectos de reducir la duración de la doble antiagregación, en este brazo del estudio se plantea un análisis aislado de los riesgos propios asociados a una antiagregación de sólo un mes en pacientes con alto riesgo de sangrado o que por distintos motivos médicos no pueden recibir doble antiagregación durante más de un mes.
Aunque me plantearía mantener tal cual los nombres resumidos, por ejemplo Onyx ONE Clear, traduciría, por ejemplo,
A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Estudio de brazo único con [Resolute Onyx] y un mes de doble antiagregación en pacientes con alto riesgo de sangrado considerados no aptos para recibir doble antiagregación durante más de un mes (Onyx ONE Clear).
Refs:
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (Onyx ONE)
Brief Summary:
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Masking Description:Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).Primary Purpose:TreatmentOfficial Title:Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
https://clinicaltrials.gov/ct2/show/NCT03647475
A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Brief Summary:
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Masking:None (Open Label)Primary Purpose:Treatment Official Title:Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Experimental: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal will be evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.
https://clinicaltrials.gov/ct2/show/NCT03344653
Results from the RESOLUTE ONYX ONE-MONTH DAPT Study will also build on the RESOLUTE Pooled DAPT Interruption analysis that showed no increased risk of stent thrombosis with DAPT interruption or discontinuation after one-month.
https://www.dicardiology.com/content/medtronic-announces-glo...
The study, called XIENCE Short DAPT, will evaluate if three months of DAPT is non-inferior to the current standard of 12 months after implantation with a Xience stent for patients who are at high risk of bleeding.
https://www.dicardiology.com/content/abbott-initiates-xience...
Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet therapy (S-DAPT) after drug-eluting stent (DES) implantation.
https://www.dicardiology.com/content/meta-analysis-compares-...
--------------------------------------------------
Note added at 5 days (2018-11-13 10:34:55 GMT) Post-grading
--------------------------------------------------
Gracias a ti por el feedback, Julia; el contexto más amplio siempre resulta determinante y las opciones que pueden plantearse aquí no pueden generalmente ser otra cosa sino pistas para investigar el texto fuente o el contexto más amplio sugerido por éste.
En este caso en particular, ausencia de eventos adversos es lectura razonable después de todo; ¡lamento haberte casi confundido con mis elucubraciones!
Estudio de brazo único con [implantación de *stent* seguido de] un mes de doble antiagregación en pacientes con alto riesgo de sangrado y sin eventos adversos durante el primer mes tras implantación
Sí, definitivamente suena razonable. Y aunque no aparezca esta ausencia de eventos adversos entre los criterios de inclusión/exclusión del planteamiento del estudio supongo que debemos entender que aparecerá en el protocolo específico del mismo tras la implantación del stent, confirmando el sentido de la expresión original.
Nuevamente, gracias por compartir la respuesta del cliente! ¡Saludos! ;)
Aunque me plantearía mantener tal cual los nombres resumidos, por ejemplo Onyx ONE Clear, traduciría, por ejemplo,
A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Estudio de brazo único con [Resolute Onyx] y un mes de doble antiagregación en pacientes con alto riesgo de sangrado considerados no aptos para recibir doble antiagregación durante más de un mes (Onyx ONE Clear).
Refs:
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (Onyx ONE)
Brief Summary:
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Masking Description:Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).Primary Purpose:TreatmentOfficial Title:Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.
https://clinicaltrials.gov/ct2/show/NCT03647475
A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Brief Summary:
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Masking:None (Open Label)Primary Purpose:Treatment Official Title:Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Experimental: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal will be evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.
https://clinicaltrials.gov/ct2/show/NCT03344653
Results from the RESOLUTE ONYX ONE-MONTH DAPT Study will also build on the RESOLUTE Pooled DAPT Interruption analysis that showed no increased risk of stent thrombosis with DAPT interruption or discontinuation after one-month.
https://www.dicardiology.com/content/medtronic-announces-glo...
The study, called XIENCE Short DAPT, will evaluate if three months of DAPT is non-inferior to the current standard of 12 months after implantation with a Xience stent for patients who are at high risk of bleeding.
https://www.dicardiology.com/content/abbott-initiates-xience...
Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet therapy (S-DAPT) after drug-eluting stent (DES) implantation.
https://www.dicardiology.com/content/meta-analysis-compares-...
--------------------------------------------------
Note added at 5 days (2018-11-13 10:34:55 GMT) Post-grading
--------------------------------------------------
Gracias a ti por el feedback, Julia; el contexto más amplio siempre resulta determinante y las opciones que pueden plantearse aquí no pueden generalmente ser otra cosa sino pistas para investigar el texto fuente o el contexto más amplio sugerido por éste.
En este caso en particular, ausencia de eventos adversos es lectura razonable después de todo; ¡lamento haberte casi confundido con mis elucubraciones!
Estudio de brazo único con [implantación de *stent* seguido de] un mes de doble antiagregación en pacientes con alto riesgo de sangrado y sin eventos adversos durante el primer mes tras implantación
Sí, definitivamente suena razonable. Y aunque no aparezca esta ausencia de eventos adversos entre los criterios de inclusión/exclusión del planteamiento del estudio supongo que debemos entender que aparecerá en el protocolo específico del mismo tras la implantación del stent, confirmando el sentido de la expresión original.
Nuevamente, gracias por compartir la respuesta del cliente! ¡Saludos! ;)
Note from asker:
| ¡Muchísimas gracias, Chema! Yo también pensé que tu opción era la más acertada, pero el cliente acaba de confirmar que "one-month clear" hace referencia a la ausencia de eventos/acontecimientos al mes de la implantación del stent. Nuevamente gracias por tu tiempo. |
Peer comment(s):
| neutral |
Stuart and Aida Nelson
: por lo que leí acerca de los estudios Onyx esto me parece más acertado, sin embargo por falta de evidencia del texto fuente no sabemos exactamente y por eso no pongo un 'agree', buen trabajo, Chema, saludos :)
2 hrs
|
|
Muchas gracias por el comentario, Aida ;)
|
Discussion
Exclusion Criteria:
Pregnant and breastfeeding women
Subjects requiring a planned PCI procedure after 1 month of index procedure
Active bleeding at the time of inclusion
Cardiogenic shock
A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
Participation in another clinical study within 12 months after index procedure
Subjects with life expectancy of less than 2 years
https://clinicaltrials.gov/ct2/show/NCT03344653
Me parece más razonable en cambio en este contexto específico que patients considered one month clear aluda a pacientes en los que no es recomendable que la doble antiagregación supere el mes (por alto riesgo de sangrado o por otros motivos). Ver rta...