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Sample translations submitted: 1
English to Spanish: Consentimieto MOBILE ODT General field: Medical Detailed field: Medical (general)
Source text - English “Pilot Evaluation of the Mobile ODT device adapted to smartphones, for cervix images compared to a standard colposcopy in the detection of cervical dysplasia”Mobile ODT pilot evaluation adapted to smartphones for cervix imaging, compared to standard colposcopy for cervical dysplasia detection .
Principal Researcher: Bruce Kahn, M.D
Co-Researchers:
Sonia Contreras, Dr. C.
Marcela Merino. Lic.
Octavio Alberto Villalobos-Méndez, Dr.
Marta María Madiedo-Camargo, Dr.
Contact number for study questions: Dr. Octavio Villalobos,Tel. (664) 607-1682
Sonia Contreras,Tel. (619) 623-6846
Study location: Centro Médico Pro Salud
Av. Juan Ojeda Robles 14445,
Col. Guadalupe Victoria, C.P. 22426,
Tijuana, B.C., México.
Sponsor:Vodafone Americas Foundation Wireless Innovation Project,
Through the International Community Foundation.
Why is this study taking place?
This investigation is taking place with the objective to study if the use of smartphones with an adapted microscopic low cost lens, can be used to detect pre-cancerous changes in the cervix. The study pretends to analyze if the Mobile ODT camera adapted to a smartphone, can provide high resolution images as good as the ones obtained from more expensive microscopic systems which are used nowadays. (Conventional colposcopy).
Colposcopy consists of examining the cervix through a microscope. This is the standard procedure that is done when women receive an abnormal cervix cytology or a HPV (Human Papilloma Virus) abnormal detection test. When the PapanicolaouPapanicolaou or HPV test comes back abnormal, a colposcopy is performed to determine if precancerous changes are present in any suspect tears present in the cervix. Colposcopy is used to identify the exact places where the biopsies should be taken. Biopsies are then evaluated by pathologists to determine is precancerous changes are present. If an abnormality is detected by the pathologists, a doctor or health provider will determine next steps and necessary treatment if necessary.
Since the doctor or health provider that performs PapanicolaouPapanicolaou or cervical HPV recommended that you take a colposcopy, researchers also ask that on top of receiving y our standard colposcopy exam, you participate in the study to allow us to take additional images with the Mobile ODT camera. This will help compare both sets of images taken with each type of technology.
The sponsor of the Mobile ODT and the manufacturer of the device or camera have provided the equipment to perform this pilot study . This investigation is financed by a donation granted to the International Community Foundation in San Diego, CA and to United Frontiers Pro Salud by Vodaphone Americas Foundation Wireless Innovations Project 2014.
50 people will participate in this pilot study in Tijuana.
How long will I be part of the study?
If you are convinced by the study and you accept to participate, your participation will end when your colposcopy service visit is over.
What will happen to me during the study?
To understand what will take place in the visit as part of your study, it is important to know what the standard colposcopy procedure works.
A standard colposcopy visit includes the following steps:
1. Esto es similar a tener una prueba estándar de Papanicolaou .This is similar to having a standard Papanicolaou. Once the patient is put in the examination table, a speculum is inserted inside the vagina and the cervix becomes visible. This is similar to a standard PapanicolaouPapanicolaou procedure.
2. Then the cervix is examined with a colposcopy. A colposcopy is a microscope specifically designed to examine the cervix where cervix cancers can be found. Sometimes a picture is taken and registered in your clinical history.
3. Big cotton swabs are used to bathe the cervix in vinegar. The chemical name of this vinegar is "acetic acid". This vinegar is a soft acid and will not cause any stinging sensation.
4. The vinegar allows the cervix to be "moistened" for two minutes. During this time, the vinegar produces white spots or other visible changes in the tissue that may be pre-cancerous.
5. After looking for white spots or other abnormal changes, the cervix is inspected. Sometimes, another picture is taken and saved in your medical history.
6. A green filter is put in front of the colposcopy lens. This helps detect pre-cancerous vascular changes.
7. Using the information obtained from this procedures, a decision is taken as to where the biopsy should be taken.
8. The biopsy is taken. This usually causes a quick and sharp pinching sensation. Anesthesia of the area is not necessary.
9. A mustard color liquid iron solution is placed in the place where the biopsy was done to prevent the bleeding.
10. The entire procedure takes approximately 15-20 minutes.
Once more, the steps mentioned above are part of the standard procedure for the evaluation of any abnormal PapanicolaouPapanicolaou smears and is only done if you decide to participate in the study.
If you decide to be included in the study, a standard colposcopy is done, and additional images of your cervix with at smartphone and the microscopic lens accessory of the Mobile ODT M3 are taken. Those images will be taken before, during and after the vinegar is applied to the cervix. This study as part of the standard procedure should not add more than 5 minutes to the total time of the procedure. This images will then be compared with the images obtained through conventional colposcopy.
No medical decision about your care will be taken based on the images taken with the smartphone device. The decisions will be based on the images taken with the standard colposcopy. You will receive additional standard medical attention if you participate in the study or not.
Could you experiment any secondary effects or discomfort?
Any discomfort that you may feel is part of the standard colposcopy procedure. This could be a small and short discomfort and include discomfort during the examination with the speculum and during the biopsy. The study procedure should not cause any additional discomfort or secondary effect.
Will I get any benefit if I participate?
We don´t expect you to benefit for participating in this study, but other people with your condition can benefit in the future if the technology results to be the same or better than conventional colposcopy.
Will I get paid?
No, you will not be paid for participating in the study.
Is there any cost associated to participating in the study?
No, there will not be any cost associated with participating in this study.
What are my rights if I participate?
You will be able to call the support team if you have any questions about the study. The phone number will be provided in the upper part of the consent form.
You can decide not to participate in the study and you can also refrain from participating once it has initiated.
Whichever decision you take, your medical attention in Pro Salud will not be affected.
If you have any questions about your rights, call Pro Salud.
You are NOT obligated to participate in this study. You will continue having all your legal rights if you participate or not in this study.
You have the right to be informed about any new development that may cause you to change your mind about participating or not in the study.
What are my responsibilities if I decide to participate?
By participating in the study, you are expected to follow instructions of the investigation personnel.
What happens with confidentiality?
The medical personnel in Pro Salud will keep your personal information confidential. The images of your specific procedure will be assigned study numbers in order for them to be identifiable. This study numbers will be kept safely in Pro Salud´s archive. Only study personnel will have access to the information. Your name and any other identification information will not be shared with anyone else. The procedure images with the study numbers and without a name, will only be shared and reviewed by Pro Salud´s gynecologists, scientists that work for Mobile ODT and medical experts collaborating with Scripsps Health, among others.
For more information, please refer to the authorization to use your private medical information at the end of this consent form.
What happens if I have complications during the study?
If you have complications during the study, you will immediately be examined in the Gynecology Office or the Pro Salud Medical Center Surgery Center, open from Monday to Friday from 09:00 am to 7:00 pm and Saturdays from 9:00 am to 2pm.
If you need urgent medical attention during the study, it will be provided in agreement with institutional guidelines.
The study does not have available funds to cover your out of work hours. You are not giving up to any of your legal rights by participating in this study.
Pro Salud, the study doctor or the sponsor are benefiting from this study?
Pro Salud has received a subvention to cover the costs of this investigation and to promote a higher number of cervix cancer detection in vulnerable populations.
I agree to participate
I have read and understood the study explanation. The study has also been explained by Drs. Miedo, Avalos, Ibarra, García, Dr. Villalobos, Nurse Nancy García or the Social Security Medical Interns. I have had the opportunity to make questions and I have had satisfactory answers. I agree to participate in this study. I have not been forced or coerced into participating.
I have read the attached authorization document to use my private medical information, which contains important information about the investigation studies. I sign this consent form and the authorization to use my private medical information. A signed copy of both documents will be given to me.
______________ _______________ _______________
Patient Name Patient Signature Agreement Date
_______________ _____________________ ________________
Health Provider Name Health Provider Signature Procedure Date
_____________________________
Investigation Study patient Code
Translation - Spanish “Pilot Evaluation of the Mobile ODT device adapted to smartphones, for cervix images compared to a standard colposcopy in the detection of cervical dysplasia”Mobile ODT pilot evaluation adapted to smartphones for cervix imaging, compared to standard colposcopy for cervical dysplasia detection .
Principal Researcher: Bruce Kahn, M.D
Co-Researchers:
Sonia Contreras, Dr. C.
Marcela Merino. Lic.
Octavio Alberto Villalobos-Méndez, Dr.
Marta María Madiedo-Camargo, Dr.
Contact number for study questions: Dr. Octavio Villalobos,Tel. (664) 607-1682
Sonia Contreras,Tel. (619) 623-6846
Study location: Centro Médico Pro Salud
Av. Juan Ojeda Robles 14445,
Col. Guadalupe Victoria, C.P. 22426,
Tijuana, B.C., México.
Sponsor:Vodafone Americas Foundation Wireless Innovation Project,
Through the International Community Foundation.
Why is this study taking place?
This investigation is taking place with the objective to study if the use of smartphones with an adapted microscopic low cost lens, can be used to detect pre-cancerous changes in the cervix. The study pretends to analyze if the Mobile ODT camera adapted to a smartphone, can provide high resolution images as good as the ones obtained from more expensive microscopic systems which are used nowadays. (Conventional colposcopy).
Colposcopy consists of examining the cervix through a microscope. This is the standard procedure that is done when women receive an abnormal cervix cytology or a HPV (Human Papilloma Virus) abnormal detection test. When the PapanicolaouPapanicolaou or HPV test comes back abnormal, a colposcopy is performed to determine if precancerous changes are present in any suspect tears present in the cervix. Colposcopy is used to identify the exact places where the biopsies should be taken. Biopsies are then evaluated by pathologists to determine is precancerous changes are present. If an abnormality is detected by the pathologists, a doctor or health provider will determine next steps and necessary treatment if necessary.
Since the doctor or health provider that performs PapanicolaouPapanicolaou or cervical HPV recommended that you take a colposcopy, researchers also ask that on top of receiving y our standard colposcopy exam, you participate in the study to allow us to take additional images with the Mobile ODT camera. This will help compare both sets of images taken with each type of technology.
The sponsor of the Mobile ODT and the manufacturer of the device or camera have provided the equipment to perform this pilot study . This investigation is financed by a donation granted to the International Community Foundation in San Diego, CA and to United Frontiers Pro Salud by Vodaphone Americas Foundation Wireless Innovations Project 2014.
50 people will participate in this pilot study in Tijuana.
How long will I be part of the study?
If you are convinced by the study and you accept to participate, your participation will end when your colposcopy service visit is over.
What will happen to me during the study?
To understand what will take place in the visit as part of your study, it is important to know what the standard colposcopy procedure works.
A standard colposcopy visit includes the following steps:
1. Esto es similar a tener una prueba estándar de Papanicolaou .This is similar to having a standard Papanicolaou. Once the patient is put in the examination table, a speculum is inserted inside the vagina and the cervix becomes visible. This is similar to a standard PapanicolaouPapanicolaou procedure.
2. Then the cervix is examined with a colposcopy. A colposcopy is a microscope specifically designed to examine the cervix where cervix cancers can be found. Sometimes a picture is taken and registered in your clinical history.
3. Big cotton swabs are used to bathe the cervix in vinegar. The chemical name of this vinegar is "acetic acid". This vinegar is a soft acid and will not cause any stinging sensation.
4. The vinegar allows the cervix to be "moistened" for two minutes. During this time, the vinegar produces white spots or other visible changes in the tissue that may be pre-cancerous.
5. After looking for white spots or other abnormal changes, the cervix is inspected. Sometimes, another picture is taken and saved in your medical history.
6. A green filter is put in front of the colposcopy lens. This helps detect pre-cancerous vascular changes.
7. Using the information obtained from this procedures, a decision is taken as to where the biopsy should be taken.
8. The biopsy is taken. This usually causes a quick and sharp pinching sensation. Anesthesia of the area is not necessary.
9. A mustard color liquid iron solution is placed in the place where the biopsy was done to prevent the bleeding.
10. The entire procedure takes approximately 15-20 minutes.
Once more, the steps mentioned above are part of the standard procedure for the evaluation of any abnormal PapanicolaouPapanicolaou smears and is only done if you decide to participate in the study.
If you decide to be included in the study, a standard colposcopy is done, and additional images of your cervix with at smartphone and the microscopic lens accessory of the Mobile ODT M3 are taken. Those images will be taken before, during and after the vinegar is applied to the cervix. This study as part of the standard procedure should not add more than 5 minutes to the total time of the procedure. This images will then be compared with the images obtained through conventional colposcopy.
No medical decision about your care will be taken based on the images taken with the smartphone device. The decisions will be based on the images taken with the standard colposcopy. You will receive additional standard medical attention if you participate in the study or not.
Could you experiment any secondary effects or discomfort?
Any discomfort that you may feel is part of the standard colposcopy procedure. This could be a small and short discomfort and include discomfort during the examination with the speculum and during the biopsy. The study procedure should not cause any additional discomfort or secondary effect.
Will I get any benefit if I participate?
We don´t expect you to benefit for participating in this study, but other people with your condition can benefit in the future if the technology results to be the same or better than conventional colposcopy.
Will I get paid?
No, you will not be paid for participating in the study.
Is there any cost associated to participating in the study?
No, there will not be any cost associated with participating in this study.
What are my rights if I participate?
You will be able to call the support team if you have any questions about the study. The phone number will be provided in the upper part of the consent form.
You can decide not to participate in the study and you can also refrain from participating once it has initiated.
Whichever decision you take, your medical attention in Pro Salud will not be affected.
If you have any questions about your rights, call Pro Salud.
You are NOT obligated to participate in this study. You will continue having all your legal rights if you participate or not in this study.
You have the right to be informed about any new development that may cause you to change your mind about participating or not in the study.
What are my responsibilities if I decide to participate?
By participating in the study, you are expected to follow instructions of the investigation personnel.
What happens with confidentiality?
The medical personnel in Pro Salud will keep your personal information confidential. The images of your specific procedure will be assigned study numbers in order for them to be identifiable. This study numbers will be kept safely in Pro Salud´s archive. Only study personnel will have access to the information. Your name and any other identification information will not be shared with anyone else. The procedure images with the study numbers and without a name, will only be shared and reviewed by Pro Salud´s gynecologists, scientists that work for Mobile ODT and medical experts collaborating with Scripsps Health, among others.
For more information, please refer to the authorization to use your private medical information at the end of this consent form.
What happens if I have complications during the study?
If you have complications during the study, you will immediately be examined in the Gynecology Office or the Pro Salud Medical Center Surgery Center, open from Monday to Friday from 09:00 am to 7:00 pm and Saturdays from 9:00 am to 2pm.
If you need urgent medical attention during the study, it will be provided in agreement with institutional guidelines.
The study does not have available funds to cover your out of work hours. You are not giving up to any of your legal rights by participating in this study.
Pro Salud, the study doctor or the sponsor are benefiting from this study?
Pro Salud has received a subvention to cover the costs of this investigation and to promote a higher number of cervix cancer detection in vulnerable populations.
I agree to participate
I have read and understood the study explanation. The study has also been explained by Drs. Miedo, Avalos, Ibarra, García, Dr. Villalobos, Nurse Nancy García or the Social Security Medical Interns. I have had the opportunity to make questions and I have had satisfactory answers. I agree to participate in this study. I have not been forced or coerced into participating.
I have read the attached authorization document to use my private medical information, which contains important information about the investigation studies. I sign this consent form and the authorization to use my private medical information. A signed copy of both documents will be given to me.
______________ _______________ _______________
Patient Name Patient Signature Agreement Date
_______________ _____________________ ________________
Health Provider Name Health Provider Signature Procedure Date
_____________________________
Investigation Study patient Code
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