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English to German: Patient Collective General field: Medical Detailed field: Medical (general)
Source text - English 1 Definition of the patient collective
1.1 Inclusion criteria for ENROLMENT IN THE STUDY
• small cell lung cancer stage I-IIIA confirmed by histology/cytology
• no previous treatment of the small cell lung cancer
• measurable disease in the patient according to RECIST classification
• male and female patients aged 18-75 years (inclusive)
• general condition of the patient (ECOG) < 2
• life expectation 12 weeks
• negative pregnancy test in women of child-bearing age
• adequate haemogram, adequate renal and hepatic function defined as follows:
neutrophilic granulocytes 1.5 x 109/L
platelet count 100 x 109/L
total bilirubin 1.5 x upper normal limit
serum creatinine 1.5 x upper normal limit
AST/ALT 2.5 x upper normal limit
• written declaration of consent of the patient to participate in the study
• patients must be available for regular treatment and follow-up.
1.2 Additional criteria for RANDOMISATION (after 4 cycles TEC)
• PR or CR after 4 cycles TEC
• operability according to the guidelines of the German Pneumology Society
1.3 Exclusion criteria
• history of known malignant disease (with the exception of the study indication) or existing secondary malignancy, with the exception of a curatively treated non-melanomatous skin cancer, carcinoma in situ of the cervix or other malignancies, that had undergone curative surgery more than 5 years before inclusion in the study
• metastasised disease
• functional inoperability. The size of the resection should include the extent of spread of the primary tumour at the time of diagnosis.
• significant heart disease, e.g. uncontrolled hypertension, unstable angina pectoris, decompensated heart failure, myocardial infarction in the 6 months preceding inclusion in the study or treatment-requiring cardiac ventricular arrhythmias, 2nd or 3rd degree AV-block.
• motor or sensory neuropathy > Grade 1 according to CTC criteria version 2.0
• manifest severe infection or other serious medical conditions that could restrict the treatment of the patient as required by the Trial Protocol, including previous allergic reactions to drugs containing Cremophor (e.g. in teniposide or ciclosporin)
[…]
Translation - German 1 Definition des Patientenkollektivs
1.1 Aufnahmekriterien zur STUDIENAUFNAHME
• kleinzelliger Lungenkrebs Stadium I-IIIA, bestätigt durch Histologie/Zytologie
• keine vorherige Behandlung von kleinzelligem Lungenkrebs
• nachweisbare Erkrankung des Patienten nach RECIST-Klassifikation
• männliche und weibliche Patienten im Alter von (einschließlich) 18-75 Jahren
• Allgemeinzustand des Patienten (ECOG) < 2
• Lebenserwartung 12 Wochen
• negativer Schwangerschaftstest bei Frauen im gebährfähigen Alter
• hinreichendes Hämogramm, hinreichende renale and hepatische Funktion, definiert wie folgt:
neutrophile Granulozyten 1,5 x 109/L
Plättchenzahl 100 x 109/L
Gesamtbilirubin 1,5 x obere Normalgrenze
Serumkreatinin 1,5 x obere Normalgrenze
AST/ALT 2,5 x obere Normalgrenze
• schriftliche Einverständniserklärung des Patienten über die Teilnahme an der Studie
• Patienten müssen zur regelmäßigen Behandlung und Verlaufskontrolle verfügbar sein.
1.2 Zusätzliche Aufnahmekriterien für RANDOMISIERUNG (nach 4 TEC-Zyklen)
• PR oder CR nach 4 TEC-Zyklen
• Operabilität nach den Leitlinien der Deutschen Gesellschaft für Pneumologie
1.3 Ausschlusskriterien
• Vorgeschichte einer bekannten malignen Erkrankung (mit Ausnahme der Prüfindikation) oder bestehende sekundäre Malignome, mit Ausnahme von medizinisch behandeltem nicht-melanozytärem Hautkrebs, einem Zervixkarzinom in situ oder anderen malignen Erkrankungen, die mehr als 5 Jahre vor der Aufnahme in die Studie operativ behandelt wurden.
• Metastasen
• funktionale Inoperabilität. Das Ausmaß der Resektion sollte die Verbreitung des primären Tumors zum Zeitpunkt der Diagnose umfassen.
• Schwerwiegende Herzerkrankung, z.B. unkontrollierte Hypertonie, instabile Angina pectoris, dekompensierte Herzinsuffizienz, Myokardinfarkt während der 6 Monate vor der Aufnahme in die Studie oder behandlungsbedürftige ventrikuläre Arrhythmie, AV-block 2. oder 3. Grades.
• Motorische oder sensorische Neuropathie > Grad 1 nach den CTC-Kriterien Version 2.0
• Manifeste schwerwiegende Infektion oder andere ernste gesundheitliche Probleme, welche die Behandlung des Patienten nach Vorschrift des Versuchsprotokolls einschränken könnten, einschließlich vorhergehender allergischer Reaktionen auf Cremophor enthaltende Medikamente (z.B. Tenisposid oder Ciclosporin)
[…]
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Master's degree - University of Central Lancashire
Experience
Years of experience: 13. Registered at ProZ.com: Nov 2011.
It all started with a childhood dream: exploring the world! German born, I started travelling at 15 and lived in the USA. Back in my homecountry, it drew me to study languages which then led me to live in France. Then England. Then Spain. Then England, again. In that way, I take the fact that intepreters are also cultural intermediaries very serious and go live in the respective country.
I work professionally, accurately and punctually. My philosophy is to always be prepared, up to date, cost-effective and of benefit to others. I believe that success lies in the skill to be able to focus on the right aspects and have the right portion of serenity. And for all interpreters, the following good old English saying is so true: Keep calm and carry on!
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