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English to Italian: A Clinical Trial inclusion criteria General field: Medical
Source text - English Population:
Inclusion Criteria
• Signed written informed consent according to IGH/EU/GCP and national local laws
• Newly diagnosed untreated ITP adult patients
• Age > 18 < 80 years
• Platelet count 20 x109/L and 8 (according to grading scale at paragraph 7.1)
• Baseline Quality of Life evaluation questionnaire filled in
Exclusion criteria
• Active malignancy at time of study entry
• Steroids administration (PDN 2 times upper normal limit)
• HCVAb, HIVAb, HBsAg, HBcAb seropositive status
• Chronic liver disease
• Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis
• Intake of drugs not previously taken within one week before diagnosis
• Bleeding score 15 due to ICH or to GI bleeding (according to grading scale at paragraph 7.1, Tab. 3)
• Active gastric ulcer.
* The results of autoimmunity markers will be mandatory for patient eligibility. However, in order to avoid delay in
treatment start, patients can be randomized before the results of these tests are available. If evidence of positivity, the patient
will be considered not eligible even if the treatment has been started
Translation - Italian Popolazione:
Criteri di inclusione
• Consenso informato scritto e firmato in accordo alle normative ICH/EU/GCP e alle normative nazionali
• Pazienti adulti con nuova diagnosi di PTI
• Età > 18 < 80 anni
• Piastrine 20 x109/L e 8 (secondo la scala riportata
nel paragrafo 7.1 del protocollo)
• Questionario sulla Qualità di Vita compilato al momento dell’inserimento in studio
Criteri di esclusione
• Malattie maligne concomitanti attive al momento della registrazione in studio
• Somministrazione di steroidi (PDN 2 volte del massimo valore nomale )
• Sieropositività per HCVAb, HIVAb, HBsAg, HBcAb
• Insufficienza epatica cronica
• Malattia virale documentata dalla positività di IgM specifiche , o vaccinazioni, entrambe un mese prima della diagnosi
• Uso di farmaci, mai assunti in precedenza, una settimana prima della diagnosi
• Eventi emorragici di grado 15 a livello del sistema nervoso centrale o dell’apparato gastro-intestinale (secondo la scala riportante i diversi gradi al paragrafo 7.1, tab.3 del protocollo)
• Ulcera gastrica attiva.
* I risultati dei marcatori dell’ autoimmunità saranno obbligatori per valutare l’eleggibilità dei pazienti. Nonostante questo, onde evitare un ritardo nell’inizio della terapia, i pazienti saranno randomizzati prima che i risultati dei marcatori siano disponibili. In caso di positività, il paziente sarà considerato non eleggibile, anche se la terapia è già stata iniziata.
English to Italian: Pharmaceutical Annex to the Agreement General field: Medical Detailed field: Law: Contract(s)
Source text - English Pharmaceutical Annex to the Agreement
Intergroup Study XXXXXX
ARTICLE I – PURPOSE
The purpose of this pharmaceutical annex is to specify the pharmaceutical conditions in which the company, XXXX, will support the Research below.
This annex is a supplement to the agreement drawn up for the purposes of the clinical trial between the YYYY, and the company. It cannot be dissociated there from.
In terms of pharmaceutical responsibility, this annex is signed, for the YYYY, by Pr. Sergio XXXX, as Vice-President of YYYY, and for XXXX, by XXXX, as responsible pharmacist.
ARTICLE II – RESEARCH CHARACTERISTICS
YYYY is taking the initiative to carry out biomedical research and is the Sponsor of a clinical trial entitled, “A randomized phase III study to compare X combined to X versus standard X and X-based chemotherapy (X regimen) for newly diagnosed, non high-risk acute promyelocytic leukaemia”, X code, EudraCT code X.
With the understanding that Professor XX, Department of Clinical Haematology, Policlinico X di Roma, is named coordinating investigator for this clinical trial, the characteristics of which are as follows:
• Principal objectives:
The primary objective of the trial is to compare the event-free survival in the two arms.
The secondary objectives are: to compare CR, OS and CIR rates in the two arms; to compare the toxicity profile in the two arms; to compare the kinetics of MRD in the two arms and to compare the duration of patient hospitalization in the two arms.
• Type of trial / methodology:
A randomised phase III study.
• Duration of the trial:
Therapy follow-up time is /- 5.5 years.
• Number of patients:
162 patients.
• Number of investigational Italian centres:
/- 50 centres.
• Dosage of X:
0.15 mg/kg/day.
Translation - Italian Appendice sul Farmaco
Studio intergruppo XXXXXX
ARTICOLO I - OBIETTIVO
L'obiettivo di quest'appendice sul farmaco sperimentale è di specificare le condizioni in cui l'azienda, XXXX, finanzierà la ricerca di cui sotto.
Quest'appendice è un documento aggiuntivo all'accordo stipulato ai fini dello studio clinico tra il YYYY e l'azienda. Essa non può essere separata da questo.
In termini di responsabilità per quanto riguarda il farmaco, la presente appendice è controfirmata, per YYYY, dal Prof. XXXX, come Vice-Presidente del YYYY, e per XXXX, da. XXXX, come farmacista responsabile.
ARTICOLO II - CARATTERISTICHE DELLA RICERCA
Il YYYY, di propria iniziativa, intende eseguire ricerca biomedica ed è lo Sponsor dello studio clinico "Studio randomizzato di fase III per confrontare la terapia con X in combinazione con X (X versus X più chemioterapia a base di X per pazienti con leucemia promielocitica acuta di nuova diagnosi non ad alto rischio", codice X, codice EudraCT X.
Il Professor X, Dipartimento di Ematologia Clinica, Policlinico X di Roma è il coordinatore dello studio, le cui caratteristiche sono:
• Obiettivi principali:
L'obiettivo primario dello studio è confrontare la sopravvivenza libera di eventi nei due bracci di terapia.
Gli obiettivi secondari sono: confrontare nei due bracci la RC, la sopravvivenza globale e la percentuale d’incidenza cumulativa di recidiva, il profilo di tossicità, la cinetica della malattia minima residua e la durata dell'ospedalizzazione.
• Tipo di studio/metodologia:
Studio randomizzato di fase III.
• Durata dello studio:
Terapia follow-up: /- 5,5 anni.
• Campione dello studio:
162 pazienti.
• Numero di centri partecipanti in Italia:
/- 50 centri.
Spanish to Italian (Universidad de Alicante, verified) Italian to Spanish (Universidad de Alicante, verified) English to Spanish (Universidad de Alicante, verified) English to Italian (Universidad de Alicante, verified)
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Memberships
AITI, Tremédica, European Medical Writers Association (EMWA), ASETRAD
Software
Adobe Acrobat, Microsoft Excel, Microsoft Office Pro, Microsoft Word, Pages, Passolo, Powerpoint, SDL TRADOS, SDLX
Completely bilingual (Spanish mother tongue and Italian at mother tongue level).
Translation & Interpreting at the University of Alicante (Spain): English, Italian, Arabic and Italian.
10 years experience in clinical trials medical translation and writing.
Specialization domains:
- Medical: pharmaceuticals, health care, dentistry, oncology, clinical research, patient reported outcomes (translation of full protocol synopsis, patient information sheets, abstracts, publications, CRFs)
- Sports: cross-country skiing, running, free-climbing (brochures, news, press releases, technical gear advertisements).
- Gastronomy: recipes, menus, marcom texts.
Domains in which I also work:
- Telecommunications
- Science (general)
- IT
- Business correspondence
Recent projects include:
Clinical trials International organizations: full protocol synopsis, patient’s information sheets, CRFs, patients reports, etc.
Collaboration with different translation agencies: workshop brochures; pediatric dentistry papers, medical softwares, clinical manuscripts.
PR Officer at the European Medical Writers Organization.
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