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Ausgangstext - Englisch Duration of Trial: Each subject will participate in the trial for approximately 90 days from the time the subject and his or her parent(s) or legal representative signs the Informed Assent/Consent Form through the final contact. After a screening and tapering phase, each subject will be receiving assigned treatment for approximately 56 days. After completion of the 8-week treatment period, each subject who is still younger than 18 years of age and meets the inclusion and exclusion criteria may continue in the long-term extension trial (open-label, active treatment). After his or her last dose, each subject will be followed for at least 30 days.
Sample Size: At least 400 subjects will be screened, assuming screen failure rate of 25%. At least 300 subjects will be randomly assigned treatment in the trial with 100 subjects assigned to each of the 3 treatment arms. There will be 86% power to establish superiority of at least one xxx dose compared with placebo in improving symptoms of schizophrenia as measured by the change in PANSS total score from baseline to Day 56 using the mixed model for repeated measures (MMRM) approach. This power assumes a scenario of an 8 point difference compared with placebo in favor of the 2.5 mg or 5 mg BID xxx dose groups, assumptions on (co)variance and drop-out (i.e. 40% drop-out after 8 weeks) derived from the adult xxx schizophrenia program and publications on other antipsychotic compounds that are registered for adolescents with schizophrenia, and uses a two-sided alpha of 0.045 and Hochberg's procedure to correct for multiplicity.
Übersetzung - Serbisch Trajanje ispitivanja: svaki ispitanik će učestvovati u ispitivanju približno 90 dana od trenutka kada ispitanik i njegov(i)/njen(i) roditelj(i) ili pravni zastupnik potpišu Obrazac informisanog pristanka/saglasnosti sve do poslednjeg kontakta. Posle faze skrininga i postepenog smanjivanja doze leka, svaki ispitanik će dobiti prepisanu terapiju na približno 56 dana. Nakon završetka osmonedeljnog perioda, svaki ispitanik koji nije napunio 18 godina i zadovoljava kriterijume za uključivanje i isključivanje može da ostane u dugoročnom produženom ispitivanju (otvoreno, sa aktivnom terapijom). Nakon što dobije poslednju dozu, svaki ispitanik će biti praćen najmanje 30 dana.
Veličina uzorka: Na skriningu će biti najmanje 400 ispitanika, a pretpostavlja se da će procenat ispitanika koji ne prođu skrining biti 25%. Najmanje 300 ispitanika će biti randomizovano na terapiju u ispitivanju u kojem će po 100 ispitanika biti uključeno u svaku od 3 terapijske grane. Statistička snaga će iznositi 86% za određivanje superiornosti barem jedne doze xxx u odnosu na placebo u poboljšanju simptoma shizofrenije, prema vrednosti promene ukupnog rezultata na skali PANSS od osnovne posete do 56. dana dobijenoj pomoću mešovitog modela ponovljenih mera (MMRM). Ova statistička snaga pretpostavlja scenario sa razlikom od 8 tačaka u poređenju sa placebom u korist grupa sa dozama od 2,5 ili 5 mg xxx b.i.d., pri čemu su pretpostavke o (ko)varijansi i napuštanju studije (tj. 40% napuštanja posle 8 nedelja) izvedene iz programa upotrebe xxx za shizofreniju kod odraslih i publikacija o drugim antipsihotičkim jedinjenjima koja su registrovana za lečenje shizofrenije kod odraslih, i koristi dvostranu alfu od 0,045 i Hohbergovu proceduru radi korekcije multipliciteta.
Englisch > Serbisch: Drug Attitude Inventory (questionnaire) General field: Medizin Detailed field: Medizin: Pharmazie
Ausgangstext - Englisch The aim of this questionnaire is to gain some understanding of what people think about medications and what experiences people have of them. Your answers will be used for research purposes only, are strictly confidential and will in no way affect your treatment.
How to fill in this questionnaire:
Read each statement and decide whether it is true as applied to you or false as applied to you.
If a statement is TRUE or MOSTLY TRUE to you, circle the T at the end of the line.
If a statement is FALSE or MOSTLY FALSE to you, circle the F at the end of the line.
If you want to change an answer, mark an X over the incorrect answer and circle the correct answer
If a statement is not worded quite the way you would put it, please decide whether the answer is mostly true or mostly false to you.
There are no right or wrong answers. Please give YOUR OWN OPINION, not what you think we might want to hear.
Do not spend too much time on any one question.
Please answer every question.
Übersetzung - Serbisch Cilj ovog upitnika je da se dobiju neka saznanja o tome šta ljudi misle o lekovima i kakva su im iskustva sa njima. Vaši odgovori će se koristiti samo u svrhe istraživanja, strogo su poverljivi i ni na koji način neće uticati na vaše lečenje.
Kako popuniti ovaj upitnik:
Pročitajte svaku izjavu i odlučite da li je ona u vašem slučaju tačna ili netačna.
Ukoliko je izjava TAČNA ili UGLAVNOM TAČNA za vas, zaokružite T na kraju reda.
Ukoliko je izjava NETAČNA ili UGLAVNOM NETAČNA za vas, zaokružite N na kraju reda.
Ukoliko želite da promenite odgovor, napišite X preko pogrešnog odgovora i zaokružite pravi odgovor.
Ukoliko izjava nije napisana baš onim rečima koje biste vi upotrebili, molimo vas da odlučite da li je ta izjava uglavnom tačna ili netačna za vas.
Ne postoje tačni i netačni odgovori. Treba da date SVOJE SOPSTVENO MIŠLJENJE, a ne ono što mislite da bismo mi možda voleli da čujemo.
Ne trošite previše vremena ni na jedno pitanje.
Odgovorite na svako pitanje.
Ausgangstext - Englisch Regular-fit trousers in soft cotton twill with subtle stretch for maximum comfort. Zip fly with button, diagonal side pockets, and welt back pockets with button. Refined details include corozo buttons.
Übersetzung - Serbisch Pantalone srednjeg kroja od mekog, blago rastegljivog pamučnog kepera koji pruža izuzetnu udobnost. Imaju šlic s rajsferšlusom i dugmetom, kose bočne džepove i paspulirane zadnje džepove sa dugmetom. Korozo dugmići daju prefinjenost ovom komadu.
Englisch > Serbisch: Pacemaker and ICD analyzer General field: Medizin Detailed field: Medizin: Kardiologie
Ausgangstext - Englisch This device is a portable medical diagnostic device
intended to be used during the implantation of pacemakers
and defibrillators to evaluate the placement
and integrity of pacing leads and to determine the
appropriate pacing parameters for the implanted
device.
Only trained medical personnel may use the device.
While the device is in use, the medical staff must
continuously monitor the patient with the aid of a
surface ECG monitor, and emergency resuscitation
equipment must be readily available.
Depending on the patient's condition and depending
on the scope and type of pacing program, the following
possible complications associated with the use of
pacing system analyzers are reported in medical
references: life-threatening atrial and ventricular
arrhythmia, bradycardia, tachycardia, and asystole.
Übersetzung - Serbisch Овај уређај је преносиви медицински дијагностички
уређај намењен за употребу током уградње
пејсмејкера и дефибрилатора како би се проценило
смештање и интегритет електрода за стимулацију и
одредило како треба поставити параметре за
уграђени уређај.
Уређај може користити искључиво обучено
медицинско особље. Док је уређај у употреби,
медицинско особље мора непрекидно да прати
стање пацијента преко површинског ЕКГ уређаја за
мониторинг, а опрема за реанимацију за хитне
случајеве мора увек да буде при руци и спремна за
употребу.
У зависности од стања пацијента и опсега и типа
програма стимулације, као могуће компликације
повезане са употребом анализатора система за
стимулацију, медицински извори наводе следеће:
животно угрожавајућа атријална и вентрикуларна
аритмија, брадикардија, тахикардија и асистолија.
Englisch > Serbisch: In Vitro Diagnostics General field: Medizin Detailed field: Medizin: Instrumente
Ausgangstext - Englisch Studies indicate that nucleic acid-based amplification assays for HBV DNA will allow detection of HBV infection several weeks before HBsAg detection.
The introduction of NAT for HIV-1, HCV, and HBV has improved blood safety.
However, the advent of HBV NAT has raised new issues.
HBV replicates more slowly during the pre-seroconversion window period than HIV-1 and HCV, and low levels of HBV DNA can be found in serologically negative samples during early stages of infection and in HBc antibody-positive/HBsAg-negative samples during later stages of infection.
Übersetzung - Serbisch Istraživanja pokazuju da testovi na bazi amplifikacije nukleinskih kiselina HBV DNK omogućavaju otkrivanje infekcije HBV nekoliko nedelja pre otkrivanja HBsAg.
Uvođenje NAT testiranja HIV-1, HCV i HBV dovelo je do povećanja bezbednosti krvi.
Međutim, sa pojavom HBV NAT pojavile su se nove poteškoće.
HBV se replikuje sporije u periodu pre serokonverzije (period prozora) nego što to čine HIV-1 i HCV, pa se niski nivoi DNK HBV mogu naći u serološki negativnim uzorcima u ranim fazama infekcije, kao i u uzorcima pozitivnim na antitela HBc/negativnim na HBsAg u kasnijim fazama infekcije.
Englisch > Serbisch: Right ventricular biopsy guiding catheter General field: Medizin Detailed field: Medizin: Instrumente
Ausgangstext - Englisch RIGHT VENTRICULAR BIOPSY GUIDING CATHETER:
INSTRUCTIONS FOR USE
READ INSTRUCTIONS PRIOR TO USE
Indications:
Vascular Right Ventricular Biopsy Guiding Catheter is intended to be used for the percutaneous introduction of biopsy forceps into the right ventricle of the heart.
Contraindications:
None known
Warnings:
For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness or death. Cleaning, disinfection and re-sterilization may compromise the essential material and design characteristics of the device leading to device failure.
Übersetzung - Serbisch VODEĆI KATETER ZA BIOPSIJU DESNE SRČANE KOMORE:
UPUTSTVO ZA UPOTREBU
PROČITAJTE UPUTSTVO PRE UPOTREBE
Indikacije:
Vaskularni vodeći kateter za biopsiju desne srčane komore namenjen je za perkutano uvođenje forcepsa za biopsiju u desnu srčanu komoru.
Kontraindikacije:
Nisu poznate
Upozorenja:
Isključivo za upotrebu kod jednog pacijenta. Nemojte ponovo koristiti, obrađivati niti sterilisati ovaj proizvod. Ponovna upotreba, obrada ili sterilizacija mogu ugroziti strukturni integritet uređaja, odn. stvoriti rizik od kontaminacije uređaja, što može prouzrokovati povredu, bolest ili smrt pacijenta. Čišćenje, dezinfekcija i sterilizacija mogu ugroziti sastavni materijal i karakteristike konstrukcije uređaja, što može dovesti do kvara uređaja.
Serbisch > Englisch (University of Nish,English Language and Literature, verified) Englisch > Serbisch (University of Nish,English Language and Literature, verified)
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