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clinical cutoff

Russian translation: дата окончания регистрации показателей

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:clinical cutoff
Russian translation:дата окончания регистрации показателей
Entered by: Marina Aleyeva
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- Contribute to this entry
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09:14 Aug 12, 2010
English to Russian translations [PRO]
Medical - Medical (general) / клиническое исследование
English term or phrase: clinical cutoff
в следующем контексте:
Safety Assessment Phase that was to continue until diagnosis of AML(острый миелолейкоз), death, or the clinical cutoff was reached,
whichever occurred first.
Doctor Alex
Local time: 14:13
дата окончания регистрации (показателей безопасности)
Explanation:
Мне кажется, более вероятно, что речь идет о дате, а не величине показателя. Мне встречалось в похожих контекстах:

cut-off date for adverse events – последний день регистрации нежелательных явлений


As of the clinical cut-off date of October 1, 2001, a total of 73 patients had completed the study, 124 had withdrawn early and 26 were continuing to receive open-label paroxetine having already completed a week 4 CRF.
http://www.gsk.com/media/paroxetine/depression_716_interim.p...

If a patient has no progression before a clinical cut-off or the death date is beyond the above-mentioned time interval after last tumor assessment, time to progression/death is censored on the date of last tumor assessment or study entry (in case of no post-baseline tumor assessment).
http://clinicaltrials.gov/ct2/show/NCT01161368

For some trials, a Health Authority (HA) filing occurs midway through the trial. In this situation, a clinical cut off is defined for filing purposes but the trial continues for a number of months/years afterwards.
http://www.roche-trials.com/p/gcp_spt000215.pdf

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Note added at 1 hr (2010-08-12 10:32:48 GMT)
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Еще пример: хорошо видно, что clinical cut-off - это дата прекращения регистрации показателей. По состоянию на эту дату, часть пациентов умерла, часть прекратила терапию, а часть продолжала получать препарат:

An open-label extension study to evaluate safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).

The efficacy and safety of pazopanib (paz), a multikinase angiogenesis inhibitor, was evaluated in a randomized, double-blind placebo-controlled phase III study (VEG105192)... At VEG107769 clinical cut-off (May 08), 21 (30%) pts had died, 40 (56%) pts had discontinued paz, and 31 (44%) pts were still on paz.
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_d...

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Note added at 1 hr (2010-08-12 11:01:18 GMT)
--------------------------------------------------

The final analysis was performed using all data at the clinical cut-off of
September 30, 2004

http://bloodjournal.hematologylibrary.org/cgi/reprint/109/10...
Selected response from:

Marina Aleyeva
Ukraine
Local time: 14:13
Grading comment
Большое спасибо!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +1граничная точка (клинического показателя)
Pavel Venediktov
3дата окончания регистрации (показателей безопасности)
Marina Aleyeva
3доза (или уровень препарата в орг-ме), повышение которой уже не приводит к повышению клинич. эффекта
Stanislav Korobov
3клинически значимая точка разделения
Nara Yaralyan


  

Answers


23 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
граничная точка (клинического показателя)


Explanation:
cutoff point - a value on an ordered scale (possibly a continuous scale) where a change of decision is made. For example, patients with systolic blood pressure above 180mmHg may be included in a study; those with values less than, or equal to, 180mmHg are not included: 180 would be called the cutoff point

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Note added at 25 мин (2010-08-12 09:39:37 GMT)
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In the laboratory, the task of translating this quantitative
value into a more useful form can be accomplished only if
the appropriate clinical decision threshold or cutoff point is
selected to distinguish “normal” from “abnormal” test
results. http://goo.gl/c5fe

Pavel Venediktov
Russian Federation
Local time: 14:13
Native speaker of: Native in RussianRussian
PRO pts in category: 624

Peer comments on this answer (and responses from the answerer)
agree  Igor_2006: до наступления первого из следующих событий: ...
33 mins
Login to enter a peer comment (or grade)

12 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
доза (или уровень препарата в орг-ме), повышение которой уже не приводит к повышению клинич. эффекта


Explanation:


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Note added at 13 mins (2010-08-12 09:28:14 GMT)
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возможно также, что с дальшнейшим повышением этого уровня начинается **снижение** эффективности...

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Note added at 15 mins (2010-08-12 09:30:25 GMT)
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The lower clinical cutoff reflects the point at which the drug's effect on the virus begins to decline (i.e., the virus is partially ...
www.poz.com/articles/1826_10635.shtml

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Note added at 35 mins (2010-08-12 09:50:12 GMT)
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...upper clinical cutoff, which predicts minimal response...
http://www.intmedpress.com/serveFile.cfm?sUID=e2e8ba1c-2aed-...

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Note added at 45 mins (2010-08-12 10:00:17 GMT)
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Although values 0.5 g/L were reported
as negative to clinicians, for the purposes of this study we
recorded all results independent of this clinical cutoff.
http://www.clinchem.org/cgi/reprint/50/1/112

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Note added at 50 mins (2010-08-12 10:05:01 GMT)
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Conclusions: Lower albumin concentrations, even above the **clinical cutoff of 38 g/L**, are associated ..... Serum albumin, coronary heart disease, and death. ...
www.ajcn.org/cgi/content/full/82/3/531

Stanislav Korobov
Ukraine
Local time: 14:13
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1591
Login to enter a peer comment (or grade)

58 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
клинически значимая точка разделения


Explanation:
Multitran: cut-off value - например, точка разделения между нормальным и патологическим значением какого-либо параметра

Example sentence(s):
  • Клинически значимая точка разделения для неусиленного атазанавира составляет 2,2 (соответствует приблизительно 3 мутациям), а для усиленно

    Reference: http://symona.mednet.ru/gst/library/download.php?file_name=l...
Nara Yaralyan
United States
Local time: 04:13
Native speaker of: Native in ArmenianArmenian, Native in RussianRussian
Login to enter a peer comment (or grade)

41 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
дата окончания регистрации (показателей безопасности)


Explanation:
Мне кажется, более вероятно, что речь идет о дате, а не величине показателя. Мне встречалось в похожих контекстах:

cut-off date for adverse events – последний день регистрации нежелательных явлений


As of the clinical cut-off date of October 1, 2001, a total of 73 patients had completed the study, 124 had withdrawn early and 26 were continuing to receive open-label paroxetine having already completed a week 4 CRF.
http://www.gsk.com/media/paroxetine/depression_716_interim.p...

If a patient has no progression before a clinical cut-off or the death date is beyond the above-mentioned time interval after last tumor assessment, time to progression/death is censored on the date of last tumor assessment or study entry (in case of no post-baseline tumor assessment).
http://clinicaltrials.gov/ct2/show/NCT01161368

For some trials, a Health Authority (HA) filing occurs midway through the trial. In this situation, a clinical cut off is defined for filing purposes but the trial continues for a number of months/years afterwards.
http://www.roche-trials.com/p/gcp_spt000215.pdf

--------------------------------------------------
Note added at 1 hr (2010-08-12 10:32:48 GMT)
--------------------------------------------------

Еще пример: хорошо видно, что clinical cut-off - это дата прекращения регистрации показателей. По состоянию на эту дату, часть пациентов умерла, часть прекратила терапию, а часть продолжала получать препарат:

An open-label extension study to evaluate safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC).

The efficacy and safety of pazopanib (paz), a multikinase angiogenesis inhibitor, was evaluated in a randomized, double-blind placebo-controlled phase III study (VEG105192)... At VEG107769 clinical cut-off (May 08), 21 (30%) pts had died, 40 (56%) pts had discontinued paz, and 31 (44%) pts were still on paz.
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_d...

--------------------------------------------------
Note added at 1 hr (2010-08-12 11:01:18 GMT)
--------------------------------------------------

The final analysis was performed using all data at the clinical cut-off of
September 30, 2004

http://bloodjournal.hematologylibrary.org/cgi/reprint/109/10...


Marina Aleyeva
Ukraine
Local time: 14:13
Specializes in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 380
Grading comment
Большое спасибо!
Notes to answerer
Asker: Спасибо, Марина! Вы посмотрели на проблему по-другому, и всё стало на свои места.

Login to enter a peer comment (or grade)




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Changes made by editors
Aug 15, 2010 - Changes made by Marina Aleyeva:
Created KOG entryKudoZ term » KOG term


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