MARC details
| 000 -LEADER |
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| fixed length control field |
03973nam a22006377a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
150313s20142014 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1078-0998 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
24694794 |
| 245 ## - TITLE STATEMENT |
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| Title |
AST-120 (spherical carbon adsorbent) in the treatment of perianal fistulae in mild-to-moderate Crohn's disease: FHAST-1, a phase 3, multicenter, placebo-controlled study. |
| 251 ## - Source |
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| Source |
Inflammatory Bowel Diseases. 20(5):872-81, 2014 May. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Inflamm Bowel Dis. 20(5):872-81, 2014 May. |
| 253 ## - Journal Name |
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| Journal name |
Inflammatory bowel diseases |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2014 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2014 |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2015-03-17 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: February 2001 - present, Available in print through MWHC library: 2002 - 2006 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: AST-120 (spherical carbon adsorbent) was previously reported to be effective for perianal fistula healing in Japanese patients with mild-to-moderate Crohn's disease. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: In this largest placebo-controlled trial to date to evaluate the impact of a therapeutic agent on perianal fistulae in Crohn's disease, the efficacy of AST-120 could not be confirmed. An inverse relationship was observed between both inflammatory and clinical disease activity and fistula response. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: To evaluate the efficacy and safety of AST-120 in a Western population, a phase 3, multicenter, randomized, double-blind, placebo-controlled, study (FHAST-1) was conducted in adult patients with at least 1 draining perianal fistula and a Crohn's disease activity index <400. Patients received either AST-120 or matching placebo at a dose of 2 g 3 times daily for 8 weeks. The primary endpoint was the proportion of patients with treatment success, defined as a 50% reduction in the number of draining fistulae, at both weeks 4 and 8. A multivariate model was generated to assess covariates for treatment success among baseline variables. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: Two hundred forty-nine patients were randomized (AST-120; n = 122; placebo, n = 127). The proportions of patients achieving the primary endpoint were no different between treatment groups (13.9% versus 16.5%, P = 0.6). No differences in fistula response were noted at week 4 (23.0% versus 25.2%, P = 0.77) or week 8 (27.0 versus 34.6%, P = 0.22). Serum C-reactive protein concentrations >0.6 mg/dL and Crohn's disease activity index scores >151 at baseline were associated with a reduced likelihood of treatment success (odds ratio, 0.40; confidence interval, 0.19-0.87; P = 0.02; and odds ratio, 0.45; confidence interval, 0.21-0.97; P = 0.04, respectively). |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Carbon/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Crohn Disease/co [Complications] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Gastrointestinal Agents/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Oxides/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Rectal Fistula/dt [Drug Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Adolescent |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Adult |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Crohn Disease/pa [Pathology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Double-Blind Method |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Follow-Up Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Male |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Microspheres |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Middle Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prospective Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Rectal Fistula/et [Etiology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Rectal Fistula/me [Metabolism] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Young Adult |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Health Research Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Clinical Trial, Phase III |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Multicenter Study |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Randomized Controlled Trial |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Research Support, N.I.H., Extramural |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Research Support, Non-U.S. Gov't |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Shara, Nawar M |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Wang, Hong |
| 790 ## - Authors |
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| All authors |
Hanauer S, Harris MS, Reinisch W, Shara N, Travis S, Wang H |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="http://dx.doi.org/10.1097/MIB.0000000000000031">http://dx.doi.org/10.1097/MIB.0000000000000031</a> |
| Public note |
http://dx.doi.org/10.1097/MIB.0000000000000031 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
