Hi,
I am trying to open the attached XML file into TBC-ME, by using the option
"Open With -> TopBraid (semantic XML Documents), but it gives me the error
message: "Content is not allowed in prolog." Any possible reasons?
Please let me know.
Thanks.
Regards,
Amrapali J Zaveri
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<MedlineCitation Owner="NLM" Status="In-Process">\
<PMID>20110053</PMID>\
<DateCreated>\
<Year>2010</Year>\
<Month>01</Month>\
<Day>29</Day>\
</DateCreated>\
<Article PubModel="Print">\
<Journal>\
<ISSN IssnType="Electronic">1879-114X</ISSN>\
<JournalIssue CitedMedium="Internet">\
<Volume>31 Pt 2</Volume>\
<PubDate>\
<Year>2009</Year>\
</PubDate>\
</JournalIssue>\
<Title>Clinical therapeutics</Title>\
<ISOAbbreviation>Clin Ther</ISOAbbreviation>\
</Journal>\
<ArticleTitle>Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study.</ArticleTitle>\
<Pagination>\
<MedlinePgn>2459-69</MedlinePgn>\
</Pagination>\
<Abstract>\
<AbstractText>BACKGROUND: Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor approved for the treatment of patients who have imatinib-resistant Philadelphia chromosome-positive chronic myeloid leukemia in the chronic or accelerated phase or who are unable to tolerate imatinib. Nilotinib is metabolized in the liver via oxidation and hydroxylation pathways, mediated primarily by the cytochrome P450 3A4 isozyme. Interpatient variability in systemic exposure to nilotinib has been reported to range from 32% to 64%. OBJECTIVE: This study compared the pharmacokinetics of nilotinib in subjects with hepatic impairment and subjects with normal hepatic function. METHODS: Hepatic impairment was classified as mild (Child-Pugh grade A), moderate (Child-Pugh grade B), or severe (Child-Pugh grade C). Healthy control subjects were matched with hepatically impaired subjects by age (+/-10 years) and body weight (+/-20%). All subjects received a single oral dose of nilotinib 200 mg under fasted conditions, and serial blood samples were collected at specific times up to 120 hours after dosing. Serum nilotinib concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification of 2.5 ng/mL. The pharmacokinetic parameters analyzed were C(max), T(max), AUC(0-last), AUC(0-infinity), t(1/2), CL/F, and Vz/F. Tolerability assessments included adverse events (AEs), regular monitoring of clinical laboratory measures (eg, hematology, blood chemistry, urinalysis), physical examinations, vital signs, and ECGs. Each AE was evaluated in terms of its clinical significance, severity, duration, relation to study drug, and action taken. RESULTS: The study enrolled 18 subjects with hepatic impairment (all male; age range, 47-67 years; weight range, 73.9-103.9 kg) and 9 healthy controls (all male; age range, 36-62 years; weight range, 73.3-109.5 kg). Among subjects with hepatic impairment, 6 had mild impairment, 6 moderate impairment, and 6 severe impairment. The nilotinib AUC(0-infinity) was a mean of 35%, 35%, and 19% higher in subjects with mild, moderate, and severe impairment, respectively, compared with healthy controls. The nilotinib CL/F was lower in all hepatic-impairment groups compared with healthy controls. The mean (SD) t(1/2) was 15.1 (4.97) and 16.0 (9.13) hours in the mild-impairment and control groups, respectively, but was 21.6 (7.77) and 32.4 (10.7) hours in the moderate- and severe-impairment groups, respectively, reflecting the decrease in CL/F and/or increase in Vz/F in the latter 2 groups. All AEs were mild or moderate, and the frequency of AEs was not associated with the degree of hepatic impairment. AEs included abdominal pain (1 subject with mild impairment), dyspepsia (2 with mild impairment), flatulence (1 with severe impairment), nausea (1 with mild impairment), urinary tract infection (1 with mild impairment), back pain (1 each with mild impairment and severe impairment, 1 control subject), and headache (1 each with mild impairment and severe impairment). CONCLUSIONS: After a single 200-mg dose, nilotinib pharmacokinetics were modestly affected by hepatic impairment. The extent of change in nilotinib exposure in subjects with hepatic impairment was generally within the range of variability that has been observed clinically. The results of this study suggest that dose adjustment may not be necessary in patients with hepatic impairment. Nilotinib should be used with caution, and careful clinical monitoring is recommended in this population. ClinicalTrials.gov identifier: NCT00418626.</AbstractText>\
<CopyrightInformation>Copyright 2009 Excerpta Medica Inc. All rights reserved.</CopyrightInformation>\
</Abstract>\
<Affiliation>Novartis Pharmaceuticals Corporation, Florham Park, New Jersey 07932-0675, USA. [email protected]</Affiliation>\
<AuthorList CompleteYN="Y">\
<Author ValidYN="Y">\
<LastName>Yin</LastName>\
<ForeName>Ophelia Q P</ForeName>\
<Initials>OQ</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Gallagher</LastName>\
<ForeName>Neil</ForeName>\
<Initials>N</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Tanaka</LastName>\
<ForeName>Chiaki</ForeName>\
<Initials>C</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Fisher</LastName>\
<ForeName>Deirdre</ForeName>\
<Initials>D</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Sethuraman</LastName>\
<ForeName>Venkat</ForeName>\
<Initials>V</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Zhou</LastName>\
<ForeName>Wei</ForeName>\
<Initials>W</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Lin</LastName>\
<ForeName>Tsu-Han</ForeName>\
<Initials>TH</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Heuman</LastName>\
<ForeName>Douglas</ForeName>\
<Initials>D</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Schran</LastName>\
<ForeName>Horst</ForeName>\
<Initials>H</Initials>\
</Author>\
</AuthorList>\
<Language>eng</Language>\
<DataBankList CompleteYN="Y">\
<DataBank>\
<DataBankName>ClinicalTrials.gov</DataBankName>\
<AccessionNumberList>\
<AccessionNumber>NCT00418626</AccessionNumber>\
</AccessionNumberList>\
</DataBank>\
</DataBankList>\
<PublicationTypeList>\
<PublicationType>Journal Article</PublicationType>\
<PublicationType>Research Support, Non-U.S. Gov't</PublicationType>\
</PublicationTypeList>\
</Article>\
<MedlineJournalInfo>\
<Country>United States</Country>\
<MedlineTA>Clin Ther</MedlineTA>\
<NlmUniqueID>7706726</NlmUniqueID>\
<ISSNLinking>0149-2918</ISSNLinking>\
</MedlineJournalInfo>\
<CitationSubset>IM</CitationSubset>\
</MedlineCitation>\
<PubmedData>\
<History>\
<PubMedPubDate PubStatus="accepted">\
<Year>2009</Year>\
<Month>8</Month>\
<Day>19</Day>\
</PubMedPubDate>\
<PubMedPubDate PubStatus="entrez">\
<Year>2010</Year>\
<Month>1</Month>\
<Day>30</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
<PubMedPubDate PubStatus="pubmed">\
<Year>2010</Year>\
<Month>1</Month>\
<Day>30</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
<PubMedPubDate PubStatus="medline">\
<Year>2010</Year>\
<Month>1</Month>\
<Day>30</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
</History>\
<PublicationStatus>ppublish</PublicationStatus>\
<ArticleIdList>\
<ArticleId IdType="pii">S0149-2918(09)00405-6</ArticleId>\
<ArticleId IdType="doi">10.1016/j.clinthera.2009.11.015</ArticleId>\
<ArticleId IdType="pubmed">20110053</ArticleId>\
</ArticleIdList>\
</PubmedData>\
</PubmedArticle>\
<PubmedArticle>\
<MedlineCitation Owner="NLM" Status="In-Process">\
<PMID>20110052</PMID>\
<DateCreated>\
<Year>2010</Year>\
<Month>01</Month>\
<Day>29</Day>\
</DateCreated>\
<Article PubModel="Print">\
<Journal>\
<ISSN IssnType="Electronic">1879-114X</ISSN>\
<JournalIssue CitedMedium="Internet">\
<Volume>31 Pt 2</Volume>\
<PubDate>\
<Year>2009</Year>\
</PubDate>\
</JournalIssue>\
<Title>Clinical therapeutics</Title>\
<ISOAbbreviation>Clin Ther</ISOAbbreviation>\
</Journal>\
<ArticleTitle>Effect of the CYP3A inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced solid tumors: a prospective, multicenter, open-label, randomized, two-way crossover drug-drug interaction study.</ArticleTitle>\
<Pagination>\
<MedlinePgn>2444-58</MedlinePgn>\
</Pagination>\
<Abstract>\
<AbstractText>BACKGROUND: The proteasome inhibitor bortezomib undergoes oxidative biotransformation via multiple cytochrome P450 (CYP) enzymes, with CYP3A4 identified as a partial, yet potentially important, contributor based on in vitro drug metabolism studies. OBJECTIVE: The aim of this study was to assess the effect of concomitant administration of ketoconazole on the pharmacokinetics (PK) and pharmacodynamics (PD) of bortezomib. METHODS: This was a prospective, multicenter, open-label, randomized, multiple-dose, 2-way crossover study in patients with advanced solid tumors. All patients received bortezomib 1.0 mg/m(2) IV (on days 1, 4, 8, and 11 of two 21-day cycles) and were randomized to receive concomitant ketoconazole 400 mg on days 6, 7, 8, and 9 of cycle 1 or 2. Serial blood samples were collected over the day-8 dosing interval (immediately prior to bortezomib administration, and from 5 minutes to 72 hours after administration) in cycles 1 and 2 for measurement of plasma bortezomib concentrations for noncompartmental PK analysis and blood 20S proteasome inhibition for PD analysis. All adverse events (AEs) were recorded during each cycle including serious AEs and all neurotoxicity events for up to 30 days after the last dose of bortezomib. RESULTS: Twenty-one patients (median age, 57 years; sex, 67% male; race, 86% white; median body surface area, 2.01 m(2)) were randomized to treatment. Twelve patients completed the protocol-specified dosing and PK sampling in both cycles 1 and 2. Assessment of the effect of ketoconazole on bortezomib PK and PD was based on data in these 12 PK-evaluable patients. The ratio of geometric mean bortezomib AUC(0-tlast)(AUC from time 0 to last quantifiable concentration) for bortezomib plus ketoconazole versus bortezomib alone was 1.352 (90% CI, 1.032-1.772). Consistent with this observed mean increase in bortezomib exposure, concomitant administration of ketoconazole was associated with a corresponding increase (24%-46%) in the blood proteasome inhibitory effect. CONCLUSION: Concomitant administration of the CYP3A inhibitor ketoconazole with bortezomib resulted in a mean increase of 35% in bortezomib exposure. ClinicalTrials.gov identifier: NCT00129207.</AbstractText>\
<CopyrightInformation>Copyright 2009 Excerpta Medica Inc. All rights reserved.</CopyrightInformation>\
</Abstract>\
<Affiliation>Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts 02139, USA. [email protected]</Affiliation>\
<AuthorList CompleteYN="Y">\
<Author ValidYN="Y">\
<LastName>Venkatakrishnan</LastName>\
<ForeName>Karthik</ForeName>\
<Initials>K</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Rader</LastName>\
<ForeName>Michael</ForeName>\
<Initials>M</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Ramanathan</LastName>\
<ForeName>Ramesh K</ForeName>\
<Initials>RK</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Ramalingam</LastName>\
<ForeName>Suresh</ForeName>\
<Initials>S</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chen</LastName>\
<ForeName>Eric</ForeName>\
<Initials>E</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Riordan</LastName>\
<ForeName>William</ForeName>\
<Initials>W</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Trepicchio</LastName>\
<ForeName>William</ForeName>\
<Initials>W</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Cooper</LastName>\
<ForeName>Michael</ForeName>\
<Initials>M</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Karol</LastName>\
<ForeName>Michael</ForeName>\
<Initials>M</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>von Moltke</LastName>\
<ForeName>Lisa</ForeName>\
<Initials>L</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Neuwirth</LastName>\
<ForeName>Rachel</ForeName>\
<Initials>R</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Egorin</LastName>\
<ForeName>Merrill</ForeName>\
<Initials>M</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chatta</LastName>\
<ForeName>Gurkamal</ForeName>\
<Initials>G</Initials>\
</Author>\
</AuthorList>\
<Language>eng</Language>\
<DataBankList CompleteYN="Y">\
<DataBank>\
<DataBankName>ClinicalTrials.gov</DataBankName>\
<AccessionNumberList>\
<AccessionNumber>NCT00129207</AccessionNumber>\
</AccessionNumberList>\
</DataBank>\
</DataBankList>\
<PublicationTypeList>\
<PublicationType>Journal Article</PublicationType>\
<PublicationType>Research Support, Non-U.S. Gov't</PublicationType>\
</PublicationTypeList>\
</Article>\
<MedlineJournalInfo>\
<Country>United States</Country>\
<MedlineTA>Clin Ther</MedlineTA>\
<NlmUniqueID>7706726</NlmUniqueID>\
<ISSNLinking>0149-2918</ISSNLinking>\
</MedlineJournalInfo>\
<CitationSubset>IM</CitationSubset>\
</MedlineCitation>\
<PubmedData>\
<History>\
<PubMedPubDate PubStatus="accepted">\
<Year>2009</Year>\
<Month>9</Month>\
<Day>22</Day>\
</PubMedPubDate>\
<PubMedPubDate PubStatus="entrez">\
<Year>2010</Year>\
<Month>1</Month>\
<Day>30</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
<PubMedPubDate PubStatus="pubmed">\
<Year>2010</Year>\
<Month>1</Month>\
<Day>30</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
<PubMedPubDate PubStatus="medline">\
<Year>2010</Year>\
<Month>1</Month>\
<Day>30</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
</History>\
<PublicationStatus>ppublish</PublicationStatus>\
<ArticleIdList>\
<ArticleId IdType="pii">S0149-2918(09)00402-0</ArticleId>\
<ArticleId IdType="doi">10.1016/j.clinthera.2009.11.012</ArticleId>\
<ArticleId IdType="pubmed">20110052</ArticleId>\
</ArticleIdList>\
</PubmedData>\
</PubmedArticle>\
<PubmedArticle>\
<MedlineCitation Owner="NLM" Status="In-Process">\
<PMID>20135748</PMID>\
<DateCreated>\
<Year>2010</Year>\
<Month>02</Month>\
<Day>04</Day>\
</DateCreated>\
<Article PubModel="Print">\
<Journal>\
<ISSN IssnType="Electronic">1532-0987</ISSN>\
<JournalIssue CitedMedium="Internet">\
<Volume>29</Volume>\
<Issue>2</Issue>\
<PubDate>\
<Year>2010</Year>\
<Month>Feb</Month>\
</PubDate>\
</JournalIssue>\
<Title>The Pediatric infectious disease journal</Title>\
<ISOAbbreviation>Pediatr. Infect. Dis. J.</ISOAbbreviation>\
</Journal>\
<ArticleTitle>Probiotics have clinical, microbiologic, and immunologic efficacy in acute infectious diarrhea.</ArticleTitle>\
<Pagination>\
<MedlinePgn>135-8</MedlinePgn>\
</Pagination>\
<Abstract>\
<AbstractText>BACKGROUND: Acute infectious diarrhea is a major cause of childhood morbidity and economic burden for families. We evaluate the clinical, microbiologic, and immunologic effects of probiotics in acute infectious diarrhea. METHODS: Children (n = 304) aged 3 months to 6 years hospitalized for acute diarrhea were randomized to receive Bio-three (a mixture of Bacillus mesentericus, Enterococcus faecalis, and Clostridium butyricum) or placebo orally 3 times daily for 7 days. Fecal samples were homogenized for bacterial culture and blood cells were isolated for cell culture and cytokine analysis. This study is registered (NCT00463190). RESULTS: The mean duration of diarrhea after start of therapy was 60.1 hours in the probiotics group versus 86.3 hours in the placebo group (P = 0.003). Hospital stay was shorter in the probiotics group than in the placebo group (P = 0.009). Counts of Bifidobacteria and Lactobacillus species were elevated in stool culture of the probiotics (Bio-three) group. IL-10 was increased in the serum and supernatants of cell culture in the probiotics group, and tumor necrosis factor-alpha values were down-regulated. Interferon- gamma and IL-12 were mildly elevated in the probiotics group, compared with the placebo group. CONCLUSIONS: This probiotics mixture reduced the severity of diarrhea and length of hospital stay in children with acute diarrhea. In addition to restoring beneficial intestinal flora, probiotics may enhance host protective immunity such as down-regulation of pro-inflammatory cytokines and up-regulation of anti-inflammatory cytokines.</AbstractText>\
</Abstract>\
<Affiliation>Division of Gastroenterology, Department of Pediatrics, Chang Gung Children's Hospital, Taiwan.</Affiliation>\
<AuthorList CompleteYN="Y">\
<Author ValidYN="Y">\
<LastName>Chen</LastName>\
<ForeName>Chien-Chang</ForeName>\
<Initials>CC</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Kong</LastName>\
<ForeName>Man-Shan</ForeName>\
<Initials>MS</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Lai</LastName>\
<ForeName>Ming-Wei</ForeName>\
<Initials>MW</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chao</LastName>\
<ForeName>Hsun-Chin</ForeName>\
<Initials>HC</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chang</LastName>\
<ForeName>Kuei-Wen</ForeName>\
<Initials>KW</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chen</LastName>\
<ForeName>Shih-Yen</ForeName>\
<Initials>SY</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Huang</LastName>\
<ForeName>Yhu-Chering</ForeName>\
<Initials>YC</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chiu</LastName>\
<ForeName>Cheng-Hsun</ForeName>\
<Initials>CH</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Li</LastName>\
<ForeName>Wen-Chen</ForeName>\
<Initials>WC</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Lin</LastName>\
<ForeName>Pen-Yi</ForeName>\
<Initials>PY</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Chen</LastName>\
<ForeName>Chih-Jung</ForeName>\
<Initials>CJ</Initials>\
</Author>\
<Author ValidYN="Y">\
<LastName>Li</LastName>\
<ForeName>Tzou-Yien</ForeName>\
<Initials>TY</Initials>\
</Author>\
</AuthorList>\
<Language>eng</Language>\
<DataBankList CompleteYN="Y">\
<DataBank>\
<DataBankName>ClinicalTrials.gov</DataBankName>\
<AccessionNumberList>\
<AccessionNumber>NCT00463190</AccessionNumber>\
</AccessionNumberList>\
</DataBank>\
</DataBankList>\
<PublicationTypeList>\
<PublicationType>Journal Article</PublicationType>\
<PublicationType>Research Support, Non-U.S. Gov't</PublicationType>\
</PublicationTypeList>\
</Article>\
<MedlineJournalInfo>\
<Country>United States</Country>\
<MedlineTA>Pediatr Infect Dis J</MedlineTA>\
<NlmUniqueID>8701858</NlmUniqueID>\
<ISSNLinking>0891-3668</ISSNLinking>\
</MedlineJournalInfo>\
<CitationSubset>IM</CitationSubset>\
</MedlineCitation>\
<PubmedData>\
<History>\
<PubMedPubDate PubStatus="entrez">\
<Year>2010</Year>\
<Month>2</Month>\
<Day>6</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
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<Year>2010</Year>\
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<Day>6</Day>\
<Hour>6</Hour>\
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<PubMedPubDate PubStatus="medline">\
<Year>2010</Year>\
<Month>2</Month>\
<Day>6</Day>\
<Hour>6</Hour>\
<Minute>0</Minute>\
</PubMedPubDate>\
</History>\
<PublicationStatus>ppublish</PublicationStatus>\
<ArticleIdList>\
<ArticleId IdType="pubmed">20135748</ArticleId>\
</ArticleIdList>\
</PubmedData>\
</PubmedArticle>\
}
