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  1. Article ; Online: Providing researchers with online access to NHLBI biospecimen collections: The results of the first six years of the NHLBI BioLINCC program.

    Giffen, Carol A / Wagner, Elizabeth L / Adams, John T / Hitchcock, Denise M / Welniak, Lisbeth A / Brennan, Sean P / Carroll, Leslie E

    PloS one

    2017  Volume 12, Issue 6, Page(s) e0178141

    Abstract: The National Heart, Lung, and Blood Institute (NHLBI), within the United States' National Institutes of Health (NIH), established the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in 2008 to develop the infrastructure ... ...

    Abstract The National Heart, Lung, and Blood Institute (NHLBI), within the United States' National Institutes of Health (NIH), established the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) in 2008 to develop the infrastructure needed to link the contents of the NHLBI Biorepository and the NHLBI Data Repository, and to promote the utilization of these scientific resources by the broader research community. Program utilization metrics were developed to measure the impact of BioLINCC on Biorepository access by researchers, including visibility, program efficiency, user characteristics, scientific impact, and research types. Input data elements were defined and are continually populated as requests move through the process of initiation through fulfillment and publication. This paper reviews the elements of the tracking metrics which were developed for BioLINCC and reports the results for the first six on-line years of the program.
    MeSH term(s) Biological Specimen Banks/organization & administration ; Humans ; Internet ; National Heart, Lung, and Blood Institute (U.S.) ; National Institutes of Health (U.S.) ; Program Development ; Specimen Handling/methods ; United States
    Language English
    Publishing date 2017
    Publishing country United States
    Document type Journal Article
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0178141
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Use of the National Heart, Lung, and Blood Institute Data Repository.

    Coady, Sean A / Mensah, George A / Wagner, Elizabeth L / Goldfarb, Miriam E / Hitchcock, Denise M / Giffen, Carol A

    The New England journal of medicine

    2017  Volume 376, Issue 19, Page(s) 1849–1858

    Abstract: Background: Research on data sharing from clinical trials has focused on elucidating perceptions, barriers, and attitudes among trialists and study participants with respect to sharing data. However, little information exists regarding utilization or ... ...

    Abstract Background: Research on data sharing from clinical trials has focused on elucidating perceptions, barriers, and attitudes among trialists and study participants with respect to sharing data. However, little information exists regarding utilization or associated publication of articles once clinical trial data have been widely shared.
    Methods: We analyzed administrative records of investigator requests for data access, linked publications, and bibliometrics to describe the use of the National Heart, Lung, and Blood Institute data repository.
    Results: From January 2000 through May 2016, a total of 370 investigators requested data from 1 or more clinical trials. Requests for trial data have been increasing, with 195 investigators (53%) initiating requests during the last 4.4 years of the study period. The predominant reason for requesting data was post hoc secondary analysis of new questions (72%), followed by analytic or statistical approaches to clinical trials (9%) and meta-analyses or pooled study research (7%). Of 172 requests with online project descriptions, only 2 requests were initiated for reanalysis of primary-outcome findings. Data from 88 of 100 available clinical trials were requested at least once, and the median time from repository availability to first request was 235 days. A total of 277 articles were published on the basis of data from 47 trials. Citation metrics from 224 articles indicated that half of the publications have cumulative citations that rank in the top 34% normalized for subject category and year of publication.
    Conclusions: Demand for trial data for secondary analysis has been increasing. Requesting data for the a priori purpose of reanalysis or verification of original findings was rare.
    MeSH term(s) Bibliometrics ; Clinical Trials as Topic ; Datasets as Topic/statistics & numerical data ; Humans ; Information Dissemination ; Kaplan-Meier Estimate ; National Heart, Lung, and Blood Institute (U.S.) ; Observational Studies as Topic ; Periodicals as Topic/statistics & numerical data ; United States
    Language English
    Publishing date 2017-03-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMsa1603542
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Providing Contemporary Access to Historical Biospecimen Collections: Development of the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).

    Giffen, Carol A / Carroll, Leslie E / Adams, John T / Brennan, Sean P / Coady, Sean A / Wagner, Elizabeth L

    Biopreservation and biobanking

    2015  Volume 13, Issue 4, Page(s) 271–279

    Abstract: The National Heart, Lung, and Blood Institute (NHLBI), within the United States' National Institutes of Health (NIH), established a Biorepository in 1976 that initially archived biospecimens from population-based blood product safety surveys. It was ... ...

    Abstract The National Heart, Lung, and Blood Institute (NHLBI), within the United States' National Institutes of Health (NIH), established a Biorepository in 1976 that initially archived biospecimens from population-based blood product safety surveys. It was later expanded to biospecimens from clinical and epidemiological studies in heart, lung, and blood disorders. The NHLBI also established a Data Repository in 2000 to store and distribute study data from NHLBI-sponsored research. The NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) was established in 2008 to develop the infrastructure needed to link the contents of these two related NHLBI Repositories, facilitate access to repository resources, and streamline request processes. Three key program subcomponents were developed simultaneously: 1) the linkage of biospecimen electronic inventory records with their clinical or characterization data; 2) the development and implementation of a website with both public-facing information and private processing workspaces; and 3) the development of processes to maximize efficiency via a web-based system while maintaining workflow control, document tracking, and secure processes. The BioLINCC website was launched on October 1, 2009 with eight biospecimen collections and data from 72 research studies. By the end of the fourth online year, 38 biospecimen collections were linked and posted, and data from 108 research studies had been made available for request. The number of registered users by the end of the fourth online year approached 2600, and continues to show a trend towards an increasing rate of new users per year. BioLINCC has fulfilled 381 requests comprising 851 data collections, as well as 600 teaching dataset requests and 75 data renewal agreements. 154 biospecimen requests comprising 147,388 biospecimens were fulfilled or actively in process. We conclude that the BioLINCC program has been successful in its goal to increase the visibility and utilization of NHLBI biospecimen and data repository resources.
    MeSH term(s) Biological Products ; Biological Specimen Banks ; Data Collection ; Humans ; Internet ; National Heart, Lung, and Blood Institute (U.S.) ; Program Development ; Software ; Specimen Handling/methods ; United States
    Chemical Substances Biological Products
    Language English
    Publishing date 2015-08
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2593993-2
    ISSN 1947-5543 ; 1947-5535
    ISSN (online) 1947-5543
    ISSN 1947-5535
    DOI 10.1089/bio.2014.0050
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Association of high-evidence gastric cancer susceptibility loci and somatic gene expression levels with survival.

    Sung, Hyuna / Hu, Nan / Yang, Howard H / Giffen, Carol A / Zhu, Bin / Song, Lei / Su, Hua / Wang, Chaoyu / Parisi, Dominick M / Goldstein, Alisa M / Taylor, Philip R / Hyland, Paula L

    Carcinogenesis

    2017  Volume 38, Issue 11, Page(s) 1119–1128

    Abstract: Eleven high-evidence single-nucleotide polymorphisms (SNPs) at nine loci for gastric cancer (GC) risk were reported, but their associations with survival remain unknown. In this study, we examined associations between SNP and GC survival by anatomic ... ...

    Abstract Eleven high-evidence single-nucleotide polymorphisms (SNPs) at nine loci for gastric cancer (GC) risk were reported, but their associations with survival remain unknown. In this study, we examined associations between SNP and GC survival by anatomic location and histology among 1147 incident cases from the Shanxi Upper Gastrointestinal Genetics Project. We further examined whether SNPs were expression quantitative trait loci in normal and tumor gastric tissues, and whether tumor versus normal somatic mRNA differences in 126 cases were associated with survival. No SNPs were associated with GC survival overall. However, subtype-specific associations were observed for gastric cardia adenocarcinomas at MUC1/TRIM46/1q22 rs2070803 [HRAA versus GA+GG = 2.16; 95% confidence interval (CI) = 1.24-3.78; P = 0.0068] and LTA/TNF/6p21.33 rs1799724 (HRTT+CT versus CC = 1.30; 95% CI = 1.07-1.57; P = 0.0077), and for diffuse-type GC at PSCA/8q24.3 rs2294008 (HRTT versus CT+CC = 1.99; 95% CI = 1.33-2.97; P = 7.8E-04). Rs2294008T was a cis-expression quantitative trait loci for PSCA, upregulating mRNA in normal gastric (β = 0.60; P = 5.7E-21) and GC (β = 0.30; P = 0.0089) tissues. Cases in the highest quartile (the smallest downregulation of tumor PSCA) had shortest survival than cases with the most downregulated PSCA (median survival of 0.47 years in the highest quartile versus 3.73 years in the lowest quartile; hazard ratio = 9.70; 95% CI = 2.46-38.4; P = 0.0012). Less striking effects for mRNA levels were observed for MTX1 at 1q22 in gastric cardia adenocarcinoma and for JRK at 8q24.3 in diffuse GC. Our results suggest three high-evidence GC risk loci have prognostic importance in GC subtypes. Future studies in well-characterized independent populations are warranted to validate our findings and further investigate the clinical utility of these variants in predicting GC prognosis.
    MeSH term(s) Adenocarcinoma/etiology ; Adenocarcinoma/genetics ; Asian Continental Ancestry Group/genetics ; Case-Control Studies ; Down-Regulation/genetics ; Female ; Gene Expression/genetics ; Genetic Predisposition to Disease/genetics ; Genome-Wide Association Study/methods ; Genotype ; Humans ; Male ; Middle Aged ; Polymorphism, Single Nucleotide/genetics ; Prognosis ; Quantitative Trait Loci/genetics ; RNA, Messenger/genetics ; Risk Factors ; Stomach Neoplasms/etiology ; Stomach Neoplasms/genetics ; Up-Regulation/genetics
    Chemical Substances RNA, Messenger
    Language English
    Publishing date 2017-11-09
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Intramural
    ZDB-ID 603134-1
    ISSN 1460-2180 ; 0143-3334
    ISSN (online) 1460-2180
    ISSN 0143-3334
    DOI 10.1093/carcin/bgx090
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Esophageal Squamous Dysplasia is Common in Asymptomatic Kenyans: A Prospective, Community-Based, Cross-Sectional Study.

    Mwachiro, Michael M / Burgert, Stephen L / Lando, Justus / Chepkwony, Robert / Bett, Collins / Bosire, Claire / Abnet, Christian C / Githanga, Jessie / Waweru, Wairimu / Giffen, Carol A / Murphy, Gwen / White, Russell E / Topazian, Mark D / Dawsey, Sanford M

    The American journal of gastroenterology

    2016  Volume 111, Issue 4, Page(s) 500–507

    Abstract: Objectives: Esophageal squamous cell carcinoma (ESCC) is endemic in east Africa and is a leading cause of cancer death among Kenyans. The asymptomatic precursor lesion of ESCC is esophageal squamous dysplasia (ESD). We aimed to determine the prevalence ... ...

    Abstract Objectives: Esophageal squamous cell carcinoma (ESCC) is endemic in east Africa and is a leading cause of cancer death among Kenyans. The asymptomatic precursor lesion of ESCC is esophageal squamous dysplasia (ESD). We aimed to determine the prevalence of ESD in asymptomatic adult residents of southwestern Kenya.
    Methods: In this prospective, community-based, cross-sectional study, 305 asymptomatic adult residents completed questionnaires and underwent video endoscopy with Lugol's iodine chromoendoscopy and mucosal biopsy for detection of ESD.
    Results: Study procedures were well tolerated, and there were no adverse events. The overall prevalence of ESD was 14.4% (95% confidence interval (CI): 10-19%), including 11.5% with low-grade dysplasia and 2.9% with high-grade dysplasia. The prevalence of ESD was >20% among men aged >50 years and women aged >60 years. Residence location was significantly associated with ESD (Zone A adjusted odds ratio (OR) 2.37, 95% CI: 1.06-5.30 and Zone B adjusted OR 2.72, 95% CI: 1.12-6.57, compared with Zone C). Iodine chromoendoscopy with biopsy of unstained lesions was more sensitive than white-light endoscopy or random mucosal biopsy for detection of ESD and had 67% sensitivity and 70% specificity.
    Conclusions: ESD is common among asymptomatic residents of southwestern Kenya and is especially prevalent in persons aged >50 years and those living in particular local regions. Lugol's iodine chromoendoscopy is necessary for detection of most ESD but has only moderate sensitivity and specificity in this setting. Screening for ESD is warranted in this high-risk population, and endoscopic screening of Kenyans is feasible, safe, and acceptable, but more accurate and less invasive screening tests are needed.
    MeSH term(s) Adult ; Biopsy ; Carcinoma, Squamous Cell/epidemiology ; Carcinoma, Squamous Cell/pathology ; Cross-Sectional Studies ; Early Detection of Cancer ; Esophageal Neoplasms/epidemiology ; Esophageal Neoplasms/pathology ; Esophageal Squamous Cell Carcinoma ; Esophagoscopy ; Esophagus/pathology ; Female ; Humans ; Iodides ; Kenya/epidemiology ; Male ; Middle Aged ; Precancerous Conditions/epidemiology ; Precancerous Conditions/pathology ; Prevalence ; Prospective Studies ; Risk Factors ; Sensitivity and Specificity ; Surveys and Questionnaires
    Chemical Substances Iodides ; Lugol's solution (T66M6Y3KSA)
    Language English
    Publishing date 2016-02-23
    Publishing country United States
    Document type Journal Article
    ZDB-ID 390122-1
    ISSN 1572-0241 ; 0002-9270
    ISSN (online) 1572-0241
    ISSN 0002-9270
    DOI 10.1038/ajg.2016.26
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  6. Article ; Online: Serum cytokine analysis in a positive chemoprevention trial: selenium, interleukin-2, and an association with squamous preneoplastic disease.

    Roth, Mark J / Katki, Hormuzd A / Wei, Wen-Qiang / Qiao, You-Lin / Bagni, Rachel / Wang, Guo-Qing / Whitby, Denise / Dong, Zhi-Wei / Gail, Mitchell H / Limburg, Paul J / Giffen, Carol A / Taylor, Philip R / Dawsey, Sanford M

    Cancer prevention research (Philadelphia, Pa.)

    2010  Volume 3, Issue 7, Page(s) 810–817

    Abstract: This study represents a multiplex cytokine analysis of serum from a 10-month randomized, controlled trial of 238 subjects that investigated the effects of selenomethionine and/or celecoxib in subjects with mild or moderate esophageal squamous dysplasia. ... ...

    Abstract This study represents a multiplex cytokine analysis of serum from a 10-month randomized, controlled trial of 238 subjects that investigated the effects of selenomethionine and/or celecoxib in subjects with mild or moderate esophageal squamous dysplasia. The original chemoprevention study found that, among those with mild dysplasia, selenomethionine treatment favorably altered dysplasia grade. The current analysis found that selenomethionine downregulated interleukin (IL)-2 by 9% (P = 0.04), whereas celecoxib downregulated IL-7 by 11% (P = 0.006) and upregulated IL-13 by 17% (P = 0.008). In addition, an increase in IL-7 tertile from baseline to t10 was significantly associated with an increase in dysplasia grade, both overall [odds ratio (OR), 1.47; P = 0.03] and among those with mild dysplasia at t0 (OR, 2.53; P = 0.001). An increase in IL-2 tertile from baseline to t10 was also nonsignificantly associated with worsening dysplasia for all participants (OR, 1.32; P = 0.098) and significantly associated with worsening dysplasia among those with mild dysplasia at baseline (OR, 2.0; P = 0.01). The association of increased IL-2 with worsening dysplasia remained significant in those on selenomethionine treatment who began the trial with mild dysplasia (OR, 2.52; P = 0.03). The current study shows that selenomethionine supplementation decreased serum IL-2 levels, whereas celecoxib treatment decreased IL-7 levels and increased IL-13 levels during a 10-month randomized chemoprevention trial. An increase in IL-2 or IL-7 was associated with increased severity of dysplasia over the course of the trial, especially in those who began the trial with mild dysplasia. The favorable effect of selenomethionine on esophageal dysplasia in the original trial may have been mediated in part by its effect in reducing the levels of IL-2.
    MeSH term(s) Adult ; Aged ; Anticarcinogenic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Celecoxib ; Cytokines/blood ; Esophageal Neoplasms/blood ; Esophageal Neoplasms/prevention & control ; Female ; Humans ; Interleukin-2/blood ; Male ; Middle Aged ; Neoplasms, Squamous Cell/blood ; Neoplasms, Squamous Cell/prevention & control ; Odds Ratio ; Precancerous Conditions/blood ; Precancerous Conditions/drug therapy ; Pyrazoles/therapeutic use ; Selenomethionine/therapeutic use ; Sulfonamides/therapeutic use
    Chemical Substances Anticarcinogenic Agents ; Cytokines ; Interleukin-2 ; Pyrazoles ; Sulfonamides ; Selenomethionine (964MRK2PEL) ; Celecoxib (JCX84Q7J1L)
    Language English
    Publishing date 2010-06-29
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Intramural
    ZDB-ID 2434717-6
    ISSN 1940-6215 ; 1940-6207
    ISSN (online) 1940-6215
    ISSN 1940-6207
    DOI 10.1158/1940-6207.CAPR-09-0269
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6766: Show issues Location:
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  7. Article ; Online: Aryl hydrocarbon receptor expression is associated with a family history of upper gastrointestinal tract cancer in a high-risk population exposed to aromatic hydrocarbons.

    Roth, Mark J / Wei, Wen-Qiang / Baer, Jessica / Abnet, Christian C / Wang, Guo-Qing / Sternberg, Lawrence R / Warner, Andrew C / Johnson, Laura Lee / Lu, Ning / Giffen, Carol A / Dawsey, Sanford M / Qiao, You-Lin / Cherry, James

    Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology

    2009  Volume 18, Issue 9, Page(s) 2391–2396

    Abstract: Background: Polycyclic aromatic hydrocarbon (PAH) exposure is a risk factor for esophageal squamous cell carcinoma, and PAHs are ligands of the aryl hydrocarbon receptor (AhR). This study measured the expression of AhR and related genes in frozen ... ...

    Abstract Background: Polycyclic aromatic hydrocarbon (PAH) exposure is a risk factor for esophageal squamous cell carcinoma, and PAHs are ligands of the aryl hydrocarbon receptor (AhR). This study measured the expression of AhR and related genes in frozen esophageal cell samples from patients exposed to different levels of indoor air pollution, who did or did not have high-grade squamous dysplasia and who did or did not have a family history of upper gastrointestinal tract (UGI) cancer.
    Methods: 147 samples were evaluated, including 23 (16%) from patients with high-grade dysplasia and 48 (33%) from patients without dysplasia who heated their homes with coal, without a chimney (a "high" indoor air pollution group), and 27 (18%) from patients with high-grade dysplasia and 49 (33%) from patients without dysplasia who did not heat their homes at all (a "low" indoor air pollution group). Sixty-four (44%) had a family history of UGI cancer. RNA was extracted and quantitative PCR analysis was done.
    Results: AhR gene expression was detectable in 85 (58%) of the samples and was >9-fold higher in those with a family history of UGI cancer [median expression (interquartile range), -1,964 (-18,000, -610) versus -18,000 (-18,000, -1036); P = 0.02, Wilcoxon rank-sum test]. Heating status, dysplasia category, age, gender, and smoking were not associated with AhR expression (linear regression; all P values >or= 0.1).
    Conclusion: AhR expression was higher in patients with a family history of UGI cancer. Such individuals may be more susceptible to the deleterious effects of PAH exposure, including PAH-induced cancer.
    MeSH term(s) Aged ; Air Pollution, Indoor/adverse effects ; Biomarkers, Tumor/biosynthesis ; Biomarkers, Tumor/genetics ; Carcinoma, Squamous Cell/chemically induced ; Carcinoma, Squamous Cell/genetics ; Carcinoma, Squamous Cell/metabolism ; Cross-Sectional Studies ; Esophageal Neoplasms/chemically induced ; Esophageal Neoplasms/genetics ; Esophageal Neoplasms/metabolism ; Female ; Gene Expression ; Humans ; Male ; Middle Aged ; Polycyclic Aromatic Hydrocarbons/poisoning ; Receptors, Aryl Hydrocarbon/biosynthesis ; Receptors, Aryl Hydrocarbon/genetics ; Risk Factors
    Chemical Substances Biomarkers, Tumor ; Polycyclic Aromatic Hydrocarbons ; Receptors, Aryl Hydrocarbon
    Language English
    Publishing date 2009-08-18
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural
    ZDB-ID 1153420-5
    ISSN 1538-7755 ; 1055-9965
    ISSN (online) 1538-7755
    ISSN 1055-9965
    DOI 10.1158/1055-9965.EPI-08-1098
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Treatment of chronic hepatitis C in HIV/HCV-coinfection with interferon alpha-2b+ full-course vs. 16-week delayed ribavirin.

    Bräu, Norbert / Rodriguez-Torres, Maribel / Prokupek, Dale / Bonacini, Maurizio / Giffen, Carol A / Smith, Jeffery J / Frost, Kevin R / Kostman, Jay R

    Hepatology (Baltimore, Md.)

    2004  Volume 39, Issue 4, Page(s) 989–998

    Abstract: Human immunodeficiency virus (HIV)-infected patients increasingly experience the consequences of chronic hepatitis C virus (HCV) coinfection. This trial randomized 107 patients coinfected with HIV and HCV to receive 48 weeks of interferon alfa-2b (IFN) 3 ...

    Abstract Human immunodeficiency virus (HIV)-infected patients increasingly experience the consequences of chronic hepatitis C virus (HCV) coinfection. This trial randomized 107 patients coinfected with HIV and HCV to receive 48 weeks of interferon alfa-2b (IFN) 3 million units three times weekly plus either a full course of ribavirin (RBV) at 800 mg/day (group A; n = 53) or 16 weeks of placebo, followed by RBV (group B; n = 54). The primary endpoint of sustained viral response (SVR) rate (undetectable HCV RNA at posttreatment week 24) was not different between groups A (11.3%) and B (5.6%; P =.32). Within group A, the SVR rate was lower in genotype 1 (2.5%) than in genotypes 2 through 4 (41.7%; P =.002). Fifty-five patients discontinued therapy prematurely, mostly because of adverse events or patient decisions. At treatment week 12, the percentage of CD4+ cells rose in group A (+4.1%; P <.001), but not in group B (-0.3%). A significant proportion (22%) of patients who were HIV viremic at baseline had undetectable HIV RNA at week 12. By week 16, the hemoglobin level decreased more in group A (-2,52 g/dL) than in group B (-1.02 g/dL; P <.001). In group A, the hemoglobin decline was steeper in patients receiving zidovudine (azidothymidine [AZT], -3.64 g/dL vs. no AZT, -2.08 g/dL), and patients receiving zidovudine had more anemia-related RBV dose reductions (AZT, 60% vs. no AZT, 16%). In conclusion, HCV therapy with IFN plus RBV is relatively safe in patients coinfected with HIV and HCV, but frequent treatment discontinuations and anemia-related RBV dose reductions contribute to a poor SVR rate. Control of HIV infection improves rather than worsens during therapy.
    MeSH term(s) Adult ; Aged ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Drug Therapy, Combination ; Female ; HIV Infections/complications ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Interferon-alpha/administration & dosage ; Interferon-alpha/adverse effects ; Male ; Middle Aged ; RNA, Viral/blood ; Recombinant Proteins ; Ribavirin/administration & dosage ; Ribavirin/adverse effects ; Treatment Outcome
    Chemical Substances Antiviral Agents ; Interferon-alpha ; RNA, Viral ; Recombinant Proteins ; interferon alfa-2b (43K1W2T1M6) ; Ribavirin (49717AWG6K)
    Language English
    Publishing date 2004-04
    Publishing country United States
    Document type Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 604603-4
    ISSN 1527-3350 ; 0270-9139
    ISSN (online) 1527-3350
    ISSN 0270-9139
    DOI 10.1002/hep.20107
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Cytologic detection of esophageal squamous cell carcinoma and its precursor lesions using balloon samplers and liquid-based cytology in asymptomatic adults in Llinxian, China.

    Pan, Qin-Jing / Roth, Mark J / Guo, Hui-Qin / Kochman, Michael L / Wang, Guo-Qing / Henry, Michael / Wei, Wen-Qiang / Giffen, Carol A / Lu, Ning / Abnet, Christian C / Hao, Chang-Qing / Taylor, Philip R / Qiao, You-Lin / Dawsey, Sanford M

    Acta cytologica

    2008  Volume 52, Issue 1, Page(s) 14–23

    Abstract: Objective: Esophageal squamous cell carcinoma (ESCC) is associated with very high regional mortality rates in several countries. Our initial test of esophageal cytology screening devices found them not sensitive enough for an early detection program. ... ...

    Abstract Objective: Esophageal squamous cell carcinoma (ESCC) is associated with very high regional mortality rates in several countries. Our initial test of esophageal cytology screening devices found them not sensitive enough for an early detection program. The current study tested a newly designed "mechanical" balloon and a traditional Chinese inflatable balloon, followed by liquid-based cytology, to detect biopsy-proven squamous dysplasia and early cancer.
    Study design: Participants were randomized to a cytologic sampler, followed by endoscopy with iodine staining. For each patient, the cytologic diagnosis (test) was compared with the worst endoscopic biopsy diagnosis (truth).
    Results: Seven hundred forty subjects completed both examinations. Approximately 30% showed atypical squamous cells of undetermined significance (ASCUS), and 10% showed squamous intraepithelial lesions. Seven hundred twenty-five subjects (98%) had satisfactory biopsies, and 32% had low grade dysplasia or worse disease. Defining > ASCUS, favor neoplastic, as a positive screening test, the sensitivities/specificities of the mechanical and inflatable balloons were 39%/85% and 46%/84%, respectively, for detecting any squamous dysplasia or cancer.
    Conclusion: These esophageal cell samplers performed equivalently, but the accuracy was still too low for a primary screening test. These results highlight the need to develop new cytologic criteria or molecular markers that can better detect early squamous esophageal disease [corrected]
    MeSH term(s) Adult ; Aged ; Carcinoma, Squamous Cell/diagnosis ; Carcinoma, Squamous Cell/epidemiology ; Carcinoma, Squamous Cell/pathology ; China/epidemiology ; Cytological Techniques ; Esophageal Neoplasms/diagnosis ; Esophageal Neoplasms/epidemiology ; Esophageal Neoplasms/pathology ; Esophagoscopy ; Female ; Humans ; Male ; Middle Aged ; Precancerous Conditions/diagnosis ; Precancerous Conditions/epidemiology ; Precancerous Conditions/pathology
    Language English
    Publishing date 2008-01
    Publishing country Switzerland
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 80003-x
    ISSN 1938-2650 ; 0001-5547
    ISSN (online) 1938-2650
    ISSN 0001-5547
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Cytologic Detection of Esophageal Squamous Cell Carcinoma and Its Precursor Lesions Using Balloon Samplers and Liquid-Based Cytology in Asymptomatic Adults in Linxian, China

    Pan, Qin-Jing / Roth, Mark J. / Guo, Hui-Qin / Kochman, Michael L. / Wang, Guo-Qing / Henry, Michael / Wei, Wen-Qiang / Giffen, Carol A. / Lu, Ning / Abnet, Christian C. / Hao, Chang-Qing / Taylor, Philip R. / Qiao, You-Lin / Dawsey, Sanford M.

    Acta Cytologica

    2011  Volume 52, Issue 1, Page(s) 14–23

    Institution From the Departments of Cytology, Endoscopy, Cancer Epidemiology and Pathology, Cancer Institute, Chinese Academy of Medical Sciences, Beijing, China; Nutritional Epidemiology Branch and Genetic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland; Gastroenterology Division, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; Department of Cytology, University of Maryland, Baltimore, Maryland; and Information Management Services, Silver Spring, Maryland, U.S.A
    Language English
    Publishing date 2011-02-15
    Publisher S. Karger AG
    Publishing place Basel, Switzerland
    Document type Article
    Note Nongynecologic Cytopathology
    ZDB-ID 80003-x
    ISSN 1938-2650 ; 0001-5547
    ISSN (online) 1938-2650
    ISSN 0001-5547
    DOI 10.1159/000325430
    Database Karger publisher's database

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