tbuckley/cabot-search huggingface dataset:
SAT0562 The Consort Criteria for Eligibilty, Study Settings, Locations, and Center Effects are Seldom Met in Randomised Clinical Trials
Authors: S. Yurdakul, B. Nezhdi Mustafa, I. Fresko, E. Seyahi, H. Yazici
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> The internal and external validity of randomised controlled trials require detailed analyses of modes of patient recruitment, description of the settings and locations of the study and the individual center effects as described in the CONSORT statement (1,2). However, most of the trials published in major rheumatology journals lack this information. <h3>Objectives</h3> We surveyed the reporting of the eligibility criteria for participants, the settings and locations where the data were collected according to CONSORT and the center effects on outcomes in randomised clinical trials in major rheumatology journals. <h3>Methods</h3> A hand search was made for randomised controlled trials published in 2011 and 2012 in <i>Ann Rheum Dis, Arthritis Rheum, Rheumatology, J Rheumatol, and Clin Exp Rheumatol</i>. The items were separately tabulated for <i>eligibility criteria for participants</i> such as referral or self selection, <i>the settings and locations of the study</i> such as country, city; the immediate environment the study was performed in such as community, office practice, hospital clinic, inpatient unit, primary, secondary and tertiary health care and other factors related to the setting exemplified by climate, physical factors, economics, geography, social and cultural milieu (race and education), and problems with transportation. The individual center effects on outcomes in the main text were also explored. Two observers separately evaluated the papers and the disagreements were resolved by consensus. <h3>Results</h3> We evaluated 102 studies including four with childhood diseases. The following data were available for referral patterns: physician referrals (n=5), self selection (n=6) or both (n=2); locations: country (n=54), continent (n=12), and local city (n=31); settings: community (n=2), hospital clinic (n=27), inpatient unit (n=2); secondary (n=1) or tertiary health care centers (n=13); socio-economics (n=6), educational levels (n= 5), and race (n=42). No data were given for the remaining items. Multicenter differences were only reported in 1 of 24 papers in <i>Ann Rheum Dis</i>, 8 of 28 in <i>Arthritis Rheum</i>, 1 of 6 in <i>Rheumatology</i>, 2 of 11 in <i>J Rheumatol</i>, and 1of 3 in <i>Clin Exp Rheumatol</i>. <h3>Conclusions</h3> A few randomised controlled trials give enough information on eligibility criteria for participants and the settings and locations as well as the center effects. These cast doubt on the robustness of the results. More data are needed to apply these outcomes to other patient populations. <h3>References</h3> Schulz et al. CONSORT 2010 Statement: updated guidelines for reporting paralel group randomised trials. BMJ 2010;340:c332. Moher et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869 <h3>Disclosure of Interest</h3> None Declared
TCT-310 Impact of Ischemic EKG Changes during the Acetylcholine Provocation Test on 12-month Clinical Outcomes in Patients with Vasospastic Angina
Authors: Sung Il Im, Seung-Woon Rha, Byoung Geol Choi, Se Yeon Choi, Yoonjee Park, Raghavender Goud Akkala, Sunki Lee, Ji Bak Kim, Jin oh Na, Cheol Ung Choi, Hong Euy Lim, Jin Won Kim, Eung Ju Kim, Chang Gyu Park, Hong Seog Seo, Dong Joo Oh
Journal: Journal of the American College of Cardiology (2013)
Regional Cerebral Blood Flow and Vascular Reserve in Neuronal Migration Disorder Assessed by Tc-99m Hexamethylpropylene Amineoxime SPECT with Acetazolamide Challenge
Authors: T Kojima, S Mizumura, S I Kumita, H Nakajo, T Kumazaki, T Kitamura, K Fukino, A Teramoto
Journal: Clinical Nuclear Medicine (2000)

A 20-month-old boy had left hemiparesis and mental retardation. Magnetic resonance imaging revealed agyria-pachygyria in the right cerebral hemisphere, but magnetic resonance angiography showed no arterial stenosis or hypoplasia. Resting SPECT showed reduced Tc-99m hexamethylpropylene amineoxime accumulation in the affected cortex compared with the contralateral unaffected cortex, but during acetazolamide administration accumulation in the affected cortex was similar to that in the unaffected cortex. These findings suggest that the vasodilator function of the affected cortex was intact. This supports the contention that the low accumulation of cerebral blood flow tracer in migration disorder does not reflect impaired cerebral blood supply but rather reduced tissue activity.
Clinical Variation of Autoimmune Polyendocrinopathy–Candidiasis–Ectodermal Dystrophy (APECED) in a Series of 68 Patients
Authors: Pekka Ahonen, Sinikka Myllärniemi, Ilkka Sipilä, Jaakko Perheentupa
Journal: New England Journal of Medicine (1990)

To define the clinical picture and course of the autosomal recessive disease called autoimmune polyendocrinopathy—candidiasis—ectodermal dystrophy (APECED), we report data from our 10-month to 31-year follow-up of 68 patients from 54 families, now 10 months to 53 years of age.
Abstract 833: Effects of ERCC2 and ERCC4 genetic polymorphisms on survival of patients with esophageal cancer
Authors: Jang-Ming Lee, Shi-Yi Yang, Pei-Wen Yang, Tzu-Hsuen Chuang, Jin-Shing Chen, Hsao-Hsun Hsu, Pei-Ming Huang, Yung-Chie Lee
Journal: Cancer Research (2010)

Abstract Effects of ERCC2 and ERCC4 genetic polymorphisms on survival of patients with esophageal cancer Jang-Ming Lee1; Shi-Yi Yang2; Pei-Wen Yang1; Tzu-Hsuen Chuang 1; Jin-Shing Chen1; Hsao-Hsun Hsu1; Pei-Ming Huang1; and Yung-Chie Lee1. 1Department of Surgery, National Taiwan University Hospital; 2Graduate Institute of Epidemiology, National Taiwan University, Taipei Background: XPD/ERCC2 (ERCC2) and XPF/ERCC4 (ERCC4) are the genes involved in nucleotide excision repair (NER). The clinical roles of the genetic polymorphism of ERCC2 on R156R (rs238406) and rs3136038 within ERCC4 promoter region in esophageal cancer are unknown. Methods: We evaluated 400 patients with esophageal cancer collected from 1996 to 2009 at National Taiwan University Hospital. The genotypes of ERCC2 on R156R and ERCC4 on rs3136038 within promoter region were analyzed with the TaqMan assay from the genomic DNA of peripheral leukocytes. The results of the genotyping were correlated to the survival of the patients. Results: There is no significant difference in clinical characteristics among the enrolled patients among different genotypes of ERCC2 and 4. The C/C genotype of ERCC2 R156R shows an insignificant unfavorable progression-free survival (PFS) compared to other genotypes (A/A or C/A) (adjusted [HR] = 1.17, 95% CI=0.90-1.51, P=0.236). The ERCC4 rs3136038 G/A genotype displays significant association with worse PFS compared to other genotypes (A/A or G/G) (adjusted [HR] = 1.29, 95% CI=1.02-1.62, P=0.033). Combining these two polymorphisms, these two unfavorable genotypes (C/C on ERCC2 R156R and G/A on ERCC4 rs3136038) display dose-dependently to associate a worse overall and progression free survival with a significant HR of death and disease progression in the patients with both of the unfavorable genotypes comparing with those who without (adjusted [HR] = 1.49, 95% CI=1.04-2.15, P=0.031 for overall survival[OS]; adjusted [HR] = 1.57, 95% CI=1.09-2.26, P=0.015 for progression free survival [PFS]). Kaplan-Meier survival curves demonstrated a significant different distribution of OS and PFS between all patients by the number of unfavorable genotypes of ERCC2 and 4. (P=0.049 for OS and P=0.040 for PFS). Conclusion: Our study demonstrated that the genetic variants of ERCC2 and ERCC4 may play a role for the clinical outcome in ECa patients. The patients of esophageal cancer with both C/C on ERCC2 R156R and G/A on ERCC4 rs3136038 may require closer follow-up after treatment. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 833.
Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study
Authors: M. Martin, P. Fumoleau, J.A. Dewar, J. Albanell, S.A. Limentani, M. Campone, J.C. Chang, M. Patre, A. Strasak, S.L. de Haas, J. Xu, J.A. Garcia-Saenz
Journal: Annals of Oncology (2016)
Laparoscopic and endoscopic cooperative surgery for duodenal tumor resection
Authors: Fumitoshi Hirokawa, Michihiro Hayashi, Yoshiharu Miyamoto, Mitsuhiro Asakuma, Tetsunosuke Shimizu, Koji Komeda, Yoshihiro Inoue, Eiji Umegaki, Kazuhisa Uchiyama
Journal: Endoscopy (2014)

A 66-year-old man was diagnosed with early duodenal cancer in the third portion of the duodenum ([Fig. 1 a, b]). Surgical removal of the tumor was performed.
Abstract 2552: A genome-wide association study of prostate cancer in West African men.
Authors: Michael B. Cook, Zhaoming Wang, Edward D. Yeboah, Andrew A. Adjei, Yao Tettey, Richard B. Biritwum, Evelyn Tay, Ann Truelove, Shelley Niwa, Lisa Chu, Meredith Yeager, Amy Hutchinson, Kai Yu, Christopher A. Haiman, Ann Hsing, Stephen J. Chanock
Journal: Cancer Research (2013)

Abstract Age-adjusted mortality rates for prostate cancer are higher for Africa compared with North America or Western Europe. In addition, African American men are noted to have higher age-adjusted incidence rates of this malignancy than European American men. Coupled with the fact that West Africa is the principal ancestral region of African-American men has led to the hypothesis that there may exist distinct ancestral genetic profiles which mediate prostate cancer risk. In addition, advantages of conducting a genome-wide association study (GWAS) of prostate cancer in African men include a more discrete linkage disequilibrium (LD) structure, a higher number of private single nucleotide polymorphisms (SNPs), the predominance of symptomatic disease, and assessment of unique exposures. The Ghana Prostate Study was conducted collaboratively involving the US National Cancer Institute (NCI) and the University of Ghana during 2006-2012. The NCI Cancer Genomics Research Laboratory genotyped 494 prostate cancer cases and 498 population controls using the Illumina HumanOmni5-Quad BeadChip. Associations were assessed using multivariate logistic regression adjusted for age and genetic ancestry. We sought to validate the 30 most promising SNP associations with prostate cancer through the African American Prostate Cancer GWAS Consortium. A novel locus at 10p14 for prostate cancer risk was the strongest signal detected, and the 8 SNPs at this locus were in LD. This locus is located 360 kb 5’ of GATA3 and the 8 SNPs reside within an intron of LincRNA gene RP11-543F8.2. Analysis of African 1000 Genomes Project data did not indicate LD between 10p14 SNPs and splice or exonic SNPs of this gene, while HaploReg found no significant enrichment of enhancer elements. None of the most promising 30 SNPs replicated in the African American Prostate Cancer GWAS Consortium. This may be due to chance or differences in population genetics, environment, and/or proportion of symptomatic disease. Further genetic studies of prostate cancer in African men are needed to validate the 10p14 susceptibility locus. Citation Format: Michael B. Cook, Zhaoming Wang, Edward D. Yeboah, Andrew A. Adjei, Yao Tettey, Richard B. Biritwum, Evelyn Tay, Ann Truelove, Shelley Niwa, Lisa Chu, Meredith Yeager, Amy Hutchinson, Kai Yu, Christopher A. Haiman, African American Prostate Cancer GWAS Consortium, Robert N. Hoover, Ann Hsing, Stephen J. Chanock. A genome-wide association study of prostate cancer in West African men. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 2552. doi:10.1158/1538-7445.AM2013-2552
AB1335 The clinicopathologic characteristics of granulomatosis with polyangiitis (wegener’s): Retrospective study of 45 patients in korea
Authors: H.W. Kim, J.W. Kim, C.H. Im, K.C. Shin, E.Y. Lee, E.B. Lee, Y.W. Song
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> The epidemiologic studies of granulomatosis with polyangiitis (Wegener's) (GPA) have been reported primarily in European/American countries while there are only a few data available from Asian area. Recent clinical studies from Japan and China indicated that there is a geographical difference in the incidence of GPA (1, 2) and the different ANCA pattern between Asian and Caucasian may be associated with different clinical manifestations. <h3>Objectives</h3> The aim of this study is to anlayze the clinicopathologic characteristics of Korean patients with GPA. <h3>Methods</h3> We retrospectively reviewed 45 patients with GPA regarding clinical manifestations including histology, positivity of ANCA, categorization of disease stages, disease activity states in a single tertiary referral hospital. Patients were categorized into a predominant form based on immunopathologic scoring system of granulomatous-vasculitic activity (3). <h3>Results</h3> Thirty-one patients (68.9%) showed ANCA positivity (C-ANCA/P-ANCA, 44.4%/20.0%, proteinase-3 (PR3) ANCA/myeloperoxidase (MPO) ANCA, 48.4%/16.1%). ANCA positive patients (female 29.6%) were associated with higher frequency of renal involvement (51.6% vs 7.1%, p=0.004), elevated serum creatinine (29.0% vs 0%, p=0.018) and higher mortality (29% vs 7.1%, p=0.041) compared with ANCA negative patients. Thirty-three patients (73.3%, female 60.6%) were categorized into a granulomatous form, whereas vasculitic form and mixed form were found in 8.9% and 17.8% respectively. Age at diagnosis were younger (51.2 vs 62.3, p=0.045), and initial remission rate (69.7% vs 25.0%) and the relapse rate (60.8% vs 0%) were higher in granulomatous form compared with vasculitic form. <h3>Conclusions</h3> Taken together, in Korean patients with GPA, ANCA positivity was found in 68.9% and associated with renal involvement and higher mortality. The granulomatous form was predominant. <h3>References</h3> Fujimoto S, Watts RA, Kobayashi S, Suzuki K, Jayne DR, Scott DGet al. Comparison of the epidemiology of anti-neutrophil cytoplasmic antibody-associated vasculitis between Japan and the U.K. Rheumatology (Oxford).2011;50:1916-20. Chen M, Yu F, Zhang Y, Zou WZ, Zhao MH, Wang HY. Characteristics of Chinese patients with Wegener's granulomatosis with anti-myeloperoxidase autoantibodies. Kidney Int. 2005; 68: 2225-29. Pierrot-Deseilligny Despujol C, Pouchot J, Pagnoux C, Coste J, Guillevin L. Predictors at diagnosis of a first Wegener's granulomatosis relapse after obtaining complete remission. Rheumatol. 2010;49: 2181-90. <h3>Disclosure of Interest</h3> None Declared
AB0218 Changes in ACPA during 24-Week Therapy with Tocilizumab (TCZ) for Rheumatoid Arthritis (RA) PREDICT Long-Term Progression of Articular Destruction: 2-Year Results of Extended Actor Study
Authors: A. Sagawa
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Anti-citrullinated protein antibodies (ACPA) aggravate inflammation, activate osteoclasts, and accelerate bone resorption in RA patients.<sup>1</sup> We previously reported that a decrease in ACPA was observed during 52 weeks of TCZ therapy, and that there was a possibility of rapid radiographic progression being predicted from ACPA levels.<sup>2</sup> However, the predictability of long-term progression of articular destruction in terms of changes in ACPA in patients on TCZ, the only IL-6 inhibitor currently available, remains unclear. <h3>Objectives</h3> This study aimed to examine whether changes in ACPA during 104 weeks of TCZ therapy can serve as a predictive factor for long-term progression of articular destruction in RA patients not adequately responding to existing treatment. <h3>Methods</h3> This was a long-term administration study carried out in succession to the Actor Study that began in 2008. The observation period in this study was 104 weeks. TCZ at a dose of 8 mg/kg was given every 4 weeks. Anti-CCP antibodies were measured by enzyme-linked immunosorbent assay (ELISA) at each TCZ administration. Changes in ACPA and progression of articular destruction were evaluated over 104 weeks. The relationships between ACPA changes at 4, 12, and 24 weeks of TCZ therapy and the modified total sharp score (mTSS) at 2 years were evaluated. <h3>Results</h3> Of 58 patients who enrolled in the Actor Study, 22 in whom the study parameters were measurable over 104 weeks were evaluated in this study. The median ACPA level [interquartile range] decreased from 154 [52-545] before therapy to 70 [19-319] after 104 weeks of therapy (P=0.05). There was no correlation between changes in ACPA and changes in DAS28 or CDAI after 104 weeks of therapy. Progression of articular destruction was found in 4 patients. When patients who showed progression of articular destruction were compared with those without such progression (defined as ΔmTSS&lt;0.5 per year), the ACPA level tended to be higher in the former at 24 weeks (P=0.05). <h3>Conclusions</h3> The results confirmed ACPA to also be decreased by TCZ therapy lasting as long as 104 weeks. This study, together with the previous report of the Actor Study, has provided the first evidence of ACPA being decreased by an IL-6 inhibitor. In addition, the fact that the ACPA level was high until 24 weeks in patients with progression of articular destruction raises the possibility that articular destruction over a long period can be predicted by ACPA. <h3>References</h3> J Clin Invest. 2012;122(5):1791-802. Sagawa A. Ann Rheum Dis 2013;72(Suppl3):445 <h3>Disclosure of Interest</h3> None declared <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.3975
AB1134 Efficacy and safety of therapy by etanercept in combination with methotrexate for patients with juvenile idiopathic arthritis
Authors: E. Alexeeva, S. Valiyeva, T. Bzarova, K. Isayeva, R. Denisova, T. Sleptsova, E. Mitenko, N. Tsurikova, A. Chomakhidze, A. Fetisova
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Juvenile idiopathic arthritis (JIA) - a chronic disease that leads to early disability of patients. Treatment of JIA is one of the most complex and urgent problems of rheumatology. The opportunity to achieve sustained remission with conventional antirheumatic drugs remains unlikely for many patients. However, the use of new expensive drugs for the treatment of JIA, biological agents, can achieve prolonged remission of the disease and improves prognosis. <h3>Objectives</h3> Evaluate the efficacy and safety of etanercept therapy in combination with methotrexate in patients with JIA. <h3>Methods</h3> Have been examined 25 patients aged 8 (6, 11) years old: 8 boys and 17 girls. 17 of them - with polyarthritis, 8 – with oligoarthritis. Etanercept was administered subcutaneously twice per week at a dose of 0.4 mg/kg of body weight (maximum 25 mg) for patients receiving methotrexate at a dose of 15 mg/m<sup>2</sup> per week. The treatment was during 48 weeks. The drug was canceled for 3 patients due to inefficiencies in terms of: 5 Weeks, 5 and 6 months. The effectiveness of therapy was evaluated according to criteria of the American College of Rheumatology (ACR Pedi-) - 30,50,70% improvement. <h3>Results</h3> After 1 month of etanercept treatment by ACR pediatric criteria, 30% improvement was achieved in 72% of patients, 50% -in 40% of patients and 70% - in 12% of patients. After 6 months of treatment the improvement remained in 90% of children by the ACR50 criterion, and ACR70 criterion have been registered in 59%. After 48 weeks of etanercept therapy, the improvement of 50 and 70% have been registered in 100 and 86% of patients respectively. After 6 months of treatment status of inactive disease was reported in 59% of patients and after 12 months – in 86% of patients. Adverse events were mild or medium-heavy (3) and did not require discontinuation of the drug, acute bronchitis, exacerbation of herpetic infection (1), rinitis (1), pain at the injection site (1). <h3>Conclusions</h3> Etanercept is highly effective and safe for patients with oligo and polyarthritis, it causes the development of remission after a year of therapy in 86% of patients. <h3>Disclosure of Interest</h3> None Declared
SP0010 Long-term economic outcomes of modern treatment: Sick leave and work disability
Authors: I.F. Petersson
Journal: Annals of the Rheumatic Diseases (2013)

Modern treatment for patients with chronic inflammatory joint diseases includes pharmacological as well as rehabilitation and joint surgery when needed. The major shift over the past decade in the pharmacological treatment strategies includes tight inflammation control by optimizing conventional DMARD therapy and when needed adding on biologic therapies. Within the area of non-pharmacological treatment changes have also occurred with more individualized/tailored information, training and physical treatment programs. The major focus in outcomes within rheumatology has been patient oriented measures and measures of disease activity/disease severity. With the modern strategies for earlier diagnosis, earlier and more effective treatment and tight control also other outcomes have become relevant. These include measures of work related outcomes on both presenteeism and absenteeism. Levels of sick leave and disability pensions reflect the absenteeism and validated PROs such as WPAI are used to reflect productivity/presenteeism. All this information and in addition measures of direct and indirect costs can be used for both health economic modeling and calculations. It is important for patients, health care providers, clinicians and politicians/decision makers to include the now well established long term benefits of modern treatment in the scope of rheumatological health care and treatment. Several studies confirm the severe negative impact on work ability from chronic inflammatory joint diseases but also the positive changes for patients with optimal modern treatment. <h3>References</h3> Iversen MD, Petersson IF. Design issues and priorities in team and nonpharmacological arthritis care research. J Rheumatol. 2006 Sep;33(9):1904-7. Petersson IF. Team care. Traditions and new trends. J Rheumatol. 2006 Sep;33(9):1895-6. Strömbeck B, Jacobsson LT, Bremander A, Englund M, Heide A, Turkiewicz A, Petersson IF. Patients with ankylosing spondylitis have increased sick leave - A registry based case control study over seven years. Rheumatology (Oxford). 2009 Mar;48(3):289-92 Strömbeck B, Englund E, Bremander A, Jacobsson L, Kedza L, Kobelt G, Petersson IF. Cost of illness from the public payers’ perspective in patients with ankylosing spondylitis.J Rheumatol. 2010 Nov;37(11):2348-55. Olofsson T, Englund M, Saxne T, Jöud A, Jacobsson LT H, Geborek P, Allaire S, Petersson IF. Decrease in sick leave among patients with rheumatoid arthritis in the first 12 months after start of treatment with tumour necrosis factor antagonists: a population-based controlled cohort study. Ann Rheum Dis. 2010 Dec;69(12):2131-6. Kristensen LE, Petersson IF, Geborek P, Jöud A, Saxne T, Jacobsson LTH, Englund M. Sick leave in patients with ankylosing spondylitis before and after anti-TNF therapy: a population-based cohort study. Rheumatology (Oxford). 2011 May 12. [Epub ahead of print] <h3>Disclosure of Interest</h3> I. Petersson Speakers Bureau: Pfizer, Abbott, UCB Pharma