bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Smoking MUMS (Maternal Use of Medications and Safety) Study: protocol for a population-based cohort study using linked administrative data
Authors: Havard Alys , Jorm Louisa R , Preen David , Daube Michael , Kemp Anna , Einarsdóttir Kristjana , Randall Deborah , Tran Duong Thuy 
Published: September 2013

IntroductionApproximately 14% of Australian women smoke during pregnancy. Although the risk of adverse outcomes is reduced by smoking cessation, less than 35% of Australian women quit smoking spontaneously during pregnancy. Evidence for the efficacy of bupropion, varenicline or nicotine replacement therapy as smoking cessation aids in the non-pregnant population suggest that pharmacotherapy for smoking cessation is worth exploring in women of childbearing age. Currently, little is known about the utilisation, effectiveness and safety of pharmacotherapies for smoking cessation during pregnancy; neither the extent to which they are used prior to pregnancy nor whether their use has changed in response to related policy reforms. The Smoking MUMS (Maternal Use of Medications and Safety) Study will explore these issues using linked person-level data for a population-based cohort of Australian mothers.Methods and analysisThe cohort will be assembled by linking administrative health records for all women who gave birth in New South Wales or Western Australia since 2003 and their children, including records relating to childbirth, use of pharmaceuticals, hospital admissions, emergency department presentations and deaths. These longitudinal linked data will be used to identify utilisation of smoking cessation pharmacotherapies during and between pregnancies and to explore the associated smoking cessation rates and maternal and child health outcomes. Subgroup and temporal analyses will identify potential differences between population groups including indigenous mothers and social security recipients and track changes associated with policy reforms that have made alternative smoking cessation pharmacotherapies available.Ethics and disseminationEthical approval has been obtained for this study. To enhance the translation of the project's findings into policy and practice, policy and clinical stakeholders will be engaged through a reference group and a policy forum will be held. Outputs from the project will include scientific papers and summary reports designed for policy audiences.
A population-based case–control study on social factors and risk of testicular germ cell tumours
Authors: Schmeisser Nils , Conway David I , Stang Andreas , Jahn Ingeborg , Stegmaier Christa , Baumgardt-Elms Cornelia , Jöckel Karl-Heinz , Behrens Thomas , Ahrens Wolfgang 
Published: September 2013

ObjectivesIncidence rates for testicular cancer have risen over the last few decades. Findings of an association between the risk of testicular cancer and social factors are controversial. The association of testicular cancer and different indicators of social factors were examined in this study.DesignCase–control study.SettingPopulation-based multicentre study in four German regions (city states Bremen and Hamburg, the Saarland region and the city of Essen).ParticipantsThe study included 797 control participants and 266 participants newly diagnosed with testicular cancer of which 167 cases were classified as seminoma and 99 as non-seminoma. The age of study participants ranged from 15 to 69 years.MethodsSocial position was classified by educational attainment level, posteducational training, occupational sectors according to Erikson-Goldthorpe-Portocarrero (EGP) and the socioeconomic status (SES) on the basis of the International SocioEconomic Index of occupational status (ISEI). ORs and corresponding 95% CIs (95% CIs) were calculated for the whole study sample and for seminoma and non-seminoma separately.ResultsTesticular cancer risk was modestly increased among participants with an apprenticeship (OR=1.7 (95% CI 1.0 to 2.8)) or a university degree (OR=1.6 (95% CI 0.9 to 2.8)) relative to those whose education was limited to school. Analysis of occupational sectors revealed an excess risk for farmers and farm-related occupations. No clear trend was observed for the analyses according to the ISEI-scale.ConclusionsSocial factors based on occupational measures were not a risk factor for testicular cancer in this study. The elevated risk in farmers and farm-related occupations warrants further research including analysis of occupational exposures.
Factorial Validity and Invariance of Four Psychosocial Constructs of Colorectal Cancer Screening: Does Screening Experience Matter?
Authors: Murphy Caitlin C. , McQueen Amy , Bartholomew L. Kay , del Junco Deborah J. , Coan Sharon P. , Vernon Sally W. 
Published: September 2013

Abstract
Background: Few studies have examined the psychometric properties and invariance of scales measuring constructs relevant to colorectal cancer screening (CRCS). We sought to: (i) evaluate the factorial validity of four core constructs associated with CRCS (benefits, barriers, self-efficacy, and optimism); and (ii) examine measurement invariance by screening status (currently screened, overdue, never screened).
Methods: We used baseline survey data from a longitudinal behavioral intervention trial to increase CRCS among U.S. veterans. Respondents were classified as currently screened (n = 3,498), overdue (n = 418), and never screened (n = 1,277). The measurement model was developed using a random half of the sample and then validated with the second half of the sample and the full baseline sample (n = 5,193). Single- and multi-group confirmatory factor analysis was used to examine measurement invariance by screening status.
Results: The four-factor measurement model demonstrated good fit. Factor loadings, item intercepts, and residual item variance and covariance were invariant when comparing participants never screened and overdue for CRCS, indicating strict measurement invariance. All factor loadings were invariant among the currently screened and overdue groups. Only the benefits scale was invariant across current screeners and never screeners. Non-invariant items were primarily from the barriers scale.
Conclusion: Our findings provide additional support for the construct validity of scales of CRCS benefits, barriers, self-efficacy, and optimism. A greater understanding of the differences between current and never screeners may improve measurement invariance.
Impact: Measures of benefits, barriers, self-efficacy, and optimism may be used to specify intervention targets and effectively assess change pre- and post-intervention across screening groups. Cancer Epidemiol Biomarkers Prev; 22(12); 2295–302. ©2013 AACR.
DNA Demethylating Agents Synergize with Oncolytic HSV1 against Malignant Gliomas
Authors: Okemoto Kazuo , Kasai Kazue , Wagner Benjamin , Haseley Amy , Meisen Hans , Bolyard Chelsea , Mo Xiaokui , Wehr Allison , Lehman Amy , Fernandez Soledad , Kaur Balveen , Chiocca E. Antonio 
Published: September 2013

Abstract
Purpose: Oncolytic viruses (OV) based on herpes simplex virus type 1 (HSV1) are being used in clinical trials for a variety of cancers. The OV, rQNestin34.5, uses a nestin promoter/enhancer to selectively drive robust viral replication in malignant glioma cells. We have discovered that this promoter becomes extensively methylated in infected glioma cells, reducing OV efficacy.
Experimental Design: We used demethylating drugs [5-azacytidine (5-Aza)], decitabine, or valproic acid (VPA) in both in vitro and in vivo malignant glioma models to determine if they improved the efficacy of rQNestin34.5 therapy.
Results: The use of demethylating agents, such as 5-Aza, improved OV replication and tumor cell lysis in vitro and, in fact, synergized pharmacologically on Chou–Talalay analysis. In vivo, the combination of the demethylating agents, 5-Aza or decitabine, with rQNestin34.5 significantly prolonged the survivorship of athymic mice harboring intracranial human glioma xenografts over single agent alone.
Conclusion: These results, thus, provide further justification for the exploration of demethylating agents when combined with the OV, rQNestin34.5, in preclinical therapeutics and, possibly, clinical trials for malignant glioma. Clin Cancer Res; 19(21); 5952–9. ©2013 AACR.
A Negative Feedback of the HIF-1α Pathway via Interferon-Stimulated Gene 15 and ISGylation
Authors: Yeh Yen-Hsiu , Yang Yu-Chen , Hsieh Mei-Yi , Yeh Yen-Cheng , Li Tsai-Kun 
Published: September 2013

Abstract
Purpose: The IFN-stimulated gene 15 (ISG15)- and ubiquitin-conjugation pathways play roles in mediating hypoxic and inflammatory responses. To identify interaction(s) between these two tumor microenvironments, we investigated the effect of ISG15 on the activity of the master hypoxic transcription factor HIF-1α.
Experimental Design: IFN and desferoxamine treatments were used to induce the expression of ISGs and HIF-1α, respectively. Interactions between HIF-1α and the ISG15 and ISGylation system were studied using knockdown of mRNA expression, immunoblotting, coimmunoprecipitation, and pull-down analyses. Effects of the ISG15 and ISGylation system on the HIF-1α–directed processes were examined using reporter, reverse transcription polymerase chain reaction (RT-PCR), and tumorigenic growth assays.
Results: We found that the level of the free form of HIF-1α is differentially regulated by IFN treatment, and that the free ISG15 level is lower under hypoxia. Mechanism-directed studies have shown that HIF-1α not only interacts physically with ISG15, but is also ISGylated in multiple domains. ISG15 expression disrupts the functional dimerization of HIF-1α and -1β. Subsequently, expression of the ISG15 and/or ISGylation system attenuates HIF-1α–mediated gene expression and tumorigenic growth.
Conclusion: In summary, our results revealed cross-talk between inflammatory and hypoxic pathways through the ISGylation of HIF-1α. On the basis of these results, we propose a novel negative feedback loop for the HIF-1α–mediated pathway involving the regulation of HIF-1α via IFN-induced ISGylation. Clin Cancer Res; 19(21); 5927–39. ©2013 AACR.
Evaluation of Utility of Pharmacokinetic Studies in Phase I Trials of Two Oncology Drugs
Authors: Wu Kehua , House Larry , Ramírez Jacqueline , Seminerio Michael J. , Ratain Mark J. 
Published: September 2013

Abstract
Purpose: There are many phase I trials of oncology drug combinations, very few of which report clinically significant pharmacokinetic interactions. We hypothesized that the utility of such pharmacokinetic drug–drug interaction (DDI) studies is low in the absence of a mechanistic hypothesis.
Experimental Design: We retrospectively reviewed 152 phase I (two drug) combination studies published between 2007 and 2011.
Results: Only 28 (18%) studies had an implicit or explicit rationale, either inhibition/induction of a drug-metabolizing enzyme or transporter, cosubstrates for the same enzyme or transporter, potential for end-organ toxicity, or protein binding. Only 12 (8%) studies demonstrated a statistically significant DDI, on the basis of change in clearance (or area under the curve) of parent drug and/or active metabolite. There was a strong association between a rationale and a demonstrable drug interaction, as only 2% of studies without a rationale demonstrated a DDI, compared with 32% of studies with a rationale (Fisher exact test; P &lt; 10−6).
Conclusion: DDI studies should not be routinely performed as part of phase I trials of oncology combinations. Clin Cancer Res; 19(21); 6039–43. ©2013 AACR.
Individualized Systems Medicine Strategy to Tailor Treatments for Patients with Chemorefractory Acute Myeloid Leukemia
Authors: Pemovska Tea , Kontro Mika , Yadav Bhagwan , Edgren Henrik , Eldfors Samuli , Szwajda Agnieszka , Almusa Henrikki , Bespalov Maxim M. , Ellonen Pekka , Elonen Erkki , Gjertsen Bjørn T. , Karjalainen Riikka , Kulesskiy Evgeny , Lagström Sonja , Lehto Anna , Lepistö Maija , Lundán Tuija , Majumder Muntasir Mamun , Marti Jesus M. Lopez , Mattila Pirkko , Murumägi Astrid , Mustjoki Satu , Palva Aino , Parsons Alun , Pirttinen Tero , Rämet Maria E. , Suvela Minna , Turunen Laura , Västrik Imre , Wolf Maija , Knowles Jonathan , Aittokallio Tero , Heckman Caroline A. , Porkka Kimmo , Kallioniemi Olli , Wennerberg Krister 
Published: September 2013

Abstract
We present an individualized systems medicine (ISM) approach to optimize cancer drug therapies one patient at a time. ISM is based on (i) molecular profiling and ex vivo drug sensitivity and resistance testing (DSRT) of patients' cancer cells to 187 oncology drugs, (ii) clinical implementation of therapies predicted to be effective, and (iii) studying consecutive samples from the treated patients to understand the basis of resistance. Here, application of ISM to 28 samples from patients with acute myeloid leukemia (AML) uncovered five major taxonomic drug-response subtypes based on DSRT profiles, some with distinct genomic features (e.g., MLL gene fusions in subgroup IV and FLT3-ITD mutations in subgroup V). Therapy based on DSRT resulted in several clinical responses. After progression under DSRT-guided therapies, AML cells displayed significant clonal evolution and novel genomic changes potentially explaining resistance, whereas ex vivo DSRT data showed resistance to the clinically applied drugs and new vulnerabilities to previously ineffective drugs.
Significance: Here, we demonstrate an ISM strategy to optimize safe and effective personalized cancer therapies for individual patients as well as to understand and predict disease evolution and the next line of therapy. This approach could facilitate systematic drug repositioning of approved targeted drugs as well as help to prioritize and de-risk emerging drugs for clinical testing. Cancer Discov; 3(12); 1416–29. ©2013 AACR.
See related commentary by Hourigan and Karp, p. 1336
This article is highlighted in the In This Issue feature, p. 1317
CD8+ T-cell Responses Rapidly Select for Antigen-Negative Tumor Cells in the Prostate
Authors: Bak S. Peter , Barnkob Mike Stein , Wittrup K. Dane , Chen Jianzhu 
Published: September 2013

Abstract
Stimulation of patients' immune systems for the treatment of solid tumors is an emerging therapeutic paradigm. The use of enriched autologous T cells for adoptive cell therapy or vaccination with antigen-loaded dendritic cells have shown clinical efficacy in melanoma and prostate cancer, respectively. However, the long-term effects of immune responses on selection and outgrowth of antigen-negative tumor cells in specific tumor types must be determined to understand and achieve long-term therapeutic effects. In this study, we have investigated the expression of a tumor-specific antigen in situ after treatment with tumor-specific CD8+ T cells in an autochthonous mouse model of prostate cancer. After T-cell treatment, aggregates of dead antigen-positive tumor cells were concentrated in the lumen of the prostate gland and were eventually eliminated from the prostate tissue. Despite the elimination of antigen-positive tumor cells, prostate tumor continued to grow in T-cell–treated mice. Interestingly, the remaining tumor cells were antigen negative and downregulated MHC class I expression. These results show that CD8+ T cells are effective in eliminating antigen-bearing prostate tumor cells but they also can select for the outgrowth of antigen-negative tumor cells. These findings provide insights into the requirements for an effective cancer immunotherapy within the prostate that not only induces potent immune responses but also avoids selection and outgrowth of antigen-negative tumor cells. Cancer Immunol Res; 1(6); 393–401. ©2013 AACR.
Lipoprotein Apheresis in Patients With Maximally Tolerated Lipid-Lowering Therapy, Lipoprotein(a)-Hyperlipoproteinemia, and Progressive Cardiovascular Disease
Authors: Leebmann Josef , Roeseler Eberhard , Julius Ulrich , Heigl Franz , Spitthoever Ralf , Heutling Dennis , Breitenberger Paul , Maerz Winfried , Lehmacher Walter , Heibges Andreas , Klingel Reinhard 
Published: September 2013

Background—
Lipoprotein(a) (Lp(a)) hyperlipoproteinemia is a major risk factor for cardiovascular disease, which is not affected by treatment of other cardiovascular risk factors. This study sought to assess the effect of chronic lipoprotein apheresis (LA) on the incidence of cardiovascular events in patients with progressive cardiovascular disease receiving maximally tolerated lipid-lowering treatment.

Methods and Results—

In a prospective observational multicenter study, 170 patients were investigated who commenced LA because of Lp(a)-hyperlipoproteinemia and progressive cardiovascular disease. Patients were characterized regarding plasma lipid status, lipid-lowering drug treatment, and variants at the LPA gene locus. The incidence rates of cardiovascular events 2 years before (y-2 and y-1) and prospectively 2 years during LA treatment (y+1, y+2) were compared. The mean age of patients was 51 years at the first cardiovascular event and 57 years at the first LA. Before LA, mean low-density lipoprotein cholesterol and Lp(a) were 2.56±1.04 mmol·L
−1
(99.0±40.1 mg·dL
−1
) and Lp(a) 3.74±1.63 µmol·L
−1
(104.9±45.7 mg·dL
−1
), respectively. Mean annual rates for major adverse coronary events declined from 0.41 for 2 years before LA to 0.09 for 2 years during LA (
P
<0.0001). Event rates including all vascular beds declined from 0.61 to 0.16 (
P
<0.0001). Analysis of single years revealed increasing major adverse coronary event rates from 0.30 to 0.54 (
P
=0.001) for y-2 to y-1 before LA, decline to 0.14 from y-1 to y+1 (
P
<0.0001) and to 0.05 from y+1 to y+2 (
P
=0.014).

Conclusions—
In patients with Lp(a)-hyperlipoproteinemia, progressive cardiovascular disease, and maximally tolerated lipid-lowering medication, LA effectively lowered the incidence rate of cardiovascular events.

Clinical Trial Registration—

URL:
https://drks-neu.uniklinik-freiburg.de
. Unique identifier: DRKS00003119.
Migration Background and Subjective Well-Being A Multilevel Analysis Based on the European Social Survey
Authors: Hadjar Andreas , Backes Susanne 
Published: September 2013

Abstract
Contributing to the debate on the integration of migrants in Europe, this study focuses on Subjective Well-Being (SWB) of people with migration backgrounds compared to people without a migration background – specifying SWB in terms of successful integration. The analyses employ a multilevel perspective (data base: European Social Survey). On the macro level, gross domestic product (GDP), welfare regime, xenophobia and the migrant integration policy index (MIPEX) are considered; on the micro level, social origin, education, unemployment, income deprivation, relationship status, health status and controls. Findings indicate a disadvantage in SWB of first-generation migrants that goes beyond deficits regarding well-studied SWB determinants. The SWB gap between migrants and non-migrants is larger in countries with a high GDP and smaller in countries with a high MIPEX score.
The South African Women’s Theological Project: Practices of Solidarity and Degrees of Separation in the Context of the HIV Epidemic
Authors: Haddad Beverley 
Published: September 2013

Abstract
It has previously been argued that the HIV epidemic is the new kairos in South Africa. The Circle of African Women Theologians has been at the forefront of theologising this crisis, particularly as it affects women. This article seeks to analyse the HIV work of six South African Circle writers namely, Denise Ackermann, Christina Landman, Madipoane Masenya, Sarojini Nadar, Miranda Pillay and Beverley Haddad. The focus of this analysis revolves around the “degrees of separation and practices of solidarity” inherent in their work. The first part of the article deals with each theologian in turn. It then identifies common threads and differences in their work employing the methodological framework of African women’s theology as outlined by Sarojini Nadar and Isabel Phiri. The article concludes with a discussion of the particularities of the South African women’s theological project and argues that the work of these six women does not deal sufficiently with “difference” or “solidarity” thus limiting their influence on the political HIV project.
Evaluating the Effects of a 532‐nm Fiber‐Based KTP Laser on Transoral Laser Surgery Supplies
Authors: Coughlan Carolyn A. , Verma Sunil P. 
Published: September 2013

ObjectiveThe KTP laser has become commonplace in transoral head and neck surgery. The interactions of this laser with commonly used supplies in transoral surgery have not been formally examined. This study evaluates the effects of the KTP laser on surgical supplies.Study DesignExperimental study.SettingThe study was conducted in an empty operating room at a university‐affiliated medical center.MethodsAn Aura XP 532‐nm KTP laser with a 600‐nm fiber was used in pulsed and continuous modes. The beam was focused at the shaft and balloon of 3 “laser‐safe” endotracheal tubes (ETTs), a polyvinyl chloride (PVC) ETT, and a Codman surgical patty. Time to penetrate was recorded.ResultsThe KTP laser beam was unable to penetrate any of the laser‐resistant ETTs. It did react with the black number markings on the PVC ETT by producing sparks but was unable to penetrate the shaft of the ETT. The KTP laser was nonreactive with all ETT cuffs except in 1 of 3 trials with the outer balloon cuff of a Rusch Lasertubus ETT when the laser was used in a continuous mode. The KTP laser caused the production of a flame upon contact with the blue radiopaque strip of the surgical patty, even when the patty was wet.ConclusionThis study demonstrates that a number of safe ETT options may be used during transoral laser microsurgery with a KTP laser. In addition, Codman surgical patties are shown to be a significant fire risk in KTP laser surgery.
Upper urinary tract tumors: how does the contrast enhancement measured in a split-bolus CTU correlate to histological staging?
Authors: Gandrup Karen L , Nordling Jørgen , Balslev Ingegerd , Thomsen Henrik S 
Published: September 2013

Background Computed tomography urography (CTU) is used widely in the work-up of patients with symptoms of urinary tract lesions. Preoperative knowledge of whether a tumor is invasive or non-invasive is important for the choice of surgery. So far there are no studies about the distinction of invasive and non-invasive tumors in ureter and renal pelvis based on the enhancement measured with Hounsfield Units. Purpose To examine the value of CTU using split-bolus technique to distinguish non-invasive from invasive urothelial carcinomas in the upper urinary tract. Material and Methods Patients who underwent nephroureterectomy between 2006 and 2011 and who had split-bolus CTU prior to surgery were included. The images were available electronically. The attenuation values before and after administration of iodine-based contrast media were measured. The radiology, patient, and pathology records were reviewed. Results Of the 158 patients who underwent unilateral nephroureterectomy 69 fulfilled the inclusion criteria. Histopathological examination revealed 31 patients with non-invasive and 38 with invasive urothelial carcinoma. Neither absolute attenuation nor change in attenuation values obtained at CTU could distinguish between invasive and non-invasive lesions. No patients had a CTU within the last year before the examination that resulted in surgery. Conclusion A split-bolus CTU cannot distinguish between invasive and non-invasive urothelial tumors in the upper urinary tract, but the examination is useful to diagnose a tumor in the renal pelvis and the ureter.