bluuebunny/crossref_metadata_2025_split huggingface dataset:
Dutch translation and linguistic validation of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)
Authors: Veldhuijzen Evalien , Walraven Iris , Mitchell Sandra A. , Moore Elizabeth Yohe , McKown Shawn M. , Lauritzen Matthew , Kim Katherine J. , Belderbos José S. A. , Aaronson Neil K. 
Published: October 2020

Abstract
Background
The U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) is a library of items for assessing symptomatic adverse events by patient self-report in oncology trials. The aim of this multi-site study was to generate and linguistically validate a Dutch language version of the U.S. PRO-CTCAE for use in the Netherlands and Dutch-speaking Belgium.

Methods
All 124 items in the PRO-CTCAE item library were translated into Dutch using established translation procedures, including dual forward translations, reconciliation, back-translation, reconciliation of the source with the back-translation, and expert reviews. Harmonization of the translation for use in both the Netherlands and Belgium was achieved via an iterative review process in which the translations were discussed and reconciled by consensus of PRO experts, clinicians and bilingual Dutch translators. The translated PRO-CTCAE™ items were completed by a geographically-diverse sample of Dutch speaking patients from the Netherlands (n = 40) and Belgium (n = 60), and who were currently receiving or who had recently completed cancer-directed therapy. Patients were diverse with respect to age, sex, educational attainment, and cancer diagnosis. Cognitive debriefing, using a semi-structured interview guide, probed for comprehension and clarity of PRO-CTCAE symptom terms, attributes (e.g. frequency, severity, interference), response choices, and understanding of ‘at its worst’ and ‘in the last 7 days’. Items for which the patient data indicated possible difficulties were considered for revision.

Results
Three items underwent minor phrasing revision and retesting was not deemed necessary. The symptom term for stretch marks was poorly understood by 12.5% of participants, and this item was revised to include parenthetical phrasing. It was retested with 10 participants from Belgium (n = 5) and the Netherlands (n = 5) and demonstrated acceptable comprehension.

Conclusions
The Dutch language version of PRO-CTCAE has been successfully developed and linguistically validated for use in oncology studies in the Netherlands and Dutch-speaking Belgium. Extending the availability of NCI PRO-CTCAE in languages beyond English increases international consistency in the capture of Patient-Reported outcomes in patients participating in cancer clinical trials.
Electronic health record and blockchain architecture: forensic chain hypothesis for human identification
Authors: Nuzzolese E. 
Published: October 2020

Abstract
Background
Forensic dental identification relies on the collection and comparison of antemortem and postmortem dental data and dental evidence. There are software solutions capable of archiving postmortem (PM) and antemortem (AM) data, with search and comparative tools which are user-centric and do not allow open search options and data mining of all dental related data, except through the use of coded data. This reduces interoperability and raises dental data incompatibility challenges. Blockchain technology could help introduce a trusted, secure, and holistic ecosystem in the electronic health record (EHR) system with a forensic interface accessed by experts in forensic pathology and forensic odontology for the purpose of identifying human remains and retrieve identifying data of compatible missing persons from the health and dental electronic record system, with the further advantage of protecting data breaches, redundancies, inconsistencies, and errors. Blockchain technology, and a forensic chain, can enhance forensic data management and human identification process by managing the missing person lists, create AM data repositories as shared data with the EHRs of living individuals, create PM data repositories of recovered from identifying autopsies unidentified persons, and support the preliminary comparison of compatible biological profiles during the final reconciliation phase.

Conclusion
In this hypothesis, author investigates possible applications of blockchain technology as a holistic technical and interoperability solution for managing both health/dental data for a medical as forensic human identification use.
PET/CT and bone marrow biopsy (BMB) in evaluating bone marrow in lymphoma
Authors: Elamir Youstina , Elazab Mohamed , Owis Ahmed S. , Elsayed Huda Fathy 
Published: October 2020

Abstract
Background
Bone marrow assessment is an important part in the Ann Arbor staging system in lymphoma. It is done routinely through posterior iliac crest bone marrow biopsy (BMB) which is an invasive technique with limited examination of one site. 18F-FDG PET/CT is now used for staging of lymphoma. The purpose of this study was to compare the sensitivity of PET/CT and BMB in detecting bone marrow infiltration (BMI) in lymphoma and determine agreement between both in assessing bone marrow and whether we can evaluate the bone marrow by PET/CT without the need of the routine BMB.

Results
PET/CT detected 24 (16.5%) cases with positive BMI that were missed by BMB. BMB detected only 2 (1.4%) cases that were missed by PET/CT. The PET/CT showed a higher sensitivity of 95.6% than BMB 46.7% in detecting BMI in lymphoma. We found a moderate agreement between PET/CT and BMB results in the whole cohort using Cohen’s k computation. It was found that 0.47 with p value less than 0.0001.

Conclusions
PET/CT can detect more bone marrow involvement in lymphoma compared with BMB. It can replace the routine invasive BMB in many cases, especially those showing multifocal uptake in both Hodgkin and non-Hodgkin lymphoma. PET/CT can also help to guide the site of the biopsy in some cases. Iliac crest BMB is still needed in cases showing diffuse FDG uptake to differentiate malignant uptake from reactive hyperplasia, and in those with limited FDG avidity and in some cases with negative uptake to exclude early infiltration if management will differ.
Diffusion-weighted magnetic resonance imaging (DWMRI) of head and neck squamous cell carcinoma: could it be an imaging biomarker for prediction of response to chemoradiation therapy
Authors: Khattab Hanan Mohamed , Montasser Moataz Mohamed , Eid Mohamed , Kandil Alaa , Desouky Salah El-Din 
Published: October 2020

Abstract
Background
Chemoradiation therapy (CRT) has become a primary definitive treatment modality for head and neck squamous cell carcinoma (HNSCC); however, not all patients respond completely to treatment. Ability to identify those patients, who would not achieve complete response, before or early during the course of CRT will allow treatment modifications to improve outcome and overall survival. The aim of this prospective study was to assess the usefulness of diffusion-weighted imaging (DWI) in prediction of early therapeutic response of HNSCC after CRT.

Results
Local control was achieved in 22 patients out of 46 patients with pathologically proven HNSCC treated by chemoradiation therapy and local failure was detected in 24 patients out of 46 patients. Pretreatment mean apparent diffusion coefficient (ADCpre) was significantly higher in local failure group (1.1 ± 0.2 × 10−3 mm2/s) than local control group (0.89 ± 0.1 × 10−3 mm2/s). An optimal cut-off value of more than 0.94 × 10−3 mm2/s was predictive of local failure with sensitivity 83.33%, specificity 59.9%, PPV 69%, NPV 76.5%. Early intra-treatment percentage change of ADC (ΔADC) was significantly lower in local failure group (21.8% ± 21.3) than in local control group (45.2% ± 27.8). An optimal cut-off value of ≤ 33% was predictive of local failure after CRT with sensitivity of 71.34%, specificity of 60%, PPV of 62.5%, and NPV of 69.2%.

Conclusions
Diffusion-weighted MRI could be a potential predictive biomarker for therapeutic response of HNSCC to CRT. Primary tumors with higher pretreatment mean ADC, and a smaller early intratreatment percentage increase of mean ADC would be more likely to fail treatment.
Relationship between thyroid dysfunction and dementia
Authors: Elbadawy Ayman M. , Mansour Ahmed E. , Abdelrassoul Ibrahim A. , Abdelmoneim Rasha O. 
Published: October 2020

Abstract
Background
Thyroid hormones are essential for normal development and function of the central nervous system. Thyroid dysfunction is associated with many neuropsychiatric disorders mainly cognitive impairment.

Results
We found a close correlation between thyroid status and cognitive dysfunction. Serum FT3 levels decreased, whereas the serum thyroid-stimulating hormone (TSH) level increased, with the decline in cognitive functions. Furthermore, the TSH level showed a negative correlation with the Mini-Mental State Examination (MMSE) scores. We suggested that thyroid function was associated with cognitive impairments induced by subcortical ischemic vascular dementia (SIVD).

Conclusion
We found that thyroid dysfunction especially subclinical hypothyroidism is associated with cognitive impairment. Dementia increases more with more increase in TSH, and the MMSE score decreases with the increase of age.
Comparison of Definitive Cervical Cancer Management With Chemotherapy and Radiation Between Two Centers With Variable Resources and Opportunities for Improved Treatment
Authors: Asamoah Francis Adumata , Yarney Joel , Scott Aba , Vanderpuye Verna , Yuan Zhigang , Fernandez Daniel C. , Montejo Michael E. , Agyeman Mervin , Boateng Samuel Ntiamoah , Anarfi Kwabena , Aidoo Charles , Shahzad Mian M. , Chern Jing-Yi , Chon Hye-Sook , Wenham Robert M. , Yamoah Kosj , Ahmed Kamran A. 
Published: October 2020

PURPOSE Cervical cancer remains a major health challenge in low- to middle-income countries. We present the experiences of two centers practicing in variable resource environments to determine predictors of improved radiochemotherapy treatment. METHODS AND MATERIALS This comparative review describes cervical cancer presentation and treatment with concurrent chemoradiotherapy with high-dose-rate brachytherapy between 2014 and 2017 at the National Radiotherapy Oncology and Nuclear Medicine Center (NRONMC) in Korle-Bu Teaching Hospital, Accra, Ghana, and Moffitt Cancer Center (MCC), Tampa, FL. RESULTS Median follow-up for this study was 16.9 months. NRONMC patients presented with predominantly stage III disease (42% v 16%; P = .002). MCC patients received para-aortic node irradiation (16%) and interstitial brachytherapy implants (19%). Median treatment duration was longer for NRONMC patients compared with MCC patients (59 v 52 days; P < .0001), and treatment duration ≥ 55 days predicted worse survival on multivariable analysis (MVA; P = .02). Stage ≥ III disease predicted poorer local control on MVA. There was a difference in local control among patients with stage III disease (58% v 91%; P = .03) but not in survival between MCC and NRONMC. No significant difference in local control was observed for stage IB, IIA, and IIB disease. CONCLUSION Although there were significant differences in disease presentation between the two centers, treatment outcomes were similar for patients with early-stage disease. Longer treatment duration and stage ≥ III disease predicted poor outcomes.
Long-Term Follow-Up of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy
Authors: Cappell Kathryn M. , Sherry Richard M. , Yang James C. , Goff Stephanie L. , Vanasse Danielle A. , McIntyre Lori , Rosenberg Steven A. , Kochenderfer James N. 
Published: October 2020

PURPOSE Anti-CD19 chimeric antigen receptors (CARs) are artificial fusion proteins that cause CD19-specific T-cell activation. Durability of remissions and incidence of long-term adverse events are critical factors determining the utility of anti-CD19 CAR T-cell therapy, but long-term follow-up of patients treated with anti-CD19 CAR T cells is limited. This work provides the longest follow-up of patients in remission after anti-CD19 CAR T-cell therapy. METHODS Between 2009 and 2015, we administered 46 CAR T-cell treatments to 43 patients (ClinicalTrials.gov identifier: NCT00924326 ). Patients had relapsed B-cell malignancies of the following types: diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma (DLBCL/PMBCL; n = 28), low-grade B-cell lymphoma (n = 8), or chronic lymphocytic leukemia (CLL; n = 7). This report focuses on long-term outcomes of these patients. The CAR used was FMC63-28Z; axicabtagene ciloleucel uses the same CAR. Cyclophosphamide plus fludarabine conditioning chemotherapy was administered before CAR T cells. RESULTS The percentages of CAR T-cell treatments resulting in a > 3-year duration of response (DOR) were 51% (95% CI, 35% to 67%) for all evaluable treatments, 48% (95% CI, 28% to 69%) for DLBCL/PMBCL, 63% (95% CI, 25% to 92%) for low-grade lymphoma, and 50% (95% CI, 16% to 84%) for CLL. The median event-free survival of all 45 evaluable treatments was 55 months. Long-term adverse effects were rare, except for B-cell depletion and hypogammaglobulinemia. Median peak blood CAR-positive cell levels were higher among patients with a DOR of > 3 years (98/µL; range, 9-1,217/µL) than among patients with a DOR of < 3 years (18/µL; range, 0-308/μL, P = .0051). CONCLUSION Complete remissions of a variety of B-cell malignancies lasting ≥ 3 years occurred after 51% of evaluable anti-CD19 CAR T-cell treatments. Remissions of up to 9 years are ongoing. Late adverse events were rare.
Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial
Authors: Dimopoulos Meletios A. , Špička Ivan , Quach Hang , Oriol Albert , Hájek Roman , Garg Mamta , Beksac Meral , Bringhen Sara , Katodritou Eirini , Chng Wee-Joo , Leleu Xavier , Iida Shinsuke , Mateos María-Victoria , Morgan Gareth , Vorog Alexander , Labotka Richard , Wang Bingxia , Palumbo Antonio , Lonial Sagar ,   on behalf of the TOURMALINE-MM4 study group
Published: October 2020

PURPOSEMaintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed.PATIENTS AND METHODSThe phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization.RESULTSPatients were randomly assigned to receive ixazomib (n = 425) or placebo (n = 281). TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4 v 9.4 months; hazard ratio [HR], 0.659; 95% CI, 0.542 to 0.801; P < .001; median follow-up, 21.1 months). Ixazomib significantly benefitted patients who achieved complete or very good partial response postinduction (median PFS, 25.6 v 12.9 months; HR, 0.586; P < .001). With ixazomib versus placebo, 36.6% versus 23.2% of patients had grade ≥ 3 treatment-emergent adverse events (TEAEs); 12.9% versus 8.0% discontinued treatment because of TEAEs. Common any-grade TEAEs included nausea (26.8% v 8.0%), vomiting (24.2% v 4.3%), and diarrhea (23.2% v 12.3%). There was no increase in new primary malignancies (5.2% v 6.2%); rates of on-study deaths were 2.6% versus 2.2%.CONCLUSIONIxazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.
Towards a Continuous Manufacturing Process of Protein-Loaded Polymeric Nanoparticle Powders
Authors: Schiller Stefan , Hanefeld Andrea , Schneider Marc , Lehr Claus-Michael 
Published: October 2020

AbstractTo develop a scalable and efficient process suitable for the continuous manufacturing of poly(lactic-co-glycolic acid) (PLGA) nanoparticles containing ovalbumin as the model protein. PLGA nanoparticles were prepared using a double emulsification spray-drying method. Emulsions were prepared using a focused ultrasound transducer equipped with a flow cell. Either poly(vinyl alcohol) (PVA) or poloxamer 407 (P-407) was used as a stabilizer. Aliquots of the emulsions were blended with different matrix excipients and spray dried, and the yield and size of the resuspended nanoparticles was determined and compared against solvent displacement. Nanoparticle sizes of spray-dried PLGA/PVA emulsions were independent of the matrix excipient and comparable with sizes from the solvent displacement method. The yield of the resuspended nanoparticles was highest for emulsions containing trehalose and leucine (79%). Spray drying of PLGA/P-407 emulsions led to agglomerated nanoparticles independent of the matrix excipient. PLGA/P-407 nanoparticles pre-formed by solvent displacement could be spray dried with limited agglomeration when PVA was added as an additional stabilizer. A comparably high and economically interesting nanoparticle yield could be achieved with a process suitable for continuous manufacturing. Further studies are needed to understand the robustness of a continuous process at commercial scale.
Case Report: Unusual association of gubernacular canal, supernumerary tooth and odontoma with an impacted canine on cone beam computed tomography
Authors: Elsayed Lubna K. , El Khateeb Sara M. , Alzahrani Suzan A. , ALHarthi Shatha Subhi , Ba-Hattab Raidan 
Published: October 2020

This report describes a clinical case of asymptomatic compound odontoma in the anterior left side of the maxilla associated with an impacted canine and supernumerary tooth with a gubernacular canal of a 47- year-old female with no relevant medical history. Cone-beam computed tomography (CBCT) was performed for precise three-dimensional localization of each structure and assessment of their spatial relationship with the associated structures before surgery. The treatment protocol involved surgical enucleation of the odontoma and open extraction of both impacted and supernumerary teeth. Patient had uneventful healing and proceeded with the prosthodontic treatment plan. An experienced clinician can accurately diagnose a compound odontoma, as it has distinctive clinical and radiographic features. Thus, early detection and management of odontomas can help correction of any dental irregularity and avoid further complications.
The Unintended Impact of Academic Research on Asset Returns: The Capital Asset Pricing Model Alpha
Authors: Horenstein Alex R. 
Published: October 2020

This paper explores a channel whereby asset-pricing anomalies can appear as investors alter portfolios according to findings in academic research. In particular, I find that assets with low realized capital asset pricing model (CAPM) alphas outperform those with high alphas, but this finding only appears after the CAPM’s publication in the 1960s. I find evidence consistent with the widespread application of the CAPM generating incentives to tilt portfolios systematically away from low CAPM alpha assets, causing such assets to be undervalued. This paper was accepted by Kay Giesecke, finance.
Speed Acquisition
Authors: Huang Shiyang , Yueshen Bart Zhou 
Published: October 2020

Speed is a salient feature of modern financial markets. This paper studies investors’ speed acquisition together with their information acquisition. Speed heterogeneity arises in equilibrium, fragmenting the information aggregation process with a nonmonotone impact on price informativeness. Various competition effects drive speed and information to be either substitutes or complements. The model cautions the possible dysfunction of price discovery: An improving information technology might complement speed acquisition, which shifts the concentration of price discovery over time, possibly hurting price informativeness. Novel predictions are discussed regarding investor composition and their investment performance. This paper was accepted by Gustavo Manso, finance.
Assortment Optimization Under Consider-Then-Choose Choice Models
Authors: Aouad Ali , Farias Vivek , Levi Retsef 
Published: October 2020

Consider-then-choose models, borne out by empirical literature in marketing and psychology, explain that customers choose among alternatives in two phases, by first screening products to decide which alternatives to consider and then ranking them. In this paper, we develop a dynamic programming framework to study the computational aspects of assortment optimization under consider-then-choose premises. Although nonparametric choice models generally lead to computationally intractable assortment optimization problems, we are able to show that for many empirically vetted assumptions on how customers consider and choose, our resulting dynamic program is efficient. Our approach unifies and subsumes several specialized settings analyzed in previous literature. Empirically, we demonstrate the predictive power of our modeling approach on a combination of synthetic and real industry data sets, where prediction errors are significantly reduced against common parametric choice models. In synthetic experiments, our algorithms lead to practical computation schemes that outperform a state-of-the-art integer programming solver in terms of running time, in several parameter regimes of interest. This paper was accepted by Yinyu Ye, optimization.
Adapting to Radical Change: The Benefits of Short-Horizon Investors
Authors: Giannetti Mariassunta , Yu Xiaoyun 
Published: October 2020

We show that, following shocks that change an industry’s competitive environment, firms with more short-term institutional investors experience smaller drops in sales and investment and have better long-term performance than similar firms affected by the shocks. To do so, these firms introduce new products, file more trademarks, intensify their innovation efforts, conduct more diversifying acquisitions, and have higher executive turnover in the aftermath of the shocks. Our findings suggest that firms with more short-term investors adapt better to the new competitive environment. Endogeneity of institutional ownership and other selection problems do not appear to drive our findings. This paper was accepted by Gustavo Manso, finance.
Information Avoidance and Medical Screening: A Field Experiment in China
Authors: Li Yufeng , Meng Juanjuan , Song Changcheng , Zheng Kai 
Published: October 2020

Will individuals, especially high-risk individuals, avoid a disease test because of information avoidance? We conduct a field experiment to investigate this issue. We vary the price of a diabetes test (price experiment) and offer both a diabetes test and a cancer test (disease experiment) after eliciting participants’ subjective beliefs about their disease risk. We find evidence that, first, some people avoid the test even when there is neither a monetary nor a transaction cost, and second, both low- and high-risk individuals select out of the test as the price increases. We explain our findings using three classes of models of anticipatory utility. This paper was accepted by Yan Chen, decision analysis.