bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical and angiographic characterization of choroidal neovascularization in diabetic retinopathy
Authors: Singh Sumit Randhir , Parameswarappa Deepika C , Govindahari Vishal , Lupidi Marco , Chhablani Jay 
Published: January 2020

Background: To report the clinical and angiographic characteristics of choroidal neovascularization in patients with diabetic retinopathy. Methods: Patients of type 2 diabetes mellitus with presence of choroidal neovascularization in at least one eye were retrospectively analyzed. The study eyes were divided into three groups based on presence (active or scarred) or absence of choroidal neovascularization (fellow eyes). Imaging characteristics of active choroidal neovascularization were recorded using optical coherence tomography, fluorescein, and indocyanine angiography. Central macular thickness, subfoveal choroidal thickness, and large choroidal vessel layer thickness were compared at baseline and final visit. Results: Our study reports the prevalence rate of choroidal neovascularization in eyes with diabetic retinopathy (0.27%; 36 out of 13,382 eyes). A total of 64 eyes of 32 patients (age, mean ± standard deviation: 68.5 ± 9.3 years) with baseline visual acuity of 0.69 ± 0.69 logarithm of minimum angle of resolution (Snellen equivalent 20/100) were included. Nonproliferative diabetic retinopathy (57 eyes) comprised the majority followed by proliferative diabetic retinopathy (7 eyes). Eyes with choroidal neovascularization (36, 56.25%) included both active (25) and scarred (11) choroidal neovascularization, with bilateral choroidal neovascularization in 4 patients. Type 1 choroidal neovascularization was the most common subtype of choroidal neovascularization on optical coherence tomography. Common etiologies for active choroidal neovascularization included age-related macular degeneration (3; 12%), myopia (1; 4%), and inflammatory choroidal neovascularization secondary to chorioretinitis (1; 4%). In the remaining 20 eyes, choroidal neovascularization formation was primarily due to diabetic choroidopathy. Conclusion: The prevalence of choroidal neovascularization in eyes with diabetic retinopathy is very low, with a lower prevalence of age-related macular degeneration. Diabetic choroidopathy plays a significant role in formation of choroidal neovascularization in eyes with diabetic retinopathy.
How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge
Authors: Mozersky Jessica T , Antes Alison L , Baldwin Kari , Jenkerson Michelle , DuBois James M 
Published: January 2020

Background: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health–funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. Methods: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal–numerical reasoning and learning orientation. Results: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). Conclusion: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training—whether online or face to face—does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.
Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial
Authors: Glassman Adam R , Beaulieu Wesley T , Stockdale Cynthia R , Beck Roy W , Bressler Neil M , Labriola Leanne T , Melia Michele , Oliver Kristina , Sun Jennifer K 
Published: January 2020

Background/Aims: In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention. Methods: Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point). Results: At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93–1.10, p = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85–1.19, p = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98–1.27, p = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98–1.56, p = .08). Conclusion: Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.
A new brain CT reference line: the lower eyelid to the inner occipital base line closely parallels the Talairach–Tournoux line
Authors: Ishizaka Hiroshi , Naka Minoru , Nagase Hiroyuki , Yanagisawa Katsumi , Kubota Toshio , Morita Hideo , Tsushima Yoshito 
Published: January 2020

Background There is no standardized brain computed tomography (CT) reference line that can be determined on both scout and reformatted sagittal CT images. Here, a tangential line from the anterior edge of the lower eyelid to the inner table of the occipital base (LEL/O line) appears nearly parallel to the Talairach–Tournoux (T/T) line, which shows a consistent intracranial anatomical relationship among subjects, and acts as a standard reference line for magnetic resonance (MR) imaging. Purpose To quantitatively validate the LEL/O line as a new standard brain CT reference line. Material and Methods We measured: angle 1 = the LEL/O line on scout images from the LEL/O line on parasagittal CT images (n=93); and angle 2 = the LEL/O line on scout images from the T/T line on high resolution midsagittal MR images (n=97). Angles in a clockwise direction were defined as positive and were expressed as mean±SD with the 95% confidence interval (CI) of the SD. Angle 2 was measured independently by two observers and intraclass correlation coefficients (ICCs) were calculated. Results Angle 1 was –0.4°±1.2° (95% CI of SD 1.1°–1.5°); angle 2 was –0.4°±2.0° (95% CI of SD, 1.8°–2.4°). The ICC in the angle 2 measurement was 0.780 ( P<0.001), which indicated high inter-observer reliability. Conclusion The LEL/O lines on scout and parasagittal CT images show practically the same gradient, and these LEL/O lines are almost parallel to the T/T line. Use of the LEL/O line either for direct scanning or reformation can minimize intra- and inter-subject variations on CT images and mismatch between CT and MR images.
Taming Consumer Resistance for Taboo Products: The Case of PeeBuddy
Authors: Jain Ruchi , Tandon Anushree , Khandelwal Ruchi 
Published: January 2020

Changes in business environments continually create opportunities for entrepreneurs to target specific emerging needs of their customers. The first disposable female urination device (FUD) PeeBuddy was launched in the Indian market in response to the emergent need among the urban women for a product facilitating safe usage of public washrooms, especially during travel. PeeBuddy is among the many social innovations (Alvord et al., 2004, p. 262), making prominent appearances in emerging economies battling resource constraints (Austin et al., 2006). The purpose of this case is to understand the ideation and execution of this social innovation in the context of countries like India where cultural traditions and subjective norms are held in high regards. In India, issues surrounding women’s personal hygiene are considered taboo for public communiqué. This case explores the use of social media marketing approaches used to circumvent extant cultural barriers hindering the adoption of PeeBuddy, which may be considered as a taboo product in the context of the Indian market. This case is aimed at students undertaking advanced marketing management and consumer behaviour courses to sensitize them about subjective norms and their deep integration within culturally dominated communities. It will establish the need for adopting innovative methods for marketing taboo products and how creativity can be used to retail such products.
Contracting Outcomes with Communication and Learning
Authors: Banerjee Priyodorshi , Srikant P. , Chakravarty Sujoy 
Published: January 2020

We show that allowing communication can increase optimal choices and efficiency in a multitask, incomplete contracting, principal–agent setting. We study two simple communication protocols, one allowing for one or more requests on non-contractible choices, and the other allowing for a request, promise and ex post payment. The protocol where principals are asked to communicate requests to the agent regarding non-contractible choices promotes better learning of optimal strategies on the part of the principals, but shows no tendency for coordination to superior outcomes. The benefits accrue mainly due to changes in the choices of principals, who issue communication, rather than those of agents. Coordination is promoted, and learning subdued, when the protocol permits promises and ex post payments, in addition to allowing a request. This protocol also increases efficiency, with the efficiency gains equal across the protocols. JEL Codes: L14, C91
Measuring Students’ Perceptions of the Medical School Learning Environment: Translation, Transcultural Adaptation, and Validation of 2 Instruments to the Brazilian Portuguese Language
Authors: Damiano Rodolfo F , Furtado Aline O , da Silva Betina N , Ezequiel Oscarina da S , Lucchetti Alessandra LG , DiLalla Lisabeth F , Tackett Sean , Shochet Robert B , Lucchetti Giancarlo 
Published: January 2020

Background: Although learning environment (LE) is an important component of medical training, there are few instruments to investigate LE in Latin American and Brazilian medical schools. Therefore, this study aims to translate, adapt transculturally, and validate the Medical School Learning Environment Scale (MSLES) and the Johns Hopkins Learning Environment Scale (JHLES) to the Brazilian Portuguese language. Method: This study was carried out between June 2016 and October 2017. Both scales have been translated and cross-culturally adapted to Brazilian Portuguese Language and then back translated and approved by the original authors. A principal components analysis (PCA) was performed for both the MSLES and the JHLES. Test–retest reliability was assessed by comparing the first administration of the MSLES and the JHLES with a second administration 45 days later. Validity was assessed by comparing the MSLES and the JHLES with 2 overall LE perception questions; a sociodemographic questionnaire; and the Depression, Anxiety, and Stress Scale (DASS-21). Results: A total of 248 out of 334 (74.2%) first- to third-year medical students from a Brazilian public university were included. Principal component analysis generated 4 factors for MSLES and 7 factors for JHLES. Both showed good reliability for the total scale (MSLES α = .809; JHLES α = .901), as well as for each subdomain. Concurrent and convergent validity were observed by the strong correlations found between both scale totals ( r = 0.749), as well as with both general LE questions: recommend the school to a friend (MSLES: r = 0.321; JHLES: r = 0.457) and overall LE rating (MSLES: r = 0.505; JHLES: r = 0.579). The 45-day test–retest comparison resulted in a Pearson correlation coefficient of 0.697 for the JHLES and 0.757 for the MSLES. Conclusions: Reliability and validity have been demonstrated for both the MSLES and the JHLES. Thus, both represent feasible options for measuring LE in Brazilian medical students.
BCL-W is dispensable for the sustained survival of select Burkitt lymphoma and diffuse large B-cell lymphoma cell lines
Authors: Diepstraten Sarah T. , Chang Catherine , Tai Lin , Gong Jia-nan , Lan Ping , Dowell Alexander C. , Taylor Graham S. , Strasser Andreas , Kelly Gemma L. 
Published: January 2020

AbstractDysregulated expression of BCL-2 family proteins allows cancer cells to escape apoptosis. To counter this, BH3-mimetic drugs that target and inhibit select BCL-2 prosurvival proteins to induce apoptosis have been developed for cancer therapy. Venetoclax, which targets BCL-2, has been effective as therapy for patients with chronic lymphocytic leukemia, and MCL-1–targeting BH3-mimetic drugs have been extensively evaluated in preclinical studies for a range of blood cancers. Recently, BCL-W, a relatively understudied prosurvival member of the BCL-2 protein family, has been reported to be abnormally upregulated in Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL), and Hodgkin lymphoma patient samples. Therefore, to determine if BCL-W would be a promising therapeutic target for B-cell lymphomas, we have examined the role of BCL-W in the sustained growth of human BL- and DLBCL-derived cell lines. We found that CRISPR/CAS9-mediated loss or short hairpin RNA-mediated knockdown of BCL-W expression in selected BL and DLBCL cell lines did not lead to spontaneous apoptosis and had no effect on their sensitivity to a range of BH3-mimetic drugs targeting other BCL-2 prosurvival proteins. Our results suggest that BCL-W is not universally required for the sustained growth and survival of human BL and DLBCL cell lines. Thus, targeting BCL-W in this subset of B-cell lymphomas may not be of broad therapeutic benefit.
Evaluation of cyclin A1–specific T cells as a potential treatment for acute myeloid leukemia
Authors: Leung Wingchi K. , Workineh Aster , Mukhi Shivani , Tzannou Ifigeneia , Brenner Daniel , Watanabe Norihiro , Leen Ann M. , Lulla Premal 
Published: January 2020

Abstract
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only curative option for relapsed or refractory acute myeloid leukemia (AML). However, more than half ultimately experience disease relapse that is associated with a dismal median survival of just 6 months, highlighting the need for novel therapies. In the current study we explore the therapeutic potential of targeting cyclin A1 (CCNA1), a cancer-testis antigen that is overexpressed in malignant blasts and leukemic stem cells. We demonstrate the immunogenicity of this antigen to native T cells, with &gt;90% of donors screened mounting a specific response. The expanded cells were Th1 polarized, polyfunctional, and cytotoxic toward CCNA1+/HLA-matched tumor cell lines. Furthermore, these cells were exquisitely specific for CCNA1 and exhibited no reactivity against other cyclin family members, including CCNA2, which shares 56% homology with CCNA1 and is ubiquitously expressed in dividing cells. Lastly, the detection of CCNA1-specific T cells in AML patients post-HSCT was associated with prolonged disease remission, suggesting the protective potential of such endogenous cells. Taken together, our findings demonstrate the feasibility of targeting CCNA1 and the potential for therapeutic benefit associated with the adoptive transfer of reactive cells.
American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support
Authors: Chou Stella T. , Alsawas Mouaz , Fasano Ross M. , Field Joshua J. , Hendrickson Jeanne E. , Howard Jo , Kameka Michelle , Kwiatkowski Janet L. , Pirenne France , Shi Patricia A. , Stowell Sean R. , Thein Swee Lay , Westhoff Connie M. , Wong Trisha E. , Akl Elie A. 
Published: January 2020

Abstract
In July 2022, these guidelines were reviewed by an expert work group convened by ASH. Review included limited searches for new evidence and discussion of the search results. Following this review, the ASH Committee on Quality agreed to continue monitoring the supporting evidence rather than revise or retire these guidelines at this time. Limited searches and expert review will be repeated annually going forward until these guidelines are revised or retired.
Background: Red cell transfusions remain a mainstay of therapy for patients with sickle cell disease (SCD), but pose significant clinical challenges. Guidance for specific indications and administration of transfusion, as well as screening, prevention, and management of alloimmunization, delayed hemolytic transfusion reactions (DHTRs), and iron overload may improve outcomes.
Objective: Our objective was to develop evidence-based guidelines to support patients, clinicians, and other healthcare professionals in their decisions about transfusion support for SCD and the management of transfusion-related complications.
Methods: The American Society of Hematology formed a multidisciplinary panel that was balanced to minimize bias from conflicts of interest and that included a patient representative. The panel prioritized clinical questions and outcomes. The Mayo Clinic Evidence-Based Practice Research Program supported the guideline development process. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to form recommendations, which were subject to public comment.
Results: The panel developed 10 recommendations focused on red cell antigen typing and matching, indications, and mode of administration (simple vs red cell exchange), as well as screening, prevention, and management of alloimmunization, DHTRs, and iron overload.
Conclusions: The majority of panel recommendations were conditional due to the paucity of direct, high-certainty evidence for outcomes of interest. Research priorities were identified, including prospective studies to understand the role of serologic vs genotypic red cell matching, the mechanism of HTRs resulting from specific alloantigens to inform therapy, the role and timing of regular transfusions during pregnancy for women, and the optimal treatment of transfusional iron overload in SCD.
Ruxolitinib for the prevention of thrombosis in polycythemia vera: a systematic review and meta-analysis
Authors: Masciulli Arianna , Ferrari Alberto , Carobbio Alessandra , Ghirardi Arianna , Barbui Tiziano 
Published: January 2020

Abstract
Ruxolitinib is a recommended second-line treatment for the prevention of thrombosis in patients with polycythemia vera who become resistant or intolerant to hydroxyurea; however, evidence regarding its efficacy in terms of thrombosis reduction is uncertain. We searched Medline, Embase, and archives of abstracts from the European Hematology Association and the American Society of Hematology annual congresses from 2014 onward for randomized controlled trials comparing the treatment vs best available therapy (BAT). Our search retrieved 80 records; after screening of abstracts and full text, the total was reduced to 16. Evidence came from 4 randomized controlled trials, including 663 patients (1057 patients per year). We estimated a thrombosis risk ratio of 0.56 for ruxolitinib BAT, corresponding to an incidence of 3.09% and 5.51% patients per year, respectively. The number of thrombotic events reported with ruxolitinib was consistently lower than that with BAT in our sample, but, globally, the difference did not reach significance (P = .098). Hard evidence in favor of ruxolitinib is lacking; a clinical trial on selected patients at high risk of thrombosis would be warranted, but its feasibility is questionable.
Skeletal muscle oxygenation and regional blood volume during incremental limb loading in interstitial lung disease
Authors: Wickerson Lisa , Mathur Sunita , Brooks Dina , Bonetti L.V. , Singer Lianne G. , Granton John , Reid W. Darlene 
Published: January 2020

IntroductionIndividuals with interstitial lung disease (ILD) exhibit reduced exercise capacity and exertional hypoxaemia. The role of peripheral (muscle) limitation to exercise tolerance in ILD is not well studied to date.MethodsA prospective cross-sectional study examined skeletal muscle oxygen saturation (SmO2) and regional blood volume of the knee extensors and elbow flexors during incremental limb loading in healthy people and people with varying severity of ILD. Isotonic concentric exercise was performed on an isokinetic dynamometer.SmO2and regional blood volume were measured by near-infrared spectroscopy over the vastus lateralis and biceps.ResultsThirteen people who were dependent on oxygen, candidates for lung transplant and with severe ILD (forced vital capacity (FVC) 59±20% predicted), 10 people who were not oxygen dependent with mild ILD (FVC 81±17% predicted) and 13 healthy people (FVC 101±14% predicted) were included. Total haemoglobin, a marker of regional blood volume, was lower at task failure in the knee extensors in participants with severe ILD compared to healthy participants (p=0.05). At task failure for both knee-extensor loading and elbow-flexor loading,SmO2was decreased to similar levels across all groups, but occurred at lower total workloads in the ILD groups (all p<0.01).ConclusionsOverall, people with severe ILD had lower levels of total work and experienced less increase in blood volume in the knee extensors after knee-extensor loading compared to healthy people. Peripheral muscle dysfunction in severe ILD may have contributed to muscle deoxygenation at lower workloads.