bluuebunny/crossref_metadata_2025_split huggingface dataset:
FLORA-5: Front-line chemoimmunotherapy (Paclitaxel-Carboplatin-Oregovomab [PCO] versus chemotherapy (Paclitaxel-Carboplatin-Placebo [PCP]) in patients with advanced epithelial ovarian cancer (EOC)—Phase III double-blind placebo controlled multinational study.
Authors: Secord Angeles Alvarez , Gupta Sunil , Reddick Cathy , Chauhan Jyoti , Gill Sarah , Schorge John O. , Gold Michael , Tewari Devansu , Breed Christopher A , Braly Patricia S. , Kuo Dennis Yi-Shin , Modesitt Susan C. , Holloway Robert W. 
Published: June 2021

TPS5606 Background: Oregovomab binds tumor-associated CA125 rendering the target antigen CA125 more immunogenic or “neoantigen-like” through altered and enhanced antigen processing and presentation to specific T cells. This phenomenon is hypothesized to bypass tumor-associated immune suppression when administered in combination with chemotherapy. In a randomized phase II study, immunization with oregovomab in a schedule-dependent combination with paclitaxel and carboplatin induced tumor immunity and demonstrated significant improvement in PFS (median (months) 41.8 PCO vs 12.3 PCP, HR 0.44 p = 0.0027, and OS median N.E. PCO vs 43.2 PCP HR O.34 (p = 0.0077)) in patients with previously untreated EOC. The FLORA-5, the definitive confirmatory global registration trial, is currently recruiting patients in the front-line setting. Methods: The study is a phase 3, multicenter, double-blind, placebo-controlled clinical trial. Optimally debulked patients with FIGO III/IV EOC and serum CA125 > 50 U/ml receiving adjuvant (Cohort 1) or neoadjuvant (Cohort 2) chemotherapy will be randomized post-surgery to paclitaxel and carboplatin with or without oregovomab. Patients with germline BRCA1/2 mutations will be excluded. Chemotherapy will be administered every 3 weeks in both cohorts. Oregovomab/placebo is administered simultaneously at cycles 1, 3, and 5 of chemotherapy with a single maintenance dose at 12 weeks following cycle 5 in Cohort 1. Neoadjuvant patients (Cohort 2) will be administered oregovomab/placebo post interval debulking surgery at cycles 4 and 6 with maintenance doses at 6- and 18-weeks following cycle 6. No other post front-line maintenance therapy is permitted. The primary objective is PFS determined by RECIST 1.1 criteria. Cohort 1 will recruit 372 patients with a 90% power to detect a difference with an alpha of 0.025 and a hazard ratio of 0.65 when 252 PFS events have been observed. Cohort 2 will be analyzed separately recruiting 232 patients with a 90% power to detect a difference with an alpha of 0.025 and a hazard ratio of 0.60 when 165 PFS events have been observed. An interim analysis for futility will be performed. Secondary objectives include OS, frequency and severity of adverse events, and quality of life. Exploratory objectives include iRECIST, TFST, TSST, PFS2, and evaluation of potential biomarkers. The study is actively enrolling in the US with 9 patients enrolled at time of submission. Centers in Europe, South America and Asia are expected to begin accruing shortly. Clinical trial information: NCT04498117.
A phase I, open-label, dose-escalation trial of BI 764532, a DLL3/CD3 bispecific antibody, in patients (pts) with small cell lung carcinoma (SCLC) or other neuroendocrine neoplasms expressing DLL3.
Authors: Wermke Martin , Felip Enriqueta , Gambardella Valentina , Kuboki Yasutoshi , Morgensztern Daniel , Oum'Hamed Zohra , Geng Junxian , Studeny Matus , Owonikoko Taofeek K. 
Published: June 2021

TPS8588 Background: First-line standard of care for pts with metastatic SCLC and neuroendocrine carcinoma (NEC) is platinum-based chemotherapy ± immunotherapy. While the addition of anti-PD1 antibodies has improved outcomes, nearly all pts relapse and prognosis is poor. There is a major unmet need for additional treatment (tx) options. BI 764532 is a delta-like ligand 3 (DLL3)/CD3 T cell engaging bispecific antibody. DLL3 is expressed on the cell surface of many SCLC and NEC tumors, but not on normal cells. In preclinical studies, BI 764532 induced cytotoxicity of DLL3-positive cells and showed anti-tumor activity in animal models. Methods: NCT04429087 is a first-in-human, open-label, dose-escalation trial of BI 764532 in adults with locally advanced/metastatic SCLC, large cell neuroendocrine lung carcinoma, NEC or small cell carcinoma of any other origin. Pts must have failed on or be ineligible for available standard therapies (including ≥1 line of platinum-based chemotherapy). Tumors must be positive for DLL3 expression (archived tissue/in-study fresh biopsy) according to central review. Pts must have ≥1 evaluable lesion (modified RECIST 1.1) outside of CNS and adequate liver, bone marrow and renal organ function. Main exclusion criteria: previous tx with T cell engagers or DLL3-targeted therapies; persistent toxicity from previous tx that has not resolved to ≤ CTCAE grade 1; immunodeficiency or receiving immunosuppressive therapy ≤7 days, prior anti-cancer therapy ≤3 wks/5 half-life periods or extensive field radiotherapy ≤2 wks of first dose of BI 764532. The main objective of phase Ia is to determine the maximum tolerated dose (MTD) or recommended dose for expansion of BI 764532, based on dose-limiting toxicities during the MTD evaluation period. Further objectives are to evaluate safety, tolerability, PK/PD and preliminary efficacy. The phase Ib objectives, endpoints and design will be specified after availability of phase Ia results. The trial will assess ≤3 dosing regimens: Regimen A (fixed iv dose once every 3 wks); Regimen B1 (fixed iv dose once every wk); Regimen B2 (step-in dose[s] followed by fixed-dose weekly doses; optional). Tx will continue until confirmed progressive disease, unacceptable toxicity, other withdrawal criteria or a maximum tx duration of 36 mos, whichever occurs first. For Phase Ia, ̃160 pts will be screened and 110 pts accrued. As of Feb 2021, pts are being recruited and treated in early dose escalation cohorts. Clinical trial information: NCT04429087.
Ipilimumab, nivolumab and tocilizumab as first-line therapy for advanced melanoma.
Authors: Mehmi Inderjit , Hamid Omid , Hodi F. Stephen , Vassalo Melinda , Malatyali Saundra , Krishnarajapet Swathi , O’Donnell Nan , Castrence Angeli , Lim Eunice , Gormley Jill , Weber Jeffrey S. 
Published: June 2021

TPS9589 Background: Interleukin 6 (IL-6) functions in the maintenance of hepatocytes, haemotopoietic progenitor cells, a variety of other tissues, and regulates the innate and adaptive immune system. IL-6 may play a role as a chronic inflammatory mediator in altering levels of acute phase proteins synthesized by the liver and circulating myeloid cells which have been shown to be associated with short survival with checkpoint inhibition and which are immune suppressive. The immunomodulatory properties of interleukin-6 may in part also be responsible for immune related adverse events, given the reversal of those toxicities observed with IL-6 receptor blockade in clinical practice. To assess if blockade of IL-6 binding is associated with a decrease in irAEs and/or an increase in efficacy defined as overall response rate (ORR) at week 24 in patients receiving ICB, we added tocilizumab to ipilimumab and nivolumab therapy. Methods: The current phase II trial is a two-stage design to assess the safety, tolerability, and grades 3-5 immune related toxicities of tocilizumab administered every 6 weeks up to week 24 in combination with ipilimumab at 1 mg/kg and nivolumab at 3 mg/kg every 3 weeks for 4 doses each during a 12 week induction period, then administered every 6 weeks with nivolumab at 240 mg flat dose every 2 weeks in maintenance for up to 24 weeks, and nivolumab alone will be given at 480 mg flat dose every 4 weeks thereafter for up to 2 years. Eligible patients include those age 18 or older with measurable and unresectable stages III/IV melanoma (cutaneous, acral, mucosal), without prior systemic treatment for metastatic disease. Adjuvant therapy (IFN-alpha, ipilimumab and/or nivolumab, or pembrolizumab) is allowed. Patients with metastatic melanoma of brain are allowed, if neurologically stable and off immunosuppressive steroids. A total of 18 patients will be treated in the first stage, and 49 additional patients in the second stage for a total of 67. The comparator data are from the N3I1 arm of Checkmate-511 trial, in which treatment-related grades 3-5 irAEs were 33.9% with a 45.6% response rate (1). Prespecified activity goal for the first stage of accrual has been met; second stage accrual began in January 2021. References: (1) Lebbé C, Meyer N, Mortier L, Marquez-Rodas I, et al. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. Journal of Clinical Oncology 2019 37:11, 867-875. Clinical trial information: NCT03999749.
Slow-Stroke Back Massage Compared With Music Therapy for Leukemia-Related Pain and Fatigue: A Randomized Controlled Trial
Authors: Miladinia Mojtaba , Voss Joachim G. , Molavynejad Shahram , Malehi Amal Saki , Zarea Kourosh , Nouri Elham Mousavi , Ahmadzadeh Ahmad 
Published: June 2021

PURPOSE: Comparison of two safe complementary medicine methods to treat cancer-related pain and fatigue in adult patients with acute leukemia during active treatment with chemotherapy. METHODS: A randomized trial with three groups (light massage, music therapy, and standard care) in Ahvaz, Iran, between 2018 and 2019. A total of 104 participants of the massage and music therapy groups received 15-minute intervention sessions, thrice weekly for 4 weeks, and participants of the control group received standard care. Cancer-related pain and fatigue intensity were measured by numeric self-report rating scales. During the 4 weeks of the interventions, pain and fatigue intensity were measured weekly. All the groups were followed up for 2 weeks after the end of the intervention. RESULTS: Pain and fatigue intensity decreased significantly over time between the intervention groups compared with the standard care group. In the massage and music therapy groups, a progressive reduction of pain and fatigue intensity over time (from the baseline to the fourth week) was observed. Fatigue intensity did not differ between the two intervention groups. Pain intensity decreased more in the massage group compared with the music therapy group. The durable effects of the massage therapy were greater compared with the music therapy 2 weeks after the intervention was completed. CONCLUSION: Light massage was more effective and persisted longer than the music therapy for controlling leukemia-related pain and fatigue in adult patients with acute leukemia.
Diagnosis and Management of Tumor-induced Osteomalacia: Perspectives From Clinical Experience
Authors: Dahir Kathryn , Zanchetta María Belén , Stanciu Irinel , Robinson Cemre , Lee Janet Y , Dhaliwal Ruban , Charles Julia , Civitelli Roberto , Roberts Mary Scott , Krolczyk Stan , Weber Thomas 
Published: June 2021

Abstract

Purpose
Tumor-induced osteomalacia (TIO) is a rare paraneoplastic syndrome of abnormal phosphate and vitamin D metabolism caused by typically small endocrine tumors that secrete fibroblast growth factor 23 (FGF23). TIO is characterized clinically by progressive musculoskeletal pain, fatigue, proximal muscle weakness, and multiple fractures, leading to long-term disability. Misdiagnosis and delayed diagnosis are common because of the nonspecific symptoms, and several years may elapse before patients receive an accurate diagnosis and appropriate treatment. Thus, it is vital that awareness of the appropriate recognition and management of TIO is increased among healthcare professionals who may encounter patients with suspected TIO.

Methods
A roundtable meeting was held on 10 January 2020 in Dallas, TX, USA, to gather perspectives on the diagnosis and treatment of TIO. The following topics were considered: clinical presentation, patient history, differential diagnosis, laboratory assessment, imaging, venous sampling, and treatment.

Results
This report provides a summary of our collective experiences in the management of TIO.

Main conclusions
Laboratory tests are mandatory to expedite TIO diagnosis and should include measurement of fasting serum phosphorus, renal phosphate reabsorption, serum 1,25-dihydroxyvitamin D, and serum FGF23 levels. Functional and anatomical imaging are essential to locate the FGF23-secreting tumor(s) causing TIO. Surgical resection is often a curative treatment when the tumor can be localized; however, better management of patients who cannot be operated on with targeted therapies is needed. Further efforts to increase awareness of TIO within the medical community, and education on recommended diagnostic and treatment pathways are required to improve the management of this debilitating disease.
Coping with Denialism: How Street-Level Bureaucrats Adapted and Responded to COVID-19 in Tanzania
Authors: Carlitz Ruth , Yamanis Thespina , Mollel Henry 
Published: June 2021

Abstract
Context: This article aims to highlight challenges and adaptations made by local health officials in Tanzania in working to contain and manage COVID-19.
Methods: The study takes an inductive approach, drawing on the reported experiences of 40 officials at different levels of government across four purposefully selected regions in July 2020. Interviewees were asked about the guidance they received to contain COVID-19, the source of that guidance, their challenges and successes in implementing the guidance, and if and how they adapted the guidance to their particular setting.
Findings: The interviews depict considerable challenges, including a lack of supplies and resources for implementing infection control, surveillance, and mitigation practices and dealing with fear and stigma. At the same time, they also provide evidence of innovation and adaptation among street-level bureaucrats. Respondents overwhelmingly praised the president, whose limited national response is seen as helpful for reducing fear and stigma.
Conclusions: Other scholars have highlighted the potential dangers of street-level discretion if local officials “make policy” in ways that contradict their agencies' stated goals. In contrast, our study suggests benefits of autonomy at the street level—particularly in contexts where the central state was relatively weak and/or acting against the public interest.
Can Gambling Increase Savings? Empirical Evidence on Prize-Linked Savings Accounts
Authors: Cole Shawn , Iverson Benjamin , Tufano Peter 
Published: June 2021

This paper studies the adoption and impact of prize-linked savings (PLS) accounts, which offer lottery-like payouts to individual account holders in lieu of interest. Using microlevel data from a bank in South Africa, we show that PLS is attractive to a broad group of individuals, with financially constrained individuals and those with no other deposit accounts particularly likely to participate. Individuals who choose to use PLS increase their total savings on average by 1% of annual income. Exploiting the random assignment of prizes, we present causal evidence that PLS substitutes for lottery gambling but is a complement to standard savings. This paper was accepted by Tyler Shumway, finance.
Knowledge translation activity of a domestic violence research network: a scoping survey
Authors: Cameron Jacqui , Humphreys Cathy , Hegarty Kelsey 
Published: June 2021

Introduction: Research networks undertake work collaboratively on complex areas of research. Few studies examine how these networks develop their knowledge translation activity. Focusing on a domestic violence research network (DVRN), the aim of this study was to answer the question: What is the shared understanding of knowledge translation and activity in a domestic violence research network?
Methods: A sample of DVRN members undertook an anonymous online survey about their knowledge translation activity.
Results: Completed by 49 of a potential 65 DVRN members (75% completion rate), findings suggested members use multiple knowledge translation definitions, and that different stages of the research process engage people with lived-experience and policymakers undertaking lower levels of engagement than practitioners. Innovative engagement mechanisms to communicate research findings were limited, and knowledge translation barriers included budget, time, capacity, limitation of models, organisational emphasis and support. Finally, there was inadequate knowledge translation evaluation.
Conclusion: Overcoming knowledge translation barriers is essential to ensure meaningful collaboration particularly with survivors who are often the missing voice of knowledge translation. Future studies could determine what impact, if any, increasing engagement of survivors and policymakers during all stages of the research process has on knowledge translation.
Responsivity enhancement of a strained silicon field-effect transistor detector at 0.3 THz using the terajet effect
Authors: Minin Igor Vladilenovich , Minin Oleg Vladilenovich , Salvador-Sánchez Juan , Delgado-Notario Juan Antonio , Calvo-Gallego Jaime , Ferrando-Bataller Miguel , Fobelets Kristel , Velázquez-Pérez Jesús Enrique , Meziani Yahya Moubarak 
Published: June 2021

We report on the enhancement of responsivity by more than one order of magnitude of a silicon-based sub-terahertz detector when a mesoscopic dielectric particle was used to localize incident radiation to a sub-wavelength volume and focus it directly onto the detector. A strained-silicon modulation field-effect transistor was used as a direct detector on an incident terahertz beam at 0.3 THz. A systematic study in which Teflon cubes were placed in front of the detector to focus the terahertz beam was performed. In this study, cubes with different sizes were investigated, and an enhancement of the responsivity up to 11 dB was observed for a cube with an edge length of 3.45 mm (or

3.45
λ

). Electromagnetic simulation results were in good agreement with the experimental ones and demonstrated that the size of the mesoscopic particle plays an important role in focalizing the electric field within an area below the diffraction limit. This approach provides an efficient, uncostly, and easy to implement method to substantially improve the responsivity and noise equivalent power of sub-terahertz detectors.
EDUCATION SPACE IN MACRO-REGIONS OF THE RUSSIAN FEDERATION: STATE AND DEVELOPMENT PROSPECTS
Authors: Babkina L. N. , Skotarenko О.V. 
Published: June 2021

The article defines characteristics of the state at all levels of education — preschool, school, primary, secondary and tertiary education in regions of Russia with the purpose of determining imbalances of these levels and the possibility of creating a proportional to a unified educational space on the territory of the Russia. The basis for creating such a space is federal projects that are aimed at implementing the national project «Education» and in the future will contribute to the further formation of a competitive national economy of a new generation — knowledge-intensive.
The main research method was a comparative analysis of specific indicators, and the information base was the data of the annual state statistical reports for the regions of the Russia.
The identified irregularity and disproportionate development of the levels of education allow to formulate the strategic goals, performance standards, and plans of specific measures to increase proportionality and reduce the uneven development of the educational environment in the regions of Russia.
“It’s not the same thing as last time I wrote a report”: Digital text sharing in changing organizations
Authors: Blåsjö Mona , Jonsson Carla 
Published: June 2021

Abstract
In the communications of modern organizations, text sharing and knowledge management are mainly digital. The digital systems that frame many types of communication consist of, e.g., intranets and document sharing software that are occasionally exchanged for new systems. Employees have to adjust to modified routines and learn new systems, and management has to make decisions about digital systems and how these are to be integrated with work processes and knowledge management. In this article, we contribute to research on work-life literacies by highlighting the increasingly frequent issue of digital text sharing in modern workplaces through the study of commercial companies, mainly through ethnographic observations and interviews. The theoretical framework comes from New Literacy Studies where literacy practices, i.e., common patterns of using reading and writing, form a key concept. Moreover, the sociolinguistic concept of metadiscourse is applied in order to uncover the reflexive orientation of participating professionals towards digital text sharing. The results show that these professionals relate the combination of digital text sharing and technological and organizational change to problems, obstacles and potential risks; ambitions of enhancing digital text sharing may exclude certain groups, and changes in digital text sharing systems per se may cause professionals to lose control. These risks are often associated with access to information: a person who cannot access information in their organization has a lower degree of agency or power over their situation. The results are discussed in light of theories concerning modern work life from New Literacy Studies.
Errors in documenting the subsoil and their impact on the investment implementation: Case study
Authors: Lendo-Siwicka Marzena , Wrzesiński Grzegorz , Pawluk Katarzyna 
Published: June 2021

AbstractImproper recognition of the subsoil is the most common cause of problems in the implementation of construction projects and construction facilities failures. Most often, their direct cause is the mismatch of the scope of geotechnical diagnosis to the appropriate geotechnical category, or substantive errors, including incomplete or incorrect interpretation in the creation of a geological-engineering model and often overlooked hydrogeological conditions. In many cases, insufficient recognition and documentation of geotechnical and/or geological and engineering conditions leads to damage and construction failures, delays in consider construction, and the increase of the investment budget. That’s why, in order to avoid the above, particular attention should be paid to proper geotechnical and geological-engineering documentation at the design and construction stages. The selected example of the investment analyzed errors in the geological-engineering documentation, which mainly concerned the lack of recognition of locally occurring organic soils, the incorrectly determined location of the groundwater table and the degree of compaction of non-cohesive soils, and numerous errors of calculated values of soil uplift pressure. The detection of the errors presented in the paper made it possible to select the correct technology for the construction of the sanitary sewage system and to increase the thickness of the horizontal shutter made of jet grouting columns in the area of the excavation. In addition, the article discusses the principles of proper calculation of limit states and subsoil testing, which have a significant impact on the implementation of planned investments.