bluuebunny/crossref_metadata_2025_split huggingface dataset:
On the individual and organizational capacities supporting impact assessment: the case of the Yukon Environmental and Socio-Economic Assessment Board
Authors: Darling Samantha , Harvey Blane , Hickey Gordon M. 
Published: May 2022

Impact assessment (IA) processes rely on the ability of assessment boards and their assessors to gather, synthesize, and interpret knowledge from a variety of sources, making IA a knowledge-based activity. IA boards in northern Canada operate in a context that prioritizes pluralism, where Indigenous knowledge is a key element of decision-making and the ability of practitioners to interact with knowledge—research capacity—affects process effectiveness, credibility, and legitimacy. Drawing on common principles from existing research capacity frameworks, we identify the dimensions of capacity most relevant to more fully realizing inclusive impact assessment processes. We then examine the Yukon Environmental and Socio-Economic Assessment Board (YESAB) as a specialized environmental governance organization with assessors whose research capacity directly impacts process outcomes. Results show that while common dimensions across knowledge-based disciplines, such as sufficient resources (e.g., financial support), are often addressed in the YESAB context, others unique to IA, like contextual understanding, require further examination. The interaction between individual and organizational research capacity is a complex balance between investing in individuals and investing in organizational supports. The proposed framework facilitates multi-scalar supports for individual assessors and assessment bodies alike to navigate balancing technical and value-driven knowledge in assessments.
Testing alternative theories of gravity by fitting the hot-spot data of Sgr A*
Authors: Shahzadi Misbah , Kološ Martin , Stuchlík Zdeněk , Habib Yousaf 
Published: May 2022

AbstractWe are fitting dynamics of electrically neutral hot-spot orbiting around Sagittarius A* (Sgr A*) source in Galactic center, represented by various modifications of the standard Kerr black hole (BH), to the three flares observed by the GRAVITY instrument on May 27, July 22, July 28, 2018. We consider stationary, axisymmetric, and asymptotically flat spacetimes describing charged BHs in general relativity (GR) combined with nonlinear electrodynamics, or reflecting the influence of dark matter (DM), or in so called parameterized dirty Kerr spacetimes, and test them using the hot-spot data. We show that the orbital frequencies as well as positions of the hot-spots orbiting the considered BHs fit the observed positions and periods of the flare orbits, and give relevant constraints on the parameters of the considered BH spacetimes and the gravity or other theories behind such modified spacetimes.
CAN HIGH-TECH INVESTMENTS IMPROVE BANKING EFFICIENCY?
Authors: BORELLO GIULIANA , PAMPURINI FRANCESCA , QUARANTA ANNA GRAZIA 
Published: May 2022

This study examines the high-tech investment activity of the banking system in the period following the Global Financial Crisis, from 2009 to 2020. To gain an understanding of the effect of the increasing interest of banks in high-tech investments, this research provides evidence of the relationship between the level of efficiency achieved by Euro Area banking groups and their high-tech investment aptitude. This paper is purely exploratory given that, to the best of our knowledge, it is one of the first to address this specific research question. We analyze in detail the association between bank efficiency (measured using a stochastic frontier approach) and different high-tech investment indicators, as well as the direction of this connection to provide an explanation for the relationship. We find a stable and overall significant relationship between banks’ efficiency and their high-tech investment aptitude. Moreover, we find that only medium efficiency banking groups that adopt a more diversified investment acquisition strategy have a positive relationship with high-tech investment aptitude; otherwise, the relationship between bank efficiency and high-tech investment indicators seems to be negative. Regulators should be aware of this bank acceleration in the enhancement of high-tech investment because it can reduce the stability of banking groups and because an increase in intangibles assets (e.g. patents) could also be motivated by an interest rather than an earnings management strategy.
DANCE: DAta-Network Co-optimization for Efficient Segmentation Model Training and Inference
Authors: Li Chaojian , Chen Wuyang , Gu Yuchen , Chen Tianlong , Fu Yonggan , Wang Zhangyang , Lin Yingyan 
Published: May 2022

Semantic segmentation for scene understanding is nowadays widely demanded, raising significant challenges for the algorithm efficiency, especially its applications on resource-limited platforms. Current segmentation models are trained and evaluated on massive high-resolution scene images (“data-level”) and suffer from the expensive computation arising from the required multi-scale aggregation (“network level”). In both folds, the computational and energy costs in training and inference are notable due to the often desired large input resolutions and heavy computational burden of segmentation models. To this end, we propose DANCE, general automated
DA
ta-
N
etwork
C
o-optimization for
E
fficient segmentation model
training and inference
. Distinct from existing efficient segmentation approaches that focus merely on light-weight network design, DANCE distinguishes itself as an automated
simultaneous
data-network
co-optimization
via both input data manipulation and network architecture slimming. Specifically, DANCE integrates automated data slimming which adaptively downsamples/drops input images and controls their corresponding contribution to the training loss guided by the images’ spatial complexity. Such a downsampling operation, in addition to slimming down the cost associated with the input size directly, also shrinks the dynamic range of input object and context scales, therefore motivating us to also adaptively slim the network to match the downsampled data. Extensive experiments and ablating studies (on four SOTA segmentation models with three popular segmentation datasets under two training settings) demonstrate that DANCE can achieve
“all-win”
towards efficient segmentation (reduced training cost, less expensive inference, and better mean Intersection-over-Union (mIoU)). Specifically, DANCE can reduce ↓25%–↓77% energy consumption in training, ↓31%–↓56% in inference, while boosting the mIoU by ↓0.71%–↑ 13.34%.
Association between Cataract Surgery and Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
Authors: Yang Lihong , Li Hongxun , Zhao Xinheng , Pan Ye 
Published: May 2022

Purpose. We performed a systematic review and meta-analysis to evaluate the association between cataract surgery and the development and progression of AMD. Methods. This meta-analysis was registered at PROSPERO (CRD42017077962). We conducted a systematic literature search in August 2020 in Embase and PubMed and included cohort studies, case-control studies, or randomized controlled trials (RCTs) if they examined the association between cataract surgery and AMD. Odds ratio (OR) was used as a measure of the association with a random effect model. The analysis was further stratified by factors that could affect the outcomes. Results. 15 studies were included in this study. In the overall analysis, cataract surgery was significantly associated with the incidence of late AMD (OR, 1.80; 95% CI, 1.26–2.56;

P

= 0.001), particularly geographic atrophy (OR, 3.20; 95% CI, 1.90–5.39;

P

≤ 0.001). No significant associations were observed between cataract surgery and the incidence of early AMD. Subgroup analysis showed that the OR for incidence of early and late AMD was significantly higher for cataract surgery performed more than 5 years compared with less than 5 years. We also found an increased risk of progression of AMD after cataract surgery performed more than 5 years (OR, 1.97; 95% CI, 1.29–3.01;

P

= 0.002). Conclusions. Our results suggest that cataract surgery may be associated with an increased risk of late AMD development and AMD progression. In addition, increasing the follow-up time since cataract surgery may further increase the risk for the development and progression of AMD. In the future, prospective multicenter studies with well-designed RCTs are required to confirm our findings.
First-in-Human Phase I/II ICONIC Trial of the ICOS Agonist Vopratelimab Alone and with Nivolumab: ICOS-High CD4 T-Cell Populations and Predictors of Response
Authors: Yap Timothy A. , Gainor Justin F. , Callahan Margaret K. , Falchook Gerald S. , Pachynski Russell K. , LoRusso Patricia , Kummar Shivaani , Gibney Geoffrey T. , Burris Howard A. , Tykodi Scott S. , Rahma Osama E. , Seiwert Tanguy Y. , Papadopoulos Kyriakos P. , Blum Murphy Mariela , Park Haeseong , Hanson Amanda , Hashambhoy-Ramsay Yasmin , McGrath Lara , Hooper Ellen , Xiao Xiaoying , Cohen Heather , Fan Martin , Felitsky Daniel , Hart Courtney , McComb Rachel , Brown Karen , Sepahi Ali , Jimenez Judith , Zhang Weidong , Baeck Johan , Laken Haley , Murray Richard , Trehu Elizabeth , Harvey Christopher J. 
Published: May 2022

Abstract

Purpose:
The first-in-human phase I/II ICONIC trial evaluated an investigational inducible costimulator (ICOS) agonist, vopratelimab, alone and in combination with nivolumab in patients with advanced solid tumors.

Patients and Methods:
In phase I, patients were treated with escalating doses of intravenous vopratelimab alone or with nivolumab. Primary objectives were safety, tolerability, MTD, and recommended phase II dose (RP2D). Phase II enriched for ICOS-positive (ICOS+) tumors; patients were treated with vopratelimab at the monotherapy RP2D alone or with nivolumab. Pharmacokinetics, pharmacodynamics, and predictive biomarkers of response to vopratelimab were assessed.

Results:
ICONIC enrolled 201 patients. Vopratelimab alone and with nivolumab was well tolerated; phase I established 0.3 mg/kg every 3 weeks as the vopratelimab RP2D. Vopratelimab resulted in modest objective response rates of 1.4% and with nivolumab of 2.3%. The prospective selection for ICOS+ tumors did not enrich for responses. A vopratelimab-specific peripheral blood pharmacodynamic biomarker, ICOS-high (ICOS-hi) CD4 T cells, was identified in a subset of patients who demonstrated greater clinical benefit versus those with no emergence of these cells [overall survival (OS), P = 0.0025]. A potential genomic predictive biomarker of ICOS-hi CD4 T-cell emergence was identified that demonstrated improvement in clinical outcomes, including OS (P = 0.0062).

Conclusions:
Vopratelimab demonstrated a favorable safety profile alone and in combination with nivolumab. Efficacy was observed only in a subset of patients with a vopratelimab-specific pharmacodynamic biomarker. A potential predictive biomarker of response was identified, which is being prospectively evaluated in a randomized phase II non–small cell lung cancer trial.
See related commentary by Lee and Fong, p. 3633
Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non–Small Cell Lung Cancer Trials Using Real-World Data
Authors: Ton Thanh G.N. , Pal Navdeep , Trinh Huong , Mahrus Sami , Bretscher Michael T. , Machado Robson J.M. , Sadetsky Natalia , Chaudhary Nayan , Lu Michael W. , Riely Gregory J. 
Published: May 2022

Abstract

Purpose:
The utility of real-world data (RWD) for use as external controls in drug development is informed by studies that replicate trial control arms for different endpoints. The purpose of this study was to replicate control arms from four non–small cell lung cancer (NSCLC) randomized controlled trials (RCT) to analyze overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) using RWD.

Patients and Methods:
This study used RWD from a nationwide de-identified database and a clinico-genomic database to replicate OS, PFS, and ORR endpoints in the chemotherapy control arms of four first-line NSCLC RCTs evaluating atezolizumab [IMpower150–wild-type (WT), IMpower130-WT, IMpower131, and IMpower132]. Additional objectives were to develop a definition of real-world PFS (rwPFS) and to evaluate the real-world response rate (rwRR) endpoint.

Results:
Baseline demographic and clinical characteristics were balanced after application of propensity score weighting methods. For rwPFS and OS, RWD external controls were generally similar to their RCT control counterparts. Across all four trials, the hazard ratio (HR) point estimates comparing trial controls with external controls were closer to 1.0 for the PFS endpoint than for the OS endpoint. An exploratory assessment of rwRR in RWD revealed a slight but nonsignificant overestimation of RCT ORR, which was unconfounded by baseline characteristics.

Conclusions:
RWD can be used to reasonably replicate the OS and PFS of chemotherapy control arms of first-line NSCLC RCTs. Additional studies can provide greater insight into the utility of RWD in drug development.
Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial
Authors: Furtado Remo H.M. , Raz Itamar , Goodrich Erica L. , Murphy Sabina A. , Bhatt Deepak L. , Leiter Lawrence A. , McGuire Darren K. , Wilding John P.H. , Aylward Philip , Dalby Anthony J , Dellborg Mikael , Dimulescu Doina , Nicolau José C. , Oude Ophuis Anthonius J.M. , Cahn Avivit , Mosenzon Ofri , Gause-Nilsson Ingrid , Langkilde Anna Maria , Sabatine Marc S. , Wiviott Stephen D. 
Published: May 2022

Background:
Dapagliflozin improved heart failure and kidney outcomes in patients with type 2 diabetes (T2DM) with or at high risk for atherosclerotic cardiovascular disease in the DECLARE-TIMI 58 trial (Dapagliflozin Effect on Cardiovascular Events – Thrombolysis in Myocardial Infarction 58). Here, the aim was to analyze the efficacy and safety of dapagliflozin stratified according to baseline systolic blood pressure (SBP).

Methods:
The DECLARE-TIMI 58 trial randomly assigned patients with T2DM and either previous atherosclerotic cardiovascular disease or atherosclerotic cardiovascular disease risk factors to dapagliflozin or placebo. Patients were categorized by baseline SBP levels: <120, 120 to 129, 130 to 139, 140 to 159, and ≥160 mm Hg (normal, elevated, stage 1, stage 2, and severe hypertension, respectively). Efficacy outcomes of interest were hospitalization for heart failure and a renal-specific composite outcome (sustained decrease in estimated glomerular filtration rate by 40%, progression to end-stage renal disease, or renal death). Safety outcomes included symptoms of volume depletion, lower extremity amputations, and acute kidney injury.

Results:

The trial comprised 17 160 patients; mean age, 64.0±6.8 years; 37.4% women; median duration of T2DM, 11 years; 40.6% with prevalent cardiovascular disease. Overall, dapagliflozin reduced SBP by 2.4 mm Hg (95% CI, 1.9–2.9;
P
<0.0001) compared with placebo at 48 months. The beneficial effects of dapagliflozin on hospitalization for heart failure and renal outcomes were consistent across all baseline SBP categories, with no evidence of modification of treatment effect (
P
interactions
=0.28 and 0.52, respectively). Among normotensive patients, the hazard ratios were 0.66 (95% CI, 0.42–1.05) and 0.39 (95% CI, 0.19–0.78), respectively, for hospitalization for heart failure and the renal-specific outcome. Events of volume depletion, amputation, and acute kidney injury did not differ with dapagliflozin overall or within any baseline SBP group.

Conclusions:
In patients with T2DM with or at high atherosclerotic cardiovascular disease risk, dapagliflozin reduced risk for hospitalization for heart failure and renal outcomes regardless of baseline SBP, with no difference in adverse events of interest at any level of baseline SBP. These results indicate that dapagliflozin provides cardiorenal benefits in patients with T2DM at high atherosclerotic cardiovascular disease risk independent of baseline blood pressure.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT01730534.
Design of the BEST‐II Randomized Clinical Trial
Authors: Mistry Eva A. , Hart Kimberly , Davis Taylor , Yeatts Sharon , Lindsell Christopher J. , Lewis Roger J. , Albers Gregory , Wanderer Jonathan P. , Prestigiacomo Charles , Bernard Gordon R. , Khatri Pooja 
Published: May 2022

Background
Prior observational studies indicate that lower systolic blood pressure (SBP) after successful endovascular treatment (EVT) is associated with better functional outcomes in patients with acute ischemic stroke. However, whether targeting SBP to levels below the guideline‐recommended target of ≤180 mm Hg is safe and efficacious remains to be determined.

Methods
The BEST (Blood Pressure After Endovascular Stroke Therapy)‐II trial (NCT04116112) is a pragmatic, phase 2, multisite, prospective, randomized, open‐label trial with blinded end‐point assessment designed to (1) compare the safety of lower SBP targets with higher SBP targets in successfully EVT‐treated patients with stroke and (2) inform the design and estimate the probability of success of a future phase 3 trial. A total of 120 patients with acute ischemic stroke who undergo successful EVT (final modified Thrombolysis in Cerebral Infarction score ≥2b) for intracranial internal carotid artery or M1 or M2 segment of the middle cerebral artery will be randomized to the SBP targets of ≤180, <160, and <140 mm Hg, to be maintained for 24 hours using intravenous nicardipine as the first‐line agent. We will assess the harm of decreased post‐EVT SBP by quantifying its linear relationship with multiple primary outcomes of final infarct volume on magnetic resonance imaging (or computed tomography) at 36 hours and utility‐weighted modified Rankin scale score at 90 days. The study is approved by the Institutional Review Boards of both participating institutions and the Data and Safety Monitoring Board.

Results
Enrollment in the BEST‐II trial began in January 2020, with 90 patients enrolled as of October 13, 2021. The trial is progressing ahead of target, with an anticipated enrollment completion date before January 2023.

Conclusions
The BEST‐II trial results will inform the stroke community of the safety of lower SBP targets in patients with acute ischemic stroke who are successfully treated with EVT and will demonstrate the feasibility of both achieving lower blood pressure targets as well as conducting an efficacy trial. Trial enrollment is on target despite the COVID‐19 pandemic.

Clinical Trial Registration Information

NCT04116112 (
https://clinicaltrials.gov/ct2/show/NCT04116112
)
Experience With Neuroform Atlas Stenting as Rescue Endovascular Treatment After Failed Mechanical Thrombectomy Secondary to Intracranial Atherosclerosis
Authors: Lajthia Orgest , Almallouhi Eyad , Kicielinski Kimberly , Lena Jonathan , Spiotta Alejandro M. , Al Kasab Sami 
Published: May 2022

Background
Patients with emergent large vessel occlusion secondary to intracranial atherosclerotic stenosis who fail mechanical thrombectomy pose a treatment challenge. The aim of this study is to report our single‐center experience using the Neuroform Atlas stent as a potential rescue modality.

Methods
Data were analyzed from a prospectively maintained database at a Comprehensive Stroke Center between January 2019 and September 2021 of all patients with intracranial atherosclerotic stenosis–emergent large vessel occlusion who underwent mechanical thrombectomy and required rescue stenting with the Neuroform Atlas. We systematically gathered demographic, clinical, procedural, and functional characteristics on patients presenting with emergent large vessel occlusion within 24 hours of last known normal. The primary outcome was the rate of revascularization following stenting.

Results
Twenty‐six patients met the inclusion criteria, with a mean age of 56.5 years, 34.6% of whom were women. On presentation, the median National Institutes of Health Stroke Scale was 11 and median Alberta Stroke Program Early Computed Tomography Score was 9. Mechanical thrombectomy was performed using a direct aspiration, first‐pass technique in all patients. Following Neuroform Atlas stent placement, 3 patients (11.5%) had moderate in‐stent stenosis, while severe stenosis was encountered in 4 patients (15.4%). The rate of successful revascularization (Thrombolysis in Cerebral Infarction 2B–3) was identified in 92.3% of the patients. On follow‐up vascular images, reocclusion occurred in 2 patients (7.7%) and symptomatic hemorrhage was encountered in 3 patients (11.5%). Excellent outcome at 90 days (modified Rankin scale 0–2) was achieved in 13 of 26 (50%) patients.

Conclusion
Our series provides preliminary safety and efficacy data regarding the use of the Neuroform Atlas stent as a rescue modality in intracranial atherosclerotic stenosis–emergent large vessel occlusion cases.
Rosai-Dorfman Disease of the Chest Wall Following Mastectomy for Breast Cancer
Authors: Merrell Mollie A. , Grenn Emily E. , Orr W. Shannon 
Published: May 2022

Rosai-Dorfman disease (RDD) is a rare benign proliferative histiocytic disorder generally affecting the cervical lymph nodes as sinus histiocytosis with massive lymphadenopathy. We present a unique case of multifocal soft tissue RDD originating from previous mastectomy site and retroperitoneum. The patient is a 62-year-old African American female with a prior history of bilateral breast invasive ductal adenocarcinoma. 2 years following completion of therapy, our patient re-presented with an abdominal wall mass. The core biopsy was discordant, and the mass had rapid growth prompting excision. After the excision of the abdominal wall mass pathology confirmed RDD. A PET confirmed a solitary mass behind the left kidney this mass was biopsied and confirmed that it was RDD in the retroperitoneum. Due to the slow growth of this mass observation was deemed reasonable. We present this case to highlight the need for further research to improve treatment guidelines and expectations
SAVI Scout® System for Excision of Non-Palpable Breast Lesions
Authors: Farha Maen J. , Simons James , Kfouri Jad , Townsend-Day Michelle 
Published: May 2022

Background The standard localization of non-palpable breast masses is wire/needle localization (WL). Newer technologies have evolved, allowing more efficient scheduling and improving surgeon and patient experiences. These include Radioactive Seed, MagSeed®, and SAVI Scout® (SS). We adopted SS at our program in July of 2017. We are reporting our experience comparing SAVI Scout® with needle localization. Study Design This is a retrospective study comparing SS and wire localization techniques for the excision of both benign and malignant lesions. Chart reviews of localized patients between 7/1/2017 and 6/30/2019, recording the age of the patient, date of procedure, localization method, pathology of lesion postexcision, number and status of margins, guidance method (mammogram vs. ultrasound), specimen size, and distance of reflector from biopsy clip, were completed to compare these localization methods with the aim of asserting their equality. Results There were 48 wire and 64 SS localized excisions. Successful lesion excision was achieved in 100% of cases for both techniques. There were 1 SS and 4 WL re-excisions for margin clearance not reaching statistical significance. 51 additional margins were obtained in the SS cases compared to 36 margins in the WL cases without a statistically significant difference. Conclusions 1- Both SS and WL achieved 100% excision of targeted lesions 2- SS localization was successfully implemented, offering more convenience for patients and providers 3- More re-excisions in the WL group as compared to the SS group did not reach statistical significance and requires further investigation 4- A prospective controlled trial comparing the different localization techniques can address questions related to effectiveness, cost, patient and provider experiences.