bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II Trial of the PARP Inhibitor, Niraparib, in BAP1 and Other DNA Damage Response Pathway-Deficient Neoplasms
Authors: George Thomas J. , Lee Ji-Hyun , DeRemer David L. , Hosein Peter J. , Staal Steven , Markham Merry Jennifer , Jones Dennie , Daily Karen C. , Chatzkel Jonathan A. , Ramnaraign Brian H. , Close Julia L. , Ezenwajiaku Nkiruka , Murphy Martina C. , Allegra Carmen J. , Rogers Sherise , Zhang Zhongyue , Li Derek , Srinivasan Gayathri , Shaheen Montaser , Hromas Robert 
Published: December 2024

PURPOSE
BRCA1-associated protein 1 (BAP1) is a critical cell cycle and DNA damage response (DDR) regulator with mutations (mBAP1) causing a functional protein loss. PARP inhibitors (PARPis) demonstrate synthetic lethality in mBAP1 preclinical models, independent of underlying BRCA status. This study aimed to explore the clinical activity of niraparib in patients with advanced tumors likely to harbor mBAP1.

METHODS
This was a phase II multicenter trial in which refractory solid tumor patients were assigned to cohort A (histology-specific tumors likely to harbor mBAP1) or cohort B (histology-agnostic tumors with other known non–BRCA-confirmed DDR mutations). All patients received niraparib 300 mg orally once daily on a 28-day cycle. The primary end point was objective response rate, and secondary end points included progression-free survival (PFS) and overall survival.

RESULTS

From August 2018 through December 2021, 37 patients were enrolled with 31 evaluable for response (cohort A, n = 18; cohort B, n = 13). In cohort A, the best response was one partial response (PR; 6%), eight stable disease (SD; 44%), and nine progressive disease (PD; 50%). This cohort stopped at the first stage following the prespecified Simon's design. mBAP1 was confirmed in 7/9 patients (78%) with PR or SD but in only 3/9 (33%) in those with PD. The median PFS in patients with mBAP1 (n = 10) was 6.7 months (95% CI, 1.0 to 9.2) versus 1.8 months (95% CI, 0.9 to 4.5) for wild-type (n = 8;
P
= .020). In cohort B, the best response was six SD (46%) and seven PD (54%), with SD in those with
ATM
,
CHEK2
,
PTEN
,
RAD50
, and
ARID1A
mutations.

CONCLUSION
Niraparib failed to meet the prespecified efficacy end point for response. However, clinical benefit was suggested in a proportion of patients who had a confirmed mBAP1, supporting further investigation.
Parents' Experiences With and Preferences for Receiving Information About Tumor Genomic Sequencing: Findings From a Qualitative Study and Implications for Practice
Authors: Greene Brittany L. , Barton Krysta S. , Bonkowski Emily , Stasi Shannon M. , Waligorski Natalie , Marron Jonathan M. , Rosenberg Abby R. 
Published: December 2024

PURPOSE
The use of up-front tumor genomic sequencing (TGS) is becoming increasingly common in pediatric oncology. Despite this, little is known about how parents receive information about TGS at the time of their child's cancer diagnosis. We aimed to describe parents' experiences with and preferences for receiving information about TGS and to use these findings to inform practical guidance for pediatric oncology clinicians.

METHODS
We conducted semistructured interviews with English-speaking parents (older than 18 years) of patients (younger than 18 years) who had TGS for a new diagnosis of cancer. We analyzed the interviews thematically. Participants also completed a short demographic survey, and we obtained medical information about participants' children via chart review.

RESULTS
We interviewed 20 parents (14 mothers; median age, 38 years) of children who underwent TGS for a newly diagnosed cancer (10 leukemias/lymphomas, three CNS tumors, seven other solid tumors). Children were 6 months to 17 years at diagnosis (median, 6 years). Fifteen parents and their children were White, two of whom were Hispanic and four of whose children were Hispanic. No participants identified themselves or their child as Black. We identified the following themes regarding information delivery about genomic testing from the interviews: (1) those in the parent role have some universal information needs; (2) information delivery preferences vary among parents, even within one family; and (3) parents desire standard yet tailored information delivery.

CONCLUSION
Parents made suggestions consistent with elements of established high-quality communication in pediatric oncology. As genomic testing is more standardly incorporated into childhood cancer care, communication with parents may need to adapt to reflect this. Our findings highlight potential opportunities to support parents in receiving information about genomic testing.
Autonomic Responses to Cold Pain: Effect of Type, Duration, and Habituation in Cryotherapy
Authors: McDowell Jasmine M. , Addington Gretchen , Metzler-Wilson Kristen , Wilson Thad E. 
Published: December 2024

ABSTRACT

Purpose
Cold limb immersion, a form of cryotherapy, can cause cardiovascular changes due to cold-pain induced autonomic reflexes. This cryotherapy treatment side effect has received less attention but could have direct implications for physical rehabilitation of individuals with cardiovascular comorbidities.

Methods
To test hypotheses related to the pressor effects of varied limb sites and surface areas of cryotherapy, two common lower limb injury sites (ankle and knee) were immersed into cold water (15 min, 1-3 °C) and then referenced to a standard cold pressor test (CPT). Beat-by-beat arterial blood pressure (finger photoplethysmography), heart rate (ECG), systemic vascular conductance (SVC; Modelflow), and calf vascular conductance (VC; venous occlusion plethysmography) were measured in 14 healthy participants.

Results
At 2 min, CPT increased mean arterial pressure (MAP; 21 ± 4 mmHg) more than either ankle or leg immersion (15 ± 4 and 15 ± 5 mmHg, respectively; P = 0.015). SVC and calf VC decreased but were not different across treatments (P = 0.417 and P = 0.086). MAP and SVC were not different from 2 min to 15 min of immersion (P = 0.164 and P = 0.522), but calf VC decreased further by the end of immersion (3.1 ± 0.5 to 2.8 ± 0.4 and 2.7 ± 3 to 1.7 ± 0.2 units; P = 0.028). MAP increases with CPT were similar with solely CPT and when CPT followed ankle or leg immersion (27 ± 5 and 23 ± 4 mmHg, respectively; P = 0.199).

Conclusions
These data indicate robust pressor responses without autonomic reflex habituation and that cryotherapy immersion location but not surface area appears to mediate cardiovascular responses. This cryotherapy side effect may be an important consideration for patients with cardiovascular-related comorbidities.
Bank Competition and Risk-Taking Under Market Integration
Authors: Dam Kaniṣka , Sengupta Rajdeep 
Published: December 2024

Linkages between bank competition and risk-taking are analyzed in a model where market integration is the principal driver of increased competition. Risk implications of across-market competition under banking market integration are significantly different from that of within-market competition. Although both modes of competition increase the number of competitor banks, across-market competition yields a bank-customer effect that can potentially reverse any relation that prevails between within-market competition and risk-taking. This result suggests that the lack of consensus in the bank competition-financial stability literature is not an anomaly but an inherent feature of the analysis. This paper was accepted by Victoria Ivashina, finance. Supplemental Material: The online appendix is available at https://doi.org/10.1287/mnsc.2022.03495 .
Salt restriction induced hyponatremia in hypertensive patients in Rwanda: A case control study
Authors: BIZIMANA Emmanuel , RUTAGANDA Eric , MUGENI Adeline , UWUMURYANGO Prisca 
Published: December 2024

Background
Salt restriction is a fundamental principle in the non-pharmacological management of hypertension. The World Health Organization recommends a daily sodium intake of less than 2 g/day. In East African countries, particularly Rwanda, there is a known prevalence of low sodium intake, with a mean sodium intake of 1.6 g/day. However, despite this dietary habit, the national protocol for treating hypertension, as well as common clinical practice, often fail to account for the low salt intake in Rwandan communities. Hypertensive patients are still frequently advised to reduce their salt intake, and in some cases, they are instructed to eliminate salt entirely.

Objectives
This study was designed to determine the association between salt restriction and hyponatremia in hypertensive patients.

Methods
A case-control study was conducted over a period of 6 months at two tertiary hospitals in Rwanda, with hyponatremia as the outcome variable and salt restriction as the exposure variable. Age, gender, and use of diuretics were matched between the case and control groups. Serum sodium concentrations were measured, and participants were then categorized into groups. Questionnaires were used for interviews.

Results
245 participants meeting the inclusion criteria were selected, with 110 (44.9%) classified as cases and 135 (55.1%) as controls. Among them, 159 (64.8%) participants were restricted from consuming salt, with 74 (46.5%) following a salt-free diet. The odds of developing hyponatremia were 9.90 (95% CI, p < 0.001) among salt-restricted participants.

Conclusion
There is a strong association between salt restriction and hyponatremia in hypertensive patients on treatment in this study.
Influence of clinical risk factors for preterm premature rupture of membranes (PPROM) on the elastic strength of fetal membranes at term: A prospective study
Authors: Robin Amaury , Tessier Doyen Nicolas , Ben Rhaiem Sami , Valette Nancy , Fermeaux Véronique , Preux Pierre-Marie , Martinez Sophie , Eyraud Jean-Luc , El Hamel Chahrazed , Riethmuller Didier , Coste Mazeau Perrine 
Published: December 2024

Introduction
Premature rupture of membranes (PROM) before 37 weeks of gestation is a common obstetrical event, whose pathophysiology is still poorly understood. Our objective was to study the mechanical strength of fetal membranes in women with a clinical risk factor for preterm premature rupture of membranes (PPROM).

Methods
We included, in a prospective, descriptive, single-center study, patients scheduled for cesarean section at term (≥ 37 weeks of gestation). For each patient, we performed uniaxial tensile tests on fetal membranes with a universal testing machine equipped with a force sensor (EZ20®, Lloyds), allowing the recording of an applied force/time curve. We collected maximum force (Fmax), maximum stress (σMax), and Young’s modulus of elasticity. The thickness of each membrane sample was also measured. We compared the values obtained according to certain clinical risk factors for PPROM such as age, body mass index, gravidity, parity, a history of PPROM or preterm birth, smoking, gestational diabetes, geographic origin, and socioeconomic level.

Results
We analyzed 31 patients and found no association between the studied risk factors and σMax. Fmax was lower in primiparous patients (p = 0.02) but increased with patient parity (p = 0.005). Gestational diabetes was associated with a higher Fmax (p = 0.033) and sub-Saharan geographical origin with a greater thickness (p = 0.0043). As membrane thickness increased, σMax (p = 0.009) and Young’s modulus decreased (p = 0.037).

Conclusion
Primiparous patients have lower membrane mechanical strength than patients who have had one or more deliveries. Mechanically, the thicker membranes are less rigid and less resistant.
Seamless trials in oncology: A cross-sectional analysis of characteristics and reporting
Authors: Klas Katarzyna , Strzebonska Karolina , Buedo Paola , Włodarczyk Alicja , Gordon Samuel , Kaszuba Paulina , Polak Maciej , Waligora Marcin 
Published: December 2024

Objectives
Seamless clinical trials have received much attention as a possible way to expedite drug development. The growing importance of seamless design can be seen in oncology research, especially in the early stages of drug development. Our objective is to examine the basic characteristics of seamless early-phase oncology trials registered on the ClinicalTrials.gov database and to determine their results reporting rates. We also aim to identify factors associated with results reporting.

Methods
Cross-sectional study. We defined seamless early-phase trials as either those registered as Phase 1/2 or Phase 1 with planned expansion cohort(s). Using the ClinicalTrials.gov registry, we searched for interventional cancer clinical trials with primary completion date (PCD) between 2016 and 2020. After trial selection, we performed manual data extraction based on the trial record description and the results posted in the trial registry. We used logistic regression to search for predictors of results reporting. Protocol: https://osf.io/m346x/.

Results
We included 1051 seamless early-phase oncology trials reported as completed (PCD) between 2016 and 2020. We provided descriptive statistics including the number of patients enrolled, study start date, primary completion date, funding, type of intervention, cancer type, design details, type of endpoints, recruitment regions, and number of trial sites. Overall, only 34.7% trials reported results on ClinicalTrials.gov. The results reporting rates for 24 months was 24.0%. The overall reporting rate for Phase 1/2 studies was over three times higher than for seamless Phase 1.

Conclusions
Our study provides cross-sectional data on seamless early-phase oncology trials registered on ClinicalTrials.gov. We highlight the challenges of the evolving clinical trial design landscape and the problem of missing results in the seamless design context, which raises serious ethical concerns. Efforts should be made to adapt the functionality of the ClinicalTrials.gov database to emerging clinical trial models.
Acute adverse reactions after multiple initially well-tolerated gadolinium-based contrast-enhanced abdomen MRIs in pediatric patients
Authors: Hojreh Azadeh , Mulabdic Amra , Heilos Andreas , Peyrl Andreas , Lampichler Katharina , Raudner Marcus , Tamandl Dietmar , Ba-Ssalamah Ahmed , Szepfalusi Zsolt 
Published: December 2024

Purpose
Repeated gadolinium-based contrast agent (GBCA)-enhanced MRIs are crucial in the diagnosis and follow-up of oncologic and chronic disorders in pediatric patients. The aim of the study was to evaluate the frequency and severity of adverse reactions to GBCAs in children after a single vs. multiple GBCA-enhanced abdomen MRIs.

Material and methods
All pediatric patients with at least one GBCA-enhanced abdominal MRI between 2009 and 2020 were retrospectively evaluated based on adverse reactions reports, according to the classification system of the American College of Radiology and guidelines on contrast agents of the European Society of Urogenital Radiology. A Student´s t-test analysis, a spearman ρ-correlation and a Chi-square test between the reported adverse reactions and the total number of GBCA applications, and the number of each applied GBCA was calculated. A p-value <0.05 was considered significant.

Results
Of 623 patients with 964 GBCA-enhanced abdomen MRIs, there were 464 patients with only one and 159 patients with multiple GBCA administrations. Of 964 GBCA doses administrated, two cases with urticaria (mild allergy-like adverse reaction) and one case with vomiting (mild chemotoxic adverse reaction) were recorded (3/964 = 0.31%), but all the reports were in patients with multiple GBCA administration (3/159 = 1.89%). No adverse reactions in patients with a single GBCA administration were observed. The reported adverse reactions correlated significantly with the total number of GBCAs (p<0.001) and the number of each GBCA (p<0.001 or p = 0.002). The independent two-tailed t-tests, and the chi-square test were significant (p<0.001, p = 0.003).

Conclusion
GBCA-associated adverse reactions are rare and mostly mild, but initially well-tolerated GBCA could cause adverse reactions due to the increase likelihood of drug hypersensitivity upon repeated GBCA exposure.
Are managers of emerging markets more opportunistic? application of Benford’s Law
Authors: Hassan Shoaib , Aksar Muhammad , Ahmad Maqbool , Kajanova Jana 
Published: December 2024

Purpose
The current research analyzes cosmetic earnings management practices in emerging and developed markets before and after the global financial crisis.

Design/Methodology/Approach
Using digital analysis, by applying Benford’s Law the study analyzes the earnings adjustments that exceed a key reference point to determine whether earnings management anomaly exists or not? Based on a sample of 87165 firm-year observations of UK, US, Brazil, Russia, India, China and Pakistan listed corporations.

Findings
Findings show that the managers of emerging markets have more incentive to manipulate earnings than their counterparts from developed markets. Further, the implementation of strict governance and legislative measures after the global financial crisis have significantly reduced the opportunistic behaviour of managers to manipulate earnings. However, the impact is lesser in emerging markets as compared to UK and US.

Research implications
The empirical findings of this research are useful for policy making and regulatory authorities, investors and other stakeholders as our findings shed light on the restriction of cosmetic earnings management practices.

Originality/Value
First study that tried to capture the cosmetic earnings management practices in both emerging and developed countries and in both pre and post financial crisis scenario.
Contrast vector imaging for differential diagnosis of focal liver lesions: Analysis of tumoral vascular structures and flow characteristics
Authors: Yoo Jeongin , Lee Jeong Min , Joo Ijin , Yoon Jeong Hee 
Published: December 2024

Purpose
To assess the efficacy of contrast vector imaging (CVI) in detecting tumoral vascular structures and flow characteristics of focal liver lesions (FLLs) for differential diagnosis.

Materials and methods
In this prospective study, 65 participants with FLLs underwent CEUS using SonoVue with high-frame-rate imaging technique between July 2019 and October 2020. CVI was obtained by post-processing arterial cine imaging of CEUS. Tumoral vascular structures, velocity histogram, and mean velocities were compared among hepatocellular carcinoma (HCC), non-HCC malignancies, and benign tumors using the Chi-square and Kruskal-Wallis tests, respectively. The areas under the receiver operating characteristic curve (AUC) of CEUS in determining HCC probability was compared to that of CEUS with CVI using a z-test.

Results
CVI was technically successful in 52 of 65 (80%) participants (19 HCCs, 13 non-HCC malignancies, and 20 benign tumors). The detectability of tumoral vascular structures was significantly higher in CEUS with CVI, compared to CEUS alone (46.2% [24/52] vs. 100.0% [52/52], p<0.001). On CEUS with CVI, complex intratumoral and peripheral vessels were frequent in HCCs (100% of HCCs, 46.2% of non-HCC malignancies, and 70.0% of benign tumors), while detour vessels were frequent in non-HCC malignancies (none of HCCs, 53.8% of non-HCC malignancies, and 10.0% of benign tumors) (p<0.001). The mean velocity of HCC (26.3 mm/s) was the highest, while that of non-HCC malignancy (20.6 mm/s) was the lowest (p<0.001). CEUS with CVI showed higher AUC, compared to CEUS in both reviewers (0.851 vs. 0.963, p = 0.005 for reviewer 1; 0.853 vs. 0.982, p = 0.023 for reviewer 2).

Conclusion
CEUS with CVI better visualized vascular structures and flow characteristics of FLLs, and showed better diagnostic performance in determining HCC probability than CEUS.
Unlocking the clinical potential of paired inspiratory and expiratory CT scans in the differential diagnosis of cystic lung diseases: A systematic review
Authors: Pinheiro Lucas Gabriel R. , Treviso Carlos Augusto , Forte Gabriele Carra , Muller Enrico Mattana , Hochhegger Bruno , Andrade Rubens Gabriel Feijó 
Published: December 2024

Introduction
Currently, high-resolution computed tomography (HRCT) is the imaging of choice for the differential diagnosis of various cystic lung lesions, including true cystic lung diseases (CLD) and lesions that may mimic them. However, the traditionally used inspiratory scan still presents a significant spectrum of overlapping radiological features. Recent studies have demonstrated variation in lesion size between inspiratory and expiratory phases, probably due to cyst-airway communication. In this study, we aimed to conduct a systematic review of paired inspiratory and expiratory HRCT in the assessment of cystic lesions as an additional tool to narrow the differential diagnosis.

Methods
A systematic search was performed in PubMed, Scopus, EMBASE, BVS, and Cochrane through August 2023. Full-text articles that performed paired inspiratory and expiratory CT scans in adult patients with cystic lung lesions were included, with the outcome measured as the reduction in lesion size according to the respiratory phase. Diagnoses were confirmed through histopathological or radiological features.

Results
Out of the 96 records, three studies met the criteria for inclusion and were analyzed, comprising a total of 149 participants and 513 cystic lesions. Pulmonary Langerhans Cell Histiocytosis (PLCH), Lymphangioleiomyomatosis (LAM) honeycombing and cystic bronchiectasis became considerably smaller during expiratory CT scans, while the size of emphysema tended to remain constant during respiratory cycles.

Conclusions
This study has suggested that paired inspiratory and expiratory CT scans can be valuable for helping differentiate between emphysema and other diseases with a cystic pattern due to their ability to reveal dynamic properties of the lesions. However, the average reduction in cyst size as a single parameter is not sufficient for further refining diagnostics. Studies exploring advanced metrics to assess the reduction in lesion diameter emerge as potential opportunities to investigate the cyst-airway communication hypothesis and further enhance the diagnostic accuracy of paired methods.