bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term follow-up of children exposed in-utero to progesterone treatment for prevention of preterm birth: study protocol of the AMPHIA follow-up
Authors: Simons Noor E , van Limburg Stirum Emilie V J , van Wassenaer-Leemhuis Aleid G , Finken Martijn J J , Aarnoudse-Moens Cornelieke S H , Oosterlaan Jaap , van Baar Anneloes , Roseboom Tessa J , Lim Arianne C , van Wely Madelon , de Boer Marjon A , Painter Rebecca C , Pajkrt Eva , Oudijk Martijn A , van t Hooft Janneke 
Published: September 2021

IntroductionPreterm birth is one of the main problems in obstetrics, and the most important cause of neonatal mortality, morbidity and neurodevelopmental impairment. Multiple gestation is an important risk factor for preterm birth, with up to 50% delivering before 37 weeks. Progesterone has a role in maintaining pregnancy and is frequently prescribed to prevent (recurrent) preterm birth and improve pregnancy outcomes in high-risk patients. However, little is known about its long-term effects in multiple gestations. The objective of this follow-up study is to assess long-term benefits and harms of prenatal exposure to progesterone treatment in multiple gestations on child development.Methods and analysisThis is a follow-up study of a multicentre, double-blind, placebo-controlled randomised trial (AMPHIA trial,ISRCTN40512715). Between 2006 and 2009 women with a multiple gestation were randomised at 16–20 weeks of gestation to weekly injections 250 mg 17α-hydroxyprogesterone caproate or placebo, until 36 weeks of gestation or delivery. The current long-term follow-up will assess all children (n=1355) born to mothers who participated in the AMPHIA trial, at 11–14 years of age, with internationally validated questionnaires, completed by themselves, their parents and their teachers.Main outcomes are child cognition and behaviourAdditional outcomes are death (perinatal and up to age 14), gender identity, educational performance and health-related problems. We will use intention-to-treat analyses comparing experimental and placebo group. To adjust for the correlation between twins, general linear mixed-effects models will be used.Ethics and disseminationAmsterdam UMC MEC provided a waiver for the Medical Research Involving Human Subjects Act (W20_234#20.268). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders, patients and participants. This protocol is published before analysis of the results.Trial registration numberNL8933.
Efficacy of clarithromycin in patients with mild COVID-19 pneumonia not receiving oxygen administration: protocol for an exploratory, multicentre, open-label, randomised controlled trial (CAME COVID-19 study)
Authors: Yamamoto Kazuko , Hosogaya Naoki , Sakamoto Noriho , Yoshida Haruo , Ishii Hiroshi , Yatera Kazuhiro , Izumikawa Koichi , Yanagihara Katsunori , Mukae Hiroshi 
Published: September 2021

IntroductionThe COVID-19 pandemic has emerged worldwide. Although several medications have been approved for treating moderate-to-severe COVID-19, very few treatment strategy has been established for patients with mild COVID-19 who do not require oxygen administration. Clarithromycin is a macrolide antimicrobial agent that has been widely used for bacterial respiratory infectious diseases. Clarithromycin also acts an immunomodulating drug and suppresses cytokine storms in viral respiratory diseases, including influenza. In this study, we aim to evaluate the efficacy of clarithromycin in patients with mild COVID-19.Methods and analysisThis is an exploratory, multicentre, open-label, randomised controlled trial. This study was initiated in May 2021 and will end in July 2022. Patients with mild COVID-19 pneumonia who do not require oxygen administration will be enrolled and randomly assigned in a 1:1:1 ratio to group A (administration of clarithromycin 800 mg/day), group B (administration of clarithromycin 400 mg/day) or group C (standard treatment without clarithromycin). The planned number of enrolled patients is 60 (20 patients × three groups). The primary endpoint is the number of days required to improve the clinical symptoms as measured by the severity score. Secondary endpoints include days for recovery of the body temperature, proportion of patients with oxygen administration, inflammatory cytokines, viral load, serum immunoglobulins, peripheral blood lymphocytes, blood biomarkers and pneumonia infiltrations.Ethics and disseminationThe study protocol was approved by the Clinical Research Review Board of Nagasaki University in accordance with the Clinical Trials Act in Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act and other current legal regulations in Japan. Written informed consent will be obtained from all the participants. The results of this study will be reported as journal publications.Trial registration numberjRCTs071210011.
Effectiveness of balance training in patients with chronic ankle instability: protocol for a systematic review and meta-analysis
Authors: Wang Ju , Zhang Di , Zhao Tianyu , Ma Jiang , Jin Song 
Published: September 2021

IntroductionLateral ankle sprains are one of the most common musculoskeletal injuries. Up to 70% of individuals who sustain lateral ankle sprains develop chronic ankle instability (CAI). Balance training has been used in patients with CAI, but the evidence for its efficacy is inconsistent. This systematic review and meta-analysis aims to determine the short-term (end of the treatment period) and long-term (6 months after treatment) effectiveness of balance training for patients with CAI.Methods and analysisWe will search PubMed, EMBASE, the Cochrane Library, Ovid, EBSCO-host, Pedro, ClinicalKey, ScienceDirect, Springer, China National Knowledge Infrastructure, Technology Periodical Database (VIP), WanFang Data and China Biology Medicine for reports of randomised trials of balance training in patients with CAI, from inception to 1 October 2021. The language will be restricted to English and Chinese, and articles will be screened and collected by two reviewers independently. Dynamic balance and functional ankle instability are the primary outcomes of this study. Secondary outcomes include pain, ankle range of motion, ankle strength and health-related quality of life. Review Manager V.5.3 software will be used for meta-analysis, and stratification analysis will be conducted for study quality according to the Jadad score. Subgroup and sensitivity analyses will be conducted. Grading of Recommendations, Assessment, Development and Evaluation will be used to assess confidence in the cumulative evidence. The protocol follows the Cochrane Handbook for Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines.Ethics and disseminationEthical approval is not required for literature-based studies. The results will be disseminated through peer-reviewed publications.
Listen, look, link and learn: a stepwise approach to use narrative quality data within resident-family-nursing staff triads in nursing homes for quality improvements
Authors: Sion Katya Y J , Rutten Johanna E R , Hamers Jan P H , de Vries Erica , Zwakhalen Sandra M G , Odekerken-Schröder Gaby , Schols Jos M G A , Verbeek Hilde 
Published: September 2021

PurposeThe use of qualitative data to assess quality of care in nursing homes from the resident’s perspective has shown to be valuable, yet more research is needed to determine how this data can be used to gain insight into the quality of care within nursing homes. Whereas it is crucial to stay close to the stories that are the strength of qualitative data, an intermittent step to classify this data can support the interpretation and use. Therefore, this study introduces an approach that enables the use of narrative quality of care data to learn from and improve with.DesignA cross-sectional mixed-methods study in which qualitative data were collected with the narrative quality assessment method Connecting Conversations and interpreted for analysis.MethodsConnecting Conversations was used to collect narrative data about experienced quality of care in nursing homes according to residents, their families and nursing staff (triads). Data analysis consisted of coding positive/negative valences in each transcript.FindingsA stepwise approach can support the use of narrative quality data consisting of four steps: (1) perform and transcribe the conversations (listen); (2) calculate a valence sore, defined as the mean %-positive within a triad (look); (3) calculate an agreement score, defined as the level of agreement between resident-family-nursing staff (link); and (4) plot scores into a graph for interpretation and learning purposes with agreement score (x-axis) and valence score (y-axis) (learn).ConclusionsNarrative quality data can be interpreted as a valence and agreement score. These scores need to be related to the raw qualitative data to gain a rich understanding of what is going well and what needs to be improved.
Severity of SARS-CoV-2 infection and albumin levels recorded at the first emergency department evaluation: a multicentre retrospective observational study
Authors: Turcato Gianni , Zaboli Arian , Kostic Irena , Melchioretto Barbara , Ciccariello Laura , Zaccaria Eleonora , Olivato Alessia , Maccagnani Antonio , Pfeifer Norbert , Bonora Antonio 
Published: September 2021

BackgroundThe aim of this study was to investigate the association between serum albumin levels in the ED and the severity of SARS-CoV-2 infection.MethodsThis is a retrospective observational study conducted from 15 March 2020 to 5 April 2020 at the EDs of three different hospitals in Italy. Data from 296 patients suffering from COVID-19 consecutively evaluated at EDs at which serum albumin levels were routinely measured on patients’ arrival in the ED were analysed. Albumin levels were measured, and whether these levels were associated with the presence of severe SARS-CoV-2 infection or 30-day survival was determined. Generalised estimating equation models were used to assess the relationship between albumin and study outcomes, and restricted cubic spline (RCS) regression was used to plot the adjusted dose-effect relationship for possible clinical confounding factors.ResultsThe mean albumin level recorded on entry was lower in patients with severe SARS-CoV-2 infection than in those whose infections were not severe (3.5 g/dL (SD 0.3) vs 4 g/dL (SD 0.5)) and in patients who had died at 30 days post-ED arrival compared with those who were alive at this time point (3.3 g/dL (SD 0.3) vs 3.8 g/dL (SD 0.4)). Albumin <3.5 g/dL was an independent risk factor for both severe infection and death at 30 days, with adjusted odd ratios of 2.924 (1.509–5.664) and 2.615 (1.131–6.051), respectively. RCS analysis indicated that there was an adjusted dose–response association between the albumin values recorded on ED and the risk of severe infection and death.ConclusionAlbumin levels measured on presentation to the ED may identify patients with SARS-CoV-2 infection in whom inflammatory processes are occurring and serve as a potentially useful marker of disease severity and prognosis.
Background modeling for dark matter search with 1.7 years of COSINE-100 data
Authors: Adhikari G. , de Souza E. Barbosa , Carlin N. , Choi J. J. , Choi S. , Djamal M. , Ezeribe A. C. , França L. E. , Ha C. , Hahn I. S. , Jeon E. J. , Jo J. H. , Joo H. W. , Kang W. G. , Kauer M. , Kim H. , Kim H. J. , Kim K. W. , Kim S. H. , Kim S. K. , Kim W. K. , Kim Y. D. , Kim Y. H. , Ko Y. J. , Lee E. K. , Lee H. , Lee H. S. , Lee H. Y. , Lee I. S. , Lee J. , Lee J. Y. , Lee M. H. , Lee S. H. , Lee S. M. , Leonard D. S. , Lynch W. A. , Manzato B. B. , Maruyama R. H. , Neal R. J. , Olsen S. L. , Park B. J. , Park H. K. , Park H. S. , Park K. S. , Pitta R. L. C. , Prihtiadi H. , Ra S. J. , Rott C. , Shin K. A. , Scarff A. , Spooner N. J. C. , Thompson W. G. , Yang L. , Yu G. H. ,   COSINE-100 Collaboration
Published: September 2021

AbstractWe present a background model for dark matter searches using an array of NaI(Tl) crystals in the COSINE-100 experiment that is located in the Yangyang underground laboratory. The model includes background contributions from both internal and external sources, including cosmogenic radionuclides and surface $$^{210}$$

210

Pb contamination. To build the model in the low energy region, with a threshold of 1 keV, we used a depth profile of $$^{210}$$

210

Pb contamination in the surface of the NaI(Tl) crystals determined in a comparison between measured and simulated spectra. We also considered the effect of the energy scale errors propagated from the statistical uncertainties and the nonlinear detector response at low energies. The 1.7 years COSINE-100 data taken between October 21, 2016 and July 18, 2018 were used for this analysis. Our Monte Carlo simulation provides a non-Gaussian peak around 50 keV originating from beta decays of bulk $$^{210}$$

210

Pb in a good agreement with the measured background. This model estimates that the activities of bulk $$^{210}$$

210

Pb and $$^{3}$$

3

H are dominating the background rate that amounts to an average level of $$2.85\pm 0.15$$

2.85
±
0.15

counts/day/keV/kg in the energy region of (1–6) keV, using COSINE-100 data with a total exposure of 97.7 kg$$\cdot $$
·
years.
Magnetized Reissner–Nordstrom–Taub–NUT spacetime and microscopic entropy
Authors: Siahaan Haryanto M. 
Published: September 2021

AbstractWe present a novel solution describing magnetized spacetime outside an electrically charged massive object equipped with NUT parameter. To get the solution, we employ the Ernst magnetization to the Reissner–Nordstrom–Taub–NUT spacetime as the seed. After discussing some physical aspects of the spacetime, we show that the extremal entropy of a magnetized Reissner–Nordstrom–Taub–NUT black hole can be reproduced by using the Cardy formula.
Accretion disk around a Schwarzschild black hole in asymptotic safety
Authors: Zuluaga Fabián H. , Sánchez Luis A. 
Published: September 2021

AbstractWe study quantum gravity effects on radiation properties of thin accretion disks around a renormalization group improved (RGI-) Schwarzschild black hole. In the infrared (IR) limit of the asymptotically safe theory with higher derivatives, the running Newton couplingG(r) depends on a free parameter which encodes the quantum effects on the spacetime geometry. By varying this parameter, modifications to thermal properties of the disk as the time averaged energy flux, the disk temperature, the differential luminosity, and the conversion efficiency of accreting mass into radiation, are obtained. In addition to a shifting of the radius of the innermost stable circular orbit (ISCO) toward small values, we find an increase of the maximum values of these thermal properties and a greater efficiency than in the classical relativistic regime. We discuss astrophysical applications of these results by using observational data of the stellar-mass black hole candidate LMC X-3. Our findings could, in principle, be used to identify quantum gravity effects through astrophysical observations.
Hysteretic dipolar and quadrupolar properties of the spin-1 Blume–Emery–Griffiths model under pair approximation
Authors: Özüm Songül , Erdem Rıza , Yalçın Orhan , Görgülüer Ömer 
Published: September 2021

As a continuation of previously published work [A. Erdinç and M. Keskin, Int. J. Mod. Phys. B 18, 1603 (2004), doi:10.1142/S0217979204024823] the hysteretic properties of magnetization ([Formula: see text]) and quadrupolar moment ([Formula: see text] have been investigated for the spin-1 Blume–Emery–Griffiths model using pair approximation. The magnetic field ([Formula: see text]) dependence of [Formula: see text] is produced for different values of the lattice coordination number ([Formula: see text]), biquadratic interaction ([Formula: see text]) and single-ion anisotropy ([Formula: see text]). The ([Formula: see text]) loops show different and novelty properties when [Formula: see text]. We also observed the hysteresis cycles in the ([Formula: see text], ([Formula: see text] and ([Formula: see text]) planes. These curves strongly depend on biquadratic interaction [Formula: see text]. Our results are found to be in good agreement with the other theoretical findings.
A BRCA1 Coiled-Coil Domain Variant Disrupting PALB2 Interaction Promotes the Development of Mammary Tumors and Confers a Targetable Defect in Homologous Recombination Repair
Authors: Pulver Emilia M. , Mukherjee Chirantani , van de Kamp Gerarda , Roobol Stefan J. , Rother Magdalena B. , van der Gulden Hanneke , de Bruijn Roebi , Lattanzio Maria Valeria , van der Burg Eline , Drenth Anne Paulien , Verkaik Nicole S. , Hahn Kerstin , Klarenbeek Sjoerd , de Korte-Grimmerink Renske , van de Ven Marieke , Pritchard Colin E.J. , Huijbers Ivo J. , Xia Bing , van Gent Dik C. , Essers Jeroen , van Attikum Haico , Ray Chaudhuri Arnab , Bouwman Peter , Jonkers Jos 
Published: September 2021

Abstract

The BRCA1 tumor suppressor gene encodes a multidomain protein for which several functions have been described. These include a key role in homologous recombination repair (HRR) of DNA double-strand breaks, which is shared with two other high-risk hereditary breast cancer suppressors, BRCA2 and PALB2. Although both BRCA1 and BRCA2 interact with PALB2, BRCA1 missense variants affecting its PALB2-interacting coiled-coil domain are considered variants of uncertain clinical significance (VUS). Using genetically engineered mice, we show here that a BRCA1 coiled-coil domain VUS, Brca1 p.L1363P, disrupts the interaction with PALB2 and leads to embryonic lethality. Brca1 p.L1363P led to a similar acceleration in the development of Trp53-deficient mammary tumors as Brca1 loss, but the tumors showed distinct histopathologic features, with more stable DNA copy number profiles in Brca1 p.L1363P tumors. Nevertheless, Brca1 p.L1363P mammary tumors were HRR incompetent and responsive to cisplatin and PARP inhibition. Overall, these results provide the first direct evidence that a BRCA1 missense variant outside of the RING and BRCT domains increases the risk of breast cancer.

Significance:
These findings reveal the importance of a patient-derived BRCA1 coiled-coil domain sequence variant in embryonic development, mammary tumor suppression, and therapy response.
See related commentary by Mishra et al., p. 6080
Targeting the IRE1α/XBP1 Endoplasmic Reticulum Stress Response Pathway in ARID1A-Mutant Ovarian Cancers
Authors: Zundell Joseph A. , Fukumoto Takeshi , Lin Jianhuang , Fatkhudinov Nail , Nacarelli Timothy , Kossenkov Andrew V. , Liu Qin , Cassel Joel , Hu Chih-Chi Andrew , Wu Shuai , Zhang Rugang 
Published: September 2021

Abstract

The SWI/SNF chromatin-remodeling complex is frequently altered in human cancers. For example, the SWI/SNF component ARID1A is mutated in more than 50% of ovarian clear cell carcinomas (OCCC), for which effective treatments are lacking. Here, we report that ARID1A transcriptionally represses the IRE1α–XBP1 axis of the endoplasmic reticulum (ER) stress response, which confers sensitivity to inhibition of the IRE1α–XBP1 pathway in ARID1A-mutant OCCC. ARID1A mutational status correlated with response to inhibition of the IRE1α–XBP1 pathway. In a conditional Arid1aflox/flox/Pik3caH1047R genetic mouse model, Xbp1 knockout significantly improved survival of mice bearing OCCCs. Furthermore, the IRE1α inhibitor B-I09 suppressed the growth of ARID1A-inactivated OCCCs in vivo in orthotopic xenograft, patient-derived xenograft, and the genetic mouse models. Finally, B-I09 synergized with inhibition of HDAC6, a known regulator of the ER stress response, in suppressing the growth of ARID1A-inactivated OCCCs. These studies define the IRE1α−XBP1 axis of the ER stress response as a targetable vulnerability for ARID1A-mutant OCCCs, revealing a promising therapeutic approach for treating ARID1A-mutant ovarian cancers.

Significance:
These findings indicate that pharmacological inhibition of the IRE1α–XBP1 pathway alone or in combination with HDAC6 inhibition represents an urgently needed therapeutic strategy for ARID1A-mutant ovarian cancers.
Mode of Delivery, Birth Characteristics, and Early-Onset Non-Hodgkin Lymphoma in a Population-Based Case–Control Study
Authors: Dwyer Kayla E. , Wang Rong , Cozen Wendy , Cartmel Brenda , Wiemels Joseph L. , Morimoto Libby M. , Metayer Catherine , Ma Xiaomei 
Published: September 2021

Abstract

Background:
The etiology of non-Hodgkin lymphoma (NHL) in children and in adolescents and young adults (AYA) is not well understood.

Methods:
We evaluated potential associations between mode of delivery, birth characteristics, and NHL risk in a population-based case–control study, which included 3,064 cases of NHL [490 with Burkitt lymphoma, 981 with diffuse large B-cell lymphoma (DLBCL), and 978 with T-cell NHL) diagnosed at the age of 0 to 37 years in California during 1988 to 2015 and 153,200 controls frequency matched on year of birth. Odds ratios (OR) and 95% confidence intervals (CI) were estimated from an unconditional multivariable logistic regression model that included year of birth and birth characteristics.

Results:
Individuals born via cesarean section had a decreased risk of pediatric Burkitt lymphoma (age 0–14 years; OR = 0.71, 95% CI: 0.51–0.99) and pediatric T-cell NHL (OR = 0.73, 95% CI: 0.55–0.97) compared with those born vaginally. Having a birth order of second (OR = 0.73, 95% CI: 0.57–0.93) or third or higher (OR = 0.76, 95% CI: 0.58–0.99) was associated with a lower risk of pediatric T-cell NHL compared with first-borns. AYA (age 15–37 years) with a heavier birthweight had an elevated risk of DLBCL (OR for each kg = 1.16, 95% CI: 1.00–1.35). Associations between other birth characteristics, including plurality, maternal age, maternal education, and NHL risk, also exhibited variations across subgroups based on age of diagnosis and histologic subtype.

Conclusions:
These findings support a role of mode of delivery and birth characteristics in the etiology of early-onset NHL.

Impact:
This study underscores the etiologic heterogeneity of early-onset NHL.
Generalizability and Transportability of the National Lung Screening Trial Data: Extending Trial Results to Different Populations
Authors: Inoue Kosuke , Hsu William , Arah Onyebuchi A. , Prosper Ashley E. , Aberle Denise R. , Bui Alex A.T. 
Published: September 2021

Abstract

Background:
Randomized controlled trials (RCT) play a central role in evidence-based healthcare. However, the clinical and policy implications of implementing RCTs in clinical practice are difficult to predict as the studied population is often different from the target population where results are being applied. This study illustrates the concepts of generalizability and transportability, demonstrating their utility in interpreting results from the National Lung Screening Trial (NLST).

Methods:
Using inverse-odds weighting, we demonstrate how generalizability and transportability techniques can be used to extrapolate treatment effect from (i) a subset of NLST to the entire NLST population and from (ii) the entire NLST to different target populations.

Results:
Our generalizability analysis revealed that lung cancer mortality reduction by LDCT screening across the entire NLST [16% (95% confidence interval [CI]: 4–24)] could have been estimated using a smaller subset of NLST participants. Using transportability analysis, we showed that populations with a higher prevalence of females and current smokers had a greater reduction in lung cancer mortality with LDCT screening [e.g., 27% (95% CI, 11–37) for the population with 80% females and 80% current smokers] than those with lower prevalence of females and current smokers.

Conclusions:
This article illustrates how generalizability and transportability methods extend estimation of RCTs' utility beyond trial participants, to external populations of interest, including those that more closely mirror real-world populations.

Impact:
Generalizability and transportability approaches can be used to quantify treatment effects for populations of interest, which may be used to design future trials or adjust lung cancer screening eligibility criteria.