Publications by authors named "Paules C"

Background: Low blood absolute lymphocyte count (ALC) may predict severe COVID-19 outcomes. Knowledge gaps remain regarding the relationship of ALC trajectory with clinical outcomes and factors associated with lymphopenia.

Methods: Our post hoc analysis of the Therapeutics for Inpatients with COVID-19 platform trial utilized proportional hazards models to assess relationships between Day (D) 0 lymphopenia (ALC < 0.

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Introduction: Suspected preterm labour (SPL) is an obstetric complication that occurs in 9% of all pregnancies and is the leading cause of antenatal hospital admissions. More than half of women with SPL deliver a premature baby which is a known risk factor for developing cardiovascular and metabolic disorders in childhood and later in adult life. On the other hand, the other half of these women will deliver at term, labelled as 'false preterm labour'.

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Management of suspected large for gestational age (LGA) fetuses remains unclear because ultrasound-estimated fetal weight (EFW) is not accurate. This was a systematic review of observational studies on fetal soft tissues measurements used alone or in combination to create a new EFW formula, to improve the screening for LGA fetuses. Studies were scored using a predefined set of independently agreed methodological criteria and an overall quality score was assigned for study design, statistical analysis, and reporting methods.

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Article Synopsis
  • The study investigates how infection rates, particularly during the COVID-19 pandemic, may relate to sudden unexpected infant death (SUID) and sudden infant death syndrome (SIDS), comparing data from before and during the pandemic.
  • It utilizes mortality data from the CDC between 2018 and 2021, focusing on cases classified under specific codes related to SUID and SIDS, to analyze monthly variations in death rates.
  • Findings reveal a significant increase in SUID risk during the pandemic period, especially beginning July 2020, indicating a notable shift in epidemiological patterns compared to the prepandemic baseline.
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Introduction: We investigated whether structured maternal lifestyle interventions based on Mediterranean diet or stress reduction influence fetal-infant neurodevelopment detected by detailed fetal neurosonography and Ages and Stages Questionnaires 3rd edition (ASQ) at 12 months old.

Methods: This was a secondary analysis of a randomized clinical trial (2017-2020), including 1,221 singleton pregnancies at high risk for small-for-gestational age. Participants were randomized into three groups at 19-23 weeks' gestation: Mediterranean diet intervention, stress reduction program, or usual care.

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Background: Tixagevimab-cilgavimab is a combination of 2 mAbs against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In December 2021, the Food and Drug Administration issued Emergency Use Authorization for intramuscular injection of tixagevimab-cilgavimab for prophylaxis against SARS-CoV-2 in immunocompromised patients. Shortly thereafter, our clinic distributed tixagevimab-cilgavimab to patients with common variable immunodeficiency.

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Introduction: The IMPACT BCN trial-a parallel-group randomized clinical trial where 1221 pregnant women at high risk for small-for-gestational age (SGA) newborns were randomly allocated at 19- to 23-week gestation into three groups: Mediterranean diet, Mindfulness-based Stress reduction or non-intervention-has demonstrated a positive effect of Mediterranean diet and Stress reduction in the prevention of SGA. However, the mechanism of action of these interventions remains still unclear. The aim of this study is to investigate the effect of Mediterranean diet and Stress reduction on placental volume and perfusion.

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Primary graft failure (PGF) and multi-lineage cytopenia (MLC) increase the risk of nonrelapse mortality in allogeneic hematopoietic cell transplants (HCT). We evaluated the impact of post-transplant cyclophosphamide (PTCy) and splenomegaly on PGF and MLC for hematological malignancies. This study included patients with PTCy (N=84) and conventional graft-vs.

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Background: Although antivirals remain important for the treatment COVID-19, methods to assess treatment efficacy are lacking. Here, we investigated the impact of remdesivir on viral dynamics and their contribution to understanding antiviral efficacy in the multicenter Adaptive COVID-19 Treatment Trial 1, which randomized patients to remdesivir or placebo.

Methods: Longitudinal specimens collected during hospitalization from a substudy of 642 patients with COVID-19 were measured for viral RNA (upper respiratory tract and plasma), viral nucleocapsid antigen (serum), and host immunologic markers.

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Article Synopsis
  • The study investigates the effectiveness of the immunomodulator baricitinib when combined with remdesivir for hospitalized COVID-19 patients, focusing on those identified as high-risk based on specific blood count metrics.
  • In the high-risk group, the combination therapy showed significant benefits, including a lower risk of death, reduced likelihood of needing invasive ventilation, and improved recovery rates compared to the placebo group.
  • The findings suggest that baricitinib+remdesivir can enhance treatment outcomes for high-risk COVID-19 patients, although it is noted that the analysis is based on data prior to the emergence of newer SARS-CoV-2 variants.
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Background: Bacterial prophylaxis with a fluoroquinolone (FQ) during autologous stem cell transplant (ASCT) is common, although not standardized among transplant centers. The addition of doxycycline (doxy) to FQ prophylaxis was previously linked to reduced neutropenic fever and bacteremia in multiple myeloma (MM) patients undergoing ASCT although several confounders were present. We compared the incidence of neutropenic fever and bacteremia between MM patients variably receiving prophylaxis with FQ alone and FQ-doxy during ASCT.

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Objective: Little is known about deployment of SARS-CoV-2-neutralizing monoclonal antibodies (mab) in skilled nursing facilities (SNFs), a high-risk population for COVID-19-related complications. We assessed the utilization of mabs in SNFs and identified facility characteristics associated with effective use.

Design: Retrospective cohort study assessing the correlation of SNF characteristics with increasing mab use.

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Background: Maternal suboptimal nutrition and high stress levels are associated with adverse fetal and infant neurodevelopment.

Objective: This study aimed to investigate if structured lifestyle interventions involving a Mediterranean diet or mindfulness-based stress reduction during pregnancy are associated with differences in fetal and neonatal brain development.

Study Design: This was a secondary analysis of the randomized clinical trial Improving Mothers for a Better Prenatal Care Trial Barcelona that was conducted in Barcelona, Spain, from 2017 to 2020.

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Article Synopsis
  • * Out of 104 placentas examined, SARS-CoV-2 was found only in samples from the Pre-VOC group, with no detections in the VOC group, indicating a significant decrease in placental infection rates with the emergence of VOCs.
  • * Furthermore, complications like preterm birth and hypertensive disorders were more common in the Pre-VOC group, while vaccination status did not show a notable impact on outcomes among women with VOC infections.
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Fetal growth restriction (FGR) affects 5-10% of pregnancies, is the largest contributor to fetal death, and can have long-term consequences for the child. Implementation of a standard clinical classification system is hampered by the multiphenotypic spectrum of small fetuses with substantial differences in perinatal risks. Machine learning and multiomics data can potentially revolutionize clinical decision-making in FGR by identifying new phenotypes.

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Background And Aims: The dietary pattern followed during pregnancy, specifically healthy dietary patterns such as the Mediterranean diet, is a key factor in the mother's and the offspring's health. Pregnant women dietary intake is not enough to cover the micronutrient requirements of pregnancy, and higher adherence to the Mediterranean diet may improve dietary quality and nutritional density. The aim of the present study was to describe the dietary nutrient intake and diet quality during pregnancy and to evaluate whether a high adherence to Mediterranean diet was associated with a more adequate intake of micronutrients.

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Importance: Maternal suboptimal nutrition and high stress levels are associated with adverse fetal and childhood neurodevelopment.

Objective: To test the hypothesis that structured interventions based on a Mediterranean diet or mindfulness-based stress reduction (MBSR) during pregnancy improve child neurodevelopment at age 2 years.

Design, Setting, And Participants: This was a prespecified analysis of the parallel-group Improving Mothers for a Better Prenatal Care Trial Barcelona (IMPACT BCN) randomized clinical trial, which was conducted at a university hospital in Barcelona, Spain, from February 2017 to March 2020.

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Article Synopsis
  • Clinical trials during infectious disease outbreaks like COVID-19 often face challenges in quickly enrolling a representative study population, which can impact treatment identification against morbidity and mortality.
  • The study assessed participant demographics in the Adaptive COVID-19 Treatment Trial (ACTT) by comparing enrolled data against COVID-19 surveillance networks and US Census information, focusing on sex, race, ethnicity, and age.
  • Results showed that while ACTT's demographic makeup somewhat aligned with COVID-NET data, it highlighted discrepancies such as a lower proportion of females enrolled compared to reference datasets, indicating that using surveillance data is more relevant than census data in understanding the affected population.
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Article Synopsis
  • A secondary analysis of the ACTT-2 trial found that baricitinib significantly reduced secondary infections by 50%.
  • This reduction was observed even after considering various patient characteristics before and after randomization.
  • The results highlight a new benefit of baricitinib and reinforce its safety as a treatment option for COVID-19.
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Background: Nursing homes were ill-equipped for the pandemic; though facilities are required to have infection control staff, only 3% have taken a basic infection control course. Little is known about the implementation of effective practices outside of the acute care setting. We proposed an intervention utilizing Project ECHO, to connect Penn State University experts with nursing home staff and administrators to explore how infection control guidelines can be implemented effectively.

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Article Synopsis
  • The study investigates the long-term effects of suspected preterm labor (SPL) on children's health, focusing on cardiometabolic profiles and neurodevelopment between ages 6-8.
  • It compares children whose mothers experienced SPL with a control group, using various assessments to evaluate neurodevelopment, cardiovascular health, and physical fitness.
  • Key outcomes include body composition, blood pressure, and cognitive abilities, alongside factors like diet and lifestyle gathered from family interviews.
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Background: Corticosteroids confer a survival benefit in individuals hospitalized with coronavirus disease 2019 (COVID-19) who require oxygen. This meta-analysis seeks to determine the duration of corticosteroids needed to optimize this mortality benefit.

Methods: Electronic databases were searched to 9 March 2022, for studies reporting corticosteroid versus no corticosteroid treatment in hospitalized COVID-19 patients.

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Article Synopsis
  • The study assessed the progression of COVID-19 treatment standards (SOC) and their impact on patient recovery and mortality rates during 2020-2021, using data from the Adaptive COVID-19 Treatment Trial (ACTT).
  • Results indicated that outcomes improved significantly from ACTT-2 to ACTT-3, with notable reductions in mortality and intubation rates, although the improvements from ACTT-1 to ACTT-2 were less pronounced.
  • The analysis also explored various factors that could explain these trends, including changes in SOC, surges in COVID-19 cases, and the emergence of different virus variants, highlighting an increase in the use of dexamethasone in later trials.
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In this study, we used magnetic resonance imaging (MRI) to identify the different brain phenotypes within apparently healthy children and to evaluate whether these phenotypes had different prenatal characteristics. We included 65 healthy children (mean age, 10 years old) with normal neurological examinations and without structural abnormalities. We performed cluster analyses to identify the different brain phenotypes in the brain MRI images.

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Background: Baricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalised patients with COVID-19.

Methods: In this randomised, double-blind, double placebo-controlled trial, patients were enrolled at 67 trial sites in the USA (60 sites), South Korea (two sites), Mexico (two sites), Singapore (two sites), and Japan (one site).

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