Publications by authors named "Andres Martinez"

145 Publications

How does qualitative data collection modality affect disclosure of sensitive information and participant experience? Findings from a quasi-experimental study.

Qual Quant 2021 Sep 2:1-20. Epub 2021 Sep 2.

FHI 360, Behavioral, Epidemiological, and Clinical Sciences, Durham, NC USA.

Focus groups (FGs) and individual interviews (IDIs) can be conducted in-person or in several different online contexts. We conducted a quasi-experimental study and assessed sharing of sensitive or dissenting information and participant comfort in FGs and IDIs across four modalities: (1) in-person, (2) online video-based, (3) online chat-based (synchronous), and (4) online email/message board-based (asynchronous). Participants were systematically assigned to one of the four modalities and randomized to one of 24 FGs or 48 IDIs ( = 171). The study topic was medical risk during pregnancy. All participants also completed a survey on their perceptions of the data collection process. We found no significant difference in the frequency of disclosure of sensitive information by modality. Text-based FGs (chat and message board) were more likely to contain dissenting opinions than visually-based FGs (in-person and video). Participants also reported feeling less rapport and personal comfort in sharing information in the FG video modality than other modalities. These findings provide initial data that can guide researchers in choosing among data collection modalities to maximize participant engagement and comfort.
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http://dx.doi.org/10.1007/s11135-021-01217-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8412398PMC
September 2021

Using financial diaries to understand the economic lives of HIV-positive pregnant women and new mothers in PMTCT in Zomba, Malawi.

PLoS One 2021 30;16(7):e0252083. Epub 2021 Jul 30.

Global Health and Population Research, Durham, North Carolina, United States of America.

Background: Economic strengthening (ES) interventions can address economic barriers to retention and adherence (R&A) to antiretroviral therapy in prevention of mother-to-child transmission (PMTCT) services. To inform tailoring of ES activities for PMTCT, we used financial diaries to understand the economic lives of women in PMTCT and examine associations between participants' finances and their R&A.

Methods: We collected financial data from a stratified sample (n = 241) of HIV-positive pregnant women and new mothers enrolled in PMTCT from three clinics in Zomba, Malawi. For 30 weeks, participants met with staff to record cash and in-kind inflows and outflows. We used clinical records to calculate a measure of R&A for each participant. We summarized diary data using R and used cox proportional hazard models to examine the relationship between R&A and participant characteristics and behavior.

Results: There were 68,097 cash transactions over 30 weeks, with 10% characterized as inflows. The median value of cash inflows was US$3.54 compared with US$0.42 for cash outflows. Fewer than 7% of total transactions were considered related to PMTCT, with the majority classified as food or drink. Participants in the rural site had the lowest hazard of non-adherence. Decreased hazard of non-adherence was also linked to having dependents and years on ART. There were significant differences in cash inflows and outflows between those who were always adherent and those who were not.

Conclusions: Financial inflows were large and erratic, whereas outflows were small but consistent. PMTCT expenses comprised a small proportion of overall expenses and focused on proper nutrition. The influence of inflows and outflows on adherence was significant but small; however, always adherent participants demonstrated smoother inflows and outflows, indicating an association between greater adherence and economic stability. Participants would benefit from interventions that bolster and stabilize their economic lives, including income generating activities in the agricultural industry and inclusion in village banks.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252083PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323884PMC
July 2021

Clinical utility of next-generation sequencing-based ctDNA testing for common and novel ALK fusions.

Lung Cancer 2021 09 17;159:66-73. Epub 2021 Jul 17.

Department of Pathology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, USA; Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York NY, USA.

Objectives: Liquid biopsy for plasma circulating tumor DNA (ctDNA) next-generation sequencing (NGS) can detect ALK fusions, though data on clinical utility of this technology in the real world is limited.

Materials And Methods: Patients with lung cancer without known oncogenic drivers or who had acquired resistance to therapy (n = 736) underwent prospective plasma ctDNA NGS. A subset of this cohort (n = 497) also had tissue NGS. We evaluated ALK fusion detection, turnaround time (TAT), plasma and tissue concordance, matching to therapy, and treatment response.

Results: ctDNA identified an ALK fusion in 21 patients (3%) with a variety of breakpoints and fusion partners, including EML4, CLTC, and PON1, a novel ALK fusion partner. TAT for ctDNA NGS was shorter than tissue NGS (10 vs. 20 days; p < 0.001). Among ALK fusions identified by ctDNA, 93% (13/14, 95% CI 66%-99%) were concordant with tissue evaluation. Among ALK fusions detected by tissue NGS, 54% (13/24, 95% CI 33%-74%) were concordant with plasma ctDNA. ctDNA matched patients to ALK-directed therapy with subsequent clinical response, including four patients matched on the basis of ctDNA results alone due to inadequate or delayed tissue testing. Serial ctDNA analysis detected MET amplification (n = 2) and ALK G1202R mutation (n = 2) as mechanisms of acquired resistance to ALK-directed therapy.

Conclusion: Our findings support a complementary role for ctDNA in detection of ALK fusions and other alterations at diagnosis and therapeutic resistance settings.
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http://dx.doi.org/10.1016/j.lungcan.2021.06.018DOI Listing
September 2021

Colon Transit Scintigraphy in Schaaf-Yang Syndrome.

Clin Nucl Med 2021 Jun 25. Epub 2021 Jun 25.

From the Nuclear Medicine Department, Complejo Hospitalario Universitario, Badajoz, Spain.

Abstract: Schaaf-Yang syndrome is a genetic disorder characterized by delayed psychomotor development, hypotonia, intellectual disability, feeding difficulties, and variable dysmorphic facial features. It is an extremely rare disorder with over 250 cases reported in the medical literature. This condition has been determined to be inherited by an autosomal dominant pattern. We present colon transit scintigraphy of a 6-year-old boy with history of chronic constipation with poor response to medical treatment, clinical characteristics, and gene mutations consistent with this syndrome. After oral administration of 111In-DTPA, planar and SPECT/CT images showed rapid proximal colonic transit and anorectal retention.
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http://dx.doi.org/10.1097/RLU.0000000000003778DOI Listing
June 2021

Adaptation and validation of simple tools to screen and monitor for oral PrEP adherence.

PLoS One 2021 27;16(5):e0251823. Epub 2021 May 27.

CONRAD, Eastern Virginia Medical School, Norfolk, Virginia, United States of America.

Introduction: Oral, vaginal and other pre-exposure prophylaxis (PrEP) products for HIV prevention are in various stages of development. Low adherence poses a serious challenge to successful evaluation in trials. In a previous study, we developed tools to screen for general adherence and specifically monitor intravaginal ring adherence within the context of HIV prevention clinical trials. This study aimed to further validate the screening tool and to adapt and provide initial psychometric validation for an oral pill monitoring tool.

Materials And Methods: We administered a cross-sectional survey between June and October 2018 at a trial site located near Cape Town, South Africa, and another in Thika, Kenya, with 193 women who had experience using daily oral pills. We fit confirmatory factor analysis models on the screening tool items to assess our previously-hypothesized subscale structure. We conducted an exploratory factor analysis of oral PrEP monitoring items to determine the underlying subscale structure. We then assessed the construct validity of each tool by comparing subscales against each other within the current sample and against our original sample, from a study conducted in four sites in South Africa, including Cape Town.

Results: The screening tool structure showed moderate evidence of construct validity. As a whole, the tool performed in a similar way to the original sample. The monitoring tool items, which were revised to assess perceptions about and experiences using daily oral PrEP, factored into five subscales that showed moderate to good reliability. Four of the five subscales had a similar structure overall to the vaginal ring monitoring tool from which they were adapted.

Conclusions: Accurate measurement of HIV-prevention product adherence is of critical importance to the assessment of product efficacy and safety in clinical trials, and the support of safe and effective product use in non-trial settings. In this study, we provide further validation for these measures, demonstrating the screening tool's utility in additional populations and adapting the monitoring tool's utility for different HIV-prevention products.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0251823PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8158999PMC
May 2021

Men's social networks, social norms, & family planning in Benin.

Glob Public Health 2021 May 25:1-15. Epub 2021 May 25.

The Institute of Reproductive Health at Georgetown University, Washington D. C., United States.

To address low family planning (FP) use and high unmet need in West Africa, attention has been paid to addressing FP-related social networks and norms. Most work focuses on women. This analysis assesses men's FP-related social networks and norms and their relation to FP use in Benin using data from baseline surveys from the Tékponon Jikuagou intervention. We descriptively analysed men's egocentric FP-related social networks and norms at the village level. Multivariable logistic regression analyses ( = 885) examined the relationship between FP-related social networks, norms, and men's current and future FP use. Twenty-three percent of men reported current modern contraception use and 47% reported intended future use. Most had few network members. While most believed it was acceptable to discuss FP, few talked with peers about FP and most did not discuss FP with their partner(s). In multivariable analyses, neither networks nor norms were significantly related to men's FP use. Men's networks being small and men rarely discussing FP indicate an opportunity for village-based approaches to engage men in FP discussions and spark FP dialogue within couples, between men, and within villages. Future work should further explore the relationship between men's social networks, norms, and FP use.
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http://dx.doi.org/10.1080/17441692.2021.1933125DOI Listing
May 2021

Automated Immunohistochemistry Assay for the Detection of Napsin-A in Formalin-Fixed Paraffin-Embedded Tissues from Lung Tumors.

Methods Mol Biol 2021 ;2279:23-33

Southern Pathology Services Inc., Ponce, Puerto Rico.

Immunohistochemistry (IHC) enables the selective detection of proteins in cells of formalin-fixed-paraffin-embedded (FFPE) tissue sections. This technique plays a key role in the identification and classification of primary lung cancer tumors through the evaluation of the expression of the aspartic proteinase Napsin-A. However, immunohistochemistry is a complex process involving many critical steps and the lack of standardization as well as inappropriate analytical conditions may contribute to inconsistent results between laboratories. Automated immunohistochemistry addresses this issue by ensuring the quality and the reproducibility of the results among different laboratories. Here we describe an automated IHC protocol used in our laboratory for the detection of Napsin-A in FFPE lung tissue sections.
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http://dx.doi.org/10.1007/978-1-0716-1278-1_3DOI Listing
April 2021

Automated TTF-1 Immunohistochemistry Assay for the Differentiation of Lung Adenocarcinoma Versus Lung Squamous Cell Carcinoma.

Methods Mol Biol 2021 ;2279:1-12

Southern Pathology Services Inc., Ponce, Puerto Rico.

Due to therapeutic advances, the subclassification of non-small cell lung carcinomas (NSCLC) between the adenocarcinomas and squamous cell carcinomas subtypes is essential for the practice of personalized and targeted medicine. The clinical management for these two NSCLC subtypes is different due to their different molecular properties and histological origins. Immunohistochemistry (IHC) markers such is TTF-1 play a key role in the differentiation of lung adenocarcinomas and squamous cell carcinomas. However, immunohistochemistry is a complex process involving many critical steps and the reliability of results depends on the standardization of the assay as well as the appropriate interpretation. Different laboratories use different reagents and different IHC approaches for the detection of TTF-1 in lung cancer tumors. Here we describe an automated IHC protocol used in our laboratory for the detection of TTF-1 in formalin-fixed, paraffin-embedded (FFPE) tissue sections from lung tumors.
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http://dx.doi.org/10.1007/978-1-0716-1278-1_1DOI Listing
April 2021

Dependence Graphs Based on Association Rules to Explore Delusional Experiences.

Multivariate Behav Res 2021 Feb 4:1-29. Epub 2021 Feb 4.

Mental Health Department, Servicio Navarro de Salud.

Methods to estimate dependence graphs among variables, have quickly gained popularity in psychopathology research. To date, multiple methods have been proposed but recent studies report several drawbacks impacting on the validity of the conclusions as it is argued that assumptions and conditions underlying the methods commonly used and the nature of the data is lacking alignment. A particularly important issue is that underlying dynamics potentially present in heterogeneous datasets are disregarded, as the methods focus on the variables but not on individuals. This work also argues that the networks may lack relevant components as current methods ignore connections beyond pairwise interactions between individual symptoms. This study addresses these issues with a novel method for constructing dependence graphs based on applying Association Rules to binary records, which is often the type of records in the psychopathology domain. To demonstrate the benefits, we examine 12 delusional experiences in a sample of 1423 subjects with psychotic disorders. We show that by extracting Association Rules using an algorithm called apriori, in addition to facilitating an intuitive interpretation, previously unseen relevant dependencies are revealed from higher order interactions among psychotic experiences in subgroups of patients.
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http://dx.doi.org/10.1080/00273171.2020.1870912DOI Listing
February 2021

Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use.

PLoS One 2020 22;15(12):e0242881. Epub 2020 Dec 22.

Women's Global Health Imperative, RTI International, San Francisco Project Office, California, United States of America.

In HIV prevention trials, male partners have influenced women's ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our intervention involved development of a Healthy Relationship Assessment Tool (HEART) that assessed both positive and negative aspects of male partner involvement in women's HIV prevention. We identified and refined 127 potential items, representing intimate partner violence, agency and social support. A structured survey, including potential items and other sociodemographic and behavioral variables was administered to former microbicide trial and non-trial participants. We conducted an exploratory factor analysis (EFA) to identify a reduced set of constructs and items to screen women who might experience social harms or benefits from vaginal ring use. We examined associations between constructs and with other survey variables to assess content and construct validity. In a subset of 10 women who participated in the survey and qualitative interviews, we used qualitative data to predict survey scores. We retained five constructs with theoretical relevance and good-to-strong reliability for the tool, including: Traditional Values; Partner Support; Partner Abuse & Control; Partner Resistance to HIV Prevention; and HIV Prevention Readiness. Predicted associations between HEART constructs, and correspondence between participants' qualitative data and HEART scores were generally correct, while those between constructs and other sociodemographic variables were more mixed. Initial validation of the HEART tool was promising. The tool will be used during the CHARISMA pilot study at the Johannesburg MTN 025/HOPE site and validated as part of a randomized controlled trial of CHARISMA within a PrEP demonstration project. Beyond clinical trial settings, HEART could assist PrEP or antiretroviral treatment (ART) providers with an easy-to-administer tool to identify risk and tailor risk reduction, empowerment and adherence counseling for microbicides, PrEP or ART related services.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242881PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7755213PMC
January 2021

Signal Processing Methods to Interpret Polychlorinated Biphenyls in Airborne Samples.

IEEE Access 2020 14;8:147738-147755. Epub 2020 Aug 14.

Department of Civil and Environmental Engineering and IIHR-Hydroscience and Engineering, University of Iowa, Iowa City, IA 52242 USA.

The main contribution of this interdisciplinary work is a robust computational framework to autonomously discover and quantify previously unknown associations between well-known (target) and potentially unknown (non-target) toxic industrial air pollutants. In this work, the variability of polychlorinated biphenyl (PCB) data is evaluated using a combination of statistical, signal processing, and graph-based informatics techniques to interpret the raw instrument signal from gas chromatography-mass spectrometry (GC/MS/MS) data sets. Specifically, minimum mean-squared techniques from the adaptive signal processing literature are extended to detect and separate coeluted (overlapped) peaks in the raw instrument signal. A graph-based visualization is provided which bridges two complementary approaches to quantitative pollution studies: (i) peak-cognizant target analysis (limits data analysis to few well-known compounds) and (ii) chemometric analysis (statistical large-scale data analysis) that is agnostic of specific compounds. Further, peak fitting techniques based on L2 error minimization are employed to autonomously calculate the amount of each PCB present with a normalized mean square error of -18.4851 dB. Graph-based visualization of associations between known and unknown compounds are developed through principal component analysis and both fuzzy c-means (FCM) and k-means clustering techniques are implemented and compared. The efficiency of these methods are compared using 150 air samples analyzed for individual PCBs with GC/MS/MS against traditional target-only techniques that perform analysis across only the known (target) PCBs. Parameter optimization techniques are employed to evaluate the relative contribution of PCB signals against ten potential source signals representing legacy signatures from historical manufacture of Aroclors and modern sources of PCBs produced as by products of pigment and polymer manufacturing. Aroclors 1232, 1254, 1016, and 1221 as well as non-Aroclor 3, 3', dichlorobiphenyl (PCB 11) were found in many of the samples as unique source signals that describe PCB mixtures in air samples collected from Chicago, IL.
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http://dx.doi.org/10.1109/ACCESS.2020.3013108DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7742762PMC
August 2020

Left ventricular non-compaction presenting as cardio-embolic stroke.

J Geriatr Cardiol 2020 Oct;17(10):645-646

Department of Neurology, University of Florida College of Medicine-Jacksonville, Florida, USA.

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http://dx.doi.org/10.11909/j.issn.1671-5411.2020.10.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657947PMC
October 2020

Dynamic Visualization of Vasospastic Angina.

Am J Med 2021 03 30;134(3):e191-e192. Epub 2020 Sep 30.

Division of Cardiology, University of Florida Health Jacksonville, Jacksonville.

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http://dx.doi.org/10.1016/j.amjmed.2020.08.042DOI Listing
March 2021

North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the Society for Pediatric Radiology Joint Position Paper on Noninvasive Imaging of Pediatric Pancreatitis: Literature Summary and Recommendations.

J Pediatr Gastroenterol Nutr 2021 01;72(1):151-167

Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.

Abstract: The reported incidence of pediatric pancreatitis is increasing. Noninvasive imaging, including ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI), play important roles in the diagnosis, staging, follow-up, and management of pancreatitis in children. In this position paper, generated by members of the Pancreas Committee of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and the Abdominal Imaging Committee of The Society for Pediatric Radiology (SPR), we review the roles of noninvasive imaging in pediatric acute, acute recurrent, and chronic pancreatitis. We discuss available evidence related to noninvasive imaging, highlighting evidence specific to pediatric populations, and we make joint recommendations for use of noninvasive imaging. Further, we highlight the need for research to define the performance and role of noninvasive imaging in pediatric pancreatitis.
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http://dx.doi.org/10.1097/MPG.0000000000002964DOI Listing
January 2021

Preliminary Assessment of a Hand and Arm Exoskeleton for Enabling Bimanual Tasks for Individuals With Hemiparesis.

IEEE Trans Neural Syst Rehabil Eng 2020 10 21;28(10):2214-2223. Epub 2020 Aug 21.

The design and preliminary assessment of a semi-powered hand and arm exoskeleton is described. The exoskeleton is designed to enable bimanual activities of daily living for individuals with chronic, upper-limb hemiparesis resulting from stroke. Specifically, the device augments the user's grasp strength and ability to extend the affected hand for bimanual tasks and supplements wrist and elbow stability while conducting these tasks. The exoskeleton is battery-powered and self-contained with all electronics and power units placed within the device structure. A preliminary assessment of the exoskeleton was performed with three subjects having right-sided upper-limb motor deficit resulting from stroke. For subjects with limited hand and arm functionality, the exoskeleton increased grasp strength and improved the ability to perform representative bimanual tasks.
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http://dx.doi.org/10.1109/TNSRE.2020.3018649DOI Listing
October 2020

Nest-departure behaviour of gynes and drones in the invasive yellowjacket (Hymenoptera: Vespidae).

Bull Entomol Res 2021 Apr 12;111(2):174-181. Epub 2020 Aug 12.

Grupo de Ecología de Poblaciones de Insectos, IFAB - Instituto de Investigaciones Forestales y Agropecuarias Bariloche- (INTA - CONICET), Bariloche, Argentina.

Inbreeding costs can be high in haplodiploid hymenopterans due to their particular mechanism of sex determination (i.e., single-locus complementary sex-determination system, sl-CSD), as it can lead to the production of sterile males. Therefore, mechanisms contributing to reduced inbred matings can be beneficial. In this sense, asynchronous nest departure of sibling drones and gynes could reduce kin encounters in social hymenopterans. Using six observation colonies, we determined under field conditions the nest departure behaviour of sibling reproductives of the social wasp Vespula germanica (Hymenoptera: Vespidae). We determined that sexuals leave the nests definitively and detected asynchronous departure not fixed to a particular caste at a seasonal scale in some colonies, as gynes or drones delayed their departure as a function of the departure of the opposite sex, depending on the colony. At a higher temporal resolution (i.e., within a day), we discovered that drones consistently began to leave nests 1 h before gynes and this difference was driven by those individuals that left on the same day as did the opposite-sex kin. Even though other mechanisms such as polyandry and differential dispersal could also be important at reducing inbred matings in the species, the observed departure patterns (i.e., in some colonies actually leave together with the opposite caste, while in others temporal segregation seems to occur) from nests could be complementary to the former and be important at reducing the negative effects of inbreeding in this invasive species.
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http://dx.doi.org/10.1017/S0007485320000462DOI Listing
April 2021

Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial.

Trials 2020 Jul 9;21(1):632. Epub 2020 Jul 9.

Neumology Department, Hospital Universitario de Burgos, Avda Islas Baleares, 3, Burgos, Spain.

Objectives: The aim of this study is to explore the effectiveness and safety of oral corticosteroids (prednisone) in the treatment of early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria.

Trial Design: Randomized clinical trial, controlled, open, parallel group, to evaluate the effectiveness of steroids in adult patients with confirmed COVID-19, with incipient pulmonary involvement, without hospital admission criteria. Patients will be stratified by the presence or not of radiological data on pneumonia.

Participants: We will include patients with early stage SARS-Cov-2 pneumonia who do not meet hospital admission criteria from the reference hospital, the Hospital Universitario de Burgos, in the region of Castilla y León, Spain. Patients will be followed-up by specialist physicians and Primary Health Care professionals.

Inclusion Criteria: - Men and women. - Age between 18 and 75 years old. - Diagnosed SARS-CoV-2 infection, by PCR and/or IgM+ antibody test and/or antigen test. - Clinical diagnosis of lung involvement: (respiratory symptoms +/- pathological auscultation +/- O2 desaturation) - Chest X-ray with mild-moderate alterations or normal. - Patients who give their verbal informed consent in front of witnesses, which will be reflected in the patients' medical records.

Exclusion Criteria: - Oxygen desaturation below 93% or P0 < 62. - Moderate-severe dyspnea or significant respiratory or general deterioration that makes admission advisable. - Chest X-ray with multifocal infiltrates. - Insulin-dependent diabetes with poor control or glycaemia in the emergency room test greater than 300 mg/ml (fasting or not). - Other significant comorbidities: Severe renal failure (creatinine clearance < 30 mL/min); cirrhosis or chronic liver disease, poorly controlled hypertension. - Heart rhythm disturbances (including prolonged QT). - Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents); cancer. - Pregnant or breast-feeding women. - Patients under use of glucocorticoids for other diseases. - History of allergy or intolerance to any of the drugs in the study (prednisone, azithromycin or hydroxychloroquine). - Patients who took one or more of the study drugs in the 7 days prior to study inclusion. - Patients taking non-suppressible drugs with risk of QT prolongation or significant interactions. - Patients unwilling or unable to participate until study completion. - Participation in another study.

Intervention And Comparator: Eligible patients will be randomized to receive standard outpatient treatment only (group 1) or standard outpatient treatment plus prednisone (group 2). - Group 1: paracetamol 1 g/8 h (on demand) + hydroxychloroquine 400 mg/12h the first day, 200 mg/12 h for 4 days + azithromycin 500 mg/24h for 5 days. - Group 2: paracetamol 1 g/8 h (on demand) + hydroxychloroquine 400 mg/12h the first day, 200 mg/12 h for 4 days + azithromycin 500 mg/24h for 5 days + prednisone 60 mg / 24 h for 3 days, 30 mg / 24 h for 3 days and 15 mg / 24 h for 3 days.

Main Outcomes: If the patient requires ambulatory observation, according to the protocol established in this respect in the Emergency Department, meets all the criteria for inclusion and none for exclusion, data will be taken by the person responsible on the data collection sheet. The main result is admission after 30 days. Secondary outcomes are 30-day ICU admission and hospital stay. The safety variable will be the occurrence of clinical symptoms or delirium related to the steroids. Also, the possible decompensations of diabetes will be measured. All tests will be on an intention-to-treat basis.

Randomisation: Treatment will be assigned according to stratified randomization by the presence or absence of radiological data of lung involvement (previously performed by random sequence 1:1 generated with Epidat and kept hidden by opaque, sealed envelopes, which will only be opened after inclusion and basal measurement).

Blinding (masking): Participants, caregivers and personnel responsible for outcomes measurement will not be blinded to group assignment, once the patient is included and the basal measurement performed, as per protocol design.

Numbers To Be Randomised (sample Size): The percentage of patients with incipient lung involvement is unknown, but given that pulmonary involvement already exists it is estimated to be around 20%. We consider that the intervention could reduce this percentage to 5%, so the necessary sample size would be 200 subjects (100 per group), with a power of 80% and an estimated loss percentage of 10%.

Trial Status: The protocol with code TAC-COVID-19, version 2.0 on date: April 16, 2020 is approved by the Spanish Drug Agency (AEMPS) and the local Ethics Committee. The trial is in the recruitment phase. Recruitment began 19 April, 2020 and is anticipated to be complete by April 2021.

Trial Registration: The trial was registered under the title "OUTPATIENT TREATMENT OF EARLY PULMONARY COVID19 WITH CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE" with EudraCT number 2020-001622-64 , registered on 3 April 2020.

Full Protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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http://dx.doi.org/10.1186/s13063-020-04575-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7344042PMC
July 2020

Omnichannel in the fashion industry: A qualitative analysis from a supply-side perspective.

Heliyon 2020 Jun 17;6(6):e04198. Epub 2020 Jun 17.

Business Department, University of Castilla-La Mancha, Faculty of Social Sciences, Cuenca, 16071, Spain.

Currently, many companies are abandoning multichannel and turning to a much more centralized model known as omnichannel, in order to gain a competitive advantage by integrating and optimizing different channels and thus the client has a unique experience. Within this context, the aim of this study is to analyse the omnichannel digital marketing strategies implemented by Spanish fashion and accessories companies in order to provide pleasant shopping experiences to their online consumers. To that end, a qualitative analysis has been carried out, specifically consisting of in-depth interviews conducted with marketing managers who implement digital strategies in their businesses to improve the online experience of consumers in an omnichannel context. From a practical perspective, this study can help inform companies' decision-making on how to best develop their consumers' omnichannel experience and, in consequence, improve consumers' behavioural responses such as personal participation, satisfaction and engagement with the firm.
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http://dx.doi.org/10.1016/j.heliyon.2020.e04198DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7303998PMC
June 2020

Endocarditis with Perivalvular Abscess Presenting as Atrioventricular Block.

Case Rep Infect Dis 2020 11;2020:7463719. Epub 2020 Jun 11.

Division of Cardiology, University of Florida College of Medicine Jacksonville, Jacksonville, FL, USA.

is an aerobic, Gram-negative bacillus first identified in 1819 (Yeung et al. 2018). infective endocarditis is extremely rare accounting for only 0.14% of all cases (Phadke and Jacob 2016, Hadano et al. 2012, Nikolakopoulos et al. 2019). We present the case of a 33-year-old male with a past medical history of Hodgkin lymphoma, nonischemic cardiomyopathy ejection fraction of 25-30%, severe aortic stenosis, hepatitis C, and active intravenous (IV) drug abuse who was admitted following a motor vehicle accident. Approximately 10 days into his admission, he developed a 39.5 degree Celsius fever, which prompted collection of blood cultures. These cultures were positive (2 out of 2) for for which he was treated with intravenous cefepime. Soon after this diagnosis, patient developed a complete AV block. Given the instability of the patient, he required emergent placement of a temporary pacing wire. Transesophageal echocardiogram was ordered and revealed an aortic root abscess. Given the comorbidities and active IV drug use, conservative management was pursued. Although rare, trends suggest that this pathogen may be on the rise. Further research is needed to better understand how to effectively manage this pathogen.
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http://dx.doi.org/10.1155/2020/7463719DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305547PMC
June 2020

Surveillance and diagnostics of the emergent Sri Lankan cassava mosaic virus (Fam. Geminiviridae) in Southeast Asia.

Virus Res 2020 08 11;285:197959. Epub 2020 May 11.

Virology Laboratory, International Center for Tropical Agriculture (CIAT), Cali, Colombia. Electronic address:

Emergent agricultural pathogens cause severe damage worldwide and their invasive potential is significantly increased by global trade, crop intensification and climate change. Standard surveillance and diagnostic protocols need to be evaluated and implemented, particularly with diseases caused by a wide range of pathogens that induce similar symptoms. Such is the case with Cassava Mosaic Disease (CMD) present in Africa and Asia, and associated with mixed virus infections and recombinant and re-assorted virus strains. CMD has been recently reported in Southeast Asia (SEA) and is already widely spread throughout this region. This communication offers an update on protocols and tools used to track the distribution of CMD and to characterize the pathogen associated with it in SEA.
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http://dx.doi.org/10.1016/j.virusres.2020.197959DOI Listing
August 2020

Application of the ROLL technique as a method of excisional biopsy in oncological pathology.

Cir Esp (Engl Ed) 2021 Jan 6;99(1):49-54. Epub 2020 May 6.

Servicio de Medicina Nuclear, Complejo Hospitalario Universitario de Badajoz, Badajoz, España.

Objective: To evaluate the utility of the ROLL (Radioguided Occult Lesion Localization) technique as a method of excisional biopsy in hypermetabolic lesions suspected of malignancy evidenced in [F]Fluordeoxiglucose PET/CT scans.

Material And Methods: 33 patients were retrospectively evaluated referred for metabolic studies due to tumoral pathology or suspected neoplastic process and presenting hypermetabolic adenopathies with high probability of malignancy. The group consisted of 19 women and 14 men, ranging from 23 to 77 years old. Patients were performed a ROLL technique for localization and removal the selected adenopathies, through the injection of [99mTc] macro-aggregates of albumin guided by ultrasound or CT. A detection probe and a portable gamma camera were used during the surgical procedure.

Results: In 31 patients (94%) the location and removal of the radiolabeled adenopathies was achieved. In one patient the location of the lesion was not possible and a second patient was not operated due to inadequate dose injection confirmed by gammagraphy study. The result of the anatomopathological study of adenopathies resulted in 23 tumor affections and 8 benign processes, including a granulomatous process.

Conclusion: The ROLL technique proved its utility as a radioguided excisional biopsy method for the study of lesions suspected of malignancy evidenced in patients undergoing PET/CT studies. The technique allowed to confirm the persistence of oncological process in some cases and the existence of false positives from the imaging study in others, modifying the patients therapeutic management.
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http://dx.doi.org/10.1016/j.ciresp.2020.04.005DOI Listing
January 2021

Drone aggregation behavior in the social wasp Vespula germanica (Hymenoptera: Vespidae): Effect of kinship and density.

Sci Rep 2020 04 28;10(1):7143. Epub 2020 Apr 28.

Grupo de Ecología de Poblaciones de Insectos, IFAB - Instituto de Investigaciones Forestales y Agropecuarias Bariloche- (INTA - CONICET), Bariloche, Argentina.

Inbreeding can have negative consequences on population viability because of the reduced fitness of the progeny. In general, most species have developed mechanisms to minimize inbreeding such as dispersal and kin avoidance behavior. In the eusocial Hymenoptera, related individuals typically share a common nest and have relatively short mating periods, this could lead to inbreeding, and because of their single-locus complementary sex determination system, it may generate diploid males that could result in infertile triploid progeny representing a cost for the colony. Vespula germanica, is an eusocial wasp that has invaded many parts of the world, despite likely facing a reduced genetic pool during the arrival phases. We ask whether male wasp display specific aggregation behavior that favors genetic diversity, key to reduce inbreeding. Through a set of laboratory experiments, we investigated the effects of drone nestmateship and density on the aggregation behavior of V. germanica drones. We show that drones avoid aggregating with their nestmates at all densities while non-nestmates are avoided only at high densities. This suggests that lek genetic diversity and density could be regulated through drone behavior and in the long run minimize inbreeding favoring invasion success.
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http://dx.doi.org/10.1038/s41598-020-64232-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7189369PMC
April 2020

Polymeric Nanofiber-Carbon Nanotube Composite Mats as Fast-Equilibrium Passive Samplers for Polar Organic Contaminants.

Environ Sci Technol 2020 06 12;54(11):6703-6712. Epub 2020 May 12.

Department of Chemical & Biochemical Engineering, University of Iowa, Iowa City, Iowa 52242, United States.

To improve the performance of polymeric electrospun nanofiber mats (ENMs) for equilibrium passive sampling applications in water, we integrated two types of multiwalled carbon nanotubes (CNTs; with and without surface carboxyl groups) into polyacrylonitrile (PAN) and polystyrene (PS) ENMs. For 11 polar and moderately hydrophobic compounds (-0.07 ≤ log ≤ 3.13), 90% of equilibrium uptake was achieved in under 0.8 days ( values) in nonmixed ENM-CNT systems. Sorption capacity of ENM-CNTs was between 2- and 50-fold greater than pure polymer ENMs, with equilibrium partition coefficients ( values) ranging from 1.4 to 3.1 log units (L/kg) depending on polymer type (hydrophilic PAN or hydrophobic PS), CNT loading (i.e., values increased with weight percent (wt %) of CNTs), and CNT type (i.e., greater uptake with carboxylated CNTs composites). During field deployment at Muddy Creek in North Liberty, Iowa, optimal ENM-CNTs (PAN with 20 wt % carboxylated CNTs) yielded atrazine concentrations in surface water with a 40% difference relative to analysis of a same-day grab sample. We also observed a mean percent difference of 30 (±20)% when comparing ENM-CNT sampler results to grab sample data collected within 1 week of deployment. With their rapid, high capacity uptake and small material footprint, ENM-CNT equilibrium passive samplers represent a promising alternative to complement traditional integrative passive samplers while offering convenience over large volume grab sampling.
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http://dx.doi.org/10.1021/acs.est.0c00609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665838PMC
June 2020

A Single-Joint Implementation of Flow Control: Knee Joint Walking Assistance for Individuals With Mobility Impairment.

IEEE Trans Neural Syst Rehabil Eng 2020 04 28;28(4):934-942. Epub 2020 Feb 28.

This paper describes the implementation of a movement control method for lower limb exoskeletons with single-joint actuation. In such applications, the single-joint must coordinate movement with other non-controlled joints. The authors have previously proposed a multi-joint control method called a flow controller, which provides several desirable characteristics for such assistance. In this paper, the authors adapt the fundamentally multi-joint flow control approach to a system with a single actuated joint, but with multiple movement degrees of freedom. The single degree of actuation flow control method was implemented on a representative system, specifically a knee exoskeleton that coordinates assistance with ipsilateral thigh movement during walking. The ability of the controller and knee exoskeleton to appropriately influence knee movement was evaluated in level walking experiments on three subjects with unilateral lower-limb impairment. Results show the device and controller provide improvements in knee movement in all subjects. Subjective feedback from the subjects indicates a high level of comfort with the controller.
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http://dx.doi.org/10.1109/TNSRE.2020.2977339DOI Listing
April 2020

Improved packing of preparative biochromatography columns by mechanical vibration.

Biotechnol Prog 2020 05 27;36(3):e2950. Epub 2019 Dec 27.

Technical University of Munich, Institute of Biochemical Engineering, Garching, Germany.

The bioprocessing industry relies on packed-bed column chromatography as its primary separation process to attain the required high product purities and fulfill the strict requirements from regulatory bodies. Conventional column packing methods rely on flow packing and/or mechanical compression. In this work, the application of ultrasound and mechanical vibration during packing was studied with respect to packing density and homogeneity. We investigated two widely used biochromatography media, incompressible ceramic hydroxyapatite, and compressible polymethacrylate-based particles, packed in a laboratory-scale column with an inner diameter of 50 mm. It was shown that ultrasonic irradiation led to reduced particle segregation during sedimentation of a homogenized slurry of polymethacrylate particles. However, the application of ultrasound did not lead to an improved microstructure of already packed columns due to the low volumetric energy input (~152 W/L) caused by high acoustic reflection losses. In contrast, the application of pneumatic mechanical vibration led to considerable improvements. Flow-decoupled axial linear vibration was most suitable at a volumetric force output of ~1,190 N/L. In the case of the ceramic hydroxyapatite particles, a 13% further decrease of the packing height was achieved and the reduced height equivalent to a theoretical plate (rHETP) was decreased by 44%. For the polymethacrylate particles, a 18% further packing consolidation was achieved and the rHETP was reduced by 25%. Hence, it was shown that applying mechanical vibration resulted in more efficiently packed columns. The application of vibration furthermore is potentially suitable for in situ elimination of flow channels near the column wall.
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http://dx.doi.org/10.1002/btpr.2950DOI Listing
May 2020

Human health risks due to airborne polychlorinated biphenyls are highest in New Bedford Harbor communities living closest to the harbor.

Sci Total Environ 2020 Mar 18;710:135576. Epub 2019 Nov 18.

Boston University School of Public Health, Department of Environmental Health, 715 Albany St., Talbot Building, Boston, MA 02118, United States.

In response to concerns raised by communities surrounding the New Bedford Harbor Superfund site, we completed a field and modeling study that concluded the harbor is the primary source of polychlorinated biphenyls (PCBs) in air around the harbor. The follow-up question from residents was whether the PCBs measured in air pose a risk to their health. The US Environmental Protection Agency focuses their site-specific, risk-based decisions for site clean-up on cancers. We focused our assessment on the non-cancer effects on the thyroid based on the congener specific patterns and concentrations of PCBs measured in air near and distant to the harbor. Human and animal studies of PCB-induced effects on the thyroid provide evidence to support our analysis. Drawing from the published toxicological data, we used a Margin of Exposure (MOE) approach to derive a human-equivalent concentration in air associated with human health effects on the thyroid. Based on the MOEs calculated herein, evaluation of the MOE indicates that changes in thyroid hormone levels are possible among people living adjacent to the Harbor. Changes in thyroid hormone levels are more likely among people who live near the harbor compared to residents living in areas distant from the harbor. This risk assessment documents potential health risks associated with proximity to a marine Superfund Site using site-specific ambient air PCB congener data.
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http://dx.doi.org/10.1016/j.scitotenv.2019.135576DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7015809PMC
March 2020

Characterization of the Hydrodynamics in the USP Basket Apparatus Using Computational Fluid Dynamics.

J Pharm Sci 2020 03 16;109(3):1231-1241. Epub 2019 Nov 16.

NCE-Formulation Sciences, Drug Product Development, AbbVie Inc., North Chicago, Illinois 60064. Electronic address:

Computational fluid dynamics (CFD) has been extensively used for the USP paddle apparatus II, but limited CFD studies have been conducted on the USP basket apparatus I. We expanded on past CFD basket studies to consider the presence of a tablet inside the basket, compared predictions to in vivo conditions, and confirmed observations around the complexity of nonuniform hydrodynamics. Tablets near the basket perimeter experienced near 5-fold increase in maximum velocity and surface shear stress compared to tablets placed at the center of the basket. At higher basket speeds, the predicted velocities at the center of the basket were closer to in vivo predictions but the surface shear stress was about 2 orders of magnitude lesser. Simulations with a high viscosity fluid (1 Pa-s) showed a 10-fold increase in shear stress on a tablet but a decrease in strain rate compared to low-viscosity medium (0.001 Pa-s) which could impact dissolution rates. Also presented are the insights into turbulent energy dissipation rates that could help in a priori prediction of dissolution rates. Overall, the CFD analysis presented in this work reveals significant differences between the basket and in vivo conditions and will help inform relevant in vitro testing.
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http://dx.doi.org/10.1016/j.xphs.2019.11.008DOI Listing
March 2020

Bilateral wunderlich syndrome secondary to synchronous bilateral testicular germ cell tumor. A case report.

Urol Case Rep 2020 Jan 24;28:101028. Epub 2019 Sep 24.

Department of Pathology, Oncology Hospital, Mexican Institute of Social Security, Mexico City, Mexico.

Testicular cancer accounts for 1% of male neoplasms, the most common histology is bilateral presentation is reported in 1-2% of cases, and germ cell tumor histology represents 90-95% of cases. Especifically, choriocarcinoma as a pure component represents 0.3-1% of these neoplasms and as a mixed component, 8%. We present a 26-year-old male patient with bilateral Wunderlich syndrome secondary to renal metastases from testicular choriocarcinoma.
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http://dx.doi.org/10.1016/j.eucr.2019.101028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796737PMC
January 2020

Maternal nutrition intervention and maternal complications in 4 districts of Bangladesh: A nested cross-sectional study.

PLoS Med 2019 10 4;16(10):e1002927. Epub 2019 Oct 4.

Alive & Thrive Headquarters Office, Washington, District of Columbia, United States of America.

Background: Maternal morbidity is common in Bangladesh, where the maternal mortality rate has plateaued over the last 6 years. Maternal undernutrition and micronutrient deficiencies contribute to morbidity, but few interventions have measured maternal outcomes. We compared reported prevalence of antepartum, intrapartum, and postpartum complications among recently delivered women between maternal nutrition intervention and control areas in Bangladesh.

Methods And Findings: We conducted a cross-sectional assessment nested within a population-based cluster-randomized trial comparing a nutrition counseling and micronutrient supplement intervention integrated within a structured home-based maternal, newborn, and child health (MNCH) program to the MNCH program alone in 10 sub-districts each across 4 Bangladesh districts. Eligible consenting women, delivering within 42-60 days of enrollment and identified by community-level health workers, completed an interviewer-administered questionnaire detailing the index pregnancy and delivery and allowed review of their home-based care register. We compared pooled and specific reported antepartum, intrapartum, and postpartum complications between study groups using hierarchical logistic regression. There were 594 women in the intervention group and 506 in the control group; overall, mean age was 24 years, 31% were primiparas, and 39% reported facility-based delivery, with no significant difference by study group. There were no significant differences between the intervention and control groups in household-level characteristics, including reported mean monthly income (intervention, 6,552 taka, versus control, 6,017 taka; p = 0.48), having electricity (69.6% versus 71.4%, p = 0.84), and television ownership (41.1% versus 38.7%, p = 0.81). Women in the intervention group had higher recorded iron and folic acid and calcium supplement consumption and mean dietary diversity scores, but reported anemia rates were similar between the 2 groups (5.7%, intervention; 6.5%, control; p = 0.83). Reported antepartum (69.4%, intervention; 79.2%, control; p = 0.12) and intrapartum (41.4%, intervention; 48.5%, control; p = 0.18) complication rates were high and not significantly different between groups. Reported postpartum complications were significantly lower among women in the intervention group than the control group (33.5% versus 48.2%, p = 0.02), and this difference persisted in adjusted analysis (adjusted odds ratio [AOR] = 0.51, 95% CI 0.32-0.82; p < 0.001). For specific conditions, odds of retained placenta (AOR = 0.35, 95% CI 0.19-0.67; p = 0.001), postpartum bleeding (AOR = 0.37, 95% CI 0.15-0.92; p = 0.033), and postpartum fever/infection (AOR = 0.27, 95% CI 0.11-0.65; p = 0.001) were significantly lower in the intervention group in adjusted analysis. There were no significant differences in reported hospitalization for antepartum (49.8% versus 45.1%, p = 0.37), intrapartum (69.9% versus 59.8%, p = 0.18), or postpartum (36.1% versus 29.9%, p = 0.49) complications between the intervention and control groups. The main limitations of this study are outcome measures based on participant report, non-probabilistic selection of community-level workers' catchment areas for sampling, some missing data for variables derived from secondary sources (e.g., dietary diversity score), and possible recall bias for reported dietary intake and supplement use.

Conclusions: Reported overall postpartum and specific intrapartum and postpartum complications were significantly lower for women in intervention areas than control areas, despite similar rates of facility-based delivery and hospitalization for reported complications, in this exploratory analysis. Maternal nutrition interventions providing intensive counseling and micronutrient supplements may reduce some pregnancy complications or impact women's ability to accurately recognize complications, but more rigorous evaluation is needed for these outcomes.
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http://dx.doi.org/10.1371/journal.pmed.1002927DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777761PMC
October 2019
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