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Article ; Online: Capitalizing on Hope: Questionable Marketing Approval and Pricing of a New ALS Drug.

Flynn, Matthew B / Flynn, James F / Palacios, Ana M

International journal of social determinants of health and health services

2024 , Page(s) 27551938241247778

Abstract: Regulatory agencies must balance patient demands to access new treatments for fatal diseases with limited treatment options while ensuring drug safety and efficacy. However, questionable U.S. regulatory actions resulted in the early approval of AMX0035 ... ...

Abstract	Regulatory agencies must balance patient demands to access new treatments for fatal diseases with limited treatment options while ensuring drug safety and efficacy. However, questionable U.S. regulatory actions resulted in the early approval of AMX0035 to treat amyotrophic lateral sclerosis (ALS) by reconvening advisory commissions to obtain positive decisions and designating the drug as a new molecular entity. Data from one randomized clinical trial suggests minimal delays in disease progression and longer survivability, but debate remains about the lack of confirmatory evidence of effectiveness owing to study limitations. A patient's decision-making process details the experience of using the drug, including perspectives on access, cost, effectiveness, and adverse effects. In line with the "nichebuster" business model, the drugmaker, Amylyx Pharmaceuticals, is charging US$158,000/year/patient and thus forecast to turn a profit on a drug with debatable clinical effectiveness prior to completing a Phase 3 trial. Early marketing approval, despite community demands, is unnecessary and may have reduced access because of the end of a compassionate use program, and the high price tag results in restricted coverage and high out-of-pocket costs. Also, the drug's key ingredients are available as a generic and a supplement.
Language	English
Publishing date	2024-04-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	3156548-7
ISSN	2755-1946
ISSN (online)	2755-1946
DOI	10.1177/27551938241247778
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Article ; Online: Characterization of folic acid, 5-methyltetrahydrofolate and synthetic folinic acid in the high-affinity folate transporters: impact on pregnancy and development.

Palacios, Ana M / Feiner, Rachel A / Cabrera, Robert M

Reproductive and developmental medicine

2022 Volume 7, Issue 2, Page(s) 102–107

Abstract: Folates are B vitamins that are essential for several molecular, cellular, and biological processes, including nucleotide synthesis, methylation, and methionine cycling. The physiological impacts of these processes on health also extend to cell ... ...

Abstract	Folates are B vitamins that are essential for several molecular, cellular, and biological processes, including nucleotide synthesis, methylation, and methionine cycling. The physiological impacts of these processes on health also extend to cell proliferation, folate deficiency anemia, and reduction of the risk of birth defects during pregnancy. The primary objective of this study was to characterize the binding affinities of different folate forms, folic acid (FA), 5-methyltetrahydrofolate (5MTHF), and folinic acid, to the folate receptors α and β, and to the bovine milk folate binding protein. These three dietary forms of folate are found in enriched grains (FA), various fruits and leafy vegetables (folinic acid), and red blood cells (5MTHF). Methods: The half maximal inhibitory concentration values and binding curves of each of these folates for each receptor were determined. Results: Our results indicated that FA had the highest affinity for all folate receptors, followed by 5MTHF, and lastly, by folinic acid, examined by several orders of magnitudes. Conclusion: These data are expected to provide new insights into the therapeutic applications of the different forms of folate in a variety of diseases.
Language	English
Publishing date	2022-07-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	3046168-6
ISSN	2589-8728 ; 2096-2924
ISSN (online)	2589-8728
ISSN	2096-2924
DOI	10.1097/RD9.0000000000000034
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Article: Parental Knowledge and Perceptions on Prevention of Sudden Unexpected Infant Death and Infant Care.

Nazaruk, Dziyana / Palacios, Ana M / Chopak-Foss, Joanne / Mayo-Gamble, Tilicia L / Marshall, Nandi A

Children (Basel, Switzerland)

2023 Volume 10, Issue 9

Abstract: 1) Background: The study's purpose was to explore the knowledge, perceptions, and confidence of mothers about infant care to reduce the risk of sudden unexpected infant death. (2) Methods: A purposeful sampling method was used to recruit 15 first-time ... ...

Abstract	(1) Background: The study's purpose was to explore the knowledge, perceptions, and confidence of mothers about infant care to reduce the risk of sudden unexpected infant death. (2) Methods: A purposeful sampling method was used to recruit 15 first-time mothers from Georgia with infants under 1 year of age. The researchers utilized the Socio-ecological model to report the results. Participants also provided recommendations on how to improve infant care and reduce the risk of SUID. (3) Results: The confidence level of infant care among most participants was low but increased over time. Mothers' knowledge level about the prevention of SUID was high, but poor emotional health could hurt their parental abilities. Most participants recognized medical providers as the main source of reliable information. However, a lack of emotional and physical support was reported by mothers. (4) Conclusions: Results suggested that a more holistic approach to infant care is needed. The healthcare system and communities should provide more physical, social, and mental support to first-time mothers, a consolidated approach to care before and after birth, and easy access to services at all stages of the process to reduce the risk of SUID.
Language	English
Publishing date	2023-09-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2732685-8
ISSN	2227-9067
ISSN	2227-9067
DOI	10.3390/children10091550
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Article ; Online: Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial.

Palacios, Ana M / Cardel, Michelle I / Parker, Erik / Dickinson, Stephanie / Houin, Valerie R / Young, Bridget / Allison, David B

The American journal of clinical nutrition

2023 Volume 117, Issue 5, Page(s) 1035–1042

Abstract: Background: Expensive lactation cookies (LCs) are marketed as milk boosters; however, their effectiveness remains unknown.: Objectives: The objective of this study was to evaluate the effectiveness of the 1-mo daily intake of LCs on changes in ... ...

Abstract	Background: Expensive lactation cookies (LCs) are marketed as milk boosters; however, their effectiveness remains unknown. Objectives: The objective of this study was to evaluate the effectiveness of the 1-mo daily intake of LCs on changes in objective and subjective milk production and breastfeeding self-efficacy. Methods: This is a 1-mo, randomized controlled trial among 18-45-y-old exclusively lactating parents of healthy, term, 2-mo-old infants living in the United States from March to December 2021. Participants (n = 176) were randomly assigned to eat daily 56.5 g of either LCs with "galactagogues" (oatmeal, brewer's yeast, flax seeds, and fenugreek) or conventional cookies containing similar weight, calories, and presentation but lacking galactagogues. The primary outcome was baseline-to-1-mo changes in human milk production rate (HMPR), measured with a validated milk expression protocol. Secondary outcomes included changes in perceived insufficient milk (PIM) and lactation self-efficacy scores. Results: Among 176 randomly assigned participants (age: 31.3 ± 5.8 y; 71.0% self-identified as White, 15.3% Hispanic/Latin, 6.3% Black, and 4.0% Asian), 90 participants (51.1%) completed endline HMPR measures and 129 (73.3%) completed secondary outcomes. Imputed models showed a mean increase in HMPR of 5.8 ± 15.7 mL/h in control participants and 5.5 ± 17.6 mL/h in the LC participants after 1 mo of daily intake of the cookie. No significant differences were observed with adjusted linear mixed models on the multiply imputed data comparing baseline-to-endline changes in HMPR, PIM, or breastfeeding self-efficacy: mean (SE) difference-in-differences for HMPR, -0.33 (4.97), P = 0.948; PIM scores (range: 5-50), -0.52 (1.83), P = 0.775; and self-efficacy scores (range: 14-70), 0.31 (2.23), P = 0.888, respectively. Conclusions: This study found no evidence for the effect of consuming LCs on HMPR, PIM, or breastfeeding self-efficacy in exclusively breastfeeding parents with an overall adequate perceived milk supply. Recommendations to consume LCs for increasing objective or subjective milk supply may deliver false hope and unnecessary financial costs at a vulnerable time. Trial registration number: This trial was registered at clinicaltrials.gov as NCT04805008.
MeSH term(s)	Infant ; Female ; Humans ; Adult ; Breast Feeding ; Lactation ; Milk, Human ; Energy Intake
Language	English
Publishing date	2023-03-14
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	280048-2
ISSN	1938-3207 ; 0002-9165
ISSN (online)	1938-3207
ISSN	0002-9165
DOI	10.1016/j.ajcnut.2023.03.010
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Article ; Online: Pulmonary Nodular Amyloidosis. A Rare Cause of Multiple Pulmonary Nodules.

Ruiz-Álvarez, Inés / Gutiérrez Palacios, Ana M / Rodríguez Díaz, Beatriz

Archivos de bronconeumologia

2020 Volume 57, Issue 3, Page(s) 227

Title translation	Amiloidosis nodular pulmonar, una causa infrecuente de nódulos pulmonares múltiples.
MeSH term(s)	Amyloidosis ; Humans ; Lung/diagnostic imaging ; Multiple Pulmonary Nodules/diagnostic imaging
Language	Spanish
Publishing date	2020-01-03
Document type	Journal Article
ZDB-ID	733126-5
ISSN	1579-2129 ; 0300-2896
ISSN (online)	1579-2129
ISSN	0300-2896
DOI	10.1016/j.arbres.2019.11.024
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Article ; Online: Differences in factors associated with anemia in Haitian children from urban and rural areas.

Palacios, Ana M / Freeland-Graves, Jeanne H / Dulience, Sherlie Jean-Louis / Delnatus, Jacques Raymond / Iannotti, Lora L

PloS one

2021 Volume 16, Issue 4, Page(s) e0247975

Abstract: Background: In Haiti, differences in the prevalence of anemia between urban and rural areas have been observed.: Objective: To identify moderating factors that may help explain the difference in the prevalence of anemia in children from poor urban vs. ...

Abstract	Background: In Haiti, differences in the prevalence of anemia between urban and rural areas have been observed. Objective: To identify moderating factors that may help explain the difference in the prevalence of anemia in children from poor urban vs. rural areas of Haiti. Methods: This cross-sectional study used secondary data from urban and rural school-based trials that assessed the effectiveness of a nutrition intervention. The study was registered at ClinicalTrials.gov as NCT02747524. A total of 300 rural- and 981 urban- children between 2.5-13 years of age were included in this analysis. Effect modification in a binary logistic generalized linear mixed model was conducted using sample weights in SPSS® version 26. Models were adjusted for age and income. School cluster was included as random effect. Results: In rural areas, stunting was more prevalent in children with anemia vs. no anemia, (16.6%, and 6.3%, P = 0.008), respectively. Also, rural children with anemia lived with fewer adults vs. rural children with no anemia, ([Formula: see text] = 2.83±1.29, and 3.30±1.54, P = 0.005), respectively. In poor urban areas, helminth morbidities were more frequent in children with anemia vs. no anemia, (21.9% vs. 13.9, P = 0.011), respectively. In the combined sample, stunting, [AOR = 2.05; 95%CI (1.32-3.18)], age [AOR = 0.89; 95%CI (0.85-0.93)], and households with more adults [AOR = 0.77; 95%CI (0.67-0.87)] were associated with anemia. Effect modification by place of residence was observed in households with more adults (t = 3.83, P<0.001). No other nutritional, dietary, sanitation or morbidity factors or effect modifiers were observed. Conclusions: In this sample, factors associated with anemia differed in poor urban and rural children from Haiti including family structure and helminth morbidities. Stunting and lower age increased the odds of anemia in the combined sample. Family structure appears to have an important role in anemia, and further research understanding the influence of family structures in anemia is needed.
MeSH term(s)	Adolescent ; Anemia/epidemiology ; Body Mass Index ; Child ; Child, Preschool ; Cross-Sectional Studies ; Diet ; Family Characteristics ; Female ; Growth Disorders/epidemiology ; Haiti/epidemiology ; Humans ; Infant ; Male ; Prevalence ; Risk Factors ; Rural Population ; Schools ; Socioeconomic Factors ; Urban Population
Language	English
Publishing date	2021-04-06
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0247975
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Article ; Online: Children Receiving a Nutrition and High-Quality Early Childhood Education Intervention Are Associated with Greater Math and Fluid Intelligence Scores: The Guatemala City Municipal Nurseries.

Palacios, Ana M / Villanueva, Lisa M / Flynn, Matthew B / Parker, Erik / Dickinson, Stephanie / Bland, Helen W / Reinhart, Greg A

Nutrients

2022 Volume 14, Issue 7

Abstract: Background: About 47% of children < 5 years of age are stunted in Guatemala. In this study, the investigators aimed to compare growth and cognitive outcomes between children in second grade that attended five Guatemala City Municipal Nurseries (GCMN) vs. ...

Abstract	Background: About 47% of children < 5 years of age are stunted in Guatemala. In this study, the investigators aimed to compare growth and cognitive outcomes between children in second grade that attended five Guatemala City Municipal Nurseries (GCMN) vs. same sex, grade, and age-matched children. Methods: A cross-sectional design nested in a retrospective cohort was implemented between 2015 and 2019. Children that attended the GCMN and matched controls completed a math test and validated receptive language and fluid intelligence tests. The primary caregivers completed a sociodemographic survey. General and generalized linear mixed effect models were used to compare children that attended the GCMN vs. controls. The models were adjusted by maternal education, sex, asset score, and other relevant covariates. Results: Children that attended the GCMN exhibited greater math and fluid intelligence scores relative to the controls in the adjusted models (ß = 6.48; 95% CI (2.35−10.61)) and (ß = 1.20; 95% CI (0.12−2.29)), respectively. Lower odds of stunting were significant for children who went to any early childcare institution (AOR = 0.28; 95% CI (0.09−0.89)). Conclusions: The importance of integrating nutrition and high-quality early childhood education interventions in cognitive and growth outcomes is highlighted in this study. The GCMN model may be a scalable model in similar low-resource settings.
MeSH term(s)	Child ; Child, Preschool ; Cross-Sectional Studies ; Growth Disorders ; Guatemala/epidemiology ; Humans ; Infant ; Intelligence ; Nurseries, Infant ; Retrospective Studies
Language	English
Publishing date	2022-03-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2518386-2
ISSN	2072-6643 ; 2072-6643
ISSN (online)	2072-6643
ISSN	2072-6643
DOI	10.3390/nu14071366
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Article ; Online: The Effects of Multiple Micronutrient Fortified Beverage and Responsive Caregiving Interventions on Early Childhood Development, Hemoglobin, and Ferritin among Infants in Rural Guatemala.

Kowalski, Alysse J / Mayen, Victor Alfonso / de Ponce, Silvia / Lambden, Kaley B / Tilton, Nick / Villanueva, Lisa M / Palacios, Ana M / Reinhart, Gregory A / Hurley, Kristen M / Black, Maureen M

Nutrients

2023 Volume 15, Issue 9

Abstract: Undernutrition and a lack of learning opportunities can jeopardize long-term growth and development among infants in low- and middle-income countries. We conducted a 6-month 2 × 2 cluster-randomized trial to assess the effects of multiple micronutrient- ... ...

Abstract	Undernutrition and a lack of learning opportunities can jeopardize long-term growth and development among infants in low- and middle-income countries. We conducted a 6-month 2 × 2 cluster-randomized trial to assess the effects of multiple micronutrient-fortified beverages and responsive caregiving interventions among infants 6-18 months in 72 community sectors in southwest Guatemala. We administered baseline and endline assessments of childhood development (Bayley Scales of Infant and Toddler Development) and socioemotional development (Brief Infant Toddler Socio-Emotional Assessment) and measured ferritin and hemoglobin on a subsample. The trial was analyzed using linear mixed models. At the baseline, the mean age (SD) was 13.0 (4.6) months, including 49% males, 32% who were stunted, 55% who were anemic, and 58% who were iron deficient. At the endline (
MeSH term(s)	Female ; Humans ; Infant ; Male ; Beverages ; Child Development ; Ferritins ; Guatemala ; Hemoglobins ; Micronutrients
Chemical Substances	Ferritins (9007-73-2) ; Hemoglobins ; Micronutrients
Language	English
Publishing date	2023-04-25
Publishing country	Switzerland
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2518386-2
ISSN	2072-6643 ; 2072-6643
ISSN (online)	2072-6643
ISSN	2072-6643
DOI	10.3390/nu15092062
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Article ; Online: CartoCell, a high-content pipeline for 3D image analysis, unveils cell morphology patterns in epithelia.

Andrés-San Román, Jesús A / Gordillo-Vázquez, Carmen / Franco-Barranco, Daniel / Morato, Laura / Fernández-Espartero, Cecilia H / Baonza, Gabriel / Tagua, Antonio / Vicente-Munuera, Pablo / Palacios, Ana M / Gavilán, María P / Martín-Belmonte, Fernando / Annese, Valentina / Gómez-Gálvez, Pedro / Arganda-Carreras, Ignacio / Escudero, Luis M

Cell reports methods

2023 Volume 3, Issue 10, Page(s) 100597

Abstract: Decades of research have not yet fully explained the mechanisms of epithelial self-organization and 3D packing. Single-cell analysis of large 3D epithelial libraries is crucial for understanding the assembly and function of whole tissues. Combining 3D ... ...

Abstract	Decades of research have not yet fully explained the mechanisms of epithelial self-organization and 3D packing. Single-cell analysis of large 3D epithelial libraries is crucial for understanding the assembly and function of whole tissues. Combining 3D epithelial imaging with advanced deep-learning segmentation methods is essential for enabling this high-content analysis. We introduce CartoCell, a deep-learning-based pipeline that uses small datasets to generate accurate labels for hundreds of whole 3D epithelial cysts. Our method detects the realistic morphology of epithelial cells and their contacts in the 3D structure of the tissue. CartoCell enables the quantification of geometric and packing features at the cellular level. Our single-cell cartography approach then maps the distribution of these features on 2D plots and 3D surface maps, revealing cell morphology patterns in epithelial cysts. Additionally, we show that CartoCell can be adapted to other types of epithelial tissues.
MeSH term(s)	Humans ; Imaging, Three-Dimensional/methods ; Image Processing, Computer-Assisted/methods ; Epithelium ; Epithelial Cells ; Cysts
Language	English
Publishing date	2023-09-25
Publishing country	United States
Document type	Journal Article
ISSN	2667-2375
ISSN (online)	2667-2375
DOI	10.1016/j.crmeth.2023.100597
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Article ; Online: A quantitative biophysical principle to explain the 3D cellular connectivity in curved epithelia.

Gómez-Gálvez, Pedro / Vicente-Munuera, Pablo / Anbari, Samira / Tagua, Antonio / Gordillo-Vázquez, Carmen / Andrés-San Román, Jesús A / Franco-Barranco, Daniel / Palacios, Ana M / Velasco, Antonio / Capitán-Agudo, Carlos / Grima, Clara / Annese, Valentina / Arganda-Carreras, Ignacio / Robles, Rafael / Márquez, Alberto / Buceta, Javier / Escudero, Luis M

Cell systems

2022 Volume 13, Issue 8, Page(s) 631–643.e8

Abstract: Epithelial cell organization and the mechanical stability of tissues are closely related. In this context, it has been recently shown that packing optimization in bended or folded epithelia is achieved by an energy minimization mechanism that leads to a ... ...

Abstract	Epithelial cell organization and the mechanical stability of tissues are closely related. In this context, it has been recently shown that packing optimization in bended or folded epithelia is achieved by an energy minimization mechanism that leads to a complex cellular shape: the "scutoid". Here, we focus on the relationship between this shape and the connectivity between cells. We use a combination of computational, experimental, and biophysical approaches to examine how energy drivers affect the three-dimensional (3D) packing of tubular epithelia. We propose an energy-based stochastic model that explains the 3D cellular connectivity. Then, we challenge it by experimentally reducing the cell adhesion. As a result, we observed an increment in the appearance of scutoids that correlated with a decrease in the energy barrier necessary to connect with new cells. We conclude that tubular epithelia satisfy a quantitative biophysical principle that links tissue geometry and energetics with the average cellular connectivity.
MeSH term(s)	Biophysics ; Cell Shape ; Epithelial Cells ; Epithelium ; Models, Biological
Language	English
Publishing date	2022-07-13
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2854138-8
ISSN	2405-4720 ; 2405-4712
ISSN (online)	2405-4720
ISSN	2405-4712
DOI	10.1016/j.cels.2022.06.003
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