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Article ; Online: Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy.

Thurman, A / Hull, L / Stuckey, B / Hatheway, J / Mauck, C / Zack, N / Friend, D

Climacteric : the journal of the International Menopause Society

2023 Volume 26, Issue 5, Page(s) 479–488

Abstract: Objective: This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy.: Methods: This was a randomized, ... ...

Abstract	Objective: This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy. Methods: This was a randomized, placebo-controlled, double-blind, phase 1/2 study of DARE-VVA1, in four doses (1, 5, 10 and 20 mg). Results: Seventeen women were enrolled and 14 completed the 8-week treatment. DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups. Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose. Active study product users had significant decreases from pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells ( Conclusions: DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product.
MeSH term(s)	Female ; Humans ; Atrophy/drug therapy ; Capsules/adverse effects ; Double-Blind Method ; Dyspareunia/drug therapy ; Gelatin/adverse effects ; Postmenopause ; Tamoxifen/adverse effects ; Treatment Outcome ; Vagina/pathology ; Vaginal Diseases/drug therapy ; Vulva/pathology
Chemical Substances	Capsules ; Gelatin (9000-70-8) ; Tamoxifen (094ZI81Y45)
Language	English
Publishing date	2023-06-08
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	1469153-x
ISSN	1473-0804 ; 1369-7137
ISSN (online)	1473-0804
ISSN	1369-7137
DOI	10.1080/13697137.2023.2211763
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Article: A comparative study of zero-shot inference with large language models and supervised modeling in breast cancer pathology classification.

Sushil, Madhumita / Zack, Travis / Mandair, Divneet / Zheng, Zhiwei / Wali, Ahmed / Yu, Yan-Ning / Quan, Yuwei / Butte, Atul J

Research square

2024

Abstract: Although supervised machine learning is popular for information extraction from clinical notes, creating large, annotated datasets requires extensive domain expertise and is time-consuming. Meanwhile, large language models (LLMs) have demonstrated ... ...

Abstract	Although supervised machine learning is popular for information extraction from clinical notes, creating large, annotated datasets requires extensive domain expertise and is time-consuming. Meanwhile, large language models (LLMs) have demonstrated promising transfer learning capability. In this study, we explored whether recent LLMs can reduce the need for large-scale data annotations. We curated a manually labeled dataset of 769 breast cancer pathology reports, labeled with 13 categories, to compare zero-shot classification capability of the GPT-4 model and the GPT-3.5 model with supervised classification performance of three model architectures: random forests classifier, long short-term memory networks with attention (LSTM-Att), and the UCSF-BERT model. Across all 13 tasks, the GPT-4 model performed either significantly better than or as well as the best supervised model, the LSTM-Att model (average macro F1 score of 0.83 vs. 0.75). On tasks with a high imbalance between labels, the differences were more prominent. Frequent sources of GPT-4 errors included inferences from multiple samples and complex task design. On complex tasks where large annotated datasets cannot be easily collected, LLMs can reduce the burden of large-scale data labeling. However, if the use of LLMs is prohibitive, the use of simpler supervised models with large annotated datasets can provide comparable results. LLMs demonstrated the potential to speed up the execution of clinical NLP studies by reducing the need for curating large annotated datasets. This may increase the utilization of NLP-based variables and outcomes in observational clinical studies.
Language	English
Publishing date	2024-02-06
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3914899/v1
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Article ; Online: Effect of captivity on the vertebral bone microstructure of xenarthran mammals.

Zack, Ellianna H / Smith, Stephanie M / Angielczyk, Kenneth D

Anatomical record (Hoboken, N.J. : 2007)

2021 Volume 305, Issue 7, Page(s) 1611–1628

Abstract: Captive specimens in museum collections facilitate study of rare taxa, but the lifestyles, diets, and lifespans of captive animals differ from their wild counterparts. Trabecular bone architecture adapts to in vivo forces, and may reflect interspecific ... ...

Abstract	Captive specimens in museum collections facilitate study of rare taxa, but the lifestyles, diets, and lifespans of captive animals differ from their wild counterparts. Trabecular bone architecture adapts to in vivo forces, and may reflect interspecific variation in ecology and behavior as well as intraspecific variation between captive and wild specimens. We compared trunk vertebrae bone microstructure in captive and wild xenarthran mammals to test the effects of ecology and captivity. We collected μCT scans of the last six presacral vertebrae in 13 fossorial, terrestrial, and suspensorial xenarthran species (body mass: 120 g to 35 kg). For each vertebra, we measured centrum length; bone volume fraction (BV.TV); trabecular number and mean thickness (Tb.Th); global compactness (GC); cross-sectional area; mean intercept length; star length distribution; and connectivity and connectivity density. Wild specimens have more robust trabeculae, but this varies with species, ecology, and pathology. Wild specimens of fossorial taxa (Dasypus) have more robust trabeculae than captives, but there is no clear difference in bone microstructure between wild and captive specimens of suspensorial taxa (Bradypus, Choloepus), suggesting that locomotor ecology influences the degree to which captivity affects bone microstructure. Captive Tamandua and Myrmecophaga have higher BV.TV, Tb.Th, and GC than their wild counterparts due to captivity-caused bone pathologies. Our results add to the understanding of variation in mammalian bone microstructure, suggest caution when including captive specimens in bone microstructure research, and indicate the need to better replicate the habitats, diets, and behavior of animals in captivity.
MeSH term(s)	Animals ; Bone Density ; Bone and Bones ; Mammals ; Spine/diagnostic imaging
Language	English
Publishing date	2021-11-01
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	2269667-2
ISSN	1932-8494 ; 1932-8486
ISSN (online)	1932-8494
ISSN	1932-8486
DOI	10.1002/ar.24817
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Article ; Online: Assessing Telehealth Through the Lens of the Provider: Considerations for the Post-COVID-19 Era.

Balchander, Divya / Cabrera, Claudia I / Zack, Brian / Porter, Stacy / Sunshine, Jeffrey / D'Anza, Brian

Telemedicine journal and e-health : the official journal of the American Telemedicine Association

2022

Abstract: Introduction: ...

Abstract	Introduction:
Language	English
Publishing date	2022-04-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	2035659-6
ISSN	1556-3669 ; 1530-5627
ISSN (online)	1556-3669
ISSN	1530-5627
DOI	10.1089/tmj.2021.0508
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Article ; Online: A phase 1/2, open-label, parallel group study to evaluate the safety and pharmacokinetics of DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8 mg progesterone intravaginal rings) over 12 weeks in healthy postmenopausal women.

Thurman, Andrea / Hull, M Louise / Stuckey, Bronwyn / Hatheway, Jessica / Zack, Nadene / Mauck, Christine / Friend, David

Menopause (New York, N.Y.)

2023 Volume 30, Issue 8, Page(s) 817–823

Abstract: ... to either DARE-HRT1 IVR1 (E2 80 μg/d with P4 4 mg/d) or DARE-HRT1 IVR2 (E2 160 μg/d with P4 8 mg/d). They used the IVR ...

Abstract	Objectives: Primary objectives were to evaluate the safety and systemic pharmacokinetics (PK) of DARE-HRT1, an intravaginal ring (IVR), which releases 17β2-Estradiol (E2) with progesterone (P4) for 28 days in healthy postmenopausal women. Methods: This was a randomized, open-label, 2-arm, parallel group study in 21 healthy postmenopausal women with an intact uterus. Women were randomized (1:1) to either DARE-HRT1 IVR1 (E2 80 μg/d with P4 4 mg/d) or DARE-HRT1 IVR2 (E2 160 μg/d with P4 8 mg/d). They used the IVR for three 28-day cycles, inserting a new IVR monthly. Safety was measured by treatment emergent adverse events and changes in systemic laboratories and the endometrial bilayer width. Baseline adjusted plasma PK of E2, P4, and estrone (E1) was described. Results: Both DARE-HRT1 IVR were safe. All treatment emergent adverse events were mild or moderate and were distributed similarly among IVR1 versus IVR2 users. Month 3 median maximum plasma ( Cmax ) P4 concentrations were 2.81 and 3.51 ng/mL and Cmax E2 was 42.95 and 77.27 pg/mL for IVR1 and IVR2 groups, respectively. Month 3 median steady state ( Css ) plasma P4 concentrations were 1.19 and 1.89 ng/mL, and Css E2 was 20.73 and 38.16 pg/mL for IVR1 and IVR2 users, respectively. Conclusions: Both DARE-HRT1 IVRs were safe and released E2 in systemic concentrations, which were in the low, normal premenopausal range. Systemic P4 concentrations predict endometrial protection. Data from this study support further development of DARE-HRT1 for the treatment of menopausal symptoms.
MeSH term(s)	Female ; Humans ; Progesterone ; Postmenopause ; Estradiol ; Estrone ; Premenopause
Chemical Substances	Progesterone (4G7DS2Q64Y) ; Estradiol (4TI98Z838E) ; Estrone (2DI9HA706A)
Language	English
Publishing date	2023-06-20
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1205262-0
ISSN	1530-0374 ; 1072-3714
ISSN (online)	1530-0374
ISSN	1072-3714
DOI	10.1097/GME.0000000000002210
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Article ; Online: A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8 mg progesterone intravaginal RinGSM) over 12 weeks in healthy postmenopausal women.

Thurman, Andrea / Hull, M Louise / Stuckey, Bronwyn / Hatheway, Jessica / Zack, Nadene / Mauck, Christine / Friend, David

Menopause (New York, N.Y.)

2023 Volume 30, Issue 9, Page(s) 940–946

Abstract: ... d with P4 4 mg/d) or DARE-HRT1 IVR2 (E2 160 μg/d with P4 8 mg/d). They used the assigned IVR ...

Abstract	Objectives: The exploratory objectives of this study were to evaluate the usability and acceptability and to conduct a preliminary evaluation of the efficacy of DARE-HRT1. DARE-HRT1 is an intravaginal ring (IVR) that releases 17β2-estradiol (E2) with progesterone (P4) over 28 days. It is the first combination E2 and P4 IVR being developed for the treatment of vasomotor symptoms (VMS) in healthy postmenopausal women with an intact uterus. Methods: This was a randomized, open-label, 2-arm, parallel group study in 21 healthy postmenopausal women. Women were randomized (1:1) to either DARE-HRT1 IVR1 (E2 80 μg/d with P4 4 mg/d) or DARE-HRT1 IVR2 (E2 160 μg/d with P4 8 mg/d). They used the assigned IVR for three 28-day cycles, inserting a new IVR monthly. Preliminary genitourinary syndrome of menopause (GSM) treatment efficacy was estimated by measuring changes from baseline in vaginal pH, vaginal maturation index (VMI), and changes in the severity of GSM symptoms. Preliminary systemic VMS efficacy was measured by changes in responses to the Menopause-Specific Quality of Life (MENQOL) questionnaire. Acceptability was assessed by product experience surveys. Results: Preliminary local GSM treatment efficacy was supported by significant decreases in vaginal pH and % parabasal cells, and significant increases in the overall VMI and % superficial cells for both IVR groups (all P values <0.01). Preliminary VMS efficacy was supported by significant decreases in all domains of the MENQOL questionnaire from baseline for both dosing groups (all P values <0.01). Conclusions: Data from this study support further development of DARE-HRT1 for the treatment of menopausal symptoms.
MeSH term(s)	Humans ; Female ; Quality of Life ; Progesterone ; Postmenopause ; Health Status ; Estradiol
Chemical Substances	Progesterone (4G7DS2Q64Y) ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2023-08-07
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1205262-0
ISSN	1530-0374 ; 1072-3714
ISSN (online)	1530-0374
ISSN	1072-3714
DOI	10.1097/GME.0000000000002230
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Article: Intercellular communication atlas reveals Oprm1 as a neuroprotective factor for retinal ganglion cells.

Qian, Cheng / Xin, Ying / Cheng, Qi / Wang, Hui / Zack, Donald / Blackshaw, Seth / Hattar, Samer / Feng-Quan, Zhou / Qian, Jiang

Research square

2023

Abstract: The progressive death of mature neurons often results in neurodegenerative diseases. While the previous studies have mostly focused on identifying intrinsic mechanisms controlling neuronal survival, the extracellular environment also plays a critical ... ...

Abstract	The progressive death of mature neurons often results in neurodegenerative diseases. While the previous studies have mostly focused on identifying intrinsic mechanisms controlling neuronal survival, the extracellular environment also plays a critical role in regulating cell viability. Here we explore how intercellular communication contributes to the survival of retinal ganglion cells (RGCs) following the optic nerve crush (ONC). Although the direct effect of the ONC is restricted to the RGCs, we observed transcriptomic responses in other retinal cells to the injury based on the single-cell RNA-seq, with astrocytes and Müller glia having the most interactions with RGCs. By comparing the RGC subclasses showing distinct resilience to ONC-induced cell death, we found that the high-survival RGCs tend to have more ligand-receptor interactions with other retinal cells, suggesting that these RGCs are intrinsically programmed to foster more communication with their surroundings. Furthermore, we identified top 47 interactions that are stronger in the high-survival RGCs, likely representing neuroprotective interactions. We performed functional assays on one of the receptors, μ opioid receptor (Oprm1), a receptor known to play roles in regulating pain, reward, and addictive behavior. Although Oprm1 is preferentially expressed in intrinsically photosensitive retinal ganglion cells (ipRGCs), its neuroprotective effect could be transferred to multiple RGC subclasses by specific overexpressing Oprm1 in pan-RGCs in ONC, excitotoxicity, and glaucoma models. Lastly, manipulating Oprm1 activity improved visual functions and altered pupillary light response in mice. Our study provides an atlas of cell-cell interactions in both intact and post-ONC retina and an effective strategy to predict molecular mechanisms in neuroprotection, underlying the principal role played by extracellular environment in supporting neuron survival.
Language	English
Publishing date	2023-08-17
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3193738/v1
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Article ; Online: Environmental Injustice Is Associated With Poorer Asthma Outcomes in School-Age Children With Asthma in Metropolitan Atlanta, Georgia.

Grunwell, Jocelyn R / Mutic, Abby D / Ezhuthachan, Idil D / Mason, Carrie / Tidwell, Mallory / Caldwell, Cherish / Norwood, Jalicae / Zack, Sydney / Jordan, Natalie / Fitzpatrick, Anne M

The journal of allergy and clinical immunology. In practice

2024

Abstract: Background: Environmental justice mandates that no person suffers disproportionately from environmental exposures. The Environmental Justice Index (EJI) provides an estimate of the environmental burden for each census tract but has not yet been used in ... ...

Abstract	Background: Environmental justice mandates that no person suffers disproportionately from environmental exposures. The Environmental Justice Index (EJI) provides an estimate of the environmental burden for each census tract but has not yet been used in asthma populations. Objective: We hypothesized that children from census tracts with high environmental injustice determined by the EJI would have a greater burden of asthma exacerbations, poorer asthma control, and poorer lung function over 12 months. Methods: Children aged 6 to 18 years with asthma (N = 575) from metropolitan Atlanta, Georgia, completed a baseline research visit. Participant addresses were geocoded to obtain the EJI Social-Environmental Ranking for each participant's census tract, which was divided into tertiles. Medical records were reviewed for 12 months for asthma exacerbations. A subset of participants completed a second research visit involving spirometry and questionnaires. Results: Census tracts with the greatest environmental injustice had more racial and ethnic minorities, lower socioeconomic status, more hazardous exposures (particularly to airborne pollutants), and greater proximity to railroads and heavily trafficked roadways. Children with asthma residing in high injustice census tracts had a longer duration of asthma, greater historical asthma-related health care utilization, poorer asthma symptom control and quality of life, and more impaired lung function. By 12 months, children from high injustice census tracts also had more asthma exacerbations with a shorter time to exacerbation and persistently more symptoms, poorer asthma control, and reduced lung function. Conclusions: Disparities in environmental justice are present in metropolitan Atlanta that may contribute to asthma outcomes in children. These findings require an additional study and action to improve health equity.
Language	English
Publishing date	2024-02-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2024.02.015
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Article: Defining incidence and complications of fibrolamellar liver cancer through tiered computational analysis of clinical data.

Zack, Travis / Losert, Kurt P / Maisel, Samantha M / Wild, Jennifer / Yaqubie, Amin / Herman, Michael / Knox, Jennifer J / Mayer, Robert J / Venook, Alan P / Butte, Atul / O'Neill, Allison F / Abou-Alfa, Ghassan K / Gordan, John D

NPJ precision oncology

2023 Volume 7, Issue 1, Page(s) 29

Abstract: The incidence and biochemical consequences of rare tumor subtypes are often hard to study. Fibrolamellar liver cancer (FLC) is a rare malignancy affecting adolescents and young adults. To better characterize the incidence and biochemical consequences of ... ...

Abstract	The incidence and biochemical consequences of rare tumor subtypes are often hard to study. Fibrolamellar liver cancer (FLC) is a rare malignancy affecting adolescents and young adults. To better characterize the incidence and biochemical consequences of this disease, we combined a comprehensive analysis of the electronic medical record and national payer data and found that FLC incidence is likely five to eight times higher than previous estimates. By employing unsupervised learning on clinical laboratory data from patients with hyperammonemia, we find that FLC-associated hyperammonemia mirrors metabolic dysregulation in urea cycle disorders. Our findings demonstrate that advanced computational analysis of rich clinical datasets can provide key clinical and biochemical insights into rare cancers.
Language	English
Publishing date	2023-03-23
Publishing country	England
Document type	Journal Article
ISSN	2397-768X
ISSN	2397-768X
DOI	10.1038/s41698-023-00371-2
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Article ; Online: Successful postcoital testing of Ovaprene: An investigational non-hormonal monthly vaginal contraceptive.

Mauck, Christine / Thurman, Andrea / Jensen, Jeffrey T / Schreiber, Courtney A / Baker, Jeff / Hou, Melody Y / Chavoustie, Steven / Dart, Clint / Wu, Hongsheng / Zack, Nadene / Hatheway, Jessica / Friend, David

Contraception

2024 Volume 132, Page(s) 110373

Abstract: Objective: Evaluate reduction in progressively motile sperm per high power field (HPF) in midcycle cervical mucus after intercourse with Ovaprene: an investigational monthly non-hormonal vaginal contraceptive consisting of a vaginal ring and mechanical ... ...

Abstract	Objective: Evaluate reduction in progressively motile sperm per high power field (HPF) in midcycle cervical mucus after intercourse with Ovaprene: an investigational monthly non-hormonal vaginal contraceptive consisting of a vaginal ring and mechanical barrier, releasing spermiostatic ferrous gluconate. Study design: Open-label, multicenter study enrolling heterosexually-active women with previous permanent contraception. Participants underwent a baseline postcoital test cycle with no device to confirm the presence of sperm, followed by one diaphragm postcoital test cycle, one Ovaprene safety cycle, and two Ovaprene postcoital test cycles. In each postcoital test cycle, participants underwent a midcycle cervical mucus evaluation to confirm an Insler score ≥10 and absence of sperm, and then returned two to four hours after vaginal intercourse for repeat cervical mucus evaluation. We considered <5 progressively motile sperm/HPF indicative of preliminary contraceptive effectiveness. Results: We enrolled 38 participants; 23 completed the study. All participants had ≥5 progressively motile sperm/HPF in the baseline cycle and <5 progressively motile sperm/HPF in all 49 Ovaprene cycles and all 35 diaphragm cycles, meeting the definition of a successful postcoital test. This was true regardless of examiner blinding, prior vaginal delivery or vaginal ring use, body mass index, or dislodgements noted by the participant or investigator. The mean of 27.2 (±17.9) progressively motile sperm/HPF in baseline postcoital test cycles was reduced to 0.5 (±1.1) and 0.5 (±1.3) progressively motile sperm/HPF in the first and second Ovaprene cycles, respectively. Ovaprene fit all participants and all could insert, position, and remove it. Conclusion: Use of Ovaprene resulted in meeting the prespecified criterion for contraceptive effect by all participants during all postcoital test cycles. Implications: The finding that use of Ovaprene, an investigational monthly non-hormonal vaginal contraceptive, resulted in postcoital testing of cervical mucus that met the pre-specified definition of success (<5 progressively motile sperm/HPF) supports further evaluation of contraceptive efficacy of the device in users at risk for pregnancy.
MeSH term(s)	Male ; Pregnancy ; Humans ; Female ; Semen ; Contraceptive Devices, Female ; Vagina ; Body Mass Index ; Contraceptive Agents
Chemical Substances	Contraceptive Agents
Language	English
Publishing date	2024-01-15
Publishing country	United States
Document type	Multicenter Study ; Journal Article
ZDB-ID	80106-9
ISSN	1879-0518 ; 0010-7824
ISSN (online)	1879-0518
ISSN	0010-7824
DOI	10.1016/j.contraception.2024.110373
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