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  1. Article ; Online: What's Past Is Prologue: Clinical Pharmacology at the Intersection of Science, Policy, and Patients.

    Zineh, Issam / Hartman, Dan

    Clinical pharmacology and therapeutics

    2019  Volume 107, Issue 1, Page(s) 33–36

    MeSH term(s) Drug Development ; Humans ; Inventions ; Organizational Innovation ; Organizations, Nonprofit ; Pharmacology, Clinical/economics ; Pharmacology, Clinical/trends ; Policy ; United States ; United States Food and Drug Administration
    Language English
    Publishing date 2019-11-01
    Publishing country United States
    Document type Journal Article
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.1650
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: A Test of Autonomy Restoration Postscripts to Mitigate Psychological Reactance to an Opt-Out Organ Donor Registry in the United States.

    Quick, Brian L / Kriss, Lauren A / Morrow, Ethan / Hartman, Dan / Koester, Brenda

    Health communication

    2023  , Page(s) 1–13

    Abstract: The organ shortage continues to present problems around the world including the United States. In response, some countries have switched from an opt-in organ donor registry to an opt-out registry. The United States currently utilizes an opt-in registry ... ...

    Abstract The organ shortage continues to present problems around the world including the United States. In response, some countries have switched from an opt-in organ donor registry to an opt-out registry. The United States currently utilizes an opt-in registry where an individual is not considered an organ donor until they register their intentions. In the current study, U.S. adults were randomly assigned to a 2 (message valence: promotional, refutational) x 2 (autonomy restoration postscript: present, not present) x 2 (social proof: high likes, low likes) posttest only control group design evaluating social media message regarding an opt-out organ donor registry for implementation in the U.S. Results revealed an interaction between message valence and autonomy on freedom threat perceptions toward the message. Consistent with psychological reactance theory, freedom threat perceptions were positively associated with reactance, which in turn was positively associated with an intention to sign a petition and call a representative to voice disapproval of the opt-out organ donor registry. The discussion is focused on pragmatic recommendations for organ donor practitioners and advocates as well as the theoretical contributions to reactance theory.
    Language English
    Publishing date 2023-07-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 1038723-7
    ISSN 1532-7027 ; 1041-0236
    ISSN (online) 1532-7027
    ISSN 1041-0236
    DOI 10.1080/10410236.2023.2232607
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Can endometrial thickness at baseline or maximum stimulated levels during IVF predict the presence of endometrial polyps in women with two failed embryo transfers?

    Hussaini, Sofia / Nayot, Dan / Hartman, Michael / Dahan, Michael H

    Archives of gynecology and obstetrics

    2022  Volume 307, Issue 5, Page(s) 1645–1653

    Abstract: Purpose: To evaluate whether different measurements of endometrial thickness pre-IVF cycle and during the IVF cycles as measured by transvaginal ultrasound are associated with the absence or presence of endometrial polyps.: Design: A retrospective ... ...

    Abstract Purpose: To evaluate whether different measurements of endometrial thickness pre-IVF cycle and during the IVF cycles as measured by transvaginal ultrasound are associated with the absence or presence of endometrial polyps.
    Design: A retrospective cohort study was conducted in a university-affiliated fertility center. Patients were women who underwent two embryo transfer cycles and failed to conceive.
    Interventions: hysteroscopic evaluation and resection of any masses.
    Results: There was no difference on comparing the groups with and without polyps in the mean endometrial thicknesses at baseline scans pre-treatment or during IVF cycle. For women who failed two embryo transfer cycles, at any given endometrial thickness the probability of the presence of a polyp was 30-40%. ROC curves failed to detect an actionable relationship with different endometrial thicknesses and the relationship with an endometrial polyp, with most areas under the curve being just above 0.5. However, once the maximum stimulated endometrial thickness was ≥ 13 mm, there was a 70% chance of a polyp being noted at hysteroscopy. This was a statistical difference in the probability of a polyp being present as compared to the lesser thicknesses (p = 0.05).
    Conclusion: Baseline or maximum stimulated endometrial thickness at IVF fails to predict with accuracy the presence of a polyp. However, if the maximum stimulated thickness was at least 13 mm, there was a higher probability of a uterine polyp being present. Such a cutoff would nevertheless miss most polyps. At any baseline thickness on CD 2-5, a polyp has a 30-40% probability of being present in women who failed two embryo transfers. ROC curves suggest that at baseline, or maximum stimulated endometrial thickness, the ability to predict a polyp is no better than flipping a coin. As such, endometrial cavity evaluation for polyps is legitimate in women with two embryo transfers irrelevant of the baseline or stimulated thickness.
    MeSH term(s) Pregnancy ; Humans ; Female ; Male ; Retrospective Studies ; Uterine Neoplasms/pathology ; Endometrium/diagnostic imaging ; Endometrium/pathology ; Hysteroscopy ; Embryo Transfer ; Polyps/diagnostic imaging ; Polyps/surgery ; Polyps/complications ; Fertilization in Vitro
    Language English
    Publishing date 2022-06-09
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 896455-5
    ISSN 1432-0711 ; 0932-0067
    ISSN (online) 1432-0711
    ISSN 0932-0067
    DOI 10.1007/s00404-022-06646-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Social Distancing to Avoid SARS-CoV-2 Infection in Cancer and Noncancer Patients.

    Kloecker, Goetz / Nolan, Joseph / Korbee, Leslie / Calhoun, Royce / Logan, Barbara / Flora, Dan / Flora, Douglas / Hartman, Philip

    Journal of patient safety

    2022  Volume 18, Issue 8, Page(s) 788–792

    Abstract: Background: Social distancing has been recommended by the Centers for Disease Control and Prevention to avoid exposure to SARS-CoV-2 ( Epidemiol Prev 2020;44:353-362).Cancer patients on or after active therapy seem to be more prone to COVID being ... ...

    Abstract Background: Social distancing has been recommended by the Centers for Disease Control and Prevention to avoid exposure to SARS-CoV-2 ( Epidemiol Prev 2020;44:353-362).Cancer patients on or after active therapy seem to be more prone to COVID being symptomatic and life-threatening. When evaluating cancer patients' risk of acquiring COVID, it is essential to know the behavior of cancer patients that will affect their risk of exposure. However, it is not known to what degree social distancing is practiced by cancer patients compared with noncancer patients and what factors lead to the decision to distance oneself.
    Method: After a pilot phase using patients' MyChart messaging, links to the electronic questionnaires were texted to patients using Twillio. Responses were stored on REDCap (Vanderbilt University, Nashville, TN). Six questions about their social distancing behavior and mask wearing were posed and responses were compared between cancer and noncancer patients. Demographics, comorbidities, and a questionnaire about anxiety (Generalized Anxiety Disorder 7-item scale) were recorded. To assess differences between cancer and noncancer groups, Bonferroni-corrected χ 2 tests and proportions confidence intervals were used.
    Results: The pilot survey was sent in mid-2020 and the full survey followed in January 2021 during a high community COVID incidence. Three hundred eighty-seven cancer patients (32.4% responded) and 503 noncancer patients (22.9% responded) completed the survey. Questions about leaving their houses, driving, shopping, friends, and family indicated that patients with cancer are more cautious ( P < 0.001). Cancer patients were up to 20% more likely to distance themselves. No difference was seen in wearing a mask-both groups wore approximately 90% of the time. Most respondents were female (63% versus 71%). Cancer patients were older (>60 y, 69% versus 45%) and less likely to work (52% versus 31%) or less likely to be White collar workers (21% versus 38%). In both groups, 54% marked "not at all anxious."
    Conclusions: Cancer patients' responses revealed a distancing behavior that would likely lower the risk exposure to SARS-CoV-2. It is unclear which of the demographic differences would account for this behavior, although remarkably anxiety was not a clear motivating factor. The high acceptance of masks is encouraging. Early publications during the pandemic and patient education suggesting a higher COVID risk for cancer patients may have reduced risk prone behavior. Considering COVID's impact on the vulnerable cancer population and uncertainty in immunosuppressed patients about clearing the virus or adequately responding to a vaccine, further studies about health behavior and health promotion during the pandemic are needed.
    MeSH term(s) Humans ; Female ; Male ; COVID-19/epidemiology ; COVID-19/prevention & control ; Physical Distancing ; SARS-CoV-2 ; Pandemics/prevention & control ; Neoplasms/epidemiology ; Neoplasms/prevention & control
    Language English
    Publishing date 2022-07-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2394324-5
    ISSN 1549-8425 ; 1549-8417
    ISSN (online) 1549-8425
    ISSN 1549-8417
    DOI 10.1097/PTS.0000000000001058
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Time to Step Up: A Call to Action For the Clinical and Quantitative Pharmacology Community to Accelerate Therapeutics for COVID-19.

    Hartman, Dan / Kern, Steven / Brown, Fran / Minton, Suzanne K / Rayner, Craig R

    Clinical and translational science

    2020  Volume 13, Issue 4, Page(s) 646–648

    Abstract: The global response to finding therapeutics for coronavirus disease 2019 (COVID-19) is chaotic even if well intentioned. There is an opportunity, but more importantly, an obligation for the global clinical and quantitative pharmacology community to come ... ...

    Abstract The global response to finding therapeutics for coronavirus disease 2019 (COVID-19) is chaotic even if well intentioned. There is an opportunity, but more importantly, an obligation for the global clinical and quantitative pharmacology community to come together and use our state-of-the-art tools and expertise to help society accelerate therapeutics to fight COVID-19. This brief commentary is a call to action and highlights how the global pharmacology community should contribute to the COVID-19 pandemic and prepare for future pandemics.
    MeSH term(s) Antiviral Agents/adverse effects ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/therapeutic use ; Betacoronavirus/drug effects ; Betacoronavirus/pathogenicity ; COVID-19 ; Coronavirus Infections/diagnosis ; Coronavirus Infections/drug therapy ; Coronavirus Infections/virology ; Dose-Response Relationship, Drug ; Drug Approval/organization & administration ; Drug Development/organization & administration ; Drug Discovery/organization & administration ; Drug Dosage Calculations ; Humans ; Pandemics ; Patient Safety ; Pharmacology, Clinical/organization & administration ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/virology ; SARS-CoV-2 ; Time Factors ; Workflow
    Chemical Substances Antiviral Agents
    Keywords covid19
    Language English
    Publishing date 2020-06-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2433157-0
    ISSN 1752-8062 ; 1752-8054
    ISSN (online) 1752-8062
    ISSN 1752-8054
    DOI 10.1111/cts.12824
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Time to Step Up

    Dan Hartman / Steven Kern / Fran Brown / Suzanne K. Minton / Craig R. Rayner

    Clinical and Translational Science, Vol 13, Iss 4, Pp 646-

    A Call to Action For the Clinical and Quantitative Pharmacology Community to Accelerate Therapeutics for COVID‐19

    2020  Volume 648

    Abstract: The global response to finding therapeutics for coronavirus disease 2019 (COVID‐19) is chaotic even if well intentioned. There is an opportunity, but more importantly, an obligation for the global clinical and quantitative pharmacology community to come ... ...

    Abstract The global response to finding therapeutics for coronavirus disease 2019 (COVID‐19) is chaotic even if well intentioned. There is an opportunity, but more importantly, an obligation for the global clinical and quantitative pharmacology community to come together and use our state‐of‐the‐art tools and expertise to help society accelerate therapeutics to fight COVID‐19. This brief commentary is a call to action and highlights how the global pharmacology community should contribute to the COVID‐19 pandemic and prepare for future pandemics.
    Keywords Therapeutics. Pharmacology ; RM1-950 ; Public aspects of medicine ; RA1-1270 ; covid19
    Language English
    Publishing date 2020-07-01T00:00:00Z
    Publisher Wiley
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Application of exposure bracketing to streamline the development of contraceptive products.

    Brown, Joshua / Goodrow, Tamra / Hartman, Dan / Hay, Justin L / Hershberger, Kevin / Hershenson, Susan / McNair, Douglas / Matthews, Bethany / Milad, Mark A / Schmidt, Stephan / Vogelsong, Kirsten M / Zhao, Ping

    Contraception: X

    2022  Volume 4, Page(s) 100072

    Abstract: Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of such ...

    Abstract Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of such products traditionally follow a conventional paradigm that includes large Phase 3 clinical trials to evaluate efficacy (pregnancy prevention) and safety of the investigational product. Exposure-bracketing is a concept that applies known pharmacokinetics and pharmacodynamics of a drug substance to inform its safe and efficacious use in humans. Several therapeutic areas have applied this concept by leveraging established drug concentration-response relationships for approved products to expedite development and shorten the timeline for the approval of an investigational product containing the same drug substance. Based on discussions at a workshop hosted by the Bill & Melinda Gates Foundation in December 2020, it appears feasible to apply exposure-bracketing to develop novel contraceptive products using well-characterized drugs.
    Language English
    Publishing date 2022-01-30
    Publishing country United States
    Document type Journal Article
    ISSN 2590-1516
    ISSN (online) 2590-1516
    DOI 10.1016/j.conx.2022.100072
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Endometrial thickness in 1,500 asymptomatic postmenopausal women not on hormone replacement therapy.

    Hartman, Alex / Wolfman, Wendy / Nayot, Dan / Hartman, Michael

    Gynecologic and obstetric investigation

    2013  Volume 75, Issue 3, Page(s) 191–195

    Abstract: Objective: To determine the normal endometrial thickness (ET) on transvaginal ultrasound (TVUS) of asymptomatic postmenopausal women not on hormone replacement therapy. A subgroup that was determined to be suspicious for having an endometrial polyp was ... ...

    Abstract Objective: To determine the normal endometrial thickness (ET) on transvaginal ultrasound (TVUS) of asymptomatic postmenopausal women not on hormone replacement therapy. A subgroup that was determined to be suspicious for having an endometrial polyp was compared with the remainder.
    Methods: This prospective study selected 1,500 consecutive asymptomatic postmenopausal women receiving TVUS assessment from January to August 2010. ET was recorded. Results were divided into those with a normal-appearing lining (n = 1,399) and those suspicious for polyp (n = 101). Results for the entire sample were obtained and the groups were compared using independent samples t tests.
    Results: Of 1,500 women aged 45-95 years, 77.1% had an ET of ≤4 mm and 92% were ≤5 mm. Independent samples t tests were performed to compare the mean age and mean ET based on polyp status (i.e. with or without a possible polyp). There was a significant difference in mean age, 67.71 vs. 62.36 years (p < 0.01) and mean ET 8.02 vs. 3.40 mm (p < 0.01) between groups.
    Conclusions: 92% of asymptomatic postmenopausal women not on hormone replacement therapy had an ET of ≤5 mm. The mean ET was 3.71 ± 1.9 mm. However, a significant group, 6.7%, had an endometrial lining suspicious for polyp. These women had a significant increase in mean age and ET.
    MeSH term(s) Aged ; Aged, 80 and over ; Asymptomatic Diseases ; Canada/epidemiology ; Cross-Sectional Studies ; Endometrium/anatomy & histology ; Endometrium/diagnostic imaging ; Female ; Hormone Replacement Therapy ; Humans ; Middle Aged ; Polyps/diagnostic imaging ; Postmenopause ; Prospective Studies ; Ultrasonography ; Uterine Diseases/diagnostic imaging
    Language English
    Publishing date 2013
    Publishing country Switzerland
    Document type Comparative Study ; Journal Article
    ZDB-ID 800003-7
    ISSN 1423-002X ; 0378-7346
    ISSN (online) 1423-002X
    ISSN 0378-7346
    DOI 10.1159/000347064
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Clinical trials in the pandemic age: What is fit for purpose?

    Hartman, Dan / Heaton, Penny / Cammack, Nick / Hudson, Ian / Dolley, Shawn / Netsi, Elena / Norman, Thea / Mundel, Trevor

    Gates open research

    2020  Volume 4, Page(s) 58

    Abstract: It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for ... ...

    Abstract It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.
    Keywords covid19
    Language English
    Publishing date 2020-06-09
    Publishing country United States
    Document type Journal Article
    ISSN 2572-4754
    ISSN (online) 2572-4754
    DOI 10.12688/gatesopenres.13146.1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Leveraging observed soil heterotrophic respiration fluxes as a novel constraint on global-scale models.

    Jian, Jinshi / Bond-Lamberty, Ben / Hao, Dalei / Sulman, Benjamin N / Patel, Kaizad F / Zheng, Jianqiu / Dorheim, Kalyn / Pennington, Stephanie C / Hartman, Melannie D / Warner, Dan / Wieder, William R

    Global change biology

    2021  Volume 27, Issue 20, Page(s) 5392–5403

    Abstract: Microbially explicit models may improve understanding and projections of carbon dynamics in response to future climate change, but their fidelity in simulating global-scale soil heterotrophic respiration ( ... ...

    Abstract Microbially explicit models may improve understanding and projections of carbon dynamics in response to future climate change, but their fidelity in simulating global-scale soil heterotrophic respiration (R
    MeSH term(s) Carbon ; Carbon Cycle ; Heterotrophic Processes ; Respiration ; Soil
    Chemical Substances Soil ; Carbon (7440-44-0)
    Language English
    Publishing date 2021-07-20
    Publishing country England
    Document type Journal Article
    ZDB-ID 1281439-8
    ISSN 1365-2486 ; 1354-1013
    ISSN (online) 1365-2486
    ISSN 1354-1013
    DOI 10.1111/gcb.15795
    Database MEDical Literature Analysis and Retrieval System OnLINE

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