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  1. Article ; Online: Heart rate stability in a clinical setting and after a short exercise in healthy male volunteers.

    Wildenbeest, Fleur W H / Hassing, Gert-Jan / Kemme, Michiel J B / Moerland, Matthijs / Gal, Pim

    Clinical physiology and functional imaging

    2023  Volume 44, Issue 1, Page(s) 36–43

    Abstract: Introduction: Limited data exist on heart rate stabilization in the domiciled nature of phase I clinical studies, particularly when frequent measurements of QT intervals are involved. The present analysis aimed to evaluate heart rate stability in the ... ...

    Abstract Introduction: Limited data exist on heart rate stabilization in the domiciled nature of phase I clinical studies, particularly when frequent measurements of QT intervals are involved. The present analysis aimed to evaluate heart rate stability in the domiciled nature of, and stabilization after a short exercise.
    Methods: Fifty-six healthy male subjects were included in this analysis. Data during a domiciled clinical setting and after a short exercise were analysed. Mean values of 30 s intervals of collected electrocardiographical data (PR, RR, QT and QTcF intervals) during a 10-min supine resting period in a domiciled nature or after walking up and down three stories (100 steps) were compared to baseline values using paired t-tests or compared to the intrasubject standard deviation.
    Results: Stable heart rates and stable QTcF intervals observed immediately upon assuming a supine position in the domiciled clinical setting. After the short exercise, PR interval and RR interval were significantly (p < 0.05) shorter for up to 120 s (mean value -9.8 ± 7.2 ms) and 30 s (-160 ± 165 ms, p < 0.05), respectively. QT and QTcF intervals were significantly (p < 0.05) shorter for up to 90 and 120 s postexercise, respectively. Both QT and QTcF intervals stabilized after 2 min, but QT interval remained prolonged while QTcF interval returned to baseline levels.
    Conclusion: In a clinical setting, male volunteers do not require a waiting period for electrocardiographic parameter normalization. However, accurate measurement of these parameters following a short exercise necessitates a minimum 2-min resting interval.
    MeSH term(s) Humans ; Male ; Heart Rate/physiology ; Electrocardiography ; Healthy Volunteers ; Volunteers ; Double-Blind Method
    Language English
    Publishing date 2023-08-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 2071203-0
    ISSN 1475-097X ; 1475-0961
    ISSN (online) 1475-097X
    ISSN 1475-0961
    DOI 10.1111/cpf.12846
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1650: Show issues Location:
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  2. Article ; Online: Blueprint for mechanistic, data-rich early phase clinical pharmacology studies in dermatology.

    Rissmann, Robert / Moerland, Matthijs / van Doorn, Martijn B A

    British journal of clinical pharmacology

    2020  Volume 86, Issue 6, Page(s) 1011–1014

    MeSH term(s) Dermatology ; Humans ; Pharmacology ; Pharmacology, Clinical ; Research
    Language English
    Publishing date 2020-04-06
    Publishing country England
    Document type Editorial
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.14293
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  3. Article: MTORC1 signaling as a biomarker in major depressive disorder and its pharmacological modulation by novel rapid-acting antidepressants.

    Cholewinski, Tomasz / Pereira, Diana / Moerland, Matthijs / Jacobs, Gabriel E

    Therapeutic advances in psychopharmacology

    2021  Volume 11, Page(s) 20451253211036814

    Abstract: Major depressive disorder (MDD) is a multifactorial psychiatric disorder with obscure pathophysiology. A biomarker-based approach in combination with standardized interview-based instruments is needed to identify MDD subtypes and novel therapeutic ... ...

    Abstract Major depressive disorder (MDD) is a multifactorial psychiatric disorder with obscure pathophysiology. A biomarker-based approach in combination with standardized interview-based instruments is needed to identify MDD subtypes and novel therapeutic targets. Recent findings support the impairment of the mammalian target of rapamycin complex 1 (mTORC1) in MDD. No well-established biomarkers of mTORC1 disease- and treatment-modulated activity are currently available for use in early phase antidepressant drug (AD) development. This review aims to summarize biomarkers of mTORC1 activity in MDD and to suggest how these could be implemented in future early clinical trials on mTORC1 modulating ADs. Therefore, a PubMed-based narrative literature review of the mTORC1 involvement in MDD was performed. We have summarized recent pre-clinical and clinical findings linking the MDD to the impaired activity of several key biomarkers related to mTORC1. Also, cases of restoration of these impairments by classical ADs and novel fast-acting investigational ADs are summarized. The presented biomarkers may be used to monitor pharmacological effects by novel rapid-acting mTORC1-targeting ADs. Based on findings in the peripheral blood mononuclear cells, we argue that those may serve as an
    Language English
    Publishing date 2021-10-28
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2646542-5
    ISSN 2045-1261 ; 2045-1253
    ISSN (online) 2045-1261
    ISSN 2045-1253
    DOI 10.1177/20451253211036814
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  4. Article ; Online: Characterizing the kinetics of presepsin and associated inflammatory biomarkers in human endotoxemia.

    Aulin, Linda B S / Kleijburg, Anne / Moerland, Matthijs / van Hasselt, J G Coen

    Inflammation research : official journal of the European Histamine Research Society ... [et al.

    2022  Volume 71, Issue 9, Page(s) 999–1001

    Abstract: In this study, we describe the kinetics of a new potential inflammatory biomarker, presepsin, together with a panel of well-established biomarkers in a human endotoxemia study. We evaluated biomarker correlations and identified combinations that could ... ...

    Abstract In this study, we describe the kinetics of a new potential inflammatory biomarker, presepsin, together with a panel of well-established biomarkers in a human endotoxemia study. We evaluated biomarker correlations and identified combinations that could hold valuable insights regarding the state of infection.
    MeSH term(s) Biomarkers ; C-Reactive Protein ; Endotoxemia ; Humans ; Kinetics ; Lipopolysaccharide Receptors ; Peptide Fragments ; Sepsis
    Chemical Substances Biomarkers ; Lipopolysaccharide Receptors ; Peptide Fragments ; presepsin protein, human ; C-Reactive Protein (9007-41-4)
    Language English
    Publishing date 2022-07-21
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 1221794-3
    ISSN 1420-908X ; 1023-3830
    ISSN (online) 1420-908X
    ISSN 1023-3830
    DOI 10.1007/s00011-022-01610-1
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    Zs.A 675: Show issues Location:
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  5. Article ; Online: The oral IRAK4 inhibitors zabedosertib and BAY1830839 suppress local and systemic immune responses in a randomized trial in healthy male volunteers.

    Jodl, Stefan J / Ten Voorde, Wouter / Klein, Stefan / Wagenfeld, Andrea / Zollmann, Frank S / Feldmüller, Maximilian / Klarenbeek, Naomi B / de Bruin, Digna T / Jansen, Manon A A / Rissmann, Robert / Rohde, Beate / Moerland, Matthijs

    Clinical and translational science

    2024  Volume 17, Issue 3, Page(s) e13771

    Abstract: This study evaluated and characterized the pharmacological activity of the orally administered interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors BAY1834845 (zabedosertib) and BAY1830839 in healthy male volunteers. Participants received one of ...

    Abstract This study evaluated and characterized the pharmacological activity of the orally administered interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors BAY1834845 (zabedosertib) and BAY1830839 in healthy male volunteers. Participants received one of either IRAK4 inhibitors or a control treatment (prednisolone 20 mg or placebo) twice daily for 7 days. Localized skin inflammation was induced by topical application of imiquimod (IMQ) cream for 3 days, starting at Day 3 of treatment. The inflammatory response was evaluated by laser speckle contrast imaging (skin perfusion) and multispectral imaging (erythema). At Day 7, participants received 1 ng/kg intravenous lipopolysaccharide (LPS). Circulating inflammatory proteins, leukocyte differentiation, acute phase proteins, and clinical parameters were evaluated before and after the systemic LPS challenge. Treatment with BAY1834845 significantly reduced the mean IMQ-induced skin perfusion response (geometric mean ratio [GMR] vs. placebo: 0.69 for BAY1834845, 0.70 for prednisolone; both p < 0.05). Treatment with BAY1834845 and BAY1830839 significantly reduced IMQ-induced erythema (GMR vs. placebo: 0.75 and 0.83, respectively, both p < 0.05; 0.86 for prednisolone, not significant). Both IRAK4 inhibitors significantly suppressed the serum TNF-α and IL-6 responses (≥80% suppression vs. placebo, p < 0.05) and inhibited C-reactive protein, procalcitonin, and IL-8 responses to intravenous LPS. This study demonstrated the pharmacological effectiveness of BAY1834845 and BAY1830839 in suppressing systemically and locally induced inflammatory responses in the same range as prednisolone, underlining the potential value of these IRAK4 inhibitors as future therapies for dermatological or other immune-mediated inflammatory diseases.
    MeSH term(s) Humans ; Male ; Interleukin-1 Receptor-Associated Kinases ; Lipopolysaccharides ; Erythema ; Prednisolone ; Imiquimod ; Immunity ; Volunteers ; Indazoles ; Pyridines
    Chemical Substances Interleukin-1 Receptor-Associated Kinases (EC 2.7.11.1) ; zabedosertib (N1GRK350ZM) ; Lipopolysaccharides ; Prednisolone (9PHQ9Y1OLM) ; Imiquimod (P1QW714R7M) ; IRAK4 protein, human (EC 2.7.11.1) ; Indazoles ; Pyridines
    Language English
    Publishing date 2024-04-18
    Publishing country United States
    Document type Randomized Controlled Trial ; 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.13771
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  6. Article ; Online: Hydroxychloroquine Effects on TLR Signalling: Underexposed but Unneglectable in COVID-19.

    In 't Veld, Aliede E / Jansen, Manon A A / Ciere, Luuk C A / Moerland, Matthijs

    Journal of immunology research

    2021  Volume 2021, Page(s) 6659410

    Abstract: The main basis for hydroxychloroquine (HCQ) treatment in COVID-19 is the compound's ability to inhibit viral ... ...

    Abstract The main basis for hydroxychloroquine (HCQ) treatment in COVID-19 is the compound's ability to inhibit viral replication
    MeSH term(s) Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Humans ; Hydroxychloroquine/therapeutic use ; Immunosuppression/methods ; SARS-CoV-2/drug effects ; SARS-CoV-2/immunology ; Severity of Illness Index ; Signal Transduction/drug effects ; Treatment Outcome ; Virus Replication/drug effects
    Chemical Substances Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH)
    Language English
    Publishing date 2021-03-09
    Publishing country Egypt
    Document type Journal Article ; Review
    ZDB-ID 2817541-4
    ISSN 2314-7156 ; 2314-8861
    ISSN (online) 2314-7156
    ISSN 2314-8861
    DOI 10.1155/2021/6659410
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  7. Article ; Online: Erratum to "Hydroxychloroquine Effects on TLR Signalling: Underexposed but Unneglectable in COVID-19".

    In 't Veld, Aliede E / Jansen, Manon A A / Ciere, Luuk C A / Moerland, Matthijs

    Journal of immunology research

    2021  Volume 2021, Page(s) 9789246

    Abstract: This corrects the article DOI: 10.1155/2021/6659410.]. ...

    Abstract [This corrects the article DOI: 10.1155/2021/6659410.].
    Language English
    Publishing date 2021-05-08
    Publishing country Egypt
    Document type Published Erratum
    ZDB-ID 2817541-4
    ISSN 2314-7156 ; 2314-8861
    ISSN (online) 2314-7156
    ISSN 2314-8861
    DOI 10.1155/2021/9789246
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  8. Article: Integration of healthy volunteers in early phase clinical trials with immuno-oncological compounds.

    Radanovic, Igor / Klarenbeek, Naomi / Rissmann, Robert / Groeneveld, Geert Jan / van Brummelen, Emilie M J / Moerland, Matthijs / Bosch, Jacobus J

    Frontiers in oncology

    2022  Volume 12, Page(s) 954806

    Abstract: Aim: Traditionally, early phase clinical trials in oncology have been performed in patients based on safety risk-benefit assessment. Therapeutic transition to immuno-oncology may open new opportunities for studies in healthy volunteers, which are ... ...

    Abstract Aim: Traditionally, early phase clinical trials in oncology have been performed in patients based on safety risk-benefit assessment. Therapeutic transition to immuno-oncology may open new opportunities for studies in healthy volunteers, which are conducted faster and are less susceptible to confounders. Aim of this study was to investigate to what extent this approach is utilized and whether pharmacodynamic endpoints are evaluated in these early phase trials. We conducted a comprehensive review of clinical trials with healthy volunteers using immunotherapies potentially relevant for oncology.
    Methods: Literature searches according to PRISMA guidelines and after registration in PROSPERO were conducted in PubMed, Embase, Web of Science and Cochrane databases with the cut-off date 20 October 2020, using search terms of relevant targets in immuno-oncology. Articles describing clinical trials with immunotherapeutics in healthy volunteers with a mechanism relevant for oncology were included. "Immunotherapeutic" was defined as compounds exhibiting effects through immunological targets. Data including study design and endpoints were extracted, with specific attention to pharmacodynamic endpoints and safety.
    Results: In total, we found 38 relevant immunotherapeutic compounds tested in HVs, with 86% of studies investigating safety, 82% investigating the pharmacokinetics (PK) and 57% including at least one pharmacodynamic (PD) endpoint. Most of the observed adverse events (AEs) were Grade 1 and 2, consisting mostly of gastrointestinal, cutaneous and flu-like symptoms. Severe AEs were leukopenia, asthenia, syncope, headache, flu-like reaction and liver enzymes increase. PD endpoints investigated comprised of cytokines, immune and inflammatory biomarkers, cell counts, phenotyping circulating immune cells and
    Discussion: Healthy volunteer studies with immuno-oncology compounds have been performed, although not to a large extent. The integration of healthy volunteers in well-designed proof-of-mechanism oriented drug development programs has advantages and could be pursued more in the future, since integrative clinical trial protocols may facilitate early dose selection and prevent cancer patients to be exposed to non-therapeutic dosing regimens.
    Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=210861, identifier CRD42020210861.
    Language English
    Publishing date 2022-08-29
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2649216-7
    ISSN 2234-943X
    ISSN 2234-943X
    DOI 10.3389/fonc.2022.954806
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  9. Article ; Online: Impact of oral administration of single strain

    Saghari, Mahdi / Gal, Pim / Grievink, Hendrika W / Klaassen, Erica S / Itano, Andrea / McHale, Duncan / Moerland, Matthijs

    Frontiers in immunology

    2022  Volume 13, Page(s) 1009304

    Abstract: Introduction: Lactococcus lactis: Methods: The trial was registered on Netherlands Trial Register (trial ID NL7519, https://trialsearch.who.int). Eighty-one healthy subjects (median 28, range 18-59 years) were randomized to 28 days of enteric-coated ... ...

    Abstract Introduction: Lactococcus lactis
    Methods: The trial was registered on Netherlands Trial Register (trial ID NL7519, https://trialsearch.who.int). Eighty-one healthy subjects (median 28, range 18-59 years) were randomized to 28 days of enteric-coated capsules at five doses (n = 13) (1.5 * 10
    Results: Repeated-measures analysis of covariances revealed no significant treatment effects on the antibody responses to KLH, number of Tregs, or KLH skin rechallenge outcomes.
    Discussion: The EDP1066 formulations did not affect the immune response to KLH immunization in healthy individuals. However, exposure to
    Netherlands trial register: trialsearch.who.int, trial ID NL7519.
    MeSH term(s) Humans ; Administration, Oral ; Cytokines ; Gastrointestinal Microbiome ; Healthy Volunteers ; Immunity ; Immunization ; Lactococcus lactis ; Lipopolysaccharides ; RNA, Ribosomal, 16S ; Adolescent ; Young Adult ; Adult ; Middle Aged
    Chemical Substances Cytokines ; keyhole-limpet hemocyanin (FV4Y0JO2CX) ; Lipopolysaccharides ; RNA, Ribosomal, 16S
    Language English
    Publishing date 2022-12-07
    Publishing country Switzerland
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2022.1009304
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  10. Article ; Online: Impact of fibre supplementation on microbiome and resilience in healthy participants: A randomized, placebo-controlled clinical trial.

    Eveleens Maarse, Boukje C / Eggink, Hannah M / Warnke, Ines / Bijlsma, Sabina / van den Broek, Tim J / Oosterman, Johanneke E / Caspers, Martien P M / Sybesma, Wilbert / Gal, Pim / van Kraaij, Sebastiaan J W / Schuren, Frank H J / Moerland, Matthijs / Hoevenaars, Femke P M

    Nutrition, metabolism, and cardiovascular diseases : NMCD

    2024  

    Abstract: Background and aims: The gut microbiome exerts important roles in health, e.g., functions in metabolism and immunology. These functions are often exerted via short-chain fatty acid (SCFA) production by gut bacteria. Studies demonstrating causal ... ...

    Abstract Background and aims: The gut microbiome exerts important roles in health, e.g., functions in metabolism and immunology. These functions are often exerted via short-chain fatty acid (SCFA) production by gut bacteria. Studies demonstrating causal relationships between interventions targeting the microbiome and clinical outcomes are limited. This study aimed to show a causal relationship between microbiome modulation through fibre intervention and health.
    Methods and results: This randomized, double-blind, cross-over study included 65 healthy subjects, aged 45-70 years, with increased metabolic risk (i.e., body mass index [BMI] 25-30 kg/m
    Conclusion: Although the intervention exerted effects on gut microbiome composition, no effects on SCFA production, on resilience or fasting metabolic and inflammatory state were observed in this cohort. REGISTRATION NUMBER CLINICALTRIALS.GOV: NCT04829396.
    Language English
    Publishing date 2024-02-06
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1067704-5
    ISSN 1590-3729 ; 0939-4753
    ISSN (online) 1590-3729
    ISSN 0939-4753
    DOI 10.1016/j.numecd.2024.01.028
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