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  1. Article ; Online: Termination of pregnancy for fetal anomaly: a systematic review of the healthcare experiences and needs of parents.

    Heaney, Suzanne / Tomlinson, Mark / Aventin, Áine

    BMC pregnancy and childbirth

    2022  Volume 22, Issue 1, Page(s) 441

    Abstract: Background: Improved technology and advances in clinical testing have resulted in increased detection rates of congenital anomalies during pregnancy, resulting in more parents being confronted with the possibility of terminating a pregnancy for this ... ...

    Abstract Background: Improved technology and advances in clinical testing have resulted in increased detection rates of congenital anomalies during pregnancy, resulting in more parents being confronted with the possibility of terminating a pregnancy for this reason. There is a large body of research on the psychological experience and impact of terminating a pregnancy for fetal anomaly. However, there remains a lack of evidence on the holistic healthcare experience of parents in this situation. To develop a comprehensive understanding of the healthcare experiences and needs of parents, this systematic review sought to summarise and appraise the literature on parents' experiences following a termination of pregnancy for fetal anomaly.
    Review question: What are the healthcare experiences and needs of parents who undergo a termination of pregnancy following an antenatal diagnosis of a fetal anomaly?
    Methods: A systematic review was undertaken with searches completed across six multi-disciplinary electronic databases (Medline, Embase, PsycINFO, CINAHL, Web of Science, and Cochrane). Eligible articles were qualitative, quantitative or mixed methods studies, published between January 2010 and August 2021, reporting the results of primary data on the healthcare experiences or healthcare needs in relation to termination of pregnancy for fetal anomaly for either, or both parents. Findings were synthesised using Thematic Analysis.
    Results: A total of 30 articles were selected for inclusion in this review of which 24 were qualitative, five quantitative and one mixed-methods. Five overarching themes emerged from the synthesis of findings: (1) Contextual impact on access to and perception of care, (2) Organisation of care, (3) Information to inform decision making, (4) Compassionate care, and (5) Partner experience.
    Conclusion: Compassionate healthcare professionals who provide non-judgemental and sensitive care can impact positively on parents' satisfaction with the care they receive. A well organised and co-ordinated healthcare system is needed to provide an effective and high-quality service.
    Trial registration: PROSPERO registration number: CRD42020175970 .
    MeSH term(s) Delivery of Health Care ; Empathy ; Female ; Health Facilities ; Health Personnel ; Humans ; Parents/psychology ; Pregnancy
    Language English
    Publishing date 2022-05-26
    Publishing country England
    Document type Journal Article ; Systematic Review
    ZDB-ID 2059869-5
    ISSN 1471-2393 ; 1471-2393
    ISSN (online) 1471-2393
    ISSN 1471-2393
    DOI 10.1186/s12884-022-04770-4
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  2. Article ; Online: Effect of tear supplements on signs, symptoms and inflammatory markers in dry eye.

    Martin, Eilidh / Oliver, Katherine M / Pearce, E Ian / Tomlinson, Alan / Simmons, Peter / Hagan, Suzanne

    Cytokine

    2018  Volume 105, Page(s) 37–44

    Abstract: Purpose: Three tear supplements were compared for their effects on the signs, symptoms and inflammatory status of subjects with dry eye disease. Assessments were made before and after both 2 and 4 weeks of treatment.: Methods: In this masked, ... ...

    Abstract Purpose: Three tear supplements were compared for their effects on the signs, symptoms and inflammatory status of subjects with dry eye disease. Assessments were made before and after both 2 and 4 weeks of treatment.
    Methods: In this masked, randomized, 3-way crossover trial, eighteen dry eye subjects were recruited. At each visit, symptoms, tear evaporation rate, stability and osmolarity were measured and tear samples were analyzed for 7 inflammatory markers, using multiplex immunoassays. The 3 treatments included carboxymethylcellulose-glycerine-castor oil (CGC), carboxymethylcellulose (CMC) and hydroxypropyl guar (HPG). The CGC and HPG drops are emulsified lipids; CGC also contains osmoprotectants. The CMC drop is a standard aqueous polymeric supplement.
    Results: Significant improvements were seen in symptoms (OSDI) and tear stability (NITBUT) with all 3 treatments at 4 weeks. At 4 weeks post-CGC, 6 out of 7 biomarkers demonstrated a >25% reduction (in 40% of subjects). The same reduction (>25%) was seen in 10% of the subjects for CMC and in none of the subjects for HPG. No significantly different change to either evaporation rate or tear osmolarity was found following any of the three treatments.
    Conclusions: In this study, the CGC treatment resulted in the greatest reduction in ocular biomarkers of inflammation, while all 3 treatments reduced symptoms and improved tear stability. These results indicate that subject-perceived symptomatic improvements are not necessarily associated with a reduction in objective measures of inflammation.
    MeSH term(s) Adult ; Biomarkers/metabolism ; Cytokines/metabolism ; Dry Eye Syndromes/drug therapy ; Dry Eye Syndromes/pathology ; Female ; Humans ; Inflammation Mediators/metabolism ; Male ; Middle Aged ; Ophthalmic Solutions/therapeutic use ; Tears/metabolism ; Young Adult
    Chemical Substances Biomarkers ; Cytokines ; Inflammation Mediators ; Ophthalmic Solutions
    Language English
    Publishing date 2018-02-14
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1018055-2
    ISSN 1096-0023 ; 1043-4666
    ISSN (online) 1096-0023
    ISSN 1043-4666
    DOI 10.1016/j.cyto.2018.02.009
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  3. Article ; Online: Use of parallel validation high-throughput screens to reduce false positives and identify novel dengue NS2B-NS3 protease inhibitors.

    Tomlinson, Suzanne M / Watowich, Stanley J

    Antiviral research

    2011  Volume 93, Issue 2, Page(s) 245–252

    Abstract: Dengue virus (DENV), a mosquito-borne member of the family Flaviviridae, is a significant global pathogen affecting primarily tropical and subtropical regions of the world and placing tremendous burden on the limited medical infrastructure that exists in ...

    Abstract Dengue virus (DENV), a mosquito-borne member of the family Flaviviridae, is a significant global pathogen affecting primarily tropical and subtropical regions of the world and placing tremendous burden on the limited medical infrastructure that exists in many of the developing countries located within these regions. Recent outbreaks in developed countries, including Australia (Hanna et al., 2009), France (La Ruche et al., 2010), Taiwan (Kuan et al., 2010), and the USA (CDC, 2010), lead many researchers to believe that continued emergence into more temperate latitudes is likely. A primary concern is that there are no approved vaccines or antiviral therapies to treat DENV infections. Since the viral NS2B-NS3 protease (DENV NS2B-NS3pro) is required for virus replication, it provides a strategic target for the development of antiviral drugs. In this study, proof-of-concept high-throughput screenings (HTSs) were performed to unambiguously identify dengue 2 virus (DEN2V) NS2B-NS3pro inhibitors from a library of 2000 compounds. Validation screens were performed in parallel to concurrently eliminate insoluble, auto-fluorescing, and/or nonspecific inhibitors. Kinetic analyses of the hits revealed that parallel substrate fluorophore (AMC) interference controls and trypsin inhibition controls were able to reduce false positive rates due to solubility and fluorophore interference while the trypsin inhibition control additionally eliminated non-specific inhibitors. We identified five DEN2V NS2B-NS3pro inhibitors that also inhibited the related West Nile virus (WNV) protease (NS2B-NS3pro), but did not inhibit the trypsin protease. Biochemical analyses revealed various mechanisms of inhibition including competitive and mixed noncompetitive inhibition, with the lowest K(i) values being 12±1.5 μM for DEN2V NS2B-NS3pro and 2±0.2 μM for WNV NS2B-NS3pro.
    MeSH term(s) Dengue/drug therapy ; Dengue/virology ; Dengue Virus/drug effects ; Dengue Virus/enzymology ; Drug Evaluation, Preclinical/methods ; Drug Evaluation, Preclinical/standards ; Enzyme Inhibitors/chemistry ; Enzyme Inhibitors/pharmacology ; False Positive Reactions ; High-Throughput Screening Assays/methods ; High-Throughput Screening Assays/standards ; Humans ; Kinetics ; Serine Endopeptidases/chemistry ; Serine Endopeptidases/metabolism ; Viral Nonstructural Proteins/antagonists & inhibitors ; Viral Nonstructural Proteins/chemistry ; Viral Nonstructural Proteins/metabolism
    Chemical Substances Enzyme Inhibitors ; NS2B protein, flavivirus ; Viral Nonstructural Proteins ; NS3 protease, dengue virus (EC 3.4.21.-) ; Serine Endopeptidases (EC 3.4.21.-)
    Language English
    Publishing date 2011-12-13
    Publishing country Netherlands
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Validation Study
    ZDB-ID 306628-9
    ISSN 1872-9096 ; 0166-3542
    ISSN (online) 1872-9096
    ISSN 0166-3542
    DOI 10.1016/j.antiviral.2011.12.003
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  4. Article ; Online: Anthracene-based inhibitors of dengue virus NS2B-NS3 protease.

    Tomlinson, Suzanne M / Watowich, Stanley J

    Antiviral research

    2010  Volume 89, Issue 2, Page(s) 127–135

    Abstract: ... Tomlinson et al., 2009a). Analogs of one of the lead compounds were purchased, tested in protease inhibition ...

    Abstract Dengue virus (DENV) is a mosquito-borne flavivirus that has strained global healthcare systems throughout tropical and subtropical regions of the world. In addition to plaguing developing nations, it has re-emerged in several developed countries with recent outbreaks in the USA (CDC, 2010), Australia (Hanna et al., 2009), Taiwan (Kuan et al., 2010) and France (La Ruche et al., 2010). DENV infection can cause significant disease, including dengue fever, dengue hemorrhagic fever, dengue shock syndrome, and death. There are no approved vaccines or antiviral therapies to prevent or treat dengue-related illnesses. However, the viral NS2B-NS3 protease complex provides a strategic target for antiviral drug development since NS3 protease activity is required for virus replication. Recently, we reported two compounds with inhibitory activity against the DENV protease in vitro and antiviral activity against dengue 2 (DEN2V) in cell culture (Tomlinson et al., 2009a). Analogs of one of the lead compounds were purchased, tested in protease inhibition assays, and the data evaluated with detailed kinetic analyses. A structure activity relationship (SAR) identified key atomic determinants (i.e. functional groups) important for inhibitory activity. Four "second series" analogs were selected and tested to validate our SAR and structural models. Here, we report improvements to inhibitory activity ranging between ∼2- and 60-fold, resulting in selective low micromolar dengue protease inhibitors.
    MeSH term(s) Anthracenes/chemistry ; Anthracenes/pharmacology ; Antiviral Agents/chemistry ; Antiviral Agents/pharmacology ; Dengue Virus/drug effects ; Dengue Virus/enzymology ; Humans ; Molecular Structure ; Protease Inhibitors/chemistry ; Protease Inhibitors/pharmacology ; Serine Endopeptidases/metabolism ; Structure-Activity Relationship ; Viral Nonstructural Proteins/antagonists & inhibitors
    Chemical Substances Anthracenes ; Antiviral Agents ; NS2B protein, flavivirus ; Protease Inhibitors ; Viral Nonstructural Proteins ; NS3 protease, dengue virus (EC 3.4.21.-) ; Serine Endopeptidases (EC 3.4.21.-)
    Language English
    Publishing date 2010-12-23
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 306628-9
    ISSN 1872-9096 ; 0166-3542
    ISSN (online) 1872-9096
    ISSN 0166-3542
    DOI 10.1016/j.antiviral.2010.12.006
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  5. Article ; Online: Phase 1 study of intraventricular

    Kramer, Kim / Pandit-Taskar, Neeta / Kushner, Brian H / Zanzonico, Pat / Humm, John L / Tomlinson, Ursula / Donzelli, Maria / Wolden, Suzanne L / Haque, Sophia / Dunkel, Ira / Souweidane, Mark M / Greenfield, Jeffrey P / Tickoo, Satish / Lewis, Jason S / Lyashchenko, Serge K / Carrasquillo, Jorge A / Chu, Bae / Horan, Christopher / Larson, Steven M /
    Cheung, Nai-Kong V / Modak, Shakeel

    Journal of hematology & oncology

    2022  Volume 15, Issue 1, Page(s) 165

    Abstract: Background: The prognosis for metastatic and recurrent tumors of the central nervous system (CNS) remains dismal, and the need for newer therapeutic targets and modalities is critical. The cell surface glycoprotein B7H3 is expressed on a range of solid ... ...

    Abstract Background: The prognosis for metastatic and recurrent tumors of the central nervous system (CNS) remains dismal, and the need for newer therapeutic targets and modalities is critical. The cell surface glycoprotein B7H3 is expressed on a range of solid tumors with a restricted expression on normal tissues. We hypothesized that compartmental radioimmunotherapy (cRIT) with the anti-B7H3 murine monoclonal antibody omburtamab injected intraventricularly could safely target CNS malignancies.
    Patients and methods: We conducted a phase I trial of intraventricular
    Results: Thirty-eight patients received 100 radioiodinated omburtamab injections. Diagnoses included metastatic neuroblastoma (n = 16) and other B7H3-expressing solid tumors (n = 22). Thirty-five patients received at least 1 cycle of treatment with both dosimetry and therapy doses. Acute toxicities included < grade 4 self-limited headache, vomiting or fever, and biochemical abnormalities. Grade 3/4 thrombocytopenia was the most common hematologic toxicity. Recommended phase 2 dose was 1850 MBq/injection. The median radiation dose to the CSF and blood by sampling was 1.01 and 0.04 mGy/MBq, respectively, showing a consistently high therapeutic advantage for CSF. Major organ exposure was well below maximum tolerated levels. In patients developing antidrug antibodies, blood clearance, and therefore therapeutic index, was significantly increased. In patients receiving cRIT for neuroblastoma, survival was markedly increased (median PFS 7.5 years) compared to historical data.
    Conclusions: cRIT with
    Trial registration: clinicaltrials.gov NCT00089245, August 5, 2004.
    MeSH term(s) Humans ; Animals ; Mice ; Tissue Distribution ; Neoplasm Recurrence, Local/drug therapy ; Antibodies, Monoclonal/adverse effects ; Central Nervous System Neoplasms/radiotherapy ; Neuroblastoma/radiotherapy ; B7 Antigens
    Chemical Substances Iodine-131 ; Antibodies, Monoclonal ; CD276 protein, human ; B7 Antigens
    Language English
    Publishing date 2022-11-12
    Publishing country England
    Document type Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2429631-4
    ISSN 1756-8722 ; 1756-8722
    ISSN (online) 1756-8722
    ISSN 1756-8722
    DOI 10.1186/s13045-022-01383-4
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  6. Article ; Online: Substrate inhibition kinetic model for West Nile virus NS2B-NS3 protease.

    Tomlinson, Suzanne M / Watowich, Stanley J

    Biochemistry

    2008  Volume 47, Issue 45, Page(s) 11763–11770

    Abstract: West Nile virus (WNV) has recently emerged in North America as a significant disease threat to humans and animals. Unfortunately, no approved antiviral drugs exist to combat WNV or other members of the genus Flavivirus in humans. The WNV NS2B-NS3 ... ...

    Abstract West Nile virus (WNV) has recently emerged in North America as a significant disease threat to humans and animals. Unfortunately, no approved antiviral drugs exist to combat WNV or other members of the genus Flavivirus in humans. The WNV NS2B-NS3 protease has been one of the primary targets for anti-WNV drug discovery and design since it is required for virus replication. As part of our efforts to develop effective WNV inhibitors, we reexamined the reaction kinetics of the NS2B-NS3 protease and the inhibition mechanisms of newly discovered inhibitors. The WNV protease showed substrate inhibition in assays utilizing fluorophore-linked peptide substrates GRR, GKR, and DFASGKR. Moreover, a substrate inhibition reaction step was required to accurately model kinetic data generated from protease assays with a peptide inhibitor. The substrate inhibition model suggested that peptide substrates could bind to two binding sites on the protease. Reaction product analogues also showed inhibition of the protease, demonstrating product inhibition in addition to and distinct from substrate inhibition. We propose that small peptide substrates and inhibitors may interact with protease residues that form either the P3-P1 binding surface (i.e., the S3-S1 sites) or the P1'-P3' interaction surface (i.e., the S1'-S3' sites). Optimization of substrate analogue inhibitors that target these two independent sites may lead to novel anti-WNV drugs.
    MeSH term(s) Binding Sites ; Catalysis/drug effects ; Kinetics ; Peptides/chemistry ; Peptides/pharmacology ; Protein Binding ; Protein Structure, Secondary ; Protein Structure, Tertiary ; Serine Endopeptidases/chemistry ; Serine Endopeptidases/metabolism ; Substrate Specificity ; Viral Nonstructural Proteins/antagonists & inhibitors ; Viral Nonstructural Proteins/chemistry ; Viral Nonstructural Proteins/metabolism ; West Nile virus/enzymology
    Chemical Substances NS2B protein, flavivirus ; Peptides ; Viral Nonstructural Proteins ; NS3 protease, dengue virus (EC 3.4.21.-) ; Serine Endopeptidases (EC 3.4.21.-)
    Language English
    Publishing date 2008-11-11
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1108-3
    ISSN 1520-4995 ; 0006-2960
    ISSN (online) 1520-4995
    ISSN 0006-2960
    DOI 10.1021/bi801034f
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    Zs.A 217: Show issues Location:
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  7. Article ; Online: Building knowledge, optimising physical and mental health and setting up healthier life trajectories in South African women (

    Norris, Shane A / Draper, Catherine E / Prioreschi, Alessandra / Smuts, C M / Ware, Lisa Jayne / Dennis, CindyLee / Awadalla, Philip / Bassani, D / Bhutta, Zulfiqar / Briollais, Laurent / Cameron, D William / Chirwa, Tobias / Fallon, B / Gray, C M / Hamilton, Jill / Jamison, J / Jaspan, Heather / Jenkins, Jennifer / Kahn, Kathleen /
    Kengne, A P / Lambert, Estelle V / Levitt, Naomi / Martin, Marie-Claude / Ramsay, Michele / Roth, Daniel / Scherer, Stephen / Sellen, Daniel / Slemming, Wiedaad / Sloboda, Deborah / Szyf, M / Tollman, Stephen / Tomlinson, Mark / Tough, Suzanne / Matthews, Stephen G / Richter, Linda / Lye, Stephen

    BMJ open

    2022  Volume 12, Issue 4, Page(s) e059914

    Abstract: Introduction: South Africa's evolving burden of disease is challenging due to a persistent infectious disease, burgeoning obesity, most notably among women and rising rates of non-communicable diseases (NCDs). With two thirds of women presenting at ... ...

    Abstract Introduction: South Africa's evolving burden of disease is challenging due to a persistent infectious disease, burgeoning obesity, most notably among women and rising rates of non-communicable diseases (NCDs). With two thirds of women presenting at their first antenatal visit either overweight or obese in urban South Africa (SA), the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and NCDs.
    Methods and analysis: Bukhali
    Ethics and dissemination: Ethical approval has been obtained from the Human Ethics Research Committee University of the Witwatersrand, Johannesburg, South Africa (M1811111), the University of Toronto, Canada (19-0066-E) and the WHO Ethics Committee (ERC.0003328). Data and biological sample sharing policies are consistent with the governance policy of the HeLTI Consortium (https://helti.org) and South African government legislation (POPIA). The recruitment and research team will obtain informed consent.
    Trial registration: This trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 25 March 2019 (identifier: PACTR201903750173871).
    Protocol version: 20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.
    MeSH term(s) Child ; Child, Preschool ; Community Health Workers ; Female ; Health Status ; Humans ; Male ; Mental Health ; Obesity/prevention & control ; Pregnancy ; South Africa
    Language English
    Publishing date 2022-04-21
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-059914
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  8. Article ; Online: The 5-HT

    Thomas, Jason M / Dourish, Colin T / Tomlinson, Jeremy / Hassan-Smith, Zaki / Hansen, Peter C / Higgs, Suzanne

    Psychopharmacology

    2017  Volume 235, Issue 1, Page(s) 257–267

    Abstract: Rationale: Brain 5-HT: Objectives: The present study examined the effects of the 5-HT: Methods: In a double-blind, placebo-controlled, crossover design, participants were randomized immediately after screening to receive oral mCPP (30mg) in a ... ...

    Abstract Rationale: Brain 5-HT
    Objectives: The present study examined the effects of the 5-HT
    Methods: In a double-blind, placebo-controlled, crossover design, participants were randomized immediately after screening to receive oral mCPP (30mg) in a single morning dose, or placebo, in a counterbalanced order. Test foods were served from a Universal Eating Monitor (UEM) that measured eating rate and fMRI BOLD signals to the sight of food and non-food images were recorded.
    Results: mCPP decreased rated appetite and intake of a palatable snack eaten in the absence of hunger but had no significant effect on the consumption of a pasta lunch (although pasta eating rate was reduced). mCPP also decreased BOLD fMRI responses to the sight of food pictures in areas of reward-associated circuitry. A post hoc analysis identified individual variability in the response to mCPP (exploratory responder-non-responder analysis). Some participants did not reduce their cookie intake after treatment with mCPP and this lack of response was associated with enhanced ratings of cookie pleasantness and enhanced baseline BOLD responses to food images in key reward and appetite circuitry.
    Conclusions: These results suggest that 5-HT
    MeSH term(s) Adult ; Analysis of Variance ; Appetite/drug effects ; Brain/drug effects ; Double-Blind Method ; Eating/drug effects ; Emotions/drug effects ; Female ; Humans ; Hunger/drug effects ; Hydrocortisone/analysis ; Hypothalamus/metabolism ; Magnetic Resonance Imaging ; Middle Aged ; Photic Stimulation/methods ; Piperazines/pharmacology ; Pro-Opiomelanocortin/metabolism ; Receptor, Serotonin, 5-HT2C/metabolism ; Saliva/metabolism ; Serotonin 5-HT2 Receptor Agonists/pharmacology ; Young Adult
    Chemical Substances Piperazines ; Receptor, Serotonin, 5-HT2C ; Serotonin 5-HT2 Receptor Agonists ; Pro-Opiomelanocortin (66796-54-1) ; 1-(3-chlorophenyl)piperazine (REY0CNO998) ; Hydrocortisone (WI4X0X7BPJ)
    Language English
    Publishing date 2017-10-28
    Publishing country Germany
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 130601-7
    ISSN 1432-2072 ; 0033-3158
    ISSN (online) 1432-2072
    ISSN 0033-3158
    DOI 10.1007/s00213-017-4764-9
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  9. Article ; Online: Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate).

    Baran, Szczepan W / Brown, Paul C / Baudy, Andreas R / Fitzpatrick, Suzanne C / Frantz, Christopher / Fullerton, Aaron / Gan, Jinping / Hardwick, Rhiannon N / Hillgren, Kathleen M / Kopec, Anna K / Liras, Jennifer L / Mendrick, Donna L / Nagao, Ryan / Proctor, William R / Ramsden, Diane / Ribeiro, Alexandre J S / Stresser, David / Sung, Kyung E / Sura, Radhakrishna /
    Tetsuka, Kazuhiro / Tomlinson, Lindsay / Van Vleet, Terry / Wagoner, Matthew P / Wang, Qin / Arslan, Sevim Yildiz / Yoder, Gorm / Ekert, Jason E

    ALTEX

    2022  Volume 39, Issue 2, Page(s) 297–314

    Abstract: Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug attrition due to safety and/ or efficacy concerns. For this technology to have an impact, the establishment of robust characterization and qualifi­cation plans ... ...

    Abstract Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug attrition due to safety and/ or efficacy concerns. For this technology to have an impact, the establishment of robust characterization and qualifi­cation plans constructed around specific contexts of use (COU) is required. This article covers the output from a workshop between the Food and Drug Administration (FDA) and Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate. The intent of the workshop was to understand how CIVM technologies are currently being applied by pharma­ceutical companies during drug development and are being tested at the FDA through various case studies in order to identify hurdles (real or perceived) to the adoption of microphysiological systems (MPS) technologies, and to address evaluation/qualification pathways for these technologies. Output from the workshop includes the alignment on a working definition of MPS, a detailed description of the eleven CIVM case studies presented at the workshop, in-depth analysis, and key take aways from breakout sessions on ADME (absorption, distribution, metabolism, and excretion), pharmacology, and safety that covered topics such as qualification and performance criteria, species differences and concordance, and how industry can overcome barriers to regulatory submission of CIVM data. In conclusion, IQ MPS Affiliate and FDA scientists were able to build a general consensus on the need for animal CIVMs for preclinical species to better determine species concordance. Furthermore, there was acceptance that CIVM technologies for use in ADME, pharmacology and safety assessment will require qualification, which will vary depending on the specific COU.
    MeSH term(s) Animal Testing Alternatives ; Animals ; Drug Evaluation, Preclinical ; Drug Industry ; Lab-On-A-Chip Devices ; Pharmaceutical Preparations/metabolism ; United States ; United States Food and Drug Administration
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2022-01-21
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 165707-0
    ISSN 1868-8551 ; 1018-4562 ; 0946-7785
    ISSN (online) 1868-8551
    ISSN 1018-4562 ; 0946-7785
    DOI 10.14573/altex.2112203
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  10. Article ; Online: The Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans: Toward Comparative Effectiveness in the Pediatric Rheumatic Diseases.

    Ringold, Sarah / Nigrovic, Peter A / Feldman, Brian M / Tomlinson, George A / von Scheven, Emily / Wallace, Carol A / Huber, Adam M / Schanberg, Laura E / Li, Suzanne C / Weiss, Pamela F / Fuhlbrigge, Robert C / Morgan, Esi M / Kimura, Yukiko

    Arthritis & rheumatology (Hoboken, N.J.)

    2018  Volume 70, Issue 5, Page(s) 669–678

    Abstract: The pediatric rheumatic diseases are a heterogeneous group of rare diseases, posing a number of challenges for the use of traditional clinical and translational research methods. Innovative comparative effectiveness approaches are needed to efficiently ... ...

    Abstract The pediatric rheumatic diseases are a heterogeneous group of rare diseases, posing a number of challenges for the use of traditional clinical and translational research methods. Innovative comparative effectiveness approaches are needed to efficiently study treatment strategies and disease outcomes. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed the consensus treatment plan (CTP) approach as a comparative effectiveness tool for research in pediatric rheumatology. CTPs are treatment strategies, developed by consensus methods among CARRA members, intended to reduce variation in treatment approaches, standardize outcome measurements, and allow for comparison of the effectiveness of different approaches with the goal of improving disease outcomes. To date, CTPs have been published for 8 different diseases and disease manifestations. The approach has been successfully piloted for juvenile localized scleroderma, systemic juvenile idiopathic arthritis (JIA), polyarticular JIA, dermatomyositis, and lupus nephritis. Large-scale studies are underway for systemic JIA and polyarticular JIA, with the CARRA patient registry serving as the data collection platform. These studies have been designed with stakeholder involvement, including active input from CARRA providers, patients, and parents, with the goal of increasing feasibility and ensuring the relevance of the outcomes. These studies include ancillary biologic specimen collection intended to support additional translational and mechanistic studies. Data from these ongoing CTP studies will provide more information on the ability of this approach to identify effective treatment strategies and improve outcomes in the pediatric rheumatic diseases.
    MeSH term(s) Biomedical Research ; Child ; Clinical Protocols/standards ; Comparative Effectiveness Research ; Consensus ; Humans ; Randomized Controlled Trials as Topic ; Registries ; Rheumatic Diseases/therapy ; Translational Medical Research
    Language English
    Publishing date 2018-03-31
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2756371-6
    ISSN 2326-5205 ; 2326-5191
    ISSN (online) 2326-5205
    ISSN 2326-5191
    DOI 10.1002/art.40395
    Database MEDical Literature Analysis and Retrieval System OnLINE

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