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  1. Article ; Online: Management of tuberculous meningitis in children.

    Schaaf, H Simon / Seddon, James A

    Paediatrics and international child health

    2021  Volume 41, Issue 4, Page(s) 231–236

    MeSH term(s) Child ; Humans ; Meningitis ; Tuberculosis, Meningeal/diagnosis ; Tuberculosis, Meningeal/drug therapy
    Language English
    Publishing date 2021-11-16
    Publishing country England
    Document type Editorial
    ZDB-ID 2649065-1
    ISSN 2046-9055 ; 2046-9047
    ISSN (online) 2046-9055
    ISSN 2046-9047
    DOI 10.1080/20469047.2021.1952818
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: UK Medical Cannabis Registry: A Patient Evaluation.

    Tait, James / Erridge, Simon / Sodergren, Mikael H

    Journal of pain & palliative care pharmacotherapy

    2023  Volume 37, Issue 2, Page(s) 170–177

    Abstract: The UK Medical Cannabis Registry is the largest real world data platform for medical cannabis outcomes in the UK, providing insight into clinical outcomes and monitoring safety of this novel therapy. This study aims to assess the functionality and ... ...

    Abstract The UK Medical Cannabis Registry is the largest real world data platform for medical cannabis outcomes in the UK, providing insight into clinical outcomes and monitoring safety of this novel therapy. This study aims to assess the functionality and accessibility of the online data collection platform and patient priorities for future research. Descriptive statistics were used to analyze quantitative data. For open-ended questions an inductive thematic analysis was performed. 600 responses were recorded. 554 (92.3%) patients had used the platform. 272 (90.4%) patients believed it was easy to input medications. 52 (8.67%) patients recorded an adverse event with 38 (73.1%) finding it easy to record. 535 (96.6%) patients had completed health questionnaires with 490 (91.6%) patients finding this easy to do. 553 (92.2%) patients agreed that contributing to the registry would impact the medical care of future patients. "Assessing the impact of medical cannabis on quality of life generally" was the top research priority for 357 (59.3%) patients. This study demonstrates that most enrolled patients found the platform easy to use and believed they were positively impacting future medical cannabis patient care. Future patient research priorities included assessment of quality of life and condition-specific outcomes.
    MeSH term(s) Humans ; Medical Marijuana/adverse effects ; Quality of Life ; Registries ; Surveys and Questionnaires ; United Kingdom
    Chemical Substances Medical Marijuana
    Language English
    Publishing date 2023-02-10
    Publishing country England
    Document type Journal Article
    ZDB-ID 2078852-6
    ISSN 1536-0539 ; 1536-0288
    ISSN (online) 1536-0539
    ISSN 1536-0288
    DOI 10.1080/15360288.2023.2174633
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Vocal Cues to Assess Arousal State of Bottlenose Dolphins ( Tursiops spp.) Involved in Public Presentations

    Rachel Probert / Bridget S. James / Simon H. Elwen / Tess Gridley

    Journal of Zoological and Botanical Gardens, Vol 4, Iss 4, Pp 711-

    2023  Volume 727

    Abstract: Emotions in animals may be expressed by arousal and understanding this often relies upon the monitoring of their behaviour. Under human care, animals’ arousal states may be linked to husbandry decisions, whereby animals may display arousal responses to ... ...

    Abstract Emotions in animals may be expressed by arousal and understanding this often relies upon the monitoring of their behaviour. Under human care, animals’ arousal states may be linked to husbandry decisions, whereby animals may display arousal responses to scheduled events such as feeding and human interaction. Here, we investigate vocal correlates of arousal associated with public presentations of bottlenose dolphins ( Tursiops spp.) in human care by comparing vocal production rates and characteristics between high and low arousal contexts. Elevated arousal during the day compared with overnight was characterised by increased signature and non-signature whistle production. High intensity broadband crack vocalisations were produced less than whistles during the day and did not correlate with increased arousal around presentation times. Three of ten dolphins increased signature whistle production before and/or after presentation sessions, indicating elevated arousal and variation in individual responses. Many individuals elevated minimum frequency and suppressed maximum frequency of signature whistles in a way that correlated with higher arousal contexts, indicating that these may therefore be good indicators of changes in arousal state. Overall, our study demonstrates that passive acoustic monitoring can provide a useful indication of arousal linked to husbandry decisions, and that individual variation in vocal responses, likely linked to personality, is important to consider.
    Keywords arousal ; bottlenose dolphins ; acoustics ; emotions ; signature whistles ; human care ; Biology (General) ; QH301-705.5 ; Zoology ; QL1-991
    Subject code 590
    Language English
    Publishing date 2023-11-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: The relationship between viral clearance rates and disease progression in early symptomatic COVID-19: a systematic review and meta-regression analysis.

    Singh, Shivani / Boyd, Simon / Schilling, William H K / Watson, James A / Mukaka, Mavuto / White, Nicholas J

    The Journal of antimicrobial chemotherapy

    2024  

    Abstract: Background: Effective antiviral drugs accelerate viral clearance in acute COVID-19 infections; the relationship between accelerating viral clearance and reducing severe clinical outcomes is unclear.: Methods: A systematic review was conducted of ... ...

    Abstract Background: Effective antiviral drugs accelerate viral clearance in acute COVID-19 infections; the relationship between accelerating viral clearance and reducing severe clinical outcomes is unclear.
    Methods: A systematic review was conducted of randomized controlled trials (RCTs) of antiviral therapies in early symptomatic COVID-19, where viral clearance data were available. Treatment benefit was defined clinically as the relative risk of hospitalization/death during follow-up (≥14 days), and virologically as the SARS-CoV-2 viral clearance rate ratio (VCRR). The VCRR is the ratio of viral clearance rates between the intervention and control arms. The relationship between the clinical and virological treatment effects was assessed by mixed-effects meta-regression.
    Results: From 57 potentially eligible RCTs, VCRRs were derived for 44 (52 384 participants); 32 had ≥1 clinical endpoint in each arm. Overall, 9.7% (R2) of the variation in clinical benefit was explained by variation in VCRRs with an estimated linear coefficient of -0.92 (95% CI: -1.99 to 0.13; P = 0.08). However, this estimate was highly sensitive to the inclusion of the recent very large PANORAMIC trial. Omitting this outlier, half the variation in clinical benefit (R2 = 50.4%) was explained by variation in VCRRs [slope -1.47 (95% CI -2.43 to -0.51); P = 0.003], i.e. higher VCRRs were associated with an increased clinical benefit.
    Conclusion: Methods of determining viral clearance in COVID-19 studies and the relationship to clinical outcomes vary greatly. As prohibitively large sample sizes are now required to show clinical treatment benefit in antiviral therapeutic assessments, viral clearance is a reasonable surrogate endpoint.
    Language English
    Publishing date 2024-02-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 191709-2
    ISSN 1460-2091 ; 0305-7453
    ISSN (online) 1460-2091
    ISSN 0305-7453
    DOI 10.1093/jac/dkae045
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.

    Simon, James A / Clayton, Anita H / Kim, Noel N / Patel, Sejal

    Sexual medicine

    2022  Volume 10, Issue 1, Page(s) 100476

    Abstract: ... improvements in endpoint measures. Simon JA, Clayton AH, Kim NN, et al. Clinically Meaningful Benefit in Women ...

    Abstract Background: The efficacy of flibanserin in treating hypoactive sexual desire disorder (HSDD) is based upon statistically significant improvements in sexual desire, satisfying sexual events, and distress. However, clinically meaningful benefit has not been well characterized.
    Aim: Evaluate clinically meaningful benefit of flibanserin.
    Methods: Data were pooled from 3 pivotal trials evaluating flibanserin 100 mg qhs in premenopausal women (flibanserin, n = 1192; placebo, n = 1215). Flibanserin trial data in postmenopausal women (flibanserin, n = 450; placebo, n = 476) were analyzed separately. Clinically meaningful benefit was evaluated by the Patient Global Impression of Improvement (PGI-I). Responders were determined through anchor-based analyses that used the PGI-I for key efficacy endpoints: satisfying sexual events (SSE), desire domain of the Female Sexual Function Index (FSFI-d), and distress associated with decreased sexual desire (FSDS-R13). Odds ratios were calculated to assess effect size and Kaplan-Meier analyses were performed to estimate onset time for treatment benefit.
    Outcomes: PGI-I, anchor-based analyses for key efficacy endpoints (SSE, FSFI-d, FSDS-R13), odds ratios, onset time for treatment benefit.
    Results: Based on the PGI-I, more patients reported clinically meaningful benefit with flibanserin treatment versus placebo (49.8% vs 33.6%, premenopausal cohort; 40.5% vs 28.7%, postmenopausal cohort). In anchor-based analyses, responder rates were significantly higher for premenopausal women on flibanserin (46.1%-55.2%) than placebo (34.1%-44.2%) for all 3 key efficacy endpoints (P < .0001). Responder rates for postmenopausal women on flibanserin were higher compared to placebo for SSE (29.8% vs 22.9%; P = .015) and FSFI-d (38.9% vs 26.3%; P = .0001). Odds ratios for key endpoints indicated that premenopausal women were 2.0-2.4 times as likely to be responders with flibanserin treatment compared to placebo. Postmenopausal women were 1.6 times as likely to be responders with flibanserin for FSFI-d. Kaplan-Meier analyses indicated significant separation between flibanserin and placebo for the key endpoints in both premenopausal and postmenopausal cohorts (log-rank tests P < .01) with earlier median response times among patients receiving flibanserin.
    Clinical implications: Patient-reported benefit assessments such as the PGI-I capture the patient's perspective and may be a useful approach in assessing overall clinical meaningfulness for sexual dysfunction therapies.
    Strengths and limitations: Strengths include a well-powered study with large enrollment, use of validated instruments, and self-assessment of treatment benefit. Limitations include pooling of trial data in premenopausal women with slightly different study designs and use of an endpoint (SSE) indirectly related to HSDD.
    Conclusion: Assessment of clinically meaningful benefit and additional responder analyses provide further support for flibanserin's efficacy beyond numerical improvements in endpoint measures. Simon JA, Clayton AH, Kim NN, et al. Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin. Sex Med 2022;10:100476.
    Language English
    Publishing date 2022-01-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2734882-9
    ISSN 2050-1161
    ISSN 2050-1161
    DOI 10.1016/j.esxm.2021.100476
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: UK Medical Cannabis Registry: Assessment of clinical outcomes in patients with insomnia.

    Vivek, Kavyesh / Karagozlu, Zekiye / Erridge, Simon / Holvey, Carl / Coomber, Ross / Rucker, James J / Weatherall, Mark W / Sodergren, Mikael H

    Brain and behavior

    2024  Volume 14, Issue 2, Page(s) e3410

    Abstract: Introduction: The primary aim of this study was to assess changes in sleep-specific health-related quality of life (HRQoL) for those prescribed cannabis-based medicinal products (CBMPs) for insomnia.: Methods: A case series of UK patients with ... ...

    Abstract Introduction: The primary aim of this study was to assess changes in sleep-specific health-related quality of life (HRQoL) for those prescribed cannabis-based medicinal products (CBMPs) for insomnia.
    Methods: A case series of UK patients with insomnia was analyzed. Primary outcomes were changes in the Single-Item Sleep-Quality Scale (SQS), Generalized Anxiety Disorder-7 (GAD-7), and EQ-5D-5L at up to 6 months from baseline. Statistical significance was identified as a p value < .050.
    Results: 61 patients were included in the analysis. There was an improvement in the SQS from baseline at 1, 3, and 6 months (p < .001). There were also improvements in the EQ-5D-5L Index value and GAD-7 at 1, 3, and 6 months (p < .050). There were 28 (45.9%) adverse events recorded by 8 patients (13.1%). There were no life-threatening/disabling adverse events.
    Conclusion: Patients with insomnia experienced an improvement in sleep quality following the initiation of CBMPs in this medium-term analysis. Fewer than 15% of participants reported one or more adverse events. However, due to the limitations of the study design, further investigation is required before definitive conclusions can be drawn on the efficacy of CBMPs in treating insomnia.
    MeSH term(s) Humans ; Sleep Initiation and Maintenance Disorders/drug therapy ; Medical Marijuana/adverse effects ; Quality of Life ; Cannabis ; Registries ; United Kingdom
    Chemical Substances Medical Marijuana
    Language English
    Publishing date 2024-02-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2623587-0
    ISSN 2162-3279 ; 2162-3279
    ISSN (online) 2162-3279
    ISSN 2162-3279
    DOI 10.1002/brb3.3410
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Measuring GPCR Stoichiometry Using Types-1, -2, and -3 Bioluminescence Resonance Energy Transfer-Based Assays.

    Felce, James H / James, John R / Davis, Simon J

    Methods in molecular biology (Clifton, N.J.)

    2019  Volume 1947, Page(s) 183–197

    Abstract: How G protein-coupled receptors are assembled is a matter of considerable interest owing in large part to their remarkable pharmacological importance. For determining receptor stoichiometry, resonance energy transfer-based methods offer considerable ... ...

    Abstract How G protein-coupled receptors are assembled is a matter of considerable interest owing in large part to their remarkable pharmacological importance. For determining receptor stoichiometry, resonance energy transfer-based methods offer considerable advantages insofar as they provide the necessary spatial resolution, and because measurements can be made in situ, relatively easily. This chapter describes three complementary stoichiometric assays that rely on measurements of bioluminescence resonance energy transfer. These quantitative approaches make it possible to identify true protein-protein interactions from non-specific associations that inevitably result from constraining proteins in cellular membranes. In our experience, concordant data obtained in two or more of these assays, benchmarked with suitable controls, strongly predict receptor stoichiometry.
    MeSH term(s) Bioluminescence Resonance Energy Transfer Techniques/methods ; Cell Membrane/metabolism ; Fluorescence ; HEK293 Cells ; Humans ; Ligands ; Luciferases, Renilla/metabolism ; Protein Binding ; Protein Conformation ; Receptors, G-Protein-Coupled/chemistry ; Receptors, G-Protein-Coupled/metabolism
    Chemical Substances Ligands ; Receptors, G-Protein-Coupled ; Luciferases, Renilla (EC 1.13.12.5)
    Language English
    Publishing date 2019-04-04
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 1940-6029
    ISSN (online) 1940-6029
    DOI 10.1007/978-1-4939-9121-1_10
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Dupilumab: Clinical Efficacy of Blocking IL-4/IL-13 Signalling in Chronic Rhinosinusitis with Nasal Polyps.

    Kariyawasam, Harsha H / James, Louisa K / Gane, Simon B

    Drug design, development and therapy

    2020  Volume 14, Page(s) 1757–1769

    Abstract: In September 2019, ...

    Abstract In September 2019,
    MeSH term(s) Antibodies, Monoclonal, Humanized/pharmacology ; Chronic Disease ; Humans ; Interleukin-13/antagonists & inhibitors ; Interleukin-13/metabolism ; Interleukin-4/antagonists & inhibitors ; Interleukin-4/metabolism ; Nasal Polyps/drug therapy ; Nasal Polyps/metabolism ; Rhinitis/drug therapy ; Rhinitis/metabolism ; Signal Transduction/drug effects
    Chemical Substances Antibodies, Monoclonal, Humanized ; IL13 protein, human ; IL4 protein, human ; Interleukin-13 ; Interleukin-4 (207137-56-2) ; dupilumab (420K487FSG)
    Language English
    Publishing date 2020-05-08
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 2451346-5
    ISSN 1177-8881 ; 1177-8881
    ISSN (online) 1177-8881
    ISSN 1177-8881
    DOI 10.2147/DDDT.S243053
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: UK Medical Cannabis Registry: An analysis of clinical outcomes of medicinal cannabis therapy for attention-deficit/hyperactivity disorder.

    Ittiphakorn, Pim / Erridge, Simon / Holvey, Carl / Coomber, Ross / Rucker, James J / Sodergren, Mikael H

    Neuropsychopharmacology reports

    2023  Volume 43, Issue 4, Page(s) 596–606

    Abstract: Aim: This study aims to analyze the health-related quality of life (HRQoL) and safety outcomes in attention-deficit/hyperactivity disorder (ADHD) patients treated with cannabis-based medicinal products (CBMPs).: Methods: Patients were identified from ...

    Abstract Aim: This study aims to analyze the health-related quality of life (HRQoL) and safety outcomes in attention-deficit/hyperactivity disorder (ADHD) patients treated with cannabis-based medicinal products (CBMPs).
    Methods: Patients were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in the following patient-reported outcome measures (PROMs) at 1, 3, 6, and 12 months from baseline: EQ-5D-5L index value, generalized anxiety disorder-7 (GAD-7) questionnaire, and the single-item sleep quality score (SQS). Secondary outcomes assessed the incidence of adverse events. Statistical significance was defined as p < 0.050.
    Results: Sixty-eight patients met the inclusion criteria. Significant improvements were identified in general HRQoL assessed by EQ-5D-5L index value at 1, 3, and 6 months (p < 0.050). Improvements were also identified in GAD-7 and SQS scores at 1, 3, 6, and 12 months (p < 0.010). 61 (89.71%) adverse events were recorded by 11 (16.18%) participants, of which most were moderate (n = 26, 38.24%).
    Conclusion: An association between CBMP treatment and improvements in anxiety, sleep quality, and general HRQoL was observed in patients with ADHD. Treatment was well tolerated at 12 months. Results must be interpreted with caution as a causative effect cannot be proven. These results, however, do provide additional support for future evaluation within randomized controlled trials.
    MeSH term(s) Humans ; Medical Marijuana/adverse effects ; Attention Deficit Disorder with Hyperactivity/drug therapy ; Attention Deficit Disorder with Hyperactivity/epidemiology ; Quality of Life ; Registries ; United Kingdom/epidemiology
    Chemical Substances Medical Marijuana
    Language English
    Publishing date 2023-12-06
    Publishing country United States
    Document type Journal Article
    ISSN 2574-173X
    ISSN (online) 2574-173X
    DOI 10.1002/npr2.12400
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: A cohort study comparing the effects of medical cannabis for anxiety patients with and without comorbid sleep disturbance.

    Murphy, Matthew / Erridge, Simon / Holvey, Carl / Coomber, Ross / Rucker, James J / Sodergren, Mikael H

    Neuropsychopharmacology reports

    2023  Volume 44, Issue 1, Page(s) 129–142

    Abstract: Background: Research on cannabis-based medicinal products (CBMPs) in anxiety remains inconclusive due to a paucity of high-quality evidence. Studies indicate a bidirectional relationship between generalized anxiety disorder (GAD) and sleep disruption, ... ...

    Abstract Background: Research on cannabis-based medicinal products (CBMPs) in anxiety remains inconclusive due to a paucity of high-quality evidence. Studies indicate a bidirectional relationship between generalized anxiety disorder (GAD) and sleep disruption, but it is unclear how this affects CBMP treatment outcomes. This study aims to compare the patient-reported outcome measures (PROMs) of patients prescribed CBMPs for GAD, with and without impaired sleep.
    Methods: Changes in PROMs were recorded from baseline to 1, 3, 6, and 12 months between those with impaired or unimpaired sleep. Multivariate logistic regression was applied to compare factors associated with a clinically significant improvement in GAD-7 at 12 months. Secondary outcomes included adverse event incidence and frequency.
    Results: Of the 302 patients that fit the inclusion criteria, mean GAD-7, single-item sleep quality, and EQ-5D-5L index values improved at all time points (p < 0.001). A relationship between sleep impairment and clinically significant changes in GAD-7 at 1 and 3 months was identified (p ≤ 0.01). On multivariate regression, only baseline GAD severity was associated with an increased likelihood of observing a clinically significant improvement in anxiety (p < 0.001). Seven hundred and seven (234%) adverse events were reported by 55 (18.21%) participants.
    Conclusions: This study observed an association between CBMP treatment and improvements in anxiety in patients with GAD. While patients with comorbid sleep disruption had greater improvements in anxiety, the differences were not maintained in a multivariate analysis. Baseline anxiety severity may be a predictor for CBMP treatment outcomes.
    MeSH term(s) Humans ; Medical Marijuana ; Cohort Studies ; Anxiety Disorders/epidemiology ; Anxiety ; Sleep
    Chemical Substances Medical Marijuana
    Language English
    Publishing date 2023-12-28
    Publishing country United States
    Document type Journal Article
    ISSN 2574-173X
    ISSN (online) 2574-173X
    DOI 10.1002/npr2.12407
    Database MEDical Literature Analysis and Retrieval System OnLINE

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