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  1. Article ; Online: Stent-Mediated Redistribution of Cerebral Venous Outflow in the Treatment of Severe Intractable Headache: A Case Report.

    Higgins, Nicholas / Hall, Frances / Pickard, John

    Journal of observational pain medicine

    2023  Volume 1, Issue 3, Page(s) 24–36

    Abstract: We describe a patient with multiple symptoms but whose primary complaint was of headache, in whom no firm diagnosis was made in two years, who was resistant to all treatment, until a markedly asymmetrical cranial venous outflow came to be regarded, not ... ...

    Abstract We describe a patient with multiple symptoms but whose primary complaint was of headache, in whom no firm diagnosis was made in two years, who was resistant to all treatment, until a markedly asymmetrical cranial venous outflow came to be regarded, not as normal variant anatomy but as fundamental to the clinical problem. Deliberately altering this anatomy in favour of a more symmetrical arrangement by stenting a hypoplastic transverse sinus brought about an immediate, profound and sustained clinical improvement. This result challenges the existing consensus on what is acceptable as normal in respect of cranial venous outflow. It raises intriguing questions about the relationship between neurological symptoms and the vagaries of cranial venous outflow anatomy. It suggests there may be new opportunities in the investigation of chronic headache.
    Language English
    Publishing date 2023-01-10
    Publishing country England
    Document type Journal Article
    ISSN 2047-0800
    ISSN (online) 2047-0800
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  2. Article ; Online: First report of improvement of coeliac disease in a patient with Sjögren's syndrome treated with rituximab.

    Nikiphorou, Elena / Hall, Frances C

    Rheumatology (Oxford, England)

    2014  Volume 53, Issue 10, Page(s) 1906–1907

    MeSH term(s) Antibodies, Monoclonal, Murine-Derived/therapeutic use ; Antirheumatic Agents/therapeutic use ; Celiac Disease/complications ; Celiac Disease/drug therapy ; Female ; Humans ; Immunologic Factors/therapeutic use ; Middle Aged ; Rituximab ; Sjogren's Syndrome/complications ; Sjogren's Syndrome/drug therapy ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal, Murine-Derived ; Antirheumatic Agents ; Immunologic Factors ; Rituximab (4F4X42SYQ6)
    Language English
    Publishing date 2014-10
    Publishing country England
    Document type Case Reports ; Letter
    ZDB-ID 1464822-2
    ISSN 1462-0332 ; 1462-0324
    ISSN (online) 1462-0332
    ISSN 1462-0324
    DOI 10.1093/rheumatology/keu161
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  3. Article: Drug review process advancement and required manufacturer and contract research oraganization responses.

    Anzai, Takayuki / Myatt, Glenn J / Hall, Frances / Finney, Brenda / Nakagawa, Kenshi / Iwata, Hijiri / Anzai, Reo / Dickinson, Anne / Freer, Matthew / Nakae, Dai / Onodera, Hiroshi / Matsuyama, Takaaki

    Journal of toxicologic pathology

    2023  Volume 37, Issue 2, Page(s) 45–53

    Abstract: The United States Senate passed the "FDA Modernization Act 2.0." on September 29, 2022. Although the effectiveness of this Bill, which aims to eliminate the mandatory use of laboratory animals in new drug development, is limited, it represents a ... ...

    Abstract The United States Senate passed the "FDA Modernization Act 2.0." on September 29, 2022. Although the effectiveness of this Bill, which aims to eliminate the mandatory use of laboratory animals in new drug development, is limited, it represents a significant trend that will change the shape of drug applications in the United States and other countries. However, pharmaceutical companies have not taken major steps towards the complete elimination of animal testing from the standpoint of product safety, where they prioritize patient safety. Nonetheless, society is becoming increasingly opposed to animal testing, and efforts will be made to use fewer animals and conduct fewer animal tests as a natural and reasonable response. These changes eventually alter the shape of new drug applications. Based on the assumption that fewer animal tests will be conducted or fewer animals will be used in testing, this study explored bioinformatics and new technologies as alternatives to compensate for reduced information and provide a picture of how future new drug applications may look. The authors also discuss the directions that pharmaceutical companies and nonclinical contract research organizations should adopt to promote the replacement, reduction, and refinement of animals used in research, teaching, testing, and exhibitions.
    Language English
    Publishing date 2023-11-22
    Publishing country Japan
    Document type Journal Article ; Review
    ZDB-ID 2128461-1
    ISSN 1881-915X ; 0914-9198
    ISSN (online) 1881-915X
    ISSN 0914-9198
    DOI 10.1293/tox.2023-0106
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  4. Article: Does treatment with DMARDs decrease the risk of cardiovascular disease in patients with RA?

    Hall, Frances C

    Nature clinical practice. Rheumatology

    2007  Volume 3, Issue 5, Page(s) 254–255

    Language English
    Publishing date 2007-05
    Publishing country United States
    Document type Comment ; Journal Article
    ZDB-ID 2228569-6
    ISSN 1745-8390 ; 1745-8382
    ISSN (online) 1745-8390
    ISSN 1745-8382
    DOI 10.1038/ncprheum0477
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  5. Article ; Online: First report of liver transplantation in Blau syndrome: The challenges faced in this rare granulomatous liver disease.

    Sinharay, Ricky / McKeown, Lorcán / Phillips, Catriona / Li, Alice / Duckworth, Adam / Hall, Frances / Griffiths, William J H

    Transplant immunology

    2021  Volume 65, Page(s) 101378

    Abstract: Blau syndrome is a rare autoinflammatory granulomatous disease caused by variants in the NOD2 gene, classically presenting in childhood. Hepatic manifestations are recognized including cholestasis and granulomatous liver disease. We describe a novel NOD2 ...

    Abstract Blau syndrome is a rare autoinflammatory granulomatous disease caused by variants in the NOD2 gene, classically presenting in childhood. Hepatic manifestations are recognized including cholestasis and granulomatous liver disease. We describe a novel NOD2 gene variant c.1471A > C, p.(Met491Leu) in an adult who developed cirrhotic complications despite selective immunotherapy, including recurrent esophageal bleeding and spontaneous bacterial peritonitis which resulted in liver transplantation. He required a second liver transplant as his first graft failed due to ischemic cholangiopathy. Disease recurrence has been observed (hitherto unreported). Of 84 patients with Blau syndrome treated with antibody therapy, five hepatic cases responded to anti-TNF therapy, with promising results if instigated before decompensation occurs. We report the first case of liver transplantation for Blau syndrome in an adult with a novel NOD2 variant. Blau related liver disease can reoccur post transplantation and is an important consideration for any future graft. LAY SUMMARY: Blau syndrome is a rare immune disease which presents in childhood. We describe the first liver transplant for this condition following development of progressive liver disease in adulthood. The patient had a newly described variant in the Blau gene (NOD2). We discuss the effectiveness of antibody therapy currently being used to control the disease, and the role of liver transplantation in Blau syndrome.
    MeSH term(s) Adult ; Arthritis ; Humans ; Liver Transplantation ; Male ; Mutation ; Nod2 Signaling Adaptor Protein/genetics ; Sarcoidosis ; Synovitis ; Tumor Necrosis Factor Inhibitors ; Uveitis
    Chemical Substances Nod2 Signaling Adaptor Protein ; Tumor Necrosis Factor Inhibitors
    Language English
    Publishing date 2021-02-20
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1160846-8
    ISSN 1878-5492 ; 0966-3274
    ISSN (online) 1878-5492
    ISSN 0966-3274
    DOI 10.1016/j.trim.2021.101378
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    Zs.A 3784: Show issues Location:
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  6. Article ; Online: Baricitinib set to join the Covid-19 therapeutic arsenal?

    Gudu, Tania / Stober, Carmel / Cope, Andrew P / Cheriyan, Joseph / Galloway, James / Wilkinson, Ian B / Kostapanos, Michalis / Jayne, David / Hall, Frances

    Rheumatology (Oxford, England)

    2021  Volume 60, Issue 4, Page(s) 1585–1587

    MeSH term(s) Antiviral Agents/immunology ; Antiviral Agents/pharmacology ; Azetidines/immunology ; Azetidines/pharmacology ; COVID-19/immunology ; Clinical Trials as Topic ; Humans ; Immunologic Factors/pharmacology ; Intracellular Signaling Peptides and Proteins/antagonists & inhibitors ; Janus Kinase Inhibitors/pharmacology ; Protein Serine-Threonine Kinases/antagonists & inhibitors ; Purines/immunology ; Purines/pharmacology ; Pyrazoles/immunology ; Pyrazoles/pharmacology ; SARS-CoV-2/drug effects ; Sulfonamides/immunology ; Sulfonamides/pharmacology ; Treatment Outcome ; COVID-19 Drug Treatment
    Chemical Substances Antiviral Agents ; Azetidines ; Immunologic Factors ; Intracellular Signaling Peptides and Proteins ; Janus Kinase Inhibitors ; Purines ; Pyrazoles ; Sulfonamides ; AAK1 protein, human (EC 2.7.11.1) ; GAK protein, human (EC 2.7.11.1) ; Protein Serine-Threonine Kinases (EC 2.7.11.1) ; baricitinib (ISP4442I3Y)
    Language English
    Publishing date 2021-01-27
    Publishing country England
    Document type Editorial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1464822-2
    ISSN 1462-0332 ; 1462-0324
    ISSN (online) 1462-0332
    ISSN 1462-0324
    DOI 10.1093/rheumatology/keab061
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  7. Article ; Online: A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's.

    Tornling, Göran / Edenius, Charlotte / Pauling, John D / Denton, Christopher P / Olsson, Anna / Kowalski, Jan / Murray, Andrea / Anderson, Marina / Bhat, Smita / Del Galdo, Francesco / Hall, Frances / Korkosz, Mariusz / Krasowska, Dorota / Olas, Jacek / Smith, Vanessa / van Laar, Jacob M / Vonk, Madelon C / Wojteczek, Anna / Herrick, Ariane L

    Rheumatology (Oxford, England)

    2024  

    Abstract: Objective: Our objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) which decreases prostaglandin E2 (PGE2) and increases prostacyclin ... ...

    Abstract Objective: Our objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) which decreases prostaglandin E2 (PGE2) and increases prostacyclin biosynthesis, improves RP.
    Methods: Patients with systemic sclerosis (SSc) and ≥7 RP attacks during the last screening week prior to a baseline visit were randomised to four weeks treatment with vipoglanstat 120 mg or placebo. A daily electronic diary captured RP attacks (duration and pain) and Raynaud's Condition Score, with change in RP attacks/week as primary end point. Cold challenge assessments were performed at baseline and end of treatment. Exploratory endpoints included patients' and physicians' global impression of change, Assessment of Scleroderma-associated Raynaud's Phenomenon questionnaire, mPGES-1 activity, and urinary excretion of arachidonic acid metabolites.
    Results: Sixty-nine subjects received vipoglanstat (n = 33) or placebo (n = 36). Mean weekly number of RP attacks (baseline; vipoglanstat 14.4[SD 6.7], placebo 18.2[12.6]) decreased by 3.4[95% CI -5.8;-1.0] and 4.2[-6.5;-2.0] attacks per week (p= 0.628) respectively. All patient reported outcomes improved, with no difference between the groups. Mean change in recovery of peripheral blood flow after cold challenge did not differ between the study groups. Vipoglanstat fully inhibited mPGES-1, resulting in 57% reduction of PGE2 and 50% increase of prostacyclin metabolites in urine. Vipoglanstat was safe and well tolerated.
    Conclusion: Although vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP. Further development and evaluation of vipoglanstat will therefore be in other diseases where mPGES-1 plays a pathogenetic role.
    Language English
    Publishing date 2024-01-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 1464822-2
    ISSN 1462-0332 ; 1462-0324
    ISSN (online) 1462-0332
    ISSN 1462-0324
    DOI 10.1093/rheumatology/keae049
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  8. Article ; Online: Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment.

    Bassan, Arianna / Steigerwalt, Ronald / Keller, Douglas / Beilke, Lisa / Bradley, Paul M / Bringezu, Frank / Brock, William J / Burns-Naas, Leigh Ann / Chambers, Jon / Cross, Kevin / Dorato, Michael / Elespuru, Rosalie / Fuhrer, Douglas / Hall, Frances / Hartke, Jim / Jahnke, Gloria D / Kluxen, Felix M / McDuffie, Eric / Schmidt, Friedemann /
    Valentin, Jean-Pierre / Woolley, David / Zane, Doris / Myatt, Glenn J

    Frontiers in toxicology

    2024  Volume 6, Page(s) 1370045

    Abstract: The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes a comprehensive integrated Weight of Evidence (WoE) approach to determine the need for a 2-year rat carcinogenicity study. In the present ... ...

    Abstract The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes a comprehensive integrated Weight of Evidence (WoE) approach to determine the need for a 2-year rat carcinogenicity study. In the present work, experts from different organizations have joined efforts to standardize as much as possible a procedural framework for the integration of evidence associated with the different ICH S1B(R1) WoE criteria. The framework uses a pragmatic consensus procedure for carcinogenicity hazard assessment to facilitate transparent, consistent, and documented decision-making and it discusses best-practices both for the organization of studies and presentation of data in a format suitable for regulatory review. First, it is acknowledged that the six WoE factors described in the addendum form an integrated network of evidence within a holistic assessment framework that is used synergistically to analyze and explain safety signals. Second, the proposed standardized procedure builds upon different considerations related to the primary sources of evidence, mechanistic analysis, alternative methodologies and novel investigative approaches, metabolites, and reliability of the data and other acquired information. Each of the six WoE factors is described highlighting how they can contribute evidence for the overall WoE assessment. A suggested reporting format to summarize the cross-integration of evidence from the different WoE factors is also presented. This work also notes that even if a 2-year rat study is ultimately required, creating a WoE assessment is valuable in understanding the specific factors and levels of human carcinogenic risk better than have been identified previously with the 2-year rat bioassay alone.
    Language English
    Publishing date 2024-04-05
    Publishing country Switzerland
    Document type Journal Article
    ISSN 2673-3080
    ISSN (online) 2673-3080
    DOI 10.3389/ftox.2024.1370045
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  9. Article: Targeting CVD risk in chronic connective tissue disease.

    Malaviya, Anshuman P / Hall, Frances C

    The Practitioner

    2012  Volume 256, Issue 1747, Page(s) 21–6, 3

    Abstract: Chronic inflammatory rheumatological conditions are associated with an increased burden of cardiovascular disease (CVD). In both rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) most excess mortality is cardiovascular. Increased CVD risk ... ...

    Abstract Chronic inflammatory rheumatological conditions are associated with an increased burden of cardiovascular disease (CVD). In both rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) most excess mortality is cardiovascular. Increased CVD risk is also associated with psoriatic arthritis, ankylosing spondylitis, antiphospholipid syndrome and systemic sclerosis. Several studies report that CVD mortality increases early in disease in RA, with increased risk of MI within one year and increased risk of hospital admission for CVD within seven years of diagnosis. A linear association has been demonstrated between subclinical carotid atherosclerosis and raised inflammatory markers. SLE is associated with 2-10 times the risk of a CVD event compared with the general population. CVD is now a leading cause of morbidity and mortality in SLE. Antiphospholipid antibodies are associated with accelerated atherosclerosis, as well as thromboses. Atherogenesis in the context of autoimmune disease results from a complex interplay between traditional risk factors, disease-specific factors and drug-related adverse effects. Chronic inflammation itself modifies the lipid profile.
    MeSH term(s) Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/prevention & control ; Connective Tissue Diseases/complications ; Connective Tissue Diseases/pathology ; Connective Tissue Diseases/therapy ; Humans ; Risk Factors
    Language English
    Publishing date 2012-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 124095-x
    ISSN 0032-6518
    ISSN 0032-6518
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  10. Article ; Online: In silico

    Keller, Douglas A / Bassan, Arianna / Amberg, Alexander / Burns Naas, Leigh Ann / Chambers, Jon / Cross, Kevin / Hall, Frances / Jahnke, Gloria D / Luniwal, Amarjit / Manganelli, Serena / Mestres, Jordi / Mihalchik-Burhans, Amy L / Woolley, David / Tice, Raymond R

    Frontiers in toxicology

    2023  Volume 5, Page(s) 1234498

    Abstract: ... In ... ...

    Abstract In silico
    Language English
    Publishing date 2023-11-13
    Publishing country Switzerland
    Document type Journal Article
    ISSN 2673-3080
    ISSN (online) 2673-3080
    DOI 10.3389/ftox.2023.1234498
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