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Pharmacokinetics and Tolerability of Zibotentan in Patients with Concurrent Moderate Renal and Moderate Hepatic Impairment
Background and ObjectiveZibotentan, a selective endothelin A receptor antagonist, is in development for chronic liver and kidney disease. The...
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Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study
BackgroundDermatomyositis is an idiopathic inflammatory myopathy characterised by rashes and progressive muscle weakness. The recent ProDERM...
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A Phase 1a Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7303509, an Anti-TGFβ3 Antibody, in Healthy Volunteers
IntroductionTransforming growth factor beta (TGFβ) cytokines (TGFβ1, TGFβ2, and TGFβ3) play critical roles in tissue fibrosis. However, treatment...
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Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials
This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509 after oral single rising doses (SRDs) or multiple...
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Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study
IntroductionAtopic dermatitis (AD) is a chronic disease that occurs mainly in children. Topical corticosteroids are the main treatment for mild to...
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Safety and Tolerability
The most common adverse effects of tDCS are erythema (skin redness), burning, tingling, itching, headache, and discomfort on the site of stimulation....
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Safety and tolerability study of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity
BackgroundMultiple vaccines have been approved since August 2021 to prevent infection with SARS-CoV-2; however, 20–40% of immunocompromised people...
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Safety and tolerability of pirfenidone in asbestosis: a prospective multicenter study
BackgroundPirfenidone slows down disease progression in idiopathic pulmonary fibrosis (IPF). Recent studies suggest a treatment effect in progressive...
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Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Novel Recombination Human Nerve Growth Factor in Healthy Chinese Subjects
BackgroundNerve growth factor (NGF), the first-discovered member of the neurotrophin family, has long been regarded as a potential drug to combat...
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Assessment of wound healing efficacy and tolerability using Cicatryl™ cream based on a suction blister model in healthy subjects
BackgroundCicatryl™ cream, a topical medical device, is indicated for the treatment of superficial wounds and small skin injuries.
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Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial
BackgroundTecarfarin (ATI-5923), a structural analog of warfarin, was designed to provide more uniform and stable anticoagulation.
Objective ...
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OCE-205, A Novel, Selective Vasopressin Receptor Mixed Agonist-Antagonist: Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics from a Phase 1 Study in Healthy Volunteers
BackgroundOCE-205, a novel, selective vasopressin V1a receptor mixed agonist/antagonist with no V2 receptor activity, may treat the portal...
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A Phase 1b, Open-Label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals with MS
Thyroid hormones are essential during developmental myelination and may play a direct role in remyelination and repair in the adult central nervous...
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Safety, Tolerability, Pharmacokinetics and Quantitative Electroencephalography Assessment of ACD856, a Novel Positive Allosteric Modulator of Trk-Receptors Following Multiple Doses in Healthy Subjects
BackgroundACD856 is a positive allosteric modulator of tropomyosin receptor kinase (Trk) receptors which has shown to have pro-cognitive and...
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Effectiveness and Tolerability of 12-Month Brivaracetam in the Real World: EXPERIENCE, an International Pooled Analysis of Individual Patient Records
Background and ObjectiveReal-world evidence studies of brivaracetam (BRV) have been restricted in scope, location, and patient numbers. The objective...
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Use of the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events to assess treatment tolerability in pulmonary arterial hypertension: qualitative patient research findings in current and former users of oral selexipag
BackgroundUnderstanding patients’ perspectives regarding drug tolerability, in addition to effectiveness, provides a complete picture of the patient...
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A 12-month prospective real-life study of opicapone efficacy and tolerability in Emirati and non-White subjects with Parkinson’s disease based in United Arab Emirates
Parkinson’s disease (PD) is the second most common neurodegenerative disorder, and the condition is complicated by the emergence of wearing off/motor...
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An open-label multiyear study of sargramostim-treated Parkinson’s disease patients examining drug safety, tolerability, and immune biomarkers from limited case numbers
BackgroundThe clinical utility and safety of sargramostim has previously been reported in cancer, acute radiation syndrome, autoimmune disease,...
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Safety, Tolerability and Pharmacokinetics of Icapamespib, a Selective Epichaperome Inhibitor, in Healthy Adults
BackgroundNeurodegenerative diseases are devastating conditions that most commonly affect individuals 65 years and older. Currently there are no...
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Efficacy and gastrointestinal tolerability of methotrexate in late-onset rheumatoid arthritis patients: a prospective cohort study
BackgroundThe proportion of the late-onset forms of disease is growing in rheumatoid arthritis (RA) population. Concerns about comorbidities and drug...