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Safety, Tolerability, and Pharmacokinetics of Same-Knee Intra-Articular Injection of Corticosteroid and Lorecivivint Within 7 Days: An Open-Label, Randomized, Parallel-Arm Study
IntroductionKnee osteoarthritis (OA) is a common painful disorder. Intra-articular (IA) corticosteroid injections are frequently prescribed to treat...
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Tolerability of endometriosis medical treatment: a comparison between combined hormonal contraceptives and progestins
Endometriosis is a chronic inflammatory disease that occurs in women of reproductive age. Much of the treatment involves hormone therapy that...
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Evaluation of the Influence of Sildenafil on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vericiguat in Healthy Adults
Background and ObjectiveVericiguat is approved for the treatment of patients with heart failure with ejection fraction < 45%. Sildenafil, indicated...
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Effectiveness and Tolerability of Methotrexate Combined with Biologics in Patients with Crohn’s Disease: A Multicenter Observational Study
BackgroundMethotrexate (MTX) combination therapy with biological agents has gained increasing interest. Here, we assessed the efficacy and...
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Individualized atomoxetine response and tolerability in children with ADHD receiving different dosage regimens: the need for CYP2D6 genoty** and therapeutic drug monitoring to dance together
Integrating CYP2D6 genoty** and therapeutic drug monitoring (TDM) is crucial for guiding individualized atomoxetine therapy in children with...
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Efficacy and Tolerability of Ramucirumab Plus Erlotinib in Taiwanese Patients with Untreated, Epidermal Growth Factor Receptor-Mutated, Stage IV Non-small Cell Lung Cancer in the RELAY Study
BackgroundIn RELAY, a randomized, double-blind, phase III trial investigating the efficacy and safety of ramucirumab+erlotinib (RAM+ERL) or...
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Randomized cross-over study investigating the tolerability and side effects of an intra-oral air-cooling device compared to ice in healthy volunteers
Oral cryotherapy (OC) is a common preventive treatment of oral mucositis (OM) and is recommended in international guidelines. Ice and air OC have...
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Effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for hemorrhoidal symptoms: a prospective, observational study
Background and aimsA high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products...
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Tolerability, safety and survival in patients with severe pulmonary arterial hypertension treated with intravenous epoprostenol (Veletri®): a prospective, 6-months, open label, observational, non-interventional study
BackgroundEpoprostenol AS (Veletri ® ), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to...
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Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application
Topical formulation and delivery technologies for pharmaceutical application should simultaneously address efficacy, safety and convenience of...
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Effectiveness and tolerability of eptinezumab in treating patients with migraine resistant to conventional preventive medications and CGRP (receptor) antibodies: a multicentre retrospective real-world analysis from Germany
BackgroundEptinezumab is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP mAb) and is used for migraine prophylaxis. Efficacy...
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Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist
IntroductionWe assessed the effect of the prandial state on the pharmacokinetics, safety, and tolerability of single and multiple doses of...
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Comparative Muscle Tolerability of Different Types and Intensities of Statins: A Network Meta-Analysis of Double-Blind Randomized Controlled Trials
PurposeThe benefits of statins for ischemic cardio-cerebrovascular diseases are well known. However, concerns around muscle adverse events still...
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A First-in-Human Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Neutralization Profile of Two Investigational Long-Acting Anti-SARS-CoV-2 Monoclonal Antibodies
IntroductionCOVID-19 remains a significant risk for the immunocompromised given their lower responsiveness to vaccination or infection. Therefore,...
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A Phase Ib Study Assessing the Safety, Tolerability, and Efficacy of the First-in-Class Wee1 Inhibitor Adavosertib (AZD1775) as Monotherapy in Patients with Advanced Solid Tumors
BackgroundAdavosertib (AZD1775) is a first-in-class, selective, small-molecule inhibitor of Wee1.
ObjectiveThe safety, tolerability,...
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Human Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC42, a Novel Farnesoid X Receptor Agonist
BackgroundASC42 is a non-steroidal farnesoid X receptor agonist currently in clinical development for chronic liver diseases, such as nonalcoholic...
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The influence of body mass index on the tolerability and effectiveness of full-weight-based paclitaxel chemotherapy in women with early-stage breast cancer
PurposeTo investigate the influence of body mass index (BMI) on the tolerability and effectiveness of full-weight-based paclitaxel chemotherapy in...
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Efficacy and tolerability of somatostatin analogues according to gender in patients with neuroendocrine tumors
As the incidence of neuroendocrine tumors has been rising, gender differences in epidemiology and clinical behavior have emerged, and interest into a...
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Tapinarof Cream 1% for Extensive Plaque Psoriasis: A Maximal Use Trial on Safety, Tolerability, and Pharmacokinetics
BackgroundTapinarof is a novel topical therapeutic aryl hydrocarbon receptor modulating agent in development for the treatment of psoriasis and...
