53,928 results match your criteria safety profile


Real-world Evidence of Axicabtagene Ciloleucel for the Treatment of Large B-Cell Lymphoma in the United States.

Transplant Cell Ther 2022 May 21. Epub 2022 May 21.

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL. Electronic address:

Background: Axicabtagene ciloleucel (axi-cel) is a standard-of-care for relapsed or refractory (r/r) large B-cell lymphoma (LBCL) with two or more lines of prior therapy. Patients receiving axi-cel in the real-world could have broader demographics, disease, and treatment profile compared to the cohort of the pivotal ZUMA-1 trial.

Objective: To evaluate the outcomes of axi-cel in the real-world setting. Read More

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Selective Pharmacologic Therapies for Dry Eye Disease Treatment: Efficacy, Tolerability, and Safety Data Review from Preclinical Studies and Pivotal Trials.

Ophthalmol Ther 2022 May 24. Epub 2022 May 24.

Virginia Eye Consultants, Norfolk, VA, USA.

Keratoconjunctivitis sicca, also known as dry eye disease (DED), is a prevalent, multifactorial disease associated with compromised ocular lubrication, ocular surface inflammation and damage, and ocular symptoms. Several anti-inflammatory, topical ophthalmic therapies are available to treat clinical signs and symptoms of DED in the USA and Europe. Cyclosporine A (CsA)-based formulations include an ophthalmic emulsion of 0. Read More

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Exploration of molecular mechanisms responsible for anti-inflammatory and anti-angiogenic attributes of methanolic extract of Viola betonicifolia.

Inflammopharmacology 2022 May 24. Epub 2022 May 24.

Department of Pharmacy,Faculty of Pharmacy, the University of Lahore, Lahore 54000, Pakistan.

Uncontrolled inflammation plays a central role in the pathogenesis of various diseases. Currently available anti-inflammatory agents on prolonged use may lead to ulcers or thrombus formation. The present study was designed to evaluate the anti-inflammatory, anti-arthritic and anti-angiogenic potentials of methanol extract of Viola betonicifolia using battery of in vivo models. Read More

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Early use of high-efficacy disease‑modifying therapies makes the difference in people with multiple sclerosis: an expert opinion.

J Neurol 2022 May 24. Epub 2022 May 24.

Department of Basic Medical Sciences, Neuroscience, and Sense Organs, University of Bari "Aldo Moro", Bari, Italy.

Multiple sclerosis (MS) is a chronic and progressive neurological disease that is characterized by neuroinflammation, demyelination and neurodegeneration occurring from the earliest phases of the disease and that may be underestimated. MS patients accumulate disability through relapse-associated worsening or progression independent of relapse activity. Early intervention with high-efficacy disease-modifying therapies (HE-DMTs) may represent the best window of opportunity to delay irreversible central nervous system damage and MS-related disability progression by hindering underlying heterogeneous pathophysiological processes contributing to disability progression. Read More

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[Janus kinase inhibitors for the treatment of atopic dermatitis-evaluation of current data and practical experience].

Hautarzt 2022 May 24. Epub 2022 May 24.

Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, Technische Universität München, Biedersteinerstr. 29, 80802, München, Deutschland.

Background: Atopic dermatitis is a common chronic inflammatory skin disease and has a major impact on patient's quality of life. Janus kinase inhibitors were recently approved for the treatment of atopic dermatitis.

Objectives: To summarize current data on efficacy and safety of Janus kinase inhibitors for the treatment of atopic dermatitis as well as guidelines for the use in clinical practice. Read More

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The efficacy and safety of tofacitinib, peficitinib, solcitinib, baricitinib, abrocitinib, and deucravacitinib in plaque psoriasis - A network meta-analysis.

J Eur Acad Dermatol Venereol 2022 May 24. Epub 2022 May 24.

Department of Dermatology, West China Hospital, Sichuan University, Chengdu, 610041, China.

Janus kinase (JAK) inhibitors are novel treatment approaches for psoriasis. However, there is no direct comparison of JAK inhibitors in plaque psoriasis. In order to compare the efficacy and safety of JAK inhibitors in psoriasis, we conducted a network meta-analysis using eligible randomized clinical trials (RCTs). Read More

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Elotuzumab plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended 3-year follow-up of a multicenter, retrospective clinical experience with 319 cases outside of controlled clinical trials.

Hematol Oncol 2022 May 24. Epub 2022 May 24.

Department of Experimental and Clinical Medicine, University "Magna Graecia" of Catanzaro, Pavia, Italy.

The combination of elotuzumab, lenalidomide, and dexamethasone (EloRd) enhanced the clinical benefit over Rd with a manageable toxicity profile in the ELOQUENT-2 trial, leading to its approval in relapsed/refractory multiple myeloma (RRMM). The present study is a 3-year follow-up update of a previously published Italian real-life RRMM cohort of patients treated with EloRd. This revised analysis entered 319 RRMM patients accrued in 41 Italian centers. Read More

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GSK2556286 Is a Novel Antitubercular Drug Candidate Effective with the Potential To Shorten Tuberculosis Treatment.

Antimicrob Agents Chemother 2022 May 24:e0013222. Epub 2022 May 24.

Diseases of the Developing World, GlaxoSmithKline R+D Limited, Tres Cantos, Madrid, Spain.

As a result of a high-throughput compound screening campaign using Mycobacterium tuberculosis-infected macrophages, a new drug candidate for the treatment of tuberculosis has been identified. GSK2556286 inhibits growth within human macrophages (50% inhibitory concentration [IC] = 0.07 μM), is active against extracellular bacteria in cholesterol-containing culture medium, and exhibits no cross-resistance with known antitubercular drugs. Read More

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PAVING THE WAY TOWARDS PRECISION VACCINOLOGY: THE PARADIGM OF MYOCARDITIS AFTER COVID-19 VACCINATION.

Clin Infect Dis 2022 May 24. Epub 2022 May 24.

Immunobiology Research Laboratory and Infectious Diseases Department "MAKKA", First Department of Paediatrics, "Aghia Sophia" Children's Hospital, Athens Medical School, 11527 Athens, Greece.

Systems vaccinology approaches have introduced novel tools for the evaluation of the safety profile of novel vaccine antigens by developing biomarkers of vaccine reactogenicity associated with potential adverse events. The use of such approaches may prove extremely advantageous in the context of a global pandemic where accelerated approval of new vaccine formulations for all ages is essential for the containment of the epidemic. The spread of SARS-COV-2 has had devastating effects on global health, but the emergency-authorization of mRNA vaccines significantly reduced SARS-COV-2-associated morbidity and mortality. Read More

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Effects of treatment with monacolin K, berberine and coenzyme Q10 on lipid metabolism in patients with moderate cardiovascular risk.

Semergen 2022 May 20. Epub 2022 May 20.

Lipid Unit and Vascular Risk. Internal Medicine Department Bellvitge University Hospital-IDIBELL, Spain; CIBEROBN, Spain; Universidad de Barcelona, Spain.

Objective: The use of nutritional supplements to treat hypercholesterolemia is gradually increasing, however further studies on their efficacy and safety are required.

Patients And Methods: The present clinical trial included patients with moderate hypercholesterolemia and cardiovascular risk who were treated either with a nutraceutical preparation containing 3.75mg of monacolin K, 515mg of berberine and 50mg of coenzyme Q10 per tablet (Lipok®) or with a placebo. Read More

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The Safety and Efficacy of Tocilizumab in Older Adult Critically Ill Patients with Coronavirus Disease 2019 (COVID-19): A Multi-center, Cohort Study.

Int J Infect Dis 2022 May 20. Epub 2022 May 20.

Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia; King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address:

Background: Evidence supports Tocilizumab (TCZ) benefit and safety in adult patients with severe COVID-19. However, its effectiveness in critically ill older adult patients remains questionable. Thus, the study aimed to evaluate the safety and efficacy of TCZ in older critically ill patients with COVID-19. Read More

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PHARMACOKINETIC-PHARMACODYNAMIC STUDY OF AMPICILLIN-CLOXACILLIN COMBINATION IN INDIAN THOROUGHBRED HORSES (Equus caballus) AND SAFETY EVALUATION OF THE COMPUTED DOSAGE REGIMEN.

J Equine Vet Sci 2022 May 20:104020. Epub 2022 May 20.

In-charge, Remount and Veterinary Corps, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, India.

The pharmacokinetics of ampicillin-cloxacillin, given as single intravenously dose of 10 mg.kg (5 mg.kg of ampicillin plus 5 mg. Read More

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Comparison of intravenous labetalol and hydralazine for severe hypertension in pregnancy in Northeastern Nigeria: A randomized controlled trial.

Pregnancy Hypertens 2022 May 8;29:1-6. Epub 2022 May 8.

Department of Obstetrics and Gynaecology, Gombe State University, Gombe, Nigeria.

Objectives: The objectives were to compare the efficacy and safety of intravenous hydralazine and labetalol for acutely lowering severe hypertension in pregnancy.

Study Design: This was a superiority parallel double-blinded randomized controlled trial conducted from October 2018 to June 2019 in two hospitals in Gombe, Nigeria. Pregnant women with a live singleton fetus at gestational age of at least 28 weeks with severe hypertension were randomized (60 per group) to receive incremental doses of either intravenous labetalol (20 mg; 40 mg; 80 mg; 80 mg; and 80 mg) or 10 mg of intravenous hydralazine - up to a maximum of 5 doses - until the target blood pressure was achieved or the study was terminated. Read More

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Cardiovascular Outcomes in Patients Initiating First-Line Treatment of Type 2 Diabetes With Sodium-Glucose Cotransporter-2 Inhibitors Versus Metformin : A Cohort Study.

Ann Intern Med 2022 May 24. Epub 2022 May 24.

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (H.S., R.J.G., E.P.).

Background: Evidence on the risk for cardiovascular events associated with use of first-line sodium-glucose cotransporter-2 inhibitors (SGLT-2i) compared with metformin is limited.

Objective: To assess cardiovascular outcomes among adults with type 2 diabetes (T2D) who initiated first-line treatment with SGLT-2i versus metformin.

Design: Population-based cohort study. Read More

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Sonidegib in the Treatment of Locally Advanced Basal Cell Carcinoma: a Retrospective Study.

Acta Derm Venereol 2022 May 23. Epub 2022 May 23.

AP-HP Department of Dermatology, Université de Paris, DMU ICARE, INSERM U976 HIPI, Team 1 Hôpital Saint-Louis, FR-75010 Paris, France.

Sonidegib, a hedgehog pathway inhibitor, is indicated for treatment of locally advanced basal cell carcinoma, based on the results of the BOLT study. However, to date, no real-world study of sonidegib has been reported. An observational, retrospective, single-centre study (PaSoS study) was conducted. Read More

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Title: Real-world practice indirect comparison between guselkumab, risankizumab and tildrakizumab: results from an Italian 28-week retrospective study.

J Dermatolog Treat 2022 May 23:1-13. Epub 2022 May 23.

Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II.

Background: Guselkumab, tildrakizumab and risankizumab, acting on interleukin(IL)23 axis, have been recently approved for psoriasis management. However, real-life data regarding their comparison are scant.

Objectives: The aim of our real life study was to perform an indirect efficacy and safety comparison among anti-IL23s, particularly focusing on difficult-to-treat areas. Read More

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Hydromorphone impurity 2,2-bishydromorphone does not exert mutagenic and clastogenic properties via QSAR prediction and Ames and micronucleus test.

Drug Chem Toxicol 2022 May 23:1-6. Epub 2022 May 23.

Fresenius Kabi Deutschland GmbH, Medical, Clinical & Regulatory Affairs, Bad Homburg, Germany.

The opioid agonist hydromorphone is indicated for the management of severe acute and chronic pain given that alternate treatments are insufficient. While the genotoxicity profile of hydromorphone is well investigated, little is known about the genotoxic potential of its impurities. In this study, 2,2-bishydromorphone was tested and for both its mutagenic potential in an Ames test performed with and tester strains up to a maximum concentration of 5 mg per plate in the absence and presence of metabolic activation. Read More

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Real-World Evidence of Efficacy and Safety of Levonadifloxacin (Oral and IV) in the Management of Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Findings of a Retrospective, Multi-Center Study.

Cureus 2022 Apr 20;14(4):e24299. Epub 2022 Apr 20.

Medical Affairs, Wockhardt Ltd., Mumbai, IND.

Background Antimicrobial resistance by bacteria poses a substantial threat to the success in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Levonadifloxacin is a novel benzoquinolizine subclass of quinolone which has a broad spectrum of activity, available in both oral and intravenous formulations for the treatment of skin structure infections caused by Gram-positive pathogens including methicillin-resistant Staphylococcus aureus (MRSA). Patients and methods This prescription event monitoring study captured data of 227 patients receiving levonadifloxacin (oral and/or IV) in a real-world setting to assess the safety and efficacy in the treatment of ABSSSI. Read More

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A comprehensive review of intravitreal immunosuppressants and biologicals used in ophthalmology.

Ther Adv Ophthalmol 2022 Jan-Dec;14:25158414221097418. Epub 2022 May 18.

All India Institute of Medical Sciences, New Delhi, New Delhi, India.

Systemic immunosuppressants and biologicals have been a valuable tool in the treatment of inflammatory diseases and malignancies. The safety profile of these drugs has been debatable, especially in localized systems, such as the eye. This has led to the search for fairly local approaches, such as intravitreal, subconjunctival, and topical route of administration. Read More

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Epidemiology, Environmental Risks, Virulence, and Resistance Determinants of From Dairy Cows in Hubei, China.

Front Microbiol 2022 4;13:858799. Epub 2022 May 4.

MOA Laboratory for Risk Assessment of Quality and Safety of Livestock and Poultry Products, Huazhong Agricultural University, Wuhan, China.

() is an opportunistic pathogen, which causes serious infections in humans and animals. To investigate the antimicrobial resistance pattern and virulence profile of , a total of 887 samples were collected from both the healthy and mastitis cows and the bedding, feed, feces, air, drinking water, spraying water, washing water, and milk cup swabs from five dairy farms in Hubei, China, during 2019 and 2020. was isolated and identified using PCR of the and 16S rDNA sequencing. Read More

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Clinical Experience using Osimertinib in Patients with Recurrent Malignant Gliomas Containing Alterations.

J Cancer Sci Clin Ther 2021 29;5(2):210-220. Epub 2021 Apr 29.

Wake Forest Baptist Health Comprehensive Cancer Center, Department of Internal Medicine, Section on Hematology and Oncology, Winston-Salem, NC, USA.

Background: alterations are commonly observed in malignant gliomas (MG). Osimertinib, an irreversible EGFR-tyrosine kinase inhibitor, effectively penetrates the blood brain barrier and achieves therapeutic concentrations in brain tissue.

Materials And Methods: This retrospective chart review identified six patients with recurrent MG and alterations who received osimertinib. Read More

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Safety of Propofol When Used for Rapid Sequence Intubation in Septic Patients: A Multicenter Cohort Study.

Hosp Pharm 2022 Apr 8;57(2):287-293. Epub 2021 Jul 8.

Methodist University Hospital, Memphis, TN, USA.

Purpose: Septic patients are at risk for hypotension, and this risk may increase during rapid sequence intubation (RSI). Sedatives such as propofol must be used carefully due to its ability to reduce vascular sympathetic tone. Since the safety of propofol for RSI is not well described in sepsis, this was a study evaluating propofol and its effects on hemodynamics when used for RSI in a septic population. Read More

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Evaluation of Biologically Inspired Ammonium Xanthommatin as a Multifunctional Cosmetic Ingredient.

JID Innov 2022 May 29;2(3):100081. Epub 2021 Nov 29.

Seaspire Skincare, Cambridge, Massachusetts, USA.

We describe the investigation of an organic natural product, ammonium xanthommatin (Xanthochrome), in a series of studies designed to not only assess its impact on endocrine receptor function in vitro but also interrogate its mutagenic potential using bacterial reverse mutation assays. As a multifunctional raw material, ammonium xanthommatin functions as an antioxidant with a broad absorption profile spanning the UV through the visible spectrum, making it an interesting target for cosmetic applications. In solution, ammonium xanthommatin contributes to <30% inhibition of hormonal activities, indicating that it is not an endocrine disruptor. Read More

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Associations of Plasma Fatty Acid Patterns During Pregnancy With Gestational Diabetes Mellitus.

Front Nutr 2022 6;9:836115. Epub 2022 May 6.

Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Background: Limited studies have explored the difference of fatty acid profile between women with and without gestational diabetes mellitus (GDM), and the results were inconsistent. Individual fatty acids tend to be interrelated because of the shared food sources and metabolic pathways. Thus, whether fatty acid patters during pregnancy were related to GDM odds needs further exploration. Read More

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A Case Report: First Long-Term Treatment With Burosumab in a Patient With Cutaneous-Skeletal Hypophosphatemia Syndrome.

Front Endocrinol (Lausanne) 2022 6;13:866831. Epub 2022 May 6.

Department of Pediatric Nephrology and Pulmonology, University Hospital Leipzig, Leipzig, Germany.

Epidermal nevus syndromes encompass a highly heterogeneous group of systemic disorders, characterized by epidermal nevi, and a spectrum of neuromuscular, ocular, and bone abnormalities. Cutaneous-skeletal hypophosphatemia syndrome (CSHS) constitutes a specific sub-entity in which elevated levels of fibroblast growth factor-23 cause hypophosphatemic rickets that are, to date, not amenable to causal therapy. Here, we report the first long-term follow-up of causal treatment with burosumab in a 3-year-old female patient with CSHS. Read More

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Risperidone Induced Hyperprolactinemia: From Basic to Clinical Studies.

Front Psychiatry 2022 6;13:874705. Epub 2022 May 6.

Department of Psychiatry, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia.

Risperidone is one of the most commonly used antipsychotics (AP), due to its safety and efficacy in reducing psychotic symptoms. Despite the favorable side effect profile, the therapy is accompanied by side effects due to the non-selectivity of this medicine. This review will briefly highlight the most important basic and clinical findings in this area, consider the clinical effects of AP-induced hyperprolactinemia (HPL), and suggest different approaches to the treatment. Read More

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Thrombectomy vs Medical Management in Mild Strokes due to Large Vessel Occlusion: Exploratory Analysis from the EXTEND-IA Trials and a Pooled International Cohort.

Ann Neurol 2022 May 22. Epub 2022 May 22.

The Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Objective: To evaluate functional and safety outcomes for endovascular thrombectomy (EVT) versus medical management (MM) in patients with large vessel occlusion (LVO) and mild neurological deficits, stratified by perfusion imaging mismatch.

Methods: Pooled cohort of patients with NIHSS<6 and ICA, M1, M2 occlusions from EXTEND-IA, EXTEND-IA-TNK I/II RCTs and prospective data from 15 EVT centers from 10/2010 to 4/2020. RAPID software estimated ischemic core and mismatch. Read More

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Indonesian consensus on systemic therapies for hepatocellular carcinoma.

Asia Pac J Clin Oncol 2022 May 22. Epub 2022 May 22.

Hepatobiliary Division, Department of Internal Medicine, Cipto Mangunkusumo National General Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.

Hepatocellular carcinoma (HCC) is a deadly cancer with a rising incidence in the last 20 years. Most patients are diagnosed late when curative treatment is no longer feasible. With the background of chronic liver disease in most patients, the management of HCC becomes more complicated, in which well-preserved liver function is a prerequisite for locoregional or systemic therapies. Read More

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Combining SJ733, an oral ATP4 inhibitor of Plasmodium falciparum, with the pharmacokinetic enhancer cobicistat: An innovative approach in antimalarial drug development.

EBioMedicine 2022 May 19;80:104065. Epub 2022 May 19.

University of Kentucky College of Pharmacy, Lexington, KY, United States.

Background: SJ733, a newly developed inhibitor of P. falciparum ATP4, has a favorable safety profile and rapid antiparasitic effect but insufficient duration to deliver a single-dose cure of malaria. We investigated the safety, tolerability, and pharmacokinetics of a multidose SJ733 regimen and a single-dose pharmacoboost approach using cobicistat to inhibit CYP3A4, thereby increasing exposure. Read More

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