267,594 results match your criteria adverse events


Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study.

BMJ Open 2022 Aug 8;12(8):e058304. Epub 2022 Aug 8.

MVZ-DRZ Sinsheim Eberbach Erbach Walldorf Heidelberg, Heidelberg, Germany.

Objectives: Since the safety of coronary CT angiography (CTA) is of great importance, especially with regard to widening indications and increasing morbidity, the aim of this study was to assess influencing factors.

Methods: Patients undergoing coronary CTA in a third-generation dual-source CT in a radiological centre were included in a clinical registry. Up to 20 mg metoprolol was administered intravenously to attain a heart rate ≤65/min. Read More

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Safety, tolerability and efficacy of agonist anti-CD27 antibody (varlilumab) administered in combination with anti-PD-1 (nivolumab) in advanced solid tumors.

J Immunother Cancer 2022 Aug;10(8)

R & D, Celldex Therapeutics Inc, Hampton, New Jersey, USA.

Background: Phase 1/2 dose-escalation and expansion study evaluating varlilumab, a fully human agonist anti-CD27 mAb, with nivolumab in anti-PD-1/L1 naïve, refractory solid tumors.

Methods: Phase 1 evaluated the safety of varlilumab (0.1-10 mg/kg) with nivolumab (3 mg/kg) administered once every 2 weeks. Read More

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The Association Between a Second Course of Cardiac Rehabilitation and Cardiovascular Outcomes Following Repeat Percutaneous Coronary Intervention Events.

J Cardiopulm Rehabil Prev 2022 Aug 4. Epub 2022 Aug 4.

Xiangya Hospital, Central South University, Changsha, China (Drs Zhang and Dun); Department of Physical Medicine and Rehabilitation, Gregorio Marañon General University Hospital, Gregorio Marañon Health Research Institute, Madrid, Spain (Dr Supervia); Departments of Quantitative Health Sciences (Mr Lennon) and Cardiovascular Medicine (Drs Sandhu, Tilbury, Squires, and Thomas), Mayo Clinic, Rochester, Minnesota; Cardiovascular Department, Peking University People's Hospital, Beijing, China (Dr Ding); Department of Cardiology, Olmsted Medical Center, Rochester, Minnesota (Dr Tabatabaei); Halifax Health, Daytona Beach, Florida (Dr Tabatabaei); and Department of Medicine, John H. Stroger Hospital of Cook County, Chicago, Illinois (Dr Vardar).

Purpose: Survivors of coronary artery disease (CAD) events are at risk for repeat events. Although evidence supports cardiac rehabilitation (CR) after an initial CAD event, it is unclear whether a repeat course of CR (CR × 2) is beneficial after a recurrent CAD event. The purpose of this study was to determine the association of CR × 2 with clinical outcomes in persons undergoing repeat percutaneous coronary intervention (PCI). Read More

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Arid5a Mediates an IL-17-Dependent Pathway That Drives Autoimmunity but Not Antifungal Host Defense.

J Immunol 2022 Aug 8. Epub 2022 Aug 8.

Division of Rheumatology & Clinical Immunology, University of Pittsburgh, Pittsburgh, PA; and

IL-17 contributes to the pathogenesis of certain autoimmune diseases, but conversely is essential for host defense against fungi. Ab-based biologic drugs that neutralize IL-17 are effective in autoimmunity but can be accompanied by adverse side effects. is a commensal fungus that is the primary causative agent of oropharyngeal and disseminated candidiasis. Read More

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Precision therapy with quinidine of KCNT1-related epileptic disorders: a systematic review.

Br J Clin Pharmacol 2022 Aug 8. Epub 2022 Aug 8.

Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Aims: Despite numerous studies on quinidine therapies for epilepsies associated with KCNT1 gene mutations, there is no consensus on its clinical utility. Thus, we reviewed studies evaluating the efficacy and safety of quinidine in KCNT1-related epileptic disorders.

Methods: Electronic databases were queried for in vivo and in vitro studies on quinidine therapy in KCNT1-related epilepsies published on or before May 1st, 2022. Read More

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Daily tenofovir disoproxil fumarate/emtricitabine and hydroxychloroquine for pre-exposure prophylaxis of COVID-19: a double-blind placebo controlled randomized trial in healthcare workers.

Clin Microbiol Infect 2022 Aug 5. Epub 2022 Aug 5.

Ministry of Health, Madrid, Spain.

Objective: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk.

Methods: EPICOS is a double-blind, placebo-controlled randomized trial conducted in Spain, Bolivia, and Venezuela. Healthcare workers with negative SARS-CoV-2 IgM/IgG test were randomly assigned to: daily TDF/FTC plus HCQ for 12 weeks, TDF/FTC plus HCQ placebo, HCQ plus TDF/FTC placebo and TDF/FTC placebo plus HCQ placebo. Read More

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Efficacy and Safety of Transjugular Intrahepatic Portosystemic Shunt in Budd-Chiari Syndrome: A Systematic Review and Meta-Analysis.

J Vasc Interv Radiol 2022 Aug 5. Epub 2022 Aug 5.

Department of Gastroenterology, Seth GS Medical College and KEM Hospital, Mumbai, India.

Purpose: The data with respect to the safety and outcome of transjugular intrahepatic portosystemic shunt (TIPS) in patients with Budd-Chiari syndrome (BCS) are scarce due to the rarity 0of the disease. Hence, this meta-analysis was conducted to assess the critical role of TIPS in the management of BCS.

Methods: A comprehensive search of literature of various databases from 2000 till October 2021 was conducted for studies evaluating the outcome of TIPS in patients with BCS. Read More

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Pulp Regenerative Cell Therapy for Mature Molars: A Report of 2 Cases.

J Endod 2022 Aug 5. Epub 2022 Aug 5.

Section of Regenerative Dental Medicine, National Center for Geriatrics and Gerontology, Research Institute, Geroscience Research Center, Obu, Aichi 474-8511, Japan.

Introduction: Regenerative cell therapy using autologous dental pulp stem cells (DPSCs) in mature single-rooted teeth is a potential alternative to traditional endodontic treatment. However, there is no evidence supporting the use of DPSCs in multi-rooted teeth. This case report aimed to demonstrate the feasibility and outcomes of pulp regenerative cell therapy in mature multi-rooted molars, which typically have a higher prevalence of apical deltas. Read More

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The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD): A Korean Chronic Kidney Disease Cohort.

J Prev Med Public Health 2022 Jul 1;55(4):313-320. Epub 2022 Jul 1.

Department of Internal Medicine, National Medical Center, Seoul, Korea.

The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) was launched in 2011 with the support of the Korea Disease Control and Prevention Agency. The study was designed with the aim of exploring the various clinical features and characteristics of chronic kidney disease (CKD) in Koreans, and elucidating the risk factors for CKD progression and adverse outcomes of CKD. For the cohort study, nephrologists at 9 tertiary university-affiliated hospitals participated in patient recruitment and follow-up. Read More

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Depression in young people.

Lancet 2022 Aug 5. Epub 2022 Aug 5.

Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.

Depression rates in young people have risen sharply in the past decade, especially in females, which is of concern because adolescence is a period of rapid social, emotional, and cognitive development and key life transitions. Adverse outcomes associated with depression in young people include depression recurrence; the onset of other psychiatric disorders; and wider, protracted impairments in interpersonal, social, educational, and occupational functioning. Thus, prevention and early intervention for depression in young people are priorities. Read More

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Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study.

Lancet Oncol 2022 Aug 5. Epub 2022 Aug 5.

Department of Melanoma Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Background: Targeted therapy and immunotherapy have shown intracranial activity in melanoma with CNS metastases, but there remains an unmet need, particularly for patients with symptomatic CNS metastases. We aimed to evaluate atezolizumab in combination with cobimetinib or vemurafenib plus cobimetinib in patients with melanoma with CNS metastases.

Methods: TRICOTEL was a multicentre, open-label, single-arm, phase 2 study done in two cohorts: a BRAF wild-type cohort and a BRAF mutation-positive cohort, recruited at 21 hospitals and oncology centres in Brazil, France, Germany, Hungary, Italy, Spain, and Switzerland. Read More

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First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements.

Eur J Cancer 2022 Aug 5;173:238-249. Epub 2022 Aug 5.

Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address:

Background: TQ-B3139 is a novel ALK tyrosine kinase inhibitor (TKI) against a broad range of ALK mutations. The aim of this first-in-human phase I trial was to investigate the safety, tolerability, pharmacokinetics, and clinical efficacy of TQ-B3139 in ALK or ROS1 positive advanced NSCLC patients.

Methods: Following a 3 + 3 design, patients received escalating daily dose of TQ-B3139 (50-800 mg) continuously in 28-day cycles. Read More

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Sarc-frailty: towards an integrated view of ageing.

Maturitas 2022 Aug 2;165:85-93. Epub 2022 Aug 2.

Division of Family Medicine, Department of Family and Community Medicine, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei City, Taiwan, ROC; Division of Geriatric Medicine, Department of Family and Community Medicine, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei City, Taiwan, ROC; Department of Biochemistry, National Defense Medical Center, Taipei City, Taiwan, ROC. Electronic address:

Objectives: Sarcopenia and frailty have both been related to adverse events in ageing, but have long been studied in parallel. The purpose of this study was to provide a better depiction of ageing by taking the advantages of both entities.

Study Design: 2532 participants were enrolled from the National Health and Nutrition Examination Survey 1999-2002. Read More

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Dynamic natural morphologies and component changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome at 1-year follow-up and clinical significance at 3-year follow-up.

Atherosclerosis 2022 Jul 31;356:1-8. Epub 2022 Jul 31.

Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing 210006, China. Electronic address:

Background And Aims: We aimed to explore the dynamic natural morphologies and main components of nonculprit subclinical atherosclerotic changes underlying lesion regression (LR) or lesion progression (LP) in patients with acute coronary syndrome.

Methods: The primary endpoints were changes in percent atheroma volume (ΔPAV), normalized total atheroma volume (ΔTAVn) and each component in nonculprit subclinical atherosclerosis from baseline to 1 year measured by optical flow ratio (OFR) software. LR or LP was defined by an increase or decrease in PAV. Read More

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3-year Outcomes of XEN Implant Compared to Trabeculectomy, With or Without Phacoemulsification for Open-angle Glaucoma.

J Glaucoma 2022 Aug 1. Epub 2022 Aug 1.

Department of Ophthalmology, Hospital General Universitario Dr. Balmis, Alicante, Spain.

Prcis: Trabeculectomy surgery reduces the intraocular pressure (IOP) more than the XEN45 implant over 3 years. There is no difference in the number of antiglaucoma medications between the two procedures. The decision to perform either trabeculectomy or XEN45 implantation must be evaluated on a case-by-case basis, taking into account the high rate of needling of the XEN45. Read More

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Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

Authors:

Ann Intern Med 2022 Aug 9. Epub 2022 Aug 9.

Background: Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.

Objective: To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.

Design: Double-blind, randomized, placebo-controlled, clinical trial. Read More

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Phase II Study of Afatinib in Patients With Tumors With Human Epidermal Growth Factor Receptor 2-Activating Mutations: Results From the National Cancer Institute-Molecular Analysis for Therapy Choice ECOG-ACRIN Trial (EAY131) Subprotocol EAY131-B.

JCO Precis Oncol 2022 Jul;6:e2200165

Massachusetts General Hospital, Boston, MA.

Purpose: National Cancer Institute-Molecular Analysis for Therapy Choice is a multicohort trial that assigns patients with advanced cancers to targeted therapies on the basis of central tumor genomic testing. Arm B evaluated afatinib, an ErbB family tyrosine kinase inhibitor, in patients with -activating mutations.

Methods: Eligible patients had selected single-nucleotide variants or insertions/deletions detected by the National Cancer Institute-Molecular Analysis for Therapy Choice next-generation sequencing assay. Read More

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Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults.

N Engl J Med 2022 Jul;387(4):299-309

From the Division of Endocrinology, Diabetes, and Hypertension (M.S.L., S.H.C., K.A.R.), the Division of Preventive Medicine (N.R.C., E.K., I.-M.L., J.E.B., J.E.M.), and the Department of Radiology (B.K.), Brigham and Women's Hospital, Harvard Medical School (M.S.L., S.H.C., N.R.C., B.K., I.-M.L., J.E.B., J.E.M.), and the Department of Epidemiology, Harvard T.H. Chan School of Public Health (N.R.C., I.-M.L., J.E.B., J.E.M.) - all in Boston; California Pacific Medical Center Research Institute (P.M.C.), and the Departments of Epidemiology and Biostatistics (P.M.C., D.C.B., D.B.) and Medicine (D.C.B.), University of California, San Francisco - both in San Francisco; and the Department of Endocrinology, Creighton University School of Medicine, Omaha, NE (J.C.G.).

Background: Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.

Methods: In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D (2000 IU per day), n-3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Read More

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Optimized dual therapy for treatment-naive patients of Helicobacter pylori infection: A large-scale prospective, multicenter, open-label, randomized controlled study.

Helicobacter 2022 Aug 8. Epub 2022 Aug 8.

Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Background: The efficacy and safety of high-dose amoxicillin (AMX) and proton pump inhibitors (PPI) dual therapy raises much more attention in recent years. Comparative studies among the dual therapies are required to explore more suitable regimens. This study compared the efficacy, adverse events, and patient compliance of three different high-dose dual regimens in treatment-naive patients of Helicobacter pylori (H. Read More

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Efficacy and safety of PD-1/PD-L1 inhibitors in triple-negative breast cancer: a systematic review and meta-analysis.

Acta Oncol 2022 Aug 8:1-11. Epub 2022 Aug 8.

Department of Breast Surgery, the First Affiliated Hospital of China Medical University, Shenyang, China.

Objective: Triple-negative breast cancer (TNBC) is a subtype of breast cancer with a poor prognosis that seriously threatens women's health. There is still a lack of effective therapeutic targets for TNBC treatment. We conducted a meta-analysis to evaluate the efficacy and safety of programmed cell death protein 1 (PD-1)/programmed death protein ligand 1 (PD-L1) inhibitors in combination with chemotherapy for TNBC patients. Read More

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Randomized single oral dose phase 1 study of safety, tolerability, and pharmacokinetics of Iminosugar UV-4 Hydrochloride (UV-4B) in healthy subjects.

PLoS Negl Trop Dis 2022 Aug 8;16(8):e0010636. Epub 2022 Aug 8.

AbViro, Bethesda, Maryland, United States of America.

Background: UV-4 (N-(9'-methoxynonyl)-1-deoxynojirimycin, also called MON-DNJ) is an iminosugar small-molecule oral drug candidate with in vitro antiviral activity against diverse viruses including dengue, influenza, and filoviruses and demonstrated in vivo efficacy against both dengue and influenza viruses. The antiviral mechanism of action of UV-4 is through inhibition of the host endoplasmic reticulum-resident α-glucosidase 1 and α-glucosidase 2 enzymes. This inhibition prevents proper glycan processing and folding of virus glycoproteins, thereby impacting virus assembly, secretion, and the fitness of nascent virions. Read More

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Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring.

PLoS One 2022 8;17(8):e0271299. Epub 2022 Aug 8.

Department of Internal Medicine, 2nd Faculty of Medicine, Motol University Hospital, Charles University in Prague, Prague, Czech Republic.

Objective: The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. Read More

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Umbilical venous catheter- and peripherally inserted central catheter-associated complications in preterm infants with birth weight < 1250 g : Results from a survey in Austria and Germany.

Wien Med Wochenschr 2022 Aug 8. Epub 2022 Aug 8.

Department of General Pediatrics and Neonatology, Saarland University Medical Center, Kirrberger Str., Building 9, 66421, Homburg, Germany.

Background And Objective: Umbilical venous catheters (UVC) and peripherally inserted central catheters (PICC) are commonly used in preterm infants but have been associated with a number of serious complications. We performed a survey in Austria and Germany to assess the use of UVCs and PICCs in preterm infants with a birth weight < 1250 g and associated rates of catheter-related adverse events.

Methods: Electronic survey of participating centers of the NeoVitaA trial. Read More

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MedDRA Labeling Groupings to Improve Safety Communication in Product Labels.

Ther Innov Regul Sci 2022 Aug 8. Epub 2022 Aug 8.

Pfizer, Worldwide Safety and Regulatory, New York, USA.

The granularity and structure of the International Council for Harmonisation's (ICH) Medical Dictionary for Regulatory Activities (MedDRA) are useful for precise coding of adverse events (AEs) for data analysis. In product labeling for healthcare practitioners, however, the granularity of MedDRA Preferred Terms (PTs) can obscure the communication of adverse reactions (ARs). Driven by a focus on patient safety, business needs, and regulatory guidance, many sponsors and regulators have begun to develop institution-specific approaches to clustering similar AR terms in medical product prescribing information on a product-by-product basis. Read More

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MINOCA: under recognized and affecting predominantly female patients-an Australian experience.

Ir J Med Sci 2022 Aug 8. Epub 2022 Aug 8.

Department of Cardiology, Peninsula Health, Frankston, VIC, 3199, Australia.

Background: Myocardial infarction with nonobstructive coronary arteries (MINOCA) is now being recognized as an important clinical entity with prognostic implications. There are limited data in relation to MINOCA in our local Australian settings.

Aim: We investigated the prevalence, clinical characteristics, major adverse cardiovascular events (MACE), and 1-year mortality of patients with MINOCA at Peninsula Health. Read More

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Effect and safety profile of belimumab and tacrolimus combination therapy in thirty-three patients with systemic lupus erythematosus.

Clin Rheumatol 2022 Aug 8. Epub 2022 Aug 8.

Immuno-Rheumatology Center, St. Luke's International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.

Introduction/objectives: Belimumab combined with mycophenolate mofetil has been proven to be effective for treating systemic lupus erythematosus (SLE) in several randomized controlled trials. Calcineurin inhibitors are also useful in controlling the activity of SLE. However, the safety and effectiveness of belimumab-calcineurin inhibitor combination therapy have not been addressed. Read More

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Adverse Outcome Pathways and Linkages to Transcriptomic Effects Relevant to Ionizing Radiation Injury.

Int J Radiat Biol 2022 Aug 8:1-26. Epub 2022 Aug 8.

Health Canada, Ottawa, Canada.

Background: In the past three decades, a large body of data on the effects of exposure to ionizing radiation and the ensuing changes in gene expression has been generated. These data have allowed for an understanding of molecular-level events and shown a level of consistency in response despite the vast formats and experimental procedures being used across institutions. However, clarity on how this information may inform strategies for health risk assessment needs to be explored. Read More

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Deploying elements of scoping review methods for Adverse Outcome Pathway development: A space travel case example.

Int J Radiat Biol 2022 Aug 8:1-38. Epub 2022 Aug 8.

Health Canada, Ottawa, Ontario, K1A 0K9, Canada.

Health protection agencies require scientific information for evidence-based decision-making and guideline development. However, vetting and collating large quantities of published research to identify relevant high-quality studies is a challenge. One approach to address this issue is the use of Adverse Outcome Pathways (AOPs) that provide a framework to assemble toxicological knowledge into causally linked chains of key events across levels of biological organization to culminate in an adverse health outcome of significance. Read More

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Smoking cessation for secondary prevention of cardiovascular disease.

Cochrane Database Syst Rev 2022 Aug 8;8:CD014936. Epub 2022 Aug 8.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Background: Smoking is a leading cause of cardiovascular disease (CVD), particularly coronary heart disease (CHD). However, quitting smoking may prevent secondary CVD events in people already diagnosed with CHD.  OBJECTIVES: To examine the impact of smoking cessation on death from CVD and major adverse cardiovascular events (MACE), in people with incident CHD. Read More

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Mixed T Helper1/T Helper2/T Cytotoxic Profile in Subjects with Chronic Chagas Disease with Hypersensitivity Reactions to Benznidazole.

Microbiol Spectr 2022 Aug 8:e0135722. Epub 2022 Aug 8.

Hospital Interzonal General de Agudos Eva Perón, Buenos Aires, Argentina.

Dermatitis is the most common adverse event during treatment with benznidazole in chronic Chagas disease and is probably mediated by T cells. A set of molecules representative of the different type IV hypersensitivity reactions was evaluated in the circulation and skin biopsies of Trypanosoma cruzi-infected subjects presenting dermatitis during benznidazole administration. Through cytometric bead assays and enzyme-linked immunosorbent assay capture techniques, the serum levels of cytokines, chemokines, proapoptotic molecules, and mediators of the activation and migration of eosinophils and T cells were measured in subjects infected with Trypanosoma cruzi who exhibited skin adverse events ( = 22) and compared with those without adverse events ( = 37) during benznidazole therapy. Read More

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