Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AEs; adverse events; ITT; intention-to-treat; MedDRA; Medical Dictionary for Regulatory Activities; MITT; modified intention-to-treat; MPP; modified per-protocol; PP; per-protocol; PT; preferred term; SD; standard deviation; SOC; system organ class; Otomy
مقالات ISI دیکشنری پزشکی برای فعالیت های نظارتی (ترجمه نشده)
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Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; The trial was registered under NCT02433834 at; http://www.clinicaltrials.gov; Asthma; Co-suspension delivery technology; Glycopyrronium; Inhaled corticosteroid use; Metered dose inhaler; ACQ-5; Asthma Control Questionnaire-5; AE; adverse event; AUC0-3;
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AEs; adverse events; ELISA; enzyme-linked immunosorbent assay; SD; standard deviation; TEAEs; treatment emergent adverse events; TMB; 3,3â²,5,5â²-tetramethylbenzidine; EPT; end-point titre; MSD; mesoscale discovery; ECL; electrochemiluminescence; Ply; p
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Arthralgia; Dipeptidyl peptidase-4 inhibitors; Meta-analysis; Systematic review; DPP-4; Dipeptidyl peptidase-4; FDA; Food and Drug Administration; GIP; Glucose-dependent insulinotropic peptide; GLP-1; Glucagon-like peptide-1; IDF; International Diabetes F
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; ALT; alanine aminotransferase; AST; aspartate aminotransferase; DRESS; drug reaction with eosinophilia and systematic symptoms; DSMB; data safety monitoring board; GGT; gamma-glutamyl transferase; GI; gastrointestinal; IL-2; interleukin
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; BL; baseline; BMI; body mass index; CGI-C; clinical global impression-change; CGI-S; clinical global impression-severity; CI; confidence interval; DSM-IV; diagnostic and statistical manual of mental disorders-IV; EP; endpoint; EPMS; ext
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Focal epilepsy; Quality of life; Seizure freedom; Lacosamide; AED; antiepileptic drug; CGIC; Clinical Global Impression of Change; CPS; complex partial seizures; CS; Completer Set; FAS; Full Analysis Set; LOCF; last observation carried forward; MedDRA; Me
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; depression; drug; adverse drug reaction; case/non case study; dépression; médicament; effet indésirable; étude cas/non cas; ADR; adverse drug report; ADRs; adverse drug reactions; CI; confidence interval; CNS; central nervous system; FDA; Food and Dru
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; adverse drug reactions; spontaneous reporting; online reporting; :; effet indésirable médicamenteux; notification spontanée; déclaration électronique; ADR; adverse drug reaction; ATC; anatomical therapeutical chemical code; FPVD; French pharmacovigil
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AMD; age-related macular degeneration; ATE; arterial thromboembolic event; CVA; cerebrovascular accident; FDA; US Food and Drug Administration; MedDRA; Medical Dictionary for Regulatory Activities; MI; myocardial infarction; OR; odds ratio; PDT; photodyna
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Sublingual immunotherapy; safety; local side effects; grading; AE; Adverse event; MedDRA; Medical Dictionary for Regulatory Activities; RCT; Randomized controlled trial; SCIT; Subcutaneous immunotherapy; SLIT; Sublingual immunotherapy; WAO; World Allergy
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; Adverse event; MedDRA; Medical Dictionary for Regulatory Activities; RADARS; Researched Abuse, Diversion, and Addiction-Related Surveillance; REMS; Risk evaluation and mitigation strategies; URDD; Unique recipients of a dispensed drug;
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AEFI; adverse events following immunization; EPI; Expanded Program on Immunization; SAE; serious adverse events; WHO; World Health Organization; China CDC; Chinese Center of Disease Control and Prevention; NIP; National Immunization Program; MedDRA; Medic
Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Haemophilus influenzae type b; Vaccine; Immunogenicity; Safety; Intramuscular; Japan; AE; adverse event; CI; confidence interval; GMT; geometric mean anti-PRP titer; Hib; Haemophilus influenzae type b; MedDRA; Medical Dictionary for Regulatory Activities;
Safety and immunogenicity of investigational recombinant botulinum vaccine, rBV A/B, in volunteers with pre-existing botulinum toxoid immunity
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; botulism; botulinum neurotoxin; Human Botulism Immune Globulin; infant botulism; pentavalent botulinum toxoid; recombinant botulinum vaccine; AEs; adverse events; AUC; area under the plasma concentration-time curve; BIG-IV; Human Botulism Immune Globulin
Safety, immunogenicity, and clinical outcomes in patients with Morquio A syndrome participating in 2 sequential open-label studies of elosulfase alfa enzyme replacement therapy (MOR-002/MOR-100), representing 5â¯years of treatment
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Morquio A; Mucopolysaccharidosis IVA; Long-term extension; Elosulfase alfa; 3MSCT; 3-min stair climb test; 6MWT; 6-min walk test; AE; adverse event; AUC0ât; area under the curve from time 0 to last measurable concentration; AUCinf; area under the curve
Depressive symptoms, depression, and the effect of biologic therapy among patients in Psoriasis Longitudinal Assessment and Registry (PSOLAR)
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; biologic therapy; depression; phototherapy; PSOLAR; psoriasis; systemic therapy; AE; adverse event; CI; confidence intervals; HADS-D; Hospital Anxiety and Depression Scale-Depression; HR; hazard ratio; HRQoL; health-related quality of life; IR; incidenc
Pegvaliase for the treatment of phenylketonuria: Results of a long-term phase 3 clinical trial program (PRISM)
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; ACMG; American College of Medical Genetics and Genomics; ADHD RS-IV IA; Attention Deficit Hyperactivity Disorder Rating Scale IV inattention subscale; AE; adverse event; CTCAE; Common Terminology Criteria for Adverse Events; DMC; Data Monitoring Committee
No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester - Evaluation of the national Embryotox cohort
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; adj; adjusted; Apgar score; appearance pulse grimace activity respiration score; CI; confidence interval; cig; cigarettes; COX; cyclooxygenase; ETOP; elective termination of pregnancy; EUROCAT; European surveillance of congenital anomalies; GW; gestationa
Pegvaliase for the treatment of phenylketonuria: A pivotal, double-blind randomized discontinuation Phase 3 clinical trial
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; ACMG; American College of Medical Genetics and Genomics; ADHD RS-IV IA; Attention Deficit Hyperactivity Disorder Rating Scale IV, inattention subscore; AE; adverse event; ANCOVA; analysis of covariance; CANTAB; Cambridge Neuropsychological Test Automated
A phase II randomized study to determine the safety and immunogenicity of the novel PIKA rabies vaccine containing the PIKA adjuvant using an accelerated regimen
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; PIKA adjuvant; Rabies vaccine; Immunogenicity; Safety; TLR3; Phase II; ACIP; Advisory Committee on Immunization Practices; AE; adverse event; CI; confidence interval; CIRB; Centralised Institutional Review Board; CSIRO; Commonwealth Scientific and Industr
Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER)
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; bone marrow; idiopathic pulmonary fibrosis; mesenchymal stem cells; safety trial; 6-MWT; 6-min walk test; Dlco; diffusing capacity of the lungs for carbon monoxide; FDA; Food and Drug Administration; hMSCs; human mesenchymal stem cells; HRCT; high-reso
Continuous longitudinal infusion of rhIGF-1/rhIGFBP-3 in extremely preterm infants: Evaluation of feasibility in a phase II study
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; BPD; bronchopulmonary dysplasia; GA; gestational age; IGF-1; insulin-like growth factor-1; IGFBP-3; insulin-like growth factor binding protein-3; IV; intravenous; IVH; intraventricular hemorrhage; MedDRA; Medical Dictionary for Regulato
Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AEs; adverse events; ALT; alanine aminotransferase; BL; baseline; CI; confidence interval; DMF; dimethyl fumarate; DMTs; disease-modifying therapies; EDSS; Expanded Disability Status Scale; ES; effect size; MedDRA; Medical Dictionary for Regulatory Activi
Long-term pulmonary complications in perinatally HIV-infected youth
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Pediatric HIV infection; pulmonary complications of HIV infection; asthma; pulmonary function testing; obstructive and restrictive pulmonary disease; reversibility of obstructive air flow with bronchodilators; chronic obstructive pulmonary disease; asthma
A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; CI; confidence interval; CR; complete response; CT; computed tomography; DCR; disease control rate; ECOG; Eastern Cooperative Oncology Group; EGFR; epidermal growth factor receptor; FAS; full analysis set; HR; hazard ratio; ILD; interst
Safety and Usage of C1-Inhibitor in Hereditary Angioedema: Berinert Registry Data
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Berinert; Plasma-derived C1-INH; Patient registry; Thromboembolic event; Real-world; Prophylaxis; On demand; Self-administration; Safety; Dosing; AE; Adverse event; C1-INH; C1 inhibitor; DVT; Deep vein thrombosis; EU; European Union; HAE; Hereditary angio
Safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in adults with tuberculosis: A phase II randomised study
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Tuberculosis; M72/AS01E vaccine; Safety; Immunogenicity; T-cell; AE; adverse event; ATP; according to protocol; BCG; Bacille Calmette-Guérin; CFP10; culture filtrate protein-10; CI; confidence interval; CMI; cell-mediated immunity; ELISA; enzyme linked i
Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Lennox-Gastaut syndrome; Rufinamide; Antiepileptic drug therapy; Randomized study; Pharmacokinetic; safety; Infants; AED; antiepileptic drug; AUC; area under the concentration-time curve; Cav; steady-state exposure; CI; confidence interval; CL/F; appare
Safety of Long-term Treatment With Certolizumab Pegol in Patients With Crohn's Disease, Based on a Pooled Analysis of Data From Clinical Trials
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; TNF; Complication; Side Effects; Pooled Analysis; AE; adverse event; CD; Crohn's disease; CI; confidence interval; IR; incidence rate; MedDRA; Medical Dictionary for Regulatory Activities; NMSC; nonmelanoma skin cancer; OL; open label; PC; placebo-contr
Original articleEfficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; atopic dermatitis; crisaborole ointment; eczema; phosphodiesterase 4; pruritus; topical therapy; AD; atopic dermatitis; AE; adverse event; ISGA; Investigator's Static Global Assessment; MedDRA; Medical Dictionary for Regulatory Activities; PDE4; phosphodi
The INTEGRATE project: Delivering solutions for efficient multi-centric clinical research and trials
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AC; Access Control; AP; Analysis Platform; BC; Breast Cancer; BRIDG; Biomedical Research Integrated Domain Group; CDM; Common Data Model; CDP; Centre for Data Protection; CIM; Common Information Model; CNS; Central Nervous System; CRP; Central Review for
Long-term efficacy and safety of intramuscular interferon beta-1a: Randomized postmarketing trial of two dosing regimens in Japanese patients with relapsing-remitting multiple sclerosis
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; ARR; annualized relapse rate; CI; confidence interval; EDSS; Expanded Disability Status Scores; Gd+; gadolinium-enhancing; IFN beta; interferon beta; IFN beta-1a; interferon beta-1a; IM; intramuscular; MedDRA; Medical Dictionary for Regulatory Activities;
Efficacy and safety of perampanel in the subgroup of elderly patients included in the phase III epilepsy clinical trials
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Adverse effects; Antiepileptic drugs; Efficacy; Elderly; Perampanel; AE; adverse event; AED; antiepileptic drug; LOCF; last observation carried forward; MedDRA; Medical Dictionary for Regulatory Activities; PER; perampanel; PK; pharmacokinetic; SAE; serio
Adverse Events following Haemophilus influenzae Type b Vaccines in the Vaccine Adverse Event Reporting System, 1990-2013
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; Adverse event; EB; Empirical Bayesian; Hib; Haemophilus influenzae type b; MedDRA; Medical Dictionary for Regulatory Activities; PT; Preferred term; SIDS; Sudden infant death syndrome; VAERS; Vaccine Adverse Event Reporting System;
Research ArticleOmbitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; HCV; hepatitis C virus; CYP3A4; cytochrome P450 isoform 3A4; RNA; ribonucleic acid; HIV; human immunodeficiency virus; LLOD; lower limit of detection; LLOQ; lower limit of quantitation; MedDRA; Medical Dictionary for Regulatory Activities; MEMS; Medicatio
Perampanel in the treatment of partial seizures: Time to onset and duration of most common adverse events from pooled Phase III and extension studies
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AED; antiepileptic drug; DB; double blind; MedDRA; Medical Dictionary for Regulatory Activities; MTD; maximum tolerated dose; OLE; open-label extension; PBO; placebo; PER; perampanel; TEAE; treatment-emergent adverse event; Antiepileptic drugs; Epilepsy;
Efficacy and safety of umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: Results of two randomized studies
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Long-acting muscarinic antagonist; Inhaled corticosteroid; Long-acting beta2 agonist; Bronchodilation; AE; adverse event; ASE; all subjects enrolled; CAT; COPD Assessment Test; CI; confidence interval; COPD; chronic obstructive pulmonary disease; FEV1; fo
Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; clear or almost clear skin; clinical trial; head to head; plaque psoriasis; secukinumab; superiority; ustekinumab; 90% or more improvement in baseline Psoriasis Area and Severity Index; AE; adverse event; DLQI; Dermatology Life Quality Index; HRQoL; healt
Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Adolescent; Antiepileptic drugs; Epilepsy; Perampanel; Post hoc analysis; AE; adverse event; AED; antiepileptic drug; ANCOVA; analysis of covariance; BMI; body mass index; CP; complex partial seizure; ECG; electrocardiogram; EU; European Union; ITT; inten
A randomized Phase 2 study of pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in patients with completely resected stage IB or II Non-Small-Cell Lung Cancer
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; CTCAE; common terminology criteria for adverse events; CI; confidence interval; DFS; disease-free survival; IHC; immunohistochemistry; i.v.; intravenous; MedDRA; medical dictionary for regulatory activities; NSCLC; Non-Small-Cell Lung C
Apport du logiciel Nadis® dans la collecte des effets indésirables des antirétroviraux : expérience en Midi-Pyrénées
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; effet indésirable; pharmacovigilance; antirétroviraux; sous-notification; notification spontanée; adverse drug reaction; pharmacovigilance; antiretroviral drugs under-reporting; spontaneous reporting; AMM; autorisation de mise sur le marché; ARV; anti
Sapropterin dihydrochloride use in pregnant women with phenylketonuria: An interim report of the PKU MOMS sub-registry
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; Apgar; Appearance, Pulse, Grimace, Activity, Respiration; BH4; tetrahydrobiopterin; BMI; Body Mass Index; CDC; Centers for Disease Control and Prevention; ID; identification; LMP; last menstrual period; OFC; occipitofrontal circumferenc
ReviewMedicinal plants used for menstrual disorders in Latin America, the Caribbean, sub-Saharan Africa, South and Southeast Asia and their uterine properties: A review
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; WHO; World Health Organization; UMC; Uppsala Monitoring Centre; ICSR; the WHO global individual case safety report database (VigiBaseâ¢); ADR; adverse drug reactions; SOC; system-organ-class; MedDRA; Medical Dictionary for Regulatory Activities; aristolo
Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: A randomized, 28-day, dose-ranging trial
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; HCV; hepatitis C virus; PegIFN; pegylated interferon; RBV; ribavirin; RVR; rapid virologic response; SVR; sustained virologic response; IL; interleukin; LOD; limit of detection; MedDRA; Medical Dictionary for Regulatory Activities; ECG; electrocardiogram;
Research ArticleA phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; HCV; hepatitis C virus; CYP3A4; cytochrome P450 isoform 3A4; RNA; ribonucleic acid; IL28B; interleukin-28B; LiPA; Versant® HCV Genotype Inno-LiPA Assay, version 2.0; MedDRA; Medical Dictionary for Regulatory Activities; OATP1B1; organic anion transportin
Adverse drug and device reactions in the oral cavity
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Epidemiology; consumer product safety; drugs; U.S. Food and Drug Administration; implants; legal liability; oral medicine; postmarketing product surveillance; safety management; AE; Adverse effect; FAERS; FDA Adverse Event Reporting System; FDA; Food and
Analysis of Upper Gastrointestinal Adverse Events Among Patients Given Dabigatran in the RE-LY Trial
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; Upset Stomach; Clinical Trial; Post Hoc Analysis; Side Effect; Toxicity; AE; adverse event; CI; confidence interval; FDA; Food and Drug Administration; GERD; gastroesophageal reflux disease; GI; gastrointestinal; H2RA; histamine-2 receptor-antagonist; Med
A pre-marketing ALT signal predicts post-marketing liver safety
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; DILI; drug induced liver injury; FDA; Food and Drug Administration; AERS; Adverse Event Reporting System; ALT; alanine aminotransferase; ULN; upper limit of normal; NDA; new drug application; EMA; European Medicines Agency; PDR; Physician's Desk Referen
A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults
Keywords: دیکشنری پزشکی برای فعالیت های نظارتی; AE; adverse event; CI; confidence interval; FFU; fluorescent focus units; GMFR; geometric mean fold rise from baseline; GMT; geometric mean titer; HAI; hemagglutination inhibition; MedDRA; Medical Dictionary for Regulatory Activities; Q/LAIV; quadrivalent