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Safety Profile of Biological Drugs in Clinical Practice: A Retrospective Pharmacovigilance Study
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Biological drugs have an active substance that is made by a living organism or derived from a living organism. They are one of the important therapy options used in a wide range of diseases especially life-threatening diseases. Biological therapy opens new opportunities for treating different diseases for which drug therapy is minimal, but they have considerable differences in the safety consequences in comparison with non-biological drugs. The aim of the current study was to assess the post-marketing safety profile of biological drugs used in Iraqi hospitals by the analysis of the reported adverse drug reactions regarding their severity, seriousness, preventability, expectedness, and outcome. It is a retrospective study of the individual case safety reports from the Iraqi Pharmacovigilance Center/Ministry of Health. There were 446 individual case safety reports in the research, involving 899 adverse drug reactions. Rituximab was found to be the drug with the highest number of adverse drug reactions with 241 adverse drug reactions (26.81% out of total adverse drug reactions). Most of the adverse drug reactions were related to general disorders and administration site conditions (22.25%). Regarding severity of adverse drug reactions, the majority of adverse drug reactions were observed in moderate levels [Level 4 (26%), and Level 3 (18%)]. The severe adverse drug reactions in patients below 18 years age group were significantly higher compared to adults and elderly. Seriousness assessment showed that the majority of adverse drug reactions were serious (52%). Rituximab was the drug for which the highest number of serious adverse drug reactions was reported (41.28% of total serious adverse drug reactions), Most of the adverse drug reactions (66%) were probably preventable. Fatality outcome was reported for 3% of adverse drug reactions while 43% of adverse drug reactions were recovered/resolved.

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Publication Date
Thu Jun 30 2011
Journal Name
Al-kindy College Medical Journal
THE PREVALENCE AND CLINICAL SIGNIFICANCE OF PERINUCLEAR ANTINEUTROPHIL CYTOPLASMIC ANTIBODY IN PATIENTS WITH INDETERMINATE COLITIS
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Background: Indeterminate colitis (IC), a term
originated by pathologists to characterize confounding
histopathlogic appearance of resected mucosa, has
become catch phrase for cases in which diagnostic
criteria at all levels elude classification as Crohn's
disease (CD) or ulcerative colitis (UC).
OBJECTIVES: evaluate the prevalence of pANCA
expression in the sera and its isotypes.
Patients and methods: PATIENTS GROUP
consisted of 60 patients (40 males and 20 females)
with indeterminate colitis and their age range was (19-
84 years). CONTROL GROUP consisted of 30 (15
males and 15 females) healthy volunteers and their
age range was (20- 66 years).
Antineutrophil cytoplasmic ( pANCA and cANCA)
te

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Publication Date
Wed Apr 01 2020
Journal Name
Malaysian Journal Of Biochemistry And Molecular Biology
Mutations in ergosterol 11 gene of fluconazol resistant candida albicans isolated from different clinical samples
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Fluconazole was used to test the susceptibility of Candida albicans isolated from different clinical samples, and to detect mutations in ERG11 gene, and their relationship to fluconazole resistance. Forty-eight isolates of Candida albicans were tested for susceptibility using the disc diffusion method (M-44). ERG11 genes of six isolates were amplified (four resistant, two susceptible) and sequenced. The sequenced genes were analyzed to detect the mutations. Out of 48 isolates of Candida albicans, 4 (8%) were resistant to fluconazole. Sixteen-point mutations were detected included 13 silent mutations, and three missense mutations. The mutations of A945C (E266D) and G1609A (V488I) were found only in susceptible Candida albicans isolates, whil

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Publication Date
Wed Aug 11 2021
Journal Name
Neuroquantology
Correlation of Vitamin D Level with Electrophysiological Findings and Clinical Grading in Carpal Tunnel Syndrome
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Carpal tunnel syndrome is a neurological disease that presented with paresthesias, pain, and numbness in the hand's median nerve compression. Vitamin D was assumed to affect both electrophysiological &clinical gradings, the study aims to assess the correlation between the deficiency of vitamin D and both electrophysiological and clinical gradings. This study was conducted in Ghazi Alhariri Hospital during the period from the first of November/2020 to the twenty-eighth of February/2021, fifty five individuals were referred to as Carpal tunnel syndrome patients, and compared to (55) control individuals, blood samples were withdrawn from the patients (3ml), centrifuged and kept in the freezer (-20°C) until the time of analysis of

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Publication Date
Mon Mar 10 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Acceleration of canine movement by laser assisted flapless corticotomy [An innovative approach in clinical orthodontics]
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Background: Corticotomy-assisted orthodontic treatment is done to induce a state of increased tissue turnover and transient osteopenia, which is followed by a faster rate of orthodontic tooth movement. It considered as an adjunct treatment option for orthodontic treatment of adults. The aim of this Study was to elucidate the effectiveness of a new surgical approach for acceleration of maxillary canine retraction in human with laser assisted flapless corticotomy and evaluate its effect on vitality of pulp and gingival sulcus depth. Materials and methods: the sample comprised of 15 Iraqi patients (9 females and 6 males; mean age 21.7), who were required extraction for their maxillary first premolars followed by retraction of the canines as pa

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Publication Date
Fri Jun 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Clinical significance of Osteoprotegerin, Vitamin D, Obestatin and some biochemical variables in Kidney failure Patients
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Chronic kidney disease (CKD) is described as an abnormalities of renal function, existing for a long period of time. By reason of the early grades of Chronic kidney disease can be experiences no symptoms, its premature identification is strenuous. initial stage CRD can cause various complications, such as anemia, matabolyic disorders of bone mineral. The study was done to assess the effect the chronic renal disease stage on the Osteoprotegerin, 1,25 dihydroxyvitamin D, Obestatin levels and some biochemical parameters in patients not undertaken dialysis therapy. In this case-control study fifty-five patients with Kidney failure and fourty healthy people were examined. Circulating concentrations of Osteoprotegerin, 1,25 dihydroxyvitamin D

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Publication Date
Wed Jun 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
The impact of the independence of the auditor to practice accounting conservatism Applied research in the financial sector companies listed on the Iraq Stock Exchange
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The study aims to verify the independence of auditors working in companies and offices of the Iraqi audit, and measure the level of accounting conservatism in the financial statements of banks and insurance companies listed on the Iraq Stock Exchange, as well as a statement after the independence of the auditor on accounting conservatism in the financial statements of banks and insurance companies listed on the market Iraq Stock Exchange, as it has been measuring the independence of the auditor using the survey form was auditors working in the Iraqi audit firms were measured the level of accounting conservatism for companies sample using a form( Basu) was a statement after variables through the use of statistical models in a mann

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Publication Date
Fri Dec 29 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Clinical Evidence: The Prolonged Dust Exposure The Disorder In Serum Oxidant - Antioxidant Balance
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Dust can  be considered as  an  important factor in  environmental

pollution which has a direct eOect on human health. In this study ,we

attempted to eval uate serum oxidant -antiox idant balance in workers dust exposed continuously and also the effect of iron and silicon content in exposed dust on the mentioned balance .The study included tbrcc groups: A group  included 20  workers of  building block factories, B  group included 20 workers in general company of grains production and C group included 15 healthy' subjects which represented control group. !ron and  silicon  contents in  dust samples of  two  studied  regions were measured. Higher levels o

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Publication Date
Mon Jun 08 2020
Journal Name
Medical Sciens
COVID-19 clinical characteristics and outcomes in 60 hospitalized Iraqi patients -Case series
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Background: since December 2019, China and in particularly Wuhan, faced an unprecedented an outbreak challenge of coronavirus disease 2019, caused by the severe acute respiratory syndrome coronavirus 2. Clinical characteristics of Iraqi patients with COVID-19 and risk factors for mortality needed to be shared with the health care providers to improve the overall disease experience. Methods: prospective, single-center study recruited patients with confirmed SARS-CoV-2 infection who were admitted to Al-Shifaa Isolation Center / Baghdad Medical City between the mid of March and the end of April 2020 until had been discharged or had died. Demographic data, information on clinical signs, symptoms, at presentation, treatment, have been collected

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Publication Date
Wed Nov 27 2019
Journal Name
Iraqi Journal Of Science
Comparative Study of Some Virulence Factors and Analysis of Phylogenetic Tree by 16S rDNA Sequencing of Aeromonas hydrophila Isolated from Clinical and Environmental Samples
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     Aeromonas hydrophila is widely distributed throughout the world and causes diseases to animals and human exposed to contaminated environments such as water and soil. This study aimed to compare between isolates of A. hydrophila collected from clinical and environmental samples, through investigating the phenotype of some virulence factors in vitro, including hemolysin, protease, lipase, nuclease and biofilm formation ability. Also, the antimicrobial susceptibility for different antibiotics was determined using disc diffusion method. For genotypic identification of isolates and phylogenetic tree construction, 16S rDNA target gene was amplified and sequenced. The phenoty

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Publication Date
Tue Jan 01 2013
Journal Name
Journal Of The College Of Languages (jcl)
A Study in Tess of the D’Urbervilles as A Call for Liberal Education for Women
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Amongst the literary writers who used their art to direct the attention towards the issue of woman and her rights in a proper life is the English poet and novelist Thomas Hardy (1840-1928), who has been praised for his “openness to the feminine principle” 1 as Irving Howe put it. Hardy’s wide readings have changed his way of dealing with and thinking about so many critical issues which started to float on the surface of the English society during the mid and late of the 19th century. His readings for a number of writers, who seem of huge impact on his writings as he later admits that – “[his] pages show harmony of view with

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