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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
Wed Mar 01 2023
Journal Name
Shift
Construction Safety Personnel Qualifications: The Impact of Education, Experience, and Certificate Programs
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Publication Date
Mon Jan 01 2018
Journal Name
International Journal Of Surgery Open
Does preoperative magnetic resonant cholangiopancreatography (MRCP), improve the safety of laparoscopic cholecystectomy?
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Publication Date
Sun Jul 01 2018
Journal Name
Journal Of Construction Engineering And Management
Measuring and Evaluating Safety Maturity of Construction Contractors: Multicriteria Decision-Making Approach
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Publication Date
Tue Oct 04 2022
Journal Name
International Journal Of Dentistry
Comparison between Rolled and Nonrolled U-Shaped Flap in the Second Stage of Dental Implant Surgery: A Randomized Clinical Trial
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Background. The presence of black triangles around the dental implant-supported prosthesis and the failure to construct adequate papillae around them bothers dental implantologists. Peri-implant surgical soft tissue management will improve esthetics, function, and implant survival. Aim. To compare the effects of rolled and nonrolled U-shaped flaps combined with a temporary crown in enhancing the soft tissue around dental implants. Materials and Methods. Forty patients were included in this study; all patients were operated on by the same maxillofacial surgeon at Al-Iraq specialized dental clinics from January 2019 to January 2020. Patients were divided randomly into two groups: group A: at the second stage of implant surgery, a U-sh

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Publication Date
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Effect of L-Carnitine as an Adjuvant Supplement on Lipid Profile in Iraqi Diabetic Patients
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Diabetes is a complex set of diseases require continuous medical care, to control blood sugar and prevent complications is .The aim of this research is to determine the effect of administration of   L carentin to diabetics on the   lipid profile. The research was conducted on sixty diabetic patients were selected from endocrinology and diabetes center / Al-Rusafa, within selected criteria. The patients divided into 3 groups (control group of healthy people and two groups of patients with diabetes who were on metformin and glibenclamide, one group took a L  carnitine in a dose of 1000 mg twice daily and a group dealing with a placebo for a period of 3 months continuously). The study found that patients who took Lc

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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effect of COX-2 Inhibitors Selectivity on Lipid Profile in Hyperlipidemic and Normolipidemic Type 2 Diabetics
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Development of NSAIDS based on inhibiting cyclooxygenase activity. However, the different physiological consequences arrised by appearance of new drugs with different selectivity to COX-2 enzyme upon their administration with their relevant affects on some cardiovascular risk factors. To study the potential effects of relatively  diclofenac and highly specific  celecoxib COX-2 inhibitors on lipid profile and serum C-reactive protein in type 2 diabetes, whom have hyperlipidemia to be compared by their effects with normolipidemic patients. A total number of 34 type 2 diabetics (14 normolipidemics and 20 hyperlipidemics) treated with either diclofenac 100mg/day or celecoxib 200mg/day for eight weeks. Analysis  of results indi

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Publication Date
Fri Mar 31 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effect of Temperature on the Stability and Release Profile of Ibuprofen Microcapsules
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The stability and releasing profile of 2:1 core: wall ratio ibuprofen microcapsules prepared by aqueous coacervation (gelatin and acacia polymers coat) and an organic coacervation methods (ethyl cellulose and sodium alginate polymers coat) in weight equivalent to 300mg drug, were studied using different storage temperatures 40°C, 50°C ,60°C and refrigerator temperature 4°C in an opened and closed container for three months (releasing profile) and four months (stability study).It was found that, these ibuprofen microcapsules were stable with expiration dates of 4.1 and 3.1 years for aqueous and an organic method respectively.Aqueous prepared ibuprofen microcapsules were found more stable than those microcapsules prepared by or

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Serum Protein Profile Of Iraqi Hydatidosis Patients with Different Sites of Infection
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Blood samples of One hundred and twenty patients from different hospitals in Baghdad infected with hydatidosis in different sites of the body (Liver, Lung, multiorgans and kidney) were collected for this study. On the other hand, 30 healthy individuals were included as a control group. This study was conducted to evaluate the effect of this disease on the serum protein profile of the patients using electrophoresis. The results revealed four different protein banding patterns with difference in number of bands and their molecular weights in comparison to the control group, and these differences depended on the site of infection. However the data showed a presence of the same band in all patients with different site of infection.

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Publication Date
Thu Jun 30 2022
Journal Name
Gsc Biological And Pharmaceutical Sciences
Revision of public health and clinical importance of amoebiasis in Iraq
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Amebiasis, related to the pathogenic parasite Entamoeba histolytica, is a prominent cause of diarrhea globally. Amebiasis is primarily a disease of impoverished communities in developing nations, although it has recently arisen as a significant infection among returning tourists and immigrants. Severe cases are linked to a high case fatality rate. Although polymerase chain reaction (PCR)-based diagnosis is becoming more widely available, it is still underutilized. Treatment with nitroimidazoles is now suggested, however novel parasite medication research is a top priority. To avoid problems, amebiasis should be considered before corticosteroid therapy. Because there is no effective vaccination, sanitation and availability to clean w

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Publication Date
Thu Jun 30 2022
Journal Name
Gsc Biological And Pharmaceutical Sciences
Revision of public health and clinical importance of amoebiasis in Iraq
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Amebiasis, related to the pathogenic parasite Entamoeba histolytica, is a prominent cause of diarrhea globally. Amebiasis is primarily a disease of impoverished communities in developing nations, although it has recently arisen as a significant infection among returning tourists and immigrants. Severe cases are linked to a high case fatality rate. Although polymerase chain reaction (PCR)-based diagnosis is becoming more widely available, it is still underutilized. Treatment with nitroimidazoles is now suggested, however novel parasite medication research is a top priority. To avoid problems, amebiasis should be considered before corticosteroid therapy. Because there is no effective vaccination, sanitation and availability to clean w

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