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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 Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Clinical Evaluation of Melatonin Alone and in Combination with Pizotifen in the Prophylaxis of Migraine
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The treatment of migraine headache targets the neurovascular mechanism and involves the use of serotonin receptor antagonists. Some of these drugs are used for the treatment of acute attacks; while others are effective as prophylactic measures to decrease the duration and frequency of attacks. Pizotifen, a 5-HTA antagonist, is one of the prophylactic drugs for which the clinical use resulted in low outcomes in reducing migraine symptoms. Melatonin, a serotonin derived neurohormone, was reported to exert many functions like sleep induction, anti-inflammatory, neurovascular regulation, cytoprotection and modulation of neurotransmitter release.  In the view of the involvement of serotonin in the pathophysiology of migraine a

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Publication Date
Sun Apr 30 2023
Journal Name
Al-kindy College Medical Journal
Knowledge, Attitudes, and Practice of Self-Medication among Medical Students at Sudan International University, Sudan
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Background: Self-medication is a practice or action taken by individuals for themselves in order to achieve and maintain health, as well as to avoid and protect against disease. The aim of this study is to evaluate the knowledge, attitudes, and practice of self-medication among medical students at Sudan International University.

Subjects & Methods: This was a prospective study that involved 288 out of 1000 students in the Faculty of Medicine at Sudan International University. Data were collected using a self-administered questionnaire from January to March 2022 to evaluate the self-medication knowledge, attitude, and practice among first, second, and third-ye

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Publication Date
Wed Aug 30 2023
Journal Name
Al-kindy College Medical Journal
Viable Strategies to Increase Clinical Trial Patient Diversity
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In the United States, the pharmaceutical industry is actively devising strategies to improve the diversity of clinical trial participants. These efforts stem from a plethora of evidence indicating that various ethnic groups respond differently to a given treatment. Thus, increasing the diversity of trial participants would not only provide more robust and representative trial data but also lead to safer and more effective therapies. Further diversifying trial participants appear straightforward, but it is a complex process requiring feedback from multiple stakeholders such as pharmaceutical sponsors, regulators, community leaders, and research sites. Therefore, the objective of this paper is to describe three viable strategies that can p

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Publication Date
Tue Aug 25 2020
Journal Name
Journal Of Clinical Medicine
Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial—2-Year Results
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Background: the aim of this study was to assess the 2-year pulp survival of deep carious lesions in teeth excavated using a self-limiting protocol in a single-blind randomized controlled clinical trial. Methods: At baseline, 101 teeth with deep carious lesions in 86 patients were excavated randomly using self-limiting or control protocols. Standardized clinical examination and periapical radiographs of teeth were performed after 1- and 2-year follow-ups (REC 14/LO/0880). Results: During the 2-year period of the study, 24 teeth failed (16 and 8 at T12 and T24, respectively). Final analysis shows that 39/63 (61.9%) of teeth were deemed successful (16/33 (48.4%) and 23/30 (76.6%) in the control and experimental groups, respectively wit

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Publication Date
Thu Jun 15 2023
Journal Name
Journal Of Baghdad College Of Dentistry
Antibacterial and cytotoxic effect of a novel biological Nano-silver fluoride synthesized from moringa oleifera leaf extract
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Background: A great dental and biomedical interest had been paid to silver nanoparticles because of their antimicrobial activity. Objective: To evaluate the antimicrobial and cytotoxic activity of a newly developed Nano-silver fluoride that was synthesized from moringa oleifera leaf extract against S. mutants.  Material and method: The green synthesis method was used to prepare Nano-silver fluoride from moringa oleifera leaf extract. The minimum inhibitory concentration and the minimum bactericidal concentration were evaluated using brain heart infusion plates, while the cytotoxicity was evaluated by the hemolytic activity. Results: Nano-silver fluoride had a bactericidal and bacteriostatic effect (MIC was 60 ppm and MBC was 120 pp

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Publication Date
Fri Nov 01 2013
Journal Name
Journal Of Cosmetics, Dermatological Sciences And Applications
Treatment of chronic paronychia: A double blind comparative clinical trial using singly vaseline, nystatin and fucidic acid ointment
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KE Sharquie, AA Noaimi, SA Galib, Journal of Cosmetics, Dermatological Sciences and Applications, 2013 - Cited by 4

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Publication Date
Mon Feb 15 2021
Journal Name
Nursing Open
Recitation of quran and music to reduce chemotherapy‐induced anxiety among adult patients with cancer: A clinical trial
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Abstract<sec><title>Aim

The aim of this study was to assess the effectiveness of listening to music or Quran in reducing cancer patients’ anxiety before chemotherapy administration. Reducing anxiety in people with cancer, prior to chemotherapy administration, is a crucial goal in nursing care.

Design

An experimental comparative study was conducted.

Methods

A simple randomization sampling method was applied. Two hundred thirty‐eight people with cancer who underwent chemotherapy were participated. They are assigned as Quran, music and control groups.

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
Efficiency and Safety of Desferioxamine Chelation Therapy in Paediatric Patients with Transfusion-Dependent Anaemia: Experience of two Centres from Sudan
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Background: Repeated blood transfusion   is   the main   therapeutic option for transfusion-dependent anaemias with consequent iron overload and organ damage .Therefore iron chelating agents are important protective measures for these patients. The aim of this study was  to investigate  the efficiency and safety of Desferroxamine  in paediatrics population subjected  to iron overload as a consequence  of repeated transfusion in a group of  Sudanese children  

Subjects & Methods: This was a descriptive cross-sectional hospital based study.  Conducted in two main paediatric reference hospitals   in, Su

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Publication Date
Tue Dec 30 2008
Journal Name
Iraqi National Journal Of Nursing Specialties
Assess the Knowledge and Practice of Thalassemic Patient about Complications of Iron Overload and Desferal Compliance
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Objectives: To assess the knowledge and practice of thalassemic patients about desferal administration and
complications of iron overload.
Methodology: The present study composed of (50) thalssemic patient who are registered in center and was
performed in Ibn Al-Atheer center for congenital anemia for the period from 15/12/2006 to 1/4/2007.
Results: The result of the study showed highly significant difference at (160.05) for knowledge of thalassemic
patients and also appear highly significant difference at (P<O.O5) for practice of thalassemic patients.
Recommendations: The study recommends that there is necessity to increase the knowledge and practice of
thalassemic patient about desferal administration to minimiz

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Publication Date
Sat Jun 30 2012
Journal Name
Al-kindy College Medical Journal
The Necessity of Teaching Diabetic Patients the Correct way of Insulin Administration: A Clinical Trial to Improve Glycemic Control
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Background: It is important to achieve good glycemic control to avoid long-term diabetic complications. It has been largely debated about the role of correct way of insulin administration to get the desired glycemic control.
Objective: To evaluate the effect of teaching diabetic patients who are on insulin therapy the correct way of injecting insulin and its effect on glycemic control.
Methods: A non randomized clinical trial with 820 diabetic patients on insulin therapy on whom A1 c estimation was performed before and after three months of teaching them the right injection technique.
Results : Sixty seven patients (8.17%) had A1 c 6.5% before they were enrolled in the study while the majority (753 patents, 91.82%) had A1 c 6.5%

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