Search results for: no observed adverse effect level

Authors: Mohd A. Azizan, Mohd Z. Zali

Abstract:

It is well established that exposure to vibration has an adverse effect on human health, comfort, and performance. However, there is little quantitative knowledge on performance combined with drowsiness level during vibration exposure. This paper reports a study investigating the influence of vibration amplitude on seated occupant reaction time and drowsiness level. Eighteen male volunteers were recruited for this experiment. Before commencing the experiment, total transmitted acceleration measured at interfaces between the seat pan and seatback to human body was adjusted to become 0.2 ms-2 r.m.s and 0.4 ms-2 r.m.s for each volunteer. Seated volunteers were exposed to Gaussian random vibration with frequency band 1-15 Hz at two level of amplitude (low vibration amplitude and medium vibration amplitude) for 20-minutes in separate days. For the purpose of drowsiness measurement, volunteers were asked to complete 10-minutes PVT test before and after vibration exposure and rate their subjective drowsiness by giving score using Karolinska Sleepiness Scale (KSS) before vibration, every 5-minutes interval and following 20-minutes of vibration exposure. Strong evidence of drowsiness was found as there was a significant increase in reaction time and number of lapse following exposure to vibration in both conditions. However, the effect is more apparent in medium vibration amplitude. A steady increase of drowsiness level can also be observed in KSS in all volunteers. However, no significant differences were found in KSS between low vibration amplitude and medium vibration amplitude. It is concluded that exposure to vibration has an adverse effect on human alertness level and more pronounced at higher vibration amplitude. Taken together, these findings suggest a role of vibration in promoting drowsiness, especially at higher vibration amplitude.

Keywords: drowsiness, human vibration, karolinska sleepiness scale, psychomotor vigilance test

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Authors: Seolah Lee, Yoohyk Jang, Soyoung Lee, Kon Chu, Sang Kun Lee

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Objective: The International League Against Epilepsy (ILAE) currently suggests a topiramate serum level range of 5-20 mg/L. However, numerous institutions have observed substantial drug response at lower levels. This study aims to investigate the correlation between topiramate serum levels, drug responsiveness, and adverse events to establish a more accurate and tailored therapeutic range. Methods: We retrospectively analyzed topiramate serum samples collected between January 2017 and January 2022 at Seoul National University Hospital. Clinical data, including serum levels, antiseizure regimens, seizure frequency, and adverse events, were collected. Patient responses were categorized as "insufficient" (reduction in seizure frequency <50%) or "sufficient" (reduction ≥ 50%). Within the "sufficient" group, further subdivisions included seizure-free and tolerable seizure subgroups. A population pharmacokinetic model estimated serum levels from spot measurements. ROC curve analysis determined the optimal serum level cut-off. Results: A total of 389 epilepsy patients, with 555 samples, were reviewed, having a mean dose of 178.4±117.9 mg/day and a serum level of 3.9±2.8 mg/L. Out of the samples, only 5.6% (n=31) exhibited insufficient response, with a mean serum level of 3.6±2.5 mg/L. In contrast, 94.4% (n=524) of samples demonstrated sufficient response, with a mean serum level of 4.0±2.8 mg/L. This difference was not statistically significant (p = 0.45). Among the 78 reported adverse events, logistic regression analysis identified a significant association between ataxia and serum concentration (p = 0.04), with an optimal cut-off value of 6.5 mg/L. In the subgroup of patients receiving monotherapy, those in the tolerable seizure group exhibited a significantly higher serum level compared to the seizure-free group (4.8±2.0 mg/L vs 3.4±2.3 mg/L, p < 0.01). Notably, patients in the tolerable seizure group displayed a higher likelihood of progressing into drug-resistant epilepsy during follow-up visits compared to the seizure-free group. Significance: This study proposed an optimal therapeutic concentration for topiramate based on the patient's responsiveness to the drug and the incidence of adverse effects. We employed a population pharmacokinetic model and analyzed topiramate serum levels to recommend a serum level below 6.5 mg/L to mitigate the risk of ataxia-related side effects. Our findings also indicated that topiramate dose elevation is unnecessary for suboptimal responders, as the drug's effectiveness plateaus at minimal doses.

Keywords: topiramate, therapeutic range, low dos, antiseizure effect

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Authors: Meena Kumari, Ajitha Sharma, Mohan Babu Amberkar, Hasitha Manohar, Joseph Thomas, K. L. Bairy

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Aim: To evaluate the pattern of occurrence of adverse drug reactions (ADRs) with platinum compounds in cancer chemotherapy at a tertiary care hospital. Methods: It was a retrospective, descriptive case record study done on patients admitted to the medical oncology ward of Kasturba Hospital, Manipal from July to November 2012. Inclusion criteria comprised of patients of both sexes and all ages diagnosed with cancer and were on platinum compounds, who developed at least one adverse drug reaction during or after the treatment period. CDSCO proforma was used for reporting ADRs. Causality was assessed using Naranjo Algorithm. Results: A total of 65 patients was included in the study. Females comprised of 67.69% and rest males. Around 49.23% of the ADRs were seen in the age group of 41-60 years, followed by 20 % in 21-40 years, 18.46% in patients over 60 years and 12.31% in 1-20 years age group. The anticancer agents which caused adverse drug reactions in our study were carboplatin (41.54%), cisplatin (36.92%) and oxaliplatin (21.54%). Most common adverse drug reactions observed were oral candidiasis (21.53%), vomiting (16.92%), anaemia (12.3%), diarrhoea (12.3%) and febrile neutropenia (0.08%). The results of the causality assessment of most of the cases were probable. Conclusion: The adverse effect of chemotherapeutic agents is a matter of concern in the pharmacological management of cancer as it affects the quality of life of patients. This information would be useful in identifying and minimizing preventable adverse drug reactions while generally enhancing the knowledge of the prescribers to deal with these adverse drug reactions more efficiently.

Keywords: adverse drug reactions, platinum compounds, cancer, chemotherapy

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Authors: Pranee Suecharoen, Ratchadaporn Soontornpas, Jaturat Kanpittaya

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Background: Contrast media has an important role for disease diagnosis through detection of pathologies. Contrast media can, however, cause adverse reactions after administration of its agents. Although non-ionic contrast media are commonly used, the incidence of adverse events is relatively low. The most common reactions found (10.5%) were mild and manageable and/or preventable. Pharmacists can play an important role in evaluating adverse reactions, including awareness of the specific preparation and the type of adverse reaction. As most common types of adverse reactions are idiosyncratic or pseudo-allergic reactions, common standards need to be established to prevent and control adverse reactions promptly and effectively. Objective: To measure the effect of using tools for symptom evaluation in order to reduce the severity, or prevent the occurrence, of adverse reactions from contrast media. Methods: Retrospective review descriptive research with data collected on adverse reactions assessment and Naranjo’s algorithm between June 2015 and May 2016. Results: 158 patients (10.53%) had adverse reactions. Of the 1,500 participants with an adverse event evaluation, 137 (9.13%) had a mild adverse reaction, including hives, nausea, vomiting, dizziness, and headache. These types of symptoms can be treated (i.e., with antihistamines, anti-emetics) and the patient recovers completely within one day. The group with moderate adverse reactions, numbering 18 cases (1.2%), had hypertension or hypotension, and shortness of breath. Severe adverse reactions numbered 3 cases (0.2%) and included swelling of the larynx, cardiac arrest, and loss of consciousness, requiring immediate treatment. No other complications under close medical supervision were recorded (i.e., corticosteroids use, epinephrine, dopamine, atropine, or life-saving devices). Using the guideline, therapies are divided into general and specific and are performed according to the severity, risk factors and ingestion of contrast media agents. Patients who have high-risk factors were screened and treated (i.e., prophylactic premedication) for prevention of severe adverse reactions, especially those with renal failure. Thus, awareness for the need for prescreening of different risk factors is necessary for early recognition and prompt treatment. Conclusion: Studying adverse reactions can be used to develop a model for reducing the level of severity and setting a guideline for a standardized, multidisciplinary approach to adverse reactions.

Keywords: role of pharmacist, management of adverse reactions, guideline for contrast media, non-ionic contrast media

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Authors: Sohanur Rahman, Elisabeth Sinnewe, Larelle (Ellie) Chapple, Sarah Osborne

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Greater political attention to global climate change exposes firms to a higher level of political uncertainty, which can lead to adverse capital market consequences. However, a higher level of discourse on environment-specific political risk (EPR) between management and investors can mitigate information asymmetry, followed by less stock price crash risk. This study examines whether EPR discourse in discourse in the earnings conference calls (ECC) reduces firm-level stock price crash risk in the US market. This research also explores if adverse disclosures via media channels further moderates the association between EPR on crash risk. Employing a dataset of 28,933 firm-year observations from 2002 to 2020, the empirical analysis reveals that EPR discourse in ECC reduces future stock price crash risk. However, adverse disclosures via media channels can offset the favourable effect of EPR discourse on crash risk. The results are robust to the potential endogeneity concern in a quasi-natural experiment setting.

Keywords: earnings conference calls, environment, environment-specific political risk discourse, environmental disclosures, information asymmetry, reputation risk, stock price crash risk

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Authors: Pranee Suecharoen, Jaturat Kanpittaya

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Background: The incidence of adverse reactions to iodinated contrast media has risen. The dearth of reports on reactions to the administration of iso- and low-osmolar contrast media should be addressed. We, therefore, studied the profile of adverse reactions to iodinated contrast media; viz., (a) the body systems affected (b) causality, (c) severity, and (d) preventability. Objective: To study adverse reactions (causes and severity) to iodinated contrast media at Srinagarind Hospital. Method: Between March and July, 2015, 1,101 patients from the Department of Radiology were observed and interviewed for the occurrence of adverse reactions. The patients were classified per Naranjo’s algorithm and through use of an adverse reactions questionnaire. Results: A total of 105 cases (9.5%) reported adverse reactions (57% male; 43% female); among whom 2% were iso-osmolar vs. 98% low-osmolar. Diagnoses included hepatoma and cholangiocarcinoma (24.8%), colorectal cancer (9.5%), breast cancer (5.7%), cervical cancer (3.8%), lung cancer (2.9%), bone cancer (1.9%), and others (51.5%). Underlying diseases included hypertension and diabetes mellitus type 2. Mild, moderate, and severe adverse reactions accounted for 92, 5 and 3%, respectively. The respective groups of escalating symptoms included (a) mild urticaria, itching, rash, nausea, vomiting, dizziness, and headache; (b) moderate hypertension, hypotension, dyspnea, tachycardia and bronchospasm; and (c) severe laryngeal edema, profound hypotension, and convulsions. All reactions could be anticipated per Naranjo’s algorithm. Conclusion: Mild to moderate adverse reactions to low-osmolar contrast media were most common and these occurred immediately after administration. For patient safety and better outcomes, improving the identification of patients likely to have an adverse reaction is essential.

Keywords: adverse reactions, contrast media, computed tomography, iodinated contrast agents

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Authors: Surender Singh, Yogendra Kumar Gupta

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Boerhaavia diffusa (BD) Linn. belonging to family Nyctaginaceae is a herbaceous plant and known as ‘punarnava’ in Hindi, used as herbal medicine for pain relief and various ailments. It is widely used as a green leafy vegetable in many Asian and African countries. The objective of present study was to investigate potential adverse effects, if any, of standardized root extract of Boerhaavia diffusa in rats following subchronic administration. In acute toxicity study, no mortality was found at a dose of 2000mg/kg which indicates that oral LD50 of Boerhaavia diffusa root extract is more than 2000mg/kg. The chronic administration of Boerhaavia diffusa for 28 days at a dose of 1000mg/kg body weight did not produce any significant changes in hematological (RBC, WBC, platelets, hemoglobin, bleeding time, clotting time) and biochemical (triglycerides, blood glucose, high density lipoprotein, serum creatinine, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase) parameters of male and female rats as compared to normal control group. All the animals survived until the scheduled necropsy, and their physical and behavioral examinations did not reveal any treatment-related adverse effects. No pathological changes were observed in histological section of heart, kidney, liver, testis, ovaries and brain of Boerhaavia diffusa treated male and female rats as compared to normal control animals.These observations from oral acute toxicitystudy suggest that the extract is practically non-toxic. Thus, it can be inferred that the Boerhaavia diffusa root extract at levels up to 1000 mg/kg/day was found to be safe and does not cause adverse effects in rats. So, the no-observed effect level (NOAEL) of the extract was found to be 1000mg/kg/day.

Keywords: Boerhaavia diffusa, histology, toxicity, sub-acute

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Authors: Peyman Mosberian-Tanha, Mona Rezaei

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Aquaculture sector is the fastest growing food sector with annual growth rate of about 10%. The sustainability of aquaculture production, however, has been debated mainly in relation to the feed ingredients used for farmed fish. The industry has been able to decrease its dependency on marine-based ingredients in line with policies for more sustainable production. As a result, plant-based ingredients have increasingly been incorporated in aquaculture feeds, especially in feeds for popular carnivorous species, salmonids. The effect of these ingredients on salmonids’ health and performance has been widely studied. In most cases, plant-based diets are associated with varying degrees of health and performance issues across salmonids, partly depending on inclusion levels of plant ingredients and the species in question. However, aquaculture sector is facing another challenge of concern. Environmental challenges in association with climate change is another issue the aquaculture sector must deal with. Data from trials in salmonids subjected to environmental challenges of various types show adverse physiological responses, partly in relation to stress. To date, there are only a limited number of studies reporting the interactive effects of adverse environmental conditions and dietary regimens on salmonids. These studies have shown that adverse environmental conditions exacerbate the detrimental effect of plant-based diets on digestive function and health in salmonids. This indicates an additional challenge for the aquaculture sector to grow in a sustainable manner. The adverse environmental conditions often studied in farmed fish is the change in certain water quality parameters such as oxygen and/or temperature that are typically altered in response to climate change and, more specifically, global warming. In a challenge study, we observed that the in the fish fed a plant-based diet, the fish’s ability to absorb dietary energy was further reduced when reared under low oxygen level. In addition, gut health in these fish was severely impaired. Some other studies also confirm the adverse effect of environmental challenge on fish’s gut health. These effects on the digestive function and gut health of salmonids may result in less resistance to diseases and weaker performance with significant economic and ethical implications. Overall, various findings indicate the multidimensional negative effects of climate change, as a major environmental issue, in different sectors, including aquaculture production. Therefore, a comprehensive evaluation of different ways to cope with climate change is essential for planning more sustainable strategies in aquaculture sector.

Keywords: aquaculture, climate change, sustainability, salmonids

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Authors: Monika Szpringer, Aneta Pawlinska

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Adverse childhood experiences are linked to various types of health and adapt problems at different stages of life. They include various types of abuse, neglect, and dysfunctional environment. They have an unfavorable impact on the development of a child and his future functioning in society. Adolescents who were exposed to bad treatment may suffer from health problems during adulthood, like chronic diseases, psychological disorders, drug addiction, and suicide attempts. Objective: The aim of the project is to assess the relationship between adverse childhood experiences and the sense of efficacy and coping with emotions among teenagers aged 16-18 taking drugs. Material And Methods: The research was carried out in the period from March to December 2018 in Mazowieckie, Świętokrzyskie, Łódzkie, and Lubelskie Voivodship. The group consisted of 600 people aged 16-18 (M=16,58; SD=0, 78), men (63,2%) aged 16-18 (M=16,60;SD= 0,78) and women (35,5%) aged 16-18 (M16,55;SD=0,79). Participants included residents from Youth Educational Centers and Youth Sociotherapy Centers. Each participant filled in Author's Questionnaire, Adverse Childhood Questionnaire, then Courtland Emotional Control Scale-CECS and Generalized Self Efficacy Scale-GSES. Results and conclusions: The most common adverse experiences, according to teenagers, were family abuse, divorce/separation/parent's death, overuse of alcohol or drugs by an inmate, and emotional neglect. Adolescents who suffered from five to twelve adverse experiences had a higher level of depression's control. Adverse childhood experiences have an importance for the level of anger and depression's control among teenagers taking drugs. The greatest importance of the level of anger's control has emotional neglect. A higher level of emotional neglect is linked to a lower ability to control anger. The greatest importance of the level of depression's control has physical abuse and emotional neglect. The higher physical abuse during childhood, and the higher frequency of emotional neglect, the bigger the depression's control. The sense of efficacy in the group of people who suffered from one to four adverse experiences is close to the sense of efficacy that suffered people from five to twelve adverse experiences. The most important factor lowering the sense of one's efficacy was the intensification of sexual abuse. It was confirmed that the intensification and frequency of adverse childhood experiences were higher among women than men. Women also characterized lower anger control and greater depression's control. The authors’ own analyses confirmed the relationship between adverse childhood experiences and the sense of efficacy and coping with emotions among teenagers aged 16-18 taking drugs.

Keywords: adolescences, adverse childhood experiences, coping with emotions, drugs

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Authors: Annie Ramanbhai Mecwan

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Cleaning validation in a pharmaceutical manufacturing facility is documented evidence that a cleaning process has effectively removed contaminants, residues from previous drug products and cleaning agents below a pre-defined threshold from the reusable tools and parts of equipment. In shared manufacturing facilities more than one drug product is prepared. After cleaning of reusable tools and parts of equipment after one drug product manufacturing, there are chances that some residues of drug substance from previously manufactured drug products may be retained on the equipment and can carried forward to the next drug product and thus cause cross-contamination. Health-based limits through the derivation of a safe threshold value called permitted daily exposure (PDE) for the residues of drug substances should be employed to identify the risks posed at these manufacturing facilities. The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed to or below this dose every day for a lifetime. There are different practices to calculate PDE. Data for all APIs in the public domain are considered to calculate PDE value though, company to company may vary the final PDE value based on different toxicologist’s perspective or their subjective evaluation. Hence, Regulatory agencies should take responsibility for publishing PDE values for all APIs as it is done for elemental PDEs. This will harmonize the PDE values all over the world and prevent the unnecessary load on manufacturers for cleaning validation

Keywords: active pharmaceutical ingredient, good manufacturing practice, NOAEL, no observed adverse effect level, permitted daily exposure

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Authors: Morteza Mirhosseini, Amir B. Khoshnevis

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The boundary layer separation and new active flow control of a NACA 0025 airfoil were studied experimentally. This new flow control is sometimes known as a co-flow jet (cfj) airfoil. This paper presents the fluctuating velocity in a wall jet over the co-flow jet airfoil subjected to an adverse pressure gradient and a curved surface. In these results, the fluctuating velocity at the inner part increasing by increased the angle of attack up to 12^o and this has due to the jet energized, while the angle of attack 20^o has different. The airfoil cord based Reynolds number has 10⁵.

Keywords: adverse pressure gradient, fluctuating velocity, wall jet, co-flow jet airfoil

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Authors: Khaliun Nyambayar, Nomindari Azzaya, Batkhuyag Purevjav

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Pharmacovigilance was officially introduced in Mongolia in 2003, in accordance with the Health Minister Order 183 for the registry of adverse drug reactions (ADR), approved in 2006 and was reviewed in 2010. This study was designed to evaluate the incidence and common types of adverse drug reactions among hospitalized children, the frequency of adverse drug reaction reported by health care providers, and the follow-up processes resulting from adverse drug reactions. A retrospective study of paediatric patients who experienced an adverse drug reaction from 2015 to 2019, extracted from the “yellow” card at the State Research Center for Maternal and Child Health, (city). A total of 417 adverse drug reactions were reported with an overall incidence was 80 (21.5%). Adverse reactions resulting from the use of antibiotics (particularly gentamycin, cephalosporins, and vancomycin) were usually mild. ADR’s were reported by physicians and nurses (93.8%), pharmacists (6.25%). Although documentation of physician notification occurred for 93% of adverse drug reactions, only 29% of cases were documented in the patient's medical chart, 13% included follow-up education for individuals involved, and 10% were updated in the allergy profile of the hospital computer system. Measures to improve the detection and reporting of adverse drug reactions by all health care professionals should be improved, to enhance our understanding of the nature and impact of these reactions in children.

Keywords: adverse drug reaction, pediatric, yellow card, Mongolia

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Authors: Shiva Kumar G.

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The present study is to know the level of noises emanated from vehicles in intersections located in urban areas using Sound Level Meter and the possibility of reducing noise levels through traffic flow optimization. The main objective is to study traffic noise level of the Intersections located at on-going metro construction activities and which are away from metro construction activities. To compare traffic noise level between stop phase, go phase and drive phase at the Intersections. To study the effect of traffic noise level of directional movement of traffic and variation in noise level during day and night times. The range of Noise level observed at intersections is between 60 to 105 decibel. The noise level of stop and drive phases were minimum and almost same where go phase had maximum noise level. By comparing noise level of directional movement of traffic, it has been noticed that Vijayanagar intersection has no significant difference in their noise level and all other intersection has a significant difference in their noise level. By comparing noise level of stop, go and drive phase it has been noticed that there was a significant difference in noise level during peak hours compared to off-peak hour. By comparing noise level between Metro and Non-Metro construction activity intersections it has been noticed that there was a significant difference in noise level. By comparing noise level during day and night times, significant differences in noise level were observed at all intersections.

Keywords: noise, metro and non-metro intersections, traffic flow optimization, stop-go and drive phase

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Authors: Zahid Hussain, Nayyab Sultan

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This study describes the preparation of zinc oxide nanoparticles and their anti-diabetic effect individually and with the combination of Momordica charantia plant extract. This plant is termed bitter melon, balsam pear, bitter gourd, or karela. Blood glucose levels in mice were monitored in their random state before and after the administration of zinc oxide nanoparticles and plant extract. The powdered form of nanoparticles and the selected plant were used as an oral treatment. Diabetes was induced in mice by using a chemical named as streptozotocin. It is an artificial diabetes-inducing chemical. In the case of zinc oxide nanoparticles (3mg/kg) and Momordica charantia plant extract (500mg/kg); the maximum anti-diabetic effect observed was 70% ± 1.6 and 75% ± 1.3, respectively. In the case of the combination of zinc oxide nanoparticles (3mg/kg) and Momordica charantia plant extract (500mg/kg), the maximum anti-diabetic effect observed was 86% ± 2.0. The results obtained were more effective as compared to standard drugs Amaryl (3mg/kg), having an effectiveness of 52% ± 2.4, and Glucophage (500mg/kg), having an effectiveness of 29% ± 2.1. Results indicate that zinc oxide nanoparticles and plant extract in combination are more helpful in treating diabetes as compared to their individual treatments. It is considered a natural treatment without any side effects rather than using standard drugs, which shows adverse side effects on health, and most probably detoxifies in liver and kidneys. More experimental work and extensive research procedures are still required in order to make them applicable to pharmaceutical industries.

Keywords: albino mice, amaryl, anti-diabetic effect, blood glucose level, Camellia sinensis, diabetes mellitus, Momordica charantia plant extract, streptozotocin, zinc oxide nanoparticles

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Authors: Rizwan Alam, Ikhtiar Khan, Aqib Iqbal

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Plants are naturally exposed to a wide variety of environmental stresses. The stresses may be biotic or/and abiotic. These environmental stresses have adverse effects on photosynthesis, water relation and nutrients uptake of plants. Fertilization of plants with exogenous minerals can enhance the drought tolerance in plants. In this experiment, canola (Brassica napus) was treated with solutions of calcium nitrate in different concentrations before the imposition of drought stress for 10 days. It was observed that drought stress decreased the tissue-K, Ca and K/Ca ratio of canola seedlings. The tissue-carbon and nitrogen contents were also depressed by the drought stress. Application of calcium nitrate, however, could alleviate the adverse effects of drought stress by showing a positive effect on all the aforementioned parameters.

Keywords: Brassica napus, calcium, carbon, potassium

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Authors: Tadesse Melaku Abegaz

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Background: there was paucity of data on the self-reported adverse drug reactions (ADRs), level of adherence and clinical outcomes with antidepressants among major depressive disorder (MDD) patients in Ethiopia. Hence, the present study sought to determine the level of adherence for and clinical outcome with antidepressants and the magnitude of ADRs. Methods: A prospective cross-sectional study was employed on MDD patients from September 2016 to January 2017 at Gondar university hospital psychiatry clinic. All patients who were available during the study period were included under the study population. The Naranjo adverse drug reaction probability scale was employed to assess the adverse drug reaction. The rate of medication adherence was determined using morisky medication adherence measurement scale eight. Clinical Outcome of patients was measured by using patient health questionnaire. Multivariable logistic carried out to determine factors for adherence and patient outcome. Results: two hundred seventy patients were participated in the study. More than half of the respondents were males 122(56.2%). The mean age of the participants was 30.94 ± 8.853. More than one-half of the subjects had low adherence to their medications 124(57.1%). About 186(85.7%) of patients encountered ADR. The most common ADR was weight gain 29(13.2). Around 198(92.2%) ADRs were probable and 19(8.8%) were possible. Patients with long standing MDD had high risk of non-adherence COR: 2.458[4.413-4.227], AOR: 2.424[1.185-4.961]. More than one-half 125(57.6) of respondents showed improved outcome. Optimal level of medication adherence was found to be associated with reduced risk of progression of the diseases COR: 0.37[0.110-5.379] and AOR: 0.432[0.201-0.909]. Conclusion: Patient reported adverse drug reactions were more prevalent in major depressive disorder patients. Adherence to medications was very poor in the setup. However, the clinical outcome was relatively higher. Long standing depression was associated with non-adherence. In addition, clinical outcome of patients were affected by non-adherence. Therefore, adherence enhancing interventions should be provided to improve medication adherence and patient outcome.

Keywords: adverse drug reactions, clinical outcomes, Ethiopia, prospective study, medication adherence

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Authors: Md. Rashed Aalm, Md. Nuruzzaman Khan, Yothin Sawangdee

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Background: Around 47% of the total pregnancies are unintended in Bangladesh, which lead to several adverse consequences, including maternal and child mortality. Use of menstrual regulation (MR) can help women to reduce unintended pregnancy related adverse consequences. We explored the prevalence and determinants of MR services among ever-married women in Bangladesh. Methods: Total of 14,346 ever-married women data were analysed from the 2017 Bangladesh Demographic and Health Survey. Our study variable was use or non-use of MR services. Individual, household, and community level factors were the explanatory factors. Multilevel mixed-effect Poisson regression model was used to determine the factors associated with MR services in Bangladesh. Results: Nearly 7% of the total women in Bangladesh use MR services. Use of MR services was found higher among women who were aged 20-30 ages (IRR 1.60, 95% CI: 1.17–2.17), who were overweight (IRR 1.43, 95% CI: 1.13–1.81), had at least 1 child (IRR 2.97, 95% CI: 2.34– 3.77) or > 2 children (IRR 3.22, 95% CI: 2.45–4.20), and the birth preceding birth interval was(2 – 4) years (IRR 1.56, 95% CI: 1.13–2.15). Around 1.39 times (95% CI: 1.11–1.73) higher likelihood of MR was found among women whose husbands were engage with business. At the community level, MR service was found lower among the women who resided in the community with higherilliteracy (IRR 0.67, 95% CI: 0.42–0.96) and the Mymensingh division (IRR 0.39, 95% CI: 0.31–0.91). Conclusion: Use of MR service is comparatively low, which indicate a significant proportion of unintended pregnancy continued toward life-birth. This could be responsible for higher adverse maternal and child health outcomes in Bangladesh. Initiatives should be taken to ensure MR services is available when women need this service.

Keywords: menstrual regulation, pattern, risk, maternal health, Bangladesh

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Authors: Hamidreza Babaali, Alireza Mojtahedi, Nasim Soori, Saba Soori

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Hydraulic jump is one of the effective ways of energy dissipation in stilling basins that the ‎energy is highly dissipated by jumping. Adverse slope surface at the end stilling basin is ‎caused to increase energy dissipation and stability of the hydraulic jump. In this study, the adverse slope ‎has been added to end of United States Bureau of Reclamation (USBR) II stilling basin in hydraulic model of Nazloochay dam with scale 1:40, and flow simulated into stilling basin using Flow-3D ‎software. The numerical model is verified by experimental data of water depth in ‎stilling basin. Then, the parameters of water level profile, Froude Number, pressure, air ‎entrainment and turbulent dissipation investigated for discharging 300 m³/s using K-Ɛ and Re-Normalization Group (RNG) turbulence ‎models. The results showed a good agreement between numerical and experimental model‎ as ‎numerical model can be used to optimize of stilling basins.‎

Keywords: experimental and numerical modelling, end adverse slope, flow ‎parameters, USBR II stilling basin

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Authors: Piao Wei, Sun Jing, Huang Jian, Wang Lijuan, Tang Yanbin, Li Jin, Huo Junsheng

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Objective: To investigate effects on the levels of SF and sTfR by the SNPs of rs855791on TMPRSS6 and rs3811647 on TF in adolescent. Methods: DNA was extracted from venous blood which were drawn from 50 subjects, and then the two SNPs of each sample were identified by Sequenom MassArray. T test and chi-square test were selected to identify the relationship between the levels of SF and sTfR in each allele carriers, and then the effects of each SNP on the levels of SF and sTfR would be assessed. Results: The level of SF of A allele carriers on rs855791 (54±28.2 ng/ml) was higher than GG carriers (33.1±20.2 ng/ml) (P<0.05), and the discrimination of the level of sTfR between each allele carrier was not observed (P>0.05); the discriminations of the different levels of SF and sTfR among each SNP on rs3811647 were not observed (P>0.05). Conclusions: The level of SF may be affected by the SNP of rs855791on TMPRSS6, and the effect of rs3811647 on TF may be weakened by the former one.

Keywords: SNP, SF, sTfR, adolescent

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Authors: Ming-Dong Wang, Abigail F. Ruby, Michelle E. Ross

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Methylphenidate is a first-line treatment drug for attention deficit hyperactivity disorder (ADHD), a common mental health disorder in children and adolescents. Over the last several decades, the rate of children and adolescents using ADHD medication has been increasing in many countries. A recent study found that the prevalence of ADHD medication use among children aged 3-18 years increased in 13 different world regions between 2001 and 2015, where the absolute increase ranged from 0.02 to 0.26% per year. The goal of this study was to examine the use of methylphenidate in Canadian children and its associated adverse reactions. Methylphenidate use information among young Canadians aged 0-14 years was extracted from IQVIA data on prescriptions dispensed by pharmacies between April 2014 and June 2020. The adverse reaction information associated with methylphenidate use was extracted from the Canada Vigilance database for the same time period. Methylphenidate use trends were analyzed based on sex, age group (0-4 years, 5-9 years, and 10-14 years), and geographical location (province). The common classes of adverse reactions associated with methylphenidate use were sorted, and the relative risks associated with methylphenidate use as compared with two second-line amphetamine medications for ADHD were estimated. This study revealed that among Canadians aged 0-14 years, every 100 people used about 25 prescriptions (or 23,000 mg) of methylphenidate per year during the study period, and the use increased with time. Boys used almost three times more methylphenidate than girls. The amount of drug used was inversely associated with age: Canadians aged 10-14 years used nearly three times as many drugs compared to those aged 5-9 years. Seasonal methylphenidate use patterns were apparent among young Canadians, but the seasonal trends differed among the three age groups. Methylphenidate use varied from region to region, and the highest methylphenidate use was observed in Quebec, where the use of methylphenidate was at least double that of any other province. During the study period, Health Canada received 304 adverse reaction reports associated with the use of methylphenidate for Canadians aged 0-14 years. The number of adverse reaction reports received for boys was 3.5 times higher than that for girls. The three most common adverse reaction classes were psychiatric disorders, nervous system disorders and injury, poisoning procedural complications. The number one commonly reported adverse reaction for boys was aggression (11.2%), while for girls, it was a tremor (9.6%). The safety profile in terms of adverse reaction classes associated with methylphenidate use was similar to that of the selected control products. Methylphenidate is a commonly used pharmaceutical product in young Canadians, particularly in the province of Quebec. Boys used approximately three times more of this product as compared to girls. Future investigation is needed to determine what factors are associated with the observed geographic variations in Canada.

Keywords: adverse reaction risk, methylphenidate, prescription trend, use variation

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Authors: Young-Taeg Kim, Gwang Ho Seo, Hyungju Oh, Ho Kyung Ha, Kuk Jin Kim

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Kim et al., hypothesized an increase in volume transport in the Korea Strait based on the concurrent increase in water temperature and mean sea level observed by the Korea Hydrographic and Oceanographic Agency (KHOA) in the vicinity of the Korea Strait from 2000 to 2009. Since then, to our best knowledge, no definitive studies have been reported on the increase in volume transport through the Korea Strait, but the observed water temperature (2000-2021) and sea level (1989-2021) in the Korea Strait and East Sea have been found to be increasing. In particular, the rapid increase rate in the mean sea level rise (2.55~3.53 mm/y) in these areas cannot be explained by only steric effect due to the increased water temperature. It is more reasonable interpretation that the sea level rise is due to an increase in the volume transport of warm and salty currents. If the increase in the volume transport is explained by the geostrophic equation without considering the sea level rise in the Korea Strait, the current velocity should increase. However, up to now, there are no reports of an increase in current velocity from direct observations using ADCP (e.g., observations of Camellia) or from various numerical models. Therefore, the increase in volume transport cannot be explained by the geostrophic equation. Another possible explanation for the increase in the volume transport is the effect of wind. Although Korea is dominated by monsoon, it is affected by winds according to El Niño and La Niña, which have a cycle of about 3 to 4 years. During El Niño (La Niña), northerly winds (southerly winds) prevail in Korea. Consequently, it is inferred that the transported volume in the Korea Strait slowly increases interannually. However, in this study, it was difficult to find a clear correlation between annually-averaged mean sea level and El Niño (or La Niña) during 1989-2021. This is probably due to the interactions of the PDO (Pacific Decadal Oscillation) and AO (Arctic Oscillation) along with the ENSO (El niño-Southern Oscillation). However, it is clear that the interannual variability of winds is affecting the volume transport in the Korean Strait. On the other hand, the effect of global sea level rise on the volume transport in the Korea Strait is small compared to the interannual variability of the volume transport, but it seems to play a constant role.

Keywords: mean sea level, volume transport, El nino, La nina

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Authors: Naureen Naeem, M. S. Aslam

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Chia seeds found to be a rich source of dietary fiber contain oil which is high in omega 6 and omega 3 fatty acids and helpful in the control of cardiovascular diseases. Owing to its spectacular significance, present research had been designed to explore its effect on cholesterol level of the individuals after consumption of chia seed oil supplemented ice cream. The project was designed in such a manner that fat of ice cream was replaced with chia seed oil in different proportions i.e., 25%, 50%, 75%, 100%. After physico-chemical and sensory evaluation of ice cream, best treatment was selected and used for efficacy trials. After baseline line study and thorough inclusion criteria 10 individuals were selected and divided into two groups. One group treated as control and the other was given chia seed oil supplemented l(50%) ice cream. Significant decrease in cholesterol level was observed in the treated group. 18% decrease in cholesterol level was observed at 40th day followed by 8% at 20th day. Similarly 20% decrease in LDL cholesterol with 14% increase in HDL cholesterol. It was recommended that further trials be conducted with sophisticated techniques to completely replace saturated fat in ice cream with unsaturated fats and to study its effect in hyperglycemia and oxidative stress.

Keywords: hypercholesterolemia, chia seed oil, HDL, triglycerides

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Authors: Vivek Saxena, Shreshtha Saxena

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Background: Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance first recognized during pregnancy. Uncontrolled or untreated GDM is associated with various adverse outcomes to the maternal and fetal health. Overt diabetes mellitus may also develop in such patients. It is universally accepted fact that first and foremost management to treat GDM is dietary control and lifestyle modification even before starting any oral hypoglycemic agent (OHA) or insulin. So, proper dietary management and little changes in the patient’s lifestyle are very effective for reducing her plasma glucose level. Objectives: Proper counselling of the patients and flexibility in their lifestyle and diet can effectively control the plasma glucose level in GDM patients. Methods: Total 60 GDM patients of age > 18 years were taken. We had three counselling sessions with the patient and other members of the family like husband, parents, and in-laws at different intervals, discussed their lifestyle and diet pattern, helped them to eliminate the factors those had an adverse effect on plasma glucose level and promoted them to acquire a healthy lifestyle. We have counselled the patient and her family member separately and then together also. They have explained how increased plasma glucose level can be effectively controlled with the little modification in their diet and routine activities. They were also taught to remain stress-free during their rest of antenatal period. We have excluded the patients from our study who were diabetic before pregnancy and patients with other comorbid illnesses like hypothyroidism and valvular heart disease. Results and conclusions: Results were very rewarding as patients could acquire a lifestyle of their choice. They were happy because extra pill burden was not there. All the 60 patients were normoglycemic in remaining antenatal period, 48 patients were delivered normally and 12 patients underwent cesarean section due to various reasons.Regular counselling of the patients regarding their disease and little alterations in diet and lifestyle controlled the plasma glucose level much effectively. The things were more easier and effective when we included other family members during our counselling session because they play a major role in patient’s day to day activity and influence her life.

Keywords: dietary management, gestational diabetes mellitus, impaired glucose tolerance, oral hypoglycemic agent, pregnancy

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Authors: Nazia Nazir

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Background: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study was to observe the effect of adding dexmedetomidine to bupivacaine for the supraclavicular block. Methods (Design): In this randomized, double-blind study, seventy ASA I & II patients of either sex undergoing elective surgeries on the upper limb were given supraclavicular block under ultrasound guidance. Group C (n=35), received 38 mL 0.25% bupivacaine + 2mL normal saline and group D received 38 mL 0.25% bupivacaine + 1 µg/kg dexmedetomidine (2mL). Patients were observed for onset, duration of motor and sensory block, duration of analgesia, sedation score, hemodynamic changes and any adverse events. Results: In group D the onset was faster (P < 0.001), duration of sensory and motor block, as well as duration of analgesia, was prolonged as compared to group C (P < 0.0001). There was significant drop in heart rate (HR) from the baseline in group D (P < 0.05) at 30, 60, 90 and 120 min, however, none of the patients dropped HR below 50/min. Mean arterial Pressure (MAP) remained unaffected. The patients in group D were effectively sedated than those in group C (P < 0.05). No adverse event was reported in either group. Conclusion: Dexmedetomidine as adjuvant to bupivacaine in supraclavicular block resulted in faster action, prolonged motor and sensory block, prolonged analgesia with hemodynamic stability and adequate sedation.

Keywords: Analgesia, bupivacaine, dexmedetomidine, supraclavicular block

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Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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Authors: Nadeem H. Meikha , Nazad H. Qader, Basheer M. Hasafa

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The trial was conducted to examine the effect of He-Ne laser therapy on the testis and serum testosterone level in adult rats. Thirty five albino Western adult male rats aged 3-4 months and weighing approximately 250-300 g were used and divided into three treatments. Testicular tissue of rats in the first and second treatments were exposed once daily for three successively days to a dose of irradiation 1.02 j/cm2 (40 second), and to 2.03 j/cm2 (80 second) respectively, while the third group left without any treatments (control). The results showed that the process of irradiation adversely affected on the level of serum testosterone concentration of the irradiated rats in the first and second treatment comparing to the normal level in the control group. While the histological examination showed that decrease in number of germ cells with 40 second of irradiation at day three, with 80 second of irradiation the decreased started at day two and three. The spermatids number decreased in rate low, medium, high respectively for three days of 40 second of irradiation, while the spermatids number were adversely affected by dropping in a rate of medium, large and very large for three days of 80 second of irradiation, respectively. In conclusion our study revealed that any reduction in sertoli cells causes adverse affect on both spermatids and germinal cells which increase with the increasing of duration and repetition of irradiation.

Keywords: He-Ne laser, rats, testosterone, spermatids

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Authors: Musarrat Jabeen, Fatima Zahra Khan, Hamida Bano, Faiza Anjum, Sara Tahir, Kainat Umar, Uzma Azam

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The aim of this study was to examine the effect of gender norms and gender equality on depression and quality of life among young and old married couples. The sample consisted of 60 old and 100 young married couples. It was mainly conducted in Islamabad, Pakistan. However, since it was convenient and snowball sampling, we were able to get the data from other cities of Pakistan as well. By using Beck Depression Scale (Aaron T. Beck), Satisfaction with Life Scale (Diener), the Ambivalent Sexism Inventory (Glick & Fiske,1996), and Gender Norms Attitude Scale(Waszak et al., 2000). It was found that the old couples have a high quality of life than young couples, which further proved them to have positive attitude towards gender equality, negative attitude towards gender norms and low level of depression. Also, couples having positive attitude towards gender equality have high level of satisfaction with life than the ones having negative attitude towards gender norms, who have low level of depression. Also, having a negative attitude towards gender norms has adverse effects on the level of depression. To achieve a high quality of life, it would be helpful to evolve with the world, especially with respect to the concepts of gender norms and equality.

Keywords: depression, gender equality, gender norms, married couples, quality of life

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Authors: Anna Rudzińska, Katarzyna Szklener, Pola Juchaniuk, Anna Rodzajweska, Katarzyna Machulska-Ciuraj, Monika Rychlik- Grabowska, Michał łOziński, Agnieszka Kolak-Bruks, SłAwomir Mańdziuk

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Introduction: Immune checkpoint inhibition (ICI) belongs to the modern forms of anti-cancer treatment. Due to the constant development and continuous research in the field of ICI, many aspects of the treatment are yet to be discovered. One of the less researched aspects of ICI treatment is the influence of the adverse effects on the treatment success rate. It is suspected that adverse events in the course of the ICI treatment indicate a better response rate and correlate with longer progression-free- survival. Methodology: The research was conducted with the usage of the documentation of the Department of Clinical Oncology and Chemotherapy. Data of the patients with a lung cancer diagnosis who were treated between 2019-2022 and received ICI treatment were analyzed. Results: Out of over 133 patients whose data was analyzed, the vast majority were diagnosed with non-small cell lung cancer. The majority of the patients did not experience adverse effects. Most adverse effects reported were classified as grade 1 or grade 2 according to CTCAE classification. Most adverse effects involved skin, thyroid and liver toxicity. Statistical significance was found for the adverse effect incidence and overall survival (OS) and progression-free survival (PFS) (p=0,0263) and for the time of toxicity onset and OS and PFS (p<0,001). The number of toxicity sites was statistically significant for prolonged PFS (p=0.0315). The highest OS was noted in the group presenting grade 1 and grade 2 adverse effects. Conclusions: Obtained results confirm the existence of the prolonged OS and PFS in the adverse-effects-charged patients, mostly in the group presenting mild to intermediate (Grade 1 and Grade 2) adverse effects and late toxicity onset. Simultaneously our results suggest a correlation between treatment response rate and the toxicity grade of the adverse effects and the time of the toxicity onset. Similar results were obtained in several similar research conducted - with the proven tendency of better survival in mild and moderate toxicity; meanwhile, other studies in the area suggested an advantage in patients with any toxicity regardless of the grade. The contradictory results strongly suggest the need for further research on this topic, with a focus on additional factors influencing the course of the treatment.

Keywords: adverse effects, immunotherapy, lung cancer, PD-1/PD-L1 inhibitors

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Authors: Li Chen

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For an aerofoil or hydrofoil in high Reynolds number flows, broadband noise is generated efficiently as the result of the turbulence convecting over the trailing edge. This noise can be related to the surface pressure fluctuations, which can be predicted by either CFD or empirical models. However, in reality, the aerofoil or hydrofoil often operates at an angle of attack. Under this situation, the flow is subjected to an Adverse-Pressure-Gradient (APG), and as a result, a flow separation may occur. This study is to assess trailing-edge noise models for such flows. In the present work, the trailing-edge noise from a 2D airfoil at 6 degree of angle of attach is investigated. Under this condition, the flow is experiencing a strong APG, and the flow separation occurs. The flow over the airfoil with a chord of 300 mm, equivalent to a Reynold Number 4x10⁵, is simulated using RANS with the SST k-ɛ turbulent model. The predicted surface pressure fluctuations are compared with the published experimental data and empirical models, and show a good agreement with the experimental data. The effect of the APG on the trailing edge noise is discussed, and the associated trailing edge noise is calculated.

Keywords: aero-acoustics, adverse-pressure gradient, computational fluid dynamics, trailing-edge noise

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Authors: Nadjet Mekaouche, Hanane Zitouni, Fatma Boudia, Habiba Fetati, A. Saleh, A. Lardjam, H. Geniaux, A. Coubret, H. Toumi

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Medicines have undeniably played a major role in prolonging shelf life and improving quality. The absolute efficacy of the drug remains a lever for innovation, its benefit/risk balance is not always assured and it does not always have the expected effects. Prior to marketing, knowledge about adverse drug reactions is incomplete. Once on the market, phase IV drug studies begin. For years, the drug was prescribed with less care to a large number of very heterogeneous patients and often in combination with other drugs. It is at this point that previously unknown adverse effects may appear, hence the need for the implementation of a pharmacovigilance system. Pharmacovigilance represents all methods for detecting, evaluating, informing and preventing the risks of adverse drug reactions. The most severe adverse events occur frequently in hospital and that a significant proportion of adverse events result in hospitalizations. In addition, the consequences of hospital adverse events in terms of length of stay, mortality and costs are considerable. It, therefore, appears necessary to develop ‘hospital pharmacovigilance’ aimed at reducing the incidence of adverse reactions in hospitals. The most widely used monitoring method in pharmacovigilance is spontaneous notification. However, underreporting of adverse drug reactions is common in many countries and is a major obstacle to pharmacovigilance assessment. It is in this context that this study aims to describe the experience of the pharmacovigilance service at the University Hospital of Oran (EHUO). This is a retrospective study extending from 2011 to 2017, carried out on archived records of declarations collected at the level of the EHUO Pharmacovigilance Department. Reporting was collected by two methods: ‘spontaneous notification’ and ‘active pharmacovigilance’ targeting certain clinical services. We counted 217 statements. It involved 56% female patients and 46% male patients. Age ranged from 5 to 78 years with an average of 46 years. The most common adverse reaction was drug toxidermy. For the drugs in question, they were essentially according to the ATC classification of anti-infectives followed by anticancer drugs. As regards the evolution of declarations by year, a low rate of notification was noted in 2011. That is why we decided to set up an active approach at the level of some services where a resident of reference attended the staffs every week. This has resulted in an increase in the number of reports. The declarations came essentially from the services where the active approach was installed. This highlights the need for ongoing communication between all relevant health actors to stimulate reporting and secure drug treatments.

Keywords: adverse drug reactions, hospital, pharmacovigilance, spontaneous notification

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