Search results for: randomized controlled trial

Authors: E. Gopi, E. Devaindran

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Objective: Non-operative management of blunt splenic trauma have started to overtake the traditional splenectomy in recent years across the grade of splenic injury. The two main non-operative methods are observation and angioembolisation. However, the post management convalescence in these groups are still being investigated. The study attempts to quantify the clinical indicators among the two in particular complications, mortalities, conversions to operative management and duration of inpatient stay. Methodology: A systematic search was done via PUBMED, MEDLINE, and EMBASE. A total of 639 articles identified and subsequently 68 articles were identified post duplicates, full text, and inclusion and exclusion criteria. Main exclusions were non-English articles without English translation, pure observational or angioembolisation articles of which no comparison data could be identified and articles looking into pure hemodynamically unstable patients. Results: 24 non randomized controlled trial, 5 clinical control trial and 39 retrospective studies analyzing a total of 23700 patients with blunt splenic trauma. Discrepancies in data were noted in the group who had observational management versus angioembolisation in particular as data was compared among the classes of splenic rupture, the protocol of management in different centers, availability of angiogram suite, and the study design. Further variability was also noted in the angioembolisation arm as the preference for treatment differs between distal versus proximal splenic artery involvement. Overall the cumulative mortality in both observational and angioembolisation group were similar, 2.78% and 5.97% respectively. The cause of death however is not directly attributed to the management itself but rather patient comorbidities, other associated injuries and conversions to splenectomy leading to post splenectomy complications. The cumulative morbidity among each group appears to be same approximately 12% in observational versus 15% in angioembolisation. However, the type of complications varies with the observational group having higher rates of inpatient stay and intrabdominal hematoma infection and angioembolisation group developing more splenic infarcts and bleeds. There were significant disparity in reporting the actual data on duration of inpatient stay and complications to allow a statistically significant quantitative analysis to be done, 15 articles however are currently being considered. Conclusions: Observational management appears to be much effective in managing lower grade splenic trauma (grade 1 and 2) where else angioembolisation appears to play a bigger role in intermediate grades (grade 3-4) in ensuring splenic function preservation. Care has to be taken however in the angioembolisation group in view of distal splenic infarct group compromising splenic function. The cumulated data of 15 articles are now being considered for a meta-analysis.

Keywords: blunt splenic trauma, conservative, non-operative, angioembolisation

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Authors: Jiyeon Kang, Yeon Jin Jeong, Hoon Heo

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Purpose: Bullying in nursing workplace has been a serious problem that increases the turnover of nurses. Few studies have examined the effects of communication training on workplace bullying for nurses, and all used a single-group design and a small sample size. Thus, more rigorous research has been needed to evaluate the effects properly. This research was aimed to identify the effects of the mobile type communication training of responses on bullying behaviors among nurses. Methods: A randomized controlled trial was performed. Subjects were 62 critical care nurses working in university hospitals in Busan, South Korea. We developed a mobile phone application to train nurses to deal with bullying situation. This application includes 6 common bullying situations and appropriate empathetic communication (non-violent communication) samples in the form of webtoons. The experimental group used this application for 4 weeks, and we measured interpersonal relationship, workplace bullying, symptom experience, and intention to leave before, post, and 8 weeks after the intervention from both experimental and control groups. The effect of the intervention was analyzed using repeated measures ANOVA. Results: The mobile type communication training developed in this study was effective for decreasing nurses’ intention to leave workplace (F = 5.11, p = .027). However, it had no effect on interpersonal relationship (F = 2.54, p = .116), workplace bullying (F = 2.99, p = .089) or symptom experience (F = 2.81, p = .099). The beneficial effects on intention to leave lasted at least up to 4 weeks after the training. Conclusion: The mobile type communication training can be utilized as an effective personal coping strategy for workplace bullying among nurses. Further studies on the long-term effects of the communication training are necessary.

Keywords: bullying, communication, mobile applications, nurses, training, workplace

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Authors: Marzieh Moattari Mitra Abbasi, Masoud Mousavinasab, Poorahmad

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Background: Nurses in their daily practice need to communicate with patients and their families as well as health professional team members. Effective communication contributes to patients’ satisfaction which is a fundamental outcome of nursing practice. There are some evidences in support of patients' dissatisfaction with nurses’ performance in communication process. Therefore improving nurses’ communication skills is a necessity for nursing scholars and nursing administrators. Objective: The aim of the present study was to evaluate the effect of a 2-days workshop on nurses’ competencies and performances in communication in a central hospital located in the sought of Iran. Materials and Method: This is a randomized controlled trial which comprised of a convenient sample of 70 eligible nurses, working in a central hospital. They were randomly divided into 2 experimental and control groups. Nurses’ competencies was measured by an Objective Structured Clinical Examination (OSCE) and their performance was measured by asking eligible patients hospitalized in the nurses work setting during a one month period to evaluate nurses' communication skills before and 2 months after intervention. The experimental group participated in a 2 day workshop on communication skills. Content included in this workshop were: the importance of communication (verbal and non verbal), basic communication skills such as initiating the communication, active listening and questioning technique. Other subjects were patient teaching, problem solving, and decision making, cross cultural communication and breaking bad news. Appropriate teaching strategies such as brief didactic sessions, small group discussion and reflection were applied to enhance participants learning. The data was analyzed using SPSS 16. Result: A significant between group differences was found in nurses’ communication skills competencies and performances in the posttest. The mean scores of the experimental group was higher than that of the control group in the total score of OSCE as well as all stations of OSCE (p<0.003). Overall posttest mean scores of patient satisfaction with nurse's communication skills and all of its four dimensions significantly differed between the two groups of the study (p<0.001). Conclusion: This study shows that the education of nurses in communication skills, improves their competencies and performances. Measurement of Nurses’ communication skills as a central component of efficient nurse patient relationship by valid and reliable methods of evaluation is recommended. Also it is necessary to integrate teaching of communication skills in continuing nursing education programs. Trial Registration Number: IRCT201204042621N11

Keywords: communication skills, simulation, performance, competency, objective structure, clinical evaluation

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Authors: Mathieu Audet, Monica Soliman, Emilie Eve Gravel, Rebecca Friesdorf

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Access to higher education is critical for reducing social inequalities. The Canada Learning Bond (CLB) is a government savings incentive aimed at increasing higher education access for children of low income families by providing money toward a Registered Education Savings Plan. To better understand the educational and financial decision-making of low income families, Employment Social Development Canada conducted qualitative fieldwork with eligible parents and children, teachers, and community organizations promoting the Bond. Insights from this fieldwork were then used to develop letters to better target the needs and experiences of eligible families. In the present study, we conducted a randomized controlled trial with children ages 12 to 13, the oldest cohort of eligible children, to test the effectiveness of the new letters. Parents or caregivers of 150,088 eligible children were assigned to one of five letter conditions promoting the Bond or to a control condition that did not receive a letter. The letter conditions were: (a) the standard letter from past outreach, (b) a letter presenting the exact amount the child was eligible to receive, enhancing the salience of benefits, (c) a letter with a social norm, (d) a letter with an image emphasizing the feasibility of higher education by presenting the diversity of options (i.e., college, trade schools, apprenticeships) – many participants interviewed viewed that university was unfeasible, and (e) a letter minimizing references to 'saving' (i.e., not framing the Bond explicitly as a savings incentive) – a concept that did not resonate with low income families who felt they could not afford to save. The exact amount was also presented in letters (c) through (e). The letter minimizing references to 'saving' and presenting the exact amount had the highest net take-up rate at 6.6%, compared to 3.5% for the standard letter group. Furthermore, this trial’s BI-informed letters showed the largest impact on take-up so far, with a net take-up of 5.7% compared to 3.0% and 3.9% in the first two trials. This research highlights the value of mixed-method approaches combining qualitative and behavioural insights methods for developing context-sensitive interventions for social programs. By gaining a deeper understanding of the needs and experiences of program users through qualitative fieldwork, and then integrating these insights into behaviourally informed communications, we were able to increase take-up of an education savings program, which may ultimately improve access to higher education in children of low income families.

Keywords: access to higher education, behavioral insights, government, innovation, mixed-methods, social programs

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Authors: M. A. Abdel-Wahed, Nayera Elmorsi Hassan, Safaa Shafik Imam, Ola G. El-Farghali, Khadija M. Alian

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Low-birth-weight is a challenging public health problem. Aim: to clarify role of zinc on enhancing catch-up growth of low-birth-weight and find out a proposed relationship between zinc effect on growth and the main growth hormone mediator, IGF-1. Methods: Study is a double-blind-randomized-placebo-controlled trial conducted on low-birth-weight-neonates delivered at Ain Shams University Maternity Hospital. It comprised 200 Low-birth-weight-neonates selected from those admitted to NICU. Neonates were randomly allocated into one of the following two groups: group I: low-birth-weight; AGA or SGA on oral zinc therapy at dose of 10 mg/day; group II: Low-birth-weight; AGA or SGA on placebo. Anthropometric measurements were taken including birth weight, length; head, waist, chest, mid-upper arm circumferences, triceps and sub-scapular skin-fold thicknesses. Results: At 12-month-old follow-up visit, mean weight, length; head (HC), waist, chest, mid-upper arm circumferences and triceps; also, infant’s proportions had values ≥ 10th percentile for weight, length and HC were significantly higher among infants of group I when compared to those of group II. Oral zinc therapy was associated with 24.88%, 25.98% and 19.6% higher proportion of values ≥ 10th percentile regarding weight, length and HC at 12-month-old visit, respectively [NNT = 4, 4 and 5, respectively]. Median IGF-1 levels measured at 6 months were significantly higher in group I compared to group II (median (range): 90 (19 – 130) ng/ml vs. 74 (21 – 130) ng/ml, respectively, p=0.023). Conclusion: Oral zinc therapy in low-birth-weight neonates was associated with significantly more catch-up growth at 12-months-old and significantly higher serum IGF-1 at 6-month-old.

Keywords: low-birth-weight, zinc, catch-up growth, neonates

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Authors: Ratna Farida Soenarto, Anas Alatas, Made Ryan Kharmayani

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Background: Conventional ultrafiltration (CUF) system was shown to be helpful in reducing anti-inflammatory mediators for patients who underwent open heart surgery. Additionally, modified ultrafiltration (MUF) has been shown to reduce anti-inflammatory mediators further while reducing interstitial fluid volume at the same time. However, there has been minimal data concerning the efficacy of combining both ultrafiltration methods. This study aims to compare inflammation marker, vascular resistance, and cardiac index on CUF+MUF patients with CUF only patients undergoing open heart surgery. Method: This is a single blind randomized controlled trial on patients undergoing open heart surgery between June 2021 - October 2021 in CiptoMangunkusumo National Referral Hospital and Jakarta Heart Hospital. Patients wererandomized using block randomization into modified ultrafiltration following conventional ultrafiltration (CUF+MUF) and conventional ultrafiltration (CUF) only. Outcome assessed in this study were 24-hoursinterleukin-6 levels, systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), and cardiac index. Results: A total of 38patients were included (19 CUF+MUF and 19 CUF subjects). There was no difference in postoperative IL-6 level between groups (p > 0.05).No difference in PVR was observed between groups.Higher difference in SVR was observed in CUF+MUF group (-646 vs. -261dyn/s/cm-5, p < 0.05). Higher cardiac index was observed on CUF+MUF group (0.93 vs. 0.48, p < 0.05). Conclusion: Patients undergoing open heart surgery with modified ultrafiltration following conventional ultrafiltration had similar systemic inflammatory response and better cardiac response than those having conventional ultrafiltration.

Keywords: open-heart, CUF, MUF, SVR, PVR, IL-6

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Authors: Maryam Panahi

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Background: Adjuvants such as ketamine, promethazine, and paracetamol could bring up patient's satisfaction and control the harmful effects of opioids besides lessening their needed doses, as seen by the fentanyl/paracetamol and fentanyl/ketamine combination before. The current study is headed to compare paracetamol and ketamine, in addition to fentanyl, applied by infusion pumps in order to pain relief following major surgery. Materials and Methods: Through a double-blinded, randomized clinical trial, patients between18 and 65 with elective surgery for tight or leg fractures with ASA Class 1 and 2 referred to a university hospital in Arak, a town in the central region of Iran, were recruited and used infusion pump for their postoperative pain control. The participants were divided into cases and controls regarding using ketamine/fentanyl (KF) or paracetamol/fentanyl (PF) infusion pumps. Results: The mean pain score was a total of 3.87, with the highest value in KF (5.06) and the lowest in PF (4.50) immediately after finishing the surgery and getting conscious when started using an infusion pump. There was no statistical difference between the groups in this regard. Concerning the side effects of the applied medications, blood pressure and heart rate had no differences comparing the groups. Conclusion: This study showed that paracetamol used in infusion pumps could be brilliant in pain control after major surgeries like those done in lower extremities and joint replacement while lessening opioid use. Although paracetamol was more effective than ketamine in the current trial, more qualified studies at bigger sizes and in other fields of surgery besides orthopedic ones would be useful to support the effects if applicable

Keywords: infusion pump, Ketamine, Paracetamol, pain

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Authors: Mahboubeh Varmaziar

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Depression is a significant public health concern affecting people of all ages and genders. Physical activity has been shown to have a positive effect on mental health, particularly in alleviating symptoms of depression. This study aims to explore the impact of continuous exercise on depression levels among young female athletes in Hamadan Province, Iran. In this randomized controlled trial, 72 women aged 20 to 35 years attending sports centers in Hamadan Province were selected through convenient sampling and randomly assigned to either the control or experimental group. The experimental group participated in a continuous exercise program consisting of 20 sessions over six weeks, with each session lasting 30 minutes. In contrast, the control group maintained their usual daily activities at the sports center. Both groups completed demographic and Beck Depression Inventory questionnaires. Data were analyzed using descriptive and inferential statistics, including two-way ANOVA. The results of the two-way ANOVA, after controlling for the pre-test effect, revealed a significant difference in the mean depression scores between the control and experimental groups (p < 0.001). This suggests that the continuous exercise program significantly reduced depression levels in the young female athletes. The findings suggest that continuous exercise is an effective non-pharmacological intervention for reducing depression in young female athletes. Incorporating regular physical activity into treatment plans may serve as a complementary therapy alongside conventional treatments, offering a low-risk and beneficial approach to managing depression.

Keywords: depression, exercise, female athletes, yong women

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Authors: Masoumeh Khailghi Sikaroudi, Mohsen Masoodi, Fazad Shidfar, Meghdad Sedaghat

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Background: The hypertonicity of internal anal sphincter resting pressure is one of the main reasons for chronic anal fissures. The aim of this study is to assess the effect of oral administration of L-arginine on anal fissure symptom improvement by relaxation of the internal anal sphincter. Method: Seventy-six chronic anal fissure patients (age: 18-65 years) took part in this randomized, double-blind, placebo-controlled trial study from February 2019 to October 2020 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were allocated into treatment (L-arginine) or placebo groups. They took a 1000 mg capsule three times a day for one month and were followed up at the end of the first and third months after receiving the intervention. Clinical symptoms, anal sphincter resting pressure, and quality of life (QoL) were completed at baseline and the end of the study. Result: The analysis of data was shown significant improvement in bleeding, fissure size, and pain within each group; however, this effect was more seen in the arginine group compared to the control group at the end of the study (P-values<0.001). Following that, a significant increase in QoL was seen just in patients who were treated with arginine (P-value=0.006). Also, the comparison of anal pressures to baseline and between groups at the end of the study showed a significant reduction in sphincter pressure in treated patients (P-value<0.001, =0.049; respectively). Conclusion: Oral administration of 3000 mg L-arginine can heal chronic anal fissures by reducing anal internal sphincter pressure with fewer side effects. However, a long-term study with more follow-up is recommended.

Keywords: L-arginine, anal fissure, sphincter pressure, clinical symptoms, quality of life

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Authors: Raman Sharma, S. K. Jain

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Aims and Objectives: Fixation of the mesh during laparoscopic total extraperitoneal (TEP) repair of inguinal hernia is thought to be necessary to prevent recurrence. However, mesh fixation may increase surgical complications and postoperative pain. Our objective was to compare the outcomes of nonfixation with fixation of polypropylene mesh by metal tacks during TEP repair of inguinal hernia. Methods: Forty patients aged 18 to72 years with inguinal hernia were included who underwent laparoscopic TEP repair of inguinal hernia with (n=20) or without (n=20) fixation of the mesh. The outcomes were operative duration, postoperative pain score, cost, in-hospital stay, time to return to normal activity, and complications. Results: Patients in whom the mesh was not fixed had shorter mean operating time (p < 0.05). We found no difference between groups in the postoperative pain score, incidence of recurrence, in-hospital stay, time to return to normal activity and complications (P > 0.05). Moreover, a net cost savings was realized for each hernia repair performed without stapled mesh. Conclusions: TEP repair without mesh fixation resulted in the shorter operating time and lower operative cost with no difference between groups in the postoperative pain score, incidence of recurrence, in-hospital stay, time to return to normal activity and complications. All this contribute to make TEP repair without mesh fixation a better choice for repair of uncomplicated inguinal hernia, especially in developing nations with scarce resources.

Keywords: postoperative pain score, inguinal hernia, nonfixation of mesh, total extra peritoneal (TEP)

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Authors: Ghazal Zahed, Leila Tabatabaee, Amirhossein Hosseini, Somaye Fatahi

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Functional retentive overflow incontinence (Retentive FI) is the most common cause of fecal soiling in children. Affected patients may have more problems with their parents and peer group, self-esteem issues, and more psychiatric comorbidities than the general population. Therapeutic interventions for Retentive FI and related problems and comorbid conditions are needed at the same time. Based on the clinical experiences, patients with retentive FI and comorbid psychiatric disorders, were accelerated in their treatment of fecal incontinence when they were being treated with Risperidone for their psychiatric comorbidities, therefore this study was conducted to evaluate the effect of Risperidone in the treatment of Retentive FI in children and adolescents. In this double-blind randomized clinical trial, 136 patients aged 4-18 years eligible for the study were randomly divided into two groups receiving Risperidone and placebo. About half of these patients had newly diagnosed psychiatric disorders and were drug naïve, this was considered in their division. In addition to polyethylene glycol, all the participants received family counseling and education for withholding behaviors and related behavioral interventions, and nonpharmacological interventions for psychiatric comorbidities. A significant correlation was observed between the duration of treatment with risperidone and the presence of psychiatric comorbidities (P <0.001) for diurnal fecal incontinence. Based on our findings in this study, Risperidone, used commonly for psychiatric disorders in children and adolescents, may be useful in the treatment of retentive fecal incontinence in the presence of psychiatric comorbidities, and along with other interventions.

Keywords: Retentive Fecal Incontinence, Risperidone, Treatment, Pediatric, Encopresis, Atypical Antipsychotics, Fecal Soiling

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Authors: Hamed Zakikhani, Mohd Khanif Yusop, Amin Soltangheisi

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A hydroponic trial was carried out to investigate the effect of molybdenum (Mo) on uptake of phosphorus (P) in different rice cultivars. The experiment was conducted using a randomized complete-block design, with a split-plot arrangement of treatments and three replications. Four rates of Mo (0, 0.01, 0.1 and 1 mg L−1) and five cultivars (MR219, HASHEMI, MR232, FAJRE and MR253) provided the main and sub-plots, respectively. Interaction of molybdenum×variety was significant on shoot phosphorus uptake (p≤0.01). Highest and lowest shoot phosphorus uptake were seen in Mo3V3 (0.6% plant-1) and Mo0V3 (0.14% plant-1) treatments, respectively. Molybdenum did not have a significant effect on root phosphorus content. According to results, application of molybdenum has a synergistic effect on uptake of phosphorus by rice plants.

Keywords: molybdenum, phosphorus, uptake, rice,

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Authors: Sameh Eldaly, Rola Essam

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Objective: The purpose of this study was to determine the benefits of low-level laser therapy for Athletic Achilles Tendinopathy. Data sources: Search strategies were conducted on 2 Randomized control trial and one pilot study. Results: three trials (103 participants) were analyzed. Laser therapy associated to eccentric exercises, when compared to eccentric exercises and placebo, had low to very low certainty of evidence in pain and function assessment. Conclusion: those three trials evidenced low to very low effect of LLLT, and the results are insufficient to support the routine use LLLT for Achilles tendinopathy.

Keywords: achilles tendinopathy, evidence-based, low-level laser therapy, review

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Authors: H. Abchiche, M. Mellal

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The aim of this work is to study the parameters that influence the rheological behavior of a complex fluid (sodium Carboxyméthylcellulose solution), on a capillary rheometer. An installation has been made to be able to vary the diameter of trial conducts. The obtained results allowed us to deduce that: the diameter of trial conducts have a remarkable effect on the rheological responds.

Keywords: bingham’s fluid, CMC, cylindrical conduit, rheological behavior

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Authors: P. Akbartehrani, M. Khaledi Pour, M. Amini, M. Khani, M. Mohajeri Tehrani, E. Ghasemi, P. Charipoor, B. Shokri

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A common problem between diabetic patients is foot ulcers which are chronic and require specialized treatment. Previous studies illustrate that Cold atmospheric plasma (CAP) has beneficial effects on wound healing and infection. Nevertheless, the comparison of different cap exposure protocols in diabetic ulcer wound healing remained to be studied. This study aims to determine the effect of two different exposure protocols on wound healing in diabetic ulcers. A prospective, randomized clinical trial was conducted at two clinics. Diabetic patients with G1 and G2 wanger classification diabetic foot ulcers were divided into two groups of study. One group was treated by the first protocol, which was treating wounds by argon-generated cold atmospheric plasma jet once a week for five weeks in a row. The other group was treated by the second protocol, which was treating wounds every three days for five weeks in a row. The wounds were treated for 40 seconds/cubic centimeter, while the nozzle tip was moved nonlocalized 1 cm above the wounds. A patient with one or more wounds could participate in different groups as wounds were separately randomized, which allow a participant to be treated several times during the study. The study's significant findings were two different reductions rate in wound size, microbial load, and two different healing speeds. This study concludes that CAP therapy by the second protocol yields more effective healing speeds, reduction in wound sizes, and microbial loads of foot ulcers in diabetic patients.

Keywords: wound healing, diabetic ulcers, cold atmospheric plasma, cold argon jet

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Authors: Ifeoma C. Afiaenyi, Elizabeth K. Ngwu, Rufina N. B. Ayogu

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Diabetes has crept into the rural areas of Nigeria, causing devastating effects on its sufferers; most of them could not afford diabetic medications. Moringa oleifera has been used extensively in animal models to demonstrate its antilipidaemic and haematinic qualities; however, there is a scarcity of data on the effect of graded levels of Moringa oleifera leaves on the lipid profile and hematological parameters in human diabetic subjects. The study determined the effect of Moringa oleifera leaves on the lipid profile and hematological parameters of type 2 diabetic subjects in Ukehe, a rural Nigerian community. Twenty-four adult male and female diabetic subjects were purposively selected for the study. These subjects were shared into four groups of six subjects each. The diets used in the study were isocaloric. A control group (diabetics, group 1) was fed diets without Moringa oleifera leaves. Experimental groups 2, 3 and 4 received 20g, 40g and 60g of Moringa oleifera leaves daily, respectively, in addition to the diets. The subjects' lipid profile and hematological parameters were measured prior to the feeding trial and at the end of the feeding trial. The feeding trial lasted for fourteen days. The data obtained were analyzed using the computer program Statistical Product for Service Solution (SPSS) for windows version 21. A Paired-samples t-test was used to compare the means of values collected before and after the feeding trial within the groups and significance was accepted at p < 0.05. There was a non-significant (p > 0.05) decrease in the mean total cholesterol of the subjects in groups 1, 2 and 3 after the feeding trial. There was a non-significant (p > 0.05) decrease in the mean triglyceride levels of the subjects in group 1 after the feeding trial. Groups 1 and 3 subjects had a non-significant (p > 0.05) decrease in their mean low-density lipoprotein (LDL) cholesterol after the feeding trial. Groups 1, 2 and 4 had a significant (p < 0.05) increase in their mean high-density lipoprotein (HDL) cholesterol after the feeding trial. A significant (p < 0.05) decrease in the mean hemoglobin level was observed only in group 4 subjects. Similarly, there was a significant (p < 0.05) decrease in the mean packed cell volume of group 4 subjects. It was only in group 4 that a significant (p < 0.05) decrease in the mean white blood cells of the subjects was also observed. The changes observed in the parameters assessed were not dose-dependent. Therefore, a similar study of longer duration and more samples is imperative to authenticate these results.

Keywords: anemia, diabetic subjects, lipid profile, moringa oleifera

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Authors: Nittaya Nokham, Nattaphon Kamon, Pipatpong Pimkhot, Pedcharada Yusuk

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Testing efficacy of a bio-product (bp) to reduce amount of arsenic was carried out in soil which were used for cultivation of organic vegetables, at Watchan Royal Project Development Center, Kulayaniwattana district, Chiang Mai. The test consists of 6 treatments e.g. Tr.1) Control: To underlie the planting pits (pp)with compost; Tr.2) Using bp: To underlie thepp with compost mixed with (+) bp at 100 g/pit; Tr.3) Using bp: To underlie the pp with compost + bp at 100 g/pit and to spray the vegetables with bp at 2 l/20 l of water, once a week; Tr.4) Using bp: To spread the compost bp on the planting area at 3 kg/1 m2 ; Tr.5) Using bp: To spread the compost + bp on the planting area at 3 kg/1 m2and to spray vegetables with bp at 2 l/20 l of water; Tr.6) Using bp: To spray vegetables with bp at 2 l/20 l of water. Result showed that after first trial of pointed cabbage cultivation, only Tr.6 had a small reduction of arsenic; while the others had higher amount of the metal. After second trial of growing red oak leaf, Tr.6 had more reduction of arsenic while Tr.5 and Tr.3 had less reduction compared to Tr.6 but more reduction than the others. In the third trial of growing mustard, very small reduction could be found on Tr.6 and Tr.5 but more reduction in Tr.3. For the fourth (last) trial with cos romaine lettuce: Tr.6, Tr.5 showed most reduction of arsenic to about half of the original amount. So, it can be concluded that this bio-product can help reducing arsenic when using this product by spraying the bp to vegetables at concentration of 2 l/20 l of water once week (Tr.6), or using the bio-product mixed with compost to spread on the planting area at 3 kg/1 m2 together with spraying the product (Tr.5). The results obtained from continuous planting 4 kinds of vegetables at the same area. The amount of arsenic found in roots and stem is very small in the 4 vegetables.

Keywords: organic vegetables, bio-product, arsenic, soil

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Authors: Ziraguen O. Williams, Shield B. Lin, Fouad N. Matari, Leslie J. Quiocho

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In a task to assist NASA in analyzing the dynamic forces caused by operational countermeasures of an astronaut’s exercise platform impacting the spacecraft, feedback delay, and signal noise were added to a simulation model of an active-controlled vibration isolation system to regulate the movement of the exercise platform. Previous simulation work was conducted primarily via MATLAB/Simulink. Two additional simulation tools used in this study were Trick and MBDyn, NASA co-developed software simulation environments. Simulation results obtained from these three tools were very similar. All simulation results support the hypothesis that an active-controlled vibration isolation system outperforms a passive-controlled system even with the addition of feedback delay and signal noise to the active-controlled system. In this paper, squat exercise was used in creating excited force to the simulation model. The exciter force from a squat exercise was calculated from the motion capture of an exerciser. The simulation results demonstrate much greater transmitted force reduction in the active-controlled system than the passive-controlled system.

Keywords: control, counterweight, isolation, vibration

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Authors: Vipin Saini, Sunil Kamboj, Suman Bala, A. Pandurangan

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The present research is aimed at fabrication of multiple-unit controlled-release tablet formulation of aceclofenac by employing acrylic polymers as the release controlling excipients for drug multi-particulates to achieve the desired objectives of maintaining the same controlled release characteristics as that prior to their compression into tablet. Various manufacturers are successfully manufacturing and marketing aceclofenac controlled release tablet by applying directly coating materials on the tablet. The basic idea behind development of such formulations was to employ aqueous acrylics polymers dispersion as an alternative to the existing approaches, wherein the forces of compression may cause twist of drug pellets, but do not have adverse effects on the drug release properties. Thus, the study was undertaken to illustrate manufacturing of controlled release aceclofenac multiple-unit tablet formulation.

Keywords: aceclofenac, multiple-unit tablets, acrylic polymers, controlled-release

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Authors: Ajay Agrawal, Pravin Shah, Shailaja Chhetri, Pappu Rijal

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Background and Objectives: Postpartum hemorrhage (PPH) is a common and occasionally life-threatening complication of labour. Cesarean section (CS) is associated with more blood loss than vaginal delivery. There is a trend for increasing CS rates in both developed and developing countries. This could increase the risk of morbidity and mortality, especially among anemic women. The objective of this study was to evaluate the effect of preoperative administration of Intravenous Tranexamic Acid (TA) on blood loss during and after elective CS delivery. Materials and Methods: It is a prospective, randomized controlled study. 160 eligible pregnant women of 37 or more POG planned for CS were randomized into two groups either to receive 10ml(1gm) of tranexamic acid intravenously or 10ml of normal saline. Blood loss was measured during and for 24 hours after operation. Results: The mean estimated blood loss was significantly lower in women treated with TA compared with women in the placebo group (392.13 ml ± 10.06 versus 498.69 ml ± 15.87, respectively; p < 0.001). The mean difference in pre-operative and post-operative hemoglobin levels was statistically significant in the tranexamic acid group than in the control group (0.31 ± 0.18 versus 0.79 ± 0.23, respectively; p < 0.001). Conclusion: Pre-operative use of tranexamic acid is associated with reduced blood loss during and after elective cesarean section. In a developing country like ours where PPH is a major threat to the life of the mothers, it seems to be a promising option.

Keywords: blood loss, cesarean section, postpartum hemorrhage, tranexamic acid

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Authors: Rohit Kothari

Abstract:

Background: Leprosyis a chronic granulomatous diseasecaused by Mycobacterium leprae (M. Lepra). Reactions may interrupt its usual chronic course.Type-1 (T1R)and type-2 lepra reaction(T2R) are acute events and signifytype-IV and type-III hypersensitivity responses, respectively. Various chemokines like CCL3, 5, 11, and CCL24 may be increased during the course of leprosy or during reactions and may serve as markers of early diagnosis, response to therapy, and prognosis. Objective: To find correlation of CCL3, 5, 11, and CCL24 in leprosy patients on multidrug therapy and their family contacts after ruling out active disease during leprosy treatment and during periods of lepra reactions. Methodology: This randomized control trial was conducted in 50 clinico-histopathologically diagnosed cases of leprosy in a tertiary care hospital in Bengaluru, India. 50 of their family contacts were adequately examined and investigated should the need be to rule out active disease. The two study-groups comprised of leprosy cases, and the age, sex, and area of residence matched healthy contactswho were given single-dose rifampicin prophylaxis, respectively. Blood samples were taken at baseline, six months, and after one yearin both the groups (on completion of MDT in leprosy cases)and also during periods of reaction if occurred in leprosy cases. Results: Our study found that at baseline, CCL5, 11, and 24 were higher in leprosy cases as compared to the healthy contacts, and the difference was statistically significant.CCL3 was also found to be higherat baseline in leprosy cases, however, the difference was not statistically significant. At six months and one year, the levels of CCL 5, 11, and 24 reduced, and the difference was statistically significant in leprosy cases, whereas it remained almost static in all the healthy contacts. Twenty patients of leprosy developed lepra reaction during the course of one year, and during reaction, the increase in CCL11 and 24 was statistically significant from baseline, whereas CCL3 and 5 did not rise significantly. One of the healthy contacts developed signs of leprosy in the form of hypopigmented numb patch and was clinico-histopathologically, and CCL11 and 24 were found to be higher with a statistically significant difference from the baseline values. Conclusion: CCL5, 11, and 24 are sensitive markers of diagnosing leprosy, response to MDT, and prognosis and are not increased in healthy contacts. CCL11 and 24 are sensitive markers of lepra reactions and may serve as one of the early diagnostic modalities for identifying lepra reaction and also leprosy in healthy contacts. To the best of our knowledge, this is the first study to evaluate these biomarkers in leprosy cases and their healthy contacts with a follow-up of upto one year with one of them developing the disease, and the same was confirmed based on these biomarkers as well.

Keywords: chemokine profile, healthy contacts, leprosy, lepra reactions

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Authors: Yasmin Sayed, Hala Hamdy, Hafez Bazaraa, Hanaa Rady, Sherif Elanwary

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Intravenous and inhaled magnesium sulfate (MgSO₄) had been recently used as an adjuvant therapy in cases suffering from the wheezy chest. Objective: We aimed to determine the possible change in the hemodynamic state in cases received intravenous or inhaled MgSO₄ in comparison to cases received standard treatment in critically ill infants and children with the wheezy chest. Methods: A randomized controlled trial comprised 81 patients suffering from wheezy chest divided into 3 groups. In addition to bronchodilators and systemic steroids, MgSO₄ was given by inhalation in group A, intravenously in group B, and group C didn't receive MgSO₄. The hemodynamic state was determined by assessment of blood pressure, heart rate, capillary refill time and the need for shock therapy or inotropic support just before and 24 hours after receiving treatment in 3 groups. Results: There was no significant difference in the hemodynamic state of the studied groups before and after treatment. Means of blood pressure were 102.2/63.2, 105.1/64.8 before and after inhaled MgSO₄; respectively. Means of blood pressure were 105.5/64.2, 104.1/64.9 before and after intravenous MgSO₄; respectively. Means of blood pressure were 107.4/62.8, 104.4/62.1 before and after standard treatment, respectively. There was a statistically insignificant reduction of the means of the heart rate in group A and group B after treatment rather than group C. There was no associated prolongation in capillary refill time and/or the need for inotropic support or shock therapy after treatment in the studied groups. Conclusion: MgSO₄ is a safe adjuvant therapy and not associated with significant alteration in the hemodynamic state in critically ill infants and children with the wheezy chest.

Keywords: critically ill infants and children, inhaled MgSO₄, intravenous MgSO₄, wheezy chest

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Authors: Mohamed Wahba

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Objective: To build a comparative arm for product (X) in specific gene mutated advanced gastrointestinal cancer using real world evidence to fulfill HTA requirements in drug evaluation. Methods: Data for product (X) were collected from phase II clinical trial while real world data for (Y) and (Z) were collected from US database. Real-world (RW) cohorts were matched to clinical trial base line characteristics using weighting by odds method. Outcomes included progression-free survival (PFS) and overall survival (OS) rates. Study location and participants: Internationally (product X, n=80) and from USA (Product Y and Z, n=73) Results: Two comparisons were made: trial cohort 1 (X) versus real-world cohort 1 (Z), trial cohort 2 (X) versus real-world cohort 2 (Y). For first line, the median OS was 9.7 months (95% CI 8.6- 11.5) and the median PFS was 5.2 months (95% CI 4.7- not reached) for real-world cohort 1. For second line, the median OS was 10.6 months (95% CI 4.7- 27.3) for real-world cohort 2 and the median PFS was 5.0 months (95% CI 2.1- 29.3). For OS analysis, results were statistically significant but not for PFS analysis. Conclusion: This study provided the clinical comparative outcomes needed for HTA evaluation.

Keywords: real world evidence, pharmacoeconomics, HTA agencies, oncology

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Authors: Ruqayya Naheed Khan, Awais Amjad Malik, Awais Naeem, Amina Khan, Asad Parvaiz

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Introduction: Axillary nodal status in breast cancer patients is a paramount prognosticator, next to primary tumor size and grade. It has been well established that patients with negative sentinel lymph node biopsy can safely avoid axillary lymph node dissection. A positive sentinel lymph node has traditionally required subsequent axillary dissection. According to ACOSOG Z11 trial, patients who underwent axillary dissection with 3 or more positive sentinel nodes or opted for observation in case of negative sentinel lymph node, did not find any difference in Overall Survival (OS) and Disease Free Survival (DFS). The Z11 trial included patients who underwent breast conserving surgery and excluded patients with mastectomies. The purpose of this study is to determine whether Z0011 can be applied to mastectomy patients as well in 1-3 positive sentinel lymph nodes and avoid unnecessary ALND. Methods: A retrospective review was conducted at Shaukat Khanam Memorial Cancer Hospital Pakistan from Jan 2015 to Dec 2017 including patients who were treated for invasive breast cancer and required upfront mastectomy. They were clinically node negative, so sentinel lymph node biopsy was performed. Patients underwent ALND with positive sentinel lymph node. A total of 156 breast cancer patients with mastectomies were reviewed. Results: 95% of the patients were female while 3% were male. Average age was 44 years. There was no difference in race, comorbidities, histology, T stage, N stage, and overall stage, use of adjuvant chemotherapy and radiation therapy. 64 patients underwent ALND for positive lymph node while 92 patients were spared of axillary dissection due to negative sentinel lymph node biopsy. Out of 64 patients, 38 patients (59%) had only 1 lymph node positive which was the sentinel node. 18 patients (28%) had 2 lymph nodes positive including the sentinel node while only 8 patients (13%) had 3 or more positive nodes. Conclusion: Keeping in mind the complications related to ALND, above results clearly show that ALND could have been avoided in 87% of patients in the setting of adjuvant radiation, possibly avoiding the morbidity associated with axillary lymphadenectomy although a prospective randomized trial needs to confirm these results.

Keywords: mastectomy, sentinel lymph node biopsy, axillary lymph node dissection, breast cancer

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Authors: Corbel Camille, Le Cerf Flora, Corveleyn Xavier

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Introduction: Aging is a physiological phenomenon accompanied by anatomical and cognitive changes leading to anxiety and pain. This could have significant impacts on quality of life, life expectancy, and the progression of cognitive disorders. Virtual Reality Intervention (VRI) is increasingly recognized as a non-pharmacological approach to alleviate pain and anxiety in children and young adults. However, while recent studies have explored the feasibility of applying VRI in the older population, confirmation through studies is still required to establish its benefits in various contexts. Objective: This pilot study, following a clinical trial methodology international recommendation for VRI in healthcare, aims to evaluate the feasibility and effects of using VRI with a 101-year-old woman residing in a nursing home undergoing weekly painful and anxious wound dressing changes. Methods: Following the international recommendations, this study focused on feasibility and preliminary results. A Single Case Experimental Design protocol consists of two distinct phases: control (Phase A) and personalized VRI (Phase B), each lasting for 6 sessions. Data were collected before, during and after the care, using measures of pain (Algoplus and numerical scale), anxiety (Hospital anxiety scale and numerical scale), VRI experience (semi-structured interview) and physiological measures. Results: The results suggest that the utilization of VRI is both feasible and well-tolerated by the participant. VRI contributed to a decrease in pain and anxiety during care sessions, with a more significant impact on pain compared to anxiety, which showed a gradual and slight decrease. Physiological data, particularly those related to stress, also indicate a reduction in physiological activity during VRI. Conclusion: This pilot study confirms the feasibility and benefits of using virtual reality in managing pain and anxiety in an older adult in a nursing home. In light of these results, it is essential that future studies focus on setting up randomized controlled trials (RCTs). These studies should involve a representative number of older adults to ensure generalizable data. This rigorous, controlled methodology will enable us to assess the effectiveness of virtual reality more accurately in various care settings, measure its impact on clinical parameters such as pain and anxiety, and explore the long-term implications of this intervention.

Keywords: anxiety reduction, nursing home, older adult, pain management, virtual reality

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Authors: Ayhan Aydoğdu, Ercan Ceyhan, Ali Kahraman, Nursel Çöl

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This research was conducted to determine effects of plant densities on seed yield and some agricultural characteristics of pea variety- Jofs in Konya ecological conditions during 2012 vegetation period. The trial was set up according to “Randomized Blocks Design” with three replications. The material “Jofs” pea variety was subjected to 3-row spaces (30, 40 and 50 cm) and 3-row distances (5, 10 and 15 cm). According to the results, difference was shown statistically for the effects of row spaces and row distances on seed yield. The highest seed yield was 2582.1 kg ha-1 on 30 cm of row spaces while 2562.2 kg ha-1 on 15 cm of distances. Consequently, the optimum planting density was determined as 30 x 15 cm for Jofs pea variety growing in Konya.

Keywords: pea, row space, row distance, seed yield

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Authors: Alok Madan, Arshad K. Hashmi

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Performance based design (PBD) is an iterative exercise in which a preliminary trial design of the building structure is selected and if the selected trial design of the building structure does not conform to the desired performance objective, the trial design is revised. In this context, development of a fundamental approach for performance based seismic design of masonry infilled frames with minimum number of trials is an important objective. The paper presents a plastic design procedure based on the energy balance concept for PBD of multi-story multi-bay masonry infilled reinforced concrete (R/C) frames subjected to near-field earthquakes. The proposed energy based plastic design procedure was implemented for trial performance based seismic design of representative masonry infilled reinforced concrete frames with various practically relevant distributions of masonry infill panels over the frame elevation. Non-linear dynamic analyses of the trial PBD of masonry infilled R/C frames was performed under the action of near-field earthquake ground motions. The results of non-linear dynamic analyses demonstrate that the proposed energy method is effective for performance based design of masonry infilled R/C frames under near-field as well as far-field earthquakes.

Keywords: masonry infilled frame, energy methods, near-fault ground motions, pushover analysis, nonlinear dynamic analysis, seismic demand

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Authors: Ben Hadj Hassen Sameh, Gaillard Corentin, Andrew Parker, Kristine Krug

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Perceptual decisions about sequences of sensory stimuli often show serial dependence. The behavioural choice on one trial is often affected by the choice on previous trials. We investigated whether the neuronal signals in extrastriate visual area V5/MT on preceding trials might influence choice on the current trial and thereby reveal the neuronal mechanisms of sequential choice effects. We analysed data from 30 single neurons recorded from V5/MT in three Rhesus monkeys making sequential choices about the direction of rotation of a three-dimensional cylinder. We focused exclusively on the responses of neurons that showed significant choice-related firing (mean choice probability =0.73) while the monkey viewed perceptually ambiguous stimuli. Application of a wavelet transform to the choice-related firing revealed differences in the frequency band of neuronal activity that depended on whether the previous trial resulted in a correct choice for an unambiguous stimulus that was in the neuron’s preferred direction (low alpha and high beta and gamma) or non-preferred direction (high alpha and low beta and gamma). To probe this in further detail, we applied a regularized linear decoder to predict the choice for an ambiguous trial by referencing the neuronal activity of the preceding unambiguous trial. Neuronal activity on a previous trial provided a significant prediction of the current choice (61% correc, 95%Cl~52%t), even when limiting analysis to preceding trials that were correct and rewarded. These findings provide a potential neuronal signature of sequential choice effects in the primate visual cortex.

Keywords: perception, decision making, attention, decoding, visual system

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Authors: Md. Mustakimur Rahman

Abstract:

On the one hand, while dealing with temporally distant international crimes (TDICs), prosecutors are likely to encounter many defendants suffering from severe physical or mental disorders. The concept of a defendant's "fitness," on the other hand, is based on the notion that an alleged perpetrator must be protected from a conviction resulting from a lack of participation or competence in making proper judgments. As a result, if a defendant is temporarily or permanently mentally ill, going through a formal criminal trial may be highly unlikely. TheExtraordinary Chambers in the Courts of Cambodia(ECCC), for example, arrested and tried IengThirth for crimes against humanity, grave breaches of the 1949 Geneva Conventions, and genocide. Still, the Trial Chamber found her incompetent to stand trial and released her in 2011. Although the prosecution had a lot of evidence against her, she was free from prosecution. It suggests that alleged war criminals may be granted immunity due to their unfitness, implying that unfitness is a hurdle to combating impunity. Given the absence of a formal criminal trial, international criminal law (ICL) should take steps to address this issue. ICL, according to Mark A. Drumbl, has yet to develop its penology; hence it borrows penological rationales from domestic criminal law. For example, international crimes tribunals such as the Nuremberg Tribunal and the Tokyo Tribunal, ad hoc tribunals have used retribution, utilitarianism, and rehabilitation as punishment justifications. On the other hand, like in the case of IengThirth, a criminal trial may not always be feasible. As a result, instead of allowing impunity, this paper proposes informal trials. This paper, for example, suggests two approaches to dealing with unfit defendants: 1) trial without punishment and 2) punishment without trial. Trial without punishment is a unique method of expressing condemnation without incarceration. "Expressivism has a broader basis than communication of punishment and sentencing," says Antony Duff. According to Drumbl, we can untangle our understanding of punishment from "the iconic preference for jailhouses" to include a larger spectrum of non-incarcerative measures like "recrimination, shame, consequence, and sanction." Non-incarcerative measures allow offenders to be punished without going through a formal criminal trial. This strategy denotes accountability for unlawful behavior. This research concludes that in many circumstances, prosecuting elderly war crimes suspects is difficult or unfeasible, but their age or illness should not be grounds for impunity. They should be accountable for their heinous activities through criminal trials or other mechanisms.

Keywords: international criminal law, international criminal punishment, international crimes tribunal, temporally distant international crimes

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Authors: Chaebong Kim, Yongmin Cho, Minkyung Han, Mooyoung Kim, KooSang Kim

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Background: Air pollution from global warming has a considerable influence on respiratory disease and atopic dermatitis (AD). Present studies base on a hypothesis about correlation between air pollutant and AD, and the results are analyzed from various points of view. Objectives: This study aimed to integrate the relevant researches for air pollutant and AD, and to perform the systematic literature review and meta-analysis to provide the basis of air pollutant control. Methods: Research materials were collected from original articles published in English academic journals including medicine, nursing and health science from August 1 to 31, 2016. We collected the materials from Pubmed, Medline, Embase, Cochrane Central database with Prisma (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) based on the Cochrane Systematic Review Manual, and performed the evaluation and analysis for selected materials. We got the research results for risk of bias using Rev-Man ver. 5.2, and meta analyses using STATA. Results: The prevalence of infantile atopic dermatitis were 1.05 times higher than other groups who were exposed to air pollution, and exposure to NO2 (1.08, 95% CI: 1.02 – 1.14), O3 (1.09, 95% CI: 1.04 – 1.15), SO2 (1.07, 95% CI: 1.02 – 1.12) in subgroup air pollutant was considerably associated with infantile atopic dermatitis. The prevalence of infantile atopic dermatitis was 1.03 times higher than other groups who were exposed to PM2.5, but the results were not statistically similar. Conclusion: Health effect from environmental pollution risen people’s interest in environmental diseases. Air pollutant was associated with AD in this study, but selected literature was based on non-RCT (Randomized Controlled Trial) study. Therefore, there was a limit in study method including control, matching, and correction of confounding variables. For clear conclusion, it is necessary to develop the appropriate tool for object of study and clear standard to measure of air pollutant.

Keywords: air pollution, atopic dermatitis, children, meta-analysis

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