Search results for: randomized control trial
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 11470

Search results for: randomized control trial

11350 Randomized Trial of Tian Jiu Therapy in San Fu Days for Patients with Chronic Asthma

Authors: Libing Zhu, Waichung Chen, Kwaicing Lo, Lei Li

Abstract:

Background: Tian Jiu Therapy (a medicinal vesiculation therapy according to traditional Chinese medicine theory) in San Fu Days (the three hottest days in a year is calculated by the Chinese ancient calendar) is widely used by patients with chronic asthma in China although from modern medicine perspective there is insufficient evidence of its effectiveness and safety issues. We investigated the efficacy and safety of Tian Jiu Therapy compared with placebo in patients with chronic asthma. Methods: Patients with chronic asthma were randomly assigned to Tian Jiu treatment group (n=165), placebo control group (n=158). Registered Chinese Medicine practitioners, in Orthopedics-Traumatology, Acupuncture, and Tui-na Clinical Centre for Teaching and Research, School of Chinese Medicine, The University of Hong Kong, administered Tian Jiu Therapy and placebo treatment in 3 times over 2 months. Patients completed questionnaires and lung function test before treatment and after treatment, 3, 6, 9, and 11 months, respectively. The primary outcome was the no of asthma-related sub-healthy symptoms and the percentage of patients with twenty-three symptoms. Results: 451 patients were recruited totally, 111 patients refused or did not participate according the appointment time and 17 did not meet the inclusion criteria. Consequently, 323 of eligible patients were enrolled. There was nothing difference between Tian Jiu Therapy group and placebo control group at the end of all treatments neither primary nor secondary outcomes. While Tian Jiu Therapy as compared with placebo significantly reduced the percentage of participants who are susceptible waken up by asthma symptoms from 27% to 14% at 2nd follow-up (P < 0.05). Similarly, Tian Jiu Therapy significantly reduced the proportion of participants who had the symptom of running nose and sneezing before onset from 18% to 8% at 2nd follow-up (P < 0.05). Additionally, Tian Jiu Therapy significantly reduced the level of asthma, the proportion of participants who don’t need to processed during asthma attack increased from 6% to 15% at 1st follow-up and 0% to 7% at 3rd follow-up (P < 0.05). Improvements also occurred with Tian Jiu Therapy group, it reduced the proportion of participants who were spontaneously sweating at 3rd follow up and diarrhea after intake of oily food at 4th follow-up (P < 0.05). Conclusion: When added to a regimen of foundational therapy for chronic asthma participants, Tian Jiu Therapy further reduced the need for medications to control asthma, improved the quality of participants’ life, and significantly reduced the level of asthma. What is more, this benefit seems to have an accumulative effect over time was in accordance with the TCM theory of 'winter disease is being cured in summer'.

Keywords: asthma, Tian Jiu Therapy, San Fu Days, triaditional Chinese medicine, clinical trial

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11349 Effects of Probiotics on Specific Immunity in Broiler Chicken in Syria

Authors: Moussa Majed, Omar Yaser

Abstract:

The main objective of this experiment was to study the impact of Probiotic compound on the specific immunity as the case study of infectious bursal disease. Total of 8000 one-day old Ross 108 broiler were randomly divided into two experimental groups; control group (4500 birds) and experimental group (3500 birds). Birds in two groups were reared under similar environmental conditions. Birds in control group received basal diets without probiotic whereas the birds in experimental one were fed basal diets supplemented with a commercial probiotic mixture) probiotic lacting k, which contains bacteria cells beyond to lactobacillus, Streptococcus and bifidobacterium genus that are isolated from gut microflora in healthy chickens(. The commercial probiotic were used according to the manufacturer instruction. 400 blood samples for each group were collected from wing vein every 5-7 days as interval period till 42 days old. Indirect Enzyme-Linked Immunosorbent Assay (ELISA) test was performed to detect the level of infectious bursal disease virus (IBDV) antibodies. The results clearly showed that the mean of immune titers was significantly (p= 0.03) higher in trail group than control one. The coefficient of variance percentages were 55% and 39% for control and trial groups respectively, this illustrates that homogeneity of immunity titers in the trail group was much better comparing with control group. The values of geometric means of titers in the control group and trial group were reported 3820 and 8133, respectively. The crude mortality rate in the experimental group was two times lower comparing with control group (14% and 28% respectively, p = 0.005

Keywords: probiotic, broiler chicken, infectious bursal disease, immunity, ELISA test

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11348 Effects and Mechanisms of an Online Short-Term Audio-Based Mindfulness Intervention on Wellbeing in Community Settings and How Stress and Negative Affect Influence the Therapy Effects: Parallel Process Latent Growth Curve Modeling of a Randomized Control

Authors: Man Ying Kang, Joshua Kin Man Nan

Abstract:

The prolonged pandemic has posed alarming public health challenges to various parts of the world, and face-to-face mental health treatment is largely discounted for the control of virus transmission, online psychological services and self-help mental health kits have become essential. Online self-help mindfulness-based interventions have proved their effects on fostering mental health for different populations over the globe. This paper was to test the effectiveness of an online short-term audio-based mindfulness (SAM) program in enhancing wellbeing, dispositional mindfulness, and reducing stress and negative affect in community settings in China, and to explore possible mechanisms of how dispositional mindfulness, stress, and negative affect influenced the intervention effects on wellbeing. Community-dwelling adults were recruited via online social networking sites (e.g., QQ, WeChat, and Weibo). Participants (n=100) were randomized into the mindfulness group (n=50) and a waitlist control group (n=50). In the mindfulness group, participants were advised to spend 10–20 minutes listening to the audio content, including mindful-form practices (e.g., eating, sitting, walking, or breathing). Then practice daily mindfulness exercises for 3 weeks (a total of 21 sessions), whereas those in the control group received the same intervention after data collection in the mindfulness group. Participants in the mindfulness group needed to fill in the World Health Organization Five Well-Being Index (WHO), Positive and Negative Affect Schedule (PANAS), Perceived Stress Scale (PSS), and Freiburg Mindfulness Inventory (FMI) four times: at baseline (T0) and at 1 (T1), 2 (T2), and 3 (T3) weeks while those in the waitlist control group only needed to fill in the same scales at pre- and post-interventions. Repeated-measure analysis of variance, paired sample t-test, and independent sample t-test was used to analyze the variable outcomes of the two groups. The parallel process latent growth curve modeling analysis was used to explore the longitudinal moderated mediation effects. The dependent variable was WHO slope from T0 to T3, the independent variable was Group (1=SAM, 2=Control), the mediator was FMI slope from T0 to T3, and the moderator was T0NA and T0PSS separately. The different levels of moderator effects on WHO slope was explored, including low T0NA or T0PSS (Mean-SD), medium T0NA or T0PSS (Mean), and high T0NA or T0PSS (Mean+SD). The results found that SAM significantly improved and predicted higher levels of WHO slope and FMI slope, as well as significantly reduced NA and PSS. FMI slope positively predict WHO slope. FMI slope partially mediated the relationship between SAM and WHO slope. Baseline NA and PSS as the moderators were found to be significant between SAM and WHO slope and between SAM and FMI slope, respectively. The conclusion was that SAM was effective in promoting levels of mental wellbeing, positive affect, and dispositional mindfulness as well as reducing negative affect and stress in community settings in China. SAM improved wellbeing faster through the faster enhancement of dispositional mindfulness. Participants with medium-to-high negative affect and stress buffered the therapy effects of SAM on wellbeing improvement speed.

Keywords: mindfulness, negative affect, stress, wellbeing, randomized control trial

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11347 Anti-lipidemic and Hematinic Potentials of Moringa Oleifera Leaves: A Clinical Trial on Type 2 Diabetic Subjects in a Rural Nigerian Community

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

Abstract:

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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11346 Relevance of the Tokyo Trial: A Comparative Perspective

Authors: Nalanda Roy

Abstract:

The project will offer a fresh and critical perspective into the Tokyo Trial judgment led by the Indian Jurist Dr. Radha Binod Pal. The project will focus on the Third World Approach to International Law (TWAIL) methodology to examine the relevance of international law from the post-colonial perspectives. The project will analyze Pal’s dissenting arguments from a new and comparative perspective, apply for work from other disciplines, and create an understanding of the significance of the historic judgment considering its contemporary relevance, and fill in the gaps that exist in the call for global justice.

Keywords: Tokyo trial, third world, judgment, international law

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11345 Victims Legal Representation before International Criminal Court: Freedom of Choice and Role of Victims Legal Representatives

Authors: Erinda Male

Abstract:

Participation of a lawyer in any criminal proceedings on behalf of an accused person or a victim is essential to a fair trial. Legal representation is particularly crucial in proceedings before international tribunals, especially in the International Criminal Court. The paper thus focuses on the importance of the legal representation of victims and defendants before the ICC, as well as on the role of the legal representative in the proceedings before the court and the principle of freedom of choice of legal representatives. Also, the paper presents a short overview of the significance of legal representatives for victims and the necessity to protect their primary role in the ICC system, and ensure that it is coherent and respectful of victims’ rights. Victim participation is an important part of the ICC Statute and it is designed to help ensure that those most affected by the crimes are able to engage with the Court. Proper and quality legal representation ensures meaningful participation of victims at stages of the proceedings before ICC. Finally, the paper acknowledges the role of legal representatives during the pre-trial, trial and post-trial phase, the different modalities in selecting the legal representatives as well as balancing victims’ participation with the right of the accused to a fair trial.

Keywords: fair trial, freedom of choice principle, international criminal court, legal representatives, victims

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11344 Novel Low-cost Bubble CPAP as an Alternative Non-invasive Oxygen Therapy for Newborn Infants with Respiratory Distress Syndrome in a Tertiary Level Neonatal Intensive Care Unit in the Philippines: A Single Blind Randomized Controlled Trial

Authors: Navid P Roodaki, Rochelle Abila, Daisy Evangeline Garcia

Abstract:

Background and Objective: Respiratory Distress Syndrome (RDS) among premature infants is a major causes of neonatal death. The use of Continuous Positive Airway Pressure (CPAP) has become a standard of care for preterm newborns with RDS hence cost-effective innovations are needed. This study compared a novel low-cost Bubble CPAP (bCPAP) device to ventilator driven CPAP in the treatment of RDS. Methods: This is a single-blind, randomized controlled trial done on May 2022 to October 2022 in a Level III Neonatal Intensive Care Unit in the Philippines. Preterm newborns (<36 weeks) with RDS were randomized to receive Vayu bCPAP device or Ventilator-derived CPAP. Arterial Blood Gases, Oxygen Saturation, administration of surfactant, and CPAP failure rates were measured. Results: Seventy preterm newborns were included. No differences were observed between the Ventilator driven CPAP and Vayu bCPAP on the PaO2 (97.51mmHg vs 97.37mmHg), So2 (97.08% vs 95.60%) levels, amount of surfactant administered between groups. There were no observed differences in CPAP failure rates between Vayu bPCAP (x̄ 3.23 days) and ventilator-driven CPAP (x̄ 2.98 days). However, a significant difference was noted on the CO2 level (40.32mmHg vs 50.70mmHg), which was higher among those hooked to Ventilator-driven CPAP (p 0.004). Conclusion: This study has shown that the novel low-cost bubble CPAP (Vayu bCPAP) can be used as an efficacious alternate non invasive oxygen therapy among preterm neonates with RDS, although the CO2 levels were higher among those hooked to ventilator driven CPAP, other outcome parameters measured showed that both devices are comparable. Recommendation: A multi-center or national study to account for geographic region, which may alter the outcomes of patients connected to different ventilatory support. Cost comparison between devices is also suggested. A mixed-method research assessing the experiences of health care professionals in assembling and utilizing the gadget is a second consideration.

Keywords: bubble CPAP, ventilator-derived CPAP; infant, premature, respiratory distress syndrome

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11343 Randomized Controlled Trial for the Management of Pain and Anxiety Using Virtual Reality During the Care of Older Hospitalized Patients

Authors: Corbel Camille, Le Cerf Flora, Capriz Françoise, Vaillant-Ciszewicz Anne-Julie, Breaud Jean, Guerin Olivier, Corveleyn Xavier

Abstract:

Background: The medical environment can generate stressful and anxiety-provoking situations for patients, particularly during painful care procedures for the older population. These stressful environments have deleterious effects on the quality of care and can even put the patient at risk and set the care team up for failure. The search for a solution is, therefore, imperative. The development of new technologies, such as virtual reality (VR), seems to be an answer to this problem. Objectives: The objective of this study is to compare the effects of virtual reality on pain and anxiety when caring for older hospitalized people with the effects of usual care. More precisely, different individual factors (age, cognitive level, individual preferences, etc.) and different virtual reality universes (personalized or non-personalized) are studied to understand the role of these factors in reducing pain and anxiety during care procedures. The aim of this study is to improve the quality of life of patients and caregivers in their work environment. Method: This mono-centered, randomized, controlled study was conducted from September 2023 to September 2024 on 120 participants recruited from the geriatric departments of the Cimiez Hospital, Nice, France. Participants are randomized into three groups: a control group, a personalized VR group and a non-personalized VR group. Each participant is followed during a painful care session. Data are collected before, during and after the care, using measures of pain (Algoplus and numerical scale) and anxiety (Hospital anxiety scale and numerical scale). Physiological assessments with an oximeter are also performed to collect both heart and respiratory rate measurements. The implementation of the care will be assessed among healthcare providers to evaluate its effects on the difficulty and fatigue associated with the care. Additionally, a questionnaire (System Usability Scale) will be administered at the conclusion of the study to determine the willingness of healthcare providers to integrate VR into their daily care practices. Result: The preliminary results indicate significant effects on anxiety (p=.001) and pain (p=<.001) following the VR intervention during care, as compared to the control group. Conclusion: The preliminary results suggest that VRI appears to be a suitable and effective method for reducing anxiety and pain among older hospitalized individuals compared with standard care. Finally, the experiences of healthcare professionals involved will also be considered to assess the impact of these interventions on working conditions and patient support.

Keywords: anxiety, care, pain, older adults, virtual reality

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11342 Effect of Vitamin D3 on Polycystic Ovary Syndrome Prognosis, Anthropometric and Body Composition Parameters of Overweight Women: A Randomized, Placebo-Controlled Clinical Trial

Authors: Nahla Al-Bayyari, Rae’d Hailat

Abstract:

Vitamin D deficiency and overweight are common in women suffering from polycystic ovary syndrome (PCOS). Weight gain in PCOS is an important factor for the development of menstrual dysfunction and signs of hyperandrogenism and alopecia. Features of PCOS such as oligomenorrhea can be predicted by anthropometric measurements as body mass index (BMI). Therefore, the aim of this trial was to study the effect of 50,000 IU/week of vitamin D₃ supplementation on the body composition and on the anthropometric measurements of overweight women with PCOS and to examine the impact of this effect on ovaries ultrasonography and menstrual cycle regularity. The study design was a prospective randomized, double-blinded placebo-controlled clinical trial conducted on 60 overweight Jordanian women aged (18-49) years with PCOS and vitamin D deficiency. The study participants were divided into two groups; vitamin D group (n = 30) who were assigned to receive 50,000 IU/week of vitamin D₃ and placebo group (n = 30) who were assigned to receive placebo tablets orally for 90 days. The anthropometric measurements and body composition were measured at baseline and after treatment for the PCOS and vitamin D deficient women. Also, assessment of the participants’ picture of ovaries by ultrasound and menstrual cycle regulatory were performed before and after treatment. Results showed that there were no significant (p > 0.05) differences between the placebo and vitamin D group basal 25(OH)D levels, body composition and anthropometric parameters. After treatment, vitamin D group serum levels of 25(OH)D increased (12.5 ± 0.61 to 50.2 ± 2.04 ng/mL, (p < 0.001), and decreased (50.2 ± 2.04 to 48.2 ± 2.03 ng/mL, p < 0.001) after 14 days of vitamin D₃ treatment cessation. There were no significant changes in the placebo group. In the vitamin D group, there were significant (p < 0.001) decreases in body weight, BMI, waist, and hip circumferences and fat mass. In addition, there were significant increases (p < 0.05) in fat free mass and total body water. These improvements in both anthropometric and body composition as well as in 25(OH)D concentrations, resulted in significant improvements in the picture of PCOS women ovaries ultrasonography and in menstrual cycle regularity, where nearly most of them (93%) had regular cycles after vitamin D₃ supplementation. In the placebo group, there were only significant decreases (p < 0.05) in waist and hip circumferences. It can be concluded that vitamin D supplementation improving serum 25(OH)D levels and PCOS prognosis by reducing body weight of overweight PCOS women and regulating their menstrual cycle.

Keywords: anthropometric, overweight, polycystic ovary syndrome, vitamin D₃

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11341 Long-Term Effects of Psychosocial Interventions for Adolescents on Depression and Anxiety: A Systematic Review and Meta-Analysis

Authors: Denis Duagi, Ben Carter, Maria Farrelly, Stephen Lisk, June S. L. Brown

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Background: Adolescence represents a distinctive phase of development, and variables linked to this developmental period could affect the efficiency of prevention and treatment for depression and anxiety, as well as the long-term prognosis. The objectives of this study were to investigate the long-term effectiveness of psychosocial interventions for adolescents on depression and anxiety symptoms and to assess the influence of different intervention parameters on the long-term effects. Methods: Searches were carried out on the 11ᵗʰ of August 2022 using five databases (Cochrane Library, Embase, Medline, PsychInfo, Web of Science), as well as trial registers. Randomized controlled trials of psychosocial interventions targeting specifically adolescents were included if they assessed outcomes at 1-year post-intervention or more. The Cochrane risk of bias-2 quality assessment tool was used. The primary outcome was depression, and studies were pooled using a standardised mean difference, with an associated 95% confidence interval, p-value, and I². The study protocol was pre-registered (CRD42022348668). Findings: A total of 57 reports (n= 46,678 participants) were included in the review. Psychosocial interventions led to small reductions in depressive symptoms, with a standardised mean difference (SMD) at 1-year of -0.08 (95%CI -0.20, -0.03, p=0.002, I²=72%), 18-months SMD=-0.12, 95% CI -0.22, -0.01, p=0.03, I²=63%) and 2-years SMD=-0.12 (95% CI -0.20, -0.03, p=0.01, I²=68%). Sub-group analyses indicated that targeted interventions produced stronger effects, particularly when delivered by trained mental health professionals (K=18, SMD=-0.24, 95% CI -0.38, -0.10, p=0.001, I²=60%). No effects were detected for anxiety at any assessment. Conclusion: Psychosocial interventions specifically targeting adolescents were shown to have small but positive effects on depression symptoms but not anxiety symptoms, which were sustained for up to 2 years. These findings highlight the potential population-level preventive effects if such psychosocial interventions become widely implemented in accessible settings such as schools.

Keywords: psychosocial, adolescent, interventions, depression, anxiety, meta-analysis, randomized controlled trial

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11340 Competing Risk Analyses in Survival Trials During COVID-19 Pandemic

Authors: Ping Xu, Gregory T. Golm, Guanghan (Frank) Liu

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In the presence of competing events, traditional survival analysis may not be appropriate and can result in biased estimates, as it assumes independence between competing events and the event of interest. Instead, competing risk analysis should be considered to correctly estimate the survival probability of the event of interest and the hazard ratio between treatment groups. The COVID-19 pandemic has provided a potential source of competing risks in clinical trials, as participants in trials may experienceCOVID-related competing events before the occurrence of the event of interest, for instance, death due to COVID-19, which can affect the incidence rate of the event of interest. We have performed simulation studies to compare multiple competing risk analysis models, including the cumulative incidence function, the sub-distribution hazard function, and the cause-specific hazard function, to the traditional survival analysis model under various scenarios. We also provide a general recommendation on conducting competing risk analysis in randomized clinical trials during the era of the COVID-19 pandemic based on the extensive simulation results.

Keywords: competing risk, survival analysis, simulations, randomized clinical trial, COVID-19 pandemic

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11339 Determination of Some Agricultural Characters of Developed Pea (Pisum sativum L.) Lines

Authors: Ercan Ceyhan, Mehmet Ali Avci

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This research was made during the 2015 growing periods in the trial filed of ‘Research Station for Department of Field Crops, Agricultural Faculty, Selcuk University’ according to ‘Randomized Blocks Design’ with 3 replications. Research material was the following pea lines; PS16, PS18, PS21, PS23, PS24, PS25, PS36, PS47, PS49, PS51, PS54, PS58, PS67, PS69, PS71, PS73, PS83, PS84, PS87 and PSKY and three cultivars and other 2 commercial varieties named as Bolero, Rondo and Ultrello. Some agronomical characteristics such as plant height (cm) number of pod per plant number of seed per pod number of seed per plant 100 seed weight (g) and seed yield (kg ha-1) were determined. Results of the research implicated that the new developed lines were superior compared with the control (commercial) varieties by means of most of the characteristics. Nevertheless, similar researches should be continued in different locations and years.

Keywords: agricultural characters, pea, Pisum sativum, seed yield

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11338 The Effect of Ice in Pain Control before Digital Nerve Block

Authors: Fatemeh Rasooli, Behzad Simiari, Pooya Payandemehr, Amir Nejati, Maryam Bahreini, Atefeh Abdollahi

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Introduction: Pain is a complex physiological reaction to tissue injury. In the course of painful procedures such as nerve block, ice has been shown to be a feasible and inexpensive material to control pain. It delays nerve conduction, actives other senses and reduces inflammatory and painful responses. This study assessed the effect of ice in reducing pain caused by needling and infiltration during digital block. Patient satisfaction recorded as a secondary outcome. Methods: This study was designed as a non-blinded randomized clinical trial approved by Tehran University of Medical Sciences Ethical Committee. Informed consent was taken from all the participants who were then randomly divided into two groups. Digital block performed by standard approach in selected patients. Tubes of ice were prepared in gloves and were fragmented at a time of application for circling around the finger. Tubes were applied for 6 minutes before digital nerve block in the site of needling in the case group. Patients in the control group underwent digital nerve block with the conventional method without ice administration. Numeric Rating Scale (NRS) used for grading pain. 0 used for no pain and 10 for the worst pain that patient had experienced until now. Scores were analyzed by Wilcoxon Rank Sum test and compared in case and control groups. Results: 100 patients aged 16-50 years were enrolled. Mean NRS scores with and without ice were 1.5 mm (S.D ± 1.44) and 6.8 mm (S.D ± 1.40) for needling pain and for infiltration pain were 2.7mm ( S.D ±1.65) and 8.5mm ( S.D ± 1.47), respectively (p<0.001). Besides, patients’ satisfactions were significantly higher in the ice group (p<0.001). Conclusion: Application of ice for 6 minutes significantly reduced pain of needling and infiltration in digital nerve block; thus, it seems to be a feasible and inexpensive material which acts effectively to decrease pain and stress before the procedure.

Keywords: digital block, ice, needle, pain

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11337 The Right to a Fair Trial in French and Spanish Constitutional Law

Authors: Chloe Fauchon

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In Europe, the right to a fair trial is enshrined in the European Convention on Human Rights, signed in 1950, in its famous Article 6, and, in the field of the European Union, in Article 47 of the Charter of Fundamental Rights, binding since 2009. The right to a fair trial is, therefore, a fundamental right protected by all the relevant treaties. The right to a fair trial is an "umbrella right" which encompasses various sub-rights and principles. Although this right applies in all the proceedings, it gets a special relevance in criminal matters and, particularly, regarding the defendant. In criminal proceedings, the parties are not equal: the accusation is represented by a State-organ, with specific prerogatives, and the defense does not benefit from these specific powers and is often inexperienced in criminal law. Equality of arms, and consequently the right to a fair trial, needs some specific mechanisms to be effective in criminal proceedings. For instance, the defendant benefits from some procedural rights, such as the right to a lawyer, the right to be informed of the charges against them, the right to confront witnesses, and so on. These rights aim to give the defendant the tools to dispute the accusation. The role of the defense is, therefore, very important in criminal matters to avoid unjustified convictions. This specificity of criminal matters justifies that the focus will be put on them during this study. Then this paper will also focus on French and Spanish legal orders. Indeed, if the European Court and Convention on Human Rights are the most famous instruments to protect the right to a fair trial, this right is also guaranteed at a constitutional level in European national legal orders in Europe. However, this enshrinement differs from one country to the other: for instance, in Spain, the right to a fair trial is protected explicitly by the 1978 constitutional text, whereas, in France, it is more of a case-law construction. Nevertheless, this difference between both legal orders does not imply huge variations in the substantive aspect of the right to a fair trial. This can be specifically explained by the submission of both States to the European Convention on Human Rights. This work aims to show that, although the French and Spanish legal orders differ in the way they protect the right to a fair trial, this right eventually has the same substantive meaning in both legal orders.

Keywords: right to a fair trial, constitutional law, French law, Spanish law, European Court of Human Rights

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11336 Growth Comparison and Intestinal Health in Broilers Fed Scent Leaf Meal (Ocimum gratissimum) and Synthetic Antibiotic

Authors: Adedoyin Akintunde Adedayo, Onilude Abiodun Anthony

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The continuous usage of synthetic antibiotics in livestock production has led to the resistance of microbial pathogens. This has prompted research to find alternative sources. This study aims to compare the growth and intestinal health of broilers fed scent leaf meal (SLM) as an alternative to synthetic antibiotics. The study used a completely randomized design (CRD) with 300 one-week-old Arbor Acres broiler chicks. The chicks were divided into six treatments with five replicates of ten birds each. The feeding trial lasted 49 days, including a one-week acclimatization period. Commercial broiler diets were used. The diets included a negative control (no leaf meal or antibiotics), a positive control (0.10% oxy-tetracycline), and four diets with different levels of SLM (0.5%, 1.0%, 1.5%, and 2.0%). The supplementation of both oxy-tetracycline and SLM improved feed intake during the finisher phase. Birds fed SLM at a 1% inclusion level showed significantly (P<0.05) improved average body weight gain (ABWG), lowered feed-to-gain ratio, and cost per kilogram of weight gain compared to other diets. The mortality (2.0%) rate was significantly higher in the negative control group. White blood cell levels varied significantly (P<0.05) in birds fed SLM-supplemented diets, and the use of 2% SLM led to an increase in liver weight. However, welfare indices were not compromised.

Keywords: Arbor Acres, phyto-biotic, synthetic antibiotic, white blood cell, liver weight

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11335 Treatment of Mycotic Dermatitis in Domestic Animals with Poly Herbal Drug

Authors: U. Umadevi, T. Umakanthan

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Globally, mycotic dermatitis is very common but there is no single proven specific allopathic treatment regimen. In this study, domestic animals with skin diseases of different age and breed from geographically varied regions of Tamil Nadu state, India were employed. Most of them have had previous treatment with native and allopathic medicines without success. Clinically, the skin lesions were found to be mild to severe. The trial animals were treated with poly herbal formulation (ointment) prepared using the indigenous medicinal plants – viz Andrographis paniculata, Lawsonia inermis and Madhuca longifolia. Allopathic antifungal drugs and ointments, povidone iodine and curabless (Terbinafine HCl, Ofloxacin, Ornidazole, Clobetasol propionate) were used in control. Comparatively, trial animals were found to have lesser course of treatment time and higher recovery rate than control. In Ethnoveterinary, this combination was tried for the first time. This herbal formulation is economical and an alternative for skin diseases.

Keywords: allopathic drugs, dermatitis, domestic animals, poly herbal formulation

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11334 The Effect of Aromatherapy with Citrus aurantium Blossom Essential Oil on Premenstrual Syndrome in University Students: A Clinical Trial Study

Authors: Neda Jamalimoghadam, Naval Heydari, Maliheh Abootalebi, Maryam Kasraeian, M. Emamghoreishi , Akbarzadeh Marzieh

Abstract:

Background: The aim was to investigate the effect of aromatherapy using Citrus aurantium blossom essential oil on premenstrual syndrome in university students. Methods: In this double-blind clinical trial was controlled on 62 students from March 2016 to February 2017. The intervention with 0.5% of C. Aurantium blossom essential oil and control was inhalation of odorless sweet almond oil in the luteal phase of the menstrual cycle. The screening questionnaire (PSST) for PMSwas filled out before and also one and two months after the intervention. Results: Mean score of overall symptoms of PMS between the Bitter orange and control groups In the first (p < 0.003) and second months (p < 0.001) of the intervention was significant. Besides, decreased the mean score of psychological symptoms in the intervention group (p < 0.001), but on physical symptoms and social function were not significant (p > 0.05). Conclusion: The aromatherapy with Citrus aurantium blossom improved the symptoms of premenstrual syndrome.

Keywords: aromatherapy, Citrus Aurantium, premenstrual syndrome, oil, students

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11333 Nurture Early for Optimal Nutrition: A Community-Based Randomized Controlled Trial to Improve Infant Feeding and Care Practices Using Participatory Learning and Actions Approach

Authors: Priyanka Patil, Logan Manikam

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Background: The first 1000 days of life are a critical window and can result in adverse health consequences due to inadequate nutrition. South-Asian (SA) communities face significant health disparities, particularly in maternal and child health. Community-based interventions, often employing Participatory-Learning and Action (PLA) approaches, have effectively addressed health inequalities in lower-income nations. The aim of this study was to assess the feasibility of implementing a PLA intervention to improve infant feeding and care practices in SA communities living in London. Methods: Comprehensive analyses were conducted to assess the feasibility/fidelity of this pilot randomized controlled trial. Summary statistics were computed to compare key metrics, including participant consent rates, attendance, retention, intervention support, and perceived effectiveness, against predefined progression rules guiding toward a definitive trial. Secondary outcomes were analyzed, drawing insights from multiple sources, such as The Children’s-Eating-Behaviour Questionnaire (CEBQ), Parental-Feeding-Style Questionnaires (PFSQ), Food-diary, and the Equality-Impact-Assessment (EIA) tool. A video analysis of children's mealtime behavior trends was conducted. Feedback interviews were collected from study participants. Results: Process-outcome measures met predefined progression rules for a definitive trial, which deemed the intervention as feasible and acceptable. The secondary outcomes analysis revealed no significant changes in children's BMI z-scores. This could be attributed to the abbreviated follow-up period of 6 months, reduced from 12 months, due to COVID-19-related delays. CEBQ analysis showed increased food responsiveness, along with decreased emotional over/undereating. A similar trend was observed in PFSQ. The EIA tool found no potential discrimination areas, and video analysis revealed a decrease in force-feeding practices. Participant feedback revealed improved awareness and knowledge sharing. Conclusion: This study demonstrates that a co-adapted PLA intervention is feasible and well-received in optimizing infant-care practices among South-Asian community members in a high-income country. These findings highlight the potential of community-based interventions to enhance health outcomes, promoting health equity.

Keywords: child health, childhood obesity, community-based, infant nutrition

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11332 The Effect of Pregabalin on Postoperative Pain after Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Clinical Trials

Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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11331 Psychiatric/Psychological Issues in the Criminal Courts In Australia

Authors: Judge Paul Smith

Abstract:

Abstract—This paper addresses the use and admissibility of psychiatric/psychological evidence in Australia Courts. There have been different approaches in the Courts to the acceptance of such expert evidence. It details how such expert evidence is admissible at trial and sentence. The methodology used is an examination of the decided cases and relevant legislative provisions which relate to the admission of such evidence. The major findings are that the evidence can be admissible if it is relevant to issues in a trial or sentence. It concludes that psychiatric/psychological evidence can be very useful and indeed may be essential at sentence or trial.

Keywords: criminal, law, psychological, evidence

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11330 The Effectiveness of Multi-Media Experiential Training Programme on Advance Care Planning in Enhancing Acute Care Nurses’ Knowledge and Confidence in Advance Care Planning Discussion: An Interim Report

Authors: Carmen W. H. Chan, Helen Y. L. Chan, Kai Chow Choi, Ka Ming Chow, Cecilia W. M. Kwan, Nancy H. Y. Ng, Jackie Robinson

Abstract:

Introduction: In Hong Kong, a significant number of deaths occur in acute care wards, which requires nurses in these settings to provide end-of-life care and lead ACP implementation. However, nurses in these settings, in fact, have very low-level involvement in ACP discussions because of limited training in ACP conversations. Objective: This study aims to assess the impact of a multi-media experiential ACP (MEACP) training program, which is guided by the experiential learning model and theory of planned behaviour, on nurses' knowledge and confidence in assisting patients with ACP. Methodology: The study utilizes a cluster randomized controlled trial with a 12-week follow-up. Eligible nurses working in acute care hospital wards are randomly assigned at the ward level, in a 1:1 ratio, to either the control group (no ACP education) or the intervention group (4-week MEACP training program). The training programme includes training through a webpage and mobile application, as well as a face-to-face training workshop with enhanced lectures and role play, which is based on the Theory of Planned Behavior and Kolb's Experiential Learning Model. Questionnaires were distributed to assess nurses' knowledge (a 10-item true/false questionnaire) and level of confidence (five-point Likert scale) in ACP at baseline (T0), four weeks after the baseline assessment (T1), and 12 weeks after T1 (T2). In this interim report, data analysis was mainly descriptive in nature. Result: The interim report focuses on the preliminary results of 165 nurses at T0 (Control: 74, Intervention: 91) over a 5-month period, 69 nurses from the control group who completed the 4-week follow-up and 65 nurses from the intervention group who completed the 4-week MEACP training program at T1. The preliminary attrition rate is 6.8% and 28.6% for the control and intervention groups, respectively, as some nurses did not complete the whole set of online modules. At baseline, the two groups were generally homogeneous in terms of their years of nursing practice, weekly working hours, working title, and level of education, as well as ACP knowledge and confidence levels. The proportion of nurses who answered all ten knowledge questions correctly increased from 13.8% (T0) to 66.2% (T1) for the intervention group and from 13% (T0) to 20.3% (T1) for the control group. The nurses in the intervention group answered an average of 7.57 and 9.43 questions correctly at T0 and T1, respectively. They showed a greater improvement in the knowledge assessment at T1 with respect to T0 when compared with their counterparts in the control group (mean difference of change score, Δ=1.22). They also exhibited a greater gain in level of confidence at T1 compared to their colleagues in the control group (Δ=0.91). T2 data is yet available. Conclusion: The prevalence of nurses engaging in ACP and their level of knowledge about ACP in Hong Kong is low. The MEACP training program can enrich nurses by providing them with more knowledge about ACP and increasing their confidence in conducting ACP.

Keywords: advance directive, advance care planning, confidence, knowledge, multi-media experiential, randomised control trial

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11329 Self-Inflating Soft Tissue Expander Outcome for Alveolar Ridge Augmentation a Randomized Controlled Clinical and Histological Study

Authors: Alaa T. Ali, Nevine H. Kheir El Din, Ehab S. Abdelhamid, Ahmed E. Amr

Abstract:

Objective: Severe alveolar bone resorption is usually associated with a deficient amount of soft tissues. soft tissue expansion is introduced to provide an adequate amount of soft tissue over the grafted area. This study aimed to assess the efficacy of sub-periosteal self-inflating osmotic tissue expanders used as preparatory surgery before horizontal alveolar ridge augmentation using autogenous onlay block bone graft. Methods: A prospective randomized controlled clinical trial was performed. Sixteen partially edentulous patients demanding horizontal bone augmentation in the anterior maxilla were randomly assigned to horizontal ridge augmentation with autogenous bone block grafts harvested from the mandibular symphysis. For the test group, soft tissue expanders were placed sub-periosteally before horizontal ridge augmentation. Impressions were taken before and after STE, and the cast models were optically scanned and superimposed to be used for volumetric analysis. Horizontal ridge augmentation was carried out after STE completion. For the control group, a periosteal releasing incision was performed during bone augmentation procedures. Implants were placed in both groups at re-entry surgery after six months period. A core biopsy was taken. Histomorphometric assessment for newly formed bone surface area, mature collagen area fraction, the osteoblasts count, and blood vessel count were performed. The change in alveolar ridge width was evaluated through bone caliper and CBCT. Results: Soft tissue expander successfully provides a Surplus amount of soft tissues in 5 out of 8 patients in the test group. Complications during the expansion period were perforation through oral mucosa occurred in two patients. Infection occurred in one patient. The mean soft tissue volume gain was 393.9 ± 322mm. After 6 months. The mean horizontal bone gains for the test and control groups were 3.14 mm and 3.69 mm, respectively. Conclusion: STE with a sub-periosteal approach is an applicable method to achieve an additional soft tissue and to reduce bone block graft exposure and wound dehiscence.

Keywords: soft tissue expander, ridge augmentation, block graft, symphysis bone block

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11328 The Impact of Continuous Exercise on Depression Levels Among Young Female Athletes in Hamadan Province, Iran

Authors: Mahboubeh Varmaziar

Abstract:

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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11327 Performance, Yolk and Serum Cholesterol of Shaver-Brown Layers Fed Moringa Leaf Meal and Sun Dried Garlic Powder

Authors: Anselm Onyimonyi, A. Abaponitus

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One hundred and ninety two Shaver-Brown layers aged 40 weeks were used in a 10 weeks feeding trial to investigate the effect of supplementary moringa leaf meal and sun-dried garlic powder (MOGA) on the performance, egg yolk and serum cholesterol profiles of the birds. The birds were randomly assigned to four treatments in a 2 x 2 factorial in a Completely Randomized Design with 48 birds per treatment. Each treatment had 24 replicates with 2 birds, each separately housed in a cell in a battery cage. Birds on treatment 1 received a standard layers mash (16.5% CP and 3000 kcalME/kg) without any MOGA. Treatment 2 birds received the control diet with 5 g moringa leaf meal/kg of feed, treatment 3 received the control diet with 5 g sun-dried garlic powder/kg of feed, treatment 4 had a combination of 5 g each of moringa leaf meal and sun dried garlic powder/kg of feed. Data were kept on daily egg production, egg weight and feed intake. 10 eggs were collected per treatment at the end of the study for yolk cholesterol determination. Blood samples from four birds per treatment were collected and used for the serum cholesterol and triglycerides determination. Results showed that bird on treatment 3 (5% moringa leaf meal/kg of feed) had significantly higher (P < 0.05) Hen Day Egg Production record of 83.3% as against 78.75%, 65.05% and 66.67% recorded for the control, T2 and T4 birds, respectively. Egg weight of 56.39 g recorded for the same birds on treatment 3 was significantly (P< 0.05) lower than the values of 62.61 g, 60.99 g and 59.33 g recorded for birds on T4, T1 and T2, respectively. Yolk and serum cholesterol profiles of the moringa leaf meal fed birds were significantly (P<0.05) lowered when compared to those of the other treatments. Comparatively, the birds on the MOGA diets had significantly reduced yolk and serum cholesterol than the control. It is concluded that supplementation of moringa leaf meal and sun dried garlic powder at the levels used in this study will result in the production of nutritionally healthier eggs with less yolk and serum cholesterol.

Keywords: performance, cholesterol, moringa, garlic

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11326 A Randomized Active Controlled Clinical Trial to Assess Clinical Efficacy and Safety of Tapentadol Nasal Spray in Moderate to Severe Post-Surgical Pain

Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

Abstract:

Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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11325 On the convergence of the Mixed Integer Randomized Pattern Search Algorithm

Authors: Ebert Brea

Abstract:

We propose a novel direct search algorithm for identifying at least a local minimum of mixed integer nonlinear unconstrained optimization problems. The Mixed Integer Randomized Pattern Search Algorithm (MIRPSA), so-called by the author, is based on a randomized pattern search, which is modified by the MIRPSA for finding at least a local minimum of our problem. The MIRPSA has two main operations over the randomized pattern search: moving operation and shrinking operation. Each operation is carried out by the algorithm when a set of conditions is held. The convergence properties of the MIRPSA is analyzed using a Markov chain approach, which is represented by an infinite countable set of state space λ, where each state d(q) is defined by a measure of the qth randomized pattern search Hq, for all q in N. According to the algorithm, when a moving operation is carried out on the qth randomized pattern search Hq, the MIRPSA holds its state. Meanwhile, if the MIRPSA carries out a shrinking operation over the qth randomized pattern search Hq, the algorithm will visit the next state, this is, a shrinking operation at the qth state causes a changing of the qth state into (q+1)th state. It is worthwhile pointing out that the MIRPSA never goes back to any visited states because the MIRPSA only visits any qth by shrinking operations. In this article, we describe the MIRPSA for mixed integer nonlinear unconstrained optimization problems for doing a deep study of its convergence properties using Markov chain viewpoint. We herein include a low dimension case for showing more details of the MIRPSA, when the algorithm is used for identifying the minimum of a mixed integer quadratic function. Besides, numerical examples are also shown in order to measure the performance of the MIRPSA.

Keywords: direct search, mixed integer optimization, random search, convergence, Markov chain

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11324 Effects of Neem (Azadirachta indica A. Juss) Kernel Inclusion in Broiler Diet on Growth Performance, Organ Weight and Gut Morphometry

Authors: Olatundun Bukola Ezekiel, Adejumo Olusoji

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A feeding trial was conducted with 100 two-weeks old broiler chicken to evaluate the influence of inclusion in broiler diets at 0, 2.5, 5, 7.5 and 10% neem kernel (used to replace equal quantity of maize) on their performance, organ weight and gut morphometry. The birds were randomly allotted to five dietary treatments, each treatment having four replicates consisting of five broilers in a completely randomized design. The diets were formulated to be iso-nitrogenous (23% CP). Weekly feed intake and changes in body weight were calculated and feed efficiency determined. At the end of the 28-day feeding trial, four broilers per treatment were selected and sacrificed for carcass evaluation. Results were subjected to statistical analysis using the analysis of variance procedures of Statistical Analysis Software The treatment means were presented with group standard errors of means and where significant, were compared using the Duncan multiple range test of the same software. The results showed that broilers fed 2.5% neem kernel inclusion diets had growth performance statistically comparable to those fed the control diet. Birds on 5, 7.5 and 10% neem kernel diets showed significant (P<0.05) increase in relative weight of liver. The absolute weight of spleen also increased significantly (P<0.05) in birds on 10 % neem kernel diet. More than 5 % neem kernel diets gave significant (P<0.05) increase in the relative weight of the kidney. The length of the small intestine significantly increased in birds fed 7.5 and 10% neem kernel diets. Significant differences (P<0.05) did not occur in the length of the large intestine, right and left caeca. It is recommended that neem kernel can be included up to 2.5% in broiler chicken diet without any deleterious effects on the performance and physiological status of the birds.

Keywords: broiler chicken, growth performance, gut morphometry, neem kernel, organ weight

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11323 Effect of Magnetic Field in Treatment of Lower Back Myofascial Pain Syndrome: A Randomized Controlled Trial

Authors: Ahmed M. F. El Shiwi

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Background: Low back pain affects about 60% to 90% of the working-age population in modern industrial society. Myofascial pain syndrome is a condition characterized by muscles shortening with increased tone and associated with trigger points that aggravated with the activity of daily living. Purpose: To examine the effects of magnetic field therapy in patients with lower back myofascial pain syndrome. Methods: Thirty patients were assigned randomly into two groups. Subjects in the experimental group (n=15) with main age of 36.73 (2.52) received traditional physical therapy program (Infrared radiation, ultrasonic, stretching and strengthening exercises for back muscles) as well as magnetic field, and control group (n=15) with main age of 37.27 (2.52) received traditional physical therapy only. The following parameters including pain severity, functional disability and lumbar range of motion (flexion, extension, right side bending, and left side bending) were measured before and after four weeks of treatment. Results: The results showed significant improvement in all parameters in the experimental group compared with those in the control group. Interpretation/Conclusion: By the present date, it is possible to conclude that a magnetic field is effective as a method of treatment for lower back myofascial pain syndrome patients with the parameters used in the present study.

Keywords: magnetic field, lower back pain, myofascial pain syndrome, biological systems engineering

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11322 The Effect of Spent Mushroom Substrate on Blood Metabolites in Kurdish Male Lambs

Authors: Alireza Vakili, Shahab Ehtesham, Mohsen Danesh Mesgaran

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The objective of this study was use different levels of spent mushroom substrate as a suitable substitute for wheat straw in the ration of male lambs. In this study 20 male lambs with the age of 90 days and initial average weight of 33± 1.7 kg were used. The animals were divided separately into single boxes with four treatments (control treatment, spent mushroom substrate 15%, spent mushroom substrate 25% and spent mushroom substrate 35%) and five replications. The experiment period was 114 days being 14 days adaptation and 90 days for breeding. On the days 36 and 94, blood samples were taken from the jugular vein. In order to carry out the trial, 20 male lambs received the four experimental diets in completely randomized design. The statistical analyses were carried out by using the GLM procedure of SAS 9.1. Means among treatments were compared by Tukey test. The results of the study showed that there was no significant differences between the serum biochemical and hematological contents of the lambs in the four treatments (p>0.05). It was concluded that spent mushroom substrate consumption has no harmful effect on the blood parameters of Kurdish male lambs.

Keywords: alternative food, nutrition, sheep performance, spent mushroom substrate

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11321 Effects of Cuminum cyminum L. Essential Oil Supplementation on Components of Metabolic Syndrome: A Clinical Trial

Authors: Ashti Morovati, Hushyar Azari, Bahram Pourghassem Gargari

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Objectives and goals: The prevalence of metabolic syndrome (MetS), as a major health burden for societies, is increasing. This clinical trial was conducted to evaluate the effects of CuEO supplementation on anthropometric indices, systolic and diastolic blood pressure, blood glucose level, insulin resistance and serum lipid level in patients suffering from MetS. Methods: This was a randomized, triple‐blind, placebo‐controlled clinical trial in which 56 patients with MetS aged 18–60 years who fulfilled the eligibility criteria were randomly allocated to an intervention or a control group. Inclusion criteria for the study were comprised of diagnosis of MetS according to the new International Federation of Diabetes. The exclusion criteria were defined as: taking herbal supplements, use of drugs having evident interaction with cumin such as anti‐depressant drugs, vitamin D, omega 3, selenium, zinc, smoking, pregnancy, or breastfeeding, suffering from cancer, having any history of gastrointestinal and hepatic, cardiovascular, thyroid and kidney disorders, and menopause. 75 mg CuEO or placebo soft gels were administered three times daily to the participants for eight weeks. The soft gel consumption was checked by asking the participants to bring the medication containers in the follow‐up visits at the 4th and the 8th weeks of the study. Data pertaining to blood pressure, height, weight, waist circumference, hip circumference and BMI, as well as food consumption were collected at the beginning and end of the study. Fasting blood samples ( glucose, triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol) were obtained and biochemical measurements were assessed at the beginning and end of the study. Results: At eight weeks, a total of 44 patients completed this study. Except for diastolic blood pressure (DBP), the other assessed variables were not significantly different between the two groups. In intra group analysis, placebo and CuEO groups both had insignificant decrements in DBP (mean difference [MD] with 95% CI: −3.31 [−7.11, 0.47] and −1.77 [−5.95, 2.40] mmHg, respectively). However, DBP was significantly lower in CuEO compared with the placebo group at the end of study (81.41 ± 5.88 vs. 84.09 ± 5.54 mmHg, MD with 95% CI: −3.98 [−7.60, −0.35] mmHg, p < .05). Conclusions: The results of this study indicated that CuEO does not have any effect on MetS components, except for DBP in patients with MetS.

Keywords: blood pressure, fasting blood glucose, lipid profile, waist circumference

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