Search results for: randomized trial
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 1613

Search results for: randomized trial

1373 Relation of Cad/Cam Zirconia Dental Implant Abutments with Periodontal Health and Final Aesthetic Aspects; A Systematic Review

Authors: Amin Davoudi

Abstract:

Aim: New approaches have been introduced to improve soft tissue indices of the dental implants. This systematic review aimed to investigate the effect of computer-aided design and computer-assisted manufacture (CAD/CAM) zirconia (Zr) implant abutments on periodontal aspects. Materials and Methods: Five electronic databases were searched thoroughly based on prior defined MeSH and non-MeSH keywords. Clinical studies were collected via hand searches in English language journals up to September 2020. Interproximal papilla stability, papilla recession, pink and white esthetic score (PES, WES), bone and gingival margin levels, color, and contour of soft tissue were reviewed. Results: The initial literature search yielded 412 articles. After the evaluation of abstracts and full texts, six studies were eligible to be screened. The study design of the included studies was a prospective cohort (n=3) and randomized clinical trial (n=3). The outcome was found to be significantly better for Zr than titanium abutments, however, the studies did not show significant differences between stock and CAD/CAM abutments. Conclusion: Papilla fill, WES, PES, and the distance from the contact point to dental crest bone of adjacent tooth and inter-tooth–implant distance were not significantly different between Zr CAD/CAM and Zr stock abutments. However, soft tissue stability and recession index were better in Zr CAD/CAM abutments.

Keywords: zirconia, CADCAM, periodental, implant

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1372 Criteria to Access Justice in Remote Criminal Trial Implementation

Authors: Inga Žukovaitė

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This work aims to present postdoc research on remote criminal proceedings in court in order to streamline the proceedings and, at the same time, ensure the effective participation of the parties in criminal proceedings and the court's obligation to administer substantive and procedural justice. This study tests the hypothesis that remote criminal proceedings do not in themselves violate the fundamental principles of criminal procedure; however, their implementation must ensure the right of the parties to effective legal remedies and a fair trial and, only then, must address the issues of procedural economy, speed and flexibility/functionality of the application of technologies. In order to ensure that changes in the regulation of criminal proceedings are in line with fair trial standards, this research will provide answers to the questions of what conditions -first of all, legal and only then organisational- are required for remote criminal proceedings to ensure respect for the parties and enable their effective participation in public proceedings, to create conditions for quality legal defence and its accessibility, to give a correct impression to the party that they are heard and that the court is impartial and fair. It also seeks to present the results of empirical research in the courts of Lithuania that was made by using the interview method. The research will serve as a basis for developing a theoretical model for remote criminal proceedings in the EU to ensure a balance between the intention to have innovative, cost-effective, and flexible criminal proceedings and the positive obligation of the State to ensure the rights of participants in proceedings to just and fair criminal proceedings. Moreover, developments in criminal proceedings also keep changing the image of the court itself; therefore, in the paper will create preconditions for future research on the impact of remote criminal proceedings on the trust in courts. The study aims at laying down the fundamentals for theoretical models of a remote hearing in criminal proceedings and at making recommendations for the safeguarding of human rights, in particular the rights of the accused, in such proceedings. The following criteria are relevant for the remote form of criminal proceedings: the purpose of judicial instance, the legal position of participants in proceedings, their vulnerability, and the nature of required legal protection. The content of the study consists of: 1. Identification of the factual and legal prerequisites for a decision to organise the entire criminal proceedings by remote means or to carry out one or several procedural actions by remote means 2. After analysing the legal regulation and practice concerning the application of the elements of remote criminal proceedings, distinguish the main legal safeguards for protection of the rights of the accused to ensure: (a) the right of effective participation in a court hearing; (b) the right of confidential consultation with the defence counsel; (c) the right of participation in the examination of evidence, in particular material evidence, as well as the right to question witnesses; and (d) the right to a public trial.

Keywords: remote criminal proceedings, fair trial, right to defence, technology progress

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1371 Effect of Fortification of Expressed Human Breast Milk with Olive Oil and Skimmed Milk in Improving Weight Gain in Very Low Birth Weight Neonates and Shortening Their Length of Hospital Stay

Authors: Sumrina Kousar

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Objective: The aim of this study was to observe the effect of fortification of expressed human breast milk with olive oil and skimmed milk in improving weight gain in very low birth weight neonates and shortening their length of hospital stay. Study Design and place: A randomized controlled trial was carried out at the Combined Military Hospital Lahore from March 2018 to March 2019. Methods: Neonates admitted with very low birth weight and gestational age of < 34 weeks were included in the study. Sixty babies were enrolled using non-probability consecutive sampling; a random number table was used to allocate them into a fortification group and a control group. The control group received expressed milk alone, while olive oil 1 ml twice daily and skimmed milk 1 gram in every third feed were added to expressed milk in the fortification group. Data was analyzed on SPSS 20. Proportions were compared by applying the chi-square test. An independent sample t-test was applied for comparing means. A p-value of ≤ 0.05 was considered significant. Results: The study comprised of 60 neonates, with 30 in each of the groups. Weight gain was 24.83±5.63 in the fortification group and 11.72±3.95 in the control group (p =< 0.001). Mean hospital stay was 20.5716.511 in the fortification group and 27.678.89 in the control group (p =< 0.043). Conclusion: Olive oil and skimmed milk fortification of breast milk was effective for weight gain and reducing the length of hospital stay in very low birth weight neonates.

Keywords: fortification, olive oil, skimmed milk, weight gain

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1370 Positivism Legal Controversy: Dilemma Carok as Madura’s Culture through Indigenous Dispute Settlement in Indonesia

Authors: M. Yasin Al-Arif, Mohammad Faisol Soleh

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The Indonesia’s Constitution in Article 18b explained that the state recognizes and respects indigenous peoples and their traditional rights that are guaranteed by the law. Despite already guaranteed its existence; in practice such indigenous law is often considered contrary to positive law by legal experts. It is because of legal positivism paradigm which requires the written law as the main reference for the settlement of legal disputes. Carok’s culture is one of the indigenous cultures of Madura to resolve legal disputes that still thrives until today. Carok’s culture is in outside the legal process, and through a fight between the disputing parties until one dies. On the other hand, the legal positivism does not give place to accommodate Carok as indigenous dispute settlement, until it must be solved through trial. This way of settlement has not been successfully satisfying the indigenous people, thus although it has been done through its verdict in the trial, but Carok still be used by them. From the explanation above, Carok’s culture must be accommodated as the main settlement process and legal process of law as the alternative to the effectiveness of dispute resolution in Madura Indonesia.

Keywords: carok, dispute settlement, legal positivism, madura’s culture

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1369 Evaluation of Phonophoresis with Dexamethasone in Treatment of Hypertrophic Burn Scar

Authors: Alireza Pishgahi, Mohammad Rahbar, Javad Shokri, Shahla Dareshiri, Yaghoub Salekzamani, Fariba Eslamian

Abstract:

Background and Objectives: Hypertrophic scars are one of the complications following a burn injury. Intralesional corticosteroid injection is an invasive method for treatment of this complication. We had design a single blinded randomized control trial to deliver dexamethasone by phonophoresis and evaluate its efficacy on hypertrophic burn scars characteristics. Material and Methods: 56 cases of hypertrophic burn scar due to burn injury allocated randomly to dexamethasone and control group. Individuals in case group received 10 sessions of dexamethasone 0.4% phonophoresis. Patients in control group had placebo phonophoresis (ultrasound with normal routine aquatic gel without any dexamethasone) with the same protocol. At the beginning of study and one week after last session, hypertrophic scar characteristics and pruritus were measured by ‘Vancouver Scar Scale’, and ‘5-D Pruritus Scale’ respectively in both groups. Results: Despite mild improvement in Vancouver Scar Scale score one week after intervention in dexamethasone phonophoresis group in comparison to control subjects, but this difference was not significant (p=0.08). Pruritus score perceived subjectively were significantly lower one week after intervention in dexamethasone groups in comparison to control subjects (p=0.00). Conclusion: Dexamethasone phonophoresis is a safe and effective treatment method for burn hypertrophic scar pruritus, but its efficacy for scar characteristics improvement needs to be evaluated by larger studies with long-term follow-up period.

Keywords: dexamethasone, hypertrophic scar, phonophoresis, pruritus

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1368 The Comparison of the Effect of Mindfulness-Based Relaxation Training and Trans Cranial Electrical Stimulation and Their Combination on Decreasing Physiological Distress in Patients with Type-2 Diabetes

Authors: Gholam Hossein Javanmard, Roghayeh Mohammadi Garegozlo

Abstract:

The present study was a randomized three-group double-blind clinical trial with repeated measures designs which aimed to determine the pure effect and combined effect of mindfulness based-relaxation (MBR) technique and Transcranial Electrical Simulation (tCES) on psychological distress decreasing of patients with type-2 diabetes. The sample of the study consisted of 30 patients with type-2 diabetes who were selected from the Diabetes Association of Bonab city in Iran. The participants were matched and then randomly assigned to the three groups of 10 subjects (MBR, CES, MBR+CES). The subjects received interventions related to their group in 10 individual sessions. Pre-test, post-test, and one-month follow-up were conducted using DASS-42. Analysis of variance with repeated measures showed a significant change in psychological distress. Multivariate covariance analysis and the paired interpersonal comparative test of Ben Foruni indicated that both interventions of MBR and CES have a similar effect on psychological distress decreasing in the post-test and follow-up phase. But, the combined therapy of MBR+CES was more efficient, and it had a more stable effect. However, all three interventions, especially combined intervention of MBR+CES, as efficient and stable treatment, are suggested for improving the psychological status of diabetic patients.

Keywords: mindfulness based-relaxation, transcranial electrical simulation, type 2 diabetes, psychological distress

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1367 Evaluation of Drought Tolerant Sunflower Hybrids Indicated Their Broad Adaptability Under Stress Environment

Authors: Saeed Rauf

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Purpose: Drought stress is a major production constraint in sunflowers and causes yield losses under tropical and subtropical environments having high evapo-tranpirational losses. Given the consequences, three trials were designed to evaluate drought-resistant sunflower hybrids. Research Methods: Field trials were conducted under a split-plot arrangement with 17 hybrids and two contrasting regimes at Sargodha, Pakistan and 7 hybrids at Karj, Iran. Water stress condition was simulated by holding water in a stress regime. Hybrids were also screened against five levels of osmotic-ally induced stress, i.e. 0-15%, under a completely randomized design with 3 replications. Findings: Hybrids H1 (C.112.× RH.344) and H3 (C.112.× RSIN.82) showed the highest seed yield ha-1 and early flowering at Karj Iran. Commercial hybrid had the highest CTD (18.2°C) followed by C112 × RH.344 (17.29 °C). Hybrid C.250 × R.SIN.82 had the highest seed yield (m-2), followed by C.112 × RH.365 and C.124 × RSIN.82 under both stress and non-stress regimes at Sargodha, Pakistan. Seedling trial results showed that 6 hybrids only germinated in 5 and 7.5% PEG-induced osmotic stress, respectively. H1 (C.112 × RH.344) and H2 (C.112 × RH.347) had the highest germination% at 5% and 7.5% osmotic stress (OS). Seedling vigor index (SVI) was the highest in H1 (C.112 × RH.344) hybrids at 5% OS, H2 had the highest SVI under 7.5% OS, followed by H3 (C112 × RH344) and H4 (C116 × RH344). Originality/Value: In view of above results, it was concluded that hybrid combination H1 had the highest seed yield under stress conditions in both environments. High seed yield may be due to its better germination and vigor index under stress conditions.

Keywords: climate change, CTD, genetic variability, osmotic stress

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1366 An Evaluation of Barriers to Implement Reverse Logistics: A Case Study of Indian Fastener Industry

Authors: D. Garg, S. Luthra, A. Haleem

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Reverse logistics (RL) is supposed to be a systematic procedure that helps in improving the environmental hazards and maintain business sustainability for industries. Industries in Indian are now opting for adoption of RL techniques in business. But, RL practices are not popular in Indian industries because of many barriers for its successful implementation. Therefore, need arises to identify and evaluate the barriers to implement RL practices by taking an Indian industries perspective. Literature review approach and case study approach have been adapted to identify relevant barriers to implement RL practices. Further, Fuzzy Decision Making Trial and Evaluation Laboratory methodology has been brought into use for evaluating causal relationships among the barriers to implement RL practices. Seven barriers out of ten barriers have been categorized into the cause group and remaining into effect group. This research will help Indian industries to manage these barriers towards effective implementing RL practices.

Keywords: barriers, decision making trial and evaluation laboratory (DEMATEL), fuzzy set theory, Indian industries, reverse logistics (RL)

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1365 L-Carnitine Supplementation and Exercise-Induced Muscle Damage

Authors: B. Nakhostin-Roohi, F. Khoshkhahesh, KH. Parandak, R. Ramazanzadeh

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Introduction: The protective effect of antioxidants in diminishing the post-exercise rise of serum CK and LDH in individuals trained for competitive sports has come to light in recent years. This study was conducted to assess the effect of Two-week L-carnitine supplementation on exercise-induced muscle damage, as well as antioxidant capacity after a bout of strenuous exercise in active healthy young men. Methodology: Twenty active healthy men volunteered for this study. Participants were randomized in a double-blind placebo-controlled fashion into two groups: L-carnitine (C group; n = 10) and placebo group (P group; n = 10). The participants took supplementation (2000 mg L-carnitine) or placebo (2000 mg lactose) daily for 2weeks before the main trial. Then, participants ran 14 km. Blood samples were taken before supplementation, before exercise, immediately, 2h and 24h after exercise. Creatine kinase (CK), and lactate dehydrogenase (LDH), and total antioxidant capacity (TAC) were measured. Results: Serum CK and LDH significantly increased after exercise in both groups (p < 0.05). Serum LDH was significantly lower in C group than P group 2h and 24h after exercise (p < 0.05). Furthermore, CK was significantly lower in C group compared with P group just 24h after exercise (p < 0.05). Plasma TAC increased significantly 14 days after supplementation and 24h after exercise in C group compared with P group (p < 0.05). Discussion and conclusion: These results suggest two-week daily oral supplementation of L-carnitine has been able to promote antioxidant capacity before and after exercise and decrease muscle damage markers through possibly inhibition of exercise-induced oxidative stress.

Keywords: L-carnitine, muscle damage, creatine kinase, Lactate dehydrogenase

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1364 Role of Lipid-Lowering Treatment in the Monocyte Phenotype and Chemokine Receptor Levels after Acute Myocardial Infarction

Authors: Carolina N. França, Jônatas B. do Amaral, Maria C.O. Izar, Ighor L. Teixeira, Francisco A. Fonseca

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Introduction: Atherosclerosis is a progressive disease, characterized by lipid and fibrotic element deposition in large-caliber arteries. Conditions related to the development of atherosclerosis, as dyslipidemia, hypertension, diabetes, and smoking are associated with endothelial dysfunction. There is a frequent recurrence of cardiovascular outcomes after acute myocardial infarction and, at this sense, cycles of mobilization of monocyte subtypes (classical, intermediate and nonclassical) secondary to myocardial infarction may determine the colonization of atherosclerotic plaques in different stages of the development, contributing to early recurrence of ischemic events. The recruitment of different monocyte subsets during inflammatory process requires the expression of chemokine receptors CCR2, CCR5, and CX3CR1, to promote the migration of monocytes to the inflammatory site. The aim of this study was to evaluate the effect of lipid-lowering treatment by six months in the monocyte phenotype and chemokine receptor levels of patients after Acute Myocardial Infarction (AMI). Methods: This is a PROBE (prospective, randomized, open-label trial with blinded endpoints) study (ClinicalTrials.gov Identifier: NCT02428374). Adult patients (n=147) of both genders, ageing 18-75 years, were randomized in a 2x2 factorial design for treatment with rosuvastatin 20 mg/day or simvastatin 40 mg/day plus ezetimibe 10 mg/day as well as ticagrelor 90 mg 2x/day and clopidogrel 75 mg, in addition to conventional AMI therapy. Blood samples were collected at baseline, after one month and six months of treatment. Monocyte subtypes (classical - inflammatory, intermediate - phagocytic and nonclassical – anti-inflammatory) were identified, quantified and characterized by flow cytometry, as well as the expressions of the chemokine receptors (CCR2, CCR5 and CX3CR1) were also evaluated in the mononuclear cells. Results: After six months of treatment, there was an increase in the percentage of classical monocytes and reduction in the nonclassical monocytes (p=0.038 and p < 0.0001 Friedman Test), without differences for intermediate monocytes. Besides, classical monocytes had higher expressions of CCR5 and CX3CR1 after treatment, without differences related to CCR2 (p < 0.0001 for CCR5 and CX3CR1; p=0.175 for CCR2). Intermediate monocytes had higher expressions of CCR5 and CX3CR1 and lower expression of CCR2 (p = 0.003; p < 0.0001 and p = 0.011, respectively). Nonclassical monocytes had lower expressions of CCR2 and CCR5, without differences for CX3CR1 (p < 0.0001; p = 0.009 and p = 0.138, respectively). There were no differences after the comparison between the four treatment arms. Conclusion: The data suggest a time-dependent modulation of classical and nonclassical monocytes and chemokine receptor levels. The higher percentage of classical monocytes (inflammatory cells) suggest a residual inflammatory risk, even under preconized treatments to AMI. Indeed, these changes do not seem to be affected by choice of the lipid-lowering strategy.

Keywords: acute myocardial infarction, chemokine receptors, lipid-lowering treatment, monocyte subtypes

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1363 Comparison of Two Transcranial Magnetic Stimulation Protocols on Spasticity in Multiple Sclerosis - Pilot Study of a Randomized and Blind Cross-over Clinical Trial

Authors: Amanda Cristina da Silva Reis, Bruno Paulino Venâncio, Cristina Theada Ferreira, Andrea Fialho do Prado, Lucimara Guedes dos Santos, Aline de Souza Gravatá, Larissa Lima Gonçalves, Isabella Aparecida Ferreira Moretto, João Carlos Ferrari Corrêa, Fernanda Ishida Corrêa

Abstract:

Objective: To compare two protocols of Transcranial Magnetic Stimulation (TMS) on quadriceps muscle spasticity in individuals diagnosed with Multiple Sclerosis (MS). Method: Clinical, crossover study, in which six adult individuals diagnosed with MS and spasticity in the lower limbs were randomized to receive one session of high-frequency (≥5Hz) and low-frequency (≤ 1Hz) TMS on motor cortex (M1) hotspot for quadriceps muscle, with a one-week interval between the sessions. To assess the spasticity was applied the Ashworth scale and were analyzed the latency time (ms) of the motor evoked potential (MEP) and the central motor conduction time (CMCT) of the bilateral quadriceps muscle. Assessments were performed before and after each intervention. The difference between groups was analyzed using the Friedman test, with a significance level of 0.05 adopted. Results: All statistical analyzes were performed using the SPSS Statistic version 26 programs, with a significance level established for the analyzes at p<0.05. Shapiro Wilk normality test. Parametric data were represented as mean and standard deviation for non-parametric variables, median and interquartile range, and frequency and percentage for categorical variables. There was no clinical change in quadriceps spasticity assessed using the Ashworth scale for the 1 Hz (p=0.813) and 5 Hz (p= 0.232) protocols for both limbs. Motor Evoked Potential latency time: in the 5hz protocol, there was no significant change for the contralateral side from pre to post-treatment (p>0.05), and for the ipsilateral side, there was a decrease in latency time of 0.07 seconds (p<0.05 ); for the 1Hz protocol there was an increase of 0.04 seconds in the latency time (p<0.05) for the contralateral side to the stimulus, and for the ipsilateral side there was a decrease in the latency time of 0.04 seconds (p=<0.05), with a significant difference between the contralateral (p=0.007) and ipsilateral (p=0.014) groups. Central motor conduction time in the 1Hz protocol, there was no change for the contralateral side (p>0.05) and for the ipsilateral side (p>0.05). In the 5Hz protocol for the contralateral side, there was a small decrease in latency time (p<0.05) and for the ipsilateral side, there was a decrease of 0.6 seconds in the latency time (p<0.05) with a significant difference between groups (p=0.019). Conclusion: A high or low-frequency session does not change spasticity, but it is observed that when the low-frequency protocol was performed, there was an increase in latency time on the stimulated side, and a decrease in latency time on the non-stimulated side, considering then that inhibiting the motor cortex increases cortical excitability on the opposite side.

Keywords: multiple sclerosis, spasticity, motor evoked potential, transcranial magnetic stimulation

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1362 Efficacy of Eutectic Mixture of Local Anaesthetics and Diclofenac Spray in Attenuating Intravenous Cannulation Pain- Paeallel Randomized Trial

Authors: Anju Rani, Geeta, Sudha Rani, Choudhary, Puhal

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Method- A total of 300 patients were studied, with 100 patients in each group. Patients aged 16-60 years, ASA grade I and II undergoing elective general surgical, urology and orthopedic procedures were included in the study. The patients were randomly allocated to any of the three groups by Using Sealed envelopes. 1. Group A: EMLA (eutectic mixture of 2.5% lidocaine with 2.5% prilocaine) - Patients receiving eutectic Lidocaine/ Prilocaine cream (2gm/10cm2) of Prilox cream), for 60- 70 min under occlusive dressing. 2. Group B - Patients receiving topical diclofenac 4 % spray gel for 60- 70 min, covering an absorption area of 50 cm2 3. Group C: control – Direct cannulation was done without any intervention. Results - Group B showed significantly least number of patients complaining pain on IV cannulation in comparison to group A and group C. The Mean VAS scores were found to be maximum in GROUP C: control-8.76 ± 4.14, then in GROUP A: EMLA- 2.54 ± 4.21.and least in GROUP B: Diclofenac 4% spray-1.13 ± 3.05. Erythema, induration and edema were significantly reported to be higher for the control group. Also group A patients reported adverse skin reactions more than patients in group B. Conclusion - It can be concluded that diclofenac spray 4 % and EMLA cream are effective in reducing the incidence and severity of venous cannulation pain as compared to the control group. However, a higher incidence of skin blanching, erythema, and oedema associated with EMLA cream and a lower incidence of these adverse effects favours the use of diclofenac spray 4%. They are promising agents for the treatment of venous cannulation pain.

Keywords: diclofenac spray, EMLA, intravenous, pain

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1361 Effects of a School-Based Mindfulness Intervention on Stress and Emotions on Students Enrolled in an Independent School

Authors: Tracie Catlett

Abstract:

Students enrolled in high-achieving schools are under tremendous pressure to perform at high levels inside and outside the classroom. Achievement pressure is a prevalent source of stress for students enrolled in high-achieving schools, and female students in particular experience a higher frequency and higher levels of stress compared to their male peers. The practice of mindfulness in a school setting is one tool that has been linked to improved self-regulation of emotions, increased positive emotions, and stress reduction. A mixed methods randomized pretest-posttest no-treatment control trial, evaluated the effects of a six-session mindfulness intervention taught during a regularly scheduled life skills period in an independent day school, one type of high-achieving school. Twenty-nine students in Grades 10 and 11 were randomized by class where Grade 11 students were in the intervention group (n = 14) and Grade 10 students were in the control group (n = 15). Findings from the study produced mixed results. There was no evidence that the mindfulness program reduced participants’ stress levels and negative emotions. In fact, contrary to what was expected, students enrolled in the intervention group experienced higher levels of stress and increased negative emotions at posttreatment when compared to pretreatment. Neither the within-group nor the between-groups changes in stress level were statistically significant, p > .05, and the between-groups effect size was small, d = .2. The study found evidence that the mindfulness program may have had a positive impact on students’ ability to regulate their emotions. The within-group comparison and the between-groups comparison at posttreatment found that students in the mindfulness course experienced statistically significant improvement in the in their ability to regulate their emotions at posttreatment, p = .009 < .05 and p =. 034 < .05, respectively. The between-groups effect size was medium, d =.7, suggesting that the positive differences in emotion regulation difficulties were substantial and have practical implications. The analysis of gender differences as they relate to stress and emotions revealed that female students perceive higher levels of stress and report experiencing stress more often than males. There were no gender differences when analyzing sources of stress experienced by the student participants. Both females and males experience regular achievement pressures related to their school performance and worry about their future, college acceptance, grades, and parental expectations. Females reported an increased awareness of their stress and actively engaged in practicing mindfulness to manage their stress. Students in the treatment group expressed that the practice of mindfulness resulted in feelings of relaxation and calmness.

Keywords: achievement pressure, adolescents, emotion regulation, emotions, high-achieving schools, independent schools, mindfulness, negative affect, positive affect, stress

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1360 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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1359 The Evaluation of the Cognitive Training Program for Older Adults with Mild Cognitive Impairment: Protocol of a Randomized Controlled Study

Authors: Hui-Ling Yang, Kuei-Ru Chou

Abstract:

Background: Studies show that cognitive training can effectively delay cognitive failure. However, there are several gaps in the previous studies of cognitive training in mild cognitive impairment: 1) previous studies enrolled mostly healthy older adults, with few recruiting older adults with cognitive impairment; 2) they also had limited generalizability and lacked long-term follow-up data and measurements of the activities of daily living functional impact. Moreover, only 37% were randomized controlled trials (RCT). 3) Limited cognitive training has been specifically developed for mild cognitive impairment. Objective: This study sought to investigate the changes in cognitive function, activities of daily living and degree of depressive symptoms in older adults with mild cognitive impairment after cognitive training. Methods: This double-blind randomized controlled study has a 2-arm parallel group design. Study subjects are older adults diagnosed with mild cognitive impairment in residential care facilities. 124 subjects will be randomized by the permuted block randomization, into intervention group (Cognitive training, CT), or active control group (Passive information activities, PIA). Therapeutic adherence, sample attrition rate, medication compliance and adverse events will be monitored during the study period, and missing data analyzed using intent-to-treat analysis (ITT). Results: Training sessions of the CT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of active control group is the same as CT group (45min/day, 3days/week, for 12 weeks, for a total of 36 sessions). The primary outcome is cognitive function, using the Mini-Mental Status Examination (MMSE); the secondary outcome indicators are: 1) activities of daily living, using the Lawton’s Instrumental Activities of Daily Living (IADLs) and 2) degree of depressive symptoms, using the Geriatric Depression Scale-Short form (GDS-SF). Latent growth curve modeling will be used in the repeated measures statistical analysis to estimate the trajectory of improvement by examining the rate and pattern of change in cognitive functions, activities of daily living and degree of depressive symptoms for intervention efficacy over time, and the effects will be evaluated immediate post-test, 3 months, 6 months and one year after the last session. Conclusions: We constructed a rigorous CT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. We expect to determine the improvement in cognitive function, activities of daily living and degree of depressive symptoms of older adults with mild cognitive impairment after using the CT.

Keywords: mild cognitive impairment, cognitive training, randomized controlled study

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1358 Assessing Effects of an Intervention on Bottle-Weaning and Reducing Daily Milk Intake from Bottles in Toddlers Using Two-Part Random Effects Models

Authors: Yungtai Lo

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Two-part random effects models have been used to fit semi-continuous longitudinal data where the response variable has a point mass at 0 and a continuous right-skewed distribution for positive values. We review methods proposed in the literature for analyzing data with excess zeros. A two-part logit-log-normal random effects model, a two-part logit-truncated normal random effects model, a two-part logit-gamma random effects model, and a two-part logit-skew normal random effects model were used to examine effects of a bottle-weaning intervention on reducing bottle use and daily milk intake from bottles in toddlers aged 11 to 13 months in a randomized controlled trial. We show in all four two-part models that the intervention promoted bottle-weaning and reduced daily milk intake from bottles in toddlers drinking from a bottle. We also show that there are no differences in model fit using either the logit link function or the probit link function for modeling the probability of bottle-weaning in all four models. Furthermore, prediction accuracy of the logit or probit link function is not sensitive to the distribution assumption on daily milk intake from bottles in toddlers not off bottles.

Keywords: two-part model, semi-continuous variable, truncated normal, gamma regression, skew normal, Pearson residual, receiver operating characteristic curve

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1357 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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1356 Effects of a School-based Mindfulness Intervention on Stress Levels and Emotion Regulation of Adolescent Students Enrolled in an Independent School

Authors: Tracie Catlett

Abstract:

Students enrolled in high-achieving schools are under tremendous pressure to perform at high levels inside and outside the classroom. Achievement pressure is a prevalent source of stress for students enrolled in high-achieving schools, and female students, in particular, experience a higher frequency and higher levels of stress compared to their male peers. The practice of mindfulness in a school setting is one tool that has been linked to improved self-regulation of emotions, increased positive emotions, and stress reduction. A mixed methods randomized pretest-posttest no-treatment control trial evaluated the effects of a six-session mindfulness intervention taught during a regularly scheduled life skills period in an independent day school, one type of high-achieving school. Twenty-nine students in Grades 10 and 11 were randomized by class, where Grade 11 students were in the intervention group (n = 14) and Grade 10 students were in the control group (n = 15). Findings from the study produced mixed results. There was no evidence that the mindfulness program reduced participants’ stress levels and negative emotions. In fact, contrary to what was expected, students enrolled in the intervention group experienced higher levels of stress and increased negative emotions at posttreatment when compared to pretreatment. Neither the within-group nor the between-groups changes in stress level were statistically significant, p > .05, and the between-groups effect size was small, d = .2. The study found evidence that the mindfulness program may have had a positive impact on students’ ability to regulate their emotions. The within-group comparison and the between-groups comparison at posttreatment found that students in the mindfulness course experienced statistically significant improvement in the in their ability to regulate their emotions at posttreatment, p = .009 < .05 and p =. 034 < .05, respectively. The between-groups effect size was medium, d =.7, suggesting that the positive differences in emotion regulation difficulties were substantial and have practical implications. The analysis of gender differences, as they relate to stress and emotions, revealed that female students perceive higher levels of stress and report experiencing stress more often than males. There were no gender differences when analyzing sources of stress experienced by the student participants. Both females and males experience regular achievement pressures related to their school performance and worry about their future, college acceptance, grades, and parental expectations. Females reported an increased awareness of their stress and actively engaged in practicing mindfulness to manage their stress. Students in the treatment group expressed that the practice of mindfulness resulted in feelings of relaxation and calmness.

Keywords: achievement pressure, adolescents, emotion regulation, emotions, high-achieving schools, independent schools, mindfulness, negative affect, positive affect, stress

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1355 Effects of Waist-to-Hip Ratio and Visceral Fat Measurements Improvement on Offshore Petrochemical Company Shift Employees' Work Efficiency

Authors: Essam Amerian

Abstract:

The aim of this study was to investigate the effects of improving waist-to-hip ratio (WHR) and visceral fat components on the health of shift workers in an offshore petrochemical company. A total of 100 male shift workers participated in the study, with an average age of 40.5 years and an average BMI of 28.2 kg/m². The study employed a randomized controlled trial design, with participants assigned to either an intervention group or a control group. The intervention group received a 12-week program that included dietary counseling, physical activity recommendations, and stress management techniques. The control group received no intervention. The outcomes measured were changes in WHR, visceral fat components, blood pressure, and lipid profile. The results showed that the intervention group had a statistically significant improvement in WHR (p<0.001) and visceral fat components (p<0.001) compared to the control group. Furthermore, there were statistically significant improvements in systolic blood pressure (p=0.015) and total cholesterol (p=0.034) in the intervention group compared to the control group. These findings suggest that implementing a 12-week program that includes dietary counseling, physical activity recommendations, and stress management techniques can effectively improve WHR, visceral fat components, and cardiovascular health among shift workers in an offshore petrochemical company.

Keywords: body composition, waist-hip-ratio, visceral fat, shift worker, work efficiency

Procedia PDF Downloads 52
1354 Comparison of the Results of a Parkinson’s Holter Monitor with Patient Diaries, in Real Conditions of Use: A Sub-Analysis of the MoMoPa-EC Clinical Trial

Authors: Alejandro Rodríguez-Molinero, Carlos Pérez-López, Jorge Hernández-Vara, Àngels Bayes-Rusiñol, Juan Carlos Martínez-Castrillo, David A. Pérez-Martínez

Abstract:

Background: Monitoring motor symptoms in Parkinson's patients is often a complex and time-consuming task for clinicians, as Hauser's diaries are often poorly completed by patients. Recently, new automatic devices (Parkinson's holter: STAT-ON®) have been developed capable of monitoring patients' motor fluctuations. The MoMoPa-EC clinical trial (NCT04176302) investigates which of the two methods produces better clinical results. In this sub-analysis, the concordance between both methods is analyzed. Methods: In the MoMoPa-EC clinical trial, 164 patients with moderate-severe Parkinson's disease and at least two hours a day of Off will be included. At the time of patient recruitment, all of them completed a seven-day motor fluctuation diary at home (Hauser’s diary) while wearing the Parkinson's holter. In this sub-analysis, 71 patients with complete data for the purpose of this comparison were included. The intraclass correlation coefficient was calculated between the patient diary entries and the Parkinson's holter data in terms of time On, Off, and time with dyskinesias. Results: The intra-class correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.74) for daily time in Off (%), 0.48 (95% CI: 0.14-0.68) for daily time in On (%), and 0.37 (95% CI %: -0.04-0.62) for daily time with dyskinesias (%). Conclusions: Both methods have a moderate agreement with each other. We will have to wait for the results of the MoMoPa-EC project to estimate which of them has the greatest clinical benefits. Acknowledgment: This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195], and the European Fund for Regional Development, 'A way to make Europe'.

Keywords: Parkinson, sensor, motor fluctuations, dyskinesia

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1353 Factors Influencing Paternal Involvement in Childcare: Empirical Evidence from Rural India

Authors: Anu Jose, Sapna Nair

Abstract:

By using the baseline data of a randomized cluster trial aiming to understand the effects of social, technological and business innovation on child development in two districts of Tamil Nadu, India, we examine the determinants of father involvement in childcare. While there is a growing literature on the role of fathers in child development and family systems, we particularly look at the effect of the attitude of mother and father towards father's involvement in childcare in rural South India. We find that father's own attitude and the mother's gatekeeping attitude significantly affect the father's behavior when other socio-economic characteristics of the parents are controlled. Further, the results are corroborated using different empirical models in which father involvement is conceptualized into three categories broadly; play, caretaking, and affection. We also examine the other socio-economic characteristics affecting paternal involvement using both quantitative and qualitative methods. For instance, child characteristics such as the age and birth order have a significant influence on the level of paternal involvement. That is, older the child, the more involved the father is and the father gets more involved in childcare of the second child as compared to the first child. The participants of the study included 1516 children of age 0 to 22 months from 1476 households. Results indicate that fathers of households where the mother and the father have less traditional attitude exhibit a higher level of involvement in childcare as opposed to parents having a more traditional attitude towards gender role in parenting. The results of this paper provide a major policy lesson aiming to improve paternal involvement in childcare.

Keywords: child development, father involvement, gender, parent’s attitude towards paternal involvement

Procedia PDF Downloads 122
1352 An Optimal Path for Virtual Reality Education using Association Rules

Authors: Adam Patterson

Abstract:

This study analyzes the self-reported experiences of virtual reality users to develop insight into an optimal learning path for education within virtual reality. This research uses a sample of 1000 observations to statistically define factors influencing (i) immersion level and (ii) motion sickness rating for virtual reality experience respondents of college age. This paper recommends an efficient duration for each virtual reality session, to minimize sickness and maximize engagement, utilizing modern machine learning methods such as association rules. The goal of this research, in augmentation with previous literature, is to inform logistical decisions relating to implementation of pilot instruction for virtual reality at the collegiate level. Future research will include a Randomized Control Trial (RCT) to quantify the effect of virtual reality education on student learning outcomes and engagement measures. Current research aims to maximize the treatment effect within the RCT by optimizing the learning benefits of virtual reality. Results suggest significant gender heterogeneity amongst likelihood of reporting motion sickness. Females are 1.7 times more likely, than males, to report high levels of motion sickness resulting from a virtual reality experience. Regarding duration, respondents were 1.29 times more likely to select the lowest level of motion sickness after an engagement lasting between 24.3 and 42 minutes. Conversely, respondents between 42 to 60 minutes were 1.2 times more likely to select the higher levels of motion sickness.

Keywords: applications and integration of e-education, practices and cases in e-education, systems and technologies in e-education, technology adoption and diffusion of e-learning

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1351 Visual Improvement with Low Vision Aids in Children with Stargardt’s Disease

Authors: Anum Akhter, Sumaira Altaf

Abstract:

Purpose: To study the effect of low vision devices i.e. telescope and magnifying glasses on distance visual acuity and near visual acuity of children with Stargardt’s disease. Setting: Low vision department, Alshifa Trust Eye Hospital, Rawalpindi, Pakistan. Methods: 52 children having Stargardt’s disease were included in the study. All children were diagnosed by pediatrics ophthalmologists. Comprehensive low vision assessment was done by me in Low vision clinic. Visual acuity was measured using ETDRS chart. Refraction and other supplementary tests were performed. Children with Stargardt’s disease were provided with different telescopes and magnifying glasses for improving far vision and near vision. Results: Out of 52 children, 17 children were males and 35 children were females. Distance visual acuity and near visual acuity improved significantly with low vision aid trial. All children showed visual acuity better than 6/19 with a telescope of higher magnification. Improvement in near visual acuity was also significant with magnifying glasses trial. Conclusions: Low vision aids are useful for improvement in visual acuity in children. Children with Stargardt’s disease who are having a problem in education and daily life activities can get help from low vision aids.

Keywords: Stargardt, s disease, low vision aids, telescope, magnifiers

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1350 The Effect of Vitamin D Supplementation on Prostate Cancer: A Systematic Review and Meta-Analysis of Clinical Trials

Authors: Simin Shahvazi, Sepideh Soltani, Seyed Mehdi Ahmadi, Russell J. De Souza, Amin Salehi-Abargouei

Abstract:

Background and Objectives: Vitamin D has received attention for its potential to disrupt cancer processes such as attenuating cell proliferation and exacerbating differentiation and apoptosis. However, whether there exists a role for vitamin D in the treatment of prostate cancer specifically remains controversial. We systematically review the literature to assess whether supplementation with vitamin D influences PSA response and overall survival in patients with prostate cancer. Methods: We searched PubMed, Scopus, ISI Web of Science and Google scholar from inception through up to 10 September 2017 for both before-and-after and randomized trials that evaluated the effect of vitamin D supplementation on the prostate specific antigen (PSA) response rate in participants with prostate cancer. The DerSimonian and Laird, inverse-weighted random-effects model was used to pool effect estimates from the studies. Heterogeneity and potential publication bias were evaluated. Subgroup analyses were also performed. Results: Twenty-two studies (16 before-after and 6 randomized controlled trials) were found and included in meta-analysis. The analysis on controlled clinical trials revealed that PSA change from baseline [weighted mean difference (WMD) = -1.66 ng/ml, 95%CI: -0.69, 0.36, P= 0.543)], PSA response (RR=1.18, 95%CI: 0.97, 1.45, P=0.104) and mortality rate (risk ratio (RR) = 1.05, 95% CI: 0.81-1.36; P=0.713) was not significantly different between vitamin D supplementation and placebo groups. Single arm trials revealed that vitamin D supplementation had had a modest effect on PSA response rate: 19% of those enrolled had at least a 50% reduction in PSA by the end of treatment (95% CI: 7% to 31%; p=0.002). Conclusion: We found that vitamin D modestly increases the PSA response rate in single arm studies. No effect on serum PSA levels, PSA response and mortality was seen in randomized controlled clinical trials. It does not seem patients with prostate cancer benefit from vitamin D supplementation.

Keywords: mortality, prostatic neoplasms, PSA response, vitamin D

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1349 Virtual Simulation as a Teaching Method for Community Health Nursing: An Investigation of Student Performance

Authors: Omar Mayyas

Abstract:

Clinical decision-making (CDM) is essential to community health nursing (CHN) education. For this reason, nursing educators are responsible for developing these skills among nursing students because nursing students are exposed to highly critical conditions after graduation. However, due to limited exposure to real-world situations, many nursing students need help developing clinical decision-making skills in this area. Therefore, the impact of Virtual Simulation (VS) on community health nursing students' clinical decision-making in nursing education has to be investigated. This study aims to examine the difference in CDM ability among CHN students who received traditional education compared to those who received VS classes, to identify the factors that may influence CDM ability differences between CHN students who received a traditional education and VS classes, and to provide recommendations for educational programs that can enhance the CDM ability of CHN students and improve the quality of care provided in community settings. A mixed-method study will conduct. A randomized controlled trial will compare the CDM ability of CHN students who received 1hr traditional class with another group who received 1hr VS scenario about diabetic patient nursing care. Sixty-four students in each group will randomly select to be exposed to the intervention from undergraduate nursing students who completed the CHN course at York University. The participants will receive the same Clinical Decision Making in Nursing Scale (CDMNS) questionnaire. The study intervention will follow the Medical Research Council (MRC) approach. SPSS and content analysis will use for data analysis.

Keywords: clinical decision-making, virtual simulation, community health nursing students, community health nursing education

Procedia PDF Downloads 43
1348 The Effect of Exercise, Reflexology and Chrome on Metabolic Syndrome

Authors: F. Arslan, S.D. Guven, A. Özcan, H. Vatansev, Ö. Taşgin

Abstract:

Weight, hypertension and dyslipidemia control and increased physical activity are required for the treatment of metabolic syndrome (METS). The purpose of this study was to investigate the effect of core exercise, reflexology and intake chrome picolinate on METS. This study comprised a twelve-week randomized controlled trial. A total of 25 university workers with metabolic risk factors participated in this study voluntarily. They were randomly divided into three groups: Those undertaking a core exercise program (n=7), reflexology intervention group (n=8) and intake chrome group (n=10). The subjects took part in a core exercise program for one hour per day, three days a week and a reflexology interfered for thirty minutes per day, one days a week and chrome group took chrome picolinate every day in week for twelve weeks. The components of metabolic syndrome were analyzed before and after the completion of all the intervention. There were significant differences at pre-prandial blood glucose in the core exercise group and at systolic blood pressure in chrome group after the twelve week interventions (p < 0.005). While High Density Lipoprotein (HDL) excluding the components of METS decreased after the interventions on the all groups; levels of HDL and the other components of METS decreased in reflexology group. There was a clear response to the twelve-week interventions in terms of METS control. Besides, the reflexology intervention should not be applied to individuals with low HDL levels and core exercise and intake chrome picolinate suggested to improve the components of METS.

Keywords: blood pressure, body mass index, exercise, METS, pre-prandial blood glucose

Procedia PDF Downloads 413
1347 Effect of Different Levels of Distillery Yeast Sludge on Immune Level, Egg Quality and Performance of Layers as a Substitute for Soybean Meal

Authors: Rana Bilal, Faiz-Ul-Hassan, Moazzam Jameel

Abstract:

There is a dire need to replace high-cost protein with more economical protein to overcome animal protein shortage in developing nations especially countries like Pakistan. In conjunction with these efforts, the current study was planned to evaluate the effects of various dried distillery yeast sludge (DYS) levels on the immune level, egg quality, and performance of layers by replacing soybean meal. The study was designed with two hundred layers of Hy-Line variety. Distillery yeast sludge was dried and ground for 2 mm mesh size and after this proximate and mineral analysis was determined. Five isocaloric and isonitrogeneous feeds were given containing C (control), 5, 10, 15, 20% distillery yeast sludge by replacing soybean meal. The trial was performed in the completely randomized design with five treatments, 4 replicates and 10 hen per replicate. Results demonstrated that feed intake, egg production, feed conversion ratio decreased (P < 0.05) with the increased dietary DYS. However, statistically significant decrease (P < 0.05) was found in hens having DYS20 diet than control. Layers on Diets C, DYS5 and DYS10 exerted a higher immune level than DYS15 and DYS20 diets. Egg weight, eggshell weight, eggshell thickness, egg albumen height as well as haugh unit score were affected significantly by the increased level of DYS. In general, results of this study demonstrated that inclusion of DYS up to 10% showed no adverse effects on health and performance of layers.

Keywords: egg quality, immunity, layers, performance

Procedia PDF Downloads 195
1346 Effect of Muscle Energy Technique on Anterior Pelvic Tilt in Lumbar Spondylosis Patients

Authors: Enas El Sayed Abutaleb, Mohamed Taher Eldesoky, Shahenda Abd El Rasol

Abstract:

Background: Muscle energy techniques (MET) have been widely used by manual therapists over the past years, but still limited research validated its use and there was limited evidence to substantiate the theories used to explain its effects. Objective: To investigate the effect of muscle energy technique (MET) on anterior pelvic tilt in patients with lumbar spondylosis. Design: Randomized controlled trial. Subjects: Thirty patients with anterior pelvic tilt from both sexes were involved, aged between 35 to 50 years old and they were divided into MET and control groups with 15 patients in each. Methods: All patients received 3 sessions/week for 4 weeks where the study group received MET, Ultrasound and Infrared, and the control group received U.S and I.R only. Pelvic angle was measured by palpation meter, pain severity by the visual analogue scale and functional disabilities by the Oswestry disability index. Results: Both groups showed significant improvement in all measured variables. The MET group was significantly better than the control group in pelvic angle, pain severity, and functional disability as p-value were (0.001, 0.0001, 0.0001) respectively. Conclusion and implication: The study group fulfilled greater improvement in all measured variables than the control group which implies that application of MET in combination with U.S and I.R were more effective in improving pelvic tilting angle, pain severity and functional disabilities than using electrotherapy only.

Keywords: anterior pelvic tilt, lumbar spondylosis, muscle energy technique exercise, pelvic tilting angle

Procedia PDF Downloads 354
1345 Growth Comparison and Intestinal Health in Broilers Fed Scent Leaf Meal (Ocimum gratissimum) and Synthetic Antibiotic

Authors: Adedoyin Akintunde Adedayo, Onilude Abiodun Anthony

Abstract:

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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1344 A Preliminary Randomized Controlled Trial of Pure L-Ascorbic Acid with Using a Needle-Free and Micro-Needle Mesotherapy in Treatment of Anti-Aging Procedure

Authors: M. Zasada, A. Markiewicz, A. Erkiert-Polguj, E. Budzisz

Abstract:

The epidermis is a keratinized stratified squamous epithelium covered by the hydro-lipid barrier. Therefore, active substances should be able to penetrate through this hydro-lipid coating. L-ascorbic acid is one of the vitamins which plays an important role in stimulation fibroblast to produce collagen type I and in hyperpigmentation lightening. Vitamin C is a water-soluble antioxidant, which protects skin from oxidation damage and rejuvenates photoaged skin. No-needle mesotherapy is a non-invasive rejuvenation technique depending on electric pulses, electroporation, and ultrasounds. These physicals factors result in deeper penetration of cosmetics. It is important to increase the penetration of L-ascorbic acid, thereby increasing the spectrum of its activity. The aim of the work was to assess the effectiveness of pure L-ascorbic acid activity in anti-aging therapy using a needle-free and micro-needling mesotherapy. The study was performed on a group of 35 healthy volunteers in accordance with the Declaration of Helsinki of 1964 and agreement of the Ethics Commissions no RNN/281/16/KE 2017. Women were randomized to mesotherapy or control group. Control group applied topically 2,5 ml serum containing 20% L-ascorbic acid with hydrate from strawberries, every 10 days for a period of 9 weeks. No-needle mesotherapy, on the left half of the face and micro-needling on the right with the same serum, was done in mesotherapy group. The pH of serum was 3.5-4, and the serum was prepared directly prior to the facial treatment. The skin parameters were measured at the beginning and before each treatment. The measurement of the forehead skin was done using Cutometer® (measurement of skin elasticity and firmness), Corneometer® (skin hydration measurement), Mexameter® (skin tone measurement). Also, the photographs were taken by Fotomedicus system. Additionally, the volunteers fulfilled the questionnaire. Serum was tested for microbiological purity and stability after the opening of the cosmetic. During the study, all of the volunteers were taken care of a dermatologist. The regular application of the serum has caused improvement of the skin parameters. Respectively, after 4 and 8 weeks improvement in hydration and elasticity has been seen (Corneometer®, Cutometer® results). Moreover, the number of hyper-pigmentated spots has decreased (Mexameter®). After 8 weeks the volunteers has claimed that the tested product has smoothing and moisturizing features. Subjective opinions indicted significant improvement of skin color and elasticity. The product containing the L-ascorbic acid used with intercellular penetration promoters demonstrates higher anti-aging efficiency than control. In vivo studies confirmed the effectiveness of serum and the impact of the active substance on skin firmness and elasticity, the degree of hydration and skin tone. Mesotherapy with pure L-ascorbic acid provides better diffusion of active substances through the skin.

Keywords: anti-aging, l-ascorbic acid, mesotherapy, promoters

Procedia PDF Downloads 243