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

Search results for: randomized trial

1523 A Top-down vs a Bottom-up Approach on Lower Extremity Motor Recovery and Balance Following Acute Stroke: A Randomized Clinical Trial

Authors: Vijaya Kumar, Vidayasagar Pagilla, Abraham Joshua, Rakshith Kedambadi, Prasanna Mithra

Abstract:

Background: Post stroke rehabilitation are aimed to accelerate for optimal sensorimotor recovery, functional gain and to reduce long-term dependency. Intensive physical therapy interventions can enhance this recovery as experience-dependent neural plastic changes either directly act at cortical neural networks or at distal peripheral level (muscular components). Neuromuscular Electrical Stimulation (NMES), a traditional bottom-up approach, mirror therapy (MT), a relatively new top down approach have found to be an effective adjuvant treatment methods for lower extremity motor and functional recovery in stroke rehabilitation. However there is a scarcity of evidence to compare their therapeutic gain in stroke recovery.Aim: To compare the efficacy of neuromuscular electrical stimulation (NMES) and mirror therapy (MT) in very early phase of post stroke rehabilitation addressed to lower extremity motor recovery and balance. Design: observer blinded Randomized Clinical Trial. Setting: Neurorehabilitation Unit, Department of Physical Therapy, Tertiary Care Hospitals. Subjects: 32 acute stroke subjects with first episode of unilateral stroke with hemiparesis, referred for rehabilitation (onset < 3 weeks), Brunnstorm lower extremity recovery stages ≥3 and MMSE score more than 24 were randomized into two group [Group A-NMES and Group B-MT]. Interventions: Both the groups received eclectic approach to remediate lower extremity recovery which includes treatment components of Roods, Bobath and Motor learning approaches for 30 minutes a day for 6 days. Following which Group A (N=16) received 30 minutes of surface NMES training for six major paretic muscle groups (gluteus maximus and medius,quadriceps, hamstrings, tibialis anterior and gastrocnemius). Group B (N=16) was administered with 30 minutes of mirror therapy sessions to facilitate lower extremity motor recovery. Outcome measures: Lower extremity motor recovery, balance and activities of daily life (ADLs) were measured by Fugyl Meyer Assessment (FMA-LE), Berg Balance Scale (BBS), Barthel Index (BI) before and after intervention. Results: Pre Post analysis of either group across the time revealed statistically significant improvement (p < 0.001) for all the outcome variables for the either group. All parameters of NMES had greater change scores compared to MT group as follows: FMA-LE (25.12±3.01 vs. 23.31±2.38), BBS (35.12±4.61 vs. 34.68±5.42) and BI (40.00±10.32 vs. 37.18±7.73). Between the groups comparison of pre post values showed no significance with FMA-LE (p=0.09), BBS (p=0.80) and BI (p=0.39) respectively. Conclusion: Though either groups had significant improvement (pre to post intervention), none of them were superior to other in lower extremity motor recovery and balance among acute stroke subjects. We conclude that eclectic approach is an effective treatment irrespective of NMES or MT as an adjunct.

Keywords: balance, motor recovery, mirror therapy, neuromuscular electrical stimulation, stroke

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1522 Institutional Legitimacy and Professional Boundary: Western Medicine-Trained Doctors' Attitudes and Behaviors toward Traditional Chinese Medicine

Authors: Xiaoli Tian

Abstract:

The recent growing interest in and use of complementary and alternative medicine is a global phenomenon. In many regions, traditional Chinese medicine (TCM), an important type of complementary and alternative medicine, has been formally integrated into the healthcare system. Consequently, today’s doctors face increasing requests and questions from patients regarding TCM. However, studies of TCM focus either on patients’ approaches to TCM and Western medicine (WM) or on the politics involved in the institutionalization of TCM. To our knowledge, sociological studies on doctors’ attitudes toward TCM are rare. This paper compares the receptivity of WM-trained Chinese doctors to TCM in Hong Kong and mainland China, in order to evaluate the interplay between professional training and dominant medical paradigms, on the one hand, and institutional legitimacy and government and client pressures to accept TCM, on the other. Based on survey and in-depth interviews with Western-medicine doctors in Hong Kong and mainland China, this research finds that: there is major difference between Western-medicine doctors’ attitude toward traditional Chinese medicine (TCM) in Hong Kong and mainland China. Doctors in Hong Kong are still suspicious toward TCM, no matter if they have exposure to TCM or not. Even some doctors who have much knowledge about TCM, such as got a diploma or certificate in TCM or tried TCM themselves, are still suspicious. This is because they hold up to the ideal of 'evidence-based medicine' and emphasize the kind of evidence based on randomized controlled trial (RCT). To Western medicine doctors in Hong Kong, this is the most reliable type of evidence for any medical practice, but it is lacking in TCM. This is the major reason why they do not trust TCM and would not refer patients to TCM in clinical practices. In contrast, western medicine doctors in mainland China also know about randomized controlled trial (RCT) and believe that’s the most reliable evidence, but they tend to think experience-based evidence is also reliable. On this basis, they think TCM also has clinical effectiveness. Research findings reveal that legitimacy based on institutional arrangements is a relevant factor, but how doctors understand their professional boundaries also play an important role. Doctors in Hong Kong are more serious about a strict professional boundary between Western medicine and TCM because they benefited from it, such as a very prestigious status and high income. Doctors in mainland China tend to be flexible about professional boundaries because they never benefited from a well-defined strict professional boundary. This is related to a long history of the lack of professionalism in China but is also aggravated by the increasing state support of TCM.

Keywords: evidence-based decision-making, institutional legitimacy, professional behavior, traditional Chinese medicine

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1521 The Effectiveness of Multiple versus Once-Only Membrane Sweeping in Uncomplicated Primi Gravida at 40 Weeks of Gestational Age in a Tertiary Care Hospital, Sri Lanka: A Randomized Controlled Trial

Authors: Jeewantha Ranawaka, Gunawardane Kapila, Wijethunaga Mudiyanselage B. G. Jayathilake

Abstract:

Introduction: Sweeping of the membranes is a fairly simple technique that may positively influence the shift from maintenance of pregnancy to the beginning of labor. Objective: To assess the effectiveness and acceptability of twice versus once-only membrane sweeping in uncomplicated primi gravid at 40 weeks of gestational age in a tertiary care hospital in Sri Lanka. Methods: A randomized controlled clinical trial was done in Ward 05 of Teaching Hospital, Kandy. The participants were primi-gravida with a singleton live fetus who was at 40 weeks of gestation with intact fetal membranes and with a Modified Bishop’s score <5. After randomization both groups received membrane sweeping at 40 weeks of gestation and the experimental group received membrane sweeping after 48 hours (40+2 days). The modified Bishop Score was assessed at 40+5 days. In two groups who did not go into natural labor at 40+5 days were managed according to the ward policy of cervical ripening and with labor induction at 40+5 days. Two different methods were used to assess discomfort and pain. Patient acceptability was assessed using recommendation to another patient and acceptance during next pregnancy. Perinatal, maternal and labour outcomes were assessed. Results: A change of the Bishops score was 67.3% (n= 31 of 46) in experimental group whereas in control group it was 57.5% (n= 38 of 66). (p = 0.21, OR-1.52, CI = 0.6 -3.34). Mean (SD) of Modified Bishop score was 6.36 (1.94) in experimental group and 6.03 (.84) in control group (p = 0.354). The probability of having the spontaneous onset of labour in experimental group was 61.6% (n=74 of 120) whereas in control group it was 45% (n= 54 of 120) (p=0.01, OR-1.966, CI = 1.17 – 3.28 NNT = 5.99). Recommending the method to another among experimental group was 75% (n= 90 of 120) whereas in control group it was 79.2% (n= 95 of 120) (p= 0.443). Accepting membrane Sweeping for subsequent pregnancy among experimental was 72.5% (n=87 of 120) whereas in control group was 72.5% (n=87 of 120) (p= 1.00) Need of formal induction of labour at 40+ 5 days in experimental group was 38.4% (n=46 of 120) whereas in control group was 61.6% (n=66 of 120) (p=0.01, OR=0.5, CI= 0.3 – 0.8, NNT=6). Neonatal outcome, labour outcome such as Cesarean -section rate, need for augmentation and maternal complications such as fever, Premature rupture of membrane, bleeding were comparable in two groups. Conclusions and Recommendations: It can be concluded that twice sweeping of membrane was effective to reduce the need of formal induction of labour and increase the chances of having spontaneous onset of labour (SOL) at 40+5 days without increasing maternal or fetal morbidity. Acceptability of twice sweeping is not different from sweeping once. Hence we recommend consideration of multiple membranes sweeping as first line for women at 40 weeks of gestation.

Keywords: acceptability, induction, labour, membrane sweeping

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1520 The Effect of Aerobic Exercise Training on the Improvement of Nursing Staff's Sleep Quality: A Randomized Controlled Study

Authors: Niu Shu Fen

Abstract:

Sleep disturbance is highly prevalent among shift-working nurses. We aimed to evaluate whether aerobic exercise (i.e., walking combined with jogging) improves objective Sleepparameters among female nurses at the end of an 8-week exercise program and 4 weeks after study completion. This single-blinded, parallel design, randomized controlled trial was conducted in the floor classroom of a would-be medical center in northern Taiwan. Sixtyeligible female nurses were randomly assigned to either aerobic exercise (n = 30) or usual care (n = 30) group. The moderate-intensity aerobic exercise program was performed over 5days (60 min per day) a week for 8 weeks after work hours. Objective sleep outcomes including total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE), were retrieved using an Actigraph device. A generalized estimated equation model was used for data analyses. The aerobic exercise group had significant improvements in TST and SE at 4 weeks and 8 weeks compared with baseline evaluation(TST: B = 70.49 and 55.96, both p < 0.001; SE: B = 5.21 and 3.98, p < 0.001 and 0.002).Significant between-group differences were observed in SOL and WASO at 4 weeks but not8 weeks compared with the baseline evaluation (SOL: B = −7.18, p = 0.03; WASO: B =−11.38, p = 0.008). The positive lasting effects for TST were observed only until the 4-week follow-up. To improve sleep quality and quantity, we encourage female nurses to regularly perform moderate-intensity aerobic exercise.

Keywords: sleep quality, aerobic exercise, nurses, shift work

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1519 The Effect of Newspaper Reporting on COVID-19 Vaccine Hesitancy: A Randomised Controlled Trial

Authors: Anna Rinaldi, Pierfrancesco Dellino

Abstract:

COVID-19 vaccine hesitancy can be observed at different rates in different countries. In June 2021, 1,068 people were surveyed in France and Italy to inquire about individual potential acceptance, focusing on time preferences in a risk-return framework: having the vaccination today, in a month, and in 3 months; perceived risks of vaccination and COVID-19; and expected benefit of the vaccine. A randomized controlled trial was conducted to understand how everyday stimuli like fact-based news about vaccines impact an audience's acceptance of vaccination. The main experiment involved two groups of participants and two different articles about vaccine-related thrombosis taken from two Italian newspapers. One article used a more abstract description and language, and the other used a more anecdotal description and concrete language; each group read only one of these articles. Two other groups were assigned categorization tasks; one was asked to complete a concrete categorization task, and the other an abstract categorization task. Individual preferences for vaccination were found to be variable and unstable over time, and individual choices of accepting, refusing, or delaying could be affected by the way news is written. In order to understand these dynamic preferences, the present work proposes a new model based on seven categories of human behaviors that were validated by a neural network. A treatment effect was observed: participants who read the articles shifted to vaccine hesitancy categories more than participants assigned to other treatments and control. Furthermore, there was a significant gender effect, showing that the type of language leading to a lower hesitancy rate for men is correlated with a higher hesitancy rate for women and vice versa. This outcome should be taken into consideration for an appropriate gender-based communication campaign aimed at achieving herd immunity. The trial was registered at ClinicalTrials.gov NCT05582564 (17/10/2022).

Keywords: vaccine hesitancy, risk elicitation, neural network, covid19

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1518 Comparison between Infusion Pumps: Fentanyl/Ketamine and Fentanyl/Paracetamol in Pain Control Following Tight and Leg Surgeries

Authors: Maryam Panahi

Abstract:

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

Keywords: infusion pump, Ketamine, Paracetamol, pain

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1517 An Assessment of Tai Chi Exercise on Cognitive Performance in Vietnamese Older Adults

Authors: Hung Manh Nguyen, Duong Dai Nguyen

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Objective: To evaluate the effects of Tai Chi exercise on cognitive performance of community-dwelling elderly in Vinh city, Vietnam. Design: A randomized controlled trial. Participants: One hundred and two subjected were recruited. Intervention: Subjects were divided randomly into two groups. Tai Chi group was assigned 6-months Tai Chi training. Control group was instructed to maintain their routine daily activities. Outcome measures: Trail Making Test (TMT) is primary outcome measure. Results: Participants in Tai Chi group reported significant improvement in TMT (part A) F(1, 71) = 78.37, p < .001, and in TMT (part B) F(1, 71)= 175.00, p < .001 in comparison with Control group. Conclusion: Tai Chi is beneficial to improve cognitive performance of the elderly.

Keywords: cognitive, elderly, Vietnam, Tai Chi

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1516 A Pilot Randomized Controlled Trial of a Physical Activity Intervention in a Low Socioeconomic Population: Focus on Mental Contrasting with Implementation Intentions

Authors: Shaun G. Abbott, Rebecca C. Reynolds, John B. F. de Wit

Abstract:

Low physical activity (PA) levels are a major public health concern in Australia. There is some evidence that PA interventions can increase PA levels via various methods, including online delivery. Low Socioeconomic Status (SES) people participate in less PA than the rest of the population, partly due to poor self-regulation behaviors associated with socioeconomic characteristics. Interventions that involve a particular method of self-regulation, Mental Contrasting with Implementation Intentions (MCII), has regularly achieved healthy behavior change, but few studies focus on PA behavior outcomes and no studies examining the effect of MCII on the PA behaviors of low SES people has been done. In this study, a pilot randomized controlled trial (RCT) will deliver MCII for PA behavior change to individuals of relative disadvantage for the first time. The current pilot study will predict sample size for a future full RCT and test the hypothesis that sedentary participants from areas of relative socioeconomic disadvantage of Sydney, who learn the MCII technique will be more physically active, have improved anthropometry and psychological indicators at the completion of a 12-week intervention compared to baseline and control. Eligible participants of relative socioeconomic disadvantage will be randomly assigned to either the ‘PA Information Plus MCII Intervention Group’ or a ‘PA Information-Only Control Group’. Both groups will attend a baseline and 12-week face-to-face consultation; where PA, anthropometric and psychological data will be gathered. The intervention group will be guided through an MCII session at the baseline appointment to establish a PA goal to aim to achieve over 12 weeks. Other than these baseline and 12-week consultations, all participant interaction will occur online. All participants will receive a ‘Fitbit’ accelerometer to record objectively. PA as a daily step count, along with a PA diary for the duration of the study. PA data will be recorded on a personalized online spreadsheet. Both groups will receive a standard PA information email at weeks 2, 4, and 8. The intervention group will also receive scripted follow-up online appointments to discuss goal progress. The current pilot study is in recruitment stage with findings to be presented at the conference in December if selected.

Keywords: implementation intentions, mental contrasting, motivation, pedometer, physical activity, socioeconomic

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1515 Risperidone for the Treatment of Retentive Fecal Incontinence in Children and Adolescents: A Randomize Clinical Trial

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

Abstract:

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

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

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1514 Comparison the Effectiveness of Pain Cognitive- Behavioral Therapy and Its Computerized Version on Reduction of Pain Intensity, Depression, Anger and Anxiety in Children with Cancer: A Randomized Controlled Trial

Authors: Najmeh Hamid, Vajiheh Hamedy , Zahra Rostamianasl

Abstract:

Background: Cancer is one of the medical problems that have been associated with pain. Moreover, the pain is combined with negative emotions such as anxiety, depression and anger. Poor pain management causes negative effects on the quality of life, which results in negative effects that continue a long time after the painful experiences. Objectives: The aim of this research was to compare the effectiveness of Common Cognitive Behavioral Therapy for Pain and its computerized version on the reduction of pain intensity, depression, anger and anxiety in children with cancer. Methods: The research method of this “Randomized Controlled Clinical Trial” was a pre, post-test and follow-up with a control group. In this research, we have examined the effectiveness of Common Cognitive Behavioral Therapy for Pain and its computerized version on the reduction of pain intensity, anxiety, depression and anger in children with cancer in Ahvaz. Two psychological interventions (cognitive behavioral therapy for pain and the computerized version) were compared with the control group. The sample consisted of 60 children aged 8 to 12 years old with different types of cancer at Shafa hospital in Ahwaz. According to the including and excluding criteria such as age, socioeconomic status, clinical diagnostic interview and other criteria, 60 subjects were selected. Then, randomly, 45 subjects were selected. The subjects were randomly divided into three groups of 15 (two experimental and one control group). The research instruments included Spielberger Anxiety Inventory (STAY-2) and International Pain Measurement Scale. The first experimental group received 6 sessions of cognitive-behavioral therapy for 6 weeks, and the second group was subjected to a computerized version of cognitive-behavioral therapy for 6 weeks, but the control group did not receive any interventions. For ethical considerations, a version of computerized cognitive-behavioral therapy was provided to them. After 6 weeks, all three groups were evaluated as post-test and eventually after a one-month follow-up. Results: The findings of this study indicated that both interventions could reduce the negative emotions (pain, anger, anxiety, depression) associated with cancer in children in comparison with a control group (p<0.0001). In addition, there were no significant differences between the two interventions (p<0.01). It means both interventions are useful for reducing the negative effects of pain and enhancing adjustment. Conclusion: we can use CBT in situations in which there is no access to psychologists and psychological services. In addition, it can be a useful alternative to conventional psychological interventions.

Keywords: pain, children, psychological intervention, cancer, anger, anxiety, depression

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1513 Effects of Molybdenum on Phosphorus Concentration in Rice (Oryza sativa L.)

Authors: Hamed Zakikhani, Mohd Khanif Yusop, Amin Soltangheisi

Abstract:

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

Keywords: molybdenum, phosphorus, uptake, rice,

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1512 Effect of Low Level Laser for Athletic Achilles Tendinopathy: A Systematic Review

Authors: Sameh Eldaly, Rola Essam

Abstract:

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

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

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1511 Induction of Labor Using Misoprostol with or without Mifepristone in Intrauterine Death: A Randomized Controlled Study

Authors: Ajay Agrawal, Pritha Basnet, Achala Thakur, Pappu Rizal, Rubina Rai

Abstract:

Context: Rapid expulsion of fetus in intrauterine fetal death (IUFD) is usually requested without any medical grounds for it. So; an efficient, safe method for induction of labor (IOL) is required. Objective: To determine if pre-treatment with mifepristone followed by IOL with misoprostol in late IUFD is more efficacious. Methods: We conducted a randomized controlled trial in 100 patients. Group-A women received single oral dose of 200 mg mifepristone, followed by induction with vaginal misoprostol after 24-hour. Group-B women were induced only with vaginal misoprostol. In each group 5 dose of misoprostol was used 4 hourly. If first cycle was unsuccessful, after break of 12 hour, second course of misoprostol was started. The primary outcome was a measure of induction to delivery time and vaginal delivery within 24 hours. Secondary outcome was to measure need of oxytocin and complications. Results: Maternal age, parity and period of gestation were comparable between groups. Number of misoprostol dose needed in group A was significantly less than group B. Mann Whitney U test showed, women in group A had significantly earlier onset of labor, however total induction to delivery interval was not significant. In group-A, 85.7% delivered within 24 hours of first dose of misoprostol while in group-B 70% delivered within 24 hour (p=0.07). More women in Group B required oxytocin. Conclusion: Pretreatment with mifepristone before IOL following late IUFD is an effective and safe regimen. It appears to shorten the duration of induction to onset of labor.

Keywords: induction of labor, intrauterine fetal death, mifepristone, misoprostol

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1510 Investigation of Cold Atmospheric Plasma Exposure Protocol on Wound Healing in Diabetic Foot Ulcer

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

Abstract:

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

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

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1509 The Effect of the Flow Pipe Diameter on the Rheological Behavior of a Polymeric Solution (CMC)

Authors: H. Abchiche, M. Mellal

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

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

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1508 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

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

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

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1507 The Trial Using Bio-Product for Reducing Arsenic Heavy Metal in Soil in Grow Organic Vegetables

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

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

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

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1506 Effect of Satureja khuzestanica Jamzad Supplementation on Inflammatory and Antioxidant Indicators in Type 2 Diabetes Patients: A Randomized Controlled Clinical Trial Study

Authors: Maryam Bordbar, Yaser Mokhayeri, Sajjad Roosta, Fatemeh Ghasemi, Saeed Choobkar, Hamidreza Nikbakht, Ebrahim Falahi

Abstract:

Objective: Diabetes mellitus type 2 is the most common metabolic disorder that is growing exponentially worldwide. Satureja Khuzestanica Jamzad is a native plant of Iran that grows widely in the south of Iran. Its antimicrobial, antioxidant, anti-inflammatory and pain-relieving effects have been documented in animal studies. The purpose of this study is to investigate the effect of consumption daily S. khuzestanica on inflammatory and antioxidant indicators in type 2 diabetic patients. Methods and Materials: In a double-blind, placebo-controlled clinical trial, 67 patients with type 2 diabetes were included and divided into two groups. One group received S. khuzestanica (capsule containing 500 mg) and the other group received placebo (500 mg talcum powder) once a day for 12 weeks. After the intervention, the inflammatory and antioxidant indicators of the two groups were compared. Results: In comparison to placebo groups, there was a significant difference in levels of total antioxidant capacity, superoxide dismutase, catalase, glutathione reductase, and glutathione peroxidase; these antioxidant indicators were higher in the intervention group (P<0.05). Moreover, a considerable decrease in weight, CRP and IL-6 levels were observed in patients in the S.Khuzestanica group. Conclusion: Our findings may provide novel complementary treatments without adverse effects for diabetes complications.

Keywords: Satureja khuzestanica Jamzad, diabetes mellitus, antioxidant indicators, IL-6, C-reactive protein

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1505 Clinical and Chemokine Profile in Leprosy Patients During Multidrug Therapy (MDT) and Their Healthy Contacts: A Randomized Control Trial

Authors: Rohit Kothari

Abstract:

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

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

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1504 Title: Real World Evidence a Tool to Overcome the Lack of a Comparative Arm in Drug Evaluation in the Context of Rare Diseases

Authors: Mohamed Wahba

Abstract:

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

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

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1503 Extending ACOSOG Z0011 to Encompass Mastectomy Patients: A Retrospective Review

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

Abstract:

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

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

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1502 Effects of Plant Densities on Seed Yield and Some Agricultural Characteristics of Jofs Pea Variety

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

Abstract:

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

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

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1501 Randomized Controlled Study of the Antipyretic Efficacy of Oral Paracetamol, Intravenous Paracetamol, and Intramuscular Diclofenac

Authors: Firjeeth C. Paramba, Vamanjore A. Naushad, Nishan K. Purayil, Osama H. Mohammed, Prem Chandra

Abstract:

Background: Fever is a common problem in adults visiting the emergency department. Extensive studies have been done in children comparing the efficacy of various antipyretics. However, studies on the efficacy of antipyretic drugs in adults are very scarce. To the best of our knowledge, no controlled trial has been carried out comparing the antipyretic efficacy of paracetamol (oral and intravenous) and intramuscular diclofenac in adults. Methods: In this parallel-group, open-label trial, participants aged 14–75 years presenting with fever who had a temperature of more than 38.5°C were enrolled and treated. Participants were randomly allocated to receive treatment with 1,000 mg oral paracetamol (n=145), 1,000 mg intravenous paracetamol (n=139), or 75 mg intramuscular diclofenac (n=150). The primary outcome was degree of reduction in mean oral temperature at 90 minutes. The efficacy of diclofenac versus oral and intravenous paracetamol was assessed by superiority comparison. Analysis was done using intention to treat principles. Results: After 90 minutes, all three groups showed a significant reduction in mean temperature, with intramuscular diclofenac showing the greatest reduction (−1.44 ± 0.43, 95% confidence interval [CI] −1.4 to −2.5) and oral paracetamol the least (−1.08 ± 0.51, 95% CI −0.99 to −2.2). After 120 minutes, there was a significant difference observed in the mean change from baseline temperature between the three treatment groups (P, 0.0001). Significant changes in temperature were observed in favor of intramuscular diclofenac over oral and intravenous paracetamol at each time point from 60 minutes through 120 minutes inclusive. Conclusion: Both intramuscular diclofenac and intravenous paracetamol showed superior antipyretic activity than oral paracetamol. However, in view of its ease of administration, intramuscular diclofenac can be used as a first-choice antipyretic in febrile adults in the emergency department.

Keywords: antipyretic, intramuscular, intravenous, paracetamol, diclofenac, emergency department

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1500 A Nutrient Formulation Affects Brain Myelination in Infants: An Investigative Randomized Controlled Trial

Authors: N. Schneider, M. Bruchhage, M. Hartweg, G. Mutungi, J. O Regan, S. Deoni

Abstract:

Observational neuroimaging studies suggest differences between breast-fed and formula-fed infants in developmental myelination, a key brain process for learning and cognitive development. However, the possible effects of a nutrient formulation on myelin development in healthy term infants in an intervention study have not been investigated. Objective was, therefore, to investigate the efficacy of a nutrient formulation with higher levels of myelin-relevant nutrients as compared to a control formulation with lower levels of the same nutrients on brain myelination and cognitive development in the first 6 months of life. The study is an ongoing randomized, controlled, double-blind, two-center, parallel-group clinical trial with a nonrandomized, non-blinded arm of exclusively breastfed infants. The current findings result from a staged statistical analysis at 6 months; the recruitment and intervention period has been completed for all participants. Follow-up visits at 12, 18 and 24 months are still ongoing. N= 81 enrolled full term, neurotypical infants of both sexes were randomized into either the investigational (N= 42) or the control group (N= 39), and N= 108 children in the breast-fed arm served as a natural reference group. The effect of a blend of docosahexaenoic acid, arachidonic acid, iron, vitamin B12, folic acid as well as sphingomyelin from a uniquely proceed whey protein concentrate enriched in alpha-lactalbumin and phospholipids in an infant nutrition product matrix was investigated. The main outcomes for the staged statistical analyses at 6 months included brain myelination measures derived from MRI. Additional outcomes were brain volume, cognitive development and safety. The full analyses set at 6 months comprised N= 66 infants. Higher levels of myelin-relevant nutrients compared to lower levels resulted in significant differences in myelin structure, volume, and rate of myelination as early as 3 and 6 months of life. The cross-sectional change of means between groups for whole-brain myelin volume was 8.4% for investigational versus control formulation (3.5% versus the breastfeeding reference) group at 3 months and increased to 36.4% for investigational versus control formulation (14.1% versus breastfeeding reference) at 6 months. No statistically significant differences were detected for early cognition scores. Safety findings were largely similar across groups. This is the first pediatric nutritional neuroimaging study demonstrating the efficacy of a myelin nutrient blend on developmental myelination in well-nourished term infants. Myelination is a critical process in learning and development. The effects were demonstrated across the brain, particularly in temporal and parietal regions, known to be functionally involved in sensory, motor and language skills. These first results add to the field of nutritional neuroscience by demonstrating early life nutrition benefits for brain architecture which may be foundational for later cognitive and behavioral outcomes. ClinicalTrials.gov Identifier: NCT03111927 (Infant Nutrition and Brain Development - Full-Text View - ClinicalTrials.gov).

Keywords: brain development, infant nutrition, MRI, myelination

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1499 Performance Based Design of Masonry Infilled Reinforced Concrete Frames for Near-Field Earthquakes Using Energy Methods

Authors: Alok Madan, Arshad K. Hashmi

Abstract:

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

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

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1498 Linear Decoding Applied to V5/MT Neuronal Activity on Past Trials Predicts Current Sensory Choices

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

Abstract:

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

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

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1497 Punishing Unfit Defendants for International Crimes Committed Decades Ago

Authors: Md. Mustakimur Rahman

Abstract:

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

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

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1496 Metabolic Cost and Perceived Exertion during Progressive and Randomized Walking Protocols

Authors: Simeon E. H. Davies

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This study investigated whether selected metabolic responses and the perception of effort varied during four different walk protocols where speed increased progressively 3, 4, 5, 6, and 7 km/hr (progressive treadmill walk (PTW); and progressive land walk (PLW); or where the participant adjusted to random changes of speed e.g. 6, 3, 7, 4, and 5 km/hr during a randomized treadmill walk (RTW); and a randomized land walk (RLW). Mean stature and mass of the seven participants was 1.75m and 70kg respectively, with a mean body fat of 15%. Metabolic measures including heart rate, relative oxygen uptake, ventilation, increased in a linear fashion up to 6 km/hr, however at 7 km/hr there was a significant increase in metabolic response notably during the PLW, and to a similar, although lesser extent in RLW, probably as a consequence of the loss of kinetic energy when turning at each cone in order to maintain the speed during each shuttle. Respiration frequency appeared to be a more sensitive indicator of physical exertion, exhibiting a rapid elevation at 5 km/hr. The perception of effort during each mode and at each speed was largely congruent during each walk protocol.

Keywords: exertion, metabolic, progressive, random, walking

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1495 Effect of Microfiltration on the Composition and Ripening of Iranian Fetta Cheese

Authors: M. Dezyani, R. Ezzati belvirdi, M. Shakerian, H. Mirzaei

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The effect of Microfiltration (MF) on proteolysis, hardness, and flavor of Feta cheese during 6 mo of aging was determined. Raw skim milk was microfiltered two-fold in two cheese making trials. In trial 1, four vats of cheese were made in 1 d using unconcentrated milk (1X), 1.26X, 1.51X, and 1.82X Concentration Factors (CF). Casein-(CN)-to-fat ratio was constant among treatments. Proteolysis during cheese aging decreased with increasing CF due to either limitation of substrate availability for chymosin due to low moisture in the nonfat substance (MNFS), inhibition of chymosin activity by high molecular weight milk serum proteins, such as α2-macroglobulin, retained in the cheese or low residual chymosin in the cheese. Hardness of fresh cheese increased, and cheese flavor intensity decreased with increasing CF. In trial 2, the 1X and 1.8X CF were compared directly. Changes made in the cheese making procedure for the 1.8X CF (more chymosin and less cooking) increased the MNFS and made proteolysis during aging more comparable for the 1X and 1.8X cheeses. The significant difference in cheese hardness due to CF in trial 1 was eliminated in trial 2. In a triangle test, panelists could not differentiate between the 1X and 1.8X cheeses. Therefore, increasing chymosin and making the composition of the two cheeses more similar allowed production of aged Fetta cheese from milk concentrated up to 1.8X by MF that was not perceived as different from aged feta cheese produced without MF.

Keywords: feta cheese, microfiltration, concentration factor, proteolysis

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1494 Post Operative Analgesia after Orthotopic Liver Transplantation; A Clinical Randomized Trial

Authors: Soudeh Tabashi, Mohammadreza Moshari, Parisa Sezari

Abstract:

Introduction: Postoperative analgesia in Orthotopic Liver Transplantation (OLT) surgery is challenging for anesthesiologists. Although OLT is one of the most extensive abdominal operations, it seems that patients don’t suffer from severe post operative pain. On the other hands drug metabolism is unpredictable due to unknown graft function. The aim of this study was to compare intraoperative infusion of remifentanil versus fentanyl in postoperative opioid demand in patients with OLT and evaluating the complications in two groups. Method: In this double-blind clinical trial 34 patients who had OLT were included. They divided randomly in two groups of Remifentanil (R) and Fentanyl (F). Patients in group R and F received infusion of Remifentanil 0.3-1 µg/Kg/min and Fentanyl 0.3-1 µg/Kg/min during maintenance of anesthesia. Post operative pain were measured in 6, 12, 18, 24 hours and second and third days after surgery with Numeric Rate Scale (NRS). Patients had received intravenous acetaminophen as rescue therapy with NRS of 3 or more. In addition to demographic information, post operative opioid consumption were recorded as the primary outcome. Intraoperative blood transfusion, intraoperative inotropic drugs consumption, weaning time and intensive care unit stay were also evaluated. Results: Total dose of acetaminophen consumption in first 3 days after surgery did not have significant difference between two groups (Pvalue=0.716). intraoperative inotrope consumption, blood transfusion and post operative weaning time and ICU stay were also similar in both groups. Conclusion: This study demonstrates that intraoperative infusion of remifentanil in OLT have the same effect on post operative pain management as fentanyl. Despite the complications of operation were not increased by remifentanil.

Keywords: liver transplantation, postoperative pain, remifentanil, fentanyl

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