Search results for: randomized clinical trial

Authors: Muhammad Tanziel Aziezi

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In Indonesia, pre-trial (in Indonesia called ‘praperadilan’) is a mechanism that is regulated on Criminal Procedure Code as a form of oversight and check and balance on the process at the stage of inquiry, investigation, and prosecution, so that actions taken by the State (in this case, the police and prosecutor) is carried out in accordance with its authority and not violate human rights. Article 77 of the Criminal Procedure Code has been set that the object may be filed pretrial is just about the lawfulness of the arrest, the lawfulness of the detention, and the legitimacy of stopping investigation and prosecution. However, since the beginning of 2015, there was a further object which is then entered as a pre-trial object, namely the lawfulness of the determination of a criminal suspect. This is because the determination of the suspect is considered as one of the forceful measures that could restrict the rights of a person, so the implementation should have oversight and checks and balances by the courts. This paper will discuss the development of the pre-trial on the lawfulness of the determination of a criminal suspect as a new judicial mechanism as the protection of human rights in Indonesia.

Keywords: criminal procedure law, pre-trial, lawfulness of determination of a criminal suspect, check and balance by the court

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

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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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Authors: B. Yermekbayeva, A. Gulyayaev, T. Nurgozhin, C. Bektur

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Cytisine aminophosphonate under the name "Cytafat" was approved for clinical trials in Republic of Kazakhstan as a putative liver protecting drug for the treatment of acute toxic hepatitis. A method of conducting the clinical trial is a double blind study. Total number of patients -71, aged from 16 to 56 years. Research on healthy volunteers determined the maximal tolerable doze of "Cytafat" as 200 mg/kg. Side effects when administered at high dozes (100-200 mg/kg) are tachycardia and increase of arterial blood pressure. The drug is tested in the treatment of 28 patients with a syndrome of hepatocellular failure (a poisoning with substitutes of alcohol, rat poison, or medical products). "Cytafat" was intravenously administered at a dose of 10 mg/kg in 200 ml of 5 % glucose solution once daily. The number of administrations: 1-3. In the comparison group, 23 patients were treated intravenously once a day with “Essenciale H” at a dose of 10 ml. 20 patients received a placebo (10 ml of glucose intravenously). In all cases of toxic hepatopathology the significant positive clinical effect of the testing drug distinguishable from placebo and surpassing the alternative was observed. Within a day after administration a sharp reduction of cytolitic syndrome parameters (ALT, AST, alkaline phosphatase, thymol turbidity test, GGT) was registered, a reduction of the severity of cholestatic syndrome (bilirubin decreased) was recorded, significantly decreased indices of lipid peroxidation. The following day, in all cases the positive dynamics was determined with ultrasound study (reduction of diffuse changes and events of reactive pancreatitis), hepatomegaly disappeared. Normalization of all parameters occurred in 2-3 times faster, than when using the drug "Essenciale H" and placebo. Average term of elimination of toxic hepatopathy when using the drug "Cytafat" -2,8 days, "Essenciale H" -7,2 days, and placebo -10,6 days. The new drug "Cytafat" has expressed cytoprotective properties.

Keywords: cytisine, cytoprotection, hepatopathy, hepatoprotection

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Authors: Nalanda Roy

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

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

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Authors: Antonio Lopez-Villegas, Rafael Bautista-Mesa, Emilio Robles-Musso, Daniel Catalan-Matamoros, Cesar Leal-Costa

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Objectives: The purpose of this trial was to evaluate the burden borne by and the costs to informal caregivers of users with telemonitoring of pacemakers. Methods: This is a controlled, non-randomised clinical trial, with data collected from informal caregivers, five years after implantation of pacemakers. The Spanish version of the Survey on Disabilities, Personal Autonomy, and Dependency Situations was used to get information on clinical and social characteristics, levels of professionalism, duration and types of care, difficulties in providing care, health status, economic and job aspects, impact on the family or leisure due to informal caregiving for patients with pacemakers. Results: After five years of follow-up, 55 users with pacemakers finished the study. Of which, 50 were helped by a caregiver, 18 were included in the telemonitoring group (TM) and 32 in the conventional follow-up group (HM). Overall, females represented 96.0% of the informal caregivers (88.89% in TM and 100.0% in HM group). The mean ages were 63.17 ± 15.92 and 63.13 ± 14.56 years, respectively (p = 0.83) in the groups. The majority (88.0%) of the caregivers declared that they had to provide their services between 6 and 7 days per week (83.33% in TM group versus 90.63% in HM group), without significant differences between both groups. The costs related to care provided by the informal caregivers were 47.04% higher in the conventional follow-up group than in the TM group. Conclusions: The results of this trial confirm that there were no significant differences between the informal caregivers regarding to baseline characteristics, workload and time worked in both groups of follow-up. The costs incurred by the informal caregivers providing care for users with pacemakers included in telemonitoring group are significantly lower than those in the conventional follow-up group. Trial registration: ClinicalTrials.gov NCT02234245. Funding: The PONIENTE study, has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: costs, disease burden, informal caregiving, pacemaker follow-up, remote monitoring, telemedicine

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Authors: Erinda Male

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

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

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Authors: Mohd Asharf Ganie, Aafia Rashid, Mohd Afzal Zargar, Showkat Ali Zargar, Syed Mudasar, Tabasum Parvaiz, Zafar Amin Shah

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Accumulating evidence suggests that Vitamin D deficiency (VDD) might at least contribute to the metabolic co-morbidities in PCOS. Hence, we aimed to study the effect of vitamin D supplementation in co-prescription with insulin sensitizers like metformin and pioglitazone on clinical, hormonal and metabolic parameters in women with PCOS. In this open label randomized, controlled trial a total of 120 women with PCOS diagnosis (AE-PCOS 2009 Criteria) were assigned to four treatment groups (n= 30 in each): group I (metformin 1 gm/day in combination with cholecalciferol 4000 IU/day), group II (pioglitazone 30 mg/day in combination with cholecalciferol 4000 IU/day), group III (metformin 1 gm /day) and group IV (pioglitazone 30 mg/day). Vitamin D supplementation was given as 60,000 units every two weeks for 24 weeks. All the subjects were routinely evaluated for clinical, biochemical, hormonal and insulin sensitivity parameters in addition to various safety parameters especially serum calcium levels at baseline and after 24 weeks of the treatment. Our results indicate that 95.5% of PCOS women were vitamin D deficient at baseline. Serum 25 (OH) D levels increased significantly (p < 0.001) in groups I and II without any adverse effects after 24 weeks of oral administration of 4000 IU cholecalciferol daily. However, serum 25 (OH) D levels remained unchanged in group III and IV. By six months, number of menstrual cycles per year increased whereas Ferriman-Gallwey score, serum total testosterone and HOMA-IR decreased significantly (P < 0.001) in the treatment groups supplemented with cholecalciferol as compared to those treated either drug alone. No significant beneficial changes were observed on weight, BMI, blood pressure, glucose tolerance and serum lipids in any of the groups supplemented with cholecalciferol. We conclude that daily dose of 4000 IU cholecalciferol might be a useful adjunct in complex treatment of PCOS with fewer adverse events. Furthermore, pioglitazone and cholecalciferol combination seems to be marginally better although there was no statistical significance.

Keywords: PCOS, vitamin D supplementation, insulin resistance, spironolactone, metformin, pioglitazone

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

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

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

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Authors: Tobias Stephan Kaeding, Rebecca Schwarz, Momme Kück, Lothar Stein

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Introduction: The goal of this randomized and controlled study is to examine whether whole-body vibration (WBV) training is able to reduce self-reported physical disability in office employees with chronic low-back pain. Materials and methods: 41 subjects (68.3% female/mean age 45.5 ± 9.1 years/mean BMI 26.6 ± 5.2) were randomly allocated to an intervention group (INT (n= 21)) or a control group (CON (n=20). The INT participated in WBV training 2.5 times per week for 3 months. The primary outcome was the change in the Roland and Morris disability questionnaire (RMQ) score over the study period. In addition, secondary outcomes included changes in the Oswestry Disability Index (ODI). Results: The compliance with the intervention in the INT reached a mean of 81.1% ± 31.2% with no long-lasting unwanted side effects. We found significant positive effects of 3 months of WBV training in the INT compared to the CON regarding the RMQ (p=0.027) and the ODI (p=0.002). Conclusions: WBV training seems to be an effective, safe and suitable intervention for the reduction of the self-reported physical disability in seated working employees with chronic low-back pain.

Keywords: back pain, exercise, occupational health management, vibration training

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Authors: E. Gopi, E. Devaindran

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

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

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

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

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

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Authors: Eric Granholm, Christophe Delay, Jason Holden, Peter Link

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Negative symptoms are an important unmet treatment needed for schizophrenia. We conducted an open trial of a novel blended intervention called mobile-assisted cognitive behavior therapy for negative symptoms (mCBTn). mCBTn is a weekly group therapy intervention combining in-person and smartphone-based CBT (CBT2go app) to improve experiential negative symptoms in people with schizophrenia. Both the therapy group and CBT2go app included recovery goal setting, thought challenging, scheduling of pleasurable activities and social interactions, and pleasure savoring interventions to modify defeatist attitudes, a target mechanism associated with negative symptoms, and improve experiential negative symptoms. We tested whether participants with schizophrenia or schizoaffective disorder (N=31) who met prospective criteria for persistent negative symptoms showed improvement in experiential negative symptoms. Retention was excellent (87% at 18 weeks) and severity of defeatist attitudes and motivation and pleasure negative symptoms declined significantly in mCBTn with large effect sizes. We also tested whether pupillary responses, a measure of cognitive effort, predicted improvement in negative symptoms mCBTn. Pupillary responses were recorded at baseline using a Tobii pupillometer during the digit span task with 3-, 6- and 9-digit spans. Mixed models showed that greater dilation during the task at baseline significantly predicted a greater reduction in experiential negative symptoms. Pupillary responses may provide a much-needed prognostic biomarker of which patients are most likely to benefit from CBT. Greater pupil dilation during a cognitive task predicted greater improvement in experiential negative symptoms. Pupil dilation has been linked to motivation and engagement of executive control, so these factors may contribute to benefits in interventions that train cognitive skills to manage negative thoughts and emotions. The findings suggest mCBTn is a feasible and effective treatment for experiential negative symptoms and justify a larger randomized controlled clinical trial. The findings also provide support for the defeatist attitude model of experiential negative symptoms and suggest that mobile-assisted interventions like mCBTn can strengthen and shorten intensive psychosocial interventions for schizophrenia.

Keywords: cognitive-behavioral therapy, mobile interventions, negative symptoms, pupillometry schizophrenia

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Authors: Marzieh Moattari Mitra Abbasi, Masoud Mousavinasab, Poorahmad

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

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

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Authors: M. Samsami, A. Hekmatdoost, N. Ebrahimi Daryani, P. Rezanejad Asl

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Ulcerative colitis (UC) is an inflammatory bowel disease in which immune and inflammatory factors are thought to be effective in this disease. Resveratrol is an antioxidant and anti-inflammatory compound. This study determined the effects of resveratrol compound on inflammatory factors in patients with ulcerative colitis. This study was a double-blind randomized clinical trial conducted on 50 patients with UC. Subjects received one capsule daily for 6 wk of either resveratrol (500 mg) or a placebo. Inflammatory factors, anthropometric measures, and IBDQ-9 (Inflammatory Bowel Disease Questionnaire-9) scores were assessed at baseline and at the end of the study. STATA12 software was used for data analysis. No significant differences were found in the background variables between the two groups at baseline. The results indicated that resveratrol supplementation for 6 week significantly decreased plasma levels of TNF-a and hs-CRP and the activity of NF-κB over the placebo group (p<0.001). Significant differences remained after adjustment for vitamin C (p<0.0001). The IBDQ-9 scores increased significantly in the resveratrol group over the placebo group (p<0.001). The findings of this study showed that resveratrol supplementation can be useful in patients with ulcerative colitis.

Keywords: IBD, inflammation, resveratrol, ulcerative colitis

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Authors: Sanaa Mekdad, Leenah Alsayed

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Pharmacists play an important role in the CDTM in the care of patients with heart failure (HF). CDTM allows specialized, dedicated clinical pharmacists in a formal agreement in collaborative practice with physicians. Thus, the aim of this study is to investigate the role of cardiology clinical pharmacists in CDTM in decreasing hospitalization and cost. We studied patients with left ventricular systolic dysfunction in a cluster-randomized selection in a tertiary care center. We allocated 296 patients to pharmacist intervention from 1480 patients. Results: With an acceptance rate of 86%, we documented 696 interventions carried out by clinical pharmacists in cardiology. The average intervention was 2.4 patients, and the admission after interventions decreased from 0.79 to. 0.24 (p value = 0.001). Conclusions: In HF CDTM, clinical pharmacists play a crucial role in enhancing medication management, patient education, and lifestyle modification of patients with chronic heart failure. These efforts improve patients' outcomes and lower costs by reducing hospitalization and other associated expenses.

Keywords: cardiology, medication management, heart failure, outpatient therapy, pharmacist-based services, chronic heart failure, heart failure recommendations, CDTM, Middle East, pharmacist-based services, quality of life, pharmacist

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Authors: Taraneh Estedlal

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The objective of this study was to review in-vivo and in-vitro studies to compare the effectiveness of bulk-fill and conventional resin composites with regard to marginal adaptation, polymerization shrinkage, and other mechanical properties.PubMed and Scopus databases was investigated for in-vitro studies and randomized clinical trials comparing incidence of fractures, color stability, marginal adaptation, pain and discomfort, recurrent caries, occlusion, pulpal reaction, and proper proximal contacts of restorations made with conventional and bulk resins. The failure rate of conventional and flowable bulk-fill resin composites was not significantly different to sculptable bulk-fill resin composites. The objective of this study was to review in-vivo and in-vitro studies to compare the effectiveness of bulk-fill and conventional resin composites with regard to marginal adaptation, polymerization shrinkage, and other mechanical properties. PubMed and Scopus databases was investigated for in-vitro studies and randomized clinical trials comparing one of the pearlier mentioned properties between bulk-fill and control composites. Despite differences in physical and in-vitro properties, failure rate of conventional and flowable bulk-fill resin composites was not significantly different to sculptable bulk-fill resin composites.

Keywords: polymerization shrinkage, color stability, marginal adaptation, recurrent caries, occlusion, pulpal reaction

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Authors: K. Hariohm, V. Prakash, J. Saravana Kumar

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Introduction and Rationale: Increased scope of Physiotherapy (PT) practice also has contributed to research in the field of PT. It is essential to determine the production and quality of the clinical trials from India since, it may reflect the scientific growth of the profession. These trends can be taken as a baseline to measure our performance and also can be used as a guideline for the future trials. Objective: To quantify and analyze qualitatively the RCT’s from India from the period 2000-2013’ May, and classify data for the information process. Methods: Studies were searched in the Medline database using the key terms “India”, “Indian”, “Physiotherapy”. Clinical trials only with PT authors were included. Trials out of scope of PT practice and on animals were excluded. Retrieved valid articles were analyzed for published year, type of participants, area of study, PEDro score, outcome measure domains of impairment, activity, participation; ‘a priori’ sample size calculation, region, and explanation of the intervention. Result: 45 valid articles were retrieved from the year 2000-2013’ May. The majority of articles were done on symptomatic participants (81%). The frequencies of conditions repeated more were low back pain (n-7) and diabetes (n-4). PEDro score with mode 5 and upper limit of 8 and lower limit 4 was found. 97.2% of studies measure the outcome at the impairment level, 34% in activity level, and 27.8% in participation level. 29.7% of studies did ‘a priori’ sample size calculation. Correlation of year trend and PEDro score found to be not significant (p>.05). Individual PEDro item analysis showed, randomization (100%), concealment (33%) baseline (76%), blinding-subject, therapist, assessor (9.1%, 0%, 10%), follow-up (89%) ITT (15%), statistics between groups (100%), measures of variance (88 %). Conclusion: The trend shows an upward slope in terms of RCTs published from India which is a good indicator. The qualitative analysis showed some gaps in the clinical trial design, which can be expected to be, fulfilled by the future researchers.

Keywords: RCT, PEDro, physical therapy, rehabilitation

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Authors: Muhammad Shafi’U Adamu

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This study examined the effects of two groups of Cognitive Behavioral Therapies (CBT) which, includes Cognitive Restructuring (CB) and Rational Emotive Behavioral Therapy (REBT), on the Psychological Distress of awaiting-trial Inmates in Correctional Centers in North-West Nigeria. The study had four specific objectives, four research questions, and four null hypotheses. The study used a quasi-experimental design that involved pre-test and post-test. The population comprised of all 7,962 awaiting-trial inmates in correctional centers in North-west Nigeria. 131 awaiting trial inmates from three intact Correctional Centers were randomly selected using the census technique. The respondents were sampled and randomly put into 3 groups (CR, REBT and Control). Kessler Psychological Distress Scale (K10) was adapted for data collection in the study. The instrument was validated by experts and subjected to a pilot study using Cronbach's Alpha with a reliability coefficient of 0.772. Each group received treatment for 8 consecutive weeks (60 minutes/week). Data collected from the field were subjected to descriptive statistics of mean, standard deviation and mean difference to answer the research questions. Inferential statistics of ANOVA and independent sample t-test were used to test the null hypotheses at P≤ 0.05 level of significance. Results in the study revealed that there was no significant difference among the pre-treatment mean scores of experimental and control groups. Statistical evidence also showed a significant difference among the mean scores of the three groups, and thus, results of the Post Hoc multiple-comparison test indicated the posttreatment reduction of psychological distress in the awaiting-trial inmates. Documented output also showed a significant difference between the post-treatment psychologically distressed mean scores of male and female awaiting-trial inmates, but there was no difference in those exposed to REBT. The research recommends that a standardized structured CBT counseling technique treatment should be designed for correctional centers across Nigeria, and CBT counseling techniques could be used in the treatment of PD in both correctional and clinical settings.

Keywords: awaiting-trial inmates, cognitive restructuring, correctional centers, rational emotive behavioral therapy

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Authors: Che Jusoh, Mohd Rahimi, Toby Mundel

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This study was designed to investigate the physiological and performance effects of a local Malaysian native starch (Metroxylin sago) on cycling in a hot (30°C) and humid (78% RH) environment. Eight male, non-heat acclimated, well-trained club cyclists (VO2max 65 ± 10 ml kg-1 min-1, peak aerobic power 397 ± 71 W) completed one familiarization and three experimental trials in our laboratory simulating cycling in environmental conditions of heat and humidity. Each trial consisted of 45 minutes at a fixed workload (55% VO2max) followed by a 15 minute time-trial (~75% VO2max). Sago in porridge form was consumed 1h before exercise (Pre), in gel form during exercise (Dur) and compared to a control trial (Con), using a random, cross-over design. Plasma glucose concentration did not differ between trials (P = 0.06) with an increase from 4.1 ± 0.6 to 6.1 ± 1.6 mmol-1 (Con), 4.8 ± 1.7 to 5.7 ± 0.4 mmol-1 (Pre) and 4.7 ± 0.8 to 6.9 ± 1.4 mmol-1 (Dur) from start to end of exercise. Plasma lactate increased (P = 0.02) from 1.6 ± 0.3 to 7.6 ± 2.2 mmol-1 (Con), 1.7 ± 0.5 to 7.3 ± 2.9 mmol-1 (Pre) and 1.6 ± 0.2 to 7.3 ± 1.8 mmol-1 (Dur) with no effect of trial (P = 0.74). No differences were found between trials for RER (P = 0.328) with values of 0.93 ± 0.05 (Con), 0.94 ± 0.04 (Pre) and 0.92 ± 0.04 (Dur). There were no differences between trials in rectal (P = 0.64) and skin (P = 0.56) temperatures; values reaching 39.1 ± 0.5°C (Con), 38.9 ± 0.4°C (Pre) and 39.1 ± 0.4°C (Dur) for rectal and 32.7 ± 1.2°C (Con), 32.8 ± 1.4°C (Pre) and 32.8 ± 1.8°C (Dur) for skin temperature, respectively. Heart rate (P = 0.07) also did not differ between trials but reached maximal values by the end of time-trial for all trials. Performance was unaffected by trial (P = 0.98) with the average work completed in 15 minutes being 221 ± 33 kJ (Con), 222 ± 31 kJ (Pre) and 219 ± 32 kJ (Dur), respectively. Therefore, the results of this investigation do not support consumption of sago, either before or during exercise, in altering the thermoregulatory, metabolic or performance responses in a hot and humid environment.

Keywords: hot and humid, physiology, time trial performance, thermoregulatory

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Authors: Madeline Foster

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Since the COVID-19 pandemic, telehealth usage for the delivery of psychotherapy has surged. The evidence base evaluating the success of telehealth interventions continues to grow, with both benefits as well as potential risks identified. This study compared two recent randomized clinical trials (RCTs) from Sweden that looked at the effectiveness of Cognitive Behavioral Therapy (CBT) delivered via telehealth (TH) versus face-to-face (FTF) for individuals with Obsessive Compulsive Disorder (OCD). The papers had mixed results. The first paper by Aspvall and colleagues compared the effect of a therapist-supported, internet-delivered stepped-care CBT program for children and adolescents aged 7 to 17 with face-to-face CBT (2021). In Aspvall’s study, the control scored a mean Y-BOCS of 10.57 and the TH intervention group scored a mean Y-BOCS of 11.57. The mean difference (0.91) met the criteria for noninferiority (p = 0.03). The second study by Lundström and colleagues also compared therapist-supported, internet-based CBT with FTF CBT for the treatment of those with DSM-5-diagnosed OCD. Conversely, while Lundström’s study reported improved symptoms across all groups, at follow up the difference in symptom severity between FTF and TH was clinically significant, with 77% of FTF participants responding to treatment compared to only 45% of TH participants. Due to the methodological limitations of Lundström’s study, it was concluded that Aspvall’s paper made a stronger scientific argument.

Keywords: telehealth, Sweden, RCT, cognitive-behavioral therapy, obsessive-compulsive disorder

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Authors: Chloe Fauchon

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

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

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Authors: Sedigheh Samimian, Sadra Ashrafi, Tahereh Khaleghdoost Mohammadi, Mohammad Reza Yeganeh, Ali Ashraf, Hamideh Hakimi, Maryam Dehghani

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Introduction: The recommended position for measuring Intra-Abdominal Pressure (IAP) is the supine position. However, patients put in this position are prone to Ventilator-associated pneumonia. This study was done to evaluate the relationship between bed head angle and IAP measurements of intubated patients in the intensive care unit. Methods: In this clinical trial, seventy-six critically ill patients under mechanical ventilation were enrolled. IAP measurement was performed every 8 hours for 24 hours using the KORN method in three different degrees of the head of bed (HOB) elevation (0°, 15°, and 30°). Bland-Altman analysis was performed to identify the bias and limits of agreement among the three HOBs. According to World Society of the Abdominal Compartment Syndrome (WSACS), we can consider two IAP techniques equivalent if a bias of <1 mmHg and limits of agreement of - 4 to +4 were found between them. Data were analyzed using SPSS statistical software (v. 19), and the significance level was considered as 0.05. Results: The prevalence of intra-abdominal hypertension was 18.42%. Mean ± standard deviation (SD) of IAP were 8.44 ± 4.02 mmHg for HOB angle 0°, 9.58 ± 4.52 for HOB angle 15°, and 11.10 ± 4.73 for HOB angle 30o (p = 0.0001). The IAP measurement bias between HOB angle 0◦ and HOB angle 15° was 1.13 mmHg. This bias was 2.66 mmHg between HOB angle 0° and HOB angle 30°. Conclusion: Elevation of HOB angle from 0 to 30 degree significantly increases IAP. It seems that the measurement of IAP at HOB angle 15° was more reliable than 30°.

Keywords: pressure, intra-abdominal hypertension, head of bed, critical care, compartment syndrome, supine position

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Authors: Muhammad Shafi'u Adamu

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This study examined the effects of two Group Cognitive Behavioural Therapies (Cognitive Restructuring and Rational Emotive Behavioural Therapy) on Psychological Distress of awaiting-trial Inmates in Correctional Centres in North-West, Nigeria. The study had four specific objectives, four research questions, and four null hypotheses. The study used a quasi-experimental design that involved pre-test and post-test. The population comprised of all 7,962 awaiting-trial inmates in correctional centres in North-west, Nigeria. 131 awaiting trial inmates from three intact Correctional Centres were randomly selected using the census technique. The respondents were sampled and randomly put into 3 groups (CR, REBT and Control). Kessler Psychological Distress Scale (K10) was adapted for data collection in the study. The instrument was validated by experts and subjected to pilot study using Cronbach's Alpha with reliability co-efficient of 0.772. Each group received treatment for 8 consecutive weeks (60 minutes/week). Data collected from the field were subjected to descriptive statistics of mean, standard deviation and mean difference to answer the research questions. Inferential statistics of ANOVA and independent sample t-test were used to test the null hypotheses at P≤ 0.05 level of significance. Results in the study revealed that there was no significant difference among the pre-treatment mean scores of experimental and control groups. Statistical evidence also showed a significant difference among the mean sores of the three groups, and thus, results of the Post Hoc multiple-comparison test indicating the posttreatment reduction of psychological distress on the awaiting-trial inmates. Documented output also showed a significant difference between the post-treatment psychologically distressed mean scores of male and female awaiting-trial inmates, but there was no difference on those exposed to REBT. The research recommends that a standardized structured CBT counselling technique treatment should be designed for correctional centres across Nigeria, and CBT counselling techniques could be used in the treatment of PD in both correctional and clinical settings.

Keywords: awaiting-trial inmates, cognitive restructuring, correctional centres, group cognitive behavioural therapies, rational emotive behavioural therapy

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Authors: Joao Paulo Matheus, Renan Fangel

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Rheumatoid arthritis is a chronic, inflammatory, systemic and progressive disease that affects the synovial joints bilaterally, causing definitive orthopedic damage. It has a higher prevalence in postmenopausal female patients. It is a disabling disease that causes joint deformities that may compromise the functionality of the affected segment. The aim of this study was to evaluate the influence of low-intensity therapeutic laser on the perception of pain and quality of life in patients with rheumatoid arthritis. This is a randomized clinical study involving 6 women with a mean age of 56.8+6.3 years. Exclusion criteria: patients with acute pain, chronic infectious disease, underlying acute or chronic underlying disease. An AsGaAl laser with 808nm wavelength, 100mW power, beam output area of 0.028cm2, power density of 3.57W/cm2 was used. The laser was applied at pre-defined points in the interphalangeal and metacarpophalangeal joints, totaling 24 points, 2 times a week, for 4 weeks, totaling 8 sessions. The Pain Inventory (IBD) and Visual Analogue Scale (VAS) were used for the analysis of pain and for the WHOQOL-bref quality of life assessment. There was no statistical difference between the onset (5.67±2.66) and the final (4.67±3.78) of treatments (p=0.70). There was also no statistical difference between the beginning (5.67±2.66) and the final (4.67±3.78) of the treatments in the VAS analysis (p=0.68). The overall mean quality of life obtained by the questionnaire at the start of treatment was 42.3±7.6, while at the end of treatment it was 58.5±7.6 (p=0.01) and the domains of the questionnaire with significant differences were: psychological domain 42.9±6.8 and 66.7±12.9 (p=0.004), social domain 39.9±5.7 and 68.1±6.3 (p=0,0005) and environmental domain 36.3±7.3 and 56.3±12.5 (p=0.003). It can be concluded that the low-intensity therapeutic laser did not produce significant changes in the painful period of rheumatoid arthritis patients. However, there was an improvement in patients' quality of life in the psychological, social and environmental aspects.

Keywords: laser therapy, pain, quality of life, rheumatoid arthritis

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Authors: Priyanka Patil, Logan Manikam

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

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

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Authors: Fateme Hadadian, Behnam Khaledi Paveh, Hosein Feizi

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Background: High number of patients with end-stage renal disease worldwide, and Iran and the patients required hemodialysis, As well as symptoms and treatment process and its impact on quality of life The researcher had to take a step towards solving these problems. Methods: In randomized clinical trial in 60 hemodialysis patients admitted to hospital hemodialysis Imam Reza (AS) were studied. Using questionnaires dialysis patients' QOL, quality of life was measured in patients and controls were divided randomly into two groups. Benson's relaxation method for the experimental group and two months at home, once per day, respectively and the control group received no special action. Immediately after the end of the period with was used for evaluating the quality of life in both the experimental and control groups were survey and data using independent t-test were used for statistical analysis. Results: The general dimensions of quality of life scores before and after intervention, there was significant difference (P=0/001). But this difference was not significant after QOL (P=0/2). Between QOL scores before and after treatment between the two groups was statistically significant (P=0/02). Conclusion: Benson relaxation has the desired effect on quality of life in hemodialysis patients and can be used as a useful method to enhance the quality of life in hemodialysis patients, implementation and training will be given.

Keywords: hemodialysis, quality of life, Benson muscle relaxation, biomedicine

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Authors: P. Vindin, R. Cordier, N. J. Wilson, H. Lee

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Engagement in community-based activities such as education, employment, and social relationships can improve the quality of life for individuals with Autism Spectrum Disorder (ASD). Community mobility is vital to attaining independence for individuals with ASD. Learning to drive and gaining a driver’s license is a critical link to community mobility; however, for individuals with ASD acquiring safe driving skills can be a challenging process. Issues related to anxiety, executive function, and social communication may affect driving behaviours. Driving training and education aimed at addressing barriers faced by learner drivers with ASD can help them improve their driving performance. A multi-site randomized controlled trial (RCT) was conducted to evaluate the effectiveness of an autism-specific driving training intervention for improving the on-road driving performance of learner drivers with ASD. The intervention was delivered via a training manual and interactive website consisting of five modules covering varying driving environments starting with a focus on off-road preparations and progressing through basic to complex driving skill mastery. Seventy-two learner drivers with ASD aged 16 to 35 were randomized using a blinded group allocation procedure into either the intervention or control group. The intervention group received 10 driving lessons with the instructors trained in the use of an autism-specific driving training protocol, whereas the control group received 10 driving lessons as usual. Learner drivers completed a pre- and post-observation drive using a standardized driving route to measure driving performance using the Driving Performance Checklist (DPC). They also completed anxiety, executive function, and social responsiveness measures. The findings showed that there were significant improvements in driving performance for both the intervention (d = 1.02) and the control group (d = 1.15). However, the differences were not significant between groups (p = 0.614) or study sites (p = 0.842). None of the potential moderator variables (anxiety, cognition, social responsiveness, and driving instructor experience) influenced driving performance. This study is an important step toward improving community mobility for individuals with ASD showing that an autism-specific driving training intervention can improve the driving performance of leaner drivers with ASD. It also highlighted the complexity of conducting a multi-site design even when sites were matched according to geography and traffic conditions. Driving instructors also need more and clearer information on how to communicate with learner drivers with restricted verbal expression.

Keywords: autism spectrum disorder, community mobility, driving training, transportation

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Authors: Judge Paul Smith

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

Keywords: criminal, law, psychological, evidence

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Authors: Ebert Brea

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

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

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Authors: Doua AlSaad, Ahmed Awaisu, Samah Elsalem, Palli Valapila Abdulrouf, Binny Thomas, Moza AlHail

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Background: It has been suggested that pyridoxine has an anti-lactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review is to evaluate the effectiveness and safety of high-dose pyridoxine in postpartum lactation inhibition. Methods: This systematic review included published trials that compared the efficacy and/or safety of pyridoxine to placebo or to other pharmacological agents for the inhibition of postpartum lactation. We searched PubMed, Embase, ScienceDirect, CINAHL, AMED, the Cochrane library, and the clinical trials registry to identify relevant literature. No limit was imposed on the year of publication of the studies, and the review included studies published until 15 January 2016. Two reviewers independently extracted data and assessed the risk of bias. Results: Seven studies were included, with a total of 1155 women, of which 471 women received pyridoxine. Three studies were randomized controlled trials, while the remaining four studies were non-randomized controlled trials. All of the included studies were relatively small (n = 18 – 482). The studies compared pyridoxine with placebo, bromocriptine, and/or stilboestrol. Pyridoxine was given orally, with a total daily dose of 450 – 600 mg for 5 to 7 days. Two trials (n = 349 participants) indicated that pyridoxine was effective in inhibiting lactation in approximately 95% of the enrolled patients. All other studies failed to demonstrate pyridoxine efficacy through either clinical assessment or prolactin level measurements. Pyridoxine safety was assessed by two trials in which no serious untoward side-effects were reported. Overall, the risk of bias for most of the studies was low to moderate. Conclusion: Current evidence supporting the effectiveness of high dose pyridoxine in the inhibition of postpartum lactation is inconsistent and insufficient. Larger randomized trials are needed to confirm the efficacy of pyridoxine in postpartum lactation inhibition. Acknowledgment: This review received a grant from the Medical Research Center of Hamad Medical Corporation in Qatar (grant number: 15100/15).

Keywords: pyridoxine, safety, effectiveness, lactation inhibition

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