Search results for: randomized controlled trial

Authors: Joyce K. Anastasi, Bernadette Capili

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Community Engagement Strategies to Assist with the Development of an RCT Among People Living with HIV Our research team focuses on developing and testing protocols to manage chronic symptoms. For many years, our team designed and implemented symptom management studies for people living with HIV (PLWH). We identify symptoms that are not curative and are not adequately controlled by conventional therapies. As an exemplar, we describe how we successfully engaged PLWH in developing and refining our research feasibility protocol for distal sensory peripheral neuropathy (DSP) associated with HIV. With input from PLWH with DSP, our research received National Institutes of Health (NIH) research funding support. Significance: DSP is one of the most common neurologic complications in HIV. It is estimated that DSP affects 21% to 50% of PLWH. The pathogenesis of DSP in HIV is complex and unclear. Proposed mechanisms include cytokine dysregulation, viral protein-produced neurotoxicity, and mitochondrial dysfunction associated with antiretroviral medications. There are no FDA-approved treatments for DSP in HIV. Purpose: Aims: 1) to explore the impact of DSP on the lives of PLWH, 2) to identify patients’ perspectives on successful treatments for DSP, 3) to identify interventions considered feasible and sensitive to the needs of PLWH with DSP, and 4) to obtain participant input for protocol/study design. Description of Process: We conducted a needs assessment with PLWH with DSP. From our needs assessment, we learned from the patients’ perspective detailed descriptions of their symptoms; physical functioning with DSP; self-care remedies tried, and desired interventions. We also asked about protocol scheduling, instrument clarity, study compensation, study-related burdens, and willingness to participate in a randomized controlled trial (RCT) with a placebo and a waitlist group. Implications: We incorporated many of the suggestions learned from the need assessment. We developed and completed a feasibility study that provided us with invaluable information that informed subsequent NIH-funded studies. In addition to our extensive clinical and research experience working with PLWH, learning from the patient perspective helped in developing our protocol and promoting a successful plan for recruitment and retention of study participants.

Keywords: clinical trial development, peripheral neuropathy, traditional medicine, HIV, AIDS

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Authors: Bae Yu been, Choi Sung won, Lee Ju yeon, Yang Dan Bi

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The purpose of this study is to develop a self-help therapy program for bipolar disorder (BD). Psychosocial treatment is adjunct to pharmacotherapy for BD, however, it is limited and they demand high costs. Therefore, the objective of the study is to overcome these limitations by developing the self-treatment for BD. The study was examined the efficacy of the self-treatment program for BD. A randomized controlled trial compared the self-help therapy (ST) intervention with a treatment as usual (TAU) group. ST group has conducted the program for 8 weeks (16 sessions). Mood chart, Quality of Life in Bipolar Disorder Questionnaire, Attitudes toward seeking professional help Scale, BIS, CERQ, YMRS, MADRS were used by pre, post, and follow up. The efficacy of the self-help therapy was analyzed by using mixed ANOVAs. There were significant differences in the rate of occurrence of mania or depression between the two groups. ST group reported stable moods on mood chart, and reductions in mood symptoms and improvements in quality of life and treatment adherence. This study was confirmed applicable to BD to the self-help therapy for patients with BD conducted first in Korea.

Keywords: self help therapy, bipolar disorder, self help, self therapy

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

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

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

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Authors: Yulistiani Yulistiani, Wenny Nilamsari, Laurin Winarso, Rizkiya Rizkiya, Zamrotul Izzah, Budi Suprapti, Arif Bachtiar

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Approximately, a million new cases of TB have been found out per year, making Indonesia as the second greatest country with TBC after India. Nevertheless, until now, there are still many patients failure to conventional therapy with oral anti tuberculosis. Thus, the discovery of supplement therapy is urgently needed. Many studies showed that probiotic had the positive impact in lung diseases, diarrhea, pneumonia and it was attributed to its capability to balance the level of cytokine pro-inflammatory and anti-inflammatory. It was demonstrated in active disease the production of IFN-γ is strongly depressed and IL-10 level increases. This study aimed to investigate the effect of probiotic (multi strains) and vitamin B complex supplementation on IFN-γ and IL-10 level in patients with TB infection during intensive phase therapy. A randomized controlled trial, open labeled was conducted in TB patients with the following criteria: 1) age 18-55 years old 2) receiving oral antituberculosis during intensive therapy 3) not using probiotic, vitamin B1, B6, B12 2 weeks before enrollment 4) willing to participate in this study and signed an informed consent. While, patients with HIV, pregnant, had the history of diabetes mellitus, using corticosteroid or other immunosuppressants were excluded. IFN-γ and IL-10 levels were drawn before observation and after a month observation. The assay was performed by ELISA. There were seven patients in treated group and five patients in controlled group obtained in this study. Between groups, there was no statistical difference in comorbid, age, and disease duration. The mean level of IFN-γ after a month observation increased in treated group and controlled group, which were 31.47 ± 105.46 pg/ml and 15.09 ± 24.23 pg/ml, respectively (p> 0.005). Although, there were not statistically different, treated group showed a greater increase of IFN-γ level than that of the controlled group. IFN-γ plays an important role in immune response to Mycobacterium Tuberculosis, by activating macrofag, monosit and furthermore killing Mycobacterium Tuberculosis. Thus the level was expected to increase after supplementation with probiotic and Vitamin B complex. While the mean level of IL-10 also increased after one month observation in the treated group and controlled group (4.28 ± 12.29 pg/ml and 5.77± 6.21 pg/ml, respectively) (p>0.005). To be compared, the increased level of IL-10 in the treated group were lower than the controlled group, although it was not statistically different. IL-10 is a cytokine anti-inflammatory, thus, the level after the observation was expected to decrease. In this study, a month therapy of probiotic and vitamin B complex was not able to demonstrate the decrease of the IL-10 level. It is suggested to prolong observation up to 2 months, because, in intensive phase, the level of cytokine anti-inflammatory is very high, so the longer therapy is needed. It is indicated that supplementation therapy with probiotic and vitamin B complex to Oral Anti-Tuberculosis may have a positive effect on increasing IFN-γ level and slowing the progression of IL-10.

Keywords: TB Infection, IFN-γ, IL-10, probiotic, vitamin B complex

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Authors: Chariya Laohavich

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Background: Some limitations and complications have been found associated with commercial mouthpiece in bronchoscopic procedure. Therefore, we invented the Rama-chest mouthpiece from plastic normal saline bottle. Objective: The aim of this study was to compare user satisfaction in Rama-chest mouthpiece with the commercial mouthpiece. Methods: A prospective randomized controlled trial between commercial mouthpiece and Rama-chest mouthpiece was conducted on patients who were underwent bronchoscopy and required mouthpiece insertion from May to June 2014. The questionnaire about satisfaction was completed by the bronchoscopists, assistant nurses, and patients. Results: Thirty procedures in both groups were investigated. Mean satisfaction scores filled by the bronchoscopists and assistant nurses were not different between both groups. However, higher satisfaction score filled by the patients was found in Rama-chest mouthpiece than the comparator (p=0.011). Complications such as abrasion, pain, and itching were observed in commercial mouthpiece but not found in Rama-chest mouthpiece. Conclusion: We have introduced Rama-chest mouthpiece and proved its usefulness comparable to the commercial mouthpiece.

Keywords: mouthpiece, bronchoscopist, bronchology, pulmonology and respiratory diseases

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Authors: Nasrin Galehdar, Sedigheh Nadri, Elham Nazari, Isan Darvishi, Abouzar Mohammadi

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Background and aim:Nausea and vomiting are complications of cesarean section. The pharmacological and non-pharmacological approaches were applied to decrease postoperative nausea and vomiting. The aim of the present study was to compare the effects of Ondansetron and acupressure on postoperative nausea and vomiting in patients undergone an elective cesarean section. Materials and method: The study was designed as a randomized clinical trial. A total of 120 patients were allocated to two equal groups. Four mgs of Ondansetron was administered for the Ondansetron group after clamping the umbilical cord. The acupressure bracelets were fastened in the PC6 point for acupressure group for 15 minutes. The patients were monitored in terms of incidence, severity, and episodes of nausea and vomiting. The data obtained were analyzed by SPSS software version 18 with a significance level of 0.05. Results: There was no significant statistical difference in nausea severity among the groups intra-operatively, in the recovery and surgery wards. The incidence and episodes of vomiting were significantly higher in patients undergone acupressure intra-operatively, in the recovery and surgery wards (P< 0.05). No significant effect of acupressure was reported in reducing postoperative nausea and vomiting. Conclusion: No significant effect of acupressure was reported in reducing postoperative nausea and vomiting. Thus, it is suggested to perform the studies with larger size and comparing the effects of acupressure with other antiemetic medications.

Keywords: ondansetron, acupressure, nausea, vomiting

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Authors: Siamak Yaghoubi, Vahideh Rashtchi, Marzieh Khezri, Hamid Kayalha, Monadi Hamidfar

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Background and objectives: Effective postoperative pain management in abdominal surgeries, which are painful procedures, plays an important role in reducing postoperative complications and increasing patient’s satisfaction. There are many techniques for pain control, one of which is Patient-Controlled Analgesia (PCA). The aim of this study was to compare the analgesic effects of morphine, paracetamol and ketorolac in the patients undergoing open cholecystectomy, using PCA method. Material and Methods: This randomized controlled trial was performed on 330 ASA (American Society of Anesthesiology) I-II patients ( three equal groups, n=110) who were scheduled for elective open cholecystectomy in Shahid Rjaee hospital of Qazvin, Iran from August 2013 until September 2015. All patients were managed by general anesthesia with TIVA (Total Intra Venous Anesthesia) technique. The control group received morphine with maximum dose of 0.02mg/kg/h, the paracetamol group received paracetamol with maximum dose of 1mg/kg/h, and the ketorolac group received ketorolac with maximum daily dose of 60mg using IV-PCA method. The parameters of pain, nausea, hemodynamic variables (BP and HR), pruritus, arterial oxygen desaturation, patient’s satisfaction and pain score were measured every two hours for 8 hours following operation in all groups. Results: There were no significant differences in demographic data between the three groups. there was a statistically significant difference with regard to the mean pain score at all times between morphine and paracetamol, morphine and ketorolac, and paracetamol and ketorolac groups (P<0.001). Results indicated a reduction with time in the mean level of postoperative pain in all three groups. At all times the mean level of pain in ketorolac group was less than that in the other two groups (p<0.001). Conclusion: According to the results of this study ketorolac is more effective than morphine and paracetamol in postoperative pain control in the patients undergoing open cholecystectomy, using PCA method.

Keywords: analgesia, cholecystectomy, ketorolac, morphine, paracetamol

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Authors: Neerja Bharti, Drishya P.

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Introduction: Thyroidectomies are extensive surgeries involving a significant degree of tissue handling and dissection and are associated with considerable postoperative pain. Regional anaesthesia techniques have immerged as possible inexpensive and safe alternatives to opioids in the management of pain after thyroidectomy. The front of the neck is innervated by branches from the cervical plexus, and hence, several approaches for superficial and deep cervical plexus block (CPB) have been described to provide postoperative analgesia after neck surgery. However, very few studies have explored the analgesic efficacy of intermediate CPB for thyroid surgery. In this study, we have evaluated the effects of ultrasound-guided bilateral intermediate CPB on perioperative opioid consumption in patients undergoing thyroidectomy under general anesthesia. Methods: In this prospective randomized controlled study, fifty ASA grade I-II adult patients undergoing thyroidectomy were randomly divided into two groups: the study group received ultrasound-guided bilateral intermediate CPB with 10 ml 0.5% ropivacaine on each side, while the control group received the same block with 10 ml normal saline on each side just after induction of anesthesia. Anesthesia was induced with propofol, fentanyl, and vecuronium and maintained with propofol infusion titrated to maintain the BIS between 40 and 60. During the postoperative period, rescue analgesia was provided with PCA fentanyl, and the pain scores, total fentanyl consumption, and incidence of nausea and vomiting during 24 hours were recorded, and overall patient satisfaction was assessed. Results: The groups were well-matched with respect to age, gender, BMI, and duration of surgery. The difference in intraoperative propofol and fentanyl consumption was not statistically significant between groups. However, the intraoperative haemodynamic parameters were better maintained in the study group than in the control group. The postoperative pain scores, as measured by VAS at rest and during movement, were lower, and the total fentanyl consumption during 24 hours was significantly less in the study group as compared to the control group. Patients in the study group reported better satisfaction scores than those in the control group. No adverse effects of ultrasound-guided intermediate CPB block were reported. Conclusion: We concluded that ultrasound-guided intermediate cervical plexus block is a safe and effective method for providing perioperative analgesia during thyroid surgery.

Keywords: thyroidectomy, cervical plexus block, pain relief, opioid consumption

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Authors: Fasanmi Samuel Sunday

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This study investigated the influence of gender and personality traits on emotional distress among awaiting trial inmates in Nigeria. Participants were three hundred and twenty (320) awaiting trial inmates, drawn from three main correctional centres in Northeast Nigeria, namely: Gashua Correctional Centre, Postiskum Correctional Centre, and Bauchi Correctional Centre. Expo facto research design was adopted. Questionnaires such as the Big Five Inventory and the Perceived Emotional Distress Inventory (PEDI) were used to measure the variables of the study. Three hypotheses were tested. Logistic regression was used for data analysis. Results of the analysis indicated that conscientiousness significantly predicted emotional distress among awaiting trial inmates. However, most of the identified personality traits did not significantly predict emotional distress among awaiting trial inmates. There was no significant gender difference in emotional distress among awaiting-trial inmates. The implications of the study were discussed.

Keywords: personality traits, emotional distress, awaiting-trial inmates, gender

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Authors: L. Kashyap, S. Jha, D. Shende, V. K. Mohan, P. Khanna, A. Aravindan, S. Kashyap, L. Singh, S. Aggarwal

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Obesity is associated with a chronic inflammatory state. During surgery, there is an interplay between anaesthetic and surgical stress vis-a-vis the already present complex immune state. Moreover, the postoperative period is dictated by inflammation, which is crucial for wound healing and regeneration. An excess of inflammatory response might hamper recovery besides increasing the risk for infection and complications. There is definite evidence of the immunosuppressive role of inhaled anaesthetic agents. This immune modulation may be brought into effect directly by influencing the innate and adaptive immunity cells. The effects of propofol on immune mechanisms in has been widely elucidated because of its popularity. It reduces superoxide generation, elastase release, and chemotaxis. However, there is no unequivocal proof of one’s superiority over the other. Hence, an anaesthetic regimen with lesser inflammatory potential and specific to the obese patient is needed. OBESITA trial protocol (2019) by Sousa and co-workers in progress aims to test the hypothesis that anaesthesia with sevoflurane results in a weaker proinflammatory response compared to propofol, as evidenced by lower IL-6 and other biomarkers and an increased macrophage differentiation into M2 phenotype in adipose tissue. IL-6 was used as the objective parameter to evaluate inflammation as it is regulated by both surgery and anesthesia. It is the most sensitive marker of the inflammatory response to tissue damage since it is released within minutes by blood leukocytes. We hypothesized that maintenance of anaesthesia with propofol would lead to less inflammation than that with desflurane. Aims: The effect of two anaesthetic techniques, total intravenous anaesthesia (TIVA) with propofol and desflurane, on surgical stress response was evaluated. The primary objective was to compare serum interleukin-6 (IL-6) levels before and after surgery. Methods: In this prospective single-blinded randomized controlled trial undertaken, 30 obese patients (BMI>30 kg/m2) undergoing laparoscopic bariatric surgery under general anaesthesia were recruited. Patients were randomized to receive desflurane or TIVA using a target-controlled infusion for maintenance of anaesthesia. As a marker of inflammation, pre-and post-surgery IL-6 levels were compared. Results: After surgery, IL-6 levels increased significantly in both groups. The rise in IL-6 was less with TIVA than with desflurane; however, it did not reach significance. IL-6 rise post-surgery correlated positively with the complexity of procedure and duration of surgery and anaesthesia, rather than anaesthetic technique. Both groups did not differ in terms of intra-operative hemodynamic and respiratory variables, time to awakening, postoperative pulmonary complications, and duration of hospital stay. The incidence of nausea was significantly higher with desflurane than with TIVA. Conclusion: Inflammatory response did not differ as a function of anaesthetic technique when propofol and desflurane were compared. Also, patient and surgical variables dictated post-operative inflammation more than the anaesthetic factors. Further, larger sample size is needed to confirm or refute these findings.

Keywords: bariatric, biomarkers, inflammation, laparoscopy

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Authors: Betelhem M. Negede, Maarten Voors, Hugo De Groote, Bart Minten

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Farmers in Ethiopia produce most of their own food during one agricultural season per year. Therefore, they need to use on-farm storage technologies to bridge the lean season and benefit from price arbitrage. Maize stored using traditional storage bags offer no protection from insects and molds, leading to high storage losses. In Ethiopia access to and use of modern storage technologies are still limited, restraining farmers to benefit from local maize price fluctuations. We used a randomized controlled trial among 871 maize farmers to evaluate the impacts of Purdue Improved Crop Storage (PICS) bags, also known as hermetic bags, on storage losses, and especially on behavioral changes with respect to consumption, marketing, and income among maize farmers in Ethiopia. This study builds upon the limited previous experimental research that has tried to understand farmers’ grain storage and post-harvest losses and identify mechanisms behind the persistence of these challenges. Our main hypothesis is that access to PICS bags allows farmers to increase production, storage and maize income. Also delay the length of maize storage, reduce maize post-harvest losses and improve their food security. Our results show that even though farmers received only three PICS bags that represent 10percent of their total maize stored, they delay their length of maize storage for sales by two weeks. However, we find no treatment effect on maize income, suggesting that the arbitrage of two weeks is too small. Also, we do not find any reduction in storage losses due to farmers’ reaction by selling early and by using cheap and readily available but potentially harmful storage chemicals. Looking at the heterogeneity treatment effects between the treatment variable and highland and lowland villages, we find a decrease in the percentage of maize stored by 4 percent in the highland villages. This confirms that location specific factors, such as agro-ecology and proximity to markets are important factors that influence whether and how much of the harvest a farmer stores. These findings highlight the benefits of hermetic storage bags, by allowing farmers to make inter-temporal arbitrage and by reducing potential health risks from storage chemicals. The main policy recommendation that emanates from our study is that postharvest losses reduction throughout the whole value chain is an important pathway to food and income security in Sub-Saharan Africa (SSA). However, future storage loss interventions with hermetic storage technologies should take into account the agro-ecology of the study area and quantify storage losses beyond farmers self-reported losses, such as the count and weigh method. Finally, studies on hermetic storage technologies indicate positive impacts on post-harvest losses and in improving food security, but the adoption and use of these technologies is currently still low in SSA. Therefore, future works on the scaling up of hermetic bags, should consider reasons why farmers only use PICS bags to store grains for consumption, which is usually related to a safety-first approach or due to lack of incentives (higher price from maize not treated with chemicals), and no grain quality check.

Keywords: arbitrage, PICS hermetic bags, post-harvest storage loss, RCT

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Authors: Foong Kiew Ooi, Aidi Naim Mohamad Samsani, Chee Keong Chen, Mohamed Saat Ismail

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Introduction: Prolonged exercise in a hot and humid environment can result in glycogen depletion and associated with loss of body fluid. Carbohydrate contained in sports beverages is beneficial for improving sports performance and preventing dehydration. Carbohydrate contained in honey is believed can be served as an alternative form of carbohydrate for enhancing sports performance. Objective: To investigate the effectiveness of honey drink compared to sports drink as a recovery aid for running performance and physiological parameters in the heat. Method: Ten male recreational athletes (age: 22.2 ± 2.0 years, VO2max: 51.5 ± 3.7 ml.kg-1.min-1) participated in this randomized cross-over study. On each trial, participants were required to run for 1 hour in the glycogen depletion phase (Run-1), followed by a rehydration phase for 2 hours and subsequently a 20 minutes time trial performance (Run-2). During Run-1, subjects were required to run on the treadmill in the heat (31°C) with 70% relative humidity at 70 % of their VO2max. During rehydration phase, participants drank either honey drink or sports drink, or plain water with amount equivalent to 150% of body weight loss in dispersed interval (60 %, 50 % and 40 %) at 0 min, 30 min and 60 min respectively. Subsequently, time trial was performed by the participants in 20 minutes and the longest distance covered was recorded. Physiological parameters were analysed using two-way ANOVA with repeated measure and time trial performance was analysed using one-way ANOVA. Results: Result showed that Acacia honey elicited a better time trial performance with significantly longer distance compared to water trial (P<0.05). However, there was no significant difference between Acacia honey and sport drink trials (P > 0.05). Acacia honey and sports drink trials elicited 249 m (8.24 %) and 211 m (6.79 %) longer in distance compared to the water trial respectively. For physiological parameters, plasma glucose, plasma insulin and plasma free fatty acids in Acacia honey and sports drink trials were significantly higher compared to the water trial respectively during rehydration phase and time trial running performance phase. There were no significant differences in body weight changes, oxygen uptake, hematocrit, plasma volume changes and plasma cortisol in all the trials. Conclusion: Acacia honey elicited greatest beneficial effects on sports performance among the drinks, thus it has potential to be used for rehydration in athletes who train and compete in hot environment.

Keywords: honey drink, rehydration, sports performance, plasma glucose, plasma insulin, plasma cortisol

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Authors: Farzad Jalilian, Mehdi Mirzaei Alavijeh, Mohammad Ahmadpanah, Behzad Karami Matin, Abbas Aghaei, Ahmad Ali Eslami

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Background: Smoking is introduced as one of the main risky factors to develop different types of diseases around the world, especially related to non-contagious diseases. The goal of the present study was assessment of the effectiveness of web based education program to prevent cigarette smoking among college students. Methods: In a randomized controlled trial, during 2014, 150 male college students in Isfahan and Kermanshah University of medical sciences were assigned to intervention group (receiving web based education program) and control groups. The study information was analyzed by SPSS software version 21 using cross-tabulation, t-test, repeated measures and GEE. Results: It was found significantly that average response for attitude towards cigarette smoking and sensation seeking after education reduced (P < 0.05). After intervention there was no significant difference between intervention and control group of cigarette smoking (P > 0.05). Conclusion: web based education have usefulness to reduce belief towards cigarette smoking.

Keywords: web-based intervention, smoking, students, Iran

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Authors: Moses Mwangi, Geert Verbeke, Geert Molenberghs

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Cross-over designs are commonly used in randomized clinical trials to estimate efficacy of a new treatment with respect to a reference treatment (placebo or standard). The main advantage of using cross-over design over conventional parallel design is its flexibility, where every subject become its own control, thereby reducing confounding effect. Jones & Kenward, discuss in detail more recent developments in the analysis of cross-over trials. We revisit the simple piecewise linear mixed-effects model, proposed by Mwangi et. al, (in press) for its first application in the analysis of cross-over trials. We compared performance of the proposed piecewise linear mixed-effects model with two commonly cited statistical models namely, (1) Grizzle model; and (2) Jones & Kenward model, used in estimation of the treatment effect, in the analysis of randomized cross-over trial. We estimate two performance measurements (mean square error (MSE) and coverage probability) for the three methods, using data simulated from the proposed piecewise linear mixed-effects model. Piecewise linear mixed-effects model yielded lowest MSE estimates compared to Grizzle and Jones & Kenward models for both small (Nobs=20) and large (Nobs=600) sample sizes. It’s coverage probability were highest compared to Grizzle and Jones & Kenward models for both small and large sample sizes. A piecewise linear mixed-effects model is a better estimator of treatment effect than its two competing estimators (Grizzle and Jones & Kenward models) in the analysis of cross-over trials. The data generating mechanism used in this paper captures two time periods for a simple 2-Treatments x 2-Periods cross-over design. Its application is extendible to more complex cross-over designs with multiple treatments and periods. In addition, it is important to note that, even for single response models, adding more random effects increases the complexity of the model and thus may be difficult or impossible to fit in some cases.

Keywords: Evaluation, Grizzle model, Jones & Kenward model, Performance measures, Simulation

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Authors: Muhammad Fatahillah Akbar

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Criminal Procedural Law is established to protect the society from the abuse of authority. To achieve that purpose, the criminal procedural law shall be established in accordance with the laws of human right and the protection of the society. One of the mechanisms to protect human rights and to ensure the compliance of authorities in criminal procedural law is pre-trial mechanism. In many countries, there are various mechanisms of pre-trial. In the recent cases in Indonesia, pre-trial has been an interesting issue. The issue is also addressed by the Constitutional Court Decision Number 21/PUU-XII/2014 which enhance the competence of pre-trial which includes the suspect determination and the legality of seizure and search. Before that decision, some pre-trial decisions have made landmark decision by enhancing the competence of pre-trial, such as the suspect determination case in Budi Gunawan Case and legality of the investigation in Hadi Purnomo Case. These pre-trial cases occurred because the society needs protection even though it is not provided by written legislations, in this matter, The Indonesian Criminal Procedural Code (KUHAP). For instance, a person can be a suspect for unlimited time because the Criminal Procedural Code does not regulate the limit of investigation, so the suspect enactment shall be able to be challenged to protect human rights. Before the Constitutional Court Decision Suspect Determination cannot be challenged so that the society is not fully protected. The Constitutional Court Decision has provided more protections. Nowadays, investigators shall be more careful in conducting the investigation. However, those decisions, including the Constitutional Court Decision are not sufficient for society to be protected by abuse of authority. For example, on 7 March 2017, a single judge, in a Pre-Trial, at the Surabaya District Court, decided that the investigation was unlawful and shall be terminated. This is not regulated according to the Code and also any decisions in pre-trial. It can be seen that the reform of pre-trial is necessary. Hence, this paper aims to examine how pre-trial shall be developed in the future to provide wide access for society to have social justice in criminal justice system. The question will be answered by normative, historical, and comparative approaches. Firstly, the paper will examine the history of pre-trial in Indonesia and also landmark decisions on pre-trial. Then, the lessons learned from other countries regarding to the pre-trial mechanism will be elaborated to show how pre-trial shall be developed and what the competences of a pre-trial are. The focus of all discussions shall be on how the society is protected and provided access to legally complain to the authority. At the end of the paper, the recommendation to reform the pre-trial mechanism will be suggested.

Keywords: pre-trial, criminal procedural law, society

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Authors: Nuraisyah H. Zulkifley, Suriani Ismail, Rosliza Abdul Manaf, Poh Y. Lim

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Taking care of a person with dementia (PWD) is one of the most problematic and challenging caregiving situations. Without proper support, caregiver would need to deal with the impact of caregiving that would lead to caregiver burden. One of the most common tools used to measure caregiver burden among caregivers of PWD is Zarit Burden Interview (ZBI). A systematic review has been conducted through searching Medline, Science Direct, Cochrane Library, Embase, PsycINFO, ProQuest, and Scopus databases to identify relevant articles that elaborate on intervention and outcomes on ZBI among informal caregiver of PWD. The articles were searched in October 2019 with no restriction on language or publication status. Inclusion criteria are randomized control trial (RCT) studies, participants were informal caregivers of PWD, ZBI measured as outcomes, and intervention group was compared with no intervention control or usual care control. Two authors reviewed and extracted the data from the full-text articles. From a total of 344 records, nine studies were selected and included in this narrative review, and eight studies were included in the meta-analysis. The types of interventions that were implemented to ease caregiver burden are psychoeducation, physical activity, psychosocial, and computer-based intervention. The meta-analysis showed that there is a significant difference in the mean score of ZBI (p = 0.006) in the intervention group compared to the control group after implementation of intervention. In conclusion, interventions such as psychoeducation, psychosocial, and physical activity can help to reduce the burden experiencing by the caregivers of PWD.

Keywords: dementia, informal caregiver, randomized control trial, Zarit burden interview

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Authors: Zia Ul Haq, Saleem Muhammad, Naeem Ullah, Abbas Shah, Abdullah Shah

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Pakistan being the developing country is facing double burden of communicable and non-communicable disease. The aspect of secondary prevention of ischemic heart disease in developing countries is the dire need for public health specialists, clinicians and policy makers. There is some evidence that psychotherapeutic measures, including psychotherapy, recreation, exercise and stress management training have positive impact on secondary prevention of cardiovascular diseases but there are some contradictory findings as well. Cardiac rehabilitation program (CRP) has not yet fully implemented in Pakistan. Psychological, physical and specific health-related quality of life (HRQoL) outcomes needs assessment with respect to its practicality, effectiveness, and success. Objectives: To determine the effect of cardiac rehabilitation program (CRP) on the health-related quality of life (HRQoL) measures of post MI patients compared to the usual care. Hypothesis: Post MI patients who receive the interventions (CRP) will have better HRQoL as compared to those who receive the usual cares. Methods: The randomized control trial was conducted at a Cardiac Rehabilitation Unit of Lady Reading Hospital (LRH), Peshawar. LRH is the biggest hospital of the Province Khyber Pakhtunkhwa (KP). A total 206 participants who had recent first myocardial infarction were inducted in the study. Participants were randomly allocated into two group i.e. usual care group (UCG) and cardiac rehabilitation group (CRG) by permuted-block randomization (PBR) method. CRP was conducted in CRG in two phases. Three HRQoL outcomes i.e. general health questionnaire (GHQ), self-rated health (SRH) and MacNew quality of life after myocardial infarction (MacNew QLMI) were assessed at baseline and follow-up visits among both groups. Data were entered and analyzed by appropriate statistical test in STATA version 12. Results: A total of 195 participants were assessed at the follow-up period due to lost-to-follow-up. The mean age of the participants was 53.66 + 8.3 years. Males were dominant in both groups i.e. 150 (76.92%). Regarding educational status, majority of the participants were illiterate in both groups i.e. 128 (65.64%). Surprisingly, there were 139 (71.28%) who were non-smoker on the whole. The comorbid status was positive in 120 (61.54%) among all the patients. The SRH at follow-up among UCG and CRG was 4.06 (95% CI: 3.93, 4.19) and 2.36 (95% CI: 2.2, 2.52) respectively (p<0.001). GHQ at the follow-up of UCG and CRG was 20.91 (95% CI: 18.83, 21.97) and 7.43 (95% CI: 6.59, 8.27) respectively (p<0.001). The MacNew QLMI at follow-up of UCG and CRG was 3.82 (95% CI: 3.7, 3.94) and 5.62 (95% CI: 5.5, 5.74) respectively (p<0.001). All the HRQoL measures showed strongly significant improvement in the CRG at follow-up period. Conclusion: HRQOL improved in post MI patients after comprehensive CRP. Education of the patients and their supervision is needed when they are involved in their rehabilitation activities. It is concluded that establishing CRP in cardiac units, recruiting post-discharged MI patients and offering them CRP does not impose high costs and can result in significant improvement in HRQoL measures. Trial registration no: ACTRN12617000832370

Keywords: cardiovascular diseases, cardiac rehabilitation, health-related quality of life, HRQoL, myocardial infarction, quality of life, QoL, rehabilitation, randomized control trial

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Authors: Naser Shagerdi Esmaeli, Mohsen Hamidpour

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Purposes: The activation of coagulation in patients with cancer contributes significantly to morbidity and mortality rates and may play a fundamental role in the host response to growing tumor’s. Patients with cancer are clearly at high risk for the development of venous thromboembolism (VTE), particularly during chemotherapy and surgery. This situation is aggravated by the use of venous access catheters and possibly growth factors. Methods: Data derived from large, randomized, controlled trials have been used to determine the true incidence of this complication of cancer and its treatment. The incidence based on the analyses of these randomized controlled trials varies from 1% for limited stage patients with breast cancer treated with tamoxifen to 60% for patients with any type of cancer who are subjected to orthopedic surgery and do not receive prophylactic therapy. Results: In view of the morbidity and mortality attributable to VTE in cancer, widespread utilization of prophylactic anticoagulation therapy, which has proven safe and effective in a variety of situations, should be considered. While migratory thrombophlebitis is a clear indicator of an underlying neoplasm, the risk of cancer in patients with the more typical form of VTE has been the subject of intense debate over recent years. Conclusion: Some investigators have suggested that the relative risk of being diagnosed with occult cancer within six months of an episode of VTE (particularly recurrent VTE) could be up to 10-fold. However, the cost-effectiveness of aggressive screening for cancer in patients with VTE has not yet been defined adequately.

Keywords: venous thromboembolism, malignancy, cancer, tumor, heparin

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Authors: Sarah-Anne Schumann, Chintan Shah, Sandeep Ponniah, Syeachia Dennis

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Effective interventions to prevent childhood obesity include limiting sugar-sweetened beverage intake (SOR: B, longitudinal study), school and home based strategies to reduce total screen time and increase physical activity, behavioral and dietary counseling, and support for parents and families (SOR: A, meta-analysis of randomized and non-randomized controlled trials). Risk factors for childhood obesity include maternal pre-pregnancy weight, high infant birth weight, early infant rapid weight gain and maternal smoking during pregnancy which may provide opportunities to intervene and prevent childhood obesity (SOR: B, meta-analysis of observational studies).

Keywords: childhood, obesity, prevent obesity, interventions to prevent obesity

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Authors: Meryem Aydin, Serdar Karadas, Ercan Ceyhan

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The research was conducted to determine effects of salt concentrations on emergence of cowpea genotypes. Trials were performed during the year of 2014 on the laboratory of Agricultural Faculty, Selcuk University. Emergency trial was set up according to “Randomized Plots Design” by two factors and four replications with three replications. Samandag, Akkiz-86, Karnikara and Sarigobek cowpea genotypes have been used as trial material in this study. Effects of the five doses of salt concentrations (control, 30 mM, 60 mM, 90 mM and 120 mM) on the ratio of emergency, speed of emergency, average time for emergency, index of sensibility were evaluated. Responses of the cowpea genotypes for salt concentrations were found different. Comparing to the control, all of the investigated characteristics on the cowpea genotypes showed significant reduction by depending on the increasing salt application. According to the effects of salt application, the cowpea genotypes Samandag and Karnikara were the most tolerant in respect to index of sensibility while the Sarigobek genotypes was the most sensitive.

Keywords: cowpea, Vigna sinensis, emergence, salt tolerant

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Authors: Jiwon Oh, Hyunjoo Oh, Seungwon Shin, Junghee Yoo, Euiju Lee

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Background and Aims: This systematic review aimed at briefly exploring how effective pharmacoacupuncture therapy for dizziness is. Methods: We searched publications in Medline, EMBASE, Cochrane Library, KoreaMed, China National Knowledge Infrastructure (CNKI), Cinii, DBpia, KSI, Kiss, KMbase, NDSL and RISS. We included randomized controlled trials and well-designed non-randomized controlled trials that compared the effects of only pharmacoacupuncture or pharmacoacupuncture and usual therapies with any controls for dizziness. Results: The risk of bias was assessed using the Cochrane tool. Three studies have been included with eligibility criteria. The prevalence of "unclear" ratings in the risk assessment results is predominantly due to the included studies reporting their findings inadequately. This review found evidence that pharmacoacupuncture therapy was effective as an add-on therapy to acupoint therapy physiotherapy and had additional benefits in increasing CER for cervical vertigo. Also, it was recommended that pharmacoacupuncture therapy was effective as an add-on therapy to Western medicine and had additional benefits in increasing CER for vasovagal syncope. Conclusions: Pharmacoacupuncture therapy had additional benefits as an add-on therapy for cervical vertigo and vasovagal syncope. However, further studies are required to overcome the limitations of the lack of study qualities.

Keywords: pharmacoacupuncture therapy, dizziness, systematic review, traditional Korean medicine

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Authors: Amanda de Oliveira Ferreira Leite, Ana Luiza del Pino Ferreira, Bruna Garcez Correa, Janaíne de Souza Mello, Marla Manquevich, Mirna Wetters Portuguez

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Objective: We sought to investigate a neuropsychological intervention focused on improving cognition, psychological aspects, and quality of life of elderly people with mild cognitive impairment. Method: A controlled and randomized study, blind to the evaluator, was executed. We evaluated 78 elderly people, divided into the neuropsychological and control groups, through a semi-structured interview, Addenbrooke’s Cognitive Examination, Katz Index, Lawton and Brody Scale, Geriatric Depression Scale, Beck Anxiety Inventory, Personal Development Scale, WHOQOL-bref and WHOQOL--old. Results: After the intervention, the neuropsychological group showed improvement in the cognitive subtests and in the total score, reduction in the frequency of symptoms associated with anxiety and depression, better psychological well-being, and quality of life. The research highlights useful intervention strategies for improving the general condition of these patients and rehabilitating damaged areas. Conclusion: We concluded that there is a relationship between neuropsychological intervention and improvement in cognitive and psychological performance, as well as in the quality of life in elderly people with mild cognitive impairment.

Keywords: aging, mild cognitive impairment, neuropsychology, quality of life

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Authors: Derick Shi-Chen Ou, Liang-Yu Chen

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Background: Acupuncture, a potential alternative, and complementary therapy revealed insufficient evidence in depression treatment. The efficacy of acupuncture treatment was still uncertainty. To evaluate the effect of acupuncture in treating depression, the randomized controlled trials (RCTs) were examined. Methods: RCTs of the acupuncture therapy in treating major depression were searched from MEDLINE from 2007 to 2017. Keywords used for searching strategy included acupuncture, acupoint, and major depressive disorder. Results: Among the nine RCTs, four studies demonstrated great improvement in acupuncture treatment and five studies revealed the effectiveness of acupuncture intervention in medication. General trends suggest that acupuncture treatment is as effective as antidepressants with minimal side effects. Conclusion: Despite the promising results from the RCTs, there are still a variety of limitations, including small sample size, imprecise enrollment criteria, difficulties with blinding, randomization, short duration of study and lack of longitudinal follow-up. Therefore, the evidence that acupuncture as an alternative therapy for depression is inconclusive. More rigorously designed RCTs should be conducted in the future.

Keywords: acupuncture, major depressive disorders, randomized clinical trials, antidepressants

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Authors: Chia-Chen Hsieh, Fei-Hsiu Hsiao

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Objective: To examine the effects of supportive care interventions on depressive symptoms in patients with lung cancer. Methods: The databases of Cochrane Central Register of Controlled Trials (CENTRAL), Ovid EMBASE, PubMed, and Chinese Electronic Periodical Services (CEPS) were searched from their inception until September 2015. We included the studies with randomized controlled trial design that compared standard care with supportive care interventions using psychotherapeutic or exercises approach. The standardized mean differences (SMD) (Cohen’s d) were calculated to estimate the treatment effects. The Cochrane Risk of Bias Tool was used for quality assessment and subgroup analysis was conducted to identify possible sources of heterogeneity. Results: A total of 1472 patients with lung cancer were identified. Compared with standard care, the overall effects of all supportive care interventions significantly reduced depressive symptoms (SMD = -0.74 with 95% CI = -1.07 to -0.41), and the effect was maintained at the 4th, 8th, and 12th weeks of follow-up. Either psychotherapy combined with psychoeducation or exercise alone produced significant improvements in depressive symptoms, while psychoeducation alone did not. The greater improvements in depressive symptoms occurred in lung cancer patients with severe depressive symptoms at baseline, total duration of interventions of less than ten weeks, and intervention provided through face-to-face delivery. Conclusions: Psychotherapy combined with psychoeducation can help patients manage the causes of depressive symptoms, including both symptom distress and psychological trauma due to lung cancer. Exercise can target the impaired respiratory function that is a cause of depressive symptoms in lung cancer patients.

Keywords: supportive care intervention, depressive symptoms, lung cancer, meta-analysis

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Authors: Alexandria Carey, Angela Starkweather, Ann Horgas, Hwayoung Cho, Jason Beneciuk

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Background/Significance: Over 3.4 million acute axial low back pain (aLBP) cases are treated annually in the United States (US) emergency departments (ED). ED patients with aLBP receive varying verbal and written discharge routine care (RC), leading to ineffective patient self-management. Ineffective self-management increase chronic low back pain (cLPB) transition risks, a chief cause of worldwide disability, with associated costs >$60 million annually. This research addresses this significant problem by evaluating an ED digital pain self-management intervention (EDPSI) focused on improving self-management through improved knowledge retainment, skills, and self-efficacy (confidence) (KSC) thus reducing aLBP to cLBP transition in ED patients discharged with aLBP. The research has significant potential to increase self-efficacy, one of the most potent mechanisms of behavior change and improve health outcomes. Focusing on accessibility and usability, the intervention may reduce discharge disparities in aLBP self-management, especially with low health literacy. Study Questions: This research will answer the following questions: 1) Will an EDPSI focused on improving KSC progress patient self-management behaviors and health status?; 2) Is the EDPSI sustainable to improve pain severity, interference, and pain recurrence?; 3) Will an EDPSI reduce aLBP to cLBP transition in patients discharged with aLBP? Aims: The pilot randomized-controlled trial (RCT) study’s objectives assess the effects of a 12-week digital self-management discharge tool in patients with aLBP. We aim to 1) Primarily assess the feasibility [recruitment, enrollment, and retention], and [intervention] acceptability, and sustainability of EDPSI on participant’s pain self-management; 2) Determine the effectiveness and sustainability of EDPSI on pain severity/interference among participants. 3) Explore patient preferences, health literacy, and changes among participants experiencing the transition to cLBP. We anticipate that EDPSI intervention will increase likelihood of achieving self-management milestones and significantly improve pain-related symptoms in aLBP. Methods: The study uses a two-group pilot RCT to enroll 30 individuals who have been seen in the ED with aLBP. Participants are randomized into RC (n=15) or RC + EDPSI (n=15) and receive follow-up surveys for 12-weeks post-intervention. EDPSI innovative content focuses on 1) highlighting discharge education; 2) provides self-management treatment options; 3) actor demonstration of ergonomics, range of motion movements, safety, and sleep; 4) complementary alternative medicine (CAM) options including acupuncture, yoga, and Pilates; 5) combination therapies including thermal application, spinal manipulation, and PT treatments. The intervention group receives Booster sessions via Zoom to assess and reinforce their knowledge retention of techniques and provide return demonstration reinforcing ergonomics, in weeks two and eight. Outcome Measures: All participants are followed for 12-weeks, assessing pain severity/ interference using the Brief Pain Inventory short-form (BPI-sf) survey, self-management (measuring KSC) using the short 13-item Patient Activation Measure (PAM), and self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ) weeks 1, 6, and 12. Feasibility is measured by recruitment, enrollment, and retention percentages. Acceptability and education satisfaction are measured using the Education-Preference and Satisfaction Questionnaire (EPSQ) post-intervention. Self-management sustainment is measured including PSEQ, PAM, and patient satisfaction and healthcare utilization (PSHU) requesting patient overall satisfaction, additional healthcare utilization, and pain management related to continued back pain or complications post-injury.

Keywords: digital, pain self-management, education, tool

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Authors: Ashti Morovati, Hushyar Azari, Bahram Pourghassem Gargari

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

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

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Authors: Mahboobeh Sadeghi, Zahra Izadi Khah, Mansour Hakim Javadi, Masoud Gholamali Lavasani

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Background: Since there is a relation between psychological and physiological factors, the aim of this study was to examine the effect of Emotion Regulation training on cognitive emotion regulation problem in patients with Multiple Sclerosis(MS) Method: In a randomized clinical trial thirty patients diagnosed with Multiple Sclerosis referred to state welfare organization were selected. The sample group was randomized into either an experimental group or a nonintervention control group. The subjects participated in 75-minute treatment sessions held three times a week for 4weeks (12 sessions). All 30 individuals were administered with Cognitive Emotion Regulation questionnaire (CERQ). Participants completed the questionnaire in pretest and post-test. Data obtained from the questionnaire was analyzed using Mancova. Results: Emotion Regulation significantly decreased the Cognitive Emotion Regulation problems patients with Multiple sclerosis (p < 0.001). Conclusions: Emotion Regulation can be used for the treatment of cognitive-emotion regulation problem in Multiple sclerosis.

Keywords: Multiple Sclerosis, cognitive-emotion regulation, emotion regulation, MS

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Authors: Deepak Nathiya1, Ramesh Roop Rai, Pratima Singh1, Preeti Raj1, Supriya Suman, Balvir Singh Tomar

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Background: Sarcopenia is a catabolic state in liver cirrhosis (LC), accelerated with a breakdown of skeletal muscle to release amino acids which adversely affects survival, health-related quality of life, and response to any underlying disease. The primary objective of the study was to investigate the long-term effect of branched-chain amino acids (BCAA) supplementations on parameters associated with improved prognosis in sarcopenic patients with LC, as well as to evaluate its impact on cirrhotic-related events. Methods: We carried out a 24 week, single-center, randomized, open-label, controlled, two cohort parallel-group intervention trial comparing the efficacy of BCAA against lactoalbumin (L-ALB) on 106 sarcopenic liver cirrhotics. The BCAA (intervention) group was treated with 7.2 g BCAA per whereas, the lactoalbumin group was also given 6.3 g of L-Albumin. The primary outcome was to assess the impact of BCAA on parameters of sarcopenia: muscle mass, muscle strength, and physical performance. The secondary outcomes were to study combined survival and maintenance of liver function changes in laboratory and clinical markers in the duration of six months. Results: Treatment with BCAA leads to significant improvement in sarcopenic parameters: muscle strength, muscle function, and muscle mass. The total cirrhotic-related complications and cumulative event-free survival occurred fewer in the BCAA group than in the L-ALB group. Prognostic markers also improved significantly in the study. Conclusion: The current clinical trial demonstrated that long-term BCAAs supplementation improved sarcopenia and prognostic markers in patients with advanced liver cirrhosis.

Keywords: sarcopenia, liver cirrhosis, BCAA, quality of life

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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: Zi Yan

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The pedagogical value of self-assessment is widely recognized. However, identifying effective methods to help students develop productive SA practices poses a significant challenge. Since most students do not acquire self-assessment skills intuitively, they need instruction and guidance. This study is a randomized controlled trial aiming to test the effect of online self-assessment diaries on students’ achievement scores compared to a control group. Two groups of secondary school students (N=59), recruited through convenience sampling, participated in the study. The two groups were randomly designated to one of two conditions: control (n = 31) and online self-assessment diary (n = 28). The participants completed a curriculum-specific pre-test and a baseline survey on the first week of the 10-week study, as well as completed a post-test and survey by the tenth week. The results showed that the SA diary intervention had a significantly positive effect on post-intervention language learning scores after controlling for baseline scores. The findings highlight the potential of self-assessment to enhance educational outcomes, emphasizing its significant implications for educational policies that promote the integration of SA strategies into pedagogical practices.

Keywords: self-assessment, online diary, academic achievement, experimenal study

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