Search results for: randomized controlled trials

Authors: Xinli Chi, Xiaoqi Wei

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Background: Body-mind theory refers to the concept that the mind and body are interconnected; in this case, combining aerobic exercise and mindfulness-based training may be beneficial for mind-body health; however, there is limited evidence regarding their effects and potential mechanisms among Chinese university students. Therefore, the current study aims to examine the preliminary effects and feasibility of the combined intervention on depressive and insomnia symptoms, as well as to explore the underlying mechanisms. Methods: This is a two-arm pilot study of a randomized, controlled trial. Sixty-one Chinese university students were randomly allocated to 8-week combined intervention group (aerobic exercise plus mindfulness, N = 36) or control group (N = 36). In addition, 8 participants in combined intervention group were later volunteer to engage in semi-structured interview. The Self-Rating Depression Scale (SDS) and the Youth Self-Rating Insomnia Scales (YSIS) were used to measure depressive and insomnia symptoms, respectively. The intervention outcome and feasibility were tested by repeated-measures ANOVA, mediation model, and qualitative analysis. Results: The study included 31 participants in the intervention group and 30 participants in the control group, all of whom completed pre-test and post-test questionnaires. The results of the repeated-measures ANOVA showed that the combined intervention was effective in reducing depressive and insomnia symptoms among university students. Moreover, the mediation analysis suggested that improvement in insomnia symptoms might be a significant mechanism for the combined intervention. Qualitative analysis identified two main themes: “Helpful aspects of mind-body state” (including 7 sub-themes) and “Factors that influence the training effects” (including 3 sub-themes). Conclusions: The study confirmed the preliminary effect and feasibility of the combined intervention of mindfulness and aerobic exercise, while also exploring the potential mechanisms underlying this effect. Additionally, qualitative data provided valuable insights for optimizing future protocols.

Keywords: combined intervention, mindfulness, aerobic exercise, depressive symptoms, insomnia symptoms

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Authors: Mohammad Khazaei, Reza Rostami, Hasan Gharayagh Zandi, Rouhollah Basatnia, Mahbubeh Ghayour Najafabadi

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Objective: Methylphenidate has been demonstrated to enhance attention and cognitive processes, and placebo treatments have also been found to improve attention and cognitive processes. Additionally, methylphenidate may have positive effects on motion perception and sports performance. Nevertheless, additional research is needed to fully comprehend the neural mechanisms underlying the effects of methylphenidate and placebo on cognitive and motor functions. Methods: In this randomized controlled trial, 18 young semi-professional basketball players aged 18-23 years were randomly and equally assigned to either a Ritalin or Placebo group. The participants performed 20 consecutive free throws; their scores were recorded on a 0-3 scale. The participants’ brain activity was recorded using electroencephalography (EEG) for 5 minutes seated with their eyes closed. The Ritalin group received a 10 mg dose of methylphenidate, while the Placebo group received a 10mg dose of placebo. The EEG was obtained 90 minutes after the drug was administere Results: There was no significant difference in the absolute power of brain waves between the pre-test and post-tests in the Placebo group. However, in the Ritalin group, a significant difference in the absolute power of brain waves was observed in the Theta band (5-6 Hz) and Beta band (21-30 Hz) between pre- and post-tests in Fp2, F8, and Fp1. In these areas, the absolute power of Beta waves was higher during the post-test than during the pre-test. The Placebo group showed a more significant difference in free throw scores than the Ritalin group. Conclusions: In conclusion, these results suggest that Ritalin effect on brain activity in areas associated with attention and cognitive processes, as well as improve basketball free throws. However, there was no significant placebo effect on brain activity performance, but it significantly affected the improvement of free throws. Further research is needed to fully understand the effects of methylphenidate and placebo on cognitive and motor functions.

Keywords: methylphenidate, placebo effect, electroencephalography, basketball free throw

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Authors: Nuo Xu, Sijing Chen

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Background: Childbirth is considered a critical traumatic event throughout our lives, positively or negatively impacting the mother's physiology, psychology, and even the whole family. Adverse birth experiences, such as labor pain, anxiety, and fear can negatively impact the mother. Studies had shown that the immersive nature of VR can distract attention from pain and increase focus on interventions for pain relief. However, the existing studies that applied VR to maternal delivery were still in their infancy and showed disparate results, and the small sample size is not representative, so this review analyzed the effects of VR in labor, such as on maternal pain and anxiety, with a view to providing a basis for future applications. Search strategy: We searched Pubmed, Embase, Web of Science, the Cochrane Library, CINAHL, China National Knowledge Infrastructure, Wan-Fang database from the building to November 17, 2021. Selection Criteria: Randomized controlled trials (RCTs) that intervened the pregnant women aged 18-35 years with gestational >34 weeks and without complications with VR technology were contained within this review. Data Collection and Analysis: Two researchers completed the study selection, data extraction, and assessment of study quality. For quantitative data we used MD or SMD, and RR (risk ratio) for qualitative data. Random-effects model and 95% confidence interval (95% CI) were used. Main Results: 12 studies were included. Using VR could relieve pain during labor (MD=-1.81, 95% CI (-2.04, -1.57), P< 0.00001) and active period (SMD=-0.41, 95% CI (-0.68, -0.14), P= 0.003), reduce anxiety (SMD=-1.39, 95% CI (-1.99, -0.78), P< 0.00001) and improve satisfaction (RR = 1.32; 95% CI (1.10, 1.59); P = 0.003), but the effect on the duration of first (SMD=-1.12, 95% CI (-2.38, 0.13), P=0.08) and second (SMD=-0.22, 95% CI (-0.67, 0.24), P=0.35) stage of labor was not statistically significant. Conclusions: Compared with conventional care, VR technology can relieve labor pain and anxiety and improve satisfaction. However, extensive experimental validation is still needed.

Keywords: virtual reality, delivery, labor pain, anxiety, meta-analysis, systematic review

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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: T. Penchev, D. Karastoyanov

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The results from experimental research of deformation by upsetting and die forging of lead specimens wit controlled impact are presented. Laboratory setup for conducting the investigations, which uses cold rocket engine operated with compressed air, is described. The results show that when using controlled impact is achieving greater plastic deformation and consumes less impact energy than at ordinary impact deformation process.

Keywords: rocket engine, forging hammer, sticking impact, plastic deformation

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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: Simeon E. H. Davies

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

Keywords: exertion, metabolic, progressive, random, walking

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Authors: Misbah Nizamani, Saira Malik

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Introduction: Bariatric surgery is the most effective treatment for patients suffering from morbid obesity. Laparoscopic sleeve gastrectomy (LSG) accounts for over 50% of total bariatric procedures. The aim of our meta-analysis is to investigate the effectiveness and safety of Enhanced Recovery After Surgery (ERAS) protocols for patients undergoing laparoscopic sleeve gastrectomy. Method: To gather data, we searched PubMed, Google Scholar, ScienceDirect, and Cochrane Central. Eligible studies were randomized controlled trials and cohort studies involving adult patients (≥18 years) undergoing bariatric surgeries, i.e., Laparoscopic sleeve gastrectomy. Outcome measures included LOS, postoperative narcotic usage, postoperative pain score, postoperative nausea and vomiting, postoperative complications and mortality, emergency department visits and readmission rates. RevMan version 5.4 was used to analyze outcomes. Results: Three RCTs and three cohorts with 1522 patients were included in this study. ERAS group and control group were compared for eight outcomes. LOS was reduced significantly in the intervention group (p=0.00001), readmission rates had borderline differences (p=0.35) and higher postoperative complications in the control group, but the result was non-significant (p=0.68), whereas postoperative pain score was significantly reduced (p=0.005). Total MME requirements became significant after performing sensitivity analysis (p= 0.0004). Postoperative mortality could not be analyzed on account of invalid data showing 0% mortality in two cohort studies. Conclusion: This systemic review indicated the effectiveness of the application of ERAS protocols in LSG in reducing the length of stay, post-operative pain and total MME requirements postoperatively, indicating the feasibility and assurance of its application.

Keywords: eras protocol, sleeve gastrectomy, bariatric surgery, enhanced recovery after surgery

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Authors: Sarah Ullrich, Juliane Rolle, Christian Beste, Nicole Wolff

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Inhibition and cognitive flexibility are essential parts of executive functions in our daily lives, as they enable the avoidance of unwanted responses or selectively switch between mental processes to generate appropriate behavior. There is growing interest in improving inhibition and response selection through brief mindfulness-based meditations. Arguably, open-monitoring meditation (OMM) improves inhibitory and flexibility performance by optimizing cognitive control and information processing. Yet, the underlying neurophysiological processes have been poorly studied. Using the Simon-Go/Nogo paradigm, the present work examined the effect of a single 15-minute smartphone app-based OMM on inhibitory performance and response selection in meditation novices. We used both behavioral and neurophysiological measures (event-related potentials, ERPs) to investigate which subprocesses of response selection and inhibition are altered after OMM. The study was conducted in a randomized crossover design with N = 32 healthy adults. We thereby investigated Go and Nogo trials in the paradigm. The results show that as little as 15 minutes of OMM can improve response selection and inhibition at behavioral and neurophysiological levels. More specifically, OMM reduces the rate of false alarms, especially during Nogo trials regardless of congruency. It appears that OMM optimizes conflict processing and response inhibition compared to no meditation, also reflected in the ERP N2 and P3 time windows. The results may be explained by the meta control model, which argues in terms of a specific processing mode with increased flexibility and inclusive decision-making under OMM. Importantly, however, the effects of OMM were only evident when there was the prior experience with the task. It is likely that OMM provides more cognitive resources, as the amplitudes of these EKPs decreased. OMM novices seem to induce finer adjustments during conflict processing after familiarization with the task.

Keywords: EEG, inhibition, meditation, Simon Nogo

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Authors: Mei Sze Wong, Huanyu Mou, Wai-Tong Chien

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Background: Breastmilk is the most nutritious food for infants to support their growth and protect them from infection. Therefore, breastfeeding promotion is an important topic for infant health; whereas, different educational and supportive approaches to interventions have been prompted and targeted at antenatal, postnatal, or both periods to promote and sustain exclusive breastfeeding. This systematic review aimed to identify the effective approaches of educational and supportive interventions to improve breastfeeding. Outcome measures were exclusive breastfeeding, partial breastfeeding, and breastfeeding self-efficacy, being analyzed in terms of ≤ 2 months, 3-5 months, and ≥ 6 months postpartum. Method: Eleven electronic databases and the reference lists of eligible articles were searched. English or Chinese articles of randomized controlled trials on educational and supportive intervention with the above breastfeeding outcomes over recent 20 years were searched. Quality appraisal and risk of bias of the studies were checked by Effective Public Health Practice Project tool and Revised Cochrane risk-of-bias tool, respectively. Results: 13 articles that met the inclusion criteria were included; and they had acceptable quality and risk of bias. The optimal structure, format, and delivery of the interventions significantly increased exclusive breastfeeding rate at ≤ 2 months and ≥ 6 months and breastfeeding self-efficacy at ≤ 2 months included: (a) delivering from antenatal to postnatal period, (b) multicomponent involving antenatal group education, postnatal individual breastfeeding coaching and telephone follow-ups, (c) both individual and group basis, (d) being guided by self-efficacy theory, and (e) having ≥ 3 sessions. Conclusion: The findings showed multicomponent theory-based interventions with ≥ 3 sessions that delivered across antenatal and postnatal period; using both face-to-face teaching and telephone follow-ups can be useful to enhance exclusive breastfeeding rate for more than 6 months and breastfeeding self-efficacy over the first two months of postpartum.

Keywords: breastfeeding self-efficacy, education, exclusive breastfeeding, primiparous, support

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Authors: Lucile Rapin, Cynthia El Hage, Rihab Gamaoun, Maria-Fernanda Arboleda, Erin Prosk

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Introduction: Sante Cannabis (SC), a Canadian group of clinics dedicated to medical cannabis, based in Montreal and in the province of Quebec, has served more than 8000 patients seeking cannabis-based treatment over the past five years. As randomized clinical trials with natural medical cannabis are scarce, real-world evidence offers the opportunity to fill research gaps between scientific evidence and clinical practice. Data on the use of medical cannabis products from SC patients were prospectively collected, leading to a large real-world database on the use of medical cannabis. The aim of this study was to report information on the profiles of both patients and prescribed medical cannabis products at SC clinics, and to assess the safety of medical cannabis among Canadian patients. Methods: This is an observational retrospective study of 1342 adult patients who were authorized with medical cannabis products between October 2017 and September 2019. Information regarding demographic characteristics, therapeutic indications for medical cannabis use, patterns in dosing and dosage form of medical cannabis and adverse effects over one-year follow-up (initial and 4 follow-up (FUP) visits) were collected. Results: 59% of SC patients were female, with a mean age of 56.7 (SD= 15.6, range= (19-97)). Cannabis products were authorized mainly for patients with a diagnosis of chronic pain (68.8% of patients), cancer (6.7%), neurological disorders (5.6%), and mood disorders (5.4 %). At initial visit, a large majority (70%) of patients were authorized exclusively medical cannabis products, 27% were authorized a combination of pharmaceutical cannabinoids and medical cannabis and 3% were prescribed only pharmaceutical cannabinoids. This pattern was recurrent over the one-year follow-up. Overall, oil was the preferred formulation (average over visits 72.5%) followed by a combination of oil and dry (average 19%), other routes of administration accounted for less than 4%. Patients were predominantly prescribed products with a balanced THC:CBD ratio (59%-75% across visits). 28% of patients reported at least one adverse effect (AE) at the 3-month follow-up visit and 12% at the six-month FUP visit. 84.8% of total AEs were mild and transient. No serious AE was reported. Overall, the most common side effects reported were dizziness (11.95% of total AEs), drowsiness (11.4%), dry mouth (5.5%), nausea (4.8%), headaches (4.6%), cough (4.4%), anxiety (4.1%) and euphoria (3.5%). Other adverse effects accounted for less than 3% of total AE. Conclusion: Our results confirm that the primary area of clinical use for medical cannabis is in pain management. Patients in this cohort are largely utilizing plant-based cannabis oil products with a balanced ratio of THC:CBD. Reported adverse effects were mild and included dizziness and drowsiness. This real-world data confirms the tolerable safety profile of medical cannabis and suggests medical indications not yet validated in controlled clinical trials. Such data offers an important opportunity for the investigation of the long-term effects of cannabinoid exposure in real-life conditions. Real-world evidence can be used to direct clinical trial research efforts on specific indications and dosing patterns for product development.

Keywords: medical cannabis, safety, real-world data, Canada

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Authors: Rimel Mwamba, Mohan Gundeti

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Introduction: The use of robot-assisted laparoscopic surgeries (RALS) has largely increased in recent years, offering faster and safer treatment options for pediatric patients. In the field of urology, RALS has shown a significant advantage over laparoscopic and open surgeries but continues to be controversial in pediatric cases due to limited comprehensive data on its use. Methods: In this review, we aim to summarize the factors associated with RALS use in pediatric cases involving pyeloplasty, ureteral reimplantation, heminephrectomy, and lower urinary tract reconstruction. We used PubMed, EMBASE, and the Cochrane Database of Systematic Reviews to systematically search for literature on the topic. We then critically assessed and compiled data on RALS outcomes, complications, and associated factors. Results: To date, numerous comparative studies have been conducted on pediatric RALS, with only one randomized control trial investigating the nuances of robotic use against standard of care treatments. These robotic approaches have shown promise in post-surgical outcomes for pediatric patients undergoing upper and lower urinary tract reconstruction. Barriers to use still persist, however, showcasing a need to increase access to the technology, refine instruments for pediatric use, address cost barriers, and provide proper training for surgeons. Conclusion: RALS providesan opportunity to improve pediatric patient outcomes for numerous urologic complications. Additional studies are required to better compare the use of RALS with current standard practices. Due to the difficult nature of conducting randomized control trials, additional prospective observational studies are needed.

Keywords: pediatric urology, robot-assisted laparoscopic surgeries (RALS), pyeloplasty, ureteral reimplantation, heminephrectomy, and lower urinary tract reconstruction

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Authors: Ashwini Patil

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Caudal block is one of the most commonly used regional anesthetic techniques in children. Currently, fentanyl is used as an adjuvant to bupivacaine to prolong analgesia but fentanyl is a narcotic. Dexamethasone, a glucocorticoid with strong anti-inflammatory effects provides improvement in post-operative analgesia and post-operative side effects. However, its analgesic efficacy and safety in comparison with fentanyl has not been extensively studied. So the objective of this randomized controlled study is to compare dexamethasone with fentanyl as an adjuvant to bupivacaine for caudal block in children in relation to the duration of caudal analgesia, post-operative analgesic requirement and incidence of post-operative nausea and vomiting. This study included 100 children, aged 1–6 years, undergoing lower abdominal surgeries. Patients were randomized into two groups, 50 each to receive a combination of dexamethasone 0.2 mg/kg along with 1 ml/kg bupivacaine 0.25% (group A) or combination of fentanyl (1 ug/kg) along with 1ml/kg bupivacaine 0.25% (group B). In the post-operative period, pain was assessed using a Modified Objective Pain Scale (MOPS) until 12 hr after surgery and rescue analgesia is administered when MOPS score 4 or more is recorded. Residual motor block, number of analgesic doses required within 24 hr after surgery, sedation scores, intra-operative and post-operative hemodynamic variables, post-operative nausea and vomiting (PONV), and other adverse effects were recorded. Data is analysed using unpaired t test and Significance level of P< 0.05 is considered statistically significant. Group A showed a significantly longer time to first analgesic requirement than group B (p<0.05). The number of rescue analgesic doses required in the first 24 h was significantly less in group A (p<0.05). Group A showed significantly lower MOPS scores than group B(p<0.05). Intra-operative and post-operative hemodynamic variables, Modified Bromage Scale scores, and sedation scores were comparable in both the groups. Group A showed significantly fewer incidences of PONV compared with group B(p<0.05). This study reveals that adding dexamethasone to bupivacaine prolongs the duration of postoperative analgesia and decreases the incidence of PONV as compared to combination of fentanyl to bupivacaine after a caudal block in pediatric patients.

Keywords: bupivacaine, caudal analgesia, dexamethasone, pediatric

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Authors: Elham Azimzadeh, Hamidollah Hassanlouei, Hadi Nobari, Georgian Badicu, Jorge Pérez-Gómez, Luca Paolo Ardigò

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Children with cerebral palsy (CP) have weak physical abilities and their limitations may have an effect on performing everyday motor activities. One of the most important and common debilitating factors in CP is the malfunction in the upper extremities to perform motor skills and there is strong evidence that task-specific training may lead to improve general upper limb function among this population. However, augmented feedback enhances the acquisition and learning of a motor task. Practice conditions may alter the difficulty, e.g., the reduced frequency of PG could be more challenging for this population to learn a motor task. So, the purpose of this study was to investigate the effect of physical guidance (PG) on learning a tracking task in children with cerebral palsy (CP). Twenty-five independently ambulant children with spastic hemiplegic CP aged 7-15 years were assigned randomly to five groups. After the pre-test, experimental groups participated in an intervention for eight sessions, 12 trials during each session. The 0% PG group received no PG; the 25% PG group received PG for three trials; the 50% PG group received PG for six trials; the 75% PG group received PG for nine trials; and the 100% PG group, received PG for all 12 trials. PG consisted of placing the experimenter's hand around the children's hand, guiding them to stay on track and complete the task. Learning was inferred by acquisition and delayed retention tests. The tests involved two blocks of 12 trials of the tracking task without any PG being performed by all participants. They were asked to make the movement as accurate as possible (i.e., fewer errors) and the number of total touches (errors) in 24 trials was calculated as the scores of the tests. The results showed that the higher frequency of PG led to more accurate performance during the practice phase. However, the group that received 75% PG had significantly better performance compared to the other groups in the retention phase. It is concluded that the optimal frequency of PG played a critical role in learning a tracking task in children with CP and likely this population may benefit from an optimal level of PG to get the appropriate amount of information confirming the challenge point framework (CPF), which state that too much or too little information will retard learning a motor skill. Therefore, an optimum level of PG may help these children to identify appropriate patterns of motor skill using extrinsic information they receive through PG and improve learning by activating the intrinsic feedback mechanisms.

Keywords: cerebral palsy, challenge point framework, motor learning, physical guidance, tracking task

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Authors: Maryam Shayani Rad, Seyed Ahmad Mohajeri, Mohsen Mouhebati, Seyed Danial Mousavi

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High blood pressure is one of the most important and serious health-threatening because of no symptoms in most people, which can lead to sudden heart attack, heart failure, and stroke. Nowadays, herbal medicine is one of the best and safest strategies for treatment that have no adverse effects. Apium graveolens (celery) can be used as an alternative treatment for many health conditions such as hypertension. Natural compounds reduce blood pressure via different mechanisms in which Apium graveolens extract provides potent calcium channel blocking properties. A randomized, double-blind, placebo-controlled, cross-over clinical trial was done to evaluate the efficacy of formulated Apium graveolens extract with a maximum yield of 3-n-butylphthalide to reduce systolic and diastolic blood pressure in patients with hypertension. 54 hypertensive patients in the range of 20-68 years old were randomly assigned to the treatment group (26 cases) and the placebo control group (26 cases) and were crossed over after washout duration. The treatment group received at least 2 grams of formulated powder in hard capsules orally, before each meal, 2 times daily. The control group received 2 grams of placebo in hard capsules orally, exactly as the same as shape, time, and doses of treatment group. Treatment was administrated in 12 weeks with 4 weeks washout period at the middle of the study, meaning 4 weeks drug consumption for the treatment group, 4 weeks washout and 4 weeks placebo consumption, and vice versa for the placebo control group. The clinical assessment was done 4 times, including at the beginning and ending of the drug and placebo consumption period by 24-hour ambulatory blood pressure monitoring (ABPM) holter, which measured blood pressure every 15 minutes continuously. There was a statistically significant decrease in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the end of drug duration compared to baseline. The changes after 4 weeks on average was about 12.34 mm Hg for the SBP (P < 0.005) and 7.83 mm Hg for the DBP (P < 0.005). The results from this clinical trial study showed this Apium graveolens extract formulation in the mentioned dosage had a significant effect on blood pressure-lowering for hypertensive patients.

Keywords: Apium graveolens extract, clinical trial, cross-over, hypertension

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Authors: Xiaoli Tian

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

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

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

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

Keywords: acceptability, induction, labour, membrane sweeping

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Authors: Maliha Ahmed Suleman, Sidra Ahmed Suleman

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Introduction: The use of pacifiers is common amongst infants and young children as a comforting behavior. These non-nutritive sucking habits can be detrimental to the developing occlusion should they persist while the permanent dentition is established. Orthodontic pacifiers have been recommended as an alternative to conventional pacifiers as they are considered to have less interference with orofacial development. However, there is a lack of consensus on whether this is true. Aim and objectives: To review the prevalence of malocclusion associated with the use of orthodontic pacifiers. Methodology: Literature was identified through a rigorous search of the Embase, Pubmed, CINAHL, and Cochrane Library databases. Articles published from 2000 onwards were included. In total, 5 suitable papers were identified. Results: One study showed that the use of orthodontic pacifiers increased the risk of malocclusion, as seen through a greater prevalence of accentuated overjet, posterior crossbites, and anterior open bites in comparison to individuals who did not use pacifiers. However, this study found that there was a clinically significant reduction in the prevalence of anterior open bites amongst orthodontic pacifier users in comparison to conventional pacifier users. Another study found that both types of pacifiers lead to malocclusion; however, they found no difference in the mean overjet and prevalence of anterior open bites amongst conventional and orthodontic pacifier users. In contrast, one study suggested that orthodontic pacifiers do not seem to be related to the development of malocclusions in the primary dentitions, and using them between the ages of 0-3 months was actually beneficial as it prevents thumb-sucking habits. One of the systemic reviews concluded that orthodontic pacifiers do not seem to reduce the occurrence of posterior crossbites; however, they could reduce the development of open bites by virtue of their thin neck design. Whereas another systematic review concluded that there were no differences as to the effects on the stomatognathic system when comparing conventional and orthodontic pacifiers. Conclusion: There is limited and conflicting evidence to support the notion that orthodontic pacifiers can reduce the prevalence of malocclusion when compared to conventional pacifiers. Well-designed randomized controlled trials are required in the future in order to thoroughly assess the effects of orthodontic pacifiers on the developing occlusion and orofacial structures.

Keywords: orthodontics, pacifier, malocclusion, review

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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: 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: Nahla Al-Bayyari, Rae’d Hailat

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

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

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Authors: Hung Manh Nguyen, Duong Dai Nguyen

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

Keywords: cognitive, elderly, Vietnam, Tai Chi

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Authors: Mohammed S. Bhader, Abdullah A. Ghaddaf, Anas Alamoudi, Amal Abualola, Renad Kalantan, Noura Alkhulaifi, Ibrahim Halawani, Mohammed Alhindi

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Background: Noninvasive neurally adjusted ventilatory assist (NAVA) is a relatively new mode of noninvasive ventilation with promising clinical and patient-ventilator outcomes for preterm infants. The aim of this systematic review was to compare NAVA to nasal continuous or positive airway pressure (NCPAP) or intermittent positive airway pressure (NIPP) for preterm infants. Methods: We searched the online databases Medline, Embase, and CENTRAL. We included randomized controlled trials (RCTs) that compared NAVA to NCPAP or NIPP for preterm infants < 37 weeks gestational age. We sought to evaluate the following outcomes: noninvasive intubation failure rate, desaturation rate, the fraction of inspired oxygen (FiO2), and length of stay in the neonatal intensive care unit (NICU). We used the mean difference (MD) to represent continuous outcomes, while the odds ratio (OR) was used to represent dichotomous outcomes. Results: A total of 11 RCTs that enrolled 429 preterm infants were deemed eligible. NAVA showed similar clinical outcomes to NCPAP or NIPP with respect to noninvasive intubation failure (RR for NAVA versus NCPAP: 0.82, 95% confidence interval (CI): 0.49 to 1.37), desaturation rate (RR for NAVA versus NCPAP: 0.69, 95%CI: 0.36 to 1.29; RR for NAVA versus NIPP: 0.58, 95%CI: 0.08 to 4.25), FiO2 (MD for NAVA versus NCPAP: –0.01, 95%CI: –0.04 to 0.02; MD for NAVA versus NIPP: –7.16, 95%CI: –22.63 to 8.31), and length of stay in the NICU (MD for NAVA versus NCPAP: 1.34, 95%CI: –4.17 to 6.85). Conclusion: NAVA showed similar clinical and ventilator-related outcomes compared to the usual care noninvasive respiratory support measures NCPAP or NIPP for preterm infants.

Keywords: preterm infants, noninvasive neurally adjusted ventilatory assist, NIV-NAVA, non-invasive ventilation, nasal continuous or positive airway pressure, NCPAP, intermittent positive airway pressure ventilation, NIPP, respiratory distress syndrome, RDS

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Authors: Juntip Kanjanasilp, Ratree Sawangjit, Kanokporn Meelap, Kwanchanok Kruthakool

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Depression is a common mental health disorder. Antidepressants are effective pharmacological treatments, but most patients have low medication adherence. This study aims to systematic review and meta-analysis what method increase the antidepressants adherence efficiently and improve clinical outcome. Systematic review of articles of randomized controlled trials obtained by a computerized literature search of The Cochrane, Library, Pubmed, Embase, PsycINFO, CINAHL, Education search, Web of Science and ThaiLIS (28 December 2017). Twenty-three studies were included and assessed the quality of research by ROB 2.0. The results reported that printing media improved in number of people who had medication adherence statistical significantly (p= 0.018), but education, phone call, and program utilization were no different (p=0.172, p=0.127, p=0.659). There was no significant difference in pharmacist’s group, health care team’s group and physician’s group (p=0.329, p=0.070, p=0.040). Times of intervention at 1 month and 6 months improved medication adherence significantly (p= 0.0001, p=0.013). There was significantly improved adherence in single intervention (p=0.027) but no different in multiple interventions (p=0.154). When we analyzed medication adherence with the mean score, no improved adherence was found, not relevant with who gives the intervention and times to intervention. However, the multiple interventions group was statistically significant improved medication adherence (p=0.040). Phone call and the physician’s group were statistically significant improved clinical outcomes in number of improved patients (0.025 and 0.020, respectively). But in the pharmacist’s group and physician’s group were not found difference in the mean score of clinical outcomes (p=0.993, p=0.120, respectively). Times to intervention and number of intervention were not significant difference than usual care. The overall intervention can increase antidepressant adherence, especially the printing media, and the appropriate timing of the intervention is at least 6 months. For effective treatment, the provider should have experience and expert in caring for patients with depressive disorders, such as a psychiatrist. Medical personnel should have knowledge in caring for these patients also.

Keywords: depression, medication adherence, clinical outcomes, systematic review, meta-analysis

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

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

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

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Authors: Ashu Rastogi, Uttam Thakur, Jimmy Pathak, Rajesh Gupta, Anil Bhansali

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Introduction: Liraglutide is known to induce weight loss and metabolic benefits in obese individuals. However, its effect after sleeve gastrectomy are not known. Methods: People with obesity (BMI>27.5 kg/m2) underwent LSG. Subsequently, participants were randomized to receive either 0.6mg liraglutide subcutaneously daily from 6 week post to be continued till 24 week (L-L group) or placebo (L-P group). Patients were assessed before surgery (baseline) and 6 weeks, 12weeks, 18weeks and 24weeks after surgery for height, weight, waist and hip circumference, BMI, body fat percentage, HbA1c, fasting C-peptide, fasting insulin, HOMA-IR, HOMA-β, GLP-1 levels (after standard OGTT). MRI abdomen was performed prior to surgery and at 24weeks post operatively for the estimation of intrapancreatic and intrahepatic fat content. Outcome measures: Primary outcomes were changes in metabolic variables of fasting and stimulated GLP-1 levels, insulin, c-peptide, plasma glucose levels. Secondary variables were indices of insulin resistance HOMA-IR, Matsuda index; and pancreatic and hepatic steatosis. Results: Thirty-eight patients undergoing LSG were screened and 29 participants were enrolled. Two patients withdrew consent and one patient died of acute coronary event. 26 patients were randomized and data analysed. Median BMI was 40.73±3.66 and 46.25±6.51; EBW of 49.225±11.14 and 651.48±4.85 in the L-P and L-L group, respectively. Baseline FPG was 132±51.48, 125±39.68; fasting insulin 21.5±13.99, 13.15±9.20, fasting GLP-1 2.4± .37, 2.4± .32, AUC GLP-1 340.78± 44 and 332.32 ± 44.1, HOMA-IR 7.0±4.2 and 4.42±4.5 in the L-P and L-L group, respectively. EBW loss was 47± 13.20 and 65.59± 24.20 (p<0.05) in the placebo versus liraglutide group. However, we did not observe inter-group difference in metabolic parameters between the groups in spite of significant intra-group changes after 6 months of LSG. Intra-pancreatic fat prior to surgery was 3.21±1.7 and 2.2±0.9 (p=0.38) that decreased to 2.14±1.8 and 1.06±0.8 (p=0.25) at 6 months in L-P and L-L group, respectively. Similarly, intra-pancreatic fat was 1.97±0.27 and 1.88±0.36 (p=0.361) at baseline that decreased to 1.14±0.44 and 1.36±0.47 (p=0.465) at 6 months in L-P and L-L group, respectively. Conclusion: Liraglutide augments extra body weight loss after sleeve gastrectomy. A decrease in intra-pancreatic and intra-hepatic fat is noticed after bariatric surgery without additive benefit of liraglutide administration.

Keywords: sleeve gastrectomy, liraglutide, intra-pancreatic fat, insulin

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Authors: Yemane Hailu Fissuh, Zhongzhan Zhang

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In biomedical researches and randomized clinical trials, the most commonly interested outcomes are time-to-event so-called survival data. The importance of robust models in this context is to compare the effect of randomly controlled experimental groups that have a sense of causality. Causal estimation is the scientific concept of comparing the pragmatic effect of treatments conditional to the given covariates rather than assessing the simple association of response and predictors. Hence, the causal effect based semiparametric transformation model was proposed to estimate the effect of treatment with the presence of possibly time-varying covariates. Due to its high flexibility and robustness, the semiparametric transformation model which shall be applied in this paper has been given much more attention for estimation of a causal effect in modeling left-truncated and right censored survival data. Despite its wide applications and popularity in estimating unknown parameters, the maximum likelihood estimation technique is quite complex and burdensome in estimating unknown parameters and unspecified transformation function in the presence of possibly time-varying covariates. Thus, to ease the complexity we proposed the modified estimating equations. After intuitive estimation procedures, the consistency and asymptotic properties of the estimators were derived and the characteristics of the estimators in the finite sample performance of the proposed model were illustrated via simulation studies and Stanford heart transplant real data example. To sum up the study, the bias of covariates was adjusted via estimating the density function for truncation variable which was also incorporated in the model as a covariate in order to relax the independence assumption of failure time and truncation time. Moreover, the expectation-maximization (EM) algorithm was described for the estimation of iterative unknown parameters and unspecified transformation function. In addition, the causal effect was derived by the ratio of the cumulative hazard function of active and passive experiments after adjusting for bias raised in the model due to the truncation variable.

Keywords: causal estimation, EM algorithm, semiparametric transformation models, time-to-event outcomes, time-varying covariate

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Authors: M. E. Joret, F. Germeys, P. Van de Craen

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Background: Previous studies have shown that ‘full’ bilingualism seems to enhance the executive functions in children, young adults and elderly people. Executive functions refer to a complex cognitive system responsible for self-controlled and planned behavior and seem to predict academic achievement. The present study aimed at investigating whether similar effects could be found in children learning their second language at school in immersion education programs. Methods: In this study, 44 children involved in immersion education for 4 to 5 years were compared to 48 children in traditional schools. All children were between 9 and 11 years old. To assess executive functions, the Simon task was used, a neuropsychological measure assessing executive functions with reaction times and accuracy on congruent and incongruent trials. To control for background measures, all children underwent the Raven’s coloured progressive matrices, to measure non-verbal intelligence and the Echelle de Vocabulaire en Images Peabody (EVIP), assessing verbal intelligence. In addition, a questionnaire was given to the parents to control for other confounding variables, such as socio-economic status (SES), home language, developmental disorders, etc. Results: There were no differences between groups concerning non-verbal intelligence and verbal intelligence. Furthermore, the immersion learners showed overall faster reaction times on both congruent and incongruent trials compared to the traditional learners, but only after 5 years of training, not before. Conclusion: These results show that the cognitive benefits found in ‘full’ bilinguals also appear in children involved in immersion education, but only after a sufficient exposure to the second language. Our results suggest that the amount of second language training needs to be sufficient before these cognitive effects may emerge.

Keywords: bilingualism, executive functions, immersion education, Simon task

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Authors: Najmeh Hamid, Vajiheh Hamedy , Zahra Rostamianasl

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

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

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

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

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

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