Search results for: randomized%20control%20trial

Authors: Richard Tanaka, Ying Zhu

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This paper studies a few randomized algorithms in application-layer peer-to-peer networks. The significant gain in scalability and resilience that peer-to-peer networks provide has made them widely used and adopted in many real-world distributed systems and applications. The unique properties of peer-to-peer networks make them particularly suitable for randomized algorithms such as random walks and gossip algorithms. Instead of simulations of peer-to-peer networks, we leverage the Docker virtual container technology to develop implementations of the peer-to-peer networks and these distributed randomized algorithms running on top of them. We can thus analyze their behaviour and performance in realistic settings. We further consider the problem of identifying high-risk bottleneck links in the network with the objective of improving the resilience and reliability of peer-to-peer networks. We propose a randomized algorithm to solve this problem and evaluate its performance by simulations.

Keywords: distributed randomized algorithms, peer-to-peer networks, virtual container technology, resilient networks

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Authors: Ebert Brea

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

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

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Authors: 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: Hassan Abo Salem, Guo Feng, Xiaolin Huang

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The objective of this study is to determine the effectiveness of mirror therapy on motor recovery and functional abilities after stroke. The following databases were searched from inception to May 2014: Cochrane Stroke, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, and PEDro. Two reviewers independently screened and selected all randomized controlled trials that evaluate the effect of mirror therapy in stroke rehabilitation.12 randomized controlled trials studies met the inclusion criteria; 10 studies utilized the effect of mirror therapy for the upper limb and 2 studies for the lower limb. Mirror therapy had a positive effect on motor recover and function; however, we found no consistent influence on activity of daily living, Spasticity and balance. This meta-analysis suggests that, Mirror therapy has additional effect on motor recovery but has a small positive effect on functional abilities after stroke. Further high-quality studies with greater statistical power are required in order to accurately determine the effectiveness of mirror therapy following stroke.

Keywords: mirror therapy, motor recovery, stroke, balance

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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: Moustafa Ibrahim Moustafa

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The purpose of this study was to determine the immediate and long term effects of a multimodal program, with the addition of cervical sagittal curve restoration and forward head correction, on severity of dizziness, disability, frequency of dizziness, and severity of cervical pain. 72 patients with cervicogenic dizziness, definite hypolordotic cervical spine, and forward head posture were randomized to experimental or a control group. Both groups received the multimodal program, additionally, the study group received the Denneroll cervical traction. All outcome measures were measured at three intervals. The general linear model indicated a significant group × time effects in favor of experimental group on measures of anterior head translation (F=329.4 P < .0005), cervical lordosis (F=293.7 P < .0005), severity of dizziness (F=262.1 P < .0005), disability (F=248.9 P < .0005), frequency of dizziness (F=53.9 P < .0005), and severity of cervical pain (F=350.1 P < .0005). The addition of Dennroll cervical traction to a multimodal program can positively affect dizziness management outcomes.

Keywords: randomized controlled trial, traction, dizziness, cervical

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Authors: Terentes Printzios Dimitrios, Loanna Gourgouli, Vlachopoulos Charalambos

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Aims: Atrial fibrillation (AF) remains one of the major causes of stroke, heart failure, sudden death and cardiovascular morbidity. Ablation techniques are becoming more appealing after the latest results of randomized trials showing the overall clinical benefit. On the other hand, imaging techniques and the frontier application of 3D printing are emerging as a valuable ally for cardiac procedures. However, no randomized trial has directly assessed the impact of preprocedural imaging and especially 3D printing guidance for AF ablation. The present study is designed to investigate for the first time the effect of 3D printing of the heart on the safety and effectiveness of the ablation procedure. Methods and design: The 3D-GALA trial is a randomized, open-label, controlled, multicentre clinical trial of 2 parallel groups designed to enroll a total of 100 patients undergoing ablation using cryo-balloon for paroxysmal and persistent AF. Patients will be randomized with a patient allocation ratio of 1: 1 to preprocedural MRI scan of the heart and 3D printing of left atrium and pulmonary veins and cryoablation versus standard cryoablation without imaging. Patients will be followed up to 6 months after the index procedure. The primary outcome measure is the reduction of radiation dose and contrast amount during pulmonary veins isolation. Secondary endpoints will include the percentage of atrial fibrillation relapse at 24h-Holter electrocardiogram monitoring at 6 months after initial treatment. Discussion: To our knowledge, the 3D-GALA trial will be the first study to provide evidence about the clinical impact of preprocedural imaging and 3D printing before cryoablation.

Keywords: atrial fibrillation, cardiac MRI, cryoablation, 3-d printing

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Authors: Paria Baharvand, Mohammad Reza Abbasi, Soha Namazi

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Introduction: Uremic pruritus (UP) is one of the major complaints in hemodialysis patients. The aim of this randomized clinical trial study was the evaluation of the anti-pruritus effect of Melatonin on hemodialysis patients with UP. Methods: This multi-centered double, blinded randomized clinical trial study was conducted on hemodialysis patients with UP that referred to the dialysis department of Imam Khomeini Hospital, Labbafinezhad Hospital and Ghiasi Hospital in Tehran, Iran, in 2018. Forty participants were enrolled and block randomization was performed by using a randomized list and divided into 2 groups of twenty patients. Evaluation of the 12-Item Pruritus Severity Scale (12-PSS), Visual analog scale (VAS), and Calculation of the affected body surface area for pruritus extent (BSA %) was performed every week. The Melatonin group received a 10 mg soft gel capsule, and the placebo group received a soft gel capsule placebo after dinner. For statistical analysis used by SPSS version 21(IRCT20180714040462N1). Results: 38 hemodialysis patients enrolled in this study. The mean age in the placebo group and in the Melatonin group was 55.88 ± 11.70 and 54.52 ± 13.00 years (p> 0.05). Also, 46% of all participants were female. Aspartate transaminase, alanine transaminase and C-reactive protein have significant differences between the two groups (p< 0.05). VAS score reduction in the two groups had a statistically significant (CI 95% = -1.71, P= 0.015(.The results of BSA% showed Melatonin had a significant effect on the decrease of the pruritus extent compared to placebo (CI 95% = -22.82, P= 0.001(. Conclusion: According to the results of this study and the preliminary effects of Melatonin on uremic pruritus, we suggest performing advanced clinical trials studies.

Keywords: Melatonin, Uremic Pruritus, hemodialysis, anti-pruritus

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Authors: Mohammad Javad Zehtab, S. Alireza Mirghasemi, Ali Majlesara, Parvin Tajik, Babak Siavashi

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Objective: There are different modalities proposed for tennis elbow treatment with few randomized trials comparing them. We designed a study to compare the effectiveness of five different modalities and determine the usefulness of recently proposed extensor grip test (EGT) in predicting the response to treatment. Methods: In a randomized controlled clinical trial 92 of 98 tennis elbow patients in Sina hospital of Tehran, Iran between 2006 and 2007 fulfill trial entry criteria, among these patients 56 (60.9%) had positive EGT result. Stratified on EGT result, patients allocated randomly to 5 treatment groups: Brace (B) group, physiotherapy (P), brace + physiotherapy (BP), injection (I) and injection + physiotherapy (IP). Results: Patients who had positive result of EGT had better response to treatments: less SOC (p = 0.06), less PFFQ and patients’ satisfaction scores (p < 0.001). Among the treatment IP was the most successful, then BP, P and B, respectively; injection was the worst treatment modality. Response to treatment was comparable in all groups between EGT positive and negative patients except bracing; in which positive EGT was correlated with a dramatic response to treatment. Conclusion: In all patients IP and then BP is recommended but in EGT negatives, bracing seems to be of no use. Injection alone is not recommended in either group.

Keywords: tennis elbow, extensor grip test, physiotherapy, tennis elbow treatment

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Authors: S. Suman, G. N. Singh

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The present manuscript addresses the estimation procedure of population parameter using Poisson probability distribution when characteristic under study possesses a rare sensitive attribute. The generalized form of unrelated randomized response model is suggested in order to acquire the truthful responses from respondents. The resultant estimators have been proposed for two situations when the information on an unrelated rare non-sensitive characteristic is known as well as unknown. The properties of the proposed estimators are derived, and the measure of confidentiality of respondent is also suggested for respondents. Empirical studies are carried out in the support of discussed theory.

Keywords: Poisson distribution, randomized response model, rare sensitive attribute, non-sensitive attribute

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Authors: Sayeeda Laeque Bangi

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Objectives: Treating white spot lesions (WSL) to create a sound and esthetically pleasing enamel surface is a question yet to be fully answered. The objective of this randomized controlled trial was to measure and compare the degree of regression of WSL during orthodontic treatment achieved by using three commercially available materials. Methods: A single-blinded randomized prospective clinical trial, comprising 80 patients categorized into four groups (one control group and three experimental groups, with 20 subjects per group) using block randomization, was conducted. Group A (control group): Colgate strong toothpaste; and experiments groups were Group B: GC tooth mousse, Group C: Phos-Flur mouthwash and Group D: SHY-NM. Subjects were instructed to use the designated dentifrice/mouthwash and photographs were taken at baseline, third and sixth months, and white spot lesions were reassessed in the maxillomandibular anterior teeth. Results: All the three groups had shown an improvement in WSL. But Group B has shown the greatest difference in mean values of decalcification index (DI) scores. Conclusion: All three commercially available products showed a regression of WSL over a 6-month duration. GC tooth mousse proved to be the most effective means of treating WSL over other regimens.

Keywords: white spot lesions, dentifrices, orthodontic therapy, remineralization

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Authors: Saeed Abbasi, Davood Farsi, Soudabeh Shafiee Ardestani, Neda Valizadeh

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Objectives: Peripheral vertigo is a common complaint of patients who are visited in emergency departments. In our study, we wanted to evaluate the effect of betahistine as an oral drug vs. intravenous diazepam for the treatment of acute peripheral vertigo. We also wanted to see the possibility of substitution of parenteral drug with an oral one with fewer side effects. Materials and Methods: In this randomized, double-blind study, 101 patients were enrolled in the study. The patients were divided in two groups in a double-blind randomized manner. Group A took oral placebo and 10 mg of intravenous diazepam. Group B received 8mg of oral betahistine and intravenous placebo. Patients’ symptoms and signs (Vertigo severity, Nausea, Vomiting, Nistagmus and Gate) were evaluated after 0, 2, 4, 6 hours by emergency physicians and data were collected by a questionnaire. Results: In both groups, there was significant improvement in vertigo (betahistine group P=0.02 and Diazepam group P=0.03). Analysis showed more improvement in vertigo severity after 4 hours of treatment in betahistine group comparing to diazepam group (P=0.02). Nausea and vomiting were significantly lower in patients receiving diazepam after 2 and 6 hours (P=0.02 & P=0.03).No statistically significant differences were found between the groups in nistagmus, equilibrium & vertigo duration. Conclusion: The results of this randomized trial showed that both drugs had acceptable therapeutic effects in peripheral vertigo, although betahistine was significantly more efficacious after 4 hours of drug intake. As for higher nausea and vomiting in betahistine group, physician should consider these side effects before drug prescription.

Keywords: acute peripheral vertigo, betahistine, diazepam, emergency department

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Authors: Somruay Apichatibutarapong, Chookiat Pudprommart

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The purpose of this study was to develop of statistical analysis by using R programming via internet applied for agriculture experimental design. Data were collected from 65 items in completely randomized design, randomized block design, Latin square design, split plot design, factorial design and nested design. The quantitative approach was used to investigate the quality of learning media on statistical analysis by using R programming via Internet by six experts and the opinions of 100 students who interested in experimental design and applied statistics. It was revealed that the experts’ opinions were good in all contents except a usage of web board and the students’ opinions were good in overall and all items.

Keywords: experimental design, r programming, applied statistics, statistical analysis

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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: Yu-Chieh Huang, Pei-Shih Chen, Tao-Hsin Tung

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Background: Urinary tract infection is the most common bacterial infection to our best knowledge. Objective: This study is to investigate whether cranberry ingesting could improve the urinary tract infection. Methods: We searched the PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 9 March 1994 and June 30, 2017, with a priori defined inclusion and exclusion criteria. The search terms included (cranberry OR Vaccinium macrocarpon OR Vaccinium oxy-coccus OR Vaccinium microcarpum OR Vaccinium erythrocarpum OR Vaccinium) AND (urinary tract infection OR bacteriuria OR pyuria) AND (effect OR effective-ness OR efficacy) AND (random OR randomized). Results: There were 26 studies met the selection criteria included among 4709 eligible participants. We analyzed all trials in meta-analysis. The random-effects pooled risk ratio (RR) for the group using cranberry versus using placebo was 0.75; 95%CI[0.63, 0.880]; p-value=0.0002) and heterogeneity was 56%. Furthermore, we divided the subjects into different subgroup to analysis. Ingesting cranberry seemed to be more effective in some subgroups, including the patients with recurrent UTI (RR, 0.71; 95%CI[0.54,0.93]; p-value=0.002) (I²= 65%) and female population (RR, 0.73, 95%CI[0.58,0.92]; p-value=0.002) (I²= 59%). The prevention effect was not different between cranberry and trimethoprim (RR, 1.25, 95%CI[0.67, 2.33]; p-value=0.49) (I²= 68%). No matter the forms of cranberry were capsules or juice, the efficacy was useful. Conclusions: It is showed that cranberry ingesting is usefully associated with prevention UTI. There are more effective in prevention of UTI in some groups.

Keywords: cranberry, effectiveness, prevention, urinary tract infect

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Authors: Akshay Patil

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Objective: Mediation analysis identifies causal pathways by testing the relationships between the NCR, the OS, and an intermediate variable that mediates the relationship between the Nimotuzumab-cisplatin-radiation (NCR) and OS. Introduction: In randomized controlled trials, the primary interest is in the mechanisms by which an intervention exerts its effects on the outcomes. Clinicians are often interested in how the intervention works (or why it does not work) through hypothesized causal mechanisms. In this work, we highlight the value of understanding causal mechanisms in randomized trial by applying causal mediation analysis in a randomized trial in oncology. Methods: Data was obtained from a phase III randomized trial (Subgroup of HPVNOCP). NCR is reported to significantly improve the OS of patients locally advanced head and neck cancer patients undergoing definitive chemoradiation. Here, based on trial data, the mediating effect of NCR on patient overall survival was systematically quantified through progression-free survival(PFS), disease free survival (DFS), Loco-regional failure (LRF), and the disease control rate (DCR), Overall response rate (ORR). Effects of potential mediators on the HR for OS with NCR versus cisplatin-radiation (CR) were analyzed by Cox regression models. Statistical analyses were performed using R software Version 3.6.3 (The R Foundation for Statistical Computing) Results: Effects of potential mediator PFS was an association between NCR treatment and OS, with an indirect-effect (IE) 0.76(0.62 – 0.95), which mediated 60.69% of the treatment effect. Taking into account baseline confounders, the overall adjusted hazard ratio of death was 0.64 (95% CI: 0.43 – 0.96; P=0.03). The DFS was also a significant mediator and had an IE 0.77 (95% CI; 0.62-0.93), 58% mediated). Smaller mediation effects (maximum 27%) were observed for LRF with IE 0.88(0.74 – 1.06). Both DCR and ORR mediated 10% and 15%, respectively, of the effect of NCR vs. CR on the OS with IE 0.65 (95% CI; 0.81 – 1.08) and 0.94(95% CI; 0.79 – 1.04). Conclusion: Our findings suggest that PFS and DFS were the most important mediators of the OS with nimotuzumab to weekly cisplatin-radiation in HPVNOCP.

Keywords: mediation analysis, cancer data, survival, NCR, HPV negative oropharyngeal

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Authors: R. C. Barbuti, M. N. Oliveira, N. P. Perina, C. Haro, P. Bosch, C. S. Bogsan, J. N. Eisig, T. Navarro-Rodriguez

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Background: The management of Helicobacter pylori (H. pylori) eradication is still a matter of discussion, full effectiveness is rarely achieved and it has many adverse effects. Probiotics are believed to have a role in eradicating and possibly preventing H. pylori infection as an adjunctive treatment. The present clinical study was undertaken to see the efficacy of a specially designed fermented milk product containing Bifidobacterium lactis B420 on the eradication of H. pylori infection in a prospective, randomized, double-blind, controlled study in humans. Method: Four test products were specially designed fermented milks, counts of viable cells in all products were 1010 Log CFU. 100 mL-1 for Bifidobacterium lactis-Bifidobacterium species 420, and 1011 Log CFU. 100 mL-1 for Streptococcus thermophiles were administered to subjects infected with H. pylori with a previous diagnosis of functional dyspepsia according to the Rome III criteria in a prospective, randomized, double-blind, placebo-controlled study in humans. Results: After FM supplementation, not all subjects showed a reduction in H. pylori colonization. Conclusion: Bifidobacterium lactis B420, administered twice a day for 90 days did not show an increase in H. pylori eradication effectiveness in Brazilian patients with functional dyspepsia.

Keywords: antibacterial therapy, Bifidobacteria fermented milk, Helicobacter pylori, probiotics

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Authors: Razieh Karimian, Kim Burton, Mohammad Mehdi Naghizadeh, Maryam Karimian

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Introduction: Habitual upper body postures are associated with online learning during the COVID-19 pandemic. This study explored whether adding an exercise routine to an ergonomic advice intervention improves these postures. Methods: In this randomized trial, 42 male adolescent students with a forward head posture were randomly divided into two equal groups, one allocated to ergonomic advice alone and the other to ergonomic advice plus an exercise routine. The angles of forward head, shoulder, and back postures were measured with a photogrammetric profile technique before and after the 8-week intervention period. Findings: During home quarantine, 76% of the students used their mobile phones, while 35% used a table-chair-computer for online learning. While significant reductions of the forward, shoulder, and back angles were found in both groups (P < 0.001), the effect was significantly greater in the exercise group (P < 0.001: forward head, shoulder, and back angles reduced by some 9, 6, and 5 degrees respectively, compared with 4 degrees in the forward head, and 2 degrees in the shoulder and back angles for ergonomic advice alone. Conclusion: The exercise routine produced a greater improvement in habitual upper body postures than ergonomic advice alone, a finding that may extend beyond online learning at home.

Keywords: randomized trial, online learning, adolescent, posture, exercise, ergonomic advice

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Authors: Pitchaporn Purngpiputtrakul, Suttasinee Petsakul, Sunisa Chatmongkolchart

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Nasogastric tube (NGT) insertion in anaesthetized and intubated patients can be challenging even for experienced anesthesiologists. Various techniques have been proposed to facilitate NGT insertion in these patients. This study aimed to compare the success rate and time required for NGT insertion between the GlideScope visualization and neck flexion with lateral neck pressure techniques. This randomized clinical trial was performed at a teaching hospital on 86 adult patients undergoing abdominal surgery under relaxant general anaesthesia who required intraoperative NGT insertion. The patients were randomized into two groups, the GlideScope group (group G) and the neck flexion with lateral neck pressure group (group F). The success rate of first and second attempts, duration of insertion, and complications were recorded. The total success rate was 79.1% in Group G compared with 76.7% in Group F (P=1) The median time required for NGT insertion was significantly longer in Group G, for both first and second attempts (97 vs 42 seconds P<0.001) and (70 vs 48.5 seconds P=0.015), respectively. Complications were reported in 23 patients (53.5%) in group G and 13 patients (30.2%) in group F. Bleeding and kinking were the most common complications in both techniques. Using GlideScope visualization to facilitate NGT insertion was comparable to neck flexion with lateral neck pressure technique in degree of success rate of insertion, while neck flexion with lateral neck pressure technique had fewer complications and was less time-consuming.

Keywords: anaesthesia, nasogastric tube, GlideScope, intubation

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Authors: Farnaz Firuzian, Farhad Choobdar, Ali Mazouri

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As Very Low Birth Weight (VLBW) neonates cannot tolerate enteral feeding, parenteral nutrition (PN) must be administered shortly after birth. To find an optimal combination of nutrition, in this study, we compare administering high glucose versus high protein intake as a component of total parenteral nutrition (TPN) to test their effect on birth weight (BW) regain in VLBW. This study employs a multi-arm randomized trial: 145 newborns with BW < 1500 g were randomized to control (C) or experimental groups: high glucose (G) or high protein (P). All samples in each group received the same TPN regimens except glucose and protein intake: Glocuse was provided by dextrose water (DW) serum: 7-15 g/kg/d (10% DW) in groups C and P versus 8.75-18.75 g/kg/d (12.5% DW) in group G. Protein provided by amino acids 3 g/kg/d for groups C and G versus 4 g/kg/d for group P. Outcomes (weight, height, and head circumference) was monitored on a daily basis until the BW was regained. Data has been gathered recently and is being processed. We hypothesize that neonates with higher amino acid intake will result in sooner BW regain than other groups. The result will be presented at the conference. The findings of this study not only can help optimize nutrition, cost reduction, and shorter NICU admission of VLBW neonates at the hospital level but eventually contribute to reduced healthcare-associated infections (HAIs) and an improved health economy.

Keywords: very low birth weight neonates, weight gain, parenteral nutrition, glucose, amino acids

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Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Calvin Pak-Wing Cheng, Julie Sittlington, Yu-Tao Xiang, Tim Man Ho Li

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Insomnia is one of the most common health problems in the general population. Insomnia can be acute, intermittent, and become chronic, often due to comorbidity with other physical and mental health conditions. Although there are conventional pharmaceutical and psychotherapeutic treatments to treat symptoms of insomnia, however; there is no robust and novel randomized controlled trial (RCT) using transdermal neurostimulation on individuals with insomnia symptoms. This gives us the impetus to execute the first nationwide RCT. Aim: To evaluate the efficacy of Electrical Vestibular Stimulation (VeNS) on individuals with insomnia in Hong Kong. Design: This study was a two-armed, double blinded, randomized, sham-controlled trial. Sampling: 60 community-dwelling adults aged 18 and 60 years with moderate insomnia symptoms or above (Insomnia Severity Index > 14) were recruited. All subjects were computerized randomized into either the active VeNS group or the sham VeNS group on a 1:1 ratio. Intervention: All participants received a home-use VeNS device and used 30-min VeNS sessions during five consecutive days across a 4-week period (total treatment hours: 10). Baseline measurements and post-VeNS evaluation of the psychological outcomes, including 1) insomnia severity, 2) sleep quality, and 3) quality of life were investigated. The short-and long-term sustainability of the VeNS intervention was assessed immediately after poststim and at a 1-month and 3-month follow-up period. Data analysis: A mixed GEE model was used to analyze the repeated measures data. Missing data were managed by multiple imputations. The level of significance was set to p < 0.05. Significance of the study: This is the first trial to examine the efficacy and safety of VeNS among adults with insomnia symptoms in Hong Kong. Findings that emerged were used to determine whether this VeNS device can be considered a self-help technological device to reduce the severity of insomnia in the community setting and to reduce the global disease burden. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04452981.

Keywords: adults, insomnia, neuromodulation, rct, vestibular stimulation

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Authors: Maryam Bahreini, Mostafa Talebi Garekani, Fatemeh Rasooli, Atefeh Abdollahi

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Introduction: Procedural sedation and analgesia have been desirable to handle painful procedures. The trend to find the agent with more efficacy and less complications is still controversial; thus, many sedative regimens have been studied. This study tried to assess the effectiveness and adverse effects of thiopental sodium-fentanyl with the known medication, ketamine-propofol for procedural sedation in the emergency department. Methods: Consenting patients were enrolled in this randomized double-blind trial to receive either 1:1 ketamine-propofol (KP) or thiopental-fentanyl (TF) 1:1 mg: Mg proportion on a weight-based dosing basis to reach the sedation level of American Society of Anesthesiologist class III/IV. The respiratory and hemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time were compared. The study was registered in Iranian randomized Control Trial Registry (Code: IRCT2015111325025N1). Results: 96 adult patients were included and randomized, 47 in the KP group and 49 in the TF group. 2.1% in the KP group and 8.1 % in the TF group experienced transient hypoxia leading to performing 4.2 % versus 8.1 % airway maneuvers for 2 groups, respectively; however, no statistically significant difference was observed between 2 combinations, and there was no report of endotracheal placement or further admission. Patient and physician satisfaction were significantly higher in the KP group. There was no difference in respiratory, gastrointestinal, cardiovascular and psychiatric adverse events, recovery time and patient recall of the procedure between groups. The efficacy and complications were not related to the type of procedure or patients’ smoking or addiction trends. Conclusion: Ketamine-propofol and thiopental-fentanyl combinations were effectively comparable although KP resulted in higher patient and provider satisfaction. It is estimated that thiopental fentanyl combination can be as potent and efficacious as ketofol with relatively similar incidence of adverse events in procedural sedation.

Keywords: adverse effects, conscious sedation, fentanyl, propofol, ketamine, safety, thiopental

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Authors: Hui-Ling Yang, Kuei-Ru Chou

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

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

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Authors: Sopana Wongtawee

Abstract:

Purpose: Adequate bowel cleansing is essential for a high quality, effective and safe colonoscopy. The aims of this study were to compare the efficacy of bowel preparation based on a low-residue diet before 8:00 followed by a clear-liquid diet, and a low-residue diet until 16:00 one day before colonoscopy using sodium phosphate solution (Xubil ®), the side effects of the two protocols and the patient satisfaction with them. Method: This was an endoscopist-blinded, prospective, randomized, controlled trial. A total of 224 patients (112 in each group) scheduled for outpatient colonoscopy met the criteria.They were randomized to either a low-residue diet consisting of white rice porridge with either fish, chicken or eggs before 8:00 followed by a clear-liquid diet (Group 1) or a low-residue diet consisting of the same food and drink, until 16:00 the day before colonoscopy(Group 2). All of them received 45 ml of sodium phosphate solution (Xubil ®) and three glasses of water (300 ml/glass) the evening before and the morning of the procedure. The cleansing efficacy of bowel preparation was rated according to the modified Rajawithi hospital bowel preparation score scale, patient satisfaction with bowel preparation was rated using Likert scale, and side effects of the 2 protocols was assessed using a patient questionnaire. Results: The cleansing efficacy between the two groups was significantly different (p=0.02). Satisfaction with bowel preparation and side effects were not different, except for the feeling of hunger in the first group (p=0.001). Conclusion: The low-residue diet consisting of white rice porridge with fish, chicken or eggs until 16:00 one day before colonoscopy achieved a better bowel-cleansing efficacy than the protocol consisting of clear liquid all day and rice porridge only before 8:00 one day before colonoscopy.

Keywords: bowel preparation, colonoscopy, sodium phosphate solution, nursing management

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Authors: Ali Faisal Saleem, Farheen Quadri, Mach Ondrej, Anita Zaidi

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Purpose: Pakistan is the final frontier for a polio-free world. Chronic malnutrition is associated with lack of effective gut immunity, and possibly associated with poliomyelitis in children received multiple OPV. We evaluate IPV dose administered together with OPV results in higher immunogenicity and mucosal immunity compared to OPV alone in chronically malnourished infants. Methods AND Materials: A community-based, unblinded-randomized-trial, conducted in 5 peri-urban, low-middle-income households of Karachi, in infants 9-12 months. Two study groups were non-malnourished (HAZ= -2 or more) and chronic malnourished (HAZ <-2SD), with 2-arms each i) OPV and ii) OPV and IPV. Two blood specimens (2ml) at baseline and at day 28 and two stool specimens (6 gm.) at day 29 and after 7 days. All infants received a bOPV challenge dose after first stool specimen. Calculates sample size was 210 in each arm. Serological (baseline compared to 28 days post-vaccine) and mucosal immunity after one week of bOPV challenge dose were study outcomes. Results: Baseline seroprevalence in malnourished infants were low compared to non-malnourished (P1, P2 and P3 (p=<0.001). There is significant rise in antibody titer and P1 seroprevalence in Mal A and B after receiving study vaccine; much higher in Mal B. Infants randomized to bOPV + IPV study vaccine showed incremental immune response against P1 (Mal B, 92.2%; Nor B, 98.4%), P2 (Mal B, 90.4%; Nor B, 94.7%), and P3 (Mal B, 85.6% and Nor B, 93.5%) was observed. A significant proportion of infants in malnourished (P1, 13%; P2, 24%; P3, 26%) and normally nourished group (P1, 5%; P2, 11%; P3, 14%) were found to be seronegative at baseline. Infants who received BOPV + IPV as their study vaccine showed a very high seroconversion response after vaccine (p=<0.001 for P1, P2 and P3). Majority of the specimens were negative at baseline (Mal A, 2%, Mal B, 1%; Nor A, 2%; Nor B, 1%), and remains negative after bOPV challenge dose (Mal A, 8%, Mal B, 6%; Nor A, 11%; Nor B, 10%). Conclusion: Malnourished-infants have low poliovirus-seroprevalence that increased remarkably after IPV. There is less viral shedding after IPV in infants.

Keywords: chronic malnutrition, infants, IPV, OPV

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

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

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

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Authors: Opara Monica, Suriani Ismail, Ahmad Iqmer Nashriq Mohd Nazan

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The true magnitude of the mortality and morbidity attributable to malaria worldwide is, at best, a scientific guess, although it is not disputable that the greatest burden is in sub-Saharan Africa. Those at highest risk are children younger than 5 years and pregnant women, particularly primigravidae. Nationally, malaria remains the third leading cause of death and is still considered a major public health problem. Therefore, this study is aimed to assess the effectiveness of health education intervention on insecticide-treated net use and its practices among pregnant women attending antenatal clinics. Materials and Methods: This study will be an intervention study with two arms double parallel randomized controlled trial (blinded) to be conducted in 3 stages. The first stage will develop health belief model (HBM) program, while in the second stage, pregnant women will be recruited, assessed (baseline data), randomized into two arms of the study, and follow-up for six months. The third stage will evaluate the impact of the intervention on HBM and disseminate the findings. Data will be collected with the use of a structured questionnaire which will contain validated tools. The main outcome measurement will be the treatment effect using HBM, while data will be analysed using SPSS, version 22. Discussion: The study will contribute to the existing knowledge on hospital-based care programs for pregnant women in developing countries where the literature is scanty. It will generally give insight into the importance of HBM measurement in interventional studies on malaria and other related infectious diseases in this setting.

Keywords: malaria, health education, insecticide-treated nets, sub-Saharan Africa

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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: Rama Krishna Supramanian, Marzuki Isahak, Noran Naqiah Hairi

Abstract:

Noise-induced hearing loss (NIHL) is one of the highest recorded occupational diseases, despite being preventable. Hearing Conservation Program (HCP) is designed to protect workers hearing and prevent them from developing hearing impairment due to occupational noise exposures. However, there is still a lack of evidence regarding the effectiveness of this program. The purpose of this study was to determine the effectiveness of a Hearing Conservation Program (HCP) in preventing or reducing audiometric threshold changes among vector control workers. This study adopts a cluster randomized controlled trial study design, with district health offices as the unit of randomization. Nine district health offices were randomly selected and 183 vector control workers were randomized to intervention or control group. The intervention included a safety and health policy, noise exposure assessment, noise control, distribution of appropriate hearing protection devices, training and education program and audiometric testing. The control group only underwent audiometric testing. Audiometric threshold changes observed in the intervention group showed improvement in the hearing threshold level for all frequencies except 500 Hz and 8000 Hz for the left ear. The hearing threshold changes range from 1.4 dB to 5.2 dB with largest improvement at higher frequencies mainly 4000 Hz and 6000 Hz. Meanwhile for the right ear, the mean hearing threshold level remained similar at 4000 Hz and 6000 Hz after 3 months of intervention. The Hearing Conservation Program (HCP) is effective in preserving the hearing of vector control workers involved in fogging activity as well as increasing their knowledge, attitude and practice towards noise-induced hearing loss (NIHL).

Keywords: adult, hearing conservation program, noise-induced hearing loss, vector control worker

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Authors: Somaye Ghafarpour, Kamran Yazdanbakhsh, Mohamad Reza Zarbakhsh, Simin Hosseinian, Samira Ghafarpour

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Unsatisfactory sleep quality is one of the most common complications of pregnancy, which can predispose mothers to postpartum depression, requiring implementing effective psychological interventions to prevent and modify behaviors accentuating sleep problems. This study was a randomized clinical controlled trial with a pre-test/post-test design aiming to investigate the effectiveness of sleep behavioral interventions during the third trimester of pregnancy on sleep quality and postpartum depression. A total of 50 pregnant mothers in the 26-30 weeks of pregnancy suffering from sleep problems (based on the score obtained from the Pittsburgh Sleep Questionnaire) were randomized into two groups (control and intervention, n= 25 per group). The data were collected using interviews, the Pittsburgh Sleep Quality Index (PSQI), and the Edinburgh Postnatal Depression Scale (EPDS) were used. The participants in the intervention group received eight 60-minute sessions of combinational training for behavioral therapy techniques. At the end of the intervention and four weeks after delivery, sleep quality and postpartum depression were evaluated. Considering that the Kolmogorov Smirnov test confirmed the normal distribution of the data, the independent t-test and analysis of covariance were used to analyze the data, showing that the behavioral interventions were effective on the overall sleep quality after delivery (p=0.001); however, no statistically significant effects were observed on postpartum depression, the sub-scales of sleep disorders, and daily functioning (p>0.05). Considering the potential effectiveness of behavioral interventions in improving sleep quality and alleviating insomnia symptoms, it is recommended to implement such measures as an effective intervention to prevent or treat these problems during prenatal and postnatal periods.

Keywords: behavioral interventions, sleep quality, postpartum depression, pregnancy, delivery

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