Search results for: randomized controlled trials

Authors: Giannis Arnaoutis, Dimitra Efthymiopoulou, Maria-Foivi Nikolopoulou, Yannis Manios

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AIM: Nitrate-containing supplements have been used extensively as ergogenic in many sports. However, extract fractions from plant-based nutritional sources high in nitrate and their effect on athletic performance, has not been systematically investigated. The purpose of the present study was to examine the possible effect of acute consumption of a “smart mixture” from beetroot and rocket on exercise capacity. MATERIAL & METHODS: 12 healthy, nonsmoking, recreationally active, males (age: 25±4 years, % fat: 15.5±5.7, Fat Free Mass: 65.8±5.6 kg, VO2 max: 45.46.1 mL . kg -1 . min -1) participated in a double-blind, placebo-controlled trial study, in a randomized and counterbalanced order. Eligibility criteria for participation in this study included normal physical examination, and absence of any metabolic, cardiovascular, or renal disease. All participants completed a time to exhaustion cycling test at 75% of their maximum power output, twice. The subjects consumed either capsules containing 360 mg of nitrate in total or placebo capsules, in the morning, under fasted state. After 3h of passive recovery the performance test followed. Blood samples were collected upon arrival of the participants and 3 hours after the consumption of the corresponding capsules. Time until exhaustion, pre- and post-test lactate concentrations, and rate of perceived exertion for the same time points were assessed. RESULTS: Paired-sample t-test analysis found a significant difference in time to exhaustion between the trial with the nitrate consumption versus placebo [16.1±3.0 Vs 13.5±2.6 min, p=0.04] respectively. No significant differences were observed for the concentrations of lactic acid as well as for the values in the Borg scale between the two trials (p>0.05). CONCLUSIONS: Based on the results of the present study, it appears that a nutritional supplement derived from vegetable extracts rich in nitrate, improves athletic performance in recreationally active young males. However, the precise mechanism is not clear and future studies are needed. Acknowledgment: This research has been co‐financed by the European Regional Development Fund of the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship and Innovation, under the call RESEARCH – CREATE – INNOVATE (project code:T2EDK-00843).

Keywords: sports performance, ergogenic supplements, nitrate, extract fractions

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Authors: Ayça Utkan Karasu, Elif Balevi Batur, Gülçin Kaymak Karataş

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The aim of this study was to examine the efficiency of virtual reality exercises with Nintendo Wii system on balance and independence in motor functions. This randomized controlled assessor-blinded study included 23 stroke inpatients with hemiparesis all within 12 months poststroke. Patients were randomly assigned to control group (n=11) or experimental group (n=12) via block randomization method. Control group participated in a conventional balance rehabilitation programme. Study group received a four-week balance training programme five times per week with a session duration of 20 minutes in addition to the conventional balance rehabilitation programme. Balance was assessed by the Berg’s balance scale, the functional reach test, the timed up and go test, the postural assessment scale for stroke, the static balance index. Also, displacement of centre of pressure sway and centre of pressure displacement during weight shifting was calculated by Emed-SX system. Independence in motor functions was assessed by The Functional Independence Measure (FIM) ambulation and FIM transfer subscales. The outcome measures were evaluated at baseline, 4th week (posttreatment), 8th week (follow-up). Repeated measures analysis of variance was performed for each of the outcome measure. Significant group time interaction was detected in the scores of the Berg’s balance scale, the functional reach test, eyes open anteroposterior and mediolateral center of pressure sway distance, eyes closed anteroposterior center of pressure sway distance, center of pressure displacement during weight shifting to effected side, unaffected side and total centre of pressure displacement during weight shifting (p < 0.05). Time effect was statistically significant in the scores of the Berg’s balance scale, the functional reach test, the timed up and go test, the postural assessment scale for stroke, the static balance index, eyes open anteroposterior and mediolateral center of pressure sway distance, eyes closed mediolateral center of pressure sway distance, the center of pressure displacement during weight shifting to effected side, the functional independence measure ambulation and transfer scores (p < 0.05). Virtual reality exercises with Nintendo Wii system combined with a conventional balance rehabilitation programme enhances balance performance and independence in motor functions in stroke patients.

Keywords: balance, hemiplegia, stroke rehabilitation, virtual reality

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

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

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

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Authors: M. Kalyan Raj, Vinay Umesh Rao, M. Sudhakar

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The work focuses on the development of a directly compressible controlled release co-processed excipient using melt granulation technique. Erodible wax matrix systems are fabricated in which three different types of waxes are co processed separately with Maize starch in different ratios by melt granulation. The resultant free flowing powder is characterized by FTIR, NMR, Mass spectrophotometer and gel permeation chromatography. Also, controlled release tablets of Aripiprazole were formulated and dissolution profile was compared with that of the target product profile given in Zysis patent (Patent no. 20100004262) for Aripiprazole once a week formulation.

Keywords: co-processing, hot melt extrusion, direct compression, maize starch, stearic acid, aripiprazole

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Authors: Shahnaz Haque, Anand Shukla, Sunita Singh, Anil Kem

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Introduction: Diabetes Mellitus is a chronic metabolic disease affecting millions worldwide. Metformin is the most commonly prescribed first line oral hypoglycemic drug for type 2 diabetes mellitus, but due to progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary. Objective: This study was designed to assess the treatment satisfaction between Sitagliptin versus Pioglitazone added to Metformin in patients with type 2 diabetes mellitus (T2DM). Methods: We conducted a prospective, open label, randomized, parallel group study in SIMS, Hapur, U.P. Eligible patients fulfilling inclusion criteria were randomized into two groups having 25 patients in each group using tab Sitagliptin 100mg, tab Pioglitazone 30mg added to ongoing tab Metformin (500mg) therapy for 16 weeks. The follow-up visits were on weeks 4,12 and 16. Result: 16 weeks later, addition of Sitagliptin 100mg compared to that of Pioglitazone 30 mg to ongoing Metformin therapy provided similar glycosylated hemoglobin (HbA1c) lowering efficacy in patients with T2DM with inadequate glycemic control on metformin monotherapy. Change in HbA1c in group1 was -0.656±0.21%(p<0.0001) whereas in group2 was -0.748±0.35%(p<0.0001). Hence decrease in HbA1c from baseline was more in group2. Both treatments were well tolerated with negligible risk of hypoglycaemia. Weight loss was observed with Sitagliptin in contrast to weight gain seen in Pioglitazone. Conclusion: In this study, Sitagliptin 100 mg along with metformin therapy in comparison to pioglitazone 30 mg plus metformin therapy was both effective, well-tolerated and improved glycemic control in both the groups. Addition of pioglitazone had cause oedema and weight gain to the patients whereas sitagliptin caused weight loss in its patients.

Keywords: sitagliptin, pioglitazone, metformin, type 2 diabetes mellitus

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Authors: Ce Liu, Wei Huo

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A nonlinear trajectory tracking controller for quadrotor helicopter based on controlled Lagrangian (CL) method is proposed in this paper. A Lagrangian system with virtual angles as generated coordinates rather than Euler angles is developed. Based on the model, the matching conditions presented by nonlinear partial differential equations are simplified and explicitly solved. Smooth tracking control laws and the range of control parameters are deduced based on the controlled energy of closed-loop system. Besides, a constraint condition for reference accelerations is deduced to identify the trackable reference trajectories by the proposed controller and to ensure the stability of the closed-loop system. The proposed method in this paper does not rely on the division of the quadrotor system, and the design of the control torques does not depend on the thrust as in backstepping or hierarchical control method. Simulations for a quadrotor model demonstrate the feasibility and efficiency of the theoretical results.

Keywords: quadrotor, trajectory tracking control, controlled lagrangians, underactuated system

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Authors: Catarina Isabel Ramos Pereira, Jorge Machado, Begona Alonso Criado, Maria João Santos

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Introduction: Gait disorders are one of the symptoms that have severe implications on the quality of life in Parkinson's disease (PD). Currently, there is no therapy to reverse or treat this condition. None of the drugs used in conventional medical treatment is entirely efficient, and all have a high incidence of side effects. Acupuncture treatment is believed to improve motor ability, but there is still little scientific evidence in individuals with PD. Aim: The aim of the study is to investigate the acute effect of acupuncture on gait parameters in Parkinson's disease. Methods: This is a randomized and controlled crossover study. The same individual patient was part of both the experimental (real acupuncture) and control group (false acupuncture/sham), and the sequence was randomized. Gait parameters were measured at two different moments, before and after treatment, using four force platforms as well as the collection of 3D markers positions taken by 11 cameras. Images were quantitatively analyzed using Qualisys Track Manager software that let us extract data related to the quality of gait and balance. Seven patients with the diagnosis of Parkinson's disease were included in the study. Results: Statistically significant differences were found in gait speed (p = 0.016), gait cadence (p = 0.006), support base width (p = 0.0001), medio-lateral oscillation (p = 0.017), left-right step length (p = 0.0002), and stride length: right-right (p = 0.0000) and left-left (p = 0.0018), time of left support phase (p = 0.029), right support phase (p = 0.025) and double support phase (p = 0.015), between the initial and final moments for the experimental group. Differences in right-left stride length were found for both groups. Conclusion: Our results show that acupuncture could enhance gait in Parkinson's disease patients. Deep research involving a larger number of volunteers should be accomplished to validate these encouraging findings.

Keywords: acupuncture, traditional Chinese medicine, Parkinson's disease, gait

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Authors: K. R. Padma, K. R. Don

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Background and aims: A balanced nutritional diet is essential in maintaining immunity and for deterrence as well as desisting of viral infections. Nevertheless, currently, very less information is available online regarding nutrition consumption during the period of coronavirus infection, i.e. (COVID-19). In our systematic review article, we portrayed and aimed to evaluate evidence from various previous clinical trials, which was based on nutritional interventions for viral diseases and given a concise overview. Methods: A systematic search was carried out employing 3 key medical databases: PubMed®, Web of Science®, and SciVerse Scopus®. Studies were performed and evaluated suitable if clinical trials in humans, appropriate immunological parameters on viral and respiratory infections, need to perform. Basic Clinical trials on nutritional vitamins, minerals, nutraceuticals as well as probiotics were included. Results: We have explored 10 review articles and extracted data for our study. A total of > 2000 participants were included and excluded several other trace elements as well as various vitamins, but in inclusion criteria mainly concentrated on those who have shown propitious immune-modulatory effects against viral respiratory infections. Conclusions: We have encapsulated the potential health benefits of some minerals, vitamins, as well as certain designer foods, nutraceuticals, and probiotics in viral infections. Based on this nutritional interventional strategy available from our present data, it could be promising to abstain and reduce the COVID-19 infection replication and boost our immunity to fight against the virus.

Keywords: COVID-19, immunity, vitamins, nutritional intervention strategy

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Authors: Dan Geneau, Mary Claire Geneau, Seth Lenetsky, Ming -Chang Tsai, Marc Klimstra

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Introduction— Horizontal force-velocity profiling (HFVP) involves modeling an athletes linear sprint kinematics to estimate valuable maximum force and velocity metrics. This approach to performance modeling has been used in field-based team sports and has recently been introduced to ice-hockey as a forward skating performance assessment. While preliminary data has been collected on ice, distance constraints of the on-ice test restrict the ability of the athletes to reach their maximal velocity which result in limits of the model to effectively estimate athlete performance. This is especially true of more elite athletes. This report explores whether athletes on-ice are able to reach a velocity plateau similar to what has been seen in overground trials. Fourteen male Major Junior ice-hockey players (BW= 83.87 +/- 7.30 kg, height = 188 ± 3.4cm cm, age = 18 ± 1.2 years n = 14) were recruited. For on-ice sprints, participants completed a standardized warm-up consisting of skating and dynamic stretching and a progression of three skating efforts from 50% to 95%. Following the warm-up, participants completed three on ice 45m sprints, with three minutes of rest in between each trial. For overground sprints, participants completed a similar dynamic warm-up to that of on-ice trials. Following the warm-up participants completed three 40m overground sprint trials. For each trial (on-ice and overground), radar was used to collect instantaneous velocity (Stalker ATS II, Texas, USA) aimed at the participant’s waist. Sprint velocities were modelled using custom Python (version 3.2) script using a mono-exponential function, similar to previous work. To determine if on-ice tirals were achieving a maximum velocity (plateau), minimum acceleration values of the modeled data at the end of the sprint were compared (using paired t-test) between on-ice and overground trials. Significant differences (P<0.001) between overground and on-ice minimum accelerations were observed. It was found that on-ice trials consistently reported higher final acceleration values, indicating a maximum maintained velocity (plateau) had not been reached. Based on these preliminary findings, it is suggested that reliable HFVP metrics cannot yet be collected from all ice-hockey populations using current methods. Elite male populations were not able to achieve a velocity plateau similar to what has been seen in overground trials, indicating the absence of a maximum velocity measure. With current velocity and acceleration modeling techniques, including a dependency of a velocity plateau, these results indicate the potential for error in on-ice HFVP measures. Therefore, these findings suggest that a greater on-ice sprint distance may be required or the need for other velocity modeling techniques, where maximal velocity is not required for a complete profile.   

Keywords: ice-hockey, sprint, skating, power

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Authors: Sathyaseelan Subramaniam, Jacqueline Bober, Jennifer Chao, Shahriar Zehtabchi

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Background: Emergency physicians frequently evaluate skin and soft tissue infections in order to differentiate abscess from cellulitis. This helps determine which patients will benefit from incision and drainage. Our objective was to determine the operating characteristics of point-of-care ultrasound (POCUS) compared to clinical examination in identifying abscesses in emergency department (ED) patients with features of skin and soft tissue infections. Methods: We performed a comprehensive search in the following databases: Medline, Web of Science, EMBASE, CINAHL and Cochrane Library. Trials were included if they compared the operating characteristics of POCUS with clinical examination in identifying skin and soft tissue abscesses. Trials that included patients with oropharyngeal abscesses or that requiring abscess drainage in the operating room were excluded. The presence of an abscess was determined by pus drainage. No pus seen on incision or resolution of symptoms without pus drainage at follow up, determined the absence of an abscess. Quality of included trials was assessed using GRADE criteria. Operating characteristics of POCUS are reported as sensitivity, specificity, positive likelihood (LR+) and negative likelihood (LR-) ratios and the respective 95% confidence intervals (CI). Summary measures were calculated by generating a hierarchical summary receiver operating characteristic model (HSROC). Results: Out of 3203 references identified, 5 observational studies with 615 patients in aggregate were included (2 adults and 3 pediatrics). We rated the quality of 3 trials as low and 2 as very low. The operating characteristics of POCUS and clinical examination in identifying soft tissue abscesses are presented in the table. The HSROC for POCUS revealed a sensitivity of 96% (95% CI = 89-98%), specificity of 79% (95% CI = 71-86), LR+ of 4.6 (95% CI = 3.2-6.8), and LR- of 0.06 (95% CI = 0.02-0.2). Conclusion: Existing evidence indicates that POCUS is useful in identifying abscesses in ED patients with skin or soft tissue infections.

Keywords: abscess, point-of-care ultrasound, pocus, skin and soft tissue infection

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Authors: Ho Young Kim, Jae Hoon Lee, Do Kyu Hwang, Im Jong Kwahk, Tae Hoon Kim, Seung Hoon Lee

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Hollow section for bridge columns has some advantages. However, current seismic design codes do not provide design regulations for hollow bridge piers. There have been many experimental studied for hollow reinforced concrete piers in the world. But, Study for hollow section for bridge piers in Korea has been begun with approximately 2000s. There has been conducted experimental study for hollow piers of flexural controlled sections by Yeungnam University, Sung kyunkwan University, Korea Expressway Corporation in 2009. This study concluded that flexural controlled sections for hollow piers showed the similar behavior to solid sections. And there have been conducted experimental study for hollow piers of compression controlled sections by Yeungnam University, Korea Institute of Construction Technology in 2012. This study concluded that compression controlled sections for hollow piers showed compression fracture of concrete in inside wall face. Samsung C&T Engineering & Construction Group has been conducted study with Yeungnam University for reduce the quantity of reinforcement details about hollow piers. Reduce the quantity of reinforcement details are triangular cross tie. This study concluded that triangular reinforcement details showed the similar behavior as compared with existing reinforcement details.

Keywords: hollow pier, flexural controlled section, compression controlled section, reduce the quantity of reinforcement, details

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Authors: Farhad Farahvash, Parya Mobaseri

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Weeds control based on their critical period leads to less production costs and risks of wide chemical application of weeds control methods. The present study considered effect of weeds control time (weeds interference after 20, 40 and 60 days, weeds full control, weeds interference and weeds control after 20, 40 and 60 days) on growth and yield of forage maize 454. The experiment based on full-randomized blocks design with three replications was conducted at research farm of Islamic Azad University of Tabriz located at 15th km of East Tabriz in 2013. According to the results, weeds interference after 40 and 60 days as well as weeds control after 20 days prevented from decrease of maize biomass resulted from weeds presence while weeds interference after 20 days, weeds interference and weeds control after 40 and 60 days led respectively to 41.2%, 35%, 25% and 32.5% decrease of forage maize biomass. The weeds-influenced decrease was manifested at different parts of the plant depending on presence period of weeds. Decrease of fresh weight of ear and fresh weight of leaf and stem was observed due to weeds interference after 20 days and weeds interference. If weeds are controlled after 60 days, decrease of ear weight and fresh weight of stem will lead to biomass decrease. Also, if weeds are controlled after 40 days, decrease of fresh weight of maize stems will result in biomass decrease. Ear traits were affected by weeds control treatment. Being affected by treatments of weeds interference after 20 days, weeds non-interference, weeds control after 40 and 60 days, ear length was shortened 29.9 %, 41.4 %, 27.6 % and 37.2 %, respectively. The stem diameter demonstrated a significant decrease although it was only affected by treatments of weeds interference and weeds control after 60 days. Considering results of the present study, generally, it is suggested to control weeds during initial 20-60 days of maize growth in order to prevent undesirable effect of weeds on growth, production and production biomass of maize and decrease of production costs.

Keywords: maize, competition, weed, biomass

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Authors: Priyanka Patil, Logan Manikam

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

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

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Authors: Mathieu Audet, Monica Soliman, Emilie Eve Gravel, Rebecca Friesdorf

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Access to higher education is critical for reducing social inequalities. The Canada Learning Bond (CLB) is a government savings incentive aimed at increasing higher education access for children of low income families by providing money toward a Registered Education Savings Plan. To better understand the educational and financial decision-making of low income families, Employment Social Development Canada conducted qualitative fieldwork with eligible parents and children, teachers, and community organizations promoting the Bond. Insights from this fieldwork were then used to develop letters to better target the needs and experiences of eligible families. In the present study, we conducted a randomized controlled trial with children ages 12 to 13, the oldest cohort of eligible children, to test the effectiveness of the new letters. Parents or caregivers of 150,088 eligible children were assigned to one of five letter conditions promoting the Bond or to a control condition that did not receive a letter. The letter conditions were: (a) the standard letter from past outreach, (b) a letter presenting the exact amount the child was eligible to receive, enhancing the salience of benefits, (c) a letter with a social norm, (d) a letter with an image emphasizing the feasibility of higher education by presenting the diversity of options (i.e., college, trade schools, apprenticeships) – many participants interviewed viewed that university was unfeasible, and (e) a letter minimizing references to 'saving' (i.e., not framing the Bond explicitly as a savings incentive) – a concept that did not resonate with low income families who felt they could not afford to save. The exact amount was also presented in letters (c) through (e). The letter minimizing references to 'saving' and presenting the exact amount had the highest net take-up rate at 6.6%, compared to 3.5% for the standard letter group. Furthermore, this trial’s BI-informed letters showed the largest impact on take-up so far, with a net take-up of 5.7% compared to 3.0% and 3.9% in the first two trials. This research highlights the value of mixed-method approaches combining qualitative and behavioural insights methods for developing context-sensitive interventions for social programs. By gaining a deeper understanding of the needs and experiences of program users through qualitative fieldwork, and then integrating these insights into behaviourally informed communications, we were able to increase take-up of an education savings program, which may ultimately improve access to higher education in children of low income families.

Keywords: access to higher education, behavioral insights, government, innovation, mixed-methods, social programs

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Authors: Nagwa E. Abd Elazim, Maha S. El-naggar, Rania H. Mohamed, Sara M. Awad

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Background: Radiodermatitis is a common side effect of radiation therapy for breast cancer. However, there is no current consensus about effective standard therapy for the prevention and management of radiation dermatitis. Topical ectoine has demonstrated efficacy in the treatment of atopic dermatitis owing to its anti-inflammatory activity. Objective: To evaluate the efficacy of topical ectoine in comparison to traditional topical dexpanthenol treatment in the management of acute radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy. Methods: Fifty patients were randomized to use either dexpanthenol 0.5% cream (25 patients), or ectoin 7% cream (25 patients), applied twice daily to the irradiated area during the radiation period and continued for 2 weeks after cessation of radiotherapy. Assessment of radiation skin toxicity using Common Terminology Criteria of Adverse Events (CTCAE) v4.0, radiation-associated symptoms, and adverse events were undertaken weekly during radiotherapy and 2 weeks after the end of radiotherapy. Results: Topical ectoine showed some clinical benefit over dexpanthenol, as shown by delayed time to onset (at week 3 versus week 2, respectively) and larger number of patients who reached grade 0 at the end of treatment (64% vs. 48%, respectively). The clinical symptoms of pain (p = 0.003) and itching (p = 0.001) attributable to radiation were less pronounced with ectoine than with dexpanthenol. Burning and hyperpigmentation were the most common side effects with ectoine. However, no significant difference between dexpanthenol and ectoine treatments was found in any of the side effects (p = 0.1). Conclusion: Ectoin was overall more effective in improving radiation dermatitis than topical dexpanthenol in breast cancer patients. Ectoin could be proposed as a preventive or curative treatment for patients undergoing postoperative irradiation for breast cancer. Further clinical studies with a larger number of patients are recommended for the confirmation of these preliminary results.

Keywords: breast cancer, dexapanthenol, ectoin, radiation dermatitis

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Authors: Shrikant V. Sangludkar, Dilip I. Sangotra, Sachin T. Bagde, Abhijeet A. Khandagale

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The paper discloses a controlled tracked humanoid robot moving platform. A driving and driven wheel are controlled by a control module to drive a robot body to move according to data signals of a monitoring module, in addition, remote transmission can be achieved, and a certain remote control function can be realized. A power management module circuit board looks after in used for providing electric drive for moving of the robot body and distribution of separate power source to be used in internal of robot system. An external port circuit board is arranged, the tracked robot moving platform can be used immediately for any data acquisition. The moving platform is simple and compact in structure, strong in adaptation performance, stable in operation and suitable for being operated in severe environments. Meanwhile, a layered modular installation structure is adopted, and therefore the moving platform is convenient to assemble and disassemble.

Keywords: moving platform, humanoid robot, embedded controlled drive, mobile robot, museum robots, self-localization, obstacle avoidance, communication

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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: Rajesh Kumar G

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A challenging aspect of any clinical trial is to carefully plan the study design to meet the study objective in optimum way and to validate the assumptions made during protocol designing. And when it is a pediatric study, there is the added challenge of stringent guidelines and difficulty in recruiting the necessary subjects. Unlike adult trials, there is not much historical data available for pediatrics, which is required to validate assumptions for planning pediatric trials. Typically, pediatric studies are initiated as soon as approval is obtained for a drug to be marketed for adults, so with the adult study historical information and with the available pediatric pilot study data or simulated pediatric data, the pediatric study can be well planned. Generalizing the historical adult study for new pediatric study is a tedious task; however, it is possible by integrating various statistical techniques and utilizing the advantage of hybrid study design, which will help to achieve the study objective in a smoother way even with the presence of many constraints. This research paper will explain how well the hybrid study design can be planned along with integrated technique (SEV) to plan the pediatric study; In brief the SEV technique (Simulation, Estimation (using borrowed adult data and applying Bayesian methods)) incorporates the use of simulating the planned study data and getting the desired estimates to Validate the assumptions.This method of validation can be used to improve the accuracy of data analysis, ensuring that results are as valid and reliable as possible, which allow us to make informed decisions well ahead of study initiation. With professional precision, this technique based on the collected data allows to gain insight into best practices when using data from historical study and simulated data alike.

Keywords: adaptive design, simulation, borrowing data, bayesian model

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Authors: Laura Canagueral-Pellice, Antonio Munar-Frau, Adaia Valls-Ontanon, Joao Carames, Federico Hernandez-Alfaro, Jordi Caballe-Serrano

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Objective: Guided bone regeneration (GBR) aims to replace the missing bone with a new structure to achieve long-term stability of rehabilitations. The aim of the present systematic review and meta-analysis is to determine the effect of barrier membranes on histological outcomes after GBR procedures. Moreover, the effect of the grafting material and tissue gain were analyzed. Materials & methods: Two independent reviewers performed an electronic search in Pubmed and Scopus, identifying all eligible publications up to March 2020. Only randomized controlled trials (RCTs) assessing a histological analysis of augmented areas were included. Results: A total of 6 publications were included for the present systematic review. A total of 110 biopsied sites were analysed; 10 corresponded to vertical bone augmentation procedures, whereas 100 analysed horizontal regeneration procedures. A mean tissue gain of 3 ± 1.48mm was obtained for horizontal defects. Histological assessment of new bone formation, residual particle and sub-epithelial connective tissue (SCT) was reported. The four main barrier membranes used were natural collagen membranes, e-PTFE, polylactic resorbable membranes and acellular dermal matrix membranes (AMDG). The analysis demonstrated that resorbable membranes result in higher values of new bone formation and lower values of residual particles and SCT. Xenograft resulted in lower new bone formation compared to allograft; however, no statistically significant differences were observed regarding residual particle and SCT. Overall, regeneration procedures adding autogenous bone, plasma derivate or growth factors achieved in general greater new bone formation and tissue gain. Conclusions: There is limited evidence favoring the effect of a certain type of barrier membrane in GBR. Data needs to be evaluated carefully; however, resorbable membranes are correlated with greater new bone formation values, especially when combined with allograft materials and/or the addition of autogenous bone, platelet reach plasma (PRP) or growth factors in the regeneration area. More studies assessing the histological outcomes of different GBR protocols and procedures testing different biomaterials are needed to maximize the clinical and histological outcomes in bone regeneration science.

Keywords: barrier membrane, graft material, guided bone regeneration, implant surgery, histology

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Authors: Eimar Yadir Quintero Tapias

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Background: Science is not generally self-correcting; many clinical studies end with the same conclusion "more research is needed." This study hypothesizes that first, we need a better appraisal of the available (and unavailable) evidence instead of creating more of the same false inquiries. Methods: Systematic review of ClinicalTrials.gov study records using the following Boolean operators: (food OR nut OR milk OR egg OR shellfish OR wheat OR peanuts) AND (allergy OR allergies OR hypersensitivity OR hypersensitivities). Variables included the status of the study (e g., active and completed), availability of results, sponsor type, sample size, among others. To determine the rates of non-publication in journals indexed by PubMed, an advanced search query using the specific Number of Clinical Trials (e.g., NCT000001 OR NCT000002 OR...) was performed. As a prophylactic measure to prevent P-hacking, data analyses only included descriptive statistics and not inferential approaches. Results: A total of 2092 study records matched the search query described above (date: September 13, 2019). Most studies were interventional (n = 1770; 84.6%) and the remainder observational (n = 322; 15.4%). Universities, hospitals, and research centers sponsored over half of these investigations (n = 1208; 57.7%), 308 studies (14.7%) were industry-funded, and 147 received NIH grants; the remaining studies got mixed sponsorship. Regarding completed studies (n = 1156; 55.2%), 248 (21.5%) have results available at the registry site, and 417 (36.1%) matched NCT numbers of journal papers indexed by PubMed. Conclusions: The internal and external validity of human research is critical for the appraisal of medical evidence. It is imperative to analyze the entire dataset of clinical studies, preferably at a patient-level anonymized raw data, before rushing to conclusions with insufficient and inadequate information. Publication bias and non-registration of clinical trials limit the evaluation of the evidence concerning therapeutic interventions for food allergy, such as oral and sublingual immunotherapy, as well as any other medical condition. Over half of the food allergy human research remains unpublished.

Keywords: allergy, clinical trials, immunology, systematic reviews

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Authors: In Kyong Yi, Yun Jeong Chae, Jihoon Hwang, Sook-Young Lee, Jong-Yeop Kim

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Background: Pentax airway scope (AWS) is a recently developed video laryngoscope for use in both normal and difficult airways, providing a good laryngeal view. The purpose of this randomized noninferior study was to evaluate the efficacy of the Pentax-AWS regarding intubation time, laryngeal view and ease of intubation in pediatric patients with normal airway, compared to Macintosh laryngoscope. Method: A total of 136 pediatric patients aged 1 to 10 with American Society of Anesthesiologists physical status I or II undergoing general anesthesia required orotracheal intubation were randomly allocated into two groups: Macintosh laryngoscope (n =68) and Pentax AWS (n=68). Anesthesia was induced with propofol, rocuronium, and sevoflurane. The primary outcome was intubation time. Cormack-Lehane laryngeal view grade, application of optimal laryngeal external manipulation (OELM), intubation difficulty scale (IDS), intubation failure rate and adverse events were also measured. Result: No significant difference was observed between the two groups regarding intubation time (Macintosh; 23[22-26] sec vs. Pentax; 23.5[22-27.75] sec, p=0.713). As for the laryngeal view grade, the Pentax group showed less number of grade 2a or higher grade cases compared to the Macintosh group (1/2a/2b/3; 52.9%/41.2%/4.4%/1.5% vs. 98.5%/1.5%/0%/0%, p=0.000). No optimal laryngeal external manipulation application was required in the Pentax group (38.2% vs. 0%, p=0.000). Intubation difficulty scale resulted in lower values for Pentax group (0 [0-2] vs. 0 [0-0.55], p=0.001). Failure rate was not different between the two groups (1.5% vs. 4.4%, p=0.619). Adverse event-wise, slightly higher incidence of bleeding (1.5% vs. 5.9%, p=0.172) and teeth injury (0% vs. 5.9%, p=0.042) occurred in the Pentax group. Conclusion: In conclusion, Pentax-AWS provided better laryngeal view, similar intubation time and similar success rate compared with Macintosh laryngoscope in children with normal airway. However, the risk of teeth injury might increase and warrant special attention.

Keywords: Pentax-AWS, pediatric, video laryngoscope, intubation

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

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

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

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Authors: Amanuel Berhanu Kesamo

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This paper presents both circuit simulation and hardware implementation of a robot vehicle that can be either controlled manually via Bluetooth with video streaming or navigate autonomously to a target point by avoiding obstacles. In manual mode, the user controls the mobile robot using C# windows form interfaced via Bluetooth. The camera mounted on the robot is used to capture and send the real time video to the user. In autonomous mode, the robot plans the shortest path to the target point while avoiding obstacles along the way. Ultrasonic sensor is used for sensing the obstacle in its environment. An efficient path planning algorithm is implemented to navigate the robot along optimal route.

Keywords: Arduino Uno, autonomous, Bluetooth module, path planning, remote controlled robot, ultra sonic sensor

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Authors: Muhammad Muzamil Khan, Asadullah Madni, Nina Filipczek, Jiayi Pan, Nayab Tahir, Hassan Shah, Vladimir Torchilin

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Lipid-polymer hybrid nanoparticles (LPHNP) are delivery systems for controlled drug delivery at tumor sites. The superior biocompatible properties of lipid and structural advantages of polymer can be obtained via this system for controlled drug delivery. In the present study, cisplatin-loaded lipid-chitosan hybrid nanoparticles were formulated by the single step ionic gelation method based on ionic interaction of positively charged chitosan and negatively charged lipid. Formulations with various chitosan to lipid ratio were investigated to obtain the optimal particle size, encapsulation efficiency, and controlled release pattern. Transmission electron microscope and dynamic light scattering analysis demonstrated a size range of 181-245 nm and a zeta potential range of 20-30 mV. Compatibility among the components and the stability of formulation were demonstrated with FTIR analysis and thermal studies, respectively. The therapeutic efficacy and cellular interaction of cisplatin-loaded LPHNP were investigated using in vitro cell-based assays in A2780/ADR ovarian carcinoma cell line. Additionally, the cisplatin loaded LPHNP exhibited a low toxicity profile in rats. The in-vivo pharmacokinetics study also proved a controlled delivery of cisplatin with enhanced mean residual time and half-life. Our studies suggested that the cisplatin-loaded LPHNP being a promising platform for controlled delivery of cisplatin in cancer therapy.

Keywords: cisplatin, lipid-polymer hybrid nanoparticle, chitosan, in vitro cell line study

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Authors: Hicham Elomari, Absa Fall, Taoufiq Elkrochni

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This present work mainly concerns the improvement of citrus water productivity in the Souss Massa region. The objective is to evaluate the effect of deficit irrigation applied during the fruit growth stage on fruit size, quality and yield of the Orogrande variety grafted on Citrus macrophylla and Citrus volkameriana. Three irrigation regimes were adopted, a control D0 of 3.6 l/h and two doses D1 (58% D0 =2.1 l/h) and D2 (236% D0 =8.5 l/h). The experimental design was a randomized complete block while keeping the same spacing between drippers, the same duration of irrigation and the beginning of trials (fruit growth stage). Results showed that at the end of the cycle from October 1, 2020, to September 30, 2021, a total water supply of 732 mm and 785 mm using the D1 dose was provided to trees of Orogrande variety, respectively grafted on Citrus macrophylla and Citrus volkameriana rootstocks. Citrus macrophylla presented largest fruit size of 38 mm compared to Citrus volkameriana (33mm) with a significant difference. Total soluble sugar (8°Brix) and juice content level (40%) were higher with the application of the D1 dose on both rootstocks. Yield of 36 Tons was not affected by the deficit irrigation. Reduction of water supply by 18% increases agronomic productivity (6 MAD/m³) and economic productivity (3 MAD/m³).

Keywords: citrus, irrigation, fruit size, fruit quality, yield

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Authors: Kye Gilder, Kevin Shan, Amy Halseth, Steve Smith

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This study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. Only serious adverse events (SAE) and adverse events leading to discontinuation of study drug (AELDSD) were collected. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focused on AEs in participants on antidepressants at baseline, as these individuals were excluded from Phase 3 trials. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age of 61 yrs, mean BMI 37.3 kg/m2, 22.8% with a history of depression, 23.1% on antidepressants, including 15.4% on an SSRI. SAEs in participants receiving antidepressants was similar between NB (10.7%) and PBO (9.9%) and also similar to overall population (9.5% NB, 8.1% PBO). SAEs in those on SSRIs were similar, 10.1% NB and PBO 9.4%. For those on SSRIs or other antidepressants, AELDSDs were similar to overall population and were primarily GI disorders. Obesity increases the risk of developing depression. For participants taking NB and antidepressants, including SSRIs, there is a similar AE profile as the overall population and data revealed no evidence of an additional health risk with combined use.

Keywords: antidepressant, Contrave, Mysimba, obesity, pharmacotherapy

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Authors: Sigal Portnoy, Jason Friedman, Eitan Raveh

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Introduction: Sensory substitution is possible due to the capacity of our brain to adapt to information transmitted by a synthetic receptor via an alternative sensory system. Practical sensory substitution systems are being developed in order to increase the functionality of individuals with sensory loss, e.g. amputees. For upper limb prosthetic-users the loss of tactile feedback compels them to allocate visual attention to their prosthesis. The effect of adding vibrotactile feedback (VTF) to the applied force has been studied, however its effect on the allocation if visual attention during dual-tasking and the response during misleading visual feedback have not been studied. We hypothesized that VTF will improve the performance and reduce visual attention during dual-task assignments in healthy individuals using a robotic hand and improve the performance in a standardized functional test, despite the presence of misleading visual feedback. Methods: For the dual-task paradigm, twenty healthy subjects were instructed to toggle two keyboard arrow keys with the left hand to retain a moving virtual car on a road on a screen. During the game, instructions for various activities, e.g. mix the sugar in the glass with a spoon, appeared on the screen. The subject performed these tasks with a robotic hand, attached to the right hand. The robotic hand was controlled by the activity of the flexors and extensors of the right wrist, recorded using surface EMG electrodes. Pressure sensors were attached at the tips of the robotic hand and induced VTF using vibrotactile actuators attached to the right arm of the subject. An eye-tracking system tracked to visual attention of the subject during the trials. The trials were repeated twice, with and without the VTF. Additionally, the subjects performed the modified box and blocks, hidden from eyesight, in a motion laboratory. A virtual presentation of a misleading visual feedback was be presented on a screen so that twice during the trial, the virtual block fell while the physical block was still held by the subject. Results: This is an ongoing study, which current results are detailed below. We are continuing these trials with transradial myoelectric prosthesis-users. In the healthy group, the VTF did not reduce the visual attention or improve performance during dual-tasking for the tasks that were typed transfer-to-target, e.g. place the eraser on the shelf. An improvement was observed for other tasks. For example, the average±standard deviation of time to complete the sugar-mixing task was 13.7±17.2s and 19.3±9.1s with and without the VTF, respectively. Also, the number of gaze shifts from the screen to the hand during this task were 15.5±23.7 and 20.0±11.6, with and without the VTF, respectively. The response of the subjects to the misleading visual feedback did not differ between the two conditions, i.e. with and without VTF. Conclusions: Our interim results suggest that the performance of certain activities of daily living may be improved by VTF. The substitution of visual sensory input by tactile feedback might require a long training period so that brain plasticity can occur and allow adaptation to the new condition.

Keywords: prosthetics, rehabilitation, sensory substitution, upper limb amputation

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Authors: Mahmood Khalghollah, Mohammad Tavallaeinejad, Mohammad Eghtesad

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The method of Controlled Lagrangian is an energy shaping control technique for under actuated Lagrangian systems. Energy shaping control design methods are appealing as they retain the underlying nonlinear dynamics and can provide stability results that hold over larger domain than can be obtained using linear design and analysis. In the present study, controlled lagrangian is employed for designing a controller in an under actuated rotating flexible plate system. In the system of rotating flexible plate, due to its nonlinear characteristics and coupled dynamics of rigid and flexible components, controller design is a known challenge. In this paper, controller objectives are considered to be vibration reduction of flexible component and position control of the tip of the plate. To achieve the goals, a method based on both kinetic and potential energy shaping is introduced. The stability of the closed-loop system is investigated and proved around its equilibrium points. Moreover, the proposed controller is shown to be robust against disturbance and plant uncertainties.

Keywords: controlled lagrangian, underactuated system, flexible rotating plate, disturbance

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Authors: Umair Shoukat Ali, Rashna Hoshang Sukhia, Mubassar Fida

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Introduction: The objective of the study was to compare outcomes in terms of Bleeding index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) with video graphics and plaque disclosing tablets (PDT) versus verbal instructions in adult orthodontic patients undergoing fixed appliance treatment (FAT). Materials and Methods: Adult orthodontic patients have recruited from outpatient orthodontic clinics who fulfilled the inclusion criteria and were randomly allocated to three groups i.e., video, PDT, and verbal groups. We included patients undergoing FAT for six months of both genders with all teeth bonded mesial to first molars having no co-morbid conditions such as rheumatic fever and diabetes mellitus. Subjects who had gingivitis as assessed by Bleeding Index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) were recruited. We excluded subjects having > 2 mm of clinical attachment loss, pregnant and lactating females, any history of periodontal therapy within the last six months, and any consumption of antibiotics or anti-inflammatory drugs within the last one month. Pre- and post-interventional measurements were taken at two intervals only for BI, GI, and OPI. The primary outcome of this trial was to evaluate the mean change in the BI, GI, and OPI in the three study groups. A computer-generated randomization list was used to allocate subjects to one of the three study groups using a random permuted block sampling of 6 and 9 to randomize the samples. No blinding of the investigator or the participants was performed. Results: A total of 99 subjects were assessed for eligibility, out of which 96 participants were randomized as three of the participants declined to be part of this trial. This resulted in an equal number of participants (32) that were analyzed in all three groups. The mean change in the oral hygiene indices score was assessed, and we found no statistically significant difference among the three interventional groups. Pre- and post-interventional results showed statistically significant improvement in the oral hygiene indices for the video and PDT groups. No statistically significant difference for age, gender, and education level on oral hygiene indices were found. Simple linear regression showed that the video group produced significantly higher mean OPI change as compared to other groups. No harm was observed during the trial. Conclusions: Visual aids performed better as compared to the verbal group. Gender, age, and education level had no statistically significant impact on the oral hygiene indices. Longer follow-ups will be required to see the long-term effects of these interventions. Trial Registration: NCT04386421 Funding: Aga Khan University and Hospital (URC 183022)

Keywords: oral hygiene, orthodontic treatment, adults, randomized clinical trial

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