Search results for: clinical trial optimization

Authors: Georges F. Hatoum, Thomas H. Temple, Silvio Garcia, Xiaodong Wu

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Soft Tissue Sarcomas (STS) represent a diverse group of malignancies with heterogeneous clinical and pathological features. The treatment of extremity STS aims to achieve optimal local tumor control, improved survival, and preservation of limb function. The National Comprehensive Cancer Network guidelines, based on the cumulated clinical data, recommend radiation therapy (RT) in conjunction with limb-sparing surgery for large, high-grade STS measuring greater than 5 cm in size. Such treatment strategy can offer a cure for patients. However, when recurrence occurs (in nearly half of patients), the prognosis is poor, with a median survival of 12 to 15 months and with only palliative treatment options available. The spatially-fractionated-radiotherapy (SFRT), with a long history of treating bulky tumors as a non-mainstream technique, has gained new attention in recent years due to its unconventional therapeutic effects, such as bystander/abscopal effects. Combining single fraction of GRID, the original form of SFRT, with conventional RT was shown to have marginally increased the rate of pathological necrosis, which has been recognized to have a positive correlation to overall survival. In an effort to consistently increase the pathological necrosis rate over 90%, multiple fractions of Lattice RT (LRT), a newer form of 3D SFRT, interdigitated with the standard RT as neoadjuvant therapy was conducted in a preliminary clinical setting. With favorable results of over 95% of necrosis rate in a small cohort of patients, a Phase I/II clinical study was proposed to exam the safety and feasibility of this new strategy. Herein the design of the clinical study is presented. In this single-arm, two-stage phase I/II clinical trial, the primary objectives are >80% of the patients achieving >90% tumor necrosis and to evaluation the toxicity; the secondary objectives are to evaluate the local control, disease free survival and overall survival (OS), as well as the correlation between clinical response and the relevant biomarkers. The study plans to accrue patients over a span of two years. All patient will be treated with the new neoadjuvant RT regimen, in which one of every five fractions of conventional RT is replaced by a LRT fraction with vertices receiving dose ≥10Gy while keeping the tumor periphery at or close to 2 Gy per fraction. Surgical removal of the tumor is planned to occur 6 to 8 weeks following the completion of radiation therapy. The study will employ a Pocock-style early stopping boundary to ensure patient safety. The patients will be followed and monitored for a period of five years. Despite much effort, the rarity of the disease has resulted in limited novel therapeutic breakthroughs. Although a higher rate of treatment-induced tumor necrosis has been associated with improved OS, with the current techniques, only 20% of patients with large, high-grade tumors achieve a tumor necrosis rate exceeding 50%. If this new neoadjuvant strategy is proven effective, an appreciable improvement in clinical outcome without added toxicity can be anticipated. Due to the rarity of the disease, it is hoped that such study could be orchestrated in a multi-institutional setting.

Keywords: lattice RT, necrosis, SFRT, soft tissue sarcoma

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Authors: Michael A. Sprayberry, Vincent C. Paquit

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Process parameter optimization in metal powder bed electron beam melting (MPBEBM) is crucial to ensure the technology's repeatability, control, and industry-continued adoption. Despite continued efforts to address the challenges via the traditional design of experiments and process mapping techniques, there needs to be more successful in an on-the-fly optimization framework that can be adapted to MPBEBM systems. Additionally, data-intensive physics-based modeling and simulation methods are difficult to support by a metal AM alloy or system due to cost restrictions. To mitigate the challenge of resource-intensive experiments and models, this paper introduces a Multi-Objective Reinforcement Learning (MORL) methodology defined as an optimization problem for MPBEBM. An off-policy MORL framework based on policy gradient is proposed to discover optimal sets of beam power (P) – beam velocity (v) combinations to maintain a steady-state melt pool depth and phase transformation. For this, an experimentally validated Eagar-Tsai melt pool model is used to simulate the MPBEBM environment, where the beam acts as the agent across the P – v space to maximize returns for the uncertain powder bed environment producing a melt pool and phase transformation closer to the optimum. The culmination of the training process yields a set of process parameters {power, speed, hatch spacing, layer depth, and preheat} where the state (P,v) with the highest returns corresponds to a refined process parameter mapping. The resultant objects and mapping of returns to the P-v space show convergence with experimental observations. The framework, therefore, provides a model-free multi-objective approach to discovery without the need for trial-and-error experiments.

Keywords: additive manufacturing, metal powder bed fusion, reinforcement learning, process parameter optimization

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Authors: Houda Abadlia, Nadia Smairi, Khaled Ghedira

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Multiobjective Particle Swarm Optimization (MOPSO) has shown an effective performance for solving test functions and real-world optimization problems. However, this method has a premature convergence problem, which may lead to lack of diversity. In order to improve its performance, this paper presents a hybrid approach which embedded the MOPSO into the island model and integrated a local search technique, Variable Neighborhood Search, to enhance the diversity into the swarm. Experiments on two series of test functions have shown the effectiveness of the proposed approach. A comparison with other evolutionary algorithms shows that the proposed approach presented a good performance in solving multiobjective optimization problems.

Keywords: particle swarm optimization, migration, variable neighborhood search, multiobjective optimization

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Authors: Manas Shah

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Black Scholes option pricing model is one of the most important concepts in modern world of computational finance. However, its practical use can be challenging as one of the input parameters must be estimated; implied volatility of the underlying security. The more precisely these values are estimated, the more accurate their corresponding estimates of theoretical option prices would be. Here, we present a novel model based on Cuckoo Search Optimization (CS) which finds more precise estimates of implied volatility than Particle Swarm Optimization (PSO) and Genetic Algorithm (GA).

Keywords: black scholes model, cuckoo search optimization, particle swarm optimization, genetic algorithm

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Authors: Hasanzadeh Tahraband F., Kheirkhah M.

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The trauma resulting from abortion causes fear, frustration, inability, lack of self-confidence, and psychological distress in women. The present study was conducted to determine the effect of midwifery counseling based on the Gamble approach on coping strategies of women with abortion. This randomized controlled clinical trial was conducted on women with abortions in April–October 2021, Karaj, Iran. Ninety-six eligible women were randomly assigned to two 48-member groups with 4, 6, and 8 blocks. The women in the intervention group participated in two 45-75-minute Gamble counseling programs. They were asked to fill out the demographic and fertility information questionnaire before the intervention and the cope operations preference inquiry questionnaire before, immediately (in the 4-6th week of the study), and three months after the intervention. The analysis of the data was done through Chi-square, independent sample t-test. The significance level was considered P<0.05. The results showed that the differences between the two groups before the intervention were not statistically significant in terms of demographic and fertility variables (P>0.05). However, the total mean score of the problem-focused dimension in 3-month post-abortion (97/34±8/69) and the emotion-focused dimension in 4-6 weeks and 3-month post-abortion (34/14±3/48 and 32/41±3/41) in the intervention group was significantly different from the control group (P<0.001). According to the results of the repeated measures ANOVA, the level of coping and its dimensions significantly changed in the intervention group over time (P<0.001). The results of the present study showed that Gamble counseling promoted the problem-focused dimension score and reduced the emotion-focused dimension score in women with abortion. It is recommended that Gamble counseling should be used as midwife-led counseling to increase coping strategies and reduce the psychological distress of women who have experienced abortion.

Keywords: midwife-led counseling, coping strategies, post-abortion, psychological distress, Iran

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

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

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

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Authors: Woolfrey K., Woolfrey M., Bolton C. L., Warchuk D.

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Objectives: Osteoarthritis is the most common joint disease of adults worldwide. Despite total knee arthroplasty (TKA) demonstrating high levels of success, 20% of patients report dissatisfaction with their result. VOXX Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, according to the pattern theory of haptic perception, which stimulates improvements in pain and function. The use of this technology in TKA patients may prove beneficial as an adjunct to recovery as many patients suffer from deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during the procedure. We hypothesized that VOXX Wellness Stasis Socks are a safe, cost-effective, and easily scalable strategy to support TKA patients through their recovery. Design: Double-blinded, placebo-controlled randomized trial. Participants: Patients scheduled to receive TKA were considered eligible for inclusion in the trial. Interventions: Intervention group (I): VOXX Wellness Stasis socks containing receptor point-activation technology. Control group (C): VOXX Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours x 6 weeks. Main Outcome Measures: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness, and physical function. Results: Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Effect size was analyzed using Cramer’s V. Consistent improvement in WOMAC scores for pain and stiffness at 2 weeks post op in the I over the C group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the I group compared to C group. Conclusions: VOXX proved to be a low cost, safe intervention in TKA to help patients improve with regard to pain, stiffness, and physical function. Disclosures: None

Keywords: osteoarthritis, RCT, pain management, total knee arthroplasty

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Authors: Dmitriy Chernov, Maria Karavassilis, Suhyoun Youn, Amna Izhar, Devasenan Devendra

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Introduction and Background: A well-structured and comprehensive departmental induction improves patient safety and job satisfaction amongst doctors. The aims of our Project were as follows: 1. Assess the perceived preparedness of junior doctors starting their rotation in Acute Medicine at Watford General Hospital. 2. Develop a supplemental Induction Guide and Pocket reference in the form of an iOS mobile application. 3. To collect feedback after implementing the mobile application following a trial period of 8 weeks with a small cohort of junior doctors. Materials and Methods: A questionnaire was distributed to all new junior trainees starting in the department of Acute Medicine to assess their experience of current induction. A mobile Induction application was developed and trialled over a period of 8 weeks, distributed in addition to the existing didactic induction session. After the trial period, the same questionnaire was distributed to assess improvement in induction experience. Analytics data were collected with users’ consent to gauge user engagement and identify areas of improvement of the application. A feedback survey about the app was also distributed. Results: A total of 32 doctors used the application during the 8-week trial period. The application was accessed 7259 times in total, with the average user spending a cumulative of 37 minutes 22 seconds on the app. The most used section was Clinical Guidelines, accessed 1490 times. The App Feedback survey revealed positive reviews: 100% of participants (n=15/15) responded that the app improved their overall induction experience compared to other placements; 93% (n=14/15) responded that the app improved overall efficiency in completing daily ward jobs compared to previous rotations; and 93% (n=14/15) responded that the app improved patient safety overall. In the Pre-App and Post-App Induction Surveys, participants reported: a 48% improvement in awareness of practical aspects of the job; a 26% improvement of awareness on locating pathways and clinical guidelines; a 40% reduction of feelings of overwhelmingness. Conclusions and recommendations: This study demonstrates the importance of technology in Medical Education and Clinical Induction. The mobile application average engagement time equates to over 20 cumulative hours of on-the-job training delivered to each user, within an 8-week period. The most used and referred to section was clinical guidelines. This shows that there is high demand for an accessible pocket guide for this type of material. This simple mobile application resulted in a significant improvement in feedback about induction in our Department of Acute Medicine, and will likely impact workplace satisfaction. Limitations of the application include: post-app surveys had a small number of participants; the app is currently only available for iPhone users; some useful sections are nested deep within the app, lacks deep search functionality across all sections; lacks real time user feedback; and requires regular review and updates. Future steps for the app include: developing a web app, with an admin dashboard to simplify uploading and editing content; a comprehensive search functionality; and a user feedback and peer ratings system.

Keywords: mobile app, doctor induction, medical education, acute medicine

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Authors: D. K. Lee, S. M. Shin, J. H. Lee

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Topology optimization technique utilizes constant element densities as design parameters. Finally, optimal distribution contours of the material densities between voids (0) and solids (1) in design domain represent the determination of topology. It means that regions with element density values become occupied by solids in design domain, while there are only void phases in regions where no density values exist. Therefore the void regions of topology optimization results provide design information to decide appropriate depositions of web-opening in structure. Contrary to the basic objective of the topology optimization technique which is to obtain optimal topology of structures, this present study proposes a new idea that topology optimization results can be also utilized for decision of proper web-opening’s position. Numerical examples of linear elastostatic structures demonstrate efficiency of methodological design processes using topology optimization in order to determinate the proper deposition of web-openings.

Keywords: topology optimization, web-opening, structure, element density, material

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Authors: Shahzamani Kiana, Esmaeil Lashgarian Hamed, Merat Shahin

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HCV and GBV-C belong to the Flaviviridae family of viruses and GBV-C is the closest virus to HCV genetically. Accumulative research is in progress all over the world to clarify clinical aspects of GBV-C. Possibility of interaction between HCV and GBV-C and also its consequence with other liver diseases are the most important clinical aspects which encourage researchers to develop a technique for simultaneous detection of these viruses. In this study a SYBR Green multiplex real time RT-PCR technique as a new economical and sensitive method was optimized for simultaneous detection of HCV/GBV-C in HCV positive plasma samples. After designing and selection of two pairs of specific primers for HCV and GBV-C, SYBR Green Real time RT-PCR technique optimization was performed separately for each virus. Establishment of multiplex PCR was the next step. Finally our technique was performed on positive and negative plasma samples. 89 cirrhotic HCV positive plasma samples (29 of genotype 3 a and 27 of genotype 1a) were collected from patients before receiving treatment. 14% of genotype 3a and 17.1% of genotype 1a showed HCV/GBV-C co-infection. As a result, 13.48% of 89 samples had HCV/GBV-C co-infection that was compatible with other results from all over the world. Data showed no apparent influence of HGV co-infection on the either clinical or virological aspect of HCV infection. Furthermore, with application of multiplex Real time RT-PCR technique, more time and cost could be saved in clinical-research settings.

Keywords: HCV, GBV-C, cirrhotic patients, multiplex real time RT- PCR

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

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

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

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Authors: Mohammadhadi Mirmohammadi, Reza Safian, Hossein Haddad

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This paper presents an innovative solution for complex multi-objective optimization problem which is a part of efforts toward maximizing rolling mill throughput and minimizing processing costs in tandem cold rolling. This computational intelligence based optimization has been applied to the rolling schedules of tandem cold rolling mill. This method involves the combination of two derivative-free optimization procedures in the form of nested loops. The first optimization loop is based on Improving Hit and Run method which focus on balance of power, force and reduction distribution in rolling schedules. The second loop is a real-coded genetic algorithm based optimization procedure which optimizes energy consumption and productivity. An experimental result of application to five stand tandem cold rolling mill is presented.

Keywords: derivative-free optimization, Improving Hit and Run method, real-coded genetic algorithm, rolling schedules of tandem cold rolling mill

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Authors: Ekaterina Sánchez Romero, Emily Gabriela Aguirre Herrera, Sandra Luz Espinoza Esquerra, Jorge García Campos

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Female, 7 months old, daughter of a mother with anemia during pregnancy, with no history of atopy in the family, since birth she presents with recurrent dermatological and gastrointestinal infections, chronically treated for recurrent diaper dermatitis. At 6 months of age, she begins with generalized pallor, hyperpigmentation in hands and feet, smooth tongue, psychomotor retardation with lack of head support, sedation, and hypoactivity. She was referred to our hospital for a fever of 38°C, severe diaper rash, and pancytopenia with HB 9.3, platelets 38000, neutrophils 0.39 MCV: 86.80 high for her age. The approach was initiated to rule out myeloproliferative syndrome, with negative immunohistochemical results of bone marrow aspirate; during her stay, she presented neurological regression, lack of sucking, and focal seizures. CT scan showed cortical atrophy. The patient was diagnosed with primary immunodeficiency due to history; gamma globulin was administered without improvement with normal results of immunoglobulins and metabolic screening. When dermatological and neurological diagnoses were ruled out as the primary cause, a nutritional factor was evaluated, and a therapeutic trial was started with the administration of vitamin B12 and zinc, presenting clinical neurological improvement and resolution of pancytopenia in 2 months. It was decided to continue outpatient management. Discussion: We present a patient with neurological, dermatological involvement, and pancytopenia, so the most common differential diagnoses in this population were ruled out. Vitamin B12 deficiency is an uncommon entity. Due to maternal and clinical history, a therapeutic trial was started resulting in an improvement. Conclusion: VitaminB12 deficiency should be considered one of the differential diagnoses in the approach to pancytopenia with megaloblastic anemia associated with dermatologic and neurologic manifestations. Early treatment can reduce irreversible damage in these patients.

Keywords: vitamin B12 deficiency, pediatrics, pancytopenia, diaper dermatitis

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Authors: Golyasamin Khanehzaei, Mohd. Bakri Ishak, Ahmad Makmom Hj Abdullah, Latifah Abd Manaf

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Abstract—Management of clinical waste is a critical problem worldwide. Immediate attention is required to manage the clinical waste in an appropriate way in newly developing economy country such as Malaysia. The increasing amount of clinical waste generated is resulted from rapid urbanization and growing number of private health care facilities in developing countries such as Malaysia. In order to develop a sensible clinical waste management system and improvement of the management, information on factors affecting clinical waste generation has the crucial role. This paper is the study of management characteristics of clinical waste and the level of efficiency of clinical waste management systems operating in private clinics located in Selangor, Malaysia. Are they following the proper international standards? By taking all of this in consideration the aim of this paper is to identify and discuss the current trend, current challenges and also the present opportunities among the challenges of clinical waste management in private clinics of Selangor, Malaysia. The SWOT analysis was characterized for the evaluation of strengths, weaknesses, opportunities and threats. The methodology for this study was constituted of direct observation, Informal interviews, Conducting SWOT analysis, conduction of one sustainability dimensions analysis and application. The results show that clinical waste management in private clinics is far from an ideal model.

Keywords: clinical waste, SWOT analysis, Selangor, Malaysia

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Authors: M. Dezyani, R. Ezzati belvirdi, M. Shakerian, H. Mirzaei

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The effect of Microfiltration (MF) on proteolysis, hardness, and flavor of Feta cheese during 6 mo of aging was determined. Raw skim milk was microfiltered two-fold in two cheese making trials. In trial 1, four vats of cheese were made in 1 d using unconcentrated milk (1X), 1.26X, 1.51X, and 1.82X Concentration Factors (CF). Casein-(CN)-to-fat ratio was constant among treatments. Proteolysis during cheese aging decreased with increasing CF due to either limitation of substrate availability for chymosin due to low moisture in the nonfat substance (MNFS), inhibition of chymosin activity by high molecular weight milk serum proteins, such as α2-macroglobulin, retained in the cheese or low residual chymosin in the cheese. Hardness of fresh cheese increased, and cheese flavor intensity decreased with increasing CF. In trial 2, the 1X and 1.8X CF were compared directly. Changes made in the cheese making procedure for the 1.8X CF (more chymosin and less cooking) increased the MNFS and made proteolysis during aging more comparable for the 1X and 1.8X cheeses. The significant difference in cheese hardness due to CF in trial 1 was eliminated in trial 2. In a triangle test, panelists could not differentiate between the 1X and 1.8X cheeses. Therefore, increasing chymosin and making the composition of the two cheeses more similar allowed production of aged Fetta cheese from milk concentrated up to 1.8X by MF that was not perceived as different from aged feta cheese produced without MF.

Keywords: feta cheese, microfiltration, concentration factor, proteolysis

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Authors: Dylan Shiting Lu, Samson Okello, Anita Chunyan Wei, Daniel Xiao Li

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Mammotome vacuum-assisted breast biopsy (MVB) introduced in 1995 can be used for the removal of benign breast lesions. Whether or not MVB is a better option compared to conventional open surgery is inconclusive. We aim to compare the clinical and patient-related outcomes between MVB and open surgery to remove benign breast tumors less than 5 cm in women. We searched English and Chinese electronic databases with the keywords of Mammotome, clinical trial (CT), vacuum-assisted breast biopsy for studies comparing MVB and open surgery until May 2021. We performed a systematic review and random-effects meta-analysis to compare incision size, operation time, intraoperative blood loss, healing time, scar length, patient satisfaction, postoperative hematoma rate, wound infection rate, postoperative ecchymosis, and postoperative sunken skin among those who have Mammotome and those who have surgery. Our analysis included nine randomized CTs with 1155 total patients (575 Mammotome, 580 surgery) and mean age 40.32 years (standard deviation 3.69). We found statistically significant favorable outcomes for Mammotome including blood loss (ml) [standardized mean difference SMD -5.03, 95%CI (-7.30, -2.76)], incision size (cm) [SMD -12.22, 95%CI (-17.40, -7.04)], operation time (min) [SMD -6.66, 95%CI (-9.01, -4.31)], scar length (cm) [SMD -7.06, 95%CI (-10.76, -3.36)], healing time (days) [SMD -6.57, 95%CI (-10.18, -2.95)], and patient satisfaction [relative risk RR 0.38, 95%CI (0.13, 1.08)]. In conclusion, Mammotome vacuum-assisted breast biopsy compared to open surgery shows better clinical and patient-related outcomes. Further studies should be done on whether or not MVB is a better option for benign breast tumors excision.

Keywords: clinical and patient outcomes, open surgery, Mammotome vacuum-assisted breast biopsy, meta-analysis

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Authors: Matthew Heidman, Susan Dallabrida, Analice Costa

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Background:Accuracy of caregiver reported outcomes is essential for infant growth and tolerability study success. Crying/fussiness, stool consistencies, and other gastrointestinal characteristics are important parameters regarding tolerability, and inter-caregiver reporting can see a significant amount of subjectivity and vary greatly within a study, compromising data. This study sought to elucidate how caregiver reported questions related to stool frequency are answered before and after a short amount of training and how training impacts caregivers’ understanding, and how they would answer the question. Methods:A digital survey was issued for 90 daysin the US (n=121) and 30 days in Mexico (n=88), targeting respondents with children ≤4 years of age. Respondents were asked a question in two formats, first without a line of training text and second with a line of training text. The question set was as follows, “If your baby had stool in his/her diaper and you changed the diaper and 10 min later there was more stool in the diaper, how many stools would you report this as?” followed by the same question beginning with “If you were given the instruction that IF there are at least 5 minutes in between stools, then it counts as two (2) stools…”.Four response items were provided for both questions, 1) 2 stools, 2) 1stool, 3) it depends on how much stool was in the first versus the second diaper, 4) There is not enough information to be able to answer the question. Response frequencies between questions were compared. Results: Responses to the question without training saw some variability in the US, with 69% selecting “2 stools”,11% selecting “1 stool”, 14% selecting “it depends on how much stool was in the first versus the second diaper”, and 7% selecting “There is not enough information to be able to answer the question” and in Mexico respondents selected 9%, 78%, 13%, and 0% respectively. However, responses to the question after training saw more consolidation in the US, with 85% of respondents selecting“2 stools,” representing an increase in those selecting the correct answer. Additionally in Mexico, with 84% of respondents selecting “1 episode” representing an increase in the those selecting the correct response. Conclusions: Caregiver reported outcomes are critical for infant growth and tolerability studies, however, they can be highly subjective and see a high variability of responses without guidance. Training is critical to standardize all caregivers’ perspective regarding how to answer questions accurately in order to provide an accurate dataset.

Keywords: infant nutrition, clinical trial optimization, stool reporting, decentralized clinical trials

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Authors: Kristian Bautista, Ruben A. Idoy

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A bio-inspired metaheuristic algorithm inspired by the theory of collective animal behavior (CAB) was integrated to density-based clustering modeled as multimodal optimization problem. The algorithm was tested on synthetic, Iris, Glass, Pima and Thyroid data sets in order to measure its effectiveness relative to CDE-based Clustering algorithm. Upon preliminary testing, it was found out that one of the parameter settings used was ineffective in performing clustering when applied to the algorithm prompting the researcher to do an investigation. It was revealed that fine tuning distance δ3 that determines the extent to which a given data point will be clustered helped improve the quality of cluster output. Even though the modification of distance δ3 significantly improved the solution quality and cluster output of the algorithm, results suggest that there is no difference between the population mean of the solutions obtained using the original and modified parameter setting for all data sets. This implies that using either the original or modified parameter setting will not have any effect towards obtaining the best global and local animal positions. Results also suggest that CDE-based clustering algorithm is better than CAB-density clustering algorithm for all data sets. Nevertheless, CAB-density clustering algorithm is still a good clustering algorithm because it has correctly identified the number of classes of some data sets more frequently in a thirty trial run with a much smaller standard deviation, a potential in clustering high dimensional data sets. Thus, the researcher recommends further investigation in the post-processing stage of the algorithm.

Keywords: clustering, metaheuristics, collective animal behavior algorithm, density-based clustering, multimodal optimization

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Authors: Sedigheh Salemi, Mahnaz Sanjari, Maryam Aalaa, Mohammad Mirzabeigi

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Clinical governance is the framework within which the health service provider is required to ongoing accountability and improvement of the quality of their services. This cross-sectional study was conducted in 661 nurses who work in government hospitals from 35 hospitals of 9 provinces in Iran. The study was approved by the Nursing Council and was carried out with the authorization of the Research Ethics Committee. The questionnaire included 24 questions in which 4 questions focused on clinical governance defining from the nurses' perspective. The reliability was evaluated by Cronbach's alpha (α=0/83). Statistical analyzes were performed, using SPSS version 16. Approximately 40% of nurses correctly answered that clinical governance is not "system of punishment and rewards for the staff". The most nurses believed that "clinical efficacy" is one of the main components of clinical governance. A few of nurses correctly responded that "Evidence Based Practice" and "management" is not part of clinical governance. The small number of nurses correctly answered that the "maintenance of patient records" and "to recognize the adverse effects" is not the role of nurse in clinical governance. Most "do not know" answer was to the "maintenance of patient records". The most nurses unanimously believed that the implementation of clinical governance led to "promoting the quality of care". About a third of nurses correctly stated that the implementation of clinical governance will not lead to "an increase in salaries and benefits of the medical team". As a member of the health team, nurses are responsible in terms of participation in quality improvement and it is necessary to create an environment in which clinical care will flourish and serve to preserve the high standards.

Keywords: clinical governance, nurses, salary, health team

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Authors: Konstancja Syller

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International law and European regulations remain hardly silent about the admissibility of evidence obtained illegally in a criminal trial. However, Article 6 of the European Convention on Human Rights guarantees the right to a fair trial, it does not normalise a proceeding status of specified sources or means of proof outright. Therefore, it is the preserve of national legislation and national law enforcement authorities to decide on this matter. In most countries, especially in Germany and Poland, a rather complex normative approach to the issue of proof obtained in violation of the right to privacy is evident, which pursues in practise to many interpretive doubts. In Germany the jurisprudence has a significant impact within the range of the matter mentioned above. The Constitutional Court and the Supreme Court of Germany protect the right to privacy quite firmly - they ruled on inadmissibility of obtaining a proof in the form of a diary or a journal as a protection measure of constitutional guaranteed right. At the same time, however, the Supreme Court is not very convinced with reference to the issue of whether materials collected as a result of an inspection, call recordings or listening to the premises, which were carried out in breach of law, can be used in a criminal trial. Generally speaking, German courts indicate a crucial importance of the principle of Truth and the principle of proportionality, which both enable a judgement to be made as to the possibility of using an evidence obtained unlawfully. Comparing, in Poland there is almost no jurisprudence of the Constitutional Tribunal relating directly to the issue of illegal evidence. It is somehow surprising, considering the doctrinal analysis of the admissibility of using such proof in a criminal trial is performed in relation to standards resulted from the Constitution. Moreover, a crucial de lega lata legal provision, which enables allowing a proof obtained in infringement of the provisions in respect of criminal proceedings or through a forbidden act, is widely criticised within the legal profession ant therefore many courts give it their own interpretation at odds with legislator’s intentions. The comparison of two civil law legal systems’ standards regarding to the admissibility of an evidence obtained in contravention of the right to privacy in a criminal trial, taking also into account EU legislation and judicature, is the conclusive aim of this article.

Keywords: criminal trial, evidence, Germany, right to privacy, Poland

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Authors: Angga S. Fajar, A. Aminullah, J. Kiyono, R. A. Safitri

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This paper discusses about the application of ANN for optimizing of bridge structure design. ANN has been applied in various field of science concerning prediction and optimization. The structural optimization has several benefit including accelerate structural design process, saving the structural material, and minimize self-weight and mass of structure. In this paper, there are three types of bridge structure that being optimized including PSC I-girder superstructure, composite steel-concrete girder superstructure, and RC bridge pier. The different optimization strategy on each bridge structure implement back propagation method of ANN is conducted in this research. The optimal weight and easier design process of bridge structure with satisfied error are achieved.

Keywords: bridge structures, ANN, optimization, back propagation

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Authors: Hye-Kyung Kang

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Social justice is a central principle of the social work profession and education. However, scholars have long questioned the profession’s commitment to putting social justice values into practice. Clinical social work has been particularly criticized for its lack of attention to social justice and for failing to address the concerns of the oppressed. One prominent criticism of clinical social work is that it often relies on individual intervention and fails to take on system-level changes or advocacy. This concern evokes the historical macro-micro tension of the social work profession where micro (e.g., mental health counseling) and macro (e.g., policy advocacy) practices are conceptualized as separate domains, creating a false binary for social workers. One contributor to this false binary seems to be that most clinical practice models do not prepare social work students and practitioners to make a clear link between clinical practice and social justice. This paper presents a model of clinical social work practice that clearly recognizes the essential and necessary connection between social justice, advocacy, and clinical practice throughout the clinical process: engagement, assessment, intervention, and evaluation. Contemporary relational theories, critical social work frameworks, and anti-oppressive practice approaches are integrated to build a clinical social work practice model that addresses the urgent need for mental health practice that not only helps and heals the person but also challenges societal oppressions and aims to change them. The application of the model is presented through case vignettes.

Keywords: social justice, clinical social work, clinical social work model, integrative model

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Authors: David Lindström

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We evaluate the performance of a numerical method for global optimization of expensive functions. The method is using a response surface to guide the search for the global optimum. This metamodel could be based on radial basis functions, kriging, or a combination of different models. We discuss how to set the cycling parameters of the optimization method to get a balance between local and global search. We also discuss the eventual problem with Runge oscillations in the response surface.

Keywords: expensive function, infill sampling criterion, kriging, global optimization, response surface, Runge phenomenon

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Authors: Jacqueline M. Dias, Amina A Khowaja

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Clinical education is one of the most important components of a nursing curriculum as it develops the students’ cognitive, psychomotor and affective skills. Clinical teaching ensures the integration of knowledge into practice. As the numbers of students increase in the field of nursing coupled with the faculty shortage, clinical preceptors are the best choice to ensure student learning in the clinical settings. The clinical preceptor role has been introduced in the undergraduate nursing programme. In Pakistan, this role emerged due to a faculty shortage. Initially, two clinical preceptors were hired. This study will explore clinical preceptors views and experiences of precepting Bachelor of Science in Nursing (BScN) students in an undergraduate program. A case study design was used. As case studies explore a single unit of study such as a person or very small number of subjects; the two clinical preceptors were fundamental to the study and served as a single case. Qualitative data were obtained through an iterative process using in depth interviews and written accounts from reflective journals that were kept by the clinical preceptors. The findings revealed that the clinical preceptors were dedicated to their roles and responsibilities. Another, key finding was that clinical preceptors’ prior knowledge and clinical experience were valuable assets to perform their role effectively. The clinical preceptors found their new role innovative and challenging; it was stressful at the same time. Findings also revealed that in the clinical agencies there were unclear expectations and role ambiguity. Furthermore, clinical preceptors had difficulty integrating theory into practice in the clinical area and they had difficulty in giving feedback to the students. Although this study is localized to one university, generalizations can be drawn from the results. The key findings indicate that the role of a clinical preceptor is demanding and stressful. Clinical preceptors need preparation prior to precepting students on clinicals. Also, institutional support is fundamental for their acceptance. This paper focuses on the views and experiences of clinical preceptors undertaking a newly established role and resonates with the literature. The following recommendations are drawn to strengthen the role of the clinical preceptors: A structured program for clinical preceptors is needed along with mentorship. Clinical preceptors should be provided with formal training in teaching and learning with emphasis on clinical teaching and giving feedback to students. Additionally, for improving integration of theory into practice, clinical modules should be provided ahead of the clinical. In spite of all the challenges, ten more clinical preceptors have been hired as the faculty shortage continues to persist.

Keywords: baccalaureate nursing education, clinical education, clinical preceptors, nursing curriculum

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Authors: Romisaa Ali

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The Policy Gradient approach is one of the deep reinforcement learning families that combines deep neural networks (DNN) with reinforcement learning RL to discover the optimum of the control problem through experience gained from the interaction between the robot and its surroundings. In contrast to earlier policy gradient algorithms, which were unable to handle these two types of error because of over-or under-estimation introduced by the deep neural network model, this article will discuss the state-of-the-art SOTA policy gradient technique, trust region policy optimization (TRPO), by applying this method in various environments compared to another policy gradient method, the Proximal Policy Optimization (PPO), to explain their robust optimization, using this SOTA to gather experience data during various training phases after observing the impact of hyper-parameters on neural network performance.

Keywords: deep neural networks, deep reinforcement learning, proximal policy optimization, state-of-the-art, trust region policy optimization

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Authors: Maha Salah, Hanaa Hashem, Mahmoud M. Alsagheir, Mohammed Salah

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Acute respiratory distress syndrome (ARDS) represents a complex clinical syndrome and carries a high risk for mortality. The severity of the clinical course, the uncertainty of the outcome, and the reliance on the full spectrum of critical care resources for treatment mean that the entire health care team is challenged. Researchers and clinicians have investigated the nature of the pathological process and explored treatment options with the goal of improving outcome. Through this application of research to practice, we know that some previous strategies have been ineffective, and innovations in mechanical ventilation, sedation, nutrition, and pharmacological intervention remain important research initiatives. Developed Clinical pathway is multidisciplinary plans of best clinical practice for this specified groups of patients that aid in the coordination and delivery of high quality care. They are a documented sequence of clinical interventions that help a patient to move, progressively through a clinical experience to a desired outcome. Although there is a lot of heterogeneity in patients with ARDS, this suggested developed clinical pathway with alternatives was built depended on a lot of researches and evidence based medicine and nursing practices which may be helping these patients to improve outcomes, quality of life and decrease mortality.

Keywords: acute respiratory distress syndrome (ARDS), clinical pathway, clinical syndrome

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Authors: Jong-Yeon Kim, Kwang-Bok Shin, Tae-Hwan Ko

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The purpose of this paper is to suggest a weight-reduction design method for the aluminum extrusion carbody structure of a double deck high-speed train using size optimization method. The size optimization method was used to optimize thicknesses of skin and rib of the aluminum extrusion for the carbody structure. Thicknesses of 1st underframe, 2nd underframe, solebar and roof frame were selected by design variables in order to conduct size optimization. The results of the size optimization analysis showed that the weight of the aluminum extrusion could be reduced by 0.61 tons (5.60%) compared to the weight of the original carbody structure.

Keywords: double deck high-speed train, size optimization, weigh-reduction, aluminum extrusion

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Authors: William Anderson, Kyle Kobold, Oleg Yakimenko

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Green microgrids using mostly renewable energy (RE) for generation, are complex systems with inherent nonlinear dynamics. Among a variety of different optimization tools there are only a few ones that adequately consider this complexity. This paper evaluates applicability of two somewhat similar optimization tools tailored for standalone RE microgrids and also assesses a machine learning tool for performance prediction that can enhance the reliability of any chosen optimization tool. It shows that one of these microgrid optimization tools has certain advantages over another and presents a detailed routine of preparing input data to simulate RE microgrid behavior. The paper also shows how neural-network-based predictive modeling can be used to validate and forecast solar power generation based on weather time series data, which improves the overall quality of standalone RE microgrid analysis.

Keywords: microgrid, renewable energy, complex systems, optimization, predictive modeling, neural networks

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Authors: Ali Rabah

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This research received no grant or financial support from any public, commercial, or none governmental agency. The author conducted this work as part of his normal research activities as a professor of Chemical Engineering at the University of Khartoum, Sudan. Abstract While fossil oil reserves have been receding, the demand for diesel and gasoline has been growing. In recent years, syngas of biomass origin has been emerging as a viable feedstock for Fischer-Tropsch (FT) synthesis, a process for manufacturing synthetic gasoline and diesel. This paper reports the optimization of syngas quality to match FT synthesis requirements. The optimization model maximizes the thermal efficiency under the constraint of H2/CO≥2.0 and operating conditions of equivalent ratio (0 ≤ ER ≤ 1.0), steam to biomass ratio (0 ≤ SB ≤ 5), and gasification temperature (500 °C ≤ Tg ≤ 1300 °C). The optimization model is executed using the optimization section of the Model Analysis Tools of the Aspen Plus simulator. The model is tested using eleven (11) types of MSW. The optimum operating conditions under which the objective function and the constraint are satisfied are ER=0, SB=0.66-1.22, and Tg=679 - 763°C. Under the optimum operating conditions, the syngas quality is H2=52.38 - 58.67-mole percent, LHV=12.55 - 17.15 MJ/kg, N2=0.38 - 2.33-mole percent, and H2/CO≥2.15. The generalized optimization model reported could be extended to any other type of biomass and coal. Keywords: MSW, Syngas, Optimization, Fischer-Tropsch.

Keywords: syngas, MSW, optimization, Fisher-Tropsh

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Authors: Nanyombi Lubimbi, Josette Niyokindi

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Background: As in many other developing countries in Africa, Rwanda suffers from a chronic shortage of skilled Health Care professionals including Clinical Instructors. This shortage negatively affects the clinical instruction quality therefore impacting student-learning outcomes. Due to poor clinical supervision, it is often noted that students have no structure or consistent guidance in their learning process. The Clinical Educators and the Rwandan counterparts identified the need to create a favorable environment for learning. Description: During orientation the expectations of the student learning process, collaboration of the clinical instructors with the nurses and Clinical Educators is outlined. The ward managers facilitate structured learning by helping the students identify a maximum of two patients using the school’s objectives to guide the appropriate selection of patients. Throughout the day, Clinical Educators with collaboration of Clinical Instructors when present conduct an ongoing assessment of learning and provide feedback to the students. Post-conference is provided once or twice a week to practice critical thinking skills of patient cases that they have been taking care of during the day. Lessons Learned: The students are found to be more confident with knowledge and skills gained during rotations. Clinical facility evaluations completed by students at the end of their rotations highlight the student’s satisfaction and recommendation for continuation of structured learning. Conclusion: Based on the satisfaction of both students and Clinical Instructors, we have identified need for structured learning during clinical rotations. We acknowledge that more evidence-based practice is necessary to effectively address the needs of nursing and midwifery students throughout the country.

Keywords: Rwanda, clinical rotation, structured learning, critical thinking skills, post-conference

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