Search results for: randomized controlled study
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 49487

Search results for: randomized controlled study

49217 Smart Container Farming: Innovative Urban Strawberry Farming Model from Japan to the World

Authors: Nishantha Giguruwa

Abstract:

This research investigates the transformative potential of smart container farming, building upon the successful cultivation of Japanese mushrooms at Sakai Farms in Aichi Prefecture, Japan, under the strategic collaboration with the Daikei Group. Inspired by this success, the study focuses on establishing an advanced urban strawberry farming laboratory with the aim of understanding strawberry farming technologies, fostering collaboration, and strategizing marketing approaches for both local and global markets. Positioned within the business framework of Sakai Farms and the Daikei Group, the study underscores the sustainability and forward-looking solutions offered by smart container farming in agriculture. The global significance of strawberries is emphasized, acknowledging their economic and cultural importance. The detailed examination of strawberry farming intricacies informs the technological framework developed for smart containers, implemented at Sakai Farms. Integral to this research is the incorporation of controlled bee pollination, a groundbreaking addition to the smart container farming model. The study anticipates future trends, outlining avenues for continuing exploration, stakeholder collaborations, policy considerations, and expansion strategies. Notably, the author expresses a strategic intent to approach the global market, leveraging the foreign student/faculty base at Ritsumeikan Asia Pacific University, where the author is affiliated. This unique approach aims to disseminate the research findings globally, contributing to the broader landscape of agricultural innovation. The integration of controlled bee pollination within this innovative framework not only enhances sustainability but also marks a significant stride in the evolution of urban agriculture, aligning with global agricultural trends.

Keywords: smart container farming, urban agriculture, strawberry farming technologies, controlled bee pollination, agricultural innovation

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49216 Hyperspectral Band Selection for Oil Spill Detection Using Deep Neural Network

Authors: Asmau Mukhtar Ahmed, Olga Duran

Abstract:

Hydrocarbon (HC) spills constitute a significant problem that causes great concern to the environment. With the latest technology (hyperspectral images) and state of the earth techniques (image processing tools), hydrocarbon spills can easily be detected at an early stage to mitigate the effects caused by such menace. In this study; a controlled laboratory experiment was used, and clay soil was mixed and homogenized with different hydrocarbon types (diesel, bio-diesel, and petrol). The different mixtures were scanned with HYSPEX hyperspectral camera under constant illumination to generate the hypersectral datasets used for this experiment. So far, the Short Wave Infrared Region (SWIR) has been exploited in detecting HC spills with excellent accuracy. However, the Near-Infrared Region (NIR) is somewhat unexplored with regards to HC contamination and how it affects the spectrum of soils. In this study, Deep Neural Network (DNN) was applied to the controlled datasets to detect and quantify the amount of HC spills in soils in the Near-Infrared Region. The initial results are extremely encouraging because it indicates that the DNN was able to identify features of HC in the Near-Infrared Region with a good level of accuracy.

Keywords: hydrocarbon, Deep Neural Network, short wave infrared region, near-infrared region, hyperspectral image

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49215 Effects of Robot-Assisted Hand Training on Upper Extremity Performance in Patients with Stroke: A Randomized Crossover Controlled, Assessor-Blinded Study

Authors: Hsin-Chieh Lee, Fen-Ling Kuo, Jui-Chi Lin

Abstract:

Background: Upper extremity functional impairment that occurs after stroke includes hemiplegia, synergy movement, muscle hypertonicity, and somatosensory impairment, which result in inefficient and inaccurate movement. Robot-assisted rehabilitation is an intensive training approach that is effective in sensorimotor and hand function recovery. However, these systems mostly focused on the proximal part of the upper limb rather than the distal part. The device used in our study was Gloreha Sinfonia, which focuses on the distal part of the upper limb and uses a dynamic support system to facilitate the whole limb function. The objective of this study was to investigate the effects of robot-assisted therapy (RT) with Gloreha device on sensorimotor, and ADLs in patients with stroke. Method: Patients with stroke (N=25) participated AB or BA (A = 12 RT sessions and B = 12 conventional therapy (CT) sessions) for 6 weeks (60 min at each session, twice a week), with 1-month break for washout period. The performance of the patients was assessed by a blinded assessor at 4 time points (pretest 1, posttest 1, pretest 2, posttest 2) which including the Fugl–Meyer Assessment-upper extremity (FMA-UE), box and block test, electromyography of the extensor digitorum communis (EDC) and brachioradialis, a grip dynamometer for motor evaluation; Semmes–Weinstein hand monofilament and Revision of the Nottingham Sensory Assessment for sensory evaluation; and the Modified Barthel Index (MBI) for assessing the ADL ability. Result: RT group significantly improved FMA-UE proximal scores (p = 0.038), FMA-UE total scores (p = 0.046), and MBI (p = 0.030). The EDC exhibited higher efficiency during the small block grasping task in the RT group than in the CT group (p = 0.050). Conclusions: RT with the Gloreha device might lead to beneficial effects on arm motor function, ADL ability, and EDC muscle recruitment efficacy in patients with subacute to chronic stroke.

Keywords: activities of daily living, hand function, robotic rehabilitation, stroke

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49214 Iontophoretic Drug Transport of Some Anti-Diabetic Agents

Authors: Ashish Jain, Satish Nayak

Abstract:

Transdermal iontophoretic drug delivery system is viable drug delivery platform technology and has a strong market worldwide. Transdermal drug delivery system is particularly desirable for therapeutic agents that need prolonged administration at controlled plasma level. This makes appropriateness to antihypertensive and anti-diabetic agents for their transdermal development. Controlled zero order absorption, easily termination of drug delivery and easy to administration also support for popularity of transdermal delivery. In this current research iontophoretic delivery of various anti diabetic agents like glipizide, glibenclamide and glimepiride were carried out. The experiments were carried out at different drug concentrations and different current densities using cathodal iontophoresis. Diffusion cell for iontophoretic permeation study was modified according to Glikfield Design. Pig skin was used for in vitro permeation study and for the in-vivo study New Zealand rabbits were used. At all concentration level iontophoresis showed enhanced permeation rate compared to passive controls. Iontophoretic transports of selected drugs were found to be increased with the current densities. Results showed that target permeation rate for selected drugs could be achieved with the aid of iontophoresis by increasing the area in an appreciable range.

Keywords: transdermal, iontophoresis, pig skin, rabbits, glipizide, glibeclamide

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49213 A Controlled Natural Language Assisted Approach for the Design and Automated Processing of Service Level Agreements

Authors: Christopher Schwarz, Katrin Riegler, Erwin Zinser

Abstract:

The management of outsourcing relationships between IT service providers and their customers proofs to be a critical issue that has to be stipulated by means of Service Level Agreements (SLAs). Since service requirements differ from customer to customer, SLA content and language structures vary largely, standardized SLA templates may not be used and an automated processing of SLA content is not possible. Hence, SLA management is usually a time-consuming and inefficient manual process. For overcoming these challenges, this paper presents an innovative and ITIL V3-conform approach for automated SLA design and management using controlled natural language in enterprise collaboration portals. The proposed novel concept is based on a self-developed controlled natural language that follows a subject-predicate-object approach to specify well-defined SLA content structures that act as templates for customized contracts and support automated SLA processing. The derived results eventually enable IT service providers to automate several SLA request, approval and negotiation processes by means of workflows and business rules within an enterprise collaboration portal. The illustrated prototypical realization gives evidence of the practical relevance in service-oriented scenarios as well as the high flexibility and adaptability of the presented model. Thus, the prototype enables the automated creation of well defined, customized SLA documents, providing a knowledge representation that is both human understandable and machine processable.

Keywords: automated processing, controlled natural language, knowledge representation, information technology outsourcing, service level management

Procedia PDF Downloads 396
49212 Callus Induction of Segmented Corm Explant of Gladiolus cv. White Prosperity and Regeneration in vitro Condition

Authors: M. Sepahvand, M. Khorushy

Abstract:

Gladiolus, being a cormous plant, it is principally propagated by the natural multiplication of new corms and cormels. In order to obtain callus from segmented corm which was obtained from in vitro culture, callus formation media were MS media supplemented with 4 levels of hormones such as 1.0 mg l-1 NAA + 0.5 mg l-1 BAP, 0.5 mg l-1 NAA + 0.25 mg l-1 BAP, 1.0 mg l-1 2, 4-D + 0.5 mg l-1 BAP, and 0.5 mg l-1 2, 4-D + 0.25 mg l-1 BAP. The results showed that the most weight of callus (2.28 g) was produced in MS callus formation media which were supplemented with 1.0 mg l-1 NAA + 0.5 mg l-1 BAP. This experiment was carried out in randomized completely design with 3 replications and each treatment with six jars. In second experiment for regeneration of callus, a factorial experiment in the form of randomized complete design with 12 treatments and 3 replications and each replication with six jars was carried out. The treatments consisted of callus culture media in 4 levels and regeneration culture media in 3 levels [control (no PGRs), MS with 0.2 mg l-1 BAP + 0.1 mg l-1 Kin + 0.01 mg l-1 NAA, and MS with 0.2 mg l-1 BAP + 0.05 mg l-1 Kin + 0.01 mg l-1 NAA]. The results showed that the best regeneration media were MS media which were supplemented with 0.2 mg l-1 BAP + 0.1 mg l-1 Kin. + 0.01 mg l-1 NAA that had the highest number of shoots (7/83 N), and shoot length (7/3 cm).

Keywords: regeneration, Segmented corm explant, callus, in vitro, gladiolus cv. white prosperity

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49211 Optimal Control of DC Motor Using Linear Quadratic Regulator

Authors: Meetty Tomy, Arxhana G Thosar

Abstract:

This paper provides the implementation of optimal control for an armature-controlled DC motor. The selection of error weighted Matrix and control weighted matrix in order to implement optimal control theory for improving the dynamic behavior of DC motor is presented. The closed loop performance of Armature controlled DC motor with derived linear optimal controller is then evaluated for the transient operating condition (starting). The result obtained from MATLAB is compared with that of PID controller and simple closed loop response of the motor.

Keywords: optimal control, DC motor, performance index, MATLAB

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49210 Exploring the Application of Additive Manufacturing in the Production of Aerogels for the Purpose of Creating Environmentally Friendly Agricultural Formulations with Controlled Release Properties

Authors: Pram Abhayawardhana, Ali Reza Nazmi, Hossein Najaf Zadeh

Abstract:

This study examines the use of additive manufacturing (AM) to develop sustainable and intelligent agricultural formulations that can gradually release fertilisers. AM offers the ability to design customised formulations with precise geometries and controlled release properties while taking into account their mechanical, chemical, and environmental properties. The study specifically investigates the use of an aerogel matrix mixed with a potential fertiliser in agriculture. Highly porous 3D printed aerogel structures were designed to enable the slow release of fertilisers. The performance of the formulated mixture is evaluated against other commonly used materials for slow-release applications. The findings suggest that the 3D printed gel made has great potential for slow-release fertilisers, providing an environmentally friendly solution for agricultural practices. The combination of AM technology and sustainable materials can play a vital role in mitigating the negative environmental impact of traditional fertilisers, as well as improving the efficiency and sustainability of agricultural production.

Keywords: 3D printing, hydrogel, aerogel, fertiliser, agriculture

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49209 Comparative Study of Outcomes of Nonfixation of Mesh versus Fixation in Laparoscopic Total Extra Peritoneal (TEP) Repair of Inguinal Hernia: A Prospective Randomized Controlled Trial

Authors: Raman Sharma, S. K. Jain

Abstract:

Aims and Objectives: Fixation of the mesh during laparoscopic total extraperitoneal (TEP) repair of inguinal hernia is thought to be necessary to prevent recurrence. However, mesh fixation may increase surgical complications and postoperative pain. Our objective was to compare the outcomes of nonfixation with fixation of polypropylene mesh by metal tacks during TEP repair of inguinal hernia. Methods: Forty patients aged 18 to72 years with inguinal hernia were included who underwent laparoscopic TEP repair of inguinal hernia with (n=20) or without (n=20) fixation of the mesh. The outcomes were operative duration, postoperative pain score, cost, in-hospital stay, time to return to normal activity, and complications. Results: Patients in whom the mesh was not fixed had shorter mean operating time (p < 0.05). We found no difference between groups in the postoperative pain score, incidence of recurrence, in-hospital stay, time to return to normal activity and complications (P > 0.05). Moreover, a net cost savings was realized for each hernia repair performed without stapled mesh. Conclusions: TEP repair without mesh fixation resulted in the shorter operating time and lower operative cost with no difference between groups in the postoperative pain score, incidence of recurrence, in-hospital stay, time to return to normal activity and complications. All this contribute to make TEP repair without mesh fixation a better choice for repair of uncomplicated inguinal hernia, especially in developing nations with scarce resources.

Keywords: postoperative pain score, inguinal hernia, nonfixation of mesh, total extra peritoneal (TEP)

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49208 Promoted Thermoelectric Properties of Polymers through Controlled Tie-Chain Incorporation

Authors: Wenjin Zhu, Ian E. Jacobs, Henning Sirringhaus

Abstract:

We have demonstrated a model system for the controlled incorporation of tie-chains into semicrystalline conjugated polymers using blends of different molecular weights that leads to a significant increase in electrical conductivity. Through careful assessment of the microstructural evolution upon tie chain incorporation we have demonstrated that no major changes in phase morphology or structural order in the crystalline domains occur and that the observed enhancement in electrical conductivity can only be explained consistently by tie chains facilitating the transport across grain boundaries between the crystalline domains. Here we studied the thermoelectric properties of aligned, ion exchange-doped ribbon phase PBTTT with blends of different molecular weight components. We demonstrate that in blended films higher electrical conductivities (up to 4810.1 S/cm), Seebeck coefficients and thermoelectric power factors of up to 172.6 μW m-1 K-2 can be achieved than in films with single component molecular weights. We investigate the underpinning thermoelectric transport physics, including structural and spectroscopic characterization, to better understand how controlled tie chain incorporation can be used to enhance the thermoelectric performance of aligned conjugated polymers.

Keywords: organic electronics, thermoelectrics, conjugated polymers, tie chain

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49207 Effect of Oral Clonidine Premedication on Subarachnoid Block Characteristics of 0.5 % Hyperbaric Bupivacaine for Laparoscopic Gynecological Procedures – A Randomized Control Study

Authors: Buchh Aqsa, Inayat Umar

Abstract:

Background- Clonidine, α 2 agonist, possesses several properties to make it valuable adjuvant for spinal anesthesia. The study was aimed to evaluate the clinical effects of oral clonidine premedication for laparoscopic gynecological procedures under subarachnoid block. Patients and method- Sixtyfour adult female patients of ASA physical status I and II, aged 25 to 45 years and scheduled for laparoscopic gynecological procedures under the subarachnoid block, were randomized into two comparable equal groups of 32 patients each to received either oral clonidine, 100 µg (Group I) or placebo (Group II), 90 minutes before the procedure. Subarachnoid block was established with of 3.5 ml of 0.5% hyperbaric bupivacaine in all patients. Onset and duration of sensory and motor block, maximum cephalad level, and the regression time to reach S1 sensory level were assessed as primary end points. Sedation, hemodynamic variability, and respiratory depression or any other side effects were evaluated as secondary outcomes. Results- The demographic profile was comparable. The intraoperative hemodynamic parameters showed significant differences between groups. Oral clonidine was accelerated the onset time of sensory and motor blockade and extended the duration of sensory block (216.4 ± 23.3 min versus 165 ± 37.2 min, P <0.05). The duration of motor block showed no significant difference. The sedation score was more than 2 in the clonidine group as compared to the control group. Conclusion- Oral clonidine premedication has extended the duration of sensory analgesia with arousable sedation. It also prevented the post spinal shivering of the subarachnoid block.

Keywords: oral clonidine, subarachnoid block, sensory analgesia, laparoscopic gynaecological

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49206 Clinical Effectiveness of Bulk-fill Resin Composite: A Review

Authors: Taraneh Estedlal

Abstract:

The objective of this study was to review in-vivo and in-vitro studies to compare the effectiveness of bulk-fill and conventional resin composites with regard to marginal adaptation, polymerization shrinkage, and other mechanical properties.PubMed and Scopus databases was investigated for in-vitro studies and randomized clinical trials comparing incidence of fractures, color stability, marginal adaptation, pain and discomfort, recurrent caries, occlusion, pulpal reaction, and proper proximal contacts of restorations made with conventional and bulk resins. The failure rate of conventional and flowable bulk-fill resin composites was not significantly different to sculptable bulk-fill resin composites. The objective of this study was to review in-vivo and in-vitro studies to compare the effectiveness of bulk-fill and conventional resin composites with regard to marginal adaptation, polymerization shrinkage, and other mechanical properties. PubMed and Scopus databases was investigated for in-vitro studies and randomized clinical trials comparing one of the pearlier mentioned properties between bulk-fill and control composites. Despite differences in physical and in-vitro properties, failure rate of conventional and flowable bulk-fill resin composites was not significantly different to sculptable bulk-fill resin composites.

Keywords: polymerization shrinkage, color stability, marginal adaptation, recurrent caries, occlusion, pulpal reaction

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49205 Management of Postoperative Pain, Intercultural Differences Among Registered Nurses: Czech Republic and Kingdom of Saudi Arabia

Authors: Denisa Mackova, Andrea Pokorna

Abstract:

The management of postoperative pain is a meaningful part of quality care. The experience and knowledge of registered nurses in postoperative pain management can be influenced by local know-how. Therefore, the research helps to understand the cultural differences between two countries with the aim of evaluating the management of postoperative pain management among the nurses from the Czech Republic and the Kingdom of Saudi Arabia. Both countries have different procedures on managing postoperative pain and the research will provide an understanding of both the advantages and disadvantages of the procedures and also highlight the knowledge and experience of registered nurses in both countries. Between the Czech Republic and the Kingdom of Saudi Arabia, the expectation is for differing results in the usage of opioid analgesia for the patients postoperatively and in the experience of registered nurses with Patient Controlled Analgesia. The aim is to evaluate the knowledge and awareness of registered nurses and to merge the data with the postoperative pain management in the early postoperative period in the Czech Republic and the Kingdom of Saudi Arabia. Also, the aim is to assess the knowledge and experience of registered nurses by using Patient Controlled Analgesia and epidural analgesia treatment in the early postoperative period. The criteria for those providing input into the study, are registered nurses, working in surgical settings (standard departments, post-anesthesia care unit, day care surgery or ICU’s) caring for patients in the postoperative period. Method: Research is being conducted by questionnaires. It is a quantitative research, a comparative study of registered nurses in the Czech Republic and the Kingdom of Saudi Arabia. Questionnaire surveys were distributed through an electronic Bristol online survey. Results: The collection of the data in the Kingdom of Saudi Arabia has been completed successfully, with 550 respondents, 77 were excluded and 473 respondents were included for statistical data analysis. The outcome of the research is expected to highlight the differences in treatment through Patient Controlled Analgesia, with more frequent use in the Kingdom of Saudi Arabia. A similar assumption is expected for treatment conducted by analgesia. We predict that opioids will be used more regularly in the Kingdom of Saudi Arabia, whilst therapy through NSAID’s being the most common approach in the Czech Republic. Discussion/Conclusion: The majority of respondents from the Kingdom of Saudi Arabia were female registered nurses from a multitude of nations. We are expecting a similar split in gender between the Czech Republic respondents; however, there will be a smaller number of nationalities. Relevance for research and practice: Output from the research will assess the knowledge, experience and practice of patient controlled analgesia and epidural analgesia treatment. Acknowledgement: This research was accepted and affiliated to the project: Postoperative pain management, knowledge and experience registered nurses (Czech Republic and Kingdom of Saudi Arabia) – SGS05/2019-2020.

Keywords: acute postoperative pain, epidural analgesia, nursing care, patient controlled analgesia

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49204 The Addition of Opioids to Bupivacaine in Bilateral Infraorbital Nerve Block for Postoperative Pain Relief in Paediatric Patients for Cleft Lip Repair-Comparative Effects of Pethidine and Fentanyl: A Prospective Randomized Double Blind Study

Authors: Mrudula Kudtarkar, Rajesh Mane

Abstract:

Introduction: Cleft lip repair is one of the common surgeries performed in India and the usual method used for post-operative analgesia is perioperative opioids and NSAIDs. There has been an increase in use of regional techniques and Opioids are the common adjuvants but their efficacy and safety have not been studied extensively in children. Aim: A prospective, randomized, double-blind study was done to compare the efficacy, duration and safety of intraoral infraorbital nerve block on post-operative pain relief using bupivacaine alone or in combination with fentanyl or pethidine in paediatric cleft lip repair. Methodology: 45 children between the age group 5 – 60 months undergoing cleft lip surgery randomly allocated into 3 groups of 15 each received bilateral intraoral infraorbital nerve block with 0.75ml of solution. Group B received 0.25% bupivacaine; group P received 0.25% bupivacaine with 0.25mg/kg pethidine, group F received 0.25% bupivacaine with 0.25microgm/kg fentanyl. Sedation after recovery, post-operative pain intensity and duration of post-operative analgesia were assessed using Modified Hannallah Pain Score. Results: The mean duration of analgesia was 17.8 hrs in Group B, 23.53 hrs in Group F and 35.13 hrs in Group P. There was statistically significant difference between the means of the three groups- ANOVA (p < 0.05). Conclusion: Thus we conclude that addition of fentanyl or pethidine to bupivacaine for Bilateral Intraoral Infraorbital Nerve Block prolong the duration of analgesia with no complications and can be used safely in paediatric patients.

Keywords: cleft lip, infraorbital block, NSAIDS, Opiods

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49203 Digital Control Algorithm Based on Delta-Operator for High-Frequency DC-DC Switching Converters

Authors: Renkai Wang, Tingcun Wei

Abstract:

In this paper, a digital control algorithm based on delta-operator is presented for high-frequency digitally-controlled DC-DC switching converters. The stability and the controlling accuracy of the DC-DC switching converters are improved by using the digital control algorithm based on delta-operator without increasing the hardware circuit scale. The design method of voltage compensator in delta-domain using PID (Proportion-Integration- Differentiation) control is given in this paper, and the simulation results based on Simulink platform are provided, which have verified the theoretical analysis results very well. It can be concluded that, the presented control algorithm based on delta-operator has better stability and controlling accuracy, and easier hardware implementation than the existed control algorithms based on z-operator, therefore it can be used for the voltage compensator design in high-frequency digitally- controlled DC-DC switching converters.

Keywords: digitally-controlled DC-DC switching converter, digital voltage compensator, delta-operator, finite word length, stability

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49202 Group Sequential Covariate-Adjusted Response Adaptive Designs for Survival Outcomes

Authors: Yaxian Chen, Yeonhee Park

Abstract:

Driven by evolving FDA recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in favor of the treatment that is best for an individual patient’s profile. However, existing CARA designs for survival outcomes often hinge on specific parametric models, constraining their applicability in clinical practice. In this article, we address this limitation by introducing a CARA design for survival outcomes (CARAS) based on the Cox model and a variance estimator. This method addresses issues of model misspecification and enhances the flexibility of the design. We also propose a group sequential overlapweighted log-rank test to preserve type I error rate in the context of group sequential trials using extensive simulation studies to demonstrate the clinical benefit, statistical efficiency, and robustness to model misspecification of the proposed method compared to traditional randomized controlled trial designs and response-adaptive randomization designs.

Keywords: cox model, log-rank test, optimal allocation ratio, overlap weight, survival outcome

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49201 A Randomized Comparative Evaluation of Efficacy of Ultrasound Guided Costoclavicular and Supraclavicular Approaches of Brachial Plexus Block for Upper Limb Surgeries

Authors: Anshul, Rajni Kalia, Sachin Kumar

Abstract:

Introduction: The costoclavicular approach, a modification to the infraclavicular approach, has been described for anesthesia for upper limb surgeries. Material And Methods: In this randomized and single-blind study, fourty patients undergoing emergency/elective upper limb surgery were allocated to two groups. Group C and S received ultrasound-guided Costoclavicular block and Supraclavicular block, respectively, with 20 ml 0.5 % ropivacaine with 8 mg dexamethasone under strict asepsis. The primary outcome assessed was the total duration of sensory and motor block in the postoperative period. Secondary outcomes were to compare the time taken to perform the procedure, block characteristics in terms of onset of motor and sensory blockade, the efficacy of analgesia with respect to the time of administration of the first rescue analgesic dose with both the blocks and note the side effects pertaining to either of the blocks. Results: The mean total duration of sensory and motor blockade was longer in group C vs. group S (p=0.002 and 0.024, respectively). The mean duration to perform a block in group S was more than in group C (p=0.012). The mean onset of sensory and motor Blockade Time in group S was more than in group C (p<0.001 and <0.001, respectively). The mean duration to perform a block in group S was more than in group C (p=0.012). Conclusion: The costoclavicular approach is better than supraclavicular in terms of rapid execution, faster onset of sensory-motor blockade, prolonged postoperative analgesia and similar PONV and safety profile.

Keywords: costoclavicular, supraclavicular, ropivacaine, dexamethasone

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49200 The Effect of Nutrition Education on Glycemic and Lipidemic Control in Iranian Patients with Type 2 Diabetes

Authors: Samira Rabiei, Faezeh Askari, Reza Rastmanesh

Abstract:

Objective: To evaluate the effects of nutrition education and adherence to a healthy diet on glycemic and lipidemic control in patients with T2DM. Material and Methods: A randomized controlled trial was conducted on 494 patients with T2DM, aged 14-87 years from both sexes who were selected by convenience sampling from referees to Aliebneabitaleb hospital in Ghom. The participants were divided into two 247 person groups by stratified randomization. Both groups received a diet adjusted based on ideal body weight, and the intervention group was additionally educated about healthy food choices regarding diabetes. Information on medications, psychological factors, diet and physical activity was obtained from questionnaires. Blood samples were collected to measure FBS, 2 hPG, HbA1c, cholesterol, and triglyceride. After 2 months, weight and biochemical parameters were measured again. Independent T-test, Mann-Whitney, Chi-square, and Wilcoxon were used as appropriate. Logistic regression was used to determine the odds ratio of abnormal glycemic and lipidemic control according to the intervention. Results: The mean weight, FBS, 2 hPG, cholesterol and triglyceride after intervention were significantly lower than before that (p < 0.05). Discussion: Nutrition education plus a weigh reducer diet is more effective on glycemic and lipidemic control than a weight reducer diet, alone.

Keywords: type 2 diabetes mellitus, nutrition education, glycemic control, lipid profile

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49199 Competing Risk Analyses in Survival Trials During COVID-19 Pandemic

Authors: Ping Xu, Gregory T. Golm, Guanghan (Frank) Liu

Abstract:

In the presence of competing events, traditional survival analysis may not be appropriate and can result in biased estimates, as it assumes independence between competing events and the event of interest. Instead, competing risk analysis should be considered to correctly estimate the survival probability of the event of interest and the hazard ratio between treatment groups. The COVID-19 pandemic has provided a potential source of competing risks in clinical trials, as participants in trials may experienceCOVID-related competing events before the occurrence of the event of interest, for instance, death due to COVID-19, which can affect the incidence rate of the event of interest. We have performed simulation studies to compare multiple competing risk analysis models, including the cumulative incidence function, the sub-distribution hazard function, and the cause-specific hazard function, to the traditional survival analysis model under various scenarios. We also provide a general recommendation on conducting competing risk analysis in randomized clinical trials during the era of the COVID-19 pandemic based on the extensive simulation results.

Keywords: competing risk, survival analysis, simulations, randomized clinical trial, COVID-19 pandemic

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49198 Evaluation of the Irritation Potential of Three Topical Formulations of Minoxidil 5% Using Patch Test

Authors: Sule Pallavi, Shah Priyank, Thavkar Amit, Mehta Suyog, Rohira Poonam

Abstract:

Minoxidil is used topically to help hair growth in the treatment of male androgenetic alopecia. The objective of this study is to compare irritation potential of three conventional formulation of minoxidil 5% topical solution of in human patch test. The study was a single centre, double blind, non-randomized controlled study in 56 healthy adult Indian subjects. Occlusive patch test for 24 hours was performed with three formulation of minoxidil 5% topical solution. Products tested included aqueous based minoxidil 5% (AnasureTM 5%, Sun Pharma, India – Brand A), alcohol based minoxidil 5% (Brand B) and aqueous based minoxidil 5% (Brand C). Isotonic saline 0.9% and 1% w/w sodium lauryl sulphate were included as negative control and positive control respectively. Patches were applied and removed after 24hours. The skin reaction was assessed and clinically scored 24 hours after the removal of the patches under constant artificial daylight source using Draize scale (0-4 points scale for erythema/wrinkles/dryness and for oedema). A combined mean score up to 2.0/8.0 indicates a product is “non-irritant” and score between 2.0/8.0 and 4.0/8.0 indicates “mildly irritant” and score above 4.0/8.0 indicates “irritant”. Follow-up was scheduled after one week to confirm recovery for any reaction. The procedure of the patch test followed the principles outlined by Bureau of Indian standards (BIS) (IS 4011:2018; Methods of Test for safety evaluation of Cosmetics-3rd revision). Fifty six subjects with mean age 30.9 years (27 males and 29 females) participated in the study. The combined mean score (± standard deviation) were: 0.13 ± 0.33 (Brand A), 0.39 ± 0.49 (Brand B), 0.22 ± 0.41 (Brand C), 2.91 ± 0.79 (Positive control) and 0.02 ± 0.13 (Negative control). The mean score of Brand A (Sun Pharma product) was significantly lower than Brand B (p=0.001) and was comparable with Brand C (p=0.21). The combined mean erythema score (± standard deviation) were: 0.09 ± 0.29 (Brand A), 0.27 ± 0.5 (Brand B), 0.18 ± 0.39 (Brand C), 2.02 ± 0.49 (Positive control) and 0.0 ± 0.0 (Negative control). The mean erythema score of Brand A was significantly lower than Brand B (p=0.01) and was comparable with Brand C (p=0.16). Any reaction observed at 24hours after patch removal subsided in a week. All the three topical formulation of minoxidil 5% were non-irritant. Brand A of 5% minoxidil (Sun Pharma) was found to be least irritant than Brand B and Brand C based on the combined mean score and mean erythema score in the human patch test as per the BIS, IS 4011;2018.

Keywords: erythema, irritation, minoxidil, patch test

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49197 The Use of Palm Kernel Cake in Ration and Its Influence on VFA, NH3 and pH Rumen Fluid of Goat

Authors: Arief, Noovirman Jamarun, Benni Satria

Abstract:

Background: The main problem in the development of livestock in Indonesia is feed both in terms of quality and quantity. On the other hand, conventional feed ingredients are expensive and difficult to obtain. Therefore, it is necessary to find alternative feed ingredients that have good quality, potential, and low cost. Feed ingredients that meet the above requirements are by-products of the palm oil industry, namely palm kernel cake (PKC). This study aims to obtain the best PKC composition for Etawa goat concentrate ration. Material and Methode : This research consists of 2 stages. Stage I is invitro study using Tilley and Terry method. The study used a Completely Randomized Design (CRD) with 4 treatments of rations and 4 replications. The treatment is the composition of the use of palm kernel cake (PKC) in the ration, namely, A). 10%, B). 20%, C). 30%, D). 40%. Other feed ingredients are corn, rice bran, tofu waste and minerals. The measured variables are the characteristics of the rumen fluid (pH, VFA and NH3). Stage II was done using the best ration of stage I (Ration C), followed by testing the use of Tithonia (Thitonia difersifolia) and agricultural waste of sweet potato leaves as a source of forage for livestock by in-vitro. The study used a Completely Randomized Design (CRD) with 3 treatments and 5 replications. The treatments were: Treatment A) Best Concentrate Ration Stage I + Titonia (Thitonia difersifolia), Treatment B) Best Concentrate Ration Stage I + Tithonia (Thitonia difersifolia) and Sweet potato Leaves, Treatment C) Best Concentrate Ration Stage I + Sweet potato leaves. The data obtained were analyzed using variance analysis while the differences between treatments were tested using the Duncant Multiple Range Test (DMRT) according to Steel and Torrie. Results of Stage II showed that the use of PKC in rations as concentrate feed combined with forage originating from Tithonia (Thitonia difersifolia) and sweet potato leaves produced pH, VFA and NH3-N which were still in normal conditions. The best treatment was obtained from diet B (P <0.05) with 6.9 pH, 116.29 mM VFA and 15mM NH3-N. Conclussion From the results of the study it can be concluded that PKC can be used as feed ingredients for dairy goat concentrate with a combination of forage from Tithonia (Tithonia difersifolia) and sweet potato leaves.

Keywords: palm oil by-product, palm kernel cake, concentrate, rumen fluid, Etawa goat

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49196 Formal Asymptotic Stability Guarantees, Analysis, and Evaluation of Nonlinear Controlled Unmanned Aerial Vehicle for Trajectory Tracking

Authors: Soheib Fergani

Abstract:

This paper concerns with the formal asymptotic stability guarantees, analysis and evaluation of a nonlinear controlled unmanned aerial vehicles (uav) for trajectory tracking purpose. As the system has been recognised as an under-actuated non linear system, the control strategy has been oriented towards a hierarchical control. The dynamics of the system and the mission purpose make it mandatory to provide an absolute proof of the vehicle stability during the maneuvers. For this sake, this work establishes the complete theoretical proof for an implementable control oriented strategy that asymptotically stabilizes (GAS and LISS) the system and has never been provided in previous works. The considered model is reorganized into two partly decoupled sub-systems. The concidered control strategy is presented into two stages: the first sub-system is controlled by a nonlinear backstepping controller that generates the desired control inputs to stabilize the second sub-system. This methodology is then applied to a harware in the loop uav simulator (SiMoDrones) that reproduces the realistic behaviour of the uav in an indoor environment has been performed to show the efficiency of the proposed strategy.

Keywords: UAV application, trajectory tracking, backstepping, sliding mode control, input to state stability, stability evaluation

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49195 Qualitative Characteristics of Meat from Lambs Fed Hydrolyzed Sugarcane

Authors: V. Endo, A. G. Silva Sobrinho, F. A. Almeida, N. L. L. Lima, G. M. Manzi, L. G. A. Cirne, N. M. B. L. Zeola

Abstract:

We used 24 Ile de France lambs, weighing between 15 and 32 kg (BW). Treatments were supplemented with concentrate: “in nature” sugarcane (IN), sugarcane hydrolyzed using 0.6% calcium oxide (CaO) under aerobic condition (AER), and sugarcane hydrolyzed using 0.6% CaO under anaerobic condition (ANA), constituting a completely randomized design with eight repetitions per treatment. Lambs were housed in individual stalls and fed into the through, allowing 10% of leftovers. Lambs were slaughtered when body weight reached 32 kg. The following parameters were determined on Longissimus lumborum muscle of hot and cold carcasses: pH and color, 45 minutes and 24 hours after slaughtering. Qualitative analysis of the meat were performed in the loins, water-holding capacity (WHC), cooking loss (CL), and shear force (SF). We used a completely randomized design with three treatments and eight repetitions. Means were compared by Tukey test at 5% significance. A higher value for redness (a*) 45 minutes after slaughter (10.48) was found for lambs fed sugarcane hydrolyzed under anaerobic conditions. The other qualitative characteristics of meat were not affected by treatments (P >0.05). The comparison of meat quality resulting from the treatments shows that it is possible to feed in nature sugarcane to lambs, thus waiving hydrolyses process and the spending with alkalizing agent.

Keywords: oxide, hydrolysis, meat quality, pH

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49194 Promoting Self-Esteem and Social Integration in Secondary German Schools: An Evaluation Study

Authors: Susanne Manes, Anni Glaeser, Katharina Wick, Bernhard Strauss, Uwe Berger

Abstract:

Introduction: Over the last decades growing rates of mental health concerns among children and adolescents have been observed. At the same time, physical well-being of children and adolescents becomes increasingly impaired as well. Schools play an important role in preventing mental and physical disorders and in promoting well-being. Self-esteem, as well as social integration, are vital influence factors for mental and physical well-being. The purpose of this study was to develop and evaluate the program 'VorteilJena' for secondary schools in Germany focusing on self-esteem and social integration to improve mental and physical well-being. Method: The school-based health promotion program was designed for students in 5th grade and higher. It consists of several short pedagogical exercises instructed by a teacher and were integrated into the regular class over the course of ten weeks. The exercises focused on fostering social integration using either tasks improving team spirit or exercises that increase tolerance and sense of belonging. Other exercises focused on strengthening the self-esteem of the students. Additionally, the program included a poster exhibition titled 'Belonging' which was put up in the school buildings. The exhibition comprised ten posters which addressed relevant risk factors and resources related to social integration and self-esteem. The study was a randomized controlled sequential study with a pre and post measurement conducted in ten German schools. A total of 1642 students (44% male) were recruited. Their age ranged from 9 to 21 years (M=12.93 years; SD= 2.11). The program was conducted in classes ranging from 5th to 12th grade. Results: The program improved wellbeing, self-esteem and social integration of the involved students compared to the control group. Differential effects depending on implementation rates or age of the students will be analyzed. Moreover, implications for future school-based health promotion programs targeting self-esteem and social integration will be discussed. Conclusion: Social integration considerably influences self-esteem and well-being of students and can be targeted by school-based programs including short and modest exercises. Since a sufficient implementation of health promotion programs is essential, the present program due to its practicability represents a good opportunity to install health promotion focusing on social integration in schools.

Keywords: social integration, well-being, health promotion in schools, self-esteem

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49193 Comparison of Effectiveness When Ketamine was Used as an Adjuvant in Intravenous Patient-Controlled Analgesia Used to Control Cancer Pain

Authors: Donghee Kang

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Background: Cancer pain is very difficult to control as the mechanism of pain is varied, and the patient has several co-morbidities. The use of Intravenous Patient-Controlled Analgesia (IV-PCA) can effectively control underlying pain and breakthrough pain. Ketamine is used in many pain patients due to its unique analgesic effect. In this study, it was checked whether there was a difference in the amount of analgesic usage, pain control degree, and side effects between patients who controlled pain with fentanyl-based IV-PCA and those who added Ketamine for pain control. Methods: Among the patients referred to this department for cancer pain, IV-PCA was applied to patients who were taking sufficient oral analgesics but could not control them or had blood clotting disorders that made the procedure difficult, and this patient group was targeted. In IV-PCA, 3000 mcg of Fentanyl, 160 mg of Nefopam, and 0.3 mg of Ramosetrone were mixed with normal saline to make a total volume of 100 ml. Group F used this IV-PCA as it is, and group K mixed 250 mg of Ketamine with normal saline to make a total volume of 100 ml. For IV-PCA, the basal rate was 0.5ml/h, the bolus was set to 1ml when pressed once, and the lockout time was set to 15 minutes. If pain was not controlled after IV-PCA application, 500 mcg of Fentanyl was added, and if excessive sedation or breathing difficulties occurred, the use was stopped for one hour. After that, the degree of daily pain control, analgesic usage, and side effects were investigated for seven days using this IV-PCA. Results: There was no difference between the two groups in the demographic data. Both groups had adequate pain control. Initial morphine milligram equivalents did not differ between the two groups, but the total amount of Fentanyl used for seven days was significantly different between the two groups [p=0.014], and group F used more Fentanyl through IV-PCA. In addition, the amount of sleeping pills used during the seven days was higher in Group F [p<0.01]. Overall, there was no difference in the frequency of side effects between the two groups, but the nausea was more frequent in Group F [p=0.031]. Discussion: When the two groups were compared, pain control was good in both groups. This seems to be because Fentanyl-based IV-PCA showed an adequate pain control effect. However, there was a significant difference in the total amount of opioid (Fentanyl) used, which is thought to be the opioid-sparing effect of Ketamine. Also, among the side effects, nausea was significantly less, which is thought to be possible because the amount of opioids used in the Ketamine group was small. The frequency of requesting sleeping pills was significantly less in the group using Ketamine, and it seems that Ketamine also helped improve sleep quality. In conclusion, using Ketamine with an opioid to control pain seems to have advantages. IV-PCA, which can be used effectively when other procedures are difficult, is more effective and safer when used together with Ketamine than opioids alone.

Keywords: cancer pain, intravenous patient-controlled analgesia, Ketamine, opioid

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49192 Effective, Affordable, and Accessible Treatment for Pregnancy’s Commonest Complication: Online Synchronous Interpersonal Psychotherapy for Mothers with Postpartum Depression

Authors: Vivian Polak, Lena Verdeli, Wendy Lou, Caroline Lovett

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Postnatal depression (PND) is a common complication of childbirth that increases the risk of future depressive episodes in women, postpartum depression in partners, as well as social, emotional, behavioural, language, and cognitive problems in offspring. Although psychotherapy, and in particular Group Interpersonal Psychotherapy (IPT-G), has been proven effective in treating PND, it remains largely inaccessible. However, research has indicated that online synchronous group therapy can be equally as effective as in-person therapy and is a more affordable and accessible modality of treatment. This study aimed to ascertain whether delivering IPT-G virtually when compared to treatment as usual, could more effectively reduce depressive and anxiety symptoms, enhance mother-infant attachment, improve the couple relationship, augment social support, improve overall functioning, and enhance the quality of life for women in rural and northern Ontario who are suffering from PND. By bridging the gap in access to mental health services during the postpartum period, this study seeks to improve the well-being of mothers and their families in rural and northern Ontario, Canada. A randomized controlled trial was conducted to determine whether virtual IPT-G plus treatment as usual would be more effective than treatment as usual alone in treating women with PND in Ontario, Canada. Preliminary results indicate that women who received virtual IPT-G had a clinically and statistically significant decrease in overall depressive symptoms compared to their counterparts who received only the treatment as usual. As such, providing online synchronous IPT-G in the perinatal period not only has the potential to improve women's outcomes in the present but also to decrease future health costs, reduce the burden on the educational and justice systems, and decrease the number of disability life years lost to postnatal depression.

Keywords: family wellbeing, group psychotherapy, interpersonal psychotherapy, postnatal depression, virtual psychotherapy

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49191 Effects of Bed Type, Corm Weight and Lifting Time on Quantitative and Qualitative Criteria of Saffron (Crocus sativus L.)

Authors: A. Mollafilabi, A. Koocheki, P. Rezvani Moghaddam, M. Nassiri Mahalati

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In order to study the effects of corm weights and times of corm lifting saffron in different planting beds, an experiment was conducted as Factorial layout based on a Randomized Complete Block Design with three replications at the Fadak Research Center of Agricultural Research in Food Science during 2010. Treatments were two corm weights (8-10, 10 < g), two planting beds (stone wool and peat moss) and five levels of lifting time (mi-June, early July, mid-July, early August and mid-August). No. of corms were 457 corms.m-2 and for 40 days and were stored for 90 days in incubation, 85% relative humidity and 25°C temperature in the darkness. Then, saffron corms were transferred to growth chamber with 17 °C in 8 hours light and 16 hours darkness. Characteristics were number of flower, fresh weight of flower, dry weight of flower, fresh and dry weight of stigma, fresh and dry weight of style, fresh and dry weight of stigma+style and Picrocrocin, Safronal and Crocin contents of saffron were measured. Results showed that the corm weight, bed type and time of corm lifting had significant effects on economical yield of saffron such as picked flowers, dry weight of stigma and fresh weight of flowers. The highest saffron economical yield was obtained in interaction of corm weight, 10 g, peat moss and lifting time in mid-June as much as 5.2 g.m-2. This yield is 11 fold of average yield of Iranian farms. Picrocrocin, Safranal and Crocin contents was graded as excellent thread in peat moss under controlled conditions compared with ISO Standard of 203.

Keywords: corm density, dry stigma, safranal-flowering, yield saffron

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49190 Hypoglossal Nerve Stimulation (Baseline vs. 12 months) for Obstructive Sleep Apnea: A Meta-Analysis

Authors: Yasmeen Jamal Alabdallat, Almutazballlah Bassam Qablan, Hamza Al-Salhi, Salameh Alarood, Ibraheem Alkhawaldeh, Obada Abunar, Adam Abdallah

Abstract:

Obstructive sleep apnea (OSA) is a disorder caused by the repeated collapse of the upper airway during sleep. It is the most common cause of sleep-related breathing disorder, as OSA can cause loud snoring, daytime fatigue, or more severe problems such as high blood pressure, cardiovascular disease, coronary artery disease, insulin-resistant diabetes, and depression. The hypoglossal nerve stimulator (HNS) is an implantable medical device that reduces the occurrence of obstructive sleep apnea by electrically stimulating the hypoglossal nerve in rhythm with the patient's breathing, causing the tongue to move. This stimulation helps keep the patient's airways clear while they sleep. This systematic review and meta-analysis aimed to assess the clinical outcome of hypoglossal nerve stimulation as a treatment of obstructive sleep apnea. A computer literature search of PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials was conducted from inception until August 2022. Studies assessing the following clinical outcomes (Apnea-Hypopnea Index (AHI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Oxygen Desaturation Indices (ODI), (Oxygen Saturation (SaO2)) were pooled in the meta-analysis using Review Manager Software. We assessed the quality of studies according to the Cochrane risk-of-bias tool for randomized trials (RoB2), Risk of Bias In Non-randomized Studies - of Interventions (ROBINS-I), and a modified version of NOS for the non-comparative cohort studies.13 Studies (Six Clinical Trials and Seven prospective cohort studies) with a total of 817 patients were included in the meta-analysis. The results of AHI were reported in 11 studies examining OSA 696 patients. We found that there was a significant improvement in the AHI after 12 months of HNS (MD = 18.2 with 95% CI, (16.7 to 19.7; I2 = 0%); P < 0.00001). Further, 12 studies reported the results of ESS after 12 months of intervention with a significant improvement in the range of sleepiness among the examined 757 OSA patients (MD = 5.3 with 95% CI, (4.75 to 5.86; I2 = 65%); P < 0.0001). Moreover, nine studies involving 699 participants reported the results of FOSQ after 12 months of HNS with a significant reported improvement (MD = -3.09 with 95% CI, (-3.41 to 2.77; I2 = 0%); P < 0.00001). In addition, ten studies reported the results of ODI with a significant improvement after 12 months of HNS among the 817 examined patients (MD = 14.8 with 95% CI, (13.25 to 16.32; I2 = 0%); P < 000001). The Hypoglossal Nerve Stimulation showed a significant positive impact on obstructive sleep apnea patients after 12 months of therapy in terms of apnea-hypopnea index, oxygen desaturation indices, manifestations of the behavioral morbidity associated with obstructive sleep apnea, and functional status resulting from sleepiness.

Keywords: apnea, meta-analysis, hypoglossal, stimulation

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49189 Response Surface Methodology to Obtain Disopyramide Phosphate Loaded Controlled Release Ethyl Cellulose Microspheres

Authors: Krutika K. Sawant, Anil Solanki

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The present study deals with the preparation and optimization of ethyl cellulose-containing disopyramide phosphate loaded microspheres using solvent evaporation technique. A central composite design consisting of a two-level full factorial design superimposed on a star design was employed for optimizing the preparation microspheres. The drug:polymer ratio (X1) and speed of the stirrer (X2) were chosen as the independent variables. The cumulative release of the drug at a different time (2, 6, 10, 14, and 18 hr) was selected as the dependent variable. An optimum polynomial equation was generated for the prediction of the response variable at time 10 hr. Based on the results of multiple linear regression analysis and F statistics, it was concluded that sustained action can be obtained when X1 and X2 are kept at high levels. The X1X2 interaction was found to be statistically significant. The drug release pattern fitted the Higuchi model well. The data of a selected batch were subjected to an optimization study using Box-Behnken design, and an optimal formulation was fabricated. Good agreement was observed between the predicted and the observed dissolution profiles of the optimal formulation.

Keywords: disopyramide phosphate, ethyl cellulose, microspheres, controlled release, Box-Behnken design, factorial design

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49188 Evaluation of the Irritation Potential of Three Topical Formulations of Minoxidil 5% + Finasteride 0.1% Using Patch Test

Authors: Joshi Rajiv, Shah Priyank, Thavkar Amit, Rohira Poonam, Mehta Suyog

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Topical formulation containing minoxidil and finasteride helps hair growth in the treatment of male androgenetic alopecia. The objective of this study is to compare the irritation potential of three conventional formulations of minoxidil 5% + finasteride 0.1% topical solution of in human patch test. The study was a single centre, double blind, non-randomized controlled study in 53 healthy adult Indian subjects. Occlusive patch test for 24 hours was performed with three formulations of minoxidil 5% + finasteride 0.1% topical solution. Products tested included aqueous based minoxidil 5% + finasteride 0.1% (AnasureTM-F, Sun Pharma, India – Brand A), lipid based minoxidil 5% + finasteride 0.1% (Brand B) and aqueous based minoxidil 5% + finasteride 0.1% (Brand C). Isotonic saline 0.9% and 1% w/w sodium lauryl sulphate were included as negative control and positive control respectively. Patches were applied and removed after 24 hours. The skin reaction was assessed and clinically scored 24 hours after the removal of the patches under constant artificial daylight source using the Draize scale (0-4 points scale for erythema/dryness//wrinkles and for oedema). Follow-up was scheduled after one week to confirm recovery for any reaction. A combined mean score up to 2.0/8.0 indicates a product is “non-irritant” and a score between 2.0/8.0 and 4.0/8.0 indicates “mildly irritant” and a score above 4.0/8.0 indicates “irritant”. The procedure of the patch test followed the principles outlined by the Bureau of Indian Standards (BIS) (IS 4011:2018; Methods of Test for safety evaluation of Cosmetics-3rd revision). Fifty three subjects with mean age 31.9 years (25 males and 28 females) participated in the study. The combined mean score ± standard deviation were: 0.06 ± 0.23 (Brand A), 0.81 ± 0.59 (Brand B), 0.38 ± 0.49 (Brand C), 2.92 ± 0.47 (positive control) and 0.0 ± 0.0 (Negative control). This means the score of Brand A (Sun Pharma product) was significantly lower than that of Brand B (p=0.001) and that of Brand C (p=0.001). The combined mean erythema score ± standard deviation were: 0.06 ± 0.23 (Brand A), 0.81 ± 0.59 (Brand B), 0.38 ± 0.49 (Brand C), 2.09 ± 0.4 (Positive control) and 0.0 ± 0.0 (Negative control). The mean erythema score of Brand A was significantly lower than Brand B (p=0.001) and that of Brand C (p=0.001). Any reaction observed at 24hours after patch removal subsided in a week. All the three topical formulations of minoxidil 5% + finasteride 0.1% were non-irritant. Brand A of minoxidil 5% + finasteride 0.1% (Sun Pharma) was found to be the least irritant than Brand B and Brand C based on the combined mean score and mean erythema score in the human patch test as per the BIS, IS 4011:2018

Keywords: erythema, finasteride, irritation, minoxidil, patch test

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