Search results for: trial

Authors: Erin V. Kelly, Nicola C. Newton, Lexine A. Stapinski, Maree Teesson

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Introduction: There is a lack of targeted prevention programs for reducing bullying and distress among adolescents involved in bullying. The current study aimed to examine the impact of a personality-targeted intervention (Preventure) on bullying (victimization and perpetration) and distress among adolescent victims/bullies with high-risk personality types. Method: A cluster randomized trial (RCT) was conducted in 26 secondary schools (2190 students) in NSW and Victoria, Australia, as part of the Climate Schools and Preventure trial. The schools were randomly allocated to Preventure (13 schools received Preventure, 13 did not). Students were followed up at 4 time points (6, 12, 24 and 36 months post-baseline). Preventure involves two group sessions, based on cognitive behavioral therapy, and tailored to four personality types shown to increase risk of substance misuse and other emotional and behavioural problems, including impulsivity, sensation-seeking, anxiety sensitivity and hopelessness. Students were allocated to the personality-targeted groups based on their scores on the Substance Use Risk Profile Scale. Bullying was measured using an amended version of the Revised Olweus Bully/Victim Scale. Psychological distress was measured using the Kessler Psychological Distress Scale. Results: Among high-risk students classified as victims at baseline, those in Preventure schools reported significantly less victimization and distress over time than those in control schools. Among high-risk students classified as bullies at baseline, those in Preventure schools reported significantly less distress over time than those in control schools (no difference for perpetration). Conclusion: Preventure is a promising intervention for reducing bullying victimization and psychological distress among adolescents involved in bullying.

Keywords: adolescents, bullying, personality, prevention

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Authors: Olatundun Bukola Ezekiel, Adejumo Olusoji

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A feeding trial was conducted with 100 two-weeks old broiler chicken to evaluate the influence of inclusion in broiler diets at 0, 2.5, 5, 7.5 and 10% neem kernel (used to replace equal quantity of maize) on their performance, organ weight and gut morphometry. The birds were randomly allotted to five dietary treatments, each treatment having four replicates consisting of five broilers in a completely randomized design. The diets were formulated to be iso-nitrogenous (23% CP). Weekly feed intake and changes in body weight were calculated and feed efficiency determined. At the end of the 28-day feeding trial, four broilers per treatment were selected and sacrificed for carcass evaluation. Results were subjected to statistical analysis using the analysis of variance procedures of Statistical Analysis Software The treatment means were presented with group standard errors of means and where significant, were compared using the Duncan multiple range test of the same software. The results showed that broilers fed 2.5% neem kernel inclusion diets had growth performance statistically comparable to those fed the control diet. Birds on 5, 7.5 and 10% neem kernel diets showed significant (P<0.05) increase in relative weight of liver. The absolute weight of spleen also increased significantly (P<0.05) in birds on 10 % neem kernel diet. More than 5 % neem kernel diets gave significant (P<0.05) increase in the relative weight of the kidney. The length of the small intestine significantly increased in birds fed 7.5 and 10% neem kernel diets. Significant differences (P<0.05) did not occur in the length of the large intestine, right and left caeca. It is recommended that neem kernel can be included up to 2.5% in broiler chicken diet without any deleterious effects on the performance and physiological status of the birds.

Keywords: broiler chicken, growth performance, gut morphometry, neem kernel, organ weight

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Authors: T. Goldstein, E. Serok, J. D. Kark

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Background and Aim: The prevalence of obesity is increasing worldwide and in Israel. To meet this challenge, our study tests a new educational approach through a controlled school-based trial to achieve an improvement in eating habits, aerobic activity, and reduced obesity in Grades 2-3. Methods and Design: A cluster randomized controlled trial allocated 4 elementary schools (3rd and 2nd-grade classes each) to intervention or control groups. This allocation was switched with the next cohort of children. Recruitment was in first grade, randomization at the beginning of second grade, evaluation of results at the end of second grade and the beginning of third grade — intervention: 5 joint parent-children classroom activities on health topics and 5 educational workshops for parents only. Alfred Adler's concepts were guiding principles. Subjects: Of 743 children in 23-second grade classes, parents provided informed consent for 508 (68%). Information of retention health habits continued for third grade. Additional parental approvals were required. Parents provided informed consent for third-grade follow-up for 432. Results: At the end of 2nd grade, the amount of aerobic activity increased in the intervention group in comparison with the control group, the difference being marginally statistically significant (p=0.061). There is a significant difference between the groups in the percentage of "no activity being done" reported at the end of second grade when in the experimental group, the percentage is lower than the control. There are differences between genders in the percentage of aerobic activity at the end of second grade (p=0.044) and in the third grade (p < 0.0001). Height increased significantly (p=0.030 ), and waist circumference declined significantly (p=0.021) in the intervention compared with the control group. There were no significant between-group differences in BMI and weight. Conclusion: There were encouraging changes in aerobic activity and in anthropometric measurements. To maintain changes over longer periods, refreshing these nutrition and activity themes annually in school using the model is required.

Keywords: aerobic activity, child obesity, Alfred Adler, schoolchildren

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Authors: B. Yermekbayeva, A. Gulyayaev, T. Nurgozhin, C. Bektur

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Cytisine aminophosphonate under the name "Cytafat" was approved for clinical trials in Republic of Kazakhstan as a putative liver protecting drug for the treatment of acute toxic hepatitis. A method of conducting the clinical trial is a double blind study. Total number of patients -71, aged from 16 to 56 years. Research on healthy volunteers determined the maximal tolerable doze of "Cytafat" as 200 mg/kg. Side effects when administered at high dozes (100-200 mg/kg) are tachycardia and increase of arterial blood pressure. The drug is tested in the treatment of 28 patients with a syndrome of hepatocellular failure (a poisoning with substitutes of alcohol, rat poison, or medical products). "Cytafat" was intravenously administered at a dose of 10 mg/kg in 200 ml of 5 % glucose solution once daily. The number of administrations: 1-3. In the comparison group, 23 patients were treated intravenously once a day with “Essenciale H” at a dose of 10 ml. 20 patients received a placebo (10 ml of glucose intravenously). In all cases of toxic hepatopathology the significant positive clinical effect of the testing drug distinguishable from placebo and surpassing the alternative was observed. Within a day after administration a sharp reduction of cytolitic syndrome parameters (ALT, AST, alkaline phosphatase, thymol turbidity test, GGT) was registered, a reduction of the severity of cholestatic syndrome (bilirubin decreased) was recorded, significantly decreased indices of lipid peroxidation. The following day, in all cases the positive dynamics was determined with ultrasound study (reduction of diffuse changes and events of reactive pancreatitis), hepatomegaly disappeared. Normalization of all parameters occurred in 2-3 times faster, than when using the drug "Essenciale H" and placebo. Average term of elimination of toxic hepatopathy when using the drug "Cytafat" -2,8 days, "Essenciale H" -7,2 days, and placebo -10,6 days. The new drug "Cytafat" has expressed cytoprotective properties.

Keywords: cytisine, cytoprotection, hepatopathy, hepatoprotection

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Authors: Praveen Adusumilli, Meher Lakshmi Konatam, Sadashivudu Gundeti, Stalin Bala

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The invention of trastuzumab has changed the treatment of breast cancer and lives of many patients all over the world. Despite many patients getting benefitted from the drug, it is out of reach for most of the patients. There is very limited real world data regarding the epidemiology and clinical outcome of Her2neu positive breast cancer patients. Materials and Methods: This is a retrospective analysis of breast cancer patients presenting to a tertiary care cancer centre in Southern India from 2007 to2013. All early and locally advanced breast cancer patients, who were Her2neu 3+ on IHC are included in the study and evaluated in terms of epidemiology, 3-year disease free survival (DFS)and 5-year overall survival(OS). Chemotherapy regimens used were-FAC 6 cycles or AC 4 cycles followed by 12 cycles of weekly paclitaxel . Trastuzumab was given after 6 cycles of FAC or weekly with paclitaxel followed by 3weekly maintenance until 1 year. Results: Over the period of this study there were 885 newly diagnosed cases of carcinoma breast, of which 242 (27%) were Her2neu positive, 360(40%) were hormone receptor positive, and 212(24%) were triple negative. A total of 71(8%) were Her2neu equivocal of which only 10 patients got FISH test done. Of the 212 newly diagnosed patients, only 74 (29%) opted to have standard of care therapy with trastuzumab at our centre, out of which 52(24%), 8(3%), received under insurance, paying basis respectively. 14(9%) patients received the care as part of clinical trial program (ALTTO trial). 7 (9.72%) patients developed decrease of ejection fraction by greater than 10%, requiring stoppage of trastuzumab out of which 5 were restarted in 2 months. Patients receiving trastuzumab along with chemotherapy had longer 3year DFS 92% vs. 60% (p value<0.0001) when compared to chemotherapy alone. 5 year OS was 87% vs 44% (p-value <0.0001) compared to chemotherapy alone. Conclusion: Trastuzumab with chemotherapy improves the DFS and OS in Her2neu positive patients. The biggest constraint is the cost of the treatment and absence of universal health security net to treat all patients with this diagnosis.

Keywords: breast cancer, Her 2 neu positive, real world data, Trastuzumab

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Authors: Tambe Daniel Atem

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Background: Clinical Research is an organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. The significance of the study is to educate the global health and life science graduates in Clinical Research in depth to perform better as it involves testing drugs on human beings. Objectives: to provide an overall understanding of the scientific approach to the evaluation of new and existing medical interventions and to apply ethical and regulatory principles appropriate to any individual research. Methodology: It is based on – Primary data analysis and Secondary data analysis. Primary data analysis: means the collection of data from journals, the internet, and other online sources. Secondary data analysis: a survey was conducted with a questionnaire to interview the Clinical Research Professionals to understand the need of training to perform clinical trials globally. The questionnaire consisted details of the professionals working with the expertise. It also included the areas of clinical research which needed intense training before entering into hardcore clinical research domain. Results: The Clinical Trials market worldwide worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the U.K, and they form one-third of the total research and development staff. There are more than 2,50,000 vacant positions globally with salary variations in the regions for a Clinical Research Coordinator. R&D cost on new drug development is estimated at US$ 70-85 billion. The cost of doing clinical trials for a new drug is US$ 200-250 million. Due to an increase trained Clinical Research Professionals India has emerged as a global hub for clinical research. The Global Clinical Trial outsourcing opportunity in India in the pharmaceutical industry increased to more than $2 billion in 2014 due to increased outsourcing from U.S and Europe to India. Conclusion: Assessment of training need is recommended for newer Clinical Research Professionals and trial sites, especially prior the conduct of larger confirmatory clinical trials.

Keywords: clinical research, clinical trials, clinical research professionals

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Authors: Denis Duagi, Ben Carter, Maria Farrelly, Stephen Lisk, June S. L. Brown

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Background: Adolescence represents a distinctive phase of development, and variables linked to this developmental period could affect the efficiency of prevention and treatment for depression and anxiety, as well as the long-term prognosis. The objectives of this study were to investigate the long-term effectiveness of psychosocial interventions for adolescents on depression and anxiety symptoms and to assess the influence of different intervention parameters on the long-term effects. Methods: Searches were carried out on the 11ᵗʰ of August 2022 using five databases (Cochrane Library, Embase, Medline, PsychInfo, Web of Science), as well as trial registers. Randomized controlled trials of psychosocial interventions targeting specifically adolescents were included if they assessed outcomes at 1-year post-intervention or more. The Cochrane risk of bias-2 quality assessment tool was used. The primary outcome was depression, and studies were pooled using a standardised mean difference, with an associated 95% confidence interval, p-value, and I². The study protocol was pre-registered (CRD42022348668). Findings: A total of 57 reports (n= 46,678 participants) were included in the review. Psychosocial interventions led to small reductions in depressive symptoms, with a standardised mean difference (SMD) at 1-year of -0.08 (95%CI -0.20, -0.03, p=0.002, I²=72%), 18-months SMD=-0.12, 95% CI -0.22, -0.01, p=0.03, I²=63%) and 2-years SMD=-0.12 (95% CI -0.20, -0.03, p=0.01, I²=68%). Sub-group analyses indicated that targeted interventions produced stronger effects, particularly when delivered by trained mental health professionals (K=18, SMD=-0.24, 95% CI -0.38, -0.10, p=0.001, I²=60%). No effects were detected for anxiety at any assessment. Conclusion: Psychosocial interventions specifically targeting adolescents were shown to have small but positive effects on depression symptoms but not anxiety symptoms, which were sustained for up to 2 years. These findings highlight the potential population-level preventive effects if such psychosocial interventions become widely implemented in accessible settings such as schools.

Keywords: psychosocial, adolescent, interventions, depression, anxiety, meta-analysis, randomized controlled trial

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Authors: Thomas S. Abia II, Citlali Garcia-Saucedo

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A continuous copper precipitation treatment (CCPT) system was conceived at Intel Chandler Site to serve as a first-of-kind (FOK) facility-scale waste copper (Cu), nickel (Ni), and manganese (Mn) co-precipitation facility. The process was designed to treat highly variable wastewater discharged from a substrate packaging research factory. The paper discusses metals co-precipitation induced by internal changes for manufacturing facilities that lack the capacity for hardware expansion due to real estate restrictions, aggressive schedules, or budgetary constraints. Herein, operating parameters such as pH and oxidation reduction potential (ORP) were examined to analyze the ability of the CCPT System to immobilize various waste metals. Additionally, influential factors such as influent concentrations and retention times were investigated to quantify the environmental variability against system performance. A total of 2,027 samples were analyzed and statistically evaluated to measure the performance of CCPT that was internally retrofitted for Mn abatement to meet environmental regulations. In order to enhance the consistency of the influent, a separate holding tank was cannibalized from another system to collect and slow-feed the segregated Mn wastewater from the factory into CCPT. As a result, the baseline influent Mn decreased from 17.2+18.7 mg¹L^-1 at pre-pilot to 5.15+8.11 mg¹L^-1 post-pilot (70.1% reduction). Likewise, the pre-trial and post-trial average influent Cu values to CCPT were 52.0+54.6 mg¹L^-1 and 33.9+12.7 mg¹L^-1, respectively (34.8% reduction). However, the raw Ni content of 0.97+0.39 mg¹L^-1 at pre-pilot increased to 1.06+0.17 mg¹L^-1 at post-pilot. The average Mn output declined from 10.9+11.7 mg¹L^-1 at pre-pilot to 0.44+1.33 mg¹L^-1 at post-pilot (96.0% reduction) as a result of the pH and ORP operating setpoint changes. In similar fashion, the output Cu quality improved from 1.60+5.38 mg¹L^-1 to 0.55+1.02 mg¹L^-1 (65.6% reduction) while the Ni output sustained a 50% enhancement during the pilot study (0.22+0.19 mg¹L^-1 reduced to 0.11+0.06 mg¹L^-1). pH and ORP were shown to be significantly instrumental to the precipitative versatility of the CCPT System.

Keywords: copper, co-precipitation, industrial wastewater treatment, manganese, optimization, pilot study

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Authors: Shashikant Iyengar, Jasmeet Kaur, Anup Singh, Arun Kumar, Ira Sahay

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Insulin resistance (IR) is a condition that occurs when cells in the body become less responsive to insulin, leading to higher levels of both insulin and glucose in the blood. This condition is linked to metabolic syndromes, including diabetes. It is crucial to address IR promptly after diagnosis to prevent long-term complications associated with high insulin and high blood glucose. This four-month case study highlights the importance of treating the underlying condition to manage diabetes effectively. Insulin is essential for regulating blood sugar levels by facilitating the uptake of glucose into cells for energy or storage. In IR individuals, cells are less efficient at taking up glucose from the blood resulting in elevated blood glucose levels. As a result of IR, beta cells produce more insulin to make up for the body's inability to use insulin effectively. This leads to high insulin levels, a condition known as hyperinsulinemia, which further impairs glucose metabolism and can contribute to various chronic diseases. In addition to regulating blood glucose, insulin has anti-catabolic effects, preventing the breakdown of molecules in the body, such as inhibiting glycogen breakdown in the liver, inhibiting gluconeogenesis, and inhibiting lipolysis. If a person is insulin-sensitive or metabolically healthy, an optimal level of insulin prevents fat cells from releasing fat and promotes the storage of glucose and fat in the body. Thus optimal insulin levels are crucial for maintaining energy balance and plays a key role in metabolic processes. During the four-month study, researchers looked at the impact of a low-carb dietary (LCD) intervention on two male individuals (A & B) who had Type-2 diabetes. Althoughvneither of these individuals were obese, they were both slightly overweight and had abdominal fat deposits. Before the trial began, important markers such as fasting blood glucose (FBG), triglycerides (TG), high-density lipoprotein (HDL) cholesterol, and Hba1c were measured. These markers are essential in defining metabolic health, their individual values and variability are integral in deciphering metabolic health. The ratio of TG to HDL is used as a surrogate marker for IR. This ratio has a high correlation with the prevalence of metabolic syndrome and with IR itself. It is a convenient measure because it can be calculated from a standard lipid profile and does not require more complex tests. In this four-month trial, an improvement in insulin sensitivity was observed through the ratio of TG/HDL, which, in turn, improves fasting blood glucose levels and HbA1c. For subject A, HbA1c dropped from 13 to 6.28, and for subject B, it dropped from 9.4 to 5.7. During the trial, neither of the subjects were taking any diabetic medications. The significant improvements in their health markers, such as better glucose control, along with an increase in energy levels, demonstrate that incorporating LCD interventions can effectively manage diabetes.

Keywords: metabolic disorder, insulin resistance, type-2 diabetes, low-carb nutrition

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Authors: Liana Gomide, Juliana Rodrigues

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The morphology of the foot defines its mode of operation and a biomechanical reform indispensable for a symmetrical distribution of plantar pressures in order not to overload some of its components in isolation. High plantar pressures at specific points in the foot may be a causal factor in several orthopedic disorders that affect the feet such as pain and stress fracture. With digital baro-podometry equipment one can observe an intensity of pressures along the entire foot and quantify some of the movements, such as a subtalar pronation present in the midfoot region. Although, they are involved in microtraumas. In clinical practice, excessive movement has been limited with the use of different taping techniques applied on the plantar arch. Thus, the objective of the present study was to analyze and compare the influence of the inelastic and elastic taping on the distribution of plantar pressure of runners pronators. This is a randomized clinical trial and blind-crossover. Twenty (20) male subjects, mean age 33 ± 7 years old, mean body mass of 71 ± 7 kg, mean height of 174 ± 6 cm, were included in the study. A data collection was carried out by a single research through barop-odometry equipment - Tekscan, model F-scan mobile. The tests were performed at three different times. In the first, an initial barop-odometric evaluation was performed, without a bandage application, with edges at a speed of 9.0 km/h. In the second and third moments, the inelastic or elastic taping was applied consecutively, according to the definition defined in the randomization. As results, it was observed that both as inelastic and elastic taping, provided significant reductions in contact pressure and peak pressure values when compared to the moment without a taping. However, an elastic taping was more effective in decreasing contact pressure (no bandage = 714 ± 201, elastic taping = 690 ± 210 and inelastic taping = 716 ± 180) and no peak pressure in the midfoot region (no bandage = 1490 ± 42, elastic taping = 1273 ± 323 and inelastic taping = 1487 ± 437). It is possible to conclude that it is an elastic taping provided by pressure in the middle region, thereby reducing the subtalar pronunciation event during the run.

Keywords: elastic taping, inelastic taping, running, subtalar pronation

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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: S. Cafiso, B. Capace, A. Di Graziano, C. D’Agostino

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Systematic monitoring of the trackbed is necessary to assure safety and quality of service in the railway system. Moreover, to produce effective management of the maintenance treatments, the assessment of bearing capacity of the railway trackbed must include ballast, sub-ballast and subgrade layers at different depths. Consequently, there is an increasing interest in obtaining a consistent measure of ballast bearing capacity with no destructive tests (NDTs) able to work in the physical and time restrictions of railway tracks in operation. Moreover, in the case of the local railway with reduced gauge, the use of the traditional high-speed track monitoring systems is not feasible. In that framework, this paper presents results from in site investigation carried out on ballast and sleepers with Ground Penetrating Radar (GPR) and Light Falling Weight Deflectometer (LWD). These equipment are currently used in road pavement maintenance where they have shown their reliability and effectiveness. Application of such Non-Destructive Tests in railway maintenance is promising but in the early stage of the investigation. More specifically, LWD was used to estimate the stiffness of ballast and sleeper support, as well. LWD, despite the limited load (6 kN in the trial test) applied directly on the sleeper, was able to detect defects in the bearing capacity at the Sleeper/Ballast interface. A dual frequency GPR was applied to detect the presence of layers’ discontinuities at different depths due to fouling phenomena that are the main causes of changing in the layer dielectric proprieties within the ballast thickness. The frequency of 2000Mhz provided high-resolution data to approximately 0.4m depth, while frequency of 600Mhz showed greater depth penetration up to 1.5 m. In the paper literature review and trial in site experience are used to identify Strengths, Weaknesses, Opportunities, and Threats (SWOT analysis) of the application of GPR and LWD for the assessment of bearing capacity of railway track-bed.

Keywords: bearing capacity, GPR, LWD, no destructive test, railway track

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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: Keng H. Kong, Louis C. Tan, Wing L. Aw, Kay Y. Tay

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Background: Fatigue is a common problem in patients with Parkinson's disease, with reported prevalence of up to 70%. Fatigue can be disabling and has adverse effects on patients' quality of life. There is currently no satisfactory treatment of fatigue. Acupuncture is effective in the treatment of fatigue, especially that related to cancer. Its role in Parkinson's disease-related fatigue is uncertain. Aims: To evaluate the clinical efficacy of acupuncture treatment in Parkinson's disease-related fatigue. Hypothesis: We hypothesize that acupuncture is effective in alleviating Parkinson's disease-related fatigue. Design: A single center, randomized, controlled study with two parallel arms. Participants: Forty participants with idiopathic Parkinson's disease will be enrolled. Interventions: Participants will be randomized to receive verum (real) acupuncture or placebo acupuncture. The retractable non-invasive sham needle will be used in the placebo group. The intervention will be administered twice a week for five weeks. Main outcome measures: The primary outcome will be the change in general fatigue score of the multidimensional fatigue inventory at week 5. Secondary outcome measures include other subscales of the multidimensional fatigue inventory, movement disorders society-unified Parkinson's disease rating scale, Parkinson's disease questionnaire-39 and geriatric depression scale. All outcome measures will be assessed at baseline (week 0), completion of intervention (week 5) and 4 weeks after completion of intervention (week 9). Results: To date, 23 participants have been recruited and nine have completed the study. The mean age is 63.5±14.2 years, mean duration of Parkinson’s disease is 6.4±1.8 years and mean MDS-UPDRS score is 8.3±2.8. The mean general fatigue score of the multidimensional fatigue inventory is 13.5±4.6. No significant adverse event related to acupuncture is noted. Potential significance: If the results are as expected, this study will provide preliminary scientific evidence for the efficacy of acupuncture in Parkinson's Disease-related fatigue, and opens the door for a larger multicentre trial to be performed. In the longer term, it may lead to the integration of acupuncture in the care of patients with Parkinson's disease.

Keywords: acupuncture, fatigue, Parkinson's disease, trial

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Authors: Benjamin Newman

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The picture of an adverse contest between two parties has often been used as an archetypal description of the Anglo-American adversarial criminal trial. However, in actuality, guilty pleas and plea-bargains have been dominating the procedure for over the last half-a-century. Characterised by two adverse parties, the court adjudicative system in the Anglo-American world adhere to the adversarial procedure, and while further features have been attributed and the values that are embedded within the procedure vary, it is a system that we have no adequate theory. Damaska had argued that the adversarial conflict-resolution mode of administration of justice stems from a liberal laissez-faire concept of a value neutral liberal state. Having said that, the court’s neutrality has been additionally rationalised in light of its liberal end as a safeguard from the state’s coercive force. Both conceptions of the court’s neutrality conflict in cases where the by-standing role disposes of its liberal duty in safeguarding the individual. Such is noticeable in plea bargains, where the defendant has the liberty to plead guilty, despite concerns over wrongful convictions and deprivation of liberty. It is an inner liberal tension within the notion of criminal adversarialism, between the laissez-faire mode which grants autonomy to the parties and the safeguarding liberal end of the trial. Langbein had asserted that the adversarial system is a criminal procedure for which we have no adequate theory, and it is by reference to political and moral theories that the research aims to articulate a normative account. The paper contemplates on the above liberal-tension, and by reference to Duff’s ‘calling-to-account’ theory, argues that autonomy is of inherent value to the criminal process, being considered a constitutive element in the process of being called to account. While the aspiration is that the defendant’s guilty plea should be genuine, the guilty-plea decision must be voluntary if it is to be considered a performative act of accountability. Thus, by valuing procedural autonomy as a necessary element within the criminal adjudicative process, it assimilates a liberal procedure, whilst maintaining the liberal end by holding the defendant to account.

Keywords: liberal theory, adversarial criminal procedure, criminal law theory, liberal perfectionism, political liberalism

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Authors: Muhammad Rizwan Tariq, Muhammad Issa Khan, Zulfiqar Ahmad, Muhammad Adnan Nasir, Muhammad Sameem Javed, Sheraz Ahmed

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Functional foods may be a good tool that can be simply utilized in reducing community health expenses. Regular consumption of rabbit meat can offer patrons with bioactive components because the manipulation in rabbit feed is much successful to raise the levels of conjugated linoleic acid, ecosapentaenoic acid, decosahexaenoic acid, polyunsaturated fatty acids, selenium, tocopherol etc. and to reduce the ω-3/ω-6 ratio which is performing a major role in curing of cardiovascular and several other diseases. In comparison to the meats of other species, rabbit meat has higher amounts of protein with essential amino acids, especially in the muscles and low cholesterol contents that also have elevated digestibility. The present study was carried out to develop the functional rabbit meat by modifying feed ingredient of rabbit diet. Thirty-day old rabbits were fed with feeds containing 2 % and 4 % oat. The feeding trial was carried out for eight weeks. Rabbits were divided into three different groups and reared for the period of two months. T0 rabbits were considered control group while T1 rabbits were reared on 4% oat, and T2 were on 2% oat in the feed. At the end of the 8 weeks, the rabbits were slaughtered. Results presented in this study concluded that 4 % oat seed supplementation enhanced n-3 PUFA in meat. It was observed that oat seed supplementation also reduced fat percentage in the meat. Utilization of oat in the feed of rabbits significantly affected the pH, protein, fat, textural and concentration of polyunsaturated fatty acids. A study trial was conducted in order to examine the impact of functional meat on the blood lipid profile of human subjects. They were given rabbit meat in comparison to the chicken meat for the period of one month. The cholesterol, triglycerides and low density lipoprotein were found to be lower in blood serum of human subject group treated with 4 % oat meat.

Keywords: functional food, functional rabbit meat, meat quality, rabbit

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Authors: Zhaoqi He

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Research Context: Endurance performance in hot environments is influenced by the interplay of hydration status and physiological responses. This study aims to investigate how dehydration, up to 2.11% body weight loss, affects the 3 km running performance of trained male athletes under conditions mimicking high temperatures. Methodology: In a randomized crossover design, five male athletes participated in two trials – euhydrated (EU) and dehydrated (HYPO). Both trials included a 70-minute preload run at 55-60% VO2max in 32°C and 50% humidity, followed by a 3-kilometer time trial. Fluid intake was restricted in HYPO to induce a 2.11% body weight loss. Physiological metrics, including heart rate, core temperature, and oxygen uptake, were measured, along with perceptual metrics like perceived exertion and thirst sensation. Findings: The 3-kilometer run completion times showed no significant differences between EU and HYPO trials (p=0.944). Physiological indicators, including heart rate, core temperature, and oxygen uptake, did not significantly vary (p>0.05). Thirst sensation was markedly higher in HYPO (p=0.013), confirming successful induction of dehydration. Other perceptual metrics and gastrointestinal comfort remained consistent. Conclusion: Contrary to the hypothesis, the study reveals that dehydration, inducing up to 2.11% body weight loss, does not significantly impair 3 km running performance in trained male athletes under hot conditions. Thirst sensation was notably higher in the dehydrated state, emphasizing the importance of considering perceptual factors in hydration strategies. The findings suggest that trained runners can maintain performance despite moderate dehydration, highlighting the need for nuanced hydration guidelines in hot-weather running.

Keywords: hypohydration, euhydration, hot environment, 3km running time trial, endurance performance, trained athletes, perceptual metrics, dehydration impact, physiological responses, hydration strategies

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Authors: Philip T. Broughton, Mark P. Bettney, Isla L. Smail

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Effective treatment of ground instability is essential when managing the impacts associated with historic mining. A field trial was undertaken by the Coal Authority to investigate the geotechnical performance and potential use of composite materials comprising resin and fill or stone to safely treat surface collapses, such as crown-holes, associated with shallow mining. Test pits were loosely filled with various granular fill materials. The fill material was injected with commercially available silicate and polyurethane resin foam products. In situ and laboratory testing was undertaken to assess the geotechnical properties of the resultant composite materials. The test pits were subsequently excavated to assess resin permeation. Drilling and resin injection was easiest through clean limestone fill materials. Recycled building waste fill material proved difficult to inject with resin; this material is thus considered unsuitable for use in resin composites. Incomplete resin permeation in several of the test pits created irregular ‘blocks’ of composite. Injected resin foams significantly improve the stiffness and resistance (strength) of the un-compacted fill material. The stiffness of the treated fill material appears to be a function of the stone particle size, its associated compaction characteristics (under loose tipping) and the proportion of resin foam matrix. The type of fill material is more critical than the type of resin to the geotechnical properties of the composite materials. Resin composites can effectively support typical design imposed loads. Compared to other traditional treatment options, such as cement grouting, the use of resin composites is potentially less disruptive, particularly for sites with limited access, and thus likely to achieve significant reinstatement cost savings. The use of resin composites is considered a suitable option for the future treatment of shallow mining collapses.

Keywords: composite material, ground improvement, mining legacy, resin

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Authors: Nicole Selvi Hill, Archchana Radhakrishnan

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Introduction: Traumatic brain injury (TBI) is a leading cause of mortality among trauma patients. In the management of TBI, the main principle is avoiding cerebral ischemia, as this is a strong determiner of neurological outcomes. The use of vasoactive drugs, such as vasopressin, has an important role in maintaining cerebral perfusion pressure to prevent secondary brain injury. Current guidelines do not suggest a preferred vasoactive drug to administer in the management of TBI, and there is a paucity of information on the therapeutic potential of vasopressin following TBI. Vasopressin is also an endogenous anti-diuretic hormone (AVP), and pathways mediated by AVP play a large role in the underlying pathological processes of TBI. This creates an overlap of discussion regarding the therapeutic potential of vasopressin following TBI. Currently, its popularity lies in vasodilatory and cardiogenic shock in the intensive care setting, with increasing support for its use in haemorrhagic and septic shock. Methodology: This is a review article based on a literature review. An electronic search was conducted via PubMed, Cochrane, EMBASE, and Google Scholar. The aim was to identify clinical studies looking at the therapeutic administration of vasopressin in severe traumatic brain injury. The primary aim was to look at the neurological outcome of patients. The secondary aim was to look at surrogate markers of cerebral perfusion measurements, such as cerebral perfusion pressure, cerebral oxygenation, and cerebral blood flow. Results: Eight papers were included in the final number. Three were animal studies; five were human studies, comprised of three case reports, one retrospective review of data, and one randomised control trial. All animal studies demonstrated the benefits of vasopressors in TBI management. One animal study showed the superiority of vasopressin in reducing intracranial pressure and increasing cerebral oxygenation over a catecholaminergic vasopressor, phenylephrine. All three human case reports were supportive of vasopressin as a rescue therapy in catecholaminergic-resistant hypotension. The retrospective review found vasopressin did not increase cerebral oedema in TBI patients compared to catecholaminergic vasopressors; and demonstrated a significant reduction in the requirements of hyperosmolar therapy in patients that received vasopressin. The randomised control trial results showed no significant differences in primary and secondary outcomes between TBI patients receiving vasopressin versus those receiving catecholaminergic vasopressors. Apart from the randomised control trial, the studies included are of low-level evidence. Conclusion: Studies favour vasopressin within certain parameters of cerebral function compared to control groups. However, the neurological outcomes of patient groups are not known, and animal study results are difficult to extrapolate to humans. It cannot be said with certainty whether vasopressin’s benefits stand above usage of other vasoactive drugs due to the weaknesses of the evidence. Further randomised control trials, which are larger, standardised, and rigorous, are required to improve knowledge in this field.

Keywords: catecholamines, cerebral perfusion pressure, traumatic brain injury, vasopressin, vasopressors

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Authors: Poulomi Bhadra, Manjushree Palit, Sanjeev P. Sahni

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Forensic science uses all branches of science for criminal investigation and trial and has increasingly emerged as an important tool in the administration of justice. However, the growth and development of this field in India has not been as rapid or widespread as compared to the more developed Western countries. For successful administration of justice, it is important that all agencies involved in law enforcement adopt an inter-professional approach towards forensic science, which is presently lacking. In light of the alarmingly high average acquittal rate in India, this study aims to examine the lack of understanding and appreciation of the importance and scope of forensic evidence and expert opinions amongst law professionals such as lawyers and judges. Based on a study of trial court cases from Delhi and surrounding areas, the study underline the areas in forensics where the criminal justice system has noticeably erred. Using this information, the authors examine the extent of forensic understanding amongst legal professionals and attempt to conclusively identify the areas in which they need further appraisal. A cross-sectional study done using a structured questionnaire was conducted amongst law professionals across age, gender, type and years of experience in court, to determine their understanding of DNA, fingerprints and other interdisciplinary scientific materials used as forensic evidence. In our study, we understand the levels of understanding amongst lawyers with regards to DNA and fingerprint evidence, and how it affects trial outcomes. We also aim to understand the factors that prevent credible and advanced awareness amongst legal personnel, amongst others. The survey identified the areas in modern and advanced forensics, such as forensic entomology, anthropology, cybercrime etc., in which Indian legal professionals are yet to attain a functional understanding. It also brings to light, what is commonly termed as the ‘CSI-effect’ in the Western courtrooms, and provides scope to study the existence of this phenomenon and its effects on the Indian courts and their judgements. This study highlighted the prevalence of unchallenged expert testimony presented by the prosecution in criminal trials and impressed upon the judicial system the need for independent analysis and evaluation of the scientist’s data and/or testimony by the defense. Overall, this study aims to define a clearer and rigid understanding of why legal professionals should have basic understanding of the interdisciplinary nature of forensic sciences. Based on the aforementioned findings, the author suggests various measures by which judges and lawyers might obtain an extensive knowledge of the advances and promising potentialities of forensic science. This includes promoting a forensic curriculum in legal studies at Bachelor’s and Master’s level as well as in mid-career professional courses. Formation of forensic-legal consultancies, in consultation with the Department of Justice, will not only assist in training police, military and law personnel but will also encourage legal research in this field. These suggestions also aim to bridge the communication gap that presently exists between law practitioners, forensic scientists and the general community’s awareness of the criminal justice system.

Keywords: forensic science, Indian legal professionals, interdisciplinary awareness, legal education

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Authors: G. Disciglio, G. Gatta, F. Lops, A. Libutti, A. Tarantino, E. Tarantino

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The experimental trial was carried out in open field at Foggia district (Apulia Region, Southern Italy), during the spring-summer season 2014, in order to evaluate the effect of four biostimulant products (RadiconÒ, Viormon plusÒ, LysodinÒ and SiaptonÒ 10L), compared with a control (no biostimulant), on the infestation of processing tomato crop (cv Dres) by the chlorophyll-lacking root parasite Phelipanche ramosa. Biostimulants consist in different categories of products (microbial inoculants, humic and fulvic acids, hydrolyzed proteins and aminoacids, seaweed extracts) which play various roles in plant growing, including the improvement of crop resistance and quali-quantitative characteristics of yield. The experimental trial was arranged according to a complete randomized block design with five treatments, each of one replicated three times. The processing tomato seedlings were transplanted on 5 May 2014. Throughout the crop cycle, P. ramosa infestation was assessed according to the number of emerged shoots (branched plants) counted in each plot, at 66, 78 and 92 day after transplanting. The tomato fruits were harvested at full-stage of maturity on 8 August 2014. From each plot, the marketable yield was measured and the quali-quantitative yield parameters (mean weight, dry matter content, colour coordinate, colour index and soluble solids content of the fruits) were determined. The whole dataset was tested according to the basic assumptions for the analysis of variance (ANOVA) and the differences between the means were determined using Tukey’s tests at the 5% probability level. The results of the study showed that none of the applied biostimulants provided a whole control of Phelipanche, although some positive effects were obtained from their application. To this respect, the RadiconÒ appeared to be the most effective in reducing the infestation of this root-parasite in tomato crop. This treatment also gave the higher tomato yield.

Keywords: biostimulant, control methods, Phelipanche ramosa, tomato crop

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

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

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

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Authors: Bhupendra G. Prajapati, Alpesh R. Patel

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The aim of this research work is to develop sustained release multi-particulates dosage form of Dexketoprofen trometamol, which is the pharmacologically active isomer of ketoprofen. The objective is to utilization of active enantiomer with minimal dose and administration frequency, extended release multi-particulates dosage form development for better patience compliance was explored. Drug loaded and sustained release coated pellets were prepared by fluidized bed coating principle by wurster coater. Microcrystalline cellulose as core pellets, povidone as binder and talc as anti-tacking agents were selected during drug loading while Kollicoat SR 30D as sustained release polymer, triethyl citrate as plasticizer and micronized talc as an anti-adherent were used in sustained release coating. Binder optimization trial in drug loading showed that there was increase in process efficiency with increase in the binder concentration. 5 and 7.5%w/w concentration of Povidone K30 with respect to drug amount gave more than 90% process efficiency while higher amount of rejects (agglomerates) were observed for drug layering trial batch taken with 7.5% binder. So for drug loading, optimum Povidone concentration was selected as 5% of drug substance quantity since this trial had good process feasibility and good adhesion of the drug onto the MCC pellets. 2% w/w concentration of talc with respect to total drug layering solid mass shows better anti-tacking property to remove unnecessary static charge as well as agglomeration generation during spraying process. Optimized drug loaded pellets were coated for sustained release coating from 16 to 28% w/w coating to get desired drug release profile and results suggested that 22% w/w coating weight gain is necessary to get the required drug release profile. Three critical process parameters of Wurster coating for sustained release were further statistically optimized for desired quality target product profile attributes like agglomerates formation, process efficiency, and drug release profile using central composite design (CCD) by Minitab software. Results show that derived design space consisting 1.0 to 1.2 bar atomization air pressure, 7.8 to 10.0 gm/min spray rate and 29-34°C product bed temperature gave pre-defined drug product quality attributes. Scanning Image microscopy study results were also dictate that optimized batch pellets had very narrow particle size distribution and smooth surface which were ideal properties for reproducible drug release profile. The study also focused on optimized dexketoprofen trometamol pellets formulation retain its quality attributes while administering with common vehicle, a liquid (water) or semisolid food (apple sauce). Conclusion: Sustained release multi-particulates were successfully developed for dexketoprofen trometamol which may be useful to improve acceptability and palatability of a dosage form for better patient compliance.

Keywords: dexketoprofen trometamol, pellets, fluid bed technology, central composite design

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Authors: Moon Jung Kim, Guil Rhim

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The clinical sensitivity of the “VEUPLEXTM TBI assay”, a clinical trial medical device, in mild traumatic brain injury was 28.6% (95% CI, 19.7%-37.5%), and the clinical specificity was 94.0% (95% CI, 89.3%). -98.7%). In addition, when the results analyzed by marker were put together, the sensitivity was higher when interpreting the two tests together than the two tests, UCHL1 and GFAP alone. Additionally, when sensitivity and specificity were analyzed based on CT results for the mild traumatic brain injury patient group, the clinical sensitivity for 2 CT-positive cases was 50.0% (95% CI: 1.3%-98.7%), and 19 CT-negative cases. The clinical specificity for cases was 68.4% (95% CI: 43.5% - 87.4%). Since the low clinical sensitivity for the two CT-positive cases was not statistically significant due to the small number of samples analyzed, it was judged necessary to secure and analyze more samples in the future. Regarding the clinical specificity analysis results for 19 CT-negative cases, there were a large number of patients who were actually clinically diagnosed with mild traumatic brain injury but actually received a CT-negative result, and about 31.6% of them showed abnormal results on VEUPLEXTM TBI assay. Although traumatic brain injury could not be detected in 31.6% of the CT scans, the possibility of actually suffering a mild brain injury could not be ruled out, so it was judged that this could be confirmed through follow-up observation of the patient. In addition, among patients with mild traumatic brain injury, CT examinations were not performed in many cases because the symptoms were very mild, but among these patients, about 25% or more showed abnormal results in the VEUPLEXTM TBI assay. In fact, no damage is observed with the naked eye immediately after traumatic brain injury, and traumatic brain injury is not observed even on CT. But in some cases, brain hemorrhage may occur (delayed cerebral hemorrhage) after a certain period of time, so the patients who did show abnormal results on VEUPLEXTM TBI assay should be followed up for the delayed cerebral hemorrhage. In conclusion, it was judged that it was difficult to judge mild traumatic brain injury with the VEUPLEXTM TBI assay only through clinical findings without CT results, that is, based on the GCS value. Even in the case of CT, it does not detect all mild traumatic brain injury, so it is difficult to necessarily judge that there is no traumatic brain injury, even if there is no evidence of traumatic brain injury in CT. And in the long term, more patients should be included to evaluate the usefulness of the VEUPLEXTM TBI assay in the detection of microscopic traumatic brain injuries without using CT.

Keywords: brain injury, traumatic brain injury, GFAP, UCHL1

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Authors: Moses Mwangi, Geert Verbeke, Geert Molenberghs

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Cross-over designs are commonly used in randomized clinical trials to estimate efficacy of a new treatment with respect to a reference treatment (placebo or standard). The main advantage of using cross-over design over conventional parallel design is its flexibility, where every subject become its own control, thereby reducing confounding effect. Jones & Kenward, discuss in detail more recent developments in the analysis of cross-over trials. We revisit the simple piecewise linear mixed-effects model, proposed by Mwangi et. al, (in press) for its first application in the analysis of cross-over trials. We compared performance of the proposed piecewise linear mixed-effects model with two commonly cited statistical models namely, (1) Grizzle model; and (2) Jones & Kenward model, used in estimation of the treatment effect, in the analysis of randomized cross-over trial. We estimate two performance measurements (mean square error (MSE) and coverage probability) for the three methods, using data simulated from the proposed piecewise linear mixed-effects model. Piecewise linear mixed-effects model yielded lowest MSE estimates compared to Grizzle and Jones & Kenward models for both small (Nobs=20) and large (Nobs=600) sample sizes. It’s coverage probability were highest compared to Grizzle and Jones & Kenward models for both small and large sample sizes. A piecewise linear mixed-effects model is a better estimator of treatment effect than its two competing estimators (Grizzle and Jones & Kenward models) in the analysis of cross-over trials. The data generating mechanism used in this paper captures two time periods for a simple 2-Treatments x 2-Periods cross-over design. Its application is extendible to more complex cross-over designs with multiple treatments and periods. In addition, it is important to note that, even for single response models, adding more random effects increases the complexity of the model and thus may be difficult or impossible to fit in some cases.

Keywords: Evaluation, Grizzle model, Jones & Kenward model, Performance measures, Simulation

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Authors: E. M. H. Maggie, M. N. A. Nazmey, M. A. Abdel-Sattar, S. A. Saied

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A successful trial of transplanting cotton is reported. Seeds grown in trays for 4-5 weeks in an easily prepared supporting medium such as peat moss or similar plant waste are tried. Careful transplanting of seedlings, with root system as intact as possible, is being made in the permanent field. The practice reduced damping-off incidence rate and allowed full winter crop revenues. Further work is needed to evaluate certain parameters such as growth curve, flowering curve, and yield at economic bases.

Keywords: cotton, transplanting cotton, damping-off diseases, environment sciences

Procedia PDF Downloads 335

Authors: Matthew Cameron, Stephen Yang, Latifa Al Kharusi, Adam Gosselin, Anissa Chirico, Pouya Gholipour Baradari

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Background: Iron supplementation has been evaluated in several randomized controlled trials (RCTs) for the potential to increase baseline hemoglobin and decrease the incidence of red blood cell (RBC) transfusion during cardiac surgery. This study's main objective was to evaluate the evidence for iron administration in cardiac surgery patients for its effect on the incidence of perioperative RBC transfusion. Methods: This systematic review protocol was registered with PROSPERO (CRD42020161927) on Dec. 19th, 2019, and was prepared as per the PRISMA guidelines. MEDLINE, EMBASE, CENTRAL, Web of Science databases, and Google Scholar were searched for RCTs evaluating perioperative iron administration in adult patients undergoing cardiac surgery. Each abstract was independently reviewed by two reviewers using predefined eligibility criteria. The primary outcome was perioperative RBC transfusion, with secondary outcomes of the number of RBC units transfused, change in ferritin level, reticulocyte count, hemoglobin, and adverse events, after iron administration. The risk of bias was assessed with the Cochrane Collaboration Risk of Bias Tool, and the primary and secondary outcomes were analyzed with a random-effects model. Results: Out of 1556 citations reviewed, five studies (n = 554 patients) met the inclusion criteria. The use of iron demonstrated no difference in transfusion incidence (RR 0.86; 95% CI 0.65 to 1.13). There was a low heterogeneity between studies (I²=0%). The trial sequential analysis suggested an optimal information size of 1132 participants, which the accrued information size did not reach. Conclusion: The current literature does not support the routine use of iron supplementation before cardiac surgery; however, insufficient data is available to draw a definite conclusion. A critical knowledge gap has been identified, and more robust RCTs are required on this topic.

Keywords: cardiac surgery, iron, iron supplementation, perioperative medicine, meta-analysis, systematic review, randomized controlled trial

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Authors: Heena Akbar, Winnie Niumata, Danielle Gallegos

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Type 2 diabetes is a significant public health problem for Māori and Pasifika communities in Queensland, who are experiencing a higher burden of morbidity and mortality from the condition. Despite this higher burden, there are few initiatives that are culturally tailored to improve prevention and management. Modification of personal behaviors through women’s wellness programs aimed at early intervention has been shown to reduce the risk of developing complications in established type 2 diabetes and may reduce hospitalization rates from preventable complications related to this disease. The 24-week Pasifika Women’s Diabetes Wellness Program (PWDWP) was culturally co-designed and co-developed with Māori and Pasifika women with type 2 diabetes through a community-academia partnership in Queensland. Underpinned by Social Cognitive Theory and the Indigenous Pacific Health frameworks to include family culture & spirituality and integrating a collectivist and whānau (family) centered approach to self-care, the program takes into consideration the cultural shame associated with acknowledging the disease and tailors the interventions using talanoa (storytelling or conversation in a relational context) as the key strategy to come to a shared meaning for behavior change. The pilot trial is a 12-week intervention followed by a 12-week follow-up period conducted with 50 women with type 2 diabetes, 25 women who will receive the intervention and 25 women who will receive usual care. The pilot program provides in-person and virtual access to culturally supported prevention and self-management of Māori and Pasifika women with type 2 diabetes with the aim to improve healthy lifestyles and reduce late hospital presentations from diabetes-related complications for better diabetes-related outcomes. This study will test and evaluate the effectiveness of the PWDWP pilot trial in partnership with Māori & Pasifika community organizations and key stakeholders for improved glycated hemoglobin (HbA1c) levels associated with poor management of type 2 diabetes.

Keywords: culturally co-designed intervention, Indigenous methodology, Māori and Pasifika communities, type 2 diabetes self-management

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Authors: Rossana Taravella, Gilberto M. Cellura, Giuseppe Cirrincione, Salvatore Asciutto, Marco Caruso, Massimo Benedetto, Renato Ciofalo, Giuliana Pace, Salvatore Novo

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Objectives: This retrospective analysis sought to evaluate 1-month outcomes and therapy effectiveness of a population of patients treated with MitraClip therapy. We describe in this article the preliminary results of primary effectiveness endpoint. Background: Percutaneous Mitral Repair is being developed to treat severe mitral regurgitation (MR), with increasing real-world cases of functional MR (FMR). In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study)II trial, the percutaneous device showed superior safety but less reduction in MR at 1year. 4-year outcomes from EVEREST II trial showed no difference in the prevalence of moderate-severe and severe MR or mortality at 4years between surgical mitral repair and percutaneous approach. Methods: We analysed retrospectively collected data from one center experience in Italy enrolled from January 2011 to December 2016. The study included 62 patients [mean age 74±11years, 43 men (69%)] with MR of at least grade3+. Most of the patients had functional MR, were in New York Heart Association (NYHA) functional class III or IV, with a large portion (78%) of mild-to-moderate Tricuspid Regurgitation (TR). One or more clips were implanted in 67 procedures (62 patients). Results and Conclusions: Severity of MR was reduced in all successfully treated patients,54(90%) were discharged with MR≤2+ (primary effectiveness endpoint). Clinical 1-month follow-up data showed an improvement in NYHA functional class (42 patients (70%) in NYHA class I-II). 60 of 62 (97 %) successfully treated patients were free from death and mitral valve surgery at 1-month follow-up. MitraClip therapy reduces functional MR with acute MR reduction to <2+ in the great majority of patients, with a large freedom from death, surgery or recurrent MR in a great portion of patients.

Keywords: MitraClip, mitral regurgitation, heart valves, catheter-based therapy

Procedia PDF Downloads 268