Search results for: randomized trial

Authors: Husaini Sama

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The study was conducted, in a 120 - day’s trial, to monitor the performance of growing Rahaji bulls fed different crop residues. There were four experimental treatments, each containing three (3) bull-calves. The first three (experimental) diets were prepared with rice straw, millet stalks and a combination of the two in equal proportions. These 3 diets were supplemented with concentrates. Treatments 1, 2 and 3 consisted of rice straw, millet stalk and combination of rice straw and millet stalk in equal ratio, respectively as basal feeds, while, Treatment 4 (containing standard diet of cow pea haulms, rice straw and wheat offal) served as control to compare with the other treatments. Data on feed intake and livability was collected on daily basis and that of live weight gain and feed conversion ratio were collected fortnightly, but data on apparent nutrient retention trial was collected towards the end of the experiment. Water was offered ad libitum. Records obtained were subjected to statistical analysis using SPSS (1988) software package in accordance with a Completely Randomized Design (CRD). Results obtained indicated that feed intake was significantly higher (P<0.05) for calves on treatments 3 and 4 compared to those on treatments 1and 2. The study observed that it was cheaper to formulate diets 2 and 3 than the other 2 diets. The control diet (T4) was observed to be relatively more expensive than the other 3 formulated diets. It was concluded from the findings that, concentrate containing combination of rice straw and cereal stalks was economical and satisfactory for feeding growing Rahaji bulls in this ecological zone (Semi-arid environment).

Keywords: rahaji bulls, crop residues, concentrates, semi-arid environment

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Authors: Konstancja Syller

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

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

Procedia PDF Downloads 131

Authors: J. Raub, H. Schillok, L. Kaupe, C. Jung-Sievers, G. Pitschel-Walz, M. Bühner, J. Gensichen, F. D. Pokal-Gruppe

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Introduction: In Germany, depression ranks among the top ten diseases with the highest disease burden and often occurs with comorbidities. Collaborative Care (CC), a concept developed in the United States for the primary care management of chronic diseases, has been identified as an efficient model for the treatment of depression in general medicine. A recent meta-analysis highlights research gaps regarding CC in patients with psychiatric multimorbidity. The highest prevalence of psychiatric comorbidities in depression is observed in anxiety disorders, post-traumatic stress disorder (PTSD), and substance use disorders. Methods: We conducted a literature search following the PRISMA guidelines with three components: Collaborative Care, Depression and randomized controlled trial on the common databases. We focused on the examination of psychiatric comorbidities in depression, specifically Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD). Results: During the screening process, we identified nine relevant articles related to PTSD, the number of articles related to Substance Use Disorder (SUD) was ten. We examined a total of 8,634 individuals. Our literature review did not reveal any overall significant superiority of the Collaborative Care model compared to Usual Care in patients with depression with comorbid Substance Use Disorder (SUD) or Posttraumatic Stress Disorder (PTSD). Discussion: Five studies demonstrate a faster and statistically significant improvement in depression outcomes among patients with Substance Use Disorder (SUD) and Posttraumatic Stress Disorder (PTSD). Currently, several randomized controlled trials on the topic of Collaborative Care in depression with psychiatric comorbidity are ongoing, such as miCare, Claro and COMET.

Keywords: Depression, primary care, collaborative care, PTSD, Substance use Disorder

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Authors: Matthieu-P. Schapranow

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Recruitment of participants for clinical trials requires the screening of a big number of potential candidates, i.e. the testing for trial-specific inclusion and exclusion criteria, which is a time-consuming and complex task. Today, a significant amount of time is spent on identification of adequate trial participants as their selection may affect the overall study results. We introduce a unique patient eligibility metric, which allows systematic ranking and classification of candidates based on trial-specific filter criteria. Our web application enables real-time analysis of patient data and assessment of candidates using freely definable inclusion and exclusion criteria. As a result, the overall time required for identifying eligible candidates is tremendously reduced whilst additional degrees of freedom for evaluating the relevance of individual candidates are introduced by our contribution.

Keywords: in-memory technology, clinical trials, screening, eligibility metric, data analysis, clustering

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Authors: K. O. Ogbedeh, C. P. Ekwe, G. O. Ihejirika, S. A. Dialoke, O. P. Onyewuchi, C. P. Anyanwu, I. E. Kalu

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As one of the major pests of field crops, termites attack groundnut at all stages of its development, especially during prolonged dry spell. Effect of palm bunch ash and neem(Azardirachta indica A. Juss) leaf powder on termite infestation in groundnut field in Owerri, Nigeria was investigated in this study. The field trial was carried out in 2016 at the Teaching and Research Farm of the Federal University of Technology, Owerri, Nigeria. The experiment was laid out in a 3x3 Factorial fitted into a Randomized Complete Block Design (RCBD) with three replications. The treatments include three rates of palm bunch ash at 0.0 (control), 1.0 and 2.0tons/ha and three rates of neem leaf powder at 0.0(control), 1.0, 2.0 tons/ha respectively. Data were collected on percentage emergence, termite incidence and termite severity. These were subjected to analysis of variance (ANOVA), and means were separated using least significant difference at 5% level of probability. The result shows that there were no significant (P= 0.05) differences in percentage emergence amongst treatment means due to palm bunch ash and neem leaf powder applications. Contrarily, palm bunch ash at 2.0 tons/ha recorded the least termite incidence especially at twelve weeks after planting (12WAP) with a value of 22.20% while control plot maintained highest values at 6WAP (48.70%) and 12WAP (48.30%) respectively. Also palm bunch ash at 2.0tons/ha depressed termite severity more than other treatments especially at 2 and 4 WAP (0.56) respectively. Control plots on the other hand consistently maintained highest termite severity throughout the trial with the highest value at 2 and 12WAP (1.56). Conclusively, palm bunch ash exhibited highest depressive action against termite on groundnut especially at higher application value (2.0tons/ha).

Keywords: groundnut, incidence, neem, palm, severity, termites

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Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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Authors: Ashti Morovati, Hushyar Azari, Bahram Pourghassem Gargari

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Objectives and goals: The prevalence of metabolic syndrome (MetS), as a major health burden for societies, is increasing. This clinical trial was conducted to evaluate the effects of CuEO supplementation on anthropometric indices, systolic and diastolic blood pressure, blood glucose level, insulin resistance and serum lipid level in patients suffering from MetS. Methods: This was a randomized, triple‐blind, placebo‐controlled clinical trial in which 56 patients with MetS aged 18–60 years who fulfilled the eligibility criteria were randomly allocated to an intervention or a control group. Inclusion criteria for the study were comprised of diagnosis of MetS according to the new International Federation of Diabetes. The exclusion criteria were defined as: taking herbal supplements, use of drugs having evident interaction with cumin such as anti‐depressant drugs, vitamin D, omega 3, selenium, zinc, smoking, pregnancy, or breastfeeding, suffering from cancer, having any history of gastrointestinal and hepatic, cardiovascular, thyroid and kidney disorders, and menopause. 75 mg CuEO or placebo soft gels were administered three times daily to the participants for eight weeks. The soft gel consumption was checked by asking the participants to bring the medication containers in the follow‐up visits at the 4th and the 8th weeks of the study. Data pertaining to blood pressure, height, weight, waist circumference, hip circumference and BMI, as well as food consumption were collected at the beginning and end of the study. Fasting blood samples ( glucose, triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol) were obtained and biochemical measurements were assessed at the beginning and end of the study. Results: At eight weeks, a total of 44 patients completed this study. Except for diastolic blood pressure (DBP), the other assessed variables were not significantly different between the two groups. In intra group analysis, placebo and CuEO groups both had insignificant decrements in DBP (mean difference [MD] with 95% CI: −3.31 [−7.11, 0.47] and −1.77 [−5.95, 2.40] mmHg, respectively). However, DBP was significantly lower in CuEO compared with the placebo group at the end of study (81.41 ± 5.88 vs. 84.09 ± 5.54 mmHg, MD with 95% CI: −3.98 [−7.60, −0.35] mmHg, p < .05). Conclusions: The results of this study indicated that CuEO does not have any effect on MetS components, except for DBP in patients with MetS.

Keywords: blood pressure, fasting blood glucose, lipid profile, waist circumference

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Authors: Geraldine Macdonald, Oliver Perra, Nina O’Neill, Laura Neeson, Kathryn Higgins

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Background: Despite improvements in recent years, almost one in six children in Northern Ireland (NI) leaves primary school without achieving the expected level in English and Maths. By early adolescence, this ratio is one in five. In 2010-11, around 9000 pupils in NI had failed to achieve the required standard in literacy and numeracy by the time they left full-time education. This paper reports the findings of an experimental evaluation of a programmed designed to improve educational outcomes of a cohort of children starting primary school in areas of high social disadvantage in Northern Ireland. The intervention: ‘Ready to Learn’ comprised two key components: a literacy-rich After School programme (one hour after school, three days per week), and a range of activities and support to promote the engagement of parents with their children’s learning, in school and at home. The intervention was delivered between September 2010 and August 2013. Study aims and objectives: The primary aim was to assess whether, and to what extent, ‘Ready to Learn’ improved the literacy of socially disadvantaged children entering primary schools compared with children in schools without access to the programme. Secondary aims included assessing the programme’s impact on children’s social, emotional and behavioural regulation, and parents’ engagement with their children’s learning. In total, 505 children (almost all) participated in the baseline assessment for the study, with good retention over seven sweeps of data collection. Study design: The intervention was evaluated by means of a cluster randomized trial, with schools as the unit of randomization and analysis. It included a qualitative component designed to examine process and implementation, and to explore the concept of parental engagement. Sixteen schools participated, with nine randomized to the experimental group. As well as outcome data relating to children, 134 semi-structured interviews were conducted with parents over the three years of the study, together with 88 interviews with school staff. Results: Given the children’s ages, not all measures used were direct measures of reading. Findings point to a positive impact of “Ready to Learn” on children’s reading achievement (comprehension and fluency), as assessed by the York Assessment of Reading Comprehension (YARC) and decoding, assessed using the Word Recognition and Phonic Skills (WRaPS3). Effects were not large, but evidence suggests that it is unusual for an after school programme to clearly to demonstrate effects on reading skills. No differences were found on three other measures of literacy-related skills: British Picture Vocabulary Scale (BPVS-II), Naming Speed and Non-word Reading Tests from the Phonological Assessment Battery (PhAB) or Concepts about Print (CAP) – the last due to an age-related ceiling effect). No differences were found between the two groups on measures of social, emotional and behavioural regulation, and due to low levels of participation, it was not possible directly to assess the contribution of the parent component to children’s outcomes. The qualitative data highlighted conflicting concepts of engagement between parents and school staff. Ready to Learn is a promising intervention that merits further support and evaluation.

Keywords: after-school, education, literacy, parental engagement

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Authors: M. Bolacali

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The aim of the study is to determine the effect of immunocastration vaccine administration at different doses on fattening performance of feedlot Holstein bulls. Bopriva® is a vaccine that stimulates the animals' own immune system to produce specific antibodies against gonadotropin releasing factor (GnRF). Ninety four Holstein male calves (309.5 ± 2.58 kg body live weight and 267 d-old) assigned to the 4 treatments. Control group; 1 mL of 0.9% saline solution was subcutaneously injected to intact bulls on 1st and 60th days of the feedlot as placebo. On the same days of the feedlot, Bopriva® at two doses of 1 mL and 1 mL for Trial-1 group, 1.5 mL, and 1.5 mL for Trial-2 group, 1.5 mL, and 1 mL for Trial-3 group were subcutaneously injected to bulls. The study was conducted in a private establishment in the Sirvan district of Siirt province and lasted 180 days. The animals were weighed at the beginning of fattening and at 30-day intervals to determine their live weights at various periods. The statistical analysis for normal distribution data of the treatment groups was carried out with the general linear model procedure of SPSS software. The fattening initial live weight in Control, Trial-1, Trial-2 and Trial-3 groups was respectively 309.21, 306.62, 312.11, and 315.39 kg. The fattening final live weight was respectively 560.88, 536.67, 548.56, and 548.25 kg. The daily live weight gain during the trial was respectively 1.40, 1.28, 1.31, and 1.29 kg/day. The cold carcass yield was respectively 51.59%, 50.32%, 50.85%, and 50.77%. Immunocastration vaccine administration at different doses did not affect the live weights and cold carcass yields of Holstein male calves reared under intensive conditions (P > 0.05). However, it was determined to reduce fattening performance between 61-120 days (P < 0.05) and 1-180 days (P < 0.01). In addition, it was determined that the best performance among the vaccine-treated groups occurred in the group administered a 1.5 mL of vaccine on the 1st and 60th study days. In animals, castration is used to control fertility, aggressive and sexual behaviors. As a result, the fact that stress is induced by physical castration in animals and active immunization against GnRF maintains performance by maximizing welfare in bulls improves carcass and meat quality and controls unwanted sexual and aggressive behavior. Considering such features, it may be suggested that immunocastration vaccine with Bopriva® can be administered as a 1.5 mL dose on the 1st and 60th days of the fattening period in Holstein bulls.

Keywords: anti-GnRF, fattening, growth, immunocastration

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Authors: Eric Granholm, Christophe Delay, Jason Holden, Peter Link

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Negative symptoms are an important unmet treatment needed for schizophrenia. We conducted an open trial of a novel blended intervention called mobile-assisted cognitive behavior therapy for negative symptoms (mCBTn). mCBTn is a weekly group therapy intervention combining in-person and smartphone-based CBT (CBT2go app) to improve experiential negative symptoms in people with schizophrenia. Both the therapy group and CBT2go app included recovery goal setting, thought challenging, scheduling of pleasurable activities and social interactions, and pleasure savoring interventions to modify defeatist attitudes, a target mechanism associated with negative symptoms, and improve experiential negative symptoms. We tested whether participants with schizophrenia or schizoaffective disorder (N=31) who met prospective criteria for persistent negative symptoms showed improvement in experiential negative symptoms. Retention was excellent (87% at 18 weeks) and severity of defeatist attitudes and motivation and pleasure negative symptoms declined significantly in mCBTn with large effect sizes. We also tested whether pupillary responses, a measure of cognitive effort, predicted improvement in negative symptoms mCBTn. Pupillary responses were recorded at baseline using a Tobii pupillometer during the digit span task with 3-, 6- and 9-digit spans. Mixed models showed that greater dilation during the task at baseline significantly predicted a greater reduction in experiential negative symptoms. Pupillary responses may provide a much-needed prognostic biomarker of which patients are most likely to benefit from CBT. Greater pupil dilation during a cognitive task predicted greater improvement in experiential negative symptoms. Pupil dilation has been linked to motivation and engagement of executive control, so these factors may contribute to benefits in interventions that train cognitive skills to manage negative thoughts and emotions. The findings suggest mCBTn is a feasible and effective treatment for experiential negative symptoms and justify a larger randomized controlled clinical trial. The findings also provide support for the defeatist attitude model of experiential negative symptoms and suggest that mobile-assisted interventions like mCBTn can strengthen and shorten intensive psychosocial interventions for schizophrenia.

Keywords: cognitive-behavioral therapy, mobile interventions, negative symptoms, pupillometry schizophrenia

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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: Conor Mccartney, Mark Lee

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Background: An essential component in ambulatory breast augmentation surgery is good analgesia. The demographic undergoing this operation is usually fit, low risk with few comorbidities. These patients do not require long-term hospitalization and do not want to spend excessive time in the hospital for financial reasons. Opiate analgesia can have significant side effects such as nausea, vomiting and sedation. Reducing volumes of postoperative opiates allows faster ambulation and discharge from day surgery. We have developed two targeted nerve blocks that can be applied by the operating surgeon in a matter of seconds under direct vision, not requiring imaging. Anecdotally we found that these targeted nerve blocks reduced opiate requirements and allowed accelerated discharge and faster return to normal activities. This was then tested in a prospective randomized, double-blind trial. Methods: 20 patients were randomized into saline (n = 10) or Ropivicaine adrenaline solution (n = 10). The operating surgeon and anesthetist were blinded to the solution. All patients were closely followed up and morphine equivalents were accurately recorded. Follow-up pain scores were recorded using the Overall Benefit of Analgesia pain questionnaire. Findings: The Ropivicaine nerve blocks significantly reduced opiate requirements postoperatively (p<0.05). Pain scores were significantly decreased in the study group (p<0.05). There were no side effects attributable to the nerve blocks. Conclusions: Intraoperative targeted nerve blocks significantly reduce postoperative opiate requirements in breast augmentation surgery. This results in faster recovery and higher patient satisfaction.

Keywords: breast augmentation, nerve block, postoperative recovery, opiate analgesia, inter pectoral block, sub serratus block

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Authors: Laila Khawaja

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In recent years, an increasing emphasis has been placed on measuring program implementation, in part because of the great variability in how complex interventions are delivered in real-life settings. There is an increased awareness that while conducting process evaluations, one should aim to identify and understand the complexities of intervention if they are to be used for future intervention development or the strategies needed to implement the same intervention in a different setting. Complex interventions are public health interventions that are not drugs or surgical procedures but have many potential active aspects of intervention. In this paper, process evaluations are aligned with MRC guidelines to identify contextual factors related to outcomes to assess the quality of implementation. This paper briefly discusses the perceptions of research team on the implementation of the intervention of ‘Engaging Adolescents in Changing Behaviour’ (EACH-B), a school-based complex intervention study aiming to improve diet and physical activity among adolescents aged 12-13 years. Through qualitative interviews and focus groups with 10 staff members, we aimed to understand their experiences and reflections on implementing the EACH-B trial delivered in 49 Schools around Hampshire, England. Data were uploaded into NVivo, and analysis was conducted using thematic analysis. The investigation revealed two overarching themes: (a) how the communication patterns with teachers were impacted during the delivery of implementation and (b) what were the team’s strategies to keep logistics aligned with the research process that impacted the overall implementation of the trial. The paper informs adaptation strategies used by the research team to establish and maintain effective communication with the teachers as well as the thoughtfulness of the team’s logistic strategy for the successful delivery of the trial.

Keywords: complex interventions, process evaluation, adaptation strategies, randomised controlled trial

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Authors: Rimel Mwamba, Mohan Gundeti

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Introduction: The use of robot-assisted laparoscopic surgeries (RALS) has largely increased in recent years, offering faster and safer treatment options for pediatric patients. In the field of urology, RALS has shown a significant advantage over laparoscopic and open surgeries but continues to be controversial in pediatric cases due to limited comprehensive data on its use. Methods: In this review, we aim to summarize the factors associated with RALS use in pediatric cases involving pyeloplasty, ureteral reimplantation, heminephrectomy, and lower urinary tract reconstruction. We used PubMed, EMBASE, and the Cochrane Database of Systematic Reviews to systematically search for literature on the topic. We then critically assessed and compiled data on RALS outcomes, complications, and associated factors. Results: To date, numerous comparative studies have been conducted on pediatric RALS, with only one randomized control trial investigating the nuances of robotic use against standard of care treatments. These robotic approaches have shown promise in post-surgical outcomes for pediatric patients undergoing upper and lower urinary tract reconstruction. Barriers to use still persist, however, showcasing a need to increase access to the technology, refine instruments for pediatric use, address cost barriers, and provide proper training for surgeons. Conclusion: RALS providesan opportunity to improve pediatric patient outcomes for numerous urologic complications. Additional studies are required to better compare the use of RALS with current standard practices. Due to the difficult nature of conducting randomized control trials, additional prospective observational studies are needed.

Keywords: pediatric urology, robot-assisted laparoscopic surgeries (RALS), pyeloplasty, ureteral reimplantation, heminephrectomy, and lower urinary tract reconstruction

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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: Pei-Hsing Huang, Wei-Ju Huang

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Investment casting is commonly used in the production of metallic components with complex shapes, due to its high dimensional precision, good surface finish, and low cost. However, the process is cumbersome, and the period between trial casting and final production can be very long, thereby limiting business opportunities and competitiveness. In this study, we replaced conventional wax injection with stereolithography (SLA) 3D printing to speed up the trial process and reduce costs. We also used silicone molds to further reduce costs to avoid the high costs imposed by photosensitive resin.

Keywords: investment casting, stereolithography, wax molding, 3D printing

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Authors: A. G. Silva Sobrinho, L. G. A. Cirne, V. T. Santana

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The aim of this trial was to evaluate fatty acid profile of meat from lambs fed on diets containing 0, 12.5 and 25.0% mulberry hay as a substitute for the concentrate. Twenty-four feedlot Ile de France lambs (average weight of 15kg and average age of 60 days) were randomized to receive the different diets and slaughtered at 32kg body weight. Increases were observed in the concentrations of the saturated pentadecanoic, heptadecanoic and arachidic fatty acids; of the monounsaturated nervonic fatty acid and of the polyunsaturated α-linolenic, ɣ-linolenic and eicosapentaenoic fatty acids. Increased conjugated linoleic acid (CLA) was also found in the meat of lambs fed on 12.5% mulberry hay. In addition, the omega-3 composition was augmented, while the omega-3/omega-6 ratio was decreased in mulberry hay-fed animals. In conclusion, a more desirable fatty acid profile was observed in lamb meat following the substitution of mulberry hay in the concentrate of fed, resulting in improved nutritional characteristics of the meat.

Keywords: alternative food, fatty acids, feedlot, sheep meat

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Authors: Muhammad Shafi’U Adamu

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This study examined the effects of two groups of Cognitive Behavioral Therapies (CBT) which, includes Cognitive Restructuring (CB) and Rational Emotive Behavioral Therapy (REBT), on the Psychological Distress of awaiting-trial Inmates in Correctional Centers in North-West Nigeria. The study had four specific objectives, four research questions, and four null hypotheses. The study used a quasi-experimental design that involved pre-test and post-test. The population comprised of all 7,962 awaiting-trial inmates in correctional centers in North-west Nigeria. 131 awaiting trial inmates from three intact Correctional Centers were randomly selected using the census technique. The respondents were sampled and randomly put into 3 groups (CR, REBT and Control). Kessler Psychological Distress Scale (K10) was adapted for data collection in the study. The instrument was validated by experts and subjected to a pilot study using Cronbach's Alpha with a reliability coefficient of 0.772. Each group received treatment for 8 consecutive weeks (60 minutes/week). Data collected from the field were subjected to descriptive statistics of mean, standard deviation and mean difference to answer the research questions. Inferential statistics of ANOVA and independent sample t-test were used to test the null hypotheses at P≤ 0.05 level of significance. Results in the study revealed that there was no significant difference among the pre-treatment mean scores of experimental and control groups. Statistical evidence also showed a significant difference among the mean scores of the three groups, and thus, results of the Post Hoc multiple-comparison test indicated the posttreatment reduction of psychological distress in the awaiting-trial inmates. Documented output also showed a significant difference between the post-treatment psychologically distressed mean scores of male and female awaiting-trial inmates, but there was no difference in those exposed to REBT. The research recommends that a standardized structured CBT counseling technique treatment should be designed for correctional centers across Nigeria, and CBT counseling techniques could be used in the treatment of PD in both correctional and clinical settings.

Keywords: awaiting-trial inmates, cognitive restructuring, correctional centers, rational emotive behavioral therapy

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

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

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

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Authors: Ercan Ceyhan, Mehmet Ali Avci

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This research was made during the 2015 growing periods in the trial filed of ‘Research Station for Department of Field Crops, Agricultural Faculty, Selcuk University’ according to ‘Randomized Blocks Design’ with 3 replications. Research material was the following pea lines; PS16, PS18, PS21, PS23, PS24, PS25, PS36, PS47, PS49, PS51, PS54, PS58, PS67, PS69, PS71, PS73, PS83, PS84, PS87 and PSKY and three cultivars and other 2 commercial varieties named as Bolero, Rondo and Ultrello. Some agronomical characteristics such as plant height (cm) number of pod per plant number of seed per pod number of seed per plant 100 seed weight (g) and seed yield (kg ha-1) were determined. Results of the research implicated that the new developed lines were superior compared with the control (commercial) varieties by means of most of the characteristics. Nevertheless, similar researches should be continued in different locations and years.

Keywords: agricultural characters, pea, Pisum sativum, seed yield

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Authors: Hamza I. Isa, Gezina C. H. Ferreira, Jan E. Crafford, Christoffel J. Botha

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Moraea pallida Bak. (yellow tulip) poisoning is the most important plant-induced cardiac glycoside toxicosis in South Africa. Cardiac glycoside poisonings collectively account for about 33 and 10 % mortalities due to plants, in large and small stock respectively, in South Africa. The toxic principle is 1α, 2α-epoxyscillirosidine, a bufadienolide. The aim of the study was to investigate the potential to develop a vaccine against epoxyscillirosidine. Epoxyscillirosidine and the related bufadienolides proscillaridin and bufalin, which are commercially available, were conjugated to the carrier proteins [Hen ovalbumin (OVA), bovine serum albumin (BSA) and keyhole limpet haemocyanin (KLH)], rendering them immunogenic. Adult male New Zealand White rabbits were immunized. In Trials 1 and 2, rabbits (n=6) were, each assigned to two groups. Experimental animals (n=3; n=4) were vaccinated with epoxyscillirosidine-OVA conjugate, while the control (n=3; n=2) were vaccinated with OVA, using Freund’s complete and incomplete and Montanide adjuvants, for Trials 1 and 2, respectively. In Trial 3, rabbits (n=15), randomly allocated to 5 equal groups (I, II, III, IV and V), were vaccinated with proscillaridin-BSA, bufalin-BSA, epoxyscillirosidine-KLH, epoxyscillirosidine-BSA conjugates, and BSA respectively, using Montanide as adjuvant. Vaccination was on Days 0, 21 and 42. Additional vaccinations were done on Day 56 and 63 for Trial 1. Vaccination was by intradermal injection of 0.4 ml of the immunogen (4 mg/ml [Trial 1] and 8 mg/ml for Trials 2 and Trial 3, respectively). Blood was collected pre-vaccination and at 3 week intervals following each vaccination. Antibody response was determined using an indirect ELISA. There was poor immune response associated with the dose (0.4 mg per rabbit) and adjuvant used in Trial 1. Antibodies were synthesized against the conjugate administered in Trial 2. For Trail 3, antibodies against the immunogens were successfully raised in rabbits with epoxyscillirosidine-KLH inducing the highest immune response. The antibodies raised against proscillaridin and bufalin cross-reacted with epoxyscillirosidine when used as antigen in the ELISA. The study successfully demonstrated the synthesis of antibodies against the bufadienolide conjugates administered. The cross-reactivity of proscillaridin and bufalin with epoxyscillirosidine could potentially be utilized as alternative to epoxyscillirosidine in future studies to prevent yellow tulp poisoning by vaccination.

Keywords: antibodies , bufadienolides, cross-reactivity, epoxyscillirosidine, Moraea pallida, poisoning

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Authors: Muhammad Shafi'u Adamu

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This study examined the effects of two Group Cognitive Behavioural Therapies (Cognitive Restructuring and Rational Emotive Behavioural Therapy) on Psychological Distress of awaiting-trial Inmates in Correctional Centres in North-West, Nigeria. The study had four specific objectives, four research questions, and four null hypotheses. The study used a quasi-experimental design that involved pre-test and post-test. The population comprised of all 7,962 awaiting-trial inmates in correctional centres in North-west, Nigeria. 131 awaiting trial inmates from three intact Correctional Centres were randomly selected using the census technique. The respondents were sampled and randomly put into 3 groups (CR, REBT and Control). Kessler Psychological Distress Scale (K10) was adapted for data collection in the study. The instrument was validated by experts and subjected to pilot study using Cronbach's Alpha with reliability co-efficient of 0.772. Each group received treatment for 8 consecutive weeks (60 minutes/week). Data collected from the field were subjected to descriptive statistics of mean, standard deviation and mean difference to answer the research questions. Inferential statistics of ANOVA and independent sample t-test were used to test the null hypotheses at P≤ 0.05 level of significance. Results in the study revealed that there was no significant difference among the pre-treatment mean scores of experimental and control groups. Statistical evidence also showed a significant difference among the mean sores of the three groups, and thus, results of the Post Hoc multiple-comparison test indicating the posttreatment reduction of psychological distress on the awaiting-trial inmates. Documented output also showed a significant difference between the post-treatment psychologically distressed mean scores of male and female awaiting-trial inmates, but there was no difference on those exposed to REBT. The research recommends that a standardized structured CBT counselling technique treatment should be designed for correctional centres across Nigeria, and CBT counselling techniques could be used in the treatment of PD in both correctional and clinical settings.

Keywords: awaiting-trial inmates, cognitive restructuring, correctional centres, group cognitive behavioural therapies, rational emotive behavioural therapy

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Authors: Natthawut Arin

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In forensic contexts, competency to stand trial assessments are the most common referrals. The defendants may attempt to endorse psychopathology symptoms and feign incompetent. Coaching, which can be teaching them test-taking strategies to avoid detection of psychopathological symptoms feigning. Recently, the Symptom Validity Testings (SVTs) were created to detect feigning. Moreover, the works of the literature showed that the effects of coaching on SVTs may be more robust to the effects of coaching. Thai Symptom Validity Test (SVT-Th) was designed as SVTs which demonstrated adequate psychometric properties and ability to classify between feigners and honest responders. Thus, the current study to examine the utility as the robustness of SVT-Th in the detection of feigned psychopathology. Participants consisted of 120 were recruited from undergraduate courses in psychology, randomly assigned to one of three groups. The SVT-Th was administered to those three scenario-experimental groups: (a) Uncoached group were asked to respond honestly (n=40), (b) Symptom-coached without warning group were asked to feign psychiatric symptoms to gain incompetency to stand trial (n=40), while (c) Test-coached with warning group were asked to feign psychiatric symptoms to avoid test detection but being incompetency to stand trial (n=40). Group differences were analyzed using one-way ANOVAs. The result revealed an uncoached group (M = 4.23, SD.= 5.20) had significantly lower SVT-Th mean scores than those both coached groups (M =185.00, SD.= 72.88 and M = 132.10, SD.= 54.06, respectively). Classification rates were calculated to determine the classification accuracy. Result indicated that SVT-Th had overall classification accuracy rates of 96.67% with acceptable of 95% sensitivity and 100% specificity rates. Overall, the results of the present study indicate that the SVT-Th yielded high adequate indices of accuracy and these findings suggest that the SVT-Th is robustness against coaching.

Keywords: incompetency to stand trial, coaching, robustness, classification accuracy

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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

Procedia PDF Downloads 126

Authors: Keith T. S. Tung, Frederick K. Ho, Rosa S. Wong, Camilla K. M. Lo, Wilfred H. S. Wong, C. B. Chow, Patrick Ip

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Objectives: Underage drinking is an important public health problem both locally and globally. Conventional prevention/intervention relies on unidirectional knowledge transfer such as mail leaflets or health talks which showed mixed results in changing the target behaviour. Previously, we conducted a school internet-based intervention which was found to be effective in reducing alcohol use among adolescents, yet the underlying mechanisms have not been properly investigated. This study, therefore, examined the mechanisms that explain how the intervention produced a change in alcohol drinking behaviours among Chinese adolescent as observed in our previous clustered randomised controlled trial (RCT) study. Methods: This is a cluster randomised controlled trial with parallel group design. Participating schools were randomised to the Internet intervention or the conventional health education group (control) with a 1:1 allocation ratio. Secondary 1–3 students of the participating schools were enrolled in this study. The Internet intervention was a web-based quiz game competition, in which participating students would answer 1,000 alcohol-related multiple-choice quiz questions. Conventional health education group received a promotional package on equivalent alcohol-related knowledge. The participants’ alcohol-related attitude, knowledge, and perceived behavioural control were self-reported before the intervention (baseline) and one month and three months after the intervention. Results: Our RCT results showed that participants in the Internet group were less likely to drink (risk ratio [RR] 0.79, p < 0.01) as well as in lesser amount (β -0.06, p < 0.05) compared to those in the control group at both post-intervention follow-ups. Within the intervention group, regression analyses showed that high quiz scorer had greater improvement in alcohol-related knowledge (β 0.28, p < 0.01) and attitude (β -0.26, p < 0.01) at 1 month after intervention, which in turn increased their perceived behavioural control against alcohol use (β 0.10 and -0.26, both p < 0.01). Attitude, compared to knowledge, was found to be a stronger contributor to the intervention effect on perceived behavioural control. Conclusions: Our internet-based intervention has demonstrated effectiveness in reducing the risk of underage drinking when compared with conventional health education. Our study results further showed an attitude to be a more important factor than knowledge in changing health-related behaviour. This has an important implication for future prevention/intervention on an underage drinking problem.

Keywords: adolescents, internet-based intervention, randomized controlled trial, underage drinking

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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

Procedia PDF Downloads 107

Authors: Corbel Camille, Le Cerf Flora, Capriz Françoise, Vaillant-Ciszewicz Anne-Julie, Breaud Jean, Guerin Olivier, Corveleyn Xavier

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Background: The medical environment can generate stressful and anxiety-provoking situations for patients, particularly during painful care procedures for the older population. These stressful environments have deleterious effects on the quality of care and can even put the patient at risk and set the care team up for failure. The search for a solution is, therefore, imperative. The development of new technologies, such as virtual reality (VR), seems to be an answer to this problem. Objectives: The objective of this study is to compare the effects of virtual reality on pain and anxiety when caring for older hospitalized people with the effects of usual care. More precisely, different individual factors (age, cognitive level, individual preferences, etc.) and different virtual reality universes (personalized or non-personalized) are studied to understand the role of these factors in reducing pain and anxiety during care procedures. The aim of this study is to improve the quality of life of patients and caregivers in their work environment. Method: This mono-centered, randomized, controlled study was conducted from September 2023 to September 2024 on 120 participants recruited from the geriatric departments of the Cimiez Hospital, Nice, France. Participants are randomized into three groups: a control group, a personalized VR group and a non-personalized VR group. Each participant is followed during a painful care session. Data are collected before, during and after the care, using measures of pain (Algoplus and numerical scale) and anxiety (Hospital anxiety scale and numerical scale). Physiological assessments with an oximeter are also performed to collect both heart and respiratory rate measurements. The implementation of the care will be assessed among healthcare providers to evaluate its effects on the difficulty and fatigue associated with the care. Additionally, a questionnaire (System Usability Scale) will be administered at the conclusion of the study to determine the willingness of healthcare providers to integrate VR into their daily care practices. Result: The preliminary results indicate significant effects on anxiety (p=.001) and pain (p=<.001) following the VR intervention during care, as compared to the control group. Conclusion: The preliminary results suggest that VRI appears to be a suitable and effective method for reducing anxiety and pain among older hospitalized individuals compared with standard care. Finally, the experiences of healthcare professionals involved will also be considered to assess the impact of these interventions on working conditions and patient support.

Keywords: anxiety, care, pain, older adults, virtual reality

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Authors: Mutavhatsindi Tshinakaho

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Invasive alien plants (IAP’s) are referred to as species that are non-native to the ecosystem under consideration. Whose introduction causes or is likely to cause economic, ecological, or environmental harm. The integrated management of the invasive plant, Tithonia diversifolia, will be assessed through two herbicide trials (one on the seedlings and the other on matured plants) and a competitive trial between Tithonia and invasive grass species. The initial herbicide trial will be undertaken at the University of Venda Agricultural greenhouse facilities, where Tithonia will be planted in pot plants and watered every after two days until they reach at least 30 cm and will then be subjected to four different herbicide treatments (Metsulfuron methyl, Fluroxypyr, Picloram, Triclopyr), water will be utilised as a control. The percentage damage to foliar will be recorded. The second herbicide trial will be undertaken at Levubu road site, where matured Tithonia will be cut at at least 10cm above the ground and the subjected to herbicide treatments (Picloram, Fluroxypyr, Imazapyr, and Water as a control). The site will be visited post treatment for assessment. For the competition trial, tall grass species will be chosen as competitors (Panicum maximum and Eragrostis murvula), they will be grown at six densities per pot in the greenhouse facilities at the University of Venda, were they will be kept watered for the duration of the experiment. At the end of the experiment, plants will be removed from pots, and the above and below ground biomass will be weighed. The expected results are to know the effective integrated management strategy for T. diversifolia, the effective rehabilitation of T. diversifolia invaded habitats, and the effective chemical control of T. diversifolia

Keywords: foliar, biomass, competition, invasion

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Authors: Ayon Mukherjee

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Covariate-adjusted response-adaptive (CARA) designs use the available responses to skew the treatment allocation in a clinical trial in towards treatment found at an interim stage to be best for a given patient's covariate profile. Extensive research has been done on various aspects of CARA designs with the patient responses assumed to follow a parametric model. However, ranges of application for such designs are limited in real-life clinical trials where the responses infrequently fit a certain parametric form. On the other hand, robust estimates for the covariate-adjusted treatment effects are obtained from the parametric assumption. To balance these two requirements, designs are developed which are free from distributional assumptions about the survival responses, relying only on the assumption of proportional hazards for the two treatment arms. The proposed designs are developed by deriving two types of optimum allocation designs, and also by using a distribution function to link the past allocation, covariate and response histories to the present allocation. The optimal designs are based on biased coin procedures, with a bias towards the better treatment arm. These are the doubly-adaptive biased coin design (DBCD) and the efficient randomized adaptive design (ERADE). The treatment allocation proportions for these designs converge to the expected target values, which are functions of the Cox regression coefficients that are estimated sequentially. These expected target values are derived based on constrained optimization problems and are updated as information accrues with sequential arrival of patients. The design based on the link function is derived using the distribution function of a probit model whose parameters are adjusted based on the covariate profile of the incoming patient. To apply such designs, the treatment allocation probabilities are sequentially modified based on the treatment allocation history, response history, previous patients’ covariates and also the covariates of the incoming patient. Given these information, an expression is obtained for the conditional probability of a patient allocation to a treatment arm. Based on simulation studies, it is found that the ERADE is preferable to the DBCD when the main aim is to minimize the variance of the observed allocation proportion and to maximize the power of the Wald test for a treatment difference. However, the former procedure being discrete tends to be slower in converging towards the expected target allocation proportion. The link function based design achieves the highest skewness of patient allocation to the best treatment arm and thus ethically is the best design. Other comparative merits of the proposed designs have been highlighted and their preferred areas of application are discussed. It is concluded that the proposed CARA designs can be considered as suitable alternatives to the traditional balanced randomization designs in survival trials in terms of the power of the Wald test, provided that response data are available during the recruitment phase of the trial to enable adaptations to the designs. Moreover, the proposed designs enable more patients to get treated with the better treatment during the trial thus making the designs more ethically attractive to the patients. An existing clinical trial has been redesigned using these methods.

Keywords: censored response, Cox regression, efficiency, ethics, optimal allocation, power, variability

Procedia PDF Downloads 134