Search results for: randomized controlled trial
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3636

Search results for: randomized controlled trial

3396 A Patient-Centered Approach to Clinical Trial Development: Real-World Evidence from a Canadian Medical Cannabis Clinic

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

Abstract:

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

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

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3395 Influence of HbA1c on Nitric Oxide Level in Patients with Type 2 Diabetes Mellitus

Authors: Dara Kutsyk, Olga Bondarenko, Mariya Sorochka

Abstract:

In 21-century type 2 diabetes (T2D) has become a global health and social problem in the whole world. The goal of treatment for patients with T2D is to prevent complications of diabetes - macrovascular diseases (heart disease, stroke, and peripheral vascular disease) and microvascular diseases (retinopathy, neuropathy and nephropathy). Nitric oxide (NO) plays an important role in maintaining vascular homeostasis. Loss of NO function is one of the earliest indicators of disease and its progression especially in patients with T2D. Aim: To compare NO level between patients with well and bad controlled glycemia in T2D. Methods: The study included 32 patients with T2D. The diagnosis of T2D was confirmed due to International Diabetes Federation (IDF) criteria 2015. Patients were divided into two groups: with well controlled glycaemia (HbA1c < 7%) and bad controlled glycaemia (HbA1c > 7%). The control group consists of 15 healthy subjects. Results: NO level in patients with T2D is significantly higher (27,2 ±3,1 µmol), compared to controls (18,86±0,9 µmol; p < 0,001). A significant difference in NO level was found between patients with bad controlled glycaemia (25,9±2,2 µmol) and well controlled glycaemia (28,7 ± 3,0 µmol; p<0,01). The study showed a moderate negative correlation between NO level and HbA1c (-0,399; р< 0,05). Conclusions: Production of NO is impaired in patients with T2D, especially with badly controlled glycaemia. With the increase in HbAc serum NO decreases. This can be the main target for prevention vascular complication in T2D.

Keywords: type 2 diabetes, glycated hemoglobin, nitric oxide, Diabetes mellitus

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3394 A Randomized, Controlled Trial to Test Habit Formation Theory for Low Intensity Physical Exercise Promotion in Older Adults

Authors: Patrick Louie Robles, Jerry Suls, Ciaran Friel, Mark Butler, Samantha Gordon, Frank Vicari, Joan Duer-Hefele, Karina W. Davidson

Abstract:

Physical activity guidelines focus on increasing moderate-intensity activity for older adults, but adherence to recommendations remains low. This is despite the fact that scientific evidence finds increasing physical activity is positively associated with health benefits. Behavior change techniques (BCTs) have demonstrated some effectiveness in reducing sedentary behavior and promoting physical activity. This pilot study uses a personalized trials (N-of-1) design, delivered virtually, to evaluate the efficacy of using five BCTs in increasing low-intensity physical activity (by 2,000 steps of walking per day) in adults aged 45-75 years old. The 5 BCTs described in habit formation theory are goal setting, action planning, rehearsal, rehearsal in a consistent context, and self-monitoring. The study recruited health system employees in the target age range who had no mobility restrictions and expressed interest in increasing their daily activity by a minimum of 2,000 steps per day at least five days per week. Participants were sent a Fitbit Charge 4 fitness tracker with an established study account and password. Participants were recommended to wear the Fitbit device 24/7 but were required to wear it for a minimum of ten hours per day. Baseline physical activity was measured by Fitbit for two weeks. Participants then engaged remotely with a clinical research coordinator to establish a “walking plan” that included a time and day interval (e.g., between 7am -8am on Monday-Friday), a location for the walk (e.g., park), and how much time the plan would need to achieve a minimum of 2,000 steps over their baseline average step count (20 minutes). All elements of the walking plan were required to remain consistent throughout the study. In the 10-week intervention phase of the study, participants received all five BCTs in a single, time-sensitive text message. The text message was delivered 30 minutes prior to the established walk time and signaled participants to begin walking when the context (i.e., day of the week, time of day) they pre-selected is encountered. Participants were asked to log both the start and conclusion of their activity session by pressing a button on the Fitbit tracker. Within 30 minutes of the planned conclusion of the activity session, participants received a text message with a link to a secure survey. Here, they noted whether they engaged in the BCTs when prompted and completed an automaticity survey to identify how “automatic” their walking behavior had become. At the end of their trial, participants received a personalized summary of their step data over time, helping them learn more about their responses to the five BCTs. Whether the use of these 5 ‘habit formation’ BCTs in combination elicits a change in physical activity behavior among older adults will be reported. This study will inform the feasibility of a virtually-delivered N-of-1 study design to effectively promote physical activity as a component of healthy aging.

Keywords: aging, exercise, habit, walking

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3393 Processing Design of Miniature Casting Incorporating Stereolithography Technologies

Authors: Pei-Hsing Huang, Wei-Ju Huang

Abstract:

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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3392 Fatty Acid Profile of Meat from Lambs Fed on Diets Containing Mulberry Hay

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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3391 Randomized, Controlled Blind Study Comparing Sacroiliac Intra-Articular Steroid Injection to Radiofrequency Denervation for Management of Sacroiliac Joint Pain

Authors: Ossama Salman

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Background and objective: Sacroiliac joint pain is a common cause for chronic axial low back pain, with up to 20% prevalence rate. To date, no effective long-term treatment intervention has been embarked on yet. The aim of our study was to compare steroid block to radiofrequency ablation for SIJ pain conditions. Methods: A randomized, blind, study was conducted in 30 patients with sacroiliac joint pain. Fifteen patients received radiofrequency denervation of L4-5 primary dorsal rami and S1-3 lateral sacral branch, and 15 patients received steroid under fluoroscopy. Those in the steroid group who did not respond to steroid injections were offered to cross over to get radiofrequency ablation. Results: At 1-, 3- and 6-months post-intervention, 73%, 60% and 53% of patients, respectively, gained ≥ 50 % pain relief in the radiofrequency (RF) ablation group. In the steroid group, at one month post intervention follow up, only 20% gained ≥ 50 % pain relief, but failed to show any improvement at 3 months and 6 months follow up. Conclusions: Radiofrequency ablation at L4 and L5 primary dorsal rami and S1-3 lateral sacral branch may provide effective and longer pain relief compared to the classic intra-articular steroid injection, in properly selected patients with suspected sacroiliac joint pain. Larger studies are called for to confirm our results and lay out the optimal patient selection and treatment parameters for this poorly comprehended disorder.

Keywords: lateral branch denervation, LBD, radio frequency, RF, sacroiliac joint, SIJ, visual analogue scale, VAS

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3390 Effects of Group Cognitive Restructuring and Rational Emotive Behavioral Therapy on Psychological Distress of Awaiting-Trial Inmates in Correctional Centers in North-West, Nigeria

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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3389 Quantitative and Qualitative Analysis of Randomized Controlled Trials in Physiotherapy from India

Authors: K. Hariohm, V. Prakash, J. Saravana Kumar

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Introduction and Rationale: Increased scope of Physiotherapy (PT) practice also has contributed to research in the field of PT. It is essential to determine the production and quality of the clinical trials from India since, it may reflect the scientific growth of the profession. These trends can be taken as a baseline to measure our performance and also can be used as a guideline for the future trials. Objective: To quantify and analyze qualitatively the RCT’s from India from the period 2000-2013’ May, and classify data for the information process. Methods: Studies were searched in the Medline database using the key terms “India”, “Indian”, “Physiotherapy”. Clinical trials only with PT authors were included. Trials out of scope of PT practice and on animals were excluded. Retrieved valid articles were analyzed for published year, type of participants, area of study, PEDro score, outcome measure domains of impairment, activity, participation; ‘a priori’ sample size calculation, region, and explanation of the intervention. Result: 45 valid articles were retrieved from the year 2000-2013’ May. The majority of articles were done on symptomatic participants (81%). The frequencies of conditions repeated more were low back pain (n-7) and diabetes (n-4). PEDro score with mode 5 and upper limit of 8 and lower limit 4 was found. 97.2% of studies measure the outcome at the impairment level, 34% in activity level, and 27.8% in participation level. 29.7% of studies did ‘a priori’ sample size calculation. Correlation of year trend and PEDro score found to be not significant (p>.05). Individual PEDro item analysis showed, randomization (100%), concealment (33%) baseline (76%), blinding-subject, therapist, assessor (9.1%, 0%, 10%), follow-up (89%) ITT (15%), statistics between groups (100%), measures of variance (88 %). Conclusion: The trend shows an upward slope in terms of RCTs published from India which is a good indicator. The qualitative analysis showed some gaps in the clinical trial design, which can be expected to be, fulfilled by the future researchers.

Keywords: RCT, PEDro, physical therapy, rehabilitation

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3388 Promoting Patients' Adherence to Home-Based Rehabilitation: A Randomised Controlled Trial of a Theory-Driven Mobile Application

Authors: Derwin K. C. Chan, Alfred S. Y. Lee

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The integrated model of self-determination theory and the theory of planned behaviour has been successfully applied to explain individuals’ adherence to health behaviours, including behavioural adherence toward rehabilitation. This study was a randomised controlled trial that examined the effectiveness of an mHealth intervention (i.e., mobile application) developed based on this integrated model in promoting treatment adherence of patients of anterior cruciate ligament rupture during their post-surgery home-based rehabilitation period. Subjects were 67 outpatients (aged between 18 and 60) who undertook anterior cruciate ligament (ACL) reconstruction surgery for less than 2 months for this study. Participants were randomly assigned either into the treatment group (who received the smartphone application; N = 32) and control group (who receive standard treatment only; N = 35), and completed psychological measures relating to the theories (e.g., motivations, social cognitive factors, and behavioural adherence) and clinical outcome measures (e.g., subjective knee function (IKDC), laxity (KT-1000), muscle strength (Biodex)) relating to ACL recovery at baseline, 2-month, and 4-month. Generalise estimating equation showed the interaction between group and time was significant on intention was only significant for intention (Wald x² = 5.23, p = .02), that of perceived behavioural control (Wald x² = 3.19, p = .07), behavioural adherence (Wald x² = 3.08, p = .08, and subjective knee evaluation (Wald x² = 2.97, p = .09) were marginally significant. Post-hoc between-subject analysis showed that control group had significant drop of perceived behavioural control (p < .01), subjective norm (p < .01) and intention (p < .01), behavioural adherence (p < .01) from baseline to 4-month, but such pattern was not observed in the treatment group. The treatment group had a significant decrease of behavioural adherence (p < .05) in the 2-month, but such a decrease was not observed in 4-month (p > .05). Although the subjective knee evaluation in both group significantly improved at 2-month and 4-month from the baseline (p < .05), and the improvements in the control group (mean improvement at 4-month = 40.18) were slightly stronger than the treatment group (mean improvement at 4-month = 34.52). In conclusion, the findings showed that the theory driven mobile application ameliorated the decline of treatment intention of home-based rehabilitation. Patients in the treatment group also reported better muscle strength than control group at 4-month follow-up. Overall, the mobile application has shown promises on tackling the problem of orthopaedics outpatients’ non-adherence to medical treatment.

Keywords: self-determination theory, theory of planned behaviour, mobile health, orthopaedic patients

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3387 Oat Bran Associated with Nutritional Counseling in Treating Obesity and Other Risk Factors for Cardiovascular Disease

Authors: Simone Raimondi De Souza, Glaucia Maria Moraes De Oliveira, Ronir Raggio Luiz, Glorimar Rosa

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Introduction: Obesity is among the main risk factors for cardiovascular disease (CVD). Genesis is multifactorial, including genetic, hormonal and environmental factors disorders, among which inadequate feeding pattern, for which nutritional counseling strategies have proven effective. The consumption of beta-glucans (soluble fibers that reportedly promote satiety) present in oat bran can be an effective strategy for preventing and treating obesity. Other benefits have been observed with oat bran consumption, such as reduction of hypercholesterolemia and hyperglycemia, two other risk factors for CVD. Objectives: To analyze the effect of oat bran consumption associated with nutritional counseling in reducing body mass index (BMI), blood cholesterol, glucose profile, waist and neck circumference in obese individuals, and to evaluate the change in eating pattern. Methods: clinical trial, randomized, double-blind, placebo-controlled, lasting 90 days with adults of both genders, with BMI ≥30kg/m2. The study was approved by the Ethics in Research involving human beings in a public institute of cardiology, in Rio de Janeiro, Brazil. Individuals were invited to participate and accepted formally by signing the Terms of Consent. Participants were randomized into oat bran group (gOB) or placebo group (gPCB) and received, respectively: morning prepared consisting of 40g oat bran, 30g of skimmed milk powder and 1g sweetener sucralose; refined flour 40g rice, 30g of milk powder and 1g sweetener sucralose. The Ten Steps to Healthy Eating, of Brazilian Ministry of Health were used to support the nutritional counseling. Variables analyzed: gender; age; BMI, waist circumference (WC) neck circumference (NC); systolic blood pressure (SBP); diastolic blood pressure (DBP); food consumption, total cholesterol (TC), LDL-cholesterol (LDL-c), HDL-cholesterol (HDL-c), non-HDL cholesterol (nHDLc), triglycerides (TG), fasting glucose (FG), fasting insulin (FI) and HOMA-IR. Dietary intake was assessed by 24-hour dietary recall. The Diet Quality Index revised for the Brazilian population (IQD-R) assessed quality of feeding pattern. Statistical analyzes were performed using SPSS version 21, considering statistically significant p-value less than 0.05. Results: A total of 38 participants were included, age = 50 ± 7,6years, 63% women. 19 subjects were placed in gOB and 19 in gPCB. After intervention, statistically significant reductions were observed in the following parameters: in gOB: IQD-R, TC, LDL-c, nHDL-c, FI, SBP, DBP, BMI, WC, NC; in gPCB: IQD-R, LDL-c, SBP, DBP, BMI, WC, NC. No statistically significant differences were observed in the results between groups. Conclusion: Our results reinforce nutritional counseling as important strategy for prevention and treatment of obesity and suggest that inclusion of oat bran in daily diet can bring additional benefits controlling risk factors for CVD. More studies are needed to establish all benefits of oat bran to human health as well as the ideal daily dose for consumption.

Keywords: oat bran, cardiovascular disease, nutritional counseling, obesity

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3386 Responsive Integrative Therapeutic Method: Paradigm for Addressing Core Deficits in Autism by Balkibekova

Authors: Balkibekova Venera Serikpaevna

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Background: Autism Spectrum Disorder (ASD) poses significant challenges in both diagnosis and treatment. Existing therapeutic interventions often target specific symptoms, necessitating the exploration of alternative approaches. This study investigates the RITM (Rhythm Integration Tapping Music) developed by Balkibekova, aiming to create imitation, social engagement and a wide range of emotions through brain development. Methods: A randomized controlled trial was conducted with 100 participants diagnosed with ASD, aged 1 to 4 years. Participants were randomly assigned to either the RITM therapy group or a control group receiving standard care. The RITM therapy, rooted in tapping rhythm to music such as: marche on the drums, waltz on bells, lullaby on musical triangle, dancing on tambourine, polka on wooden spoons. Therapy sessions were conducted over a 3 year period, with assessments at baseline, midpoint, and post-intervention. Results: Preliminary analyses reveal promising outcomes in the RITM therapy group. Participants demonstrated significant improvements in social interactions, speech understanding, birth of speech, and adaptive behaviors compared to the control group. Careful examination of subgroup analyses provides insights into the differential effectiveness of the RITM approach across various ASD profiles. Conclusions: The findings suggest that RITM therapy, as developed by Balkibekova, holds promise as intervention for ASD. The integrative nature of the approach, addressing multiple domains simultaneously, may contribute to its efficacy. Further research is warranted to validate these preliminary results and explore the long-term impact of RITM therapy on individuals with ASD. This abstract presents a snapshot of the research, emphasizing the significance, methodology, key findings, and implications of the RITM therapy method for consideration in an autism conference.

Keywords: RITM therapy, tapping rhythm, autism, mirror neurons, bright emotions, social interactions, communications

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3385 Effectiveness of Traditional Chinese Medicine in the Treatment of Eczema: A Systematic Review and Meta-Analysis Based on Eczema Area and Severity Index Score

Authors: Oliver Chunho Ma, Tszying Chang

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Background: Traditional Chinese Medicine (TCM) has been widely used in the treatment of eczema. However, there is currently a lack of comprehensive research on the overall effectiveness of TCM in treating eczema, particularly using the Eczema Area and Severity Index (EASI) score as an evaluation tool. Meta-analysis can integrate the results of multiple studies to provide more convincing evidence. Objective: To conduct a systematic review and meta-analysis based on the EASI score to evaluate the overall effectiveness of TCM in the treatment of eczema. Specifically, the study will review and analyze published clinical studies that investigate TCM treatments for eczema and use the EASI score as an outcome measure, comparing the differences in improving the severity of eczema between TCM and other treatment modalities, such as conventional Western medicine treatments. Methods: Relevant studies, including randomized controlled trials (RCTs) and non-randomized controlled trials, that involve TCM treatment for eczema and use the EASI score as an outcome measure will be searched in medical literature databases such as PubMed, CNKI, etc. Relevant data will be extracted from the selected studies, including study design, sample size, treatment methods, improvement in EASI score, etc. The methodological quality and risk of bias of the included studies will be assessed using appropriate evaluation tools (such as the Cochrane Handbook). The results of the selected studies will be statistically analyzed, including pooling effect sizes (such as standardized mean differences, relative risks, etc.), subgroup analysis (e.g., different TCM syndromes, different treatment modalities), and sensitivity analysis (e.g., excluding low-quality studies). Based on the results of the statistical analysis and quality assessment, the overall effectiveness of TCM in improving the severity of eczema will be interpreted. Expected outcomes: By integrating the results of multiple studies, we expect to provide more convincing evidence regarding the specific effects of TCM in improving the severity of eczema. Additionally, subgroup analysis and sensitivity analysis can further elucidate whether the effectiveness of TCM treatment is influenced by different factors. Besides, we will compare the results of the meta-analysis with the clinical data from our clinic. For both the clinical data and the meta-analysis results, we will perform descriptive statistics such as means, standard deviations, percentages, etc. and compare the differences between the two using statistical tests such as independent samples t-test or non-parametric tests to assess the statistical differences between them.

Keywords: Eczema, traditional Chinese medicine, EASI, systematic review, meta-analysis

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3384 I Look Powerful So You Will Yield to Me: The Effects of Embodied Power and the Perception of Power on Conflict Management

Authors: Fai-Ho E. Choi, Wing-Tung Au

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This study investigated the effects of embodiment on conflict management. As shown in the research literature, the physiological (i.e. bodily postures) can affect the emotional and cognitive proceedings of human beings, but little has been shown on whether such effects would have ramifications in decision-making related to other individuals. In this study, conflict is defined as when two parties have seemingly incompatible goals, and the two have to deal with each other in order to maximize one’s own gain. In a matched-gender experiment, university undergraduate students were randomly assigned to either the high power condition or the low power condition, with participants in each condition instructed to perform a fix set of bodily postures that would either embody them with a high sense of power or a low sense of power. One high-power participant would pair up with a low-power participant to engage in an integrative bargaining task and a dictator game. Participants also filled out a pre-trial questionnaire and a post-trial questionnaire measuring general sense of power, self-esteem and self-efficacy. Personality was controlled for. Results are expected to support our hypotheses that people who are embodied with power will be more unyielding in a conflict management situation, and that people who are dealing with another person embodied with power will be more yielding in a conflict management situation. As conflicts arise frequently both within and between organizations, a better understanding of how human beings function in conflicts is important. This study should provide evidence that bodily postures can influence the perceived sense of power of the parties involved and hence influence the conflict outcomes. Future research needs to be conducted to investigate further how people perceive themselves and how they perceive their opponents in conflicts, such that we can come up with a behavioral theory of conflict management.

Keywords: conflict management, embodiment, negotiation, perception

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3383 Determination of Some Agricultural Characters of Developed Pea (Pisum sativum L.) Lines

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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3382 Raising Antibodies against Epoxyscillirosidine, the Toxic Principle Contained in Moraea pallida Bak. in Rabbits

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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3381 Disseminating Positive Psychology Resources Online: Current Research and Future Directions

Authors: Warren Jared, Bekker Jeremy, Salazar Guy, Jackman Katelyn, Linford Lauren

Abstract:

Introduction: Positive Psychology research has burgeoned in the past 20 years; however, relatively few evidence-based resources to cultivate positive psychology skills are widely available to the general public. The positive psychology resources at www.mybestself101.org were developed to assist individuals in cultivating well-being using a variety of techniques, including gratitude, purpose, mindfulness, self-compassion, savoring, personal growth, and supportive relationships. These resources are empirically based and are built to be accessible to a broad audience. Key Objectives: This presentation highlights results from two recent randomized intervention studies of specific MBS101 learning modules. A key objective of this research is to empirically assess the efficacy and usability of these online resources. Another objective of this research is to encourage the broad dissemination of online positive psychology resources; thus, recommendations for further research and dissemination will be discussed. Methods: In both interventions, we recruited adult participants using social media advertisements. The participants completed several well-being and positive psychology construct-specific measures (savoring and self-compassion measures) at baseline and post-intervention. Participants in the experimental condition were also given a feedback questionnaire to gather qualitative data on how participants viewed the modules. Participants in the self-compassion study were randomly split between an experimental group, who received the treatment, and a control group, who were placed on a waitlist. There was no control group for the savoring study. Participants were instructed to read content on the module and practice savoring or self-compassion strategies listed in the module for a minimum of twenty minutes a day for 21 days. The intervention was semi-structured, as participants were free to choose which module activities they would complete from a menu of research-based strategies. Participants tracked which activities they completed and how long they spent on the modules each day. Results: In the savoring study, participants increased in savoring ability as indicated by multiple measures. In addition, participants increased in well-being from pre- to post-treatment. In the self-compassion study, repeated measures mixed model analyses revealed that compared to waitlist controls, participants who used the MBS101 self-compassion module experienced significant improvements in self-compassion, well-being, and body image with effect sizes ranging from medium to large. Attrition was 10.5% for the self-compassion study and 71% for the savoring study. Overall, participants indicated that the modules were generally helpful, and they particularly appreciated the specific strategy menus. Participants requested more structured course activities, more interactive content, and more practice activities overall. Recommendations: Mybestself101.org is an applied positive psychology research program that shows promise as a model for effectively disseminating evidence-based positive psychology resources that are both engaging and easily accessible. Considerable research is still needed, both to test the efficacy and usability of the modules currently available and to improve them based on participant feedback. Feedback received from participants in the randomized controlled trial led to the development of an expanded, 30-day online course called The Gift of Self-Compassion and an online mindfulness course currently in development called Mindfulness For Humans.

Keywords: positive psychology, intervention, online resources, self-compassion, dissemination, online curriculum

Procedia PDF Downloads 168
3380 Effects of Group Cognitive Restructuring and Rational Emotive Behavioral Therapy on Psychological Distress of Awaiting-Trial Inmates in Correctional Centers in North- West, Nigeria

Authors: Muhammad Shafi'u Adamu

Abstract:

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

Procedia PDF Downloads 48
3379 Optimization Analysis of Controlled Cooling Process for H-Shape Steam Beams

Authors: Jiin-Yuh Jang, Yu-Feng Gan

Abstract:

In order to improve the comprehensive mechanical properties of the steel, the cooling rate, and the temperature distribution must be controlled in the cooling process. A three-dimensional numerical model for the prediction of the heat transfer coefficient distribution of H-beam in the controlled cooling process was performed in order to obtain the uniform temperature distribution and minimize the maximum stress and the maximum deformation after the controlled cooling. An algorithm developed with a simplified conjugated-gradient method was used as an optimizer to optimize the heat transfer coefficient distribution. The numerical results showed that, for the case of air cooling 5 seconds followed by water cooling 6 seconds with uniform the heat transfer coefficient, the cooling rate is 15.5 (℃/s), the maximum temperature difference is 85℃, the maximum the stress is 125 MPa, and the maximum deformation is 1.280 mm. After optimize the heat transfer coefficient distribution in control cooling process with the same cooling time, the cooling rate is increased to 20.5 (℃/s), the maximum temperature difference is decreased to 52℃, the maximum stress is decreased to 82MPa and the maximum deformation is decreased to 1.167mm.

Keywords: controlled cooling, H-Beam, optimization, thermal stress

Procedia PDF Downloads 344
3378 Effect of Coaching Related Incompetency to Stand Trial on Symptom Validity Test: Robustness, Sensitivity, and Specificity

Authors: Natthawut Arin

Abstract:

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

Procedia PDF Downloads 115
3377 Inelastic and Elastic Taping in Plantar Pressure of Runners Pronators: Clinical Trial

Authors: Liana Gomide, Juliana Rodrigues

Abstract:

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 127
3376 Effect of Citrulline on the Physical Performance of a Soccer-Specific Exercises in Adult Professional Soccer Players

Authors: Bezuglov Eduard, Ryland Morgans, Talibov Oleg, Kalinin Evgeny, Butovsky Mikhail, Savin Evgeny, Tzgoev Eduard, Artemii Lazarev, Bekzhan Pirmakhanov, Anthony C. Hackney

Abstract:

Currently, there is conflicting evidence regarding the efficacy of citrulline for physical performance and post-exercise recovery. Moreover, the vast majority of studies conducted used physically active volunteers from the general population and heterogeneous exercise protocols that are not specific to most sports. A single use of citrulline, regardless of the dose, will not have a significant effect on physical performance and post-exercise recovery in highly trained soccer players performing sport-specific exercises at maximum intensity. To evaluate the effectiveness of a single administration of citrulline at various doses in adult male professional soccer players performing sport-specific exercise at maximum intensity. A randomized, double-blind, placebo-controlled study analyzing eighteen soccer players from the top divisions of several European countries. The participants were randomized into three groups of six and performed a field-based soccer-specific test at 115% VO2max for 18-minutes. Comparative analysis of the cardiovascular system, physical activity, subjective perceived fatigue and post-exercise recovery was conducted. There were no statistically significant differences in more than one analyzed parameter. A single application of 3 to 6 grams of citrulline does not affect physical performance, subjective feeling of fatigue and post-exercise recovery in adult professional soccer players who have performed a sport-specific test. Currently, citrulline cannot be recommended for use as a supplement in adult professional soccer players

Keywords: citrulline, performance, recovery, soccer players

Procedia PDF Downloads 78
3375 A Randomized, Controlled Trial to Test Behavior Change Techniques to Improve Low Intensity Physical Activity in Older Adults

Authors: Ciaran Friel, Jerry Suls, Mark Butler, Patrick Robles, Samantha Gordon, Frank Vicari, Karina W. Davidson

Abstract:

Physical activity guidelines focus on increasing moderate-intensity activity for older adults, but adherence to recommendations remains low. This is despite the fact that scientific evidence supports that any increase in physical activity is positively correlated with health benefits. Behavior change techniques (BCTs) have demonstrated effectiveness in reducing sedentary behavior and promoting physical activity. This pilot study uses a Personalized Trials (N-of-1) design to evaluate the efficacy of using four BCTs to promote an increase in low-intensity physical activity (2,000 steps of walking per day) in adults aged 45-75 years old. The 4 BCTs tested were goal setting, action planning, feedback, and self-monitoring. BCTs were tested in random order and delivered by text message prompts requiring participant engagement. The study recruited health system employees in the target age range, without mobility restrictions and demonstrating interest in increasing their daily activity by a minimum of 2,000 steps per day for a minimum of five days per week. Participants were sent a Fitbit® fitness tracker with an established study account and password. Participants were recommended to wear the Fitbit device 24/7 but were required to wear it for a minimum of ten hours per day. Baseline physical activity was measured by Fitbit for two weeks. In the 8-week intervention phase of the study, participants received each of the four BCTs, in random order, for a two-week period. Text message prompts were delivered daily each morning at a consistent time. All prompts required participant engagement to acknowledge receipt of the BCT message. Engagement is dependent upon the BCT message and may have included recording that a detailed plan for walking has been made or confirmed a daily step goal (action planning, goal setting). Additionally, participants may have been directed to a study dashboard to view their step counts or compare themselves to their baseline average step count (self-monitoring, feedback). At the end of each two-week testing interval, participants were asked to complete the Self-Efficacy for Walking Scale (SEW_Dur), a validated measure that assesses the participant’s confidence in walking incremental distances, and a survey measuring their satisfaction with the individual BCT that they tested. At the end of their trial, participants received a personalized summary of their step data in response to each individual BCT. The analysis will examine the novel individual-level heterogeneity of treatment effect made possible by N-of-1 design and pool results across participants to efficiently estimate the overall efficacy of the selected behavioral change techniques in increasing low-intensity walking by 2,000 steps, five days per week. Self-efficacy will be explored as the likely mechanism of action prompting behavior change. This study will inform the providers and demonstrate the feasibility of an N-of-1 study design to effectively promote physical activity as a component of healthy aging.

Keywords: aging, exercise, habit, walking

Procedia PDF Downloads 73
3374 Honey Dressing versus Silver Sulfadiazine Dressing for Wound Healing in Second Degree Thermal Burn Patients

Authors: Syed Faizan Hassan Shah

Abstract:

Introduction: Burn injuries are among the most devastating of all injuries. Burns is the fourth most common type of trauma worldwide. Ap?proximately 90 percent of burns occur in low to middle-income countries. Nearly half a million Americans each year, with approximately 40,000 hospitalizations and 3,400 deaths annually, suffer burns. The survival rate for admitted burn patients has improved consistently over the past four decades, largely attributed to national decreases in burn size, improvements in burn critical care, and advancements in burn wound care. Objectives: The present study was conducted to compare the efficacy of Honey dressing versus Silver Sulfadiazine dressing for complete wound healing in the 2nd-degree thermal burn. Study Design: A Randomized controlled trial was carried out in the Department of General Surgery/burn unit of Ayub Teaching Hospital Abbottabad from July to December 2018. The study population included thermal burn patients presenting with ASA-I, ASA-II, and body surface area less than 50% of the age group above 12 to 60 years of either gender. All the patients were randomly divided into two equal groups of patients by blocked randomization using permuted block g 6. In group ‘A,’ patients underwent dressing by honey method, and patients in group ‘B’ had silver sulfadiazine dressing. The dressing was changed every 48 hours by a senior sur?geon, and the condition of the wound was observed. Time duration till complete wound healing was noted in the Proforma. Results: A total of 100 patients were selected and divided into two groups of 50 patients in each two groups. The mean age of the patients was 27.66±13.388 ran?ging from 12 to 60 years of age, and the mean duration of complete healing of wound in days was 20.20±6.251, ranging from 2 to 30 days. Mean comparison of age with both groups, age of the patients was 21.24±3.761 (n=50) in group ‘A,’ i.e., honey dressing, and 19.16±7.911 (n=50) was in group ‘B,’ i.e., silver sulfadiazine dressing. Efficacy in the honey dressing group was found effective in 48(75.0%) and ineffect? ive in 2(5.6%) out of 50 patients. Efficacy in silver sulfadiazine dressing group 16(25.0%) was three found effective and in 34(94.4%) was inef?fective out of 50 patients. There was a statistically significant difference between both groups. (P=0.000) . Conclusion: honey dressing is more effective as compared to silver sulfadiazine dressing in terms of complete wound healing in second-degree thermal burn patients; our study also concluded the same.

Keywords: efficacy, honey dressing, silver sulfadiazine dressing, wound healing

Procedia PDF Downloads 86
3373 Integrated Management of Tithonia Diversifolia in the Vhembe Biosphere Reserve

Authors: Mutavhatsindi Tshinakaho

Abstract:

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

Procedia PDF Downloads 60
3372 Covariate-Adjusted Response-Adaptive Designs for Semi-Parametric Survival Responses

Authors: Ayon Mukherjee

Abstract:

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 137
3371 Abdominal Exercises Can Modify Abdominal Function in Postpartum Women: A Randomized Control Trial Comparing Curl-up to Drawing-in Combined With Diaphragmatic Aspiration

Authors: Yollande Sènan Djivoh, Dominique de Jaeger

Abstract:

Background: Abdominal exercises are commonly practised nowadays. Specific techniques of abdominal muscles strengthening like hypopressive exercises have recently emerged and their practice is encouraged against the practice of Curl-up especially in postpartum. The acute and the training effects of these exercises did not allow to advise one exercise to the detriment of another. However, physiotherapists remain reluctant to perform Curl-up with postpartum women because of its potential harmful effect on the pelvic floor. Design: This study was a randomized control trial registered under the number PACTR202110679363984. Objective: to observe the training effect of two experimental protocols (Curl-up versus Drawing-in+Diaphragmatic aspiration) on the abdominal wall (interrecti distance, rectus and transversus abdominis thickness, abdominal strength) in Beninese postpartum women. Pelvic floor function (tone, endurance, urinary incontinence) will be assessed to evaluate potential side effects of exercises on the pelvic floor. Method: Postpartum women diagnosed with diastasis recti were randomly assigned to one of three groups (Curl-up, Drawingin+Diaphragmatic aspiration and control). Abdominal and pelvic floor parameters were assessed before and at the end of the 6-week protocol. The interrecti distance and the abdominal muscles thickness were assessed by ultrasound and abdominal strength by dynamometer. Pelvic floor tone and strength were assessed with Biofeedback and urinary incontinence was quantified by pad test. To compare the results between the three groups and the two measurements, a two-way Anova test with repeated measures was used (p<0.05). When interaction was significant, a posthoc using Student t test, with Bonferroni correction, was used to compare the three groups regarding the difference (end value minus initial value). To complete these results, a paired Student t test was used to compare in each group the initial and end values. Results: Fifty-eight women participated in this study, divided in three groups with similar characteristics regarding their age (29±5 years), parity (2±1 children), BMI (26±4 kg/m2 ), time since the last birth (10±2 weeks), weight of their baby at birth (330±50 grams). Time effect and interaction were significant (p<0.001) for all abdominal parameters. Experimental groups improved more than control group. Curl-up group improved more (p=0.001) than Drawing-in+Diaphragmatic aspiration group regarding the interrecti distance (9.3±4.2 mm versus 6.6±4.6 mm) and abdominal strength (20.4±16.4 Newton versus 11.4±12.8 Newton). Drawingin+Diaphragmatic aspiration group improved (0.8±0.7 mm) more than Curl-up group (0.5±0.7 mm) regarding the transversus abdominis thickness (p=0.001). Only Curl-up group improved (p<0.001) the rectus abdominis thickness (1.5±1.2 mm). For pelvic floor parameters, both experimental groups improved (p=0.01) except for tone which improved (p=0.03) only in Drawing-in+Diaphragmatic aspiration group from 19.9±4.1 cmH2O to 22.2±4.5 cmH2O. Conclusion: Curl-up was more efficient to improve abdominal function than Drawingin+Diaphragmatic aspiration. However, these exercises are complementary. None of them degraded the pelvic floor, but Drawing-in+Diaphragmatic aspiration improved further the pelvic floor function. Clinical implications: Curl-up, Drawing-in and Diaphragmatic aspiration can be used for the management of abdominal function in postpartum women. Exercises must be chosen considering the specific needs of each woman’s abdominal and pelvic floor function.

Keywords: curl-up, drawing-in, diaphragmatic aspiration, hypopressive exercise, postpartum women

Procedia PDF Downloads 61
3370 Systematic Review of Dietary Fiber Characteristics Relevant to Appetite and Energy Intake Outcomes in Clinical Intervention Trials of Healthy Humans

Authors: K. S. Poutanen, P. Dussort, A. Erkner, S. Fiszman, K. Karnik, M. Kristensen, C. F. M. Marsaux, S. Miquel-Kergoat, S. Pentikäinen, P. Putz, R. E. Steinert, J. Slavin, D. J. Mela

Abstract:

Dietary fiber (DF) intake has been associated with lower body weight or less weight gain. These effects are generally attributed to putative effects of DF on appetite. Many intervention studies have tested the effect of DFs on appetite-related measures, with inconsistent results. However, DF includes a wide category of different compounds with diverse chemical and physical characteristics, and correspondingly diverse effects in human digestion. Thus, inconsistent results between DF consumption and appetite are not surprising. The specific contribution of different compounds with varying physico-chemical properties to appetite control and the mediating mechanisms are not well characterized. This systematic review aimed to assess the influence of specific DF characteristics, including viscosity, gel forming capacity, fermentability, and molecular weight, on appetite-related outcomes in healthy humans. Medline and FSTA databases were searched for controlled human intervention trials, testing the effects of well-characterized DFs on subjective satiety/appetite or energy intake outcomes. Studies were included only if they reported: 1) fiber name and origin, and 2) data on viscosity, gelling properties, fermentability, or molecular weight of the DF materials tested. The search generated 3001 unique records, 322 of which were selected for further consideration from title and abstract screening. Of these, 149 were excluded due to insufficient fiber characterization and 124 for other reasons (not original article, not randomized controlled trial, or no appetite related outcome), leaving 49 papers meeting all the inclusion criteria, most of which reported results from acute testing (<1 day). The eligible 49 papers described 90 comparisons of DFs in foods, beverages or supplements. DF-containing material of interest was efficacious for at least one appetite-related outcome in 51/90 comparisons. Gel-forming DF sources were most consistently efficacious but there were no clear associations between viscosity, MW or fermentability and appetite-related outcomes. A considerable number of papers had to be excluded from the review due to shortcomings in fiber characterization. To build understanding about the impact of DF on satiety/appetite specifically there should be clear hypotheses about the mechanisms behind the proposed beneficial effect of DF material on appetite, and sufficient data about the DF properties relevant for the hypothesized mechanisms to justify clinical testing. The hypothesized mechanisms should also guide the decision about relevant duration of exposure in studies, i.e. are the effects expected to occur during acute time frame (related to stomach emptying, digestion rate, etc.) or develop from sustained exposure (gut fermentation mediated mechanisms). More consistent measurement methods and reporting of fiber specifications and characterization are needed to establish reliable structure-function relationships for DF and health outcomes.

Keywords: appetite, dietary fiber, physico-chemical properties, satiety

Procedia PDF Downloads 204
3369 Hydration Matters: Impact on 3 km Running Performance in Trained Male Athletes Under Heat Conditions

Authors: Zhaoqi He

Abstract:

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

Procedia PDF Downloads 31
3368 The Effectiveness of Warm-Water Footbath on Fatigue in Cancer Patient Undergoing Chemotherapy

Authors: Yu-Wen Lin, Li-Ni Liu

Abstract:

Introduction: Fatigue is the most common symptoms experienced by cancer patients undergoing chemotherapy. Patients receiving anticancer therapies develop a higher proportion of fatigue compared with patients who do not receive anticancer therapies. Fatigue has significant impacts on quality of life, daily activities, mood status, and social behaviors. A warm-water footbath (WWF) at 41℃ promotes circulation and removes metabolites resulting in improving sleep and relieving fatigue. The aim of this study is to determine the effectiveness of WWF for relieving fatigue with cancer patients undergoing chemotherapy. Materials and Methods: This is a single-center, prospective, quasi-experimental design study in the oncology ward in Taiwan. Participants in this study were assigned to WWF group as experimental group and standard care group as a control group by purposive sampling. In the WWF group, the participants were asked to soak their feet in 42-43℃ water 15 minutes for consecutive 6 days at one day before chemotherapy. Each participant was evaluated for fatigue level by the Taiwanese version of the Brief Fatigue Inventory (BFI-T). BFI-T was completed for consecutive 8 days of the study. The primary outcome was compared the BFI-T score of WWF group to the standard care group. Results: There were 60 participants enrolled in this study. Thirty participants were assigned to WWF group and 30 participants were assigned to standard care group. Both groups have comparable characteristic. The BFI-T scores of both groups were increased associated with the days of chemotherapy. The highest BFI-T scores of both groups were on the day 4 of chemotherapy. The BFI-T scores of both groups were decreased since day 5 and significantly decreased in WWF group on day 5 compared to standard care group (4.17 vs. 5.7, P < .05). At the end of the study the fatigue at its worse were significantly decreased in WWF group (2.33 vs. 4.37, P < .001). There was no adverse event reported in this study. Conclusion: WWF is an easy, safe, non-invasive, and relatively inexpensive nursing intervention for improving fatigue of cancer patients undergoing chemotherapy. In summary, this study shows the WWF is a simple complementary care method, and it is effective for improving and relieving fatigue in a short time. Through improving fatigue is a way to enhance the quality of life which is important for cancer patients undergoing chemotherapy. Larger prospective randomized controlled trial and long-term effectiveness and outcomes of WWF should be performed to confirm this study.

Keywords: chemotherapy, warm-water footbath, fatigue, Taiwanese version of the brief fatigue inventory

Procedia PDF Downloads 120
3367 Aggregate Production Planning Framework in a Multi-Product Factory: A Case Study

Authors: Ignatio Madanhire, Charles Mbohwa

Abstract:

This study looks at the best model of aggregate planning activity in an industrial entity and uses the trial and error method on spreadsheets to solve aggregate production planning problems. Also linear programming model is introduced to optimize the aggregate production planning problem. Application of the models in a furniture production firm is evaluated to demonstrate that practical and beneficial solutions can be obtained from the models. Finally some benchmarking of other furniture manufacturing industries was undertaken to assess relevance and level of use in other furniture firms

Keywords: aggregate production planning, trial and error, linear programming, furniture industry

Procedia PDF Downloads 526