Search results for: randomized clinical trials
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 4656

Search results for: randomized clinical trials

4566 Irrelevant Angry Faces, Compared to Happy Faces, Facilitate the Response Inhibition

Authors: Rashmi Gupta

Abstract:

It is unclear whether arousal or valence modulates the response inhibition process. It has been suggested that irrelevant positive emotional information (e.g., happy faces) and negative emotional information (e.g., angry faces) interact with attention differently. In the present study, we used arousal-matched irrelevant happy and angry faces. These faces were used as stop-signals in the stop-signal paradigm. There were two kinds of trials: go-trials and stop-trials. Participants were required to discriminate between the letter X or O by pressing the corresponding keys on go-trials. However, a stop signal was occasionally presented on stop trials, where participants were required to withhold their motor response. A significant main effect of emotion on response inhibition was observed. It indicated that the valence of a stop signal modulates inhibitory control. We found that stop-signal reaction time was faster in response to irrelevant angry faces than happy faces, indicating that irrelevant angry faces facilitate the response inhibition process compared to happy faces. These results shed light on the interaction of emotion with cognitive control functions.

Keywords: attention, emotion, response inhibition, inhibitory control

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4565 Challenging the Traditional Practice of Continuous Abscess Cavity Packing – A Single Center, Single Blind Randomized Controlled Trial

Authors: Lakmali Anthony, Bushra Oathman, Anshini Jain, Raaj Chandra

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Introduction: Abscesses are traditionally treated by incision and drainage with the packing of the residual abscess cavity until healing. This method requires regular visits from community nurses for continuous wound packing upon discharge from the hospital and causes considerable patient discomfort. Whether abscess cavity packing offers any advantage over non-packing has not yet been adequately studied to the best of our knowledge. This study aims to determine if there are differences in clinical outcomes of time to healing, fistula formation and recurrence of abscess between abscess cavity packing vs. non-packing groups. Methods: This study was a single-center, single-blind, randomized controlled trial where patients were randomized into packing and non-packing arms. All patients over 18 years presenting to Eastern Health with an abscess requiring incision and drainage in the theatre were invited to participate. Those with underlying conditions that cause recurrent abscesses were excluded. Data were collected from December 2018 to April 2020. Results: There were 63 patients who had abscesses treated with incision and drainage that were enrolled in the study, 52 of which were suitable for analysis. Demographic characteristics were similar in both groups. The packing group had a significantly longer time to heal compared to the non-packing group. Rates of fistula formation and recurrence of abscess were low and there were no statistically significant differences between groups. The packing group had more patients with delayed healing (defined as >60 days) and required more follow-up visits compared to the non-packing group. Conclusion: This pilot study indicates that abscesses can not only be managed safely with incision and drainage alone without the need for continuous abscess cavity packing but also that non-packing may offer clinical benefits to patients with earlier healing of abscesses compared to continuous cavity packing.

Keywords: abscess packing, subcutaneous, perianal, pilonidal

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4564 Covariate-Adjusted Response-Adaptive Designs for Semi-Parametric Survival Responses

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

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4563 The Role of Clinical Pharmacist Intervention in Collaborative Drug Therapy Management to Improve Outcomes and Decrease Hospitalization in Heart Failure Clinic

Authors: Sanaa Mekdad, Leenah Alsayed

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Pharmacists play an important role in the CDTM in the care of patients with heart failure (HF). CDTM allows specialized, dedicated clinical pharmacists in a formal agreement in collaborative practice with physicians. Thus, the aim of this study is to investigate the role of cardiology clinical pharmacists in CDTM in decreasing hospitalization and cost. We studied patients with left ventricular systolic dysfunction in a cluster-randomized selection in a tertiary care center. We allocated 296 patients to pharmacist intervention from 1480 patients. Results: With an acceptance rate of 86%, we documented 696 interventions carried out by clinical pharmacists in cardiology. The average intervention was 2.4 patients, and the admission after interventions decreased from 0.79 to. 0.24 (p value = 0.001). Conclusions: In HF CDTM, clinical pharmacists play a crucial role in enhancing medication management, patient education, and lifestyle modification of patients with chronic heart failure. These efforts improve patients' outcomes and lower costs by reducing hospitalization and other associated expenses.

Keywords: cardiology, medication management, heart failure, outpatient therapy, pharmacist-based services, chronic heart failure, heart failure recommendations, CDTM, Middle East, pharmacist-based services, quality of life, pharmacist

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4562 Effects of Cow Milk and Camel Milk on Improving Covered Distance in the 6-Minute Walk Test Performed by Obese Young Adults

Authors: Mo'ath F. Bataineh

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Exercise is highly effective against obesity. Milk contains several components that support exercising and physical performance. However, there is a lack of published studies on the relationship between camel milk and ability to exercise. A pilot study was conducted with the purpose of comparing the impact of milk type (Cow vs Camel) compared with water on physical performance. Seven male obese participants (age: 20.3 ± 1.5 years; BMI: 35.7 ± 2.7 kg/m2; resting heart rate: 92.7 ± 4.7 beats per minute; training frequency: 4.4 ± 0.8 days/week) were recruited for this pilot study. In a randomized counterbalanced crossover design, participants took part in 3 trials that included ingesting 3 different pre workout drinks in a random order. The pre workout drinks were water (W), whole cow milk (CW), and whole camel milk (CM). On each trial day, participants were asked to report to the laboratory after an overnight fasting. Following a 15-minute short recovery period after their arrival to the laboratory, each participant was presented with a 500 ml of the assigned experimental drink and were asked to ingest it in one minute and at least 120 minutes prior to performing the 6-minute walk test. All drinks were presented at room temperature. Trials with different experimental drinks were performed on separate days. Participants were given at least 4 days of washout period between trials. The trial order was randomized to avoid bias due to learning effect. The 6-minute walk test was performed by all participants and immediately at the conclusion of the test, the covered distance in meters and the rating of perceived exertion (RPE) were recorded. All data were analysed using SPSS software (Version 29.0). The repeated measures ANOVA testing of collected data showed a significant main effect for treatment on covered distance in meters, F (2, 8) = 5.794, p=0.028 with a large effect size (partial eta squared (ηp2) =0.592). Also, LSD post hoc pairwise comparison analysis revealed that Camel milk and Cow milk were significantly (p = 0.044 and p = 0.020 respectively) superior to water in improving the covered distance during the test and that Camel milk tended to be better than Cow’s milk. The RPE values were not significantly different between experimental drinks (p>0.05). In conclusion, milk is superior to water as a pre workout drink, and camel milk is comparable to cow’s milk in enhancing ability to support a higher level of performance compared with water, therefore, camel milk could be used to replace cow’s milk as a suitable pre-exercise drink without expecting any negative consequences on physical performance. The fact that these positive results were obtained with obese individuals should encourage using camel milk without the fear of disturbing physical performance in other weight categories.

Keywords: camel milk, cow milk, obesity, physical performance, pre-workout drink

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4561 Photovoice-Through Photographs to Feelings: Investigation of Experience Reporting in a Randomized Controlled Study

Authors: Selina Studer, Maria Kleinstäuber, Cornelia Weise

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Background: Finding words to report what you have been through may be challenging, especially when dealing with stressful or highly emotional experiences. Photovoice (PV) represents a possible way of facilitating experience reporting. In this approach, people take photos about a particular topic (in our study: worries about the future) and talk about the topic based on the photos. So far, the benefits of Photovoice have been quantitatively insufficiently tested. There is a lack of randomized controlled trials investigating PV in comparison to other methods. This study aimed to fill this research gap. Methods: 65 participants took part in the study and were randomly assigned to the PV group, the writing group (WG), or the control group (CG). The PV group received the task to take photos of worries regarding the future for one week and send max. 5 of them to the interviewer before the interview. The WG had to write down the worries about the future and send max. 5 of them to the interviewer before the interview. The control group did not receive a specific assignment. The semi-structured interview consisted of six open-ended questions and was applied to all future worries. The questions included the content of the future worries, the meaning, and how the worry expressed itself emotionally and physically. The interview was recorded and later transcribed. After the interview, online questionnaires were filled out. They covered a range of variables such as access to emotional content, ability to describe feelings, the extent of self-disclosure, and relationship quality. Results: Contrary to our hypotheses, one-way ANOVA revealed no differences between the three conditions concerning all variables (access to emotional content, ability to describe feelings, the extent of self-disclosure, and so on), all p's > 0.14, BF₀₁ = 1.78-7.66. In a subsequent step, the words in the transcribed interviews were analyzed. The LIWC program counted how many emotional words occurred in the text and assigned them to predefined categories. Planned contrasts revealed that the PV reported more negative emotional words compared to the two groups t(62) = 2.62, p = .011, and also compared to the WG only, t(62) = 2.36, p = .022, BF₀₁ = 0.62. Conclusions and implications: The applied self-report instruments did not reveal any differences between the groups. However, the PV group used more negative emotional words than the other two groups. The discrepancy between self-report and observation variables regarding emotionality is noticeable. It is suggested that the highly educated and above-average female sample may not have needed PV to access emotional content. It is possible that the approach would yield clearer results in a clinical sample. This and other approaches are currently being investigated in a follow-up study.

Keywords: photovoice, controlled randomized study, online intervention, emotional awareness, self-disclosure, data triangulation, interviews

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4560 Clinical Validation of an Automated Natural Language Processing Algorithm for Finding COVID-19 Symptoms and Complications in Patient Notes

Authors: Karolina Wieczorek, Sophie Wiliams

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Introduction: Patient data is often collected in Electronic Health Record Systems (EHR) for purposes such as providing care as well as reporting data. This information can be re-used to validate data models in clinical trials or in epidemiological studies. Manual validation of automated tools is vital to pick up errors in processing and to provide confidence in the output. Mentioning a disease in a discharge letter does not necessarily mean that a patient suffers from this disease. Many of them discuss a diagnostic process, different tests, or discuss whether a patient has a certain disease. The COVID-19 dataset in this study used natural language processing (NLP), an automated algorithm which extracts information related to COVID-19 symptoms, complications, and medications prescribed within the hospital. Free-text patient clinical patient notes are rich sources of information which contain patient data not captured in a structured form, hence the use of named entity recognition (NER) to capture additional information. Methods: Patient data (discharge summary letters) were exported and screened by an algorithm to pick up relevant terms related to COVID-19. Manual validation of automated tools is vital to pick up errors in processing and to provide confidence in the output. A list of 124 Systematized Nomenclature of Medicine (SNOMED) Clinical Terms has been provided in Excel with corresponding IDs. Two independent medical student researchers were provided with a dictionary of SNOMED list of terms to refer to when screening the notes. They worked on two separate datasets called "A” and "B”, respectively. Notes were screened to check if the correct term had been picked-up by the algorithm to ensure that negated terms were not picked up. Results: Its implementation in the hospital began on March 31, 2020, and the first EHR-derived extract was generated for use in an audit study on June 04, 2020. The dataset has contributed to large, priority clinical trials (including International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) by bulk upload to REDcap research databases) and local research and audit studies. Successful sharing of EHR-extracted datasets requires communicating the provenance and quality, including completeness and accuracy of this data. The results of the validation of the algorithm were the following: precision (0.907), recall (0.416), and F-score test (0.570). Percentage enhancement with NLP extracted terms compared to regular data extraction alone was low (0.3%) for relatively well-documented data such as previous medical history but higher (16.6%, 29.53%, 30.3%, 45.1%) for complications, presenting illness, chronic procedures, acute procedures respectively. Conclusions: This automated NLP algorithm is shown to be useful in facilitating patient data analysis and has the potential to be used in more large-scale clinical trials to assess potential study exclusion criteria for participants in the development of vaccines.

Keywords: automated, algorithm, NLP, COVID-19

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4559 Evaluation of Three Commercially Available Materials in Reducing the White Spot Lesions During Fixed Orthodontic Treatment: A Prospective Randomized Controlled Trial

Authors: Sayeeda Laeque Bangi

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Objectives: Treating white spot lesions (WSL) to create a sound and esthetically pleasing enamel surface is a question yet to be fully answered. The objective of this randomized controlled trial was to measure and compare the degree of regression of WSL during orthodontic treatment achieved by using three commercially available materials. Methods: A single-blinded randomized prospective clinical trial, comprising 80 patients categorized into four groups (one control group and three experimental groups, with 20 subjects per group) using block randomization, was conducted. Group A (control group): Colgate strong toothpaste; and experiments groups were Group B: GC tooth mousse, Group C: Phos-Flur mouthwash and Group D: SHY-NM. Subjects were instructed to use the designated dentifrice/mouthwash and photographs were taken at baseline, third and sixth months, and white spot lesions were reassessed in the maxillomandibular anterior teeth. Results: All the three groups had shown an improvement in WSL. But Group B has shown the greatest difference in mean values of decalcification index (DI) scores. Conclusion: All three commercially available products showed a regression of WSL over a 6-month duration. GC tooth mousse proved to be the most effective means of treating WSL over other regimens.

Keywords: white spot lesions, dentifrices, orthodontic therapy, remineralization

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4558 Comparison of Deep Brain Stimulation Targets in Parkinson's Disease: A Systematic Review

Authors: Hushyar Azari

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Aim and background: Deep brain stimulation (DBS) is regarded as an important therapeutic choice for Parkinson's disease (PD). The two most common targets for DBS are the subthalamic nucleus (STN) and globus pallidus (GPi). This review was conducted to compare the clinical effectiveness of these two targets. Methods: A systematic literature search in electronic databases: Embase, Cochrane Library and PubMed were restricted to English language publications 2010 to 2021. Specified MeSH terms were searched in all databases. Studies which evaluated the Unified Parkinson's Disease Rating Scale (UPDRS) III were selected by meeting the following criteria: (1) compared both GPi and STN DBS; (2) had at least three months follow-up period; (3)at least five participants in each group; (4)conducted after 2010. Study quality assessment was performed using the Modified Jadad Scale. Results: 3577 potentially relevant articles were identified, of these, 3569 were excluded based on title and abstract, duplicate and unsuitable article removal. Eight articles satisfied the inclusion criteria and were scrutinized (458 PD patients). According to Modified Jadad Scale, the majority of included studies had low evidence quality which was a limitation of this review. 5 studies reported no statistically significant between-group difference for improvements in UPDRS ш scores. At the same time, there were some results in terms of pain, action tremor, rigidity, and urinary symptoms, which indicated that STN DBS might be a better choice. Regarding the adverse effects, GPi was superior. Conclusion: It is clear that other larger randomized clinical trials with longer follow-up periods and control groups are needed to decide which target is more efficient for deep brain stimulation in Parkinson’s disease and imposes fewer adverse effects on the patients. Meanwhile, STN seems more reasonable according to the results of this systematic review.

Keywords: brain stimulation, globus pallidus, Parkinson's disease, subthalamic nucleus

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4557 Preliminary Report on the Assessment of the Impact of the Kinesiology Taping Application versus Placebo Taping on the Knee Joint Position Sense

Authors: Anna Hadamus, Patryk Wasowski, Anna Mosiolek, Zbigniew Wronski, Sebastian Wojtowicz, Dariusz Bialoszewski

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Introduction: Kinesiology Taping is a very popular physiotherapy method, often used for healthy people, especially athletes, in order to stimulate the muscles and improve their performance. The aim of this study was to determine the effect of the muscle application of Kinesiology Taping on the joint position sense in active motion. Material and Methods: The study involved 50 healthy people - 30 men and 20 women, mean age was 23.2 years (range 18-30 years). The exclusion criteria were injuries and operations of the knee, which could affect the test results. The participants were divided randomly into two equal groups. The first group consisted of individuals with the applied Kinesiology Taping muscle application (KT group), whereas in the rest of the individuals placebo application from red adhesive tape was used (placebo group). Both applications were to enhance the effects of quadriceps muscle activity. Joint position sense (JPS) was evaluated in this study. Error of Active Reproduction of the Joint Position (EARJP) of the knee was measured in 45° flexion. The test was performed prior to applying the patch, with the applied application, then 24 hours after wearing, and after removing the tape. The interval between trials was not less than 30 minutes. Statistical analysis was performed using Statistica 12.0. We calculated distribution characteristics, Wilcoxon test, Friedman‘s ANOVA and Mann-Whitney U test. Results. In the KT group and the placebo group average test score of JPS before applying application KT were 3.48° and 5.16° respectively, after its application it was 4.84° and 4.88°, then after 24 hours of experiment JPS was 5.12° and 4.96°, and after application removal we measured 3.84° and 5.12° respectively. Differences over time in any of the groups were not statistically significant. There were also no significant differences between the groups. Conclusions: 1. Applying Kinesiology Taping to quadriceps muscle had no significant effect on the knee joint proprioception. Its use in order to improve sensorimitor skills seems therefore to be unreasonable. 2. No differences between applications of KT and placebo indicates that the clinical effect of stretch tape is minimal or absent. 3. The results are the basis for the continuation of prospective, randomized trials of numerous study groups.

Keywords: joint position sense, kinesiology taping, kinesiotaping, knee

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4556 A Randomized Active Controlled Clinical Trial to Assess Clinical Efficacy and Safety of Tapentadol Nasal Spray in Moderate to Severe Post-Surgical Pain

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

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

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

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4555 12-Week Comparative Clinical Trial with Low Dose Phentermine/Topiramate with Liraglutide on Obesity in Korea

Authors: Kyu Rae Lee

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The aim of the study is to investigate the clinical efficacy of combination therapeutic modalities using liraglutide (1.2mg/d) add on low-dose phentermine (7.5 mg/d)/topiramate (50mg/d) medication on the obese patient in the bariatric clinic. We assessed the retrospective cohort clinical analyses to the clinical efficacy of medication and combination in the patients who visited the bariatric clinic. We measured all participants’ body fat (bioelectric impedance analysis), weight, height, and the cross-sectional areas of adipose tissues (umbilicus level) after keep fasting for 8 hours at 0, 4, 12 weeks. The design of the study was opened, paired t-test and Wilcoxon test were performed using SPSS for windows (ver.18, IL, USA) for comparison of weight, body fat, and adipose tissues. The participants were one hundred twenty-eight subjects aged 44.67 (1.18) years, 28.95 (0.39) kg/m², and female (82.7%). Their body fat was 40.57 (2.23%), and waist to hip ratio was 0.96 (0.01). The mean cross-sectional area of visceral adipose tissue was 142.59 (7.06) mm², and that of subcutaneous adipose was 274.37 (9.18) mm². 73 of them (57.5%) took medication only, 54 of them took medication with liraglutide for 12 weeks. The subjects in the medication group lost 5.4165 kg, 6.8069%, and those of the combination group did 6.2481 kg, 3.564%. The mean cross-sectional areas of visceral, subcutaneous adipose tissue in the medication group significantly decreased (p=.043), even more in the combination group. (p=.028). Further controlled clinical trials should be considered in the future. We conclude that the low dose of phentermine/topiramate with liraglutide therapeutic modalities would be more effective than phentermine/topiramate medication only in obesity treatment for 12 weeks.

Keywords: low dose phentermine, topiramate, liraglutide, obesity, efficacy

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4554 Conjugated Linoleic Acid Effect on Body Weight and Body Composition in Women: Systematic Review and Meta-Analysis

Authors: Hanady Hamdallah, H. Elyse Ireland, John H. H. Williams

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Conjugated linoleic acid (CLA) is a food supplement that is reported to have multiple beneficial health effects, including being anti-carcinogenic, anti-inflammatory and anti-obesity. Animal studies have shown a significant anti-obesity effect of CLA, but results in humans were inconsistent, where some of the studies found an anti-obesity effect while other studies failed to find any decline in obesity markers after CLA supplementation. This meta-analysis aimed to determine if oral CLA supplementation has been shown to reduce obesity related markers in women. Pub Med, Cochrane Library, and Google Scholar were used to identify the eligible trials using two main searching strategies: the first one was to search eligible trials using keywords 'Conjugated linoleic acid', 'CLA', 'Women', and the second strategy was to extract the eligible trials from previously published systematic reviews and meta-analyses. The eligible trials were placebo control trials where women supplemented with CLA mixture in the form of oral capsules for 6 months or less. Also, these trials provided information about body composition expressed as body weight (BW), body mass index (BMI), total body fat (TBF), percentage body fat (BF %), and/ or lean body mass (LBM). The quality of each included study was assessed using both JADAD scale and an adapted CONSERT checklist. Meta-analysis of 8 eligible trials showed that CLA supplementation was significantly associated with reduced BW (Mean ± SD, 1.2 ± 0.26 kg, p < 0.001), BMI (0.6 ± 0.13kg/m², p < 0.001) and TBF (0.76 ± 0.26 kg, p= 0.003) in women, when supplemented over 6-16 weeks. Subgroup meta-analysis demonstrated a significant reduction in BW (1.29 ± 0.31 kg, p < 0.001), BMI (0.60 ± 0.14 kg/m², p < 0.001) and TBF (0.82 ± 0.28 kg, p= 0.003) in the trials that had recruited overweight-obese women. The second subgroup meta-analysis, that considered the menopausal status of the participants, found that CLA was significantly associated with reduced BW (1.35 ± 0.37 kg, p < 0.001; 1.05 ± 0.36 kg, p= 0.003) and BMI (0.50 ± 0.17 kg/m², p= 0.003; 0.75 ± 0.2 kg/m², p < 0.001) in both pre and post-menopausal age women, respectively. A reduction in TBF (1.09 ± 0.37 kg, p= 0.003) was only significant in post-menopausal women. Interestingly, CLA supplementation was associated with a significant reduction in BW (1.05 ± 0.35 kg, p< 0.003), BMI (0.73 ± 0.2 kg/m², p < 0.001) and TBF (1.07 ± 0.36 kg, p= 0.003) in the trials without lifestyle monitoring or interventions. No significant effect of CLA on LBM was detected in this meta-analysis. This meta-analysis suggests a moderate anti-obesity effect of CLA on BW, BMI and TBF reduction in women, when supplemented over 6-16 weeks, particularly in overweight-obese women and post-menopausal women. However, this finding requires careful interpretation due to several issues in the designs of available CLA supplementation trials. More well-designed trials are required to confirm this meta-analysis results.

Keywords: body composition, body mass index, body weight, conjugated linoleic acid

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4553 The Effect of Bihemisferic Transcranial Direct Current Stimulation Therapy on Upper Extremity Motor Functions in Stroke Patients

Authors: Dilek Cetin Alisar, Oya Umit Yemisci, Selin Ozen, Seyhan Sozay

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New approaches and treatment modalities are being developed to make patients more functional and independent in stroke rehabilitation. One of these approaches is transcranial direct stimulation therapy (tDCS), which aims to improve the hemiplegic upper limb function of stroke patients. tDCS therapy is not in the routine rehabilitation program; however, the studies about tDCS therapy on stroke rehabilitation was increased in recent years. Evaluate the effect of tDCS treatment on upper extremity motor function in patients with subacute stroke was aimed in our study. 32 stroke patients (16 tDCS group, 16 sham groups) who were hospitalized for rehabilitation in Başkent University Physical Medicine and Rehabilitation Clinic between 01.08.2016-20.01-2018 were included in the study. The conventional upper limb rehabilitation program was used for both tDCS and control group patients for 3 weeks, 5 days a week, for 60-120 minutes a day. In addition to the conventional stroke rehabilitation program in the tDAS group, bihemispheric tDCS was administered for 30 minutes daily. Patients were evaluated before treatment and after 1 week of treatment. Functional independence measure self-care score (FIM), Brunnstorm Recovery Stage (BRS), and Fugl-Meyer (FM) upper extremity motor function scale were used. There was no difference in demographic characteristics between the groups. There were no significant differences between BRS and FM scores in two groups, but there was a significant difference FIM score (p=0.05. FIM, BRS, and FM scores are significantly in the tDCS group, when before therapy and after 1 week of therapy, however, no difference is found in the shame group (p < 0,001). When FBS and FM scores were compared, there were statistical significant differences in tDCS group (p < 0,001). In conclusion, this randomized double-blind study showed that bihemispheric tDCS treatment was found to be superior to upper extremity motor and functional enhancement in addition to conventional rehabilitation methods in subacute stroke patients. In order for tDCS therapy to be used routinely in stroke rehabilitation, there is a need for more comprehensive, long-termed, randomized controlled clinical trials in order to find answers to many questions, such as the duration and intensity of treatment.

Keywords: cortical stimulation, motor function, rehabilitation, stroke

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4552 On the convergence of the Mixed Integer Randomized Pattern Search Algorithm

Authors: Ebert Brea

Abstract:

We propose a novel direct search algorithm for identifying at least a local minimum of mixed integer nonlinear unconstrained optimization problems. The Mixed Integer Randomized Pattern Search Algorithm (MIRPSA), so-called by the author, is based on a randomized pattern search, which is modified by the MIRPSA for finding at least a local minimum of our problem. The MIRPSA has two main operations over the randomized pattern search: moving operation and shrinking operation. Each operation is carried out by the algorithm when a set of conditions is held. The convergence properties of the MIRPSA is analyzed using a Markov chain approach, which is represented by an infinite countable set of state space λ, where each state d(q) is defined by a measure of the qth randomized pattern search Hq, for all q in N. According to the algorithm, when a moving operation is carried out on the qth randomized pattern search Hq, the MIRPSA holds its state. Meanwhile, if the MIRPSA carries out a shrinking operation over the qth randomized pattern search Hq, the algorithm will visit the next state, this is, a shrinking operation at the qth state causes a changing of the qth state into (q+1)th state. It is worthwhile pointing out that the MIRPSA never goes back to any visited states because the MIRPSA only visits any qth by shrinking operations. In this article, we describe the MIRPSA for mixed integer nonlinear unconstrained optimization problems for doing a deep study of its convergence properties using Markov chain viewpoint. We herein include a low dimension case for showing more details of the MIRPSA, when the algorithm is used for identifying the minimum of a mixed integer quadratic function. Besides, numerical examples are also shown in order to measure the performance of the MIRPSA.

Keywords: direct search, mixed integer optimization, random search, convergence, Markov chain

Procedia PDF Downloads 450
4551 Antihypertensive Effect of Formulated Apium graveolens: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Authors: Maryam Shayani Rad, Seyed Ahmad Mohajeri, Mohsen Mouhebati, Seyed Danial Mousavi

Abstract:

High blood pressure is one of the most important and serious health-threatening because of no symptoms in most people, which can lead to sudden heart attack, heart failure, and stroke. Nowadays, herbal medicine is one of the best and safest strategies for treatment that have no adverse effects. Apium graveolens (celery) can be used as an alternative treatment for many health conditions such as hypertension. Natural compounds reduce blood pressure via different mechanisms in which Apium graveolens extract provides potent calcium channel blocking properties. A randomized, double-blind, placebo-controlled, cross-over clinical trial was done to evaluate the efficacy of formulated Apium graveolens extract with a maximum yield of 3-n-butylphthalide to reduce systolic and diastolic blood pressure in patients with hypertension. 54 hypertensive patients in the range of 20-68 years old were randomly assigned to the treatment group (26 cases) and the placebo control group (26 cases) and were crossed over after washout duration. The treatment group received at least 2 grams of formulated powder in hard capsules orally, before each meal, 2 times daily. The control group received 2 grams of placebo in hard capsules orally, exactly as the same as shape, time, and doses of treatment group. Treatment was administrated in 12 weeks with 4 weeks washout period at the middle of the study, meaning 4 weeks drug consumption for the treatment group, 4 weeks washout and 4 weeks placebo consumption, and vice versa for the placebo control group. The clinical assessment was done 4 times, including at the beginning and ending of the drug and placebo consumption period by 24-hour ambulatory blood pressure monitoring (ABPM) holter, which measured blood pressure every 15 minutes continuously. There was a statistically significant decrease in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the end of drug duration compared to baseline. The changes after 4 weeks on average was about 12.34 mm Hg for the SBP (P < 0.005) and 7.83 mm Hg for the DBP (P < 0.005). The results from this clinical trial study showed this Apium graveolens extract formulation in the mentioned dosage had a significant effect on blood pressure-lowering for hypertensive patients.

Keywords: Apium graveolens extract, clinical trial, cross-over, hypertension

Procedia PDF Downloads 193
4550 Bifidobacterium lactis Fermented Milk Was Not Effective to Eradication of Helicobacter Pylori Infection: A Prospective, Randomized, Double-Blind, Controlled Study

Authors: R. C. Barbuti, M. N. Oliveira, N. P. Perina, C. Haro, P. Bosch, C. S. Bogsan, J. N. Eisig, T. Navarro-Rodriguez

Abstract:

Background: The management of Helicobacter pylori (H. pylori) eradication is still a matter of discussion, full effectiveness is rarely achieved and it has many adverse effects. Probiotics are believed to have a role in eradicating and possibly preventing H. pylori infection as an adjunctive treatment. The present clinical study was undertaken to see the efficacy of a specially designed fermented milk product containing Bifidobacterium lactis B420 on the eradication of H. pylori infection in a prospective, randomized, double-blind, controlled study in humans. Method: Four test products were specially designed fermented milks, counts of viable cells in all products were 1010 Log CFU. 100 mL-1 for Bifidobacterium lactis-Bifidobacterium species 420, and 1011 Log CFU. 100 mL-1 for Streptococcus thermophiles were administered to subjects infected with H. pylori with a previous diagnosis of functional dyspepsia according to the Rome III criteria in a prospective, randomized, double-blind, placebo-controlled study in humans. Results: After FM supplementation, not all subjects showed a reduction in H. pylori colonization. Conclusion: Bifidobacterium lactis B420, administered twice a day for 90 days did not show an increase in H. pylori eradication effectiveness in Brazilian patients with functional dyspepsia.

Keywords: antibacterial therapy, Bifidobacteria fermented milk, Helicobacter pylori, probiotics

Procedia PDF Downloads 274
4549 Effect of Salvadora Persica Gel on Clinical and Microbiological Parameters of Chronic Periodontitis

Authors: Tahira Hyder, Saima Quraeshi, Zohaib Akram

Abstract:

Salvadora Persica (SP) is known to have anti-inflammatory, antioxidant, anti-coagulant and anti-bacterial properties that may provide therapeutic benefits in the treatment of chronic periodontitis (CP). The current clinical trial was designed to investigate the clinical and anti-microbial effects of SP gel as an adjunct to scaling and root planning (SRP) in subjects with generalized CP. Sixty-six subjects with CP were randomized allocated into two groups: SRP + SP gel (test group) and SRP only (control group). Clinical parameters (periodontal pocket depth, gingival recession, clinical attachment level, bleeding score and plaque score) were recorded at baseline before SRP and at 6 weeks. At baseline and 6 weeks subgingival plaque samples were collected and periodontopathogen Porphyromonas Gingivalis (Pg) quantified using Real-time Polymerase Chain Reaction (RT-PCR). Both therapies reduced the mean periodontal pocket depth (PPD), plaque score (PS) and bleeding score (BOP) and improved the mean clinical attachment level (CAL) between baseline and 6 weeks. In subjects receiving adjunctive SP gel a statistically significant improvement was observed in BOP at follow-up compared to control group (15.01±3.47% and 22.81±6.81% respectively, p=0.001), while there was no statistically significant difference in periodontal pocket depth, gingival recession, clinical attachment level and plaque score between both groups. The test group displayed significantly greater Pg reduction compared to the control group after 6 weeks. The current study establishes that local delivery of SP gel into periodontal pocket in CP stimulated a significant reduction in bacteria Pg level and an improvement in gingival health, as evident from a reduced bleeding score, when used as an adjunct to SRP.

Keywords: miswak, scaling and root planing, porphyromonas gingivalis, chronic periodontitis

Procedia PDF Downloads 64
4548 Assessing the Impact of Pharmacist-Led Medication Therapy Management on Treatment Adherence and Clinical Outcomes in Cancer Patients: A Prospective Intervention Study

Authors: Omer Ibrahim Abdallh Omer

Abstract:

Cancer patients often face complex medication regimens, leading to challenges in treatment adherence and clinical outcomes. Pharmacist-led medication therapy management (MTM) has emerged as a potential solution to optimize medication use and improve patient outcomes in oncology settings. In this prospective intervention study, we aimed to evaluate the impact of pharmacist-led MTM on treatment adherence and clinical outcomes among cancer patients. Participants were randomized to receive either pharmacist-led MTM or standard care, with assessments conducted at baseline and follow-up visits. Pharmacist interventions included medication reconciliation, adherence counseling, and personalized care plans. Our findings reveal that pharmacist-led MTM significantly improved medication adherence rates and clinical outcomes compared to standard care. Patients receiving pharmacist interventions reported higher satisfaction levels and perceived value in pharmacist involvement in their cancer care. These results underscore the critical role of pharmacists in optimizing medication therapy and enhancing patient-centered care in oncology settings. Integration of pharmacist-led MTM into routine cancer care pathways holds promise for improving treatment outcomes and quality of life for cancer patients.

Keywords: cancer, medications adherence, medication therapy management, pharmacist

Procedia PDF Downloads 39
4547 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 40
4546 Comparing the Effects of Ondansetron and Acupressure in PC6 Point on Postoperative Nausea and Vomiting in Patients Undergone Elective Cesarean Section: A Randomized Clinical Trial

Authors: Nasrin Galehdar, Sedigheh Nadri, Elham Nazari, Isan Darvishi, Abouzar Mohammadi

Abstract:

Background and aim:Nausea and vomiting are complications of cesarean section. The pharmacological and non-pharmacological approaches were applied to decrease postoperative nausea and vomiting. The aim of the present study was to compare the effects of Ondansetron and acupressure on postoperative nausea and vomiting in patients undergone an elective cesarean section. Materials and method: The study was designed as a randomized clinical trial. A total of 120 patients were allocated to two equal groups. Four mgs of Ondansetron was administered for the Ondansetron group after clamping the umbilical cord. The acupressure bracelets were fastened in the PC6 point for acupressure group for 15 minutes. The patients were monitored in terms of incidence, severity, and episodes of nausea and vomiting. The data obtained were analyzed by SPSS software version 18 with a significance level of 0.05. Results: There was no significant statistical difference in nausea severity among the groups intra-operatively, in the recovery and surgery wards. The incidence and episodes of vomiting were significantly higher in patients undergone acupressure intra-operatively, in the recovery and surgery wards (P< 0.05). No significant effect of acupressure was reported in reducing postoperative nausea and vomiting. Conclusion: No significant effect of acupressure was reported in reducing postoperative nausea and vomiting. Thus, it is suggested to perform the studies with larger size and comparing the effects of acupressure with other antiemetic medications.

Keywords: ondansetron, acupressure, nausea, vomiting

Procedia PDF Downloads 90
4545 Efficacy of Topical Ectoin Therapy for Acute Radiodermatitis Associated with Breast Cancer Radiotherapy: A Randomized Controlled Study

Authors: Nagwa E. Abd Elazim, Maha S. El-naggar, Rania H. Mohamed, Sara M. Awad

Abstract:

Background: Radiodermatitis is a common side effect of radiation therapy for breast cancer. However, there is no current consensus about effective standard therapy for the prevention and management of radiation dermatitis. Topical ectoine has demonstrated efficacy in the treatment of atopic dermatitis owing to its anti-inflammatory activity. Objective: To evaluate the efficacy of topical ectoine in comparison to traditional topical dexpanthenol treatment in the management of acute radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy. Methods: Fifty patients were randomized to use either dexpanthenol 0.5% cream (25 patients), or ectoin 7% cream (25 patients), applied twice daily to the irradiated area during the radiation period and continued for 2 weeks after cessation of radiotherapy. Assessment of radiation skin toxicity using Common Terminology Criteria of Adverse Events (CTCAE) v4.0, radiation-associated symptoms, and adverse events were undertaken weekly during radiotherapy and 2 weeks after the end of radiotherapy. Results: Topical ectoine showed some clinical benefit over dexpanthenol, as shown by delayed time to onset (at week 3 versus week 2, respectively) and larger number of patients who reached grade 0 at the end of treatment (64% vs. 48%, respectively). The clinical symptoms of pain (p = 0.003) and itching (p = 0.001) attributable to radiation were less pronounced with ectoine than with dexpanthenol. Burning and hyperpigmentation were the most common side effects with ectoine. However, no significant difference between dexpanthenol and ectoine treatments was found in any of the side effects (p = 0.1). Conclusion: Ectoin was overall more effective in improving radiation dermatitis than topical dexpanthenol in breast cancer patients. Ectoin could be proposed as a preventive or curative treatment for patients undergoing postoperative irradiation for breast cancer. Further clinical studies with a larger number of patients are recommended for the confirmation of these preliminary results.

Keywords: breast cancer, dexapanthenol, ectoin, radiation dermatitis

Procedia PDF Downloads 114
4544 Odor-Color Association Stroop-Task and the Importance of an Odorant in an Odor-Imagery Task

Authors: Jonathan Ham, Christopher Koch

Abstract:

There are consistently observed associations between certain odors and colors, and there is an association between the ability to imagine vivid visual objects and imagine vivid odors. However, little has been done to investigate how the associations between odors and visual information effect visual processes. This study seeks to understand the relationship between odor imaging, color associations, and visual attention by utilizing a Stroop-task based on common odor-color associations. This Stroop-task was designed using three fruits with distinct odors that are associated with the color of the fruit: lime with green, strawberry with red, and lemon with yellow. Each possible word-color combination was presented in the experimental trials. When the word matched the associated color (lime written in green) it was considered congruent; if it did not, it was considered incongruent (lime written in red or yellow). In experiment I (n = 34) participants were asked to both imagine the odor of the fruit on the screen and identify which fruit it was, and each word-color combination was presented 20 times (a total of 180 trials, with 60 congruent and 120 incongruent instances). Response time and error rate of the participant responses were recorded. There was no significant difference in either measure between the congruent and incongruent trials. In experiment II participants (n = 18) followed the identical procedure as in the previous experiment with the addition of an odorant in the room. The odorant (orange) was not the fruit or color used in the experimental trials. With a fruit-based odorant in the room, the response times (measured in milliseconds) between congruent and incongruent trials were significantly different, with incongruent trials (M = 755.919, SD = 239.854) having significantly longer response times than congruent trials (M = 690.626, SD = 198.822), t (1, 17) = 4.154, p < 0.01. This suggests that odor imagery does affect visual attention to colors, and the ability to inhibit odor-color associations; however, odor imagery is difficult and appears to be facilitated in the presence of a related odorant.

Keywords: odor-color associations, odor imagery, visual attention, inhibition

Procedia PDF Downloads 157
4543 Virtual Simulation as a Teaching Method for Community Health Nursing: An Investigation of Student Performance

Authors: Omar Mayyas

Abstract:

Clinical decision-making (CDM) is essential to community health nursing (CHN) education. For this reason, nursing educators are responsible for developing these skills among nursing students because nursing students are exposed to highly critical conditions after graduation. However, due to limited exposure to real-world situations, many nursing students need help developing clinical decision-making skills in this area. Therefore, the impact of Virtual Simulation (VS) on community health nursing students' clinical decision-making in nursing education has to be investigated. This study aims to examine the difference in CDM ability among CHN students who received traditional education compared to those who received VS classes, to identify the factors that may influence CDM ability differences between CHN students who received a traditional education and VS classes, and to provide recommendations for educational programs that can enhance the CDM ability of CHN students and improve the quality of care provided in community settings. A mixed-method study will conduct. A randomized controlled trial will compare the CDM ability of CHN students who received 1hr traditional class with another group who received 1hr VS scenario about diabetic patient nursing care. Sixty-four students in each group will randomly select to be exposed to the intervention from undergraduate nursing students who completed the CHN course at York University. The participants will receive the same Clinical Decision Making in Nursing Scale (CDMNS) questionnaire. The study intervention will follow the Medical Research Council (MRC) approach. SPSS and content analysis will use for data analysis.

Keywords: clinical decision-making, virtual simulation, community health nursing students, community health nursing education

Procedia PDF Downloads 52
4542 Evaluation of Drought Tolerant Sunflower Hybrids Indicated Their Broad Adaptability Under Stress Environment

Authors: Saeed Rauf

Abstract:

Purpose: Drought stress is a major production constraint in sunflowers and causes yield losses under tropical and subtropical environments having high evapo-tranpirational losses. Given the consequences, three trials were designed to evaluate drought-resistant sunflower hybrids. Research Methods: Field trials were conducted under a split-plot arrangement with 17 hybrids and two contrasting regimes at Sargodha, Pakistan and 7 hybrids at Karj, Iran. Water stress condition was simulated by holding water in a stress regime. Hybrids were also screened against five levels of osmotic-ally induced stress, i.e. 0-15%, under a completely randomized design with 3 replications. Findings: Hybrids H1 (C.112.× RH.344) and H3 (C.112.× RSIN.82) showed the highest seed yield ha-1 and early flowering at Karj Iran. Commercial hybrid had the highest CTD (18.2°C) followed by C112 × RH.344 (17.29 °C). Hybrid C.250 × R.SIN.82 had the highest seed yield (m-2), followed by C.112 × RH.365 and C.124 × RSIN.82 under both stress and non-stress regimes at Sargodha, Pakistan. Seedling trial results showed that 6 hybrids only germinated in 5 and 7.5% PEG-induced osmotic stress, respectively. H1 (C.112 × RH.344) and H2 (C.112 × RH.347) had the highest germination% at 5% and 7.5% osmotic stress (OS). Seedling vigor index (SVI) was the highest in H1 (C.112 × RH.344) hybrids at 5% OS, H2 had the highest SVI under 7.5% OS, followed by H3 (C112 × RH344) and H4 (C116 × RH344). Originality/Value: In view of above results, it was concluded that hybrid combination H1 had the highest seed yield under stress conditions in both environments. High seed yield may be due to its better germination and vigor index under stress conditions.

Keywords: climate change, CTD, genetic variability, osmotic stress

Procedia PDF Downloads 47
4541 Study of Personality, Fear of Negative Evaluation and Life-Orientation in Convicts and Under-Trials

Authors: Sneh Laller, Kamini C. Tanwar

Abstract:

Human beings are social animals. The scenario is changing and people become angry towards petty things and this may lead to committing a crime. Objective: The aim of the present research is: 1. To find out the difference between convicts and under-trials on different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation; 2. To find out the difference between male and female jail inmates on different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation; 3. To find out the relationship between different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation in convicts and under-trials; 4. To find out the relationship between different dimensions of Personality, Fear of Negative Evaluation (FNE) and Life-orientation in male and female jail inmates. Method: The study was conducted on 100 participants (consisting of 50 convicts- 25 males and 25 females, and 50 under-trials- 25 males and 25 females); age range was 20-60 years. The NEO Five-Factor Inventory-3 by McCrae, Costa (2010), Brief Fear of Negative Evaluation scale- II by Leary (1983) and Life Orientation Test-R by Scheier et al. (1994) was used and purposive sampling technique was done for data collection. The t-test was applied to find out the comparison and Pearson correlation was applied to determine the relationship between personality, FNE and life-orientation in both the groups. Results: There is a significant difference in the dimension of personality that is neuroticism and life-orientation in convicts and under-trials and also, in the dimensions of personality such as neuroticism, extraversion, openness to experience and agreeableness, and FNE in male and female jail inmates. In convicts the dimension of personality, agreeableness shows significant positive correlation with life-orientation (r = 0.430**) whereas, in under-trials the dimension of personality, agreeableness shows significant positive correlation with FNE (r = 0.315*) and another dimension of personality, extraversion shows significant negative correlation with life-orientation (r = -0.409**). In male jail inmates, the dimension of personality, agreeableness shows significant positive correlation with FNE (r = 0.474**) whereas in female jail inmates, the dimension of personality, openness to experience shows significant negative correlation with FNE (r = -0.356*) and significant positive correlation of neuroticism with life-orientation (r = 0.292*). Conclusion: It was found that under-trials are neurotic and life-oriented than convicts, and female jail inmates are also neurotic and exhibit fear of negative evaluation whereas male jail inmates are extravert and agreeable.

Keywords: convicts, fear of negative evaluation, life-orientation, personality, under-trials

Procedia PDF Downloads 144
4540 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 218
4539 Effect of Perioperative Multimodal Analgesia on Postoperative Opioid Consumption and Complications in Elderly Traumatic Hip Fracture Patients: A Systematic Review of Randomised Controlled Trials

Authors: Raheel Shakoor Siddiqui, Shahbaz Malik, Manikandar Srinivas Cheruvu, Sanjay Narayana Murthy, Livio DiMascio

Abstract:

Background: elderly traumatic hip fracture patients frequently present to trauma services globally. Rising low energy falls amongst an osteoporotic aging population is the commonest cause for injury. Hip fractures in this population are a major cause for severe pain, morbidity and mortality. The term hip fracture is interchangeable with neck of femur fracture, fractured neck of femur or proximal femur fracture. Hip fracture pain management protocols and guidelines suggest conventional analgesia, nerve block and opioid based treatment as rescue analgesia. There is a current global opioid crisis with overuse, abuse and dependence. Adverse opioid related complications in vulnerable elderly patients further adds to morbidity and mortality. Systematic reviews in literature have evidenced superiority of multimodal analgesia in osteoarthritic primary joint replacements compared to opioids however, this has not yet been conducted for elderly traumatic hip fracture patients. Aims: The primary aim of this systematic review is to provide standardised evidence following Cochrane and PRISMA guidance in determining advantages of perioperative multimodal analgesia over conventional opioid based treatments in elderly traumatic hip fractures. Methods: 5 databases were searched from January 2000-2023 which identified 8 randomised controlled trials and 446 total participants. These trials met defined PICOS eligibility criteria of patient mean age ≥ 65 years presenting with a unilateral traumatic fractured neck of femur for operative intervention. Analgesic intervention with perioperative multimodal analgesia has been compared to conventional opioid based analgesia. Outcomes of interest include, primarily, the change in postoperative opioid consumption within a 0-30 postoperative period and secondarily, the change in postoperative adverse events and complications. A qualitative synthesis has been performed due to clinical heterogenicity and variance amongst trials. Results: GRADE evidence of moderate quality supports perioperative multimodal analgesia leads to a reduction in postoperative opioid consumption however, low quality evidence supports a reduction of adverse effects and complications. Conclusion: Perioperative multimodal analgesia whether used preoperative, intraoperative and/or postoperative leads to a reduction in postoperative opioid consumption for elderly traumatic hip fracture patients. This review recommends the use of perioperative multimodal analgesia as part of hip fracture pain protocols however, caution and clinical judgement should be used as the risk of adverse effects may not be lower.

Keywords: trauma, orthopaedics, hip, fracture, neck of femur fracture, analgesia, multimodal analgesia, opioid

Procedia PDF Downloads 80
4538 Conservative Treatment Versus Percutaneous Wire Fixation in treatment of Distal Radial Fracture in Elderly

Authors: Abdelfatah Elsenosy, Mahmoud Ebrahim

Abstract:

Background: Distal radius fractures are commonly encountered in orthopedic practice, especially in elderly patients. A number of clinical papers have supported the idea that anatomic restoration of the distal end of the radius is essential to gain superior results. Aim and objectives: The aim of the study is to systematically review the literature for the management of distal end radius in elderly persons (conservative treatment versus percutaneous wire fixation) as regards radiological and functional outcomes. Subjects and methods: Studies were identified from the Medline, Cochrane, EMBASE, and Google Scholar databases were searched until 2019 using combinations of the following search terms: distal radius fracture, conservative treatment, non-operative treatment, and nonsurgical treatment, surgical treatment, operative, elderly, and older. Reference lists of relevant studies were manually searched. Results: There was no statistical significance difference between CI and PKF groups’ frequency of complication in all of the selected studies. Based on the results, we recommend more analysis regarding every parameter of the radiographic and functional results and specific complications related to each fixation need to be accomplished, which requires more Randomized controlled trials (RCTs) with high quality. Conclusion: Surgical treatment seems to be more effective distal radius fracture compared with conservative treatment when the radiographic outcomes were analyzed, and no significant differences were detected in the functional outcomes and complication rate.

Keywords: radius, fracture, surgical, RCTs, conservative, radiographic, outcomes, orthopedic

Procedia PDF Downloads 133
4537 An Investigation the Effectiveness of Emotion Regulation Training on the Reduction of Cognitive-Emotion Regulation Problem in Patients with Multiple Sclerosis

Authors: Mahboobeh Sadeghi, Zahra Izadi Khah, Mansour Hakim Javadi, Masoud Gholamali Lavasani

Abstract:

Background: Since there is a relation between psychological and physiological factors, the aim of this study was to examine the effect of Emotion Regulation training on cognitive emotion regulation problem in patients with Multiple Sclerosis(MS) Method: In a randomized clinical trial thirty patients diagnosed with Multiple Sclerosis referred to state welfare organization were selected. The sample group was randomized into either an experimental group or a nonintervention control group. The subjects participated in 75-minute treatment sessions held three times a week for 4weeks (12 sessions). All 30 individuals were administered with Cognitive Emotion Regulation questionnaire (CERQ). Participants completed the questionnaire in pretest and post-test. Data obtained from the questionnaire was analyzed using Mancova. Results: Emotion Regulation significantly decreased the Cognitive Emotion Regulation problems patients with Multiple sclerosis (p < 0.001). Conclusions: Emotion Regulation can be used for the treatment of cognitive-emotion regulation problem in Multiple sclerosis.

Keywords: Multiple Sclerosis, cognitive-emotion regulation, emotion regulation, MS

Procedia PDF Downloads 441