Search results for: randomized clinical trial

Authors: Gholam Hossein Javanmard, Roghayeh Mohammadi Garegozlo

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The present study was a randomized three-group double-blind clinical trial with repeated measures designs which aimed to determine the pure effect and combined effect of mindfulness based-relaxation (MBR) technique and Transcranial Electrical Simulation (tCES) on psychological distress decreasing of patients with type-2 diabetes. The sample of the study consisted of 30 patients with type-2 diabetes who were selected from the Diabetes Association of Bonab city in Iran. The participants were matched and then randomly assigned to the three groups of 10 subjects (MBR, CES, MBR+CES). The subjects received interventions related to their group in 10 individual sessions. Pre-test, post-test, and one-month follow-up were conducted using DASS-42. Analysis of variance with repeated measures showed a significant change in psychological distress. Multivariate covariance analysis and the paired interpersonal comparative test of Ben Foruni indicated that both interventions of MBR and CES have a similar effect on psychological distress decreasing in the post-test and follow-up phase. But, the combined therapy of MBR+CES was more efficient, and it had a more stable effect. However, all three interventions, especially combined intervention of MBR+CES, as efficient and stable treatment, are suggested for improving the psychological status of diabetic patients.

Keywords: mindfulness based-relaxation, transcranial electrical simulation, type 2 diabetes, psychological distress

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Authors: Niu Shu Fen

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Sleep disturbance is highly prevalent among shift-working nurses. We aimed to evaluate whether aerobic exercise (i.e., walking combined with jogging) improves objective Sleepparameters among female nurses at the end of an 8-week exercise program and 4 weeks after study completion. This single-blinded, parallel design, randomized controlled trial was conducted in the floor classroom of a would-be medical center in northern Taiwan. Sixtyeligible female nurses were randomly assigned to either aerobic exercise (n = 30) or usual care (n = 30) group. The moderate-intensity aerobic exercise program was performed over 5days (60 min per day) a week for 8 weeks after work hours. Objective sleep outcomes including total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE), were retrieved using an Actigraph device. A generalized estimated equation model was used for data analyses. The aerobic exercise group had significant improvements in TST and SE at 4 weeks and 8 weeks compared with baseline evaluation(TST: B = 70.49 and 55.96, both p < 0.001; SE: B = 5.21 and 3.98, p < 0.001 and 0.002).Significant between-group differences were observed in SOL and WASO at 4 weeks but not8 weeks compared with the baseline evaluation (SOL: B = −7.18, p = 0.03; WASO: B =−11.38, p = 0.008). The positive lasting effects for TST were observed only until the 4-week follow-up. To improve sleep quality and quantity, we encourage female nurses to regularly perform moderate-intensity aerobic exercise.

Keywords: sleep quality, aerobic exercise, nurses, shift work

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Authors: Anna Rinaldi, Pierfrancesco Dellino

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COVID-19 vaccine hesitancy can be observed at different rates in different countries. In June 2021, 1,068 people were surveyed in France and Italy to inquire about individual potential acceptance, focusing on time preferences in a risk-return framework: having the vaccination today, in a month, and in 3 months; perceived risks of vaccination and COVID-19; and expected benefit of the vaccine. A randomized controlled trial was conducted to understand how everyday stimuli like fact-based news about vaccines impact an audience's acceptance of vaccination. The main experiment involved two groups of participants and two different articles about vaccine-related thrombosis taken from two Italian newspapers. One article used a more abstract description and language, and the other used a more anecdotal description and concrete language; each group read only one of these articles. Two other groups were assigned categorization tasks; one was asked to complete a concrete categorization task, and the other an abstract categorization task. Individual preferences for vaccination were found to be variable and unstable over time, and individual choices of accepting, refusing, or delaying could be affected by the way news is written. In order to understand these dynamic preferences, the present work proposes a new model based on seven categories of human behaviors that were validated by a neural network. A treatment effect was observed: participants who read the articles shifted to vaccine hesitancy categories more than participants assigned to other treatments and control. Furthermore, there was a significant gender effect, showing that the type of language leading to a lower hesitancy rate for men is correlated with a higher hesitancy rate for women and vice versa. This outcome should be taken into consideration for an appropriate gender-based communication campaign aimed at achieving herd immunity. The trial was registered at ClinicalTrials.gov NCT05582564 (17/10/2022).

Keywords: vaccine hesitancy, risk elicitation, neural network, covid19

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Authors: Fahmi Hassan, Noorizan Abdul Aziz, Yahaya Hassan, Hazlinda Abu Hassan

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Sepsis incidence in critical care settings is a major problem in health care. Extended antibiotic infusion is thought to be superior to traditional dosing especially when treating critically ill patients with sepsis. We compared clinical outcomes of critically ill patients with sepsis receiving 30-minute meropenem infusion and three-hour meropenem infusion. A retrospective case-control study was conducted among septic patients treated with meropenem infusion in ICUs of three hospitals. Patients included in the study received either extended or standard meropenem infusion as per the practice of individual settings. Outcomes and clinical data were retrospectively collected from the electronic databases and patients’ files. A total of 108 patients received extended meropenem infusion while another 117 patients received standard meropenem infusion. Patients receiving the extended meropenem infusion were found to have a significantly lower shorter length of hospital and ICU stay. It was also found that among those receiving extended meropenem infusion, 54.7% (64/117) had a reduction of SAPS II score, while only 44% (48/108) of patients receiving standard meropenem infusion had reduced scores. This study will strengthen the evidence in using extended meropenem infusion as a standard practice in critical care settings. As this is the first study of its kind done in Malaysia, it proves that prolonged meropenem infusion may be beneficial to critically ill patients with sepsis. However, randomized clinical trials with large sample size should be carried out in local settings in order to minimize other confounders that may influence with the result of the study.

Keywords: antibiotics, beta lactams, critical care, extended infusion, meropenem

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Authors: Hung Manh Nguyen, Duong Dai Nguyen

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Objective: To evaluate the effects of Tai Chi exercise on cognitive performance of community-dwelling elderly in Vinh city, Vietnam. Design: A randomized controlled trial. Participants: One hundred and two subjected were recruited. Intervention: Subjects were divided randomly into two groups. Tai Chi group was assigned 6-months Tai Chi training. Control group was instructed to maintain their routine daily activities. Outcome measures: Trail Making Test (TMT) is primary outcome measure. Results: Participants in Tai Chi group reported significant improvement in TMT (part A) F(1, 71) = 78.37, p < .001, and in TMT (part B) F(1, 71)= 175.00, p < .001 in comparison with Control group. Conclusion: Tai Chi is beneficial to improve cognitive performance of the elderly.

Keywords: cognitive, elderly, Vietnam, Tai Chi

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Authors: Shaun G. Abbott, Rebecca C. Reynolds, John B. F. de Wit

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Low physical activity (PA) levels are a major public health concern in Australia. There is some evidence that PA interventions can increase PA levels via various methods, including online delivery. Low Socioeconomic Status (SES) people participate in less PA than the rest of the population, partly due to poor self-regulation behaviors associated with socioeconomic characteristics. Interventions that involve a particular method of self-regulation, Mental Contrasting with Implementation Intentions (MCII), has regularly achieved healthy behavior change, but few studies focus on PA behavior outcomes and no studies examining the effect of MCII on the PA behaviors of low SES people has been done. In this study, a pilot randomized controlled trial (RCT) will deliver MCII for PA behavior change to individuals of relative disadvantage for the first time. The current pilot study will predict sample size for a future full RCT and test the hypothesis that sedentary participants from areas of relative socioeconomic disadvantage of Sydney, who learn the MCII technique will be more physically active, have improved anthropometry and psychological indicators at the completion of a 12-week intervention compared to baseline and control. Eligible participants of relative socioeconomic disadvantage will be randomly assigned to either the ‘PA Information Plus MCII Intervention Group’ or a ‘PA Information-Only Control Group’. Both groups will attend a baseline and 12-week face-to-face consultation; where PA, anthropometric and psychological data will be gathered. The intervention group will be guided through an MCII session at the baseline appointment to establish a PA goal to aim to achieve over 12 weeks. Other than these baseline and 12-week consultations, all participant interaction will occur online. All participants will receive a ‘Fitbit’ accelerometer to record objectively. PA as a daily step count, along with a PA diary for the duration of the study. PA data will be recorded on a personalized online spreadsheet. Both groups will receive a standard PA information email at weeks 2, 4, and 8. The intervention group will also receive scripted follow-up online appointments to discuss goal progress. The current pilot study is in recruitment stage with findings to be presented at the conference in December if selected.

Keywords: implementation intentions, mental contrasting, motivation, pedometer, physical activity, socioeconomic

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Authors: Nura Khattab, Fayad Al-Haimus, Teruko Kishibe, Netanel Krugliak, Melissa McGowan, Brodie Nolan

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Trauma-induced coagulopathy remains a significant contributor to mortality in severely injured patients. Fibrinogen is essential for early hemostasis and is recognized as the first coagulation factor to fall below critical levels, compromising the coagulation cascade. Early administration of fibrinogen concentrate may be feasible and effective to prevent coagulopathy. We conducted this scoping review to characterize the existing quantity of literature, and to explore the usage of prehospital fibrinogen concentrate products in improving clinical outcomes in trauma patients. Methods: A search strategy was developed in consultation with an information specialist. We searched MEDLINE, Embase, Cochrane, and Scopus from inception to May 6th 2024. English studies evaluating prehospital/military usage of fibrinogen concentrate in trauma patients were included. Studies were assessed by three independent reviewers for meeting inclusion and exclusion criteria. Reference lists of included articles were reviewed to identify additional studies meeting inclusion criteria. Clinical endpoints regarding fibrinogen concentrate were extracted and synthesized. Results: The literature search returned 1301 articles with seven studies meeting the inclusion criteria. Five studies (71%) were conducted in civilian settings and two studies (29%) were conducted in military settings. Of the included studies, three (43%) utilized a randomized control trial. We identified seven outcomes that compared varying concentrations of fibrinogen or fibrinogen concentrate to a placebo group. The outcomes included overall mortality, death from hemorrhage, thromboembolic events, clotting time, maximum clot firmness, clot stability at ER admission, and fibrinogen concentration at ER admission. Apart from thromboembolic events, all other reported outcomes showed statistically significant differences in group comparisons, determined using p values. The four (57%) non-clinical studies underscored the robustness, practicality, and degree of fibrinogen concentrate utilization in military environments and retrieval services. Conclusion: Preliminary research suggests that prehospital fibrinogen concentrate administration in traumatic bleeding patients is both feasible and effective, improving mortality and clotting parameters. While implementing a time-saving and proactive approach with fibrinogen holds potential for enhancing trauma care, the current evidence is limited. Further studies in this novel field are warranted.

Keywords: fibrinogen concentrate, prehospital, military, trauma, trauma-induced coagulopathy

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Authors: Hamed Zakikhani, Mohd Khanif Yusop, Amin Soltangheisi

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A hydroponic trial was carried out to investigate the effect of molybdenum (Mo) on uptake of phosphorus (P) in different rice cultivars. The experiment was conducted using a randomized complete-block design, with a split-plot arrangement of treatments and three replications. Four rates of Mo (0, 0.01, 0.1 and 1 mg L−1) and five cultivars (MR219, HASHEMI, MR232, FAJRE and MR253) provided the main and sub-plots, respectively. Interaction of molybdenum×variety was significant on shoot phosphorus uptake (p≤0.01). Highest and lowest shoot phosphorus uptake were seen in Mo3V3 (0.6% plant-1) and Mo0V3 (0.14% plant-1) treatments, respectively. Molybdenum did not have a significant effect on root phosphorus content. According to results, application of molybdenum has a synergistic effect on uptake of phosphorus by rice plants.

Keywords: molybdenum, phosphorus, uptake, rice,

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Authors: Sameh Eldaly, Rola Essam

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Objective: The purpose of this study was to determine the benefits of low-level laser therapy for Athletic Achilles Tendinopathy. Data sources: Search strategies were conducted on 2 Randomized control trial and one pilot study. Results: three trials (103 participants) were analyzed. Laser therapy associated to eccentric exercises, when compared to eccentric exercises and placebo, had low to very low certainty of evidence in pain and function assessment. Conclusion: those three trials evidenced low to very low effect of LLLT, and the results are insufficient to support the routine use LLLT for Achilles tendinopathy.

Keywords: achilles tendinopathy, evidence-based, low-level laser therapy, review

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Authors: H. Abchiche, M. Mellal

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The aim of this work is to study the parameters that influence the rheological behavior of a complex fluid (sodium Carboxyméthylcellulose solution), on a capillary rheometer. An installation has been made to be able to vary the diameter of trial conducts. The obtained results allowed us to deduce that: the diameter of trial conducts have a remarkable effect on the rheological responds.

Keywords: bingham’s fluid, CMC, cylindrical conduit, rheological behavior

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Authors: Ajay Agrawal, Pritha Basnet, Achala Thakur, Pappu Rizal, Rubina Rai

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Context: Rapid expulsion of fetus in intrauterine fetal death (IUFD) is usually requested without any medical grounds for it. So; an efficient, safe method for induction of labor (IOL) is required. Objective: To determine if pre-treatment with mifepristone followed by IOL with misoprostol in late IUFD is more efficacious. Methods: We conducted a randomized controlled trial in 100 patients. Group-A women received single oral dose of 200 mg mifepristone, followed by induction with vaginal misoprostol after 24-hour. Group-B women were induced only with vaginal misoprostol. In each group 5 dose of misoprostol was used 4 hourly. If first cycle was unsuccessful, after break of 12 hour, second course of misoprostol was started. The primary outcome was a measure of induction to delivery time and vaginal delivery within 24 hours. Secondary outcome was to measure need of oxytocin and complications. Results: Maternal age, parity and period of gestation were comparable between groups. Number of misoprostol dose needed in group A was significantly less than group B. Mann Whitney U test showed, women in group A had significantly earlier onset of labor, however total induction to delivery interval was not significant. In group-A, 85.7% delivered within 24 hours of first dose of misoprostol while in group-B 70% delivered within 24 hour (p=0.07). More women in Group B required oxytocin. Conclusion: Pretreatment with mifepristone before IOL following late IUFD is an effective and safe regimen. It appears to shorten the duration of induction to onset of labor.

Keywords: induction of labor, intrauterine fetal death, mifepristone, misoprostol

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Authors: Jia Guo, Qinyuan Huang, Qinyi Zhong, Yanjing Zeng, Yimeng Li, James Wiley, Kin Cheung, Jyu-Lin Chen

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Context: Mothers with abdominal obesity, particularly in China, face challenges in managing their health due to family responsibilities. Existing diabetes prevention programs do not cater specifically to this demographic. Research Aim: To assess the feasibility, acceptability, and efficacy of an mHealth-based diabetes prevention program tailored for Chinese mothers with abdominal obesity in reducing weight-related variables and diabetes risk. Methodology: A randomized controlled trial was conducted in Changsha, China, where the mHealth group received personalized modules and health messages, while the control group received general health education. Data were collected at baseline, 3 months, and 6 months. Findings: The mHealth intervention significantly improved waist circumference, modifiable diabetes risk scores, daily steps, self-efficacy for physical activity, social support for physical activity, and physical health satisfaction compared to the control group. However, no differences were found in BMI and certain other variables. Theoretical Importance: The study demonstrates the feasibility and efficacy of a tailored mHealth intervention for Chinese mothers with abdominal obesity, emphasizing the potential for such programs to improve health outcomes in this population. Data Collection: Data on various variables including weight-related measures, diabetes risk scores, behavioral and psychological factors were collected at baseline, 3 months, and 6 months from participants in the mHealth and control groups. Analysis Procedures: Generalized estimating equations were used to analyze the data collected from the mHealth and control groups at different time points during the study period. Question Addressed: The study addressed the effectiveness of an mHealth-based diabetes prevention program tailored for Chinese mothers with abdominal obesity in improving various health outcomes compared to traditional general health education approaches. Conclusion: The tailored mHealth intervention proved to be feasible and effective in improving weight-related variables, physical activity, and physical health satisfaction among Chinese mothers with abdominal obesity, highlighting its potential for delivering diabetes prevention programs to this population.

Keywords: type 2 diabetes, mHealth, obesity, prevention, mothers

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Authors: Mette Kjerholt, Thora Grothe Thomsen, Connie Bøttcher Berthelsen, Bibi Hølge Hazelton

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Academic nursing is a relatively new phenomenon in Denmark. Leadership and management training in nursing does not prepare Danish nurse leaders to become leaders for nurses with academic background, and some leaders may feel estranged with including this kind of nursing staff in clinical settings. Currently there is a debate regarding what academic nurses can contribute with in clinical practice, and some managers express concern regarding whether this will lead to less focus on clinical practice and more focus on theoretical issues that may not seem so relevant in a busy everyday clinical setting. The paper will present the experiences of integrating three advanced nurse practitioners with Ph.D. degrees (ANP) in three different clinical departments at a regional hospital in Denmark with no prior experiences with such profiles among its staff.

Keywords: leadership, advanced nurse practitioners, clinical practice, academic nursing

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Authors: Muhammad nor Farhan Sa'At, Xin Y. Lim, Terence Y. C. Tan, Siti Hajar M. Rosli, Syazwani S. Ali, Ami F. Syed Mohamed

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INTRODUCTION: Hemp (Cannabis sativa subsp. sativa), commonly used for industrial purposes, differs from marijuana by containing lower levels of delta-9-tetrahydronannabidiol- the principal psychoactive constituent in cannabis. Due to its non-psychoactive nature, there has been growing interest in hemp’s therapeutic potential, which has been investigated through pre-clinical and clinical study modalities. OBJECTIVE: To provide an overview of the current landscape of hemp research, through recent scientific findings specific to the pharmacological effects of the medicinal hemp plant and its derived compounds. METHODS: This review was conducted through a systematic search strategy according to the preferred reporting items for systematic review and meta-analysis-ScR (PRISMA-ScR) checklist on electronic databases including MEDLINE, OVID (OVFT, APC Journal Club, EBM Reviews), Cochrane Library Central and Clinicaltrials.gov. RESULTS: From 65 primary articles reviewed, there were 47 pre-clinical studies related to medicinal hemp. Interestingly, the hemp derivatives showed several potential activities such as anti-oxidative, anti-hypertensive, anti-inflammatory, anti-diabetic, anti-neuroinflammatory, anti-arthritic, anti-acne, and anti-microbial activities. Renal protective effects and estrogenic properties were also exhibited in vitro. CONCLUSION: Medicinal hemp possesses various pharmacological effects tested in vitro and in vivo. Information provided in this review could be used as tool to strengthen the study design of future clinical trial research.

Keywords: Preclinical, Herbal Medicine, Hemp, Cannabis

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Authors: Nittaya Nokham, Nattaphon Kamon, Pipatpong Pimkhot, Pedcharada Yusuk

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Testing efficacy of a bio-product (bp) to reduce amount of arsenic was carried out in soil which were used for cultivation of organic vegetables, at Watchan Royal Project Development Center, Kulayaniwattana district, Chiang Mai. The test consists of 6 treatments e.g. Tr.1) Control: To underlie the planting pits (pp)with compost; Tr.2) Using bp: To underlie thepp with compost mixed with (+) bp at 100 g/pit; Tr.3) Using bp: To underlie the pp with compost + bp at 100 g/pit and to spray the vegetables with bp at 2 l/20 l of water, once a week; Tr.4) Using bp: To spread the compost bp on the planting area at 3 kg/1 m2 ; Tr.5) Using bp: To spread the compost + bp on the planting area at 3 kg/1 m2and to spray vegetables with bp at 2 l/20 l of water; Tr.6) Using bp: To spray vegetables with bp at 2 l/20 l of water. Result showed that after first trial of pointed cabbage cultivation, only Tr.6 had a small reduction of arsenic; while the others had higher amount of the metal. After second trial of growing red oak leaf, Tr.6 had more reduction of arsenic while Tr.5 and Tr.3 had less reduction compared to Tr.6 but more reduction than the others. In the third trial of growing mustard, very small reduction could be found on Tr.6 and Tr.5 but more reduction in Tr.3. For the fourth (last) trial with cos romaine lettuce: Tr.6, Tr.5 showed most reduction of arsenic to about half of the original amount. So, it can be concluded that this bio-product can help reducing arsenic when using this product by spraying the bp to vegetables at concentration of 2 l/20 l of water once week (Tr.6), or using the bio-product mixed with compost to spread on the planting area at 3 kg/1 m2 together with spraying the product (Tr.5). The results obtained from continuous planting 4 kinds of vegetables at the same area. The amount of arsenic found in roots and stem is very small in the 4 vegetables.

Keywords: organic vegetables, bio-product, arsenic, soil

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Authors: Caio E. G. Reis, Jose G. Dórea, Teresa H. M. da Costa

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Objective: Epidemiological data shows an inverse association of coffee consumption with risk of type 2 diabetes mellitus. However, the clinical effects of coffee consumption on the glucose metabolism biomarkers remain controversial. Thus, this paper reviews clinical trials that evaluated the effects of coffee consumption on glucose metabolism. Research Design and Methods: We identified studies published until December 2014 by searching electronic databases and reference lists. We included randomized clinical trials which the intervention group received caffeinated and/or decaffeinated coffee and the control group received water or placebo treatments and measured biomarkers of glucose metabolism. The Jadad Score was applied to evaluate the quality of the studies whereas studies that scored ≥ 3 points were considered for the analyses. Results: Seven clinical trials (total of 237 subjects) were analyzed involving adult healthy, overweight and diabetic subjects. The studies were divided in short-term (1 to 3h) and long-term (2 to 16 weeks) duration. The results for short-term studies showed that caffeinated coffee consumption may increase the area under the curve for glucose response, while for long-term studies caffeinated coffee may improve the glycemic metabolism by reducing the glucose curve and increasing insulin response. These results seem to show that the benefits of coffee consumption occur in the long-term as has been shown in the reduction of type 2 diabetes mellitus risk in epidemiological studies. Nevertheless, until the relationship between long-term coffee consumption and type 2 diabetes mellitus is better understood and any mechanism involved identified, it is premature to make claims about coffee preventing type 2 diabetes mellitus. Conclusion: The findings suggest that caffeinated coffee may impairs glucose metabolism in short-term but in the long-term the studies indicate reduction of type 2 diabetes mellitus risk. More clinical trials with comparable methodology are needed to unravel this paradox.

Keywords: coffee, diabetes mellitus type 2, glucose, insulin

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Authors: Khaled M. Alhawiti

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This paper investigates the future of medicine and the use of Natural language processing. The importance of having correct clinical information available online is remarkable; improving patient care at affordable costs could be achieved using automated applications to use the online clinical information. The major challenge towards the retrieval of such vital information is to have it appropriately coded. Majority of the online patient reports are not found to be coded and not accessible as its recorded in natural language text. The use of Natural Language processing provides a feasible solution by retrieving and organizing clinical information, available in text and transforming clinical data that is available for use. Systems used in NLP are rather complex to construct, as they entail considerable knowledge, however significant development has been made. Newly formed NLP systems have been tested and have established performance that is promising and considered as practical clinical applications.

Keywords: clinical information, information retrieval, natural language processing, automated applications

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

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

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

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Authors: Jiayan Gou, Kexin He, Xin Zhang, Fei Wang, Liuni Zou

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Background: Homocysteine is a high-risk factor for cognitive decline, and folic acid supplementation can lower homocysteine levels. However, current clinical research results are inconsistent, and the effects of folic acid on homocysteine levels and cognitive function in older people are inconsistent. Objective: The objective of this study is to systematically evaluate the effects of folic acid alone or in combination with other nutrients on homocysteine levels and cognitive function in older adults. Methods: Systematic searches were conducted in five databases, including PubMed, Embase, the Cochrane Library, Web of Science, and CINAHL, from inception to June 1, 2023. Randomized controlled trials were included investigating the effects of folic acid alone or in combination with other nutrients on cognitive function in older people. Results: 17 articles were included, with six focusing on the effects of folic acid alone and 11 examining folic acid in combination with other nutrients. The study included 3,100 individuals aged 60 to 83.2 years, with a relatively equal gender distribution (approximately 51.82% male). Conclusion: Folic acid alone or combined with other nutrients can effectively lower homocysteine level and improve cognitive function in patients with mild cognitive impairment. But for patients with Alzheimer's disease and dementia, the intervention only can reduce the homocysteine level, but the improvement in cognitive function is not significant. In healthy older people, high baseline homocysteine levels (>11.3 μmol/L) and good ω-3 fatty acid status (>590 μmol/L) can enhance the improvement effect of folic acid on cognitive function. This trial has been registered on PROSPERO as CRD42023433096.

Keywords: B-complex vitamins, cognitive function, folic acid, homocysteine

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Authors: Ruqayya Naheed Khan, Awais Amjad Malik, Awais Naeem, Amina Khan, Asad Parvaiz

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Introduction: Axillary nodal status in breast cancer patients is a paramount prognosticator, next to primary tumor size and grade. It has been well established that patients with negative sentinel lymph node biopsy can safely avoid axillary lymph node dissection. A positive sentinel lymph node has traditionally required subsequent axillary dissection. According to ACOSOG Z11 trial, patients who underwent axillary dissection with 3 or more positive sentinel nodes or opted for observation in case of negative sentinel lymph node, did not find any difference in Overall Survival (OS) and Disease Free Survival (DFS). The Z11 trial included patients who underwent breast conserving surgery and excluded patients with mastectomies. The purpose of this study is to determine whether Z0011 can be applied to mastectomy patients as well in 1-3 positive sentinel lymph nodes and avoid unnecessary ALND. Methods: A retrospective review was conducted at Shaukat Khanam Memorial Cancer Hospital Pakistan from Jan 2015 to Dec 2017 including patients who were treated for invasive breast cancer and required upfront mastectomy. They were clinically node negative, so sentinel lymph node biopsy was performed. Patients underwent ALND with positive sentinel lymph node. A total of 156 breast cancer patients with mastectomies were reviewed. Results: 95% of the patients were female while 3% were male. Average age was 44 years. There was no difference in race, comorbidities, histology, T stage, N stage, and overall stage, use of adjuvant chemotherapy and radiation therapy. 64 patients underwent ALND for positive lymph node while 92 patients were spared of axillary dissection due to negative sentinel lymph node biopsy. Out of 64 patients, 38 patients (59%) had only 1 lymph node positive which was the sentinel node. 18 patients (28%) had 2 lymph nodes positive including the sentinel node while only 8 patients (13%) had 3 or more positive nodes. Conclusion: Keeping in mind the complications related to ALND, above results clearly show that ALND could have been avoided in 87% of patients in the setting of adjuvant radiation, possibly avoiding the morbidity associated with axillary lymphadenectomy although a prospective randomized trial needs to confirm these results.

Keywords: mastectomy, sentinel lymph node biopsy, axillary lymph node dissection, breast cancer

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Authors: Parastoo Parhizkar, Jaber Yaghini, Omid Fakheran

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Background: Third molar surgery is often associated with postoperative problems which cause serious impediments on daily activities and quality of life. Steroidal anti-inflammatory drugs may decrease these common post-operative complications. The purpose of this review is evaluating the available evidence regarding the efficacy of corticosteroids used as adjunctive therapy for patients undergoing third molar surgery. Methods: PubMed, Google scholar, Scopus, web of science, clinicaltrials.gov, scirus.com, Cochrane central register for controlled trials, LILACS, OpenGrey, centerwatch, isrctn, who.int and ebsco were searched without restrictions regarding the year of publication. Randomized clinical trials assessing patient-reported outcomes in patients undergoing surgical therapy, were eligible for inclusion. Study quality was assessed using the CONSORT-checklist. No meta-analysis was performed. Results: A total of twelve Randomized Clinical Trials were included in this study. Methylprednisolone and Dexamethasone may decrease postoperative side effects such as pain, trismus and edema. Based on the results both of them could improve patients’ satisfaction, and there is no significant difference between these two types of corticosteroids regarding the patient centered outcomes (p > 0.05). Intralesional and intravenous injection of Dexamethasone showed an equivalent result, with statistically significant better results (P < 0.05) in comparison with the oral treatment. Conclusion: various types of corticosteroids can enhance the patient’s satisfaction following third molar surgery. However, there is no significant difference between Dexamethasone, Prednisolone and Methylprednisolone groups in this regard. Comparing the various administration routs, local injection of Dexamethasone is quite simple, painless and cost-effective adjunctive therapy with better drug efficacy.

Keywords: third molar surgery, corticosteroids, patient-reported outcomes, health related quality of life

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Authors: Ayhan Aydoğdu, Ercan Ceyhan, Ali Kahraman, Nursel Çöl

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This research was conducted to determine effects of plant densities on seed yield and some agricultural characteristics of pea variety- Jofs in Konya ecological conditions during 2012 vegetation period. The trial was set up according to “Randomized Blocks Design” with three replications. The material “Jofs” pea variety was subjected to 3-row spaces (30, 40 and 50 cm) and 3-row distances (5, 10 and 15 cm). According to the results, difference was shown statistically for the effects of row spaces and row distances on seed yield. The highest seed yield was 2582.1 kg ha-1 on 30 cm of row spaces while 2562.2 kg ha-1 on 15 cm of distances. Consequently, the optimum planting density was determined as 30 x 15 cm for Jofs pea variety growing in Konya.

Keywords: pea, row space, row distance, seed yield

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Authors: Mbanzulu Kennedy, Zanga Josue, Wumba Roger

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Malaria and schistosomiasis remain life-threatening public health problems in sub-Saharan Africa. The infection pattern related to age indicates that preschool and school-age children are at the highest risk of malaria and schistosomiasis. Both parasitic infections, separately or combined, may have negative impacts on the haemoglobin concentration levels. The existing data revealed that artemisinin derivatives commonly used to cure malaria present also in antischistosomal activities. The current study investigated the impact of Artesunate-Amodiaquine (AS-AQ) on schistosomiasis when administered to treat malaria in rural area of Lemfu, DRC. A prospective longitudinal study including 171 coinfected children screened for anaemia, Schistosoma mansoni, and Plasmodium falciparum infections. The egg reduction rate and haemoglobin concentration were assessed four weeks after the treatment with AS-AQ, of all coinfected children of this series. One hundred and twenty-five (74.4%) out of 168 coinfected children treated and present during the assessment were found stool negative for S. mansoni eggs. Out of 43 (25.6%) children who remained positives, 37 (22%) showed a partial reduction of eggs amount, and no reduction was noted in 3.6% of coinfected. The mean of haemoglobin concentration and the prevalence of anaemia were, respectively, 10.74±1.5g/dl , 11.2±1.3g/dl, and 64.8%, 51.8%, respectively, before and after treatment, p<0.001. The AS-AQ commonly used against Plasmodium allowed curing S. mansoni in coinfected children and increasing the Hb level. For the future, the randomized and multicentric clinical trials are needed for a better understanding of the effectiveness of AS-AQ against Schistosoma spp. The trial registration number was 3487183.

Keywords: paludisme, schistosomiase, as-aq, enfants lemfu

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Authors: Kazeem Adesina Dauda, Waheed Babatunde Yahya

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To design a tree that maximizes within-node homogeneity, there is a need for a homogeneity measure that is appropriate for event history data with multiple risks. We consider the use of Deviance and Modified Cox-Snell residuals as a measure of impurity in Classification Regression Tree (CART) and compare our results with the results of Fiona (2008) in which homogeneity measures were based on Martingale Residual. Data structure approach was used to validate the performance of our proposed techniques via simulation and real life data. The results of univariate competing risk revealed that: using Deviance and Cox-Snell residuals as a response in within node homogeneity classification tree perform better than using other residuals irrespective of performance techniques. Bone marrow transplant data and double-blinded randomized clinical trial, conducted in other to compare two treatments for patients with prostate cancer were used to demonstrate the efficiency of our proposed method vis-à-vis the existing ones. Results from empirical studies of the bone marrow transplant data showed that the proposed model with Cox-Snell residual (Deviance=16.6498) performs better than both the Martingale residual (deviance=160.3592) and Deviance residual (Deviance=556.8822) in both event of interest and competing risks. Additionally, results from prostate cancer also reveal the performance of proposed model over the existing one in both causes, interestingly, Cox-Snell residual (MSE=0.01783563) outfit both the Martingale residual (MSE=0.1853148) and Deviance residual (MSE=0.8043366). Moreover, these results validate those obtained from the Monte-Carlo studies.

Keywords: within-node homogeneity, Martingale residual, modified Cox-Snell residual, classification and regression tree

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Authors: Vahid Mazloum, Mansour Sahebozamani, Amirhossein Barati, Nouzar Nakhaee, Pouya Rabiei

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Non-specific chronic low back pain (NSCLBP) is a common condition with no exact diagnosis and mechanism for its occurrence. Recently, different therapeutic exercises have taken into account to manage NSCLBP. So, the aim of this study has mainly been placed on comparing the effects of Pilates and Mackenzie exercises on quality of life (QOL) lumbar spine position sense (LSPS) in patients with NSCLBP. In this randomized clinical trial, 47 patients with NSCLBP were voluntarily divided into three groups of Pilates (n=16) (with mean age 37.1 ± 9.5 years, height 168.9 ± 7.4 cm, body mass 76.1 ± 5.9 k), McKenzie (n=15) (with mean age 42.7 ± 8.1 years, height 165.7 ± 6.8, body mass 74.1 ± 4.8 kg) and control (n=16) (with mean age 39.3 ± 9.8 years, height 168.1 ± 8.1 cm, body mass 74.2 ± 5.8 kg). Primary outcome included QOL and secondary was LSPS. Both variables were assessed by the WHOQOL-BREF questionnaires and electrogoniameter, respectively. The measurements were performed at baseline, following a 6-week intervention, and after a 4-week follow-up. The ANCOVA test at P < 0.05 was administrated to analyze the collected data using SPSS software. There was a statistically significant difference between experimental groups and the control group to improve QOL. But, no difference was seen regarding the effects of two exercises on LSPS (p < 0.05). Both Pilates and Mackenzie exercises demonstrated improvement in QOL after 6-week intervention and a 4-week follow-up while none of them considerably affected LSPS. Further studies are required to establish a supporting evidence for the effectiveness of two exercises on NSCLBP.

Keywords: pilates, Mackenzie, preconception, low back pain, physical health

Procedia PDF Downloads 190

Authors: Firjeeth C. Paramba, Vamanjore A. Naushad, Nishan K. Purayil, Osama H. Mohammed, Prem Chandra

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Background: Fever is a common problem in adults visiting the emergency department. Extensive studies have been done in children comparing the efficacy of various antipyretics. However, studies on the efficacy of antipyretic drugs in adults are very scarce. To the best of our knowledge, no controlled trial has been carried out comparing the antipyretic efficacy of paracetamol (oral and intravenous) and intramuscular diclofenac in adults. Methods: In this parallel-group, open-label trial, participants aged 14–75 years presenting with fever who had a temperature of more than 38.5°C were enrolled and treated. Participants were randomly allocated to receive treatment with 1,000 mg oral paracetamol (n=145), 1,000 mg intravenous paracetamol (n=139), or 75 mg intramuscular diclofenac (n=150). The primary outcome was degree of reduction in mean oral temperature at 90 minutes. The efficacy of diclofenac versus oral and intravenous paracetamol was assessed by superiority comparison. Analysis was done using intention to treat principles. Results: After 90 minutes, all three groups showed a significant reduction in mean temperature, with intramuscular diclofenac showing the greatest reduction (−1.44 ± 0.43, 95% confidence interval [CI] −1.4 to −2.5) and oral paracetamol the least (−1.08 ± 0.51, 95% CI −0.99 to −2.2). After 120 minutes, there was a significant difference observed in the mean change from baseline temperature between the three treatment groups (P, 0.0001). Significant changes in temperature were observed in favor of intramuscular diclofenac over oral and intravenous paracetamol at each time point from 60 minutes through 120 minutes inclusive. Conclusion: Both intramuscular diclofenac and intravenous paracetamol showed superior antipyretic activity than oral paracetamol. However, in view of its ease of administration, intramuscular diclofenac can be used as a first-choice antipyretic in febrile adults in the emergency department.

Keywords: antipyretic, intramuscular, intravenous, paracetamol, diclofenac, emergency department

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Authors: Nerella Srinivas

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This study explores the significance of patent protection for artificial intelligence (AI) innovations in the pharmaceutical sector, emphasizing applications in drug discovery, personalized medicine, and clinical trial optimization. The challenges of patenting AI-driven inventions are outlined, focusing on the classification of algorithms as abstract ideas, meeting the non-obviousness standard, and issues around defining inventorship. The methodology includes examining case studies and existing patents, with an emphasis on how companies like Benevolent AI and Insilico Medicine have successfully secured patent rights. Findings demonstrate that a strategic approach to patent protection is essential, with particular attention to showcasing AI’s technical contributions to pharmaceutical advancements. Conclusively, the study underscores the critical role of understanding patent law and innovation strategies in leveraging intellectual property rights in the rapidly advancing field of AI-driven pharmaceuticals.

Keywords: artificial intelligence, pharmaceutical industry, patent protection, drug discovery, personalized medicine, clinical trials, intellectual property, non-obviousness

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Authors: Yuxi Wang, Xuan Gao

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Traditional Chinese medicine has been used in the treatment of coronary heart disease (CHD) for centuries, and in recent years, the research data on the efficacy of traditional Chinese medicine through clinical trials has gradually increased to explore its real efficacy and internal pharmacology. However, due to the complexity of traditional Chinese medicine prescriptions, the efficacy of each component is difficult to clarify, and pharmacological research is challenging. This study aims to systematically review and clarify the clinical efficacy of traditional Chinese medicine in the treatment of coronary heart disease through a meta-analysis. Based on PubMed, CNKI database, Wanfang data, and other databases, eleven randomized controlled trials and 1091 CHD subjects were included. Two researchers conducted a systematic review of the papers and conducted a meta-analysis supporting the positive therapeutic effect of traditional Chinese medicine in the treatment of CHD.

Keywords: coronary heart disease, Chinese medicine, treatment, meta-analysis

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Authors: Alok Madan, Arshad K. Hashmi

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Performance based design (PBD) is an iterative exercise in which a preliminary trial design of the building structure is selected and if the selected trial design of the building structure does not conform to the desired performance objective, the trial design is revised. In this context, development of a fundamental approach for performance based seismic design of masonry infilled frames with minimum number of trials is an important objective. The paper presents a plastic design procedure based on the energy balance concept for PBD of multi-story multi-bay masonry infilled reinforced concrete (R/C) frames subjected to near-field earthquakes. The proposed energy based plastic design procedure was implemented for trial performance based seismic design of representative masonry infilled reinforced concrete frames with various practically relevant distributions of masonry infill panels over the frame elevation. Non-linear dynamic analyses of the trial PBD of masonry infilled R/C frames was performed under the action of near-field earthquake ground motions. The results of non-linear dynamic analyses demonstrate that the proposed energy method is effective for performance based design of masonry infilled R/C frames under near-field as well as far-field earthquakes.

Keywords: masonry infilled frame, energy methods, near-fault ground motions, pushover analysis, nonlinear dynamic analysis, seismic demand

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Authors: Ben Hadj Hassen Sameh, Gaillard Corentin, Andrew Parker, Kristine Krug

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Perceptual decisions about sequences of sensory stimuli often show serial dependence. The behavioural choice on one trial is often affected by the choice on previous trials. We investigated whether the neuronal signals in extrastriate visual area V5/MT on preceding trials might influence choice on the current trial and thereby reveal the neuronal mechanisms of sequential choice effects. We analysed data from 30 single neurons recorded from V5/MT in three Rhesus monkeys making sequential choices about the direction of rotation of a three-dimensional cylinder. We focused exclusively on the responses of neurons that showed significant choice-related firing (mean choice probability =0.73) while the monkey viewed perceptually ambiguous stimuli. Application of a wavelet transform to the choice-related firing revealed differences in the frequency band of neuronal activity that depended on whether the previous trial resulted in a correct choice for an unambiguous stimulus that was in the neuron’s preferred direction (low alpha and high beta and gamma) or non-preferred direction (high alpha and low beta and gamma). To probe this in further detail, we applied a regularized linear decoder to predict the choice for an ambiguous trial by referencing the neuronal activity of the preceding unambiguous trial. Neuronal activity on a previous trial provided a significant prediction of the current choice (61% correc, 95%Cl~52%t), even when limiting analysis to preceding trials that were correct and rewarded. These findings provide a potential neuronal signature of sequential choice effects in the primate visual cortex.

Keywords: perception, decision making, attention, decoding, visual system

Procedia PDF Downloads 139