Search results for: incomplete longitudinal clinical trials

Authors: Juntip Kanjanasilp, Ratree Sawangjit, Kanokporn Meelap, Kwanchanok Kruthakool

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Depression is a common mental health disorder. Antidepressants are effective pharmacological treatments, but most patients have low medication adherence. This study aims to systematic review and meta-analysis what method increase the antidepressants adherence efficiently and improve clinical outcome. Systematic review of articles of randomized controlled trials obtained by a computerized literature search of The Cochrane, Library, Pubmed, Embase, PsycINFO, CINAHL, Education search, Web of Science and ThaiLIS (28 December 2017). Twenty-three studies were included and assessed the quality of research by ROB 2.0. The results reported that printing media improved in number of people who had medication adherence statistical significantly (p= 0.018), but education, phone call, and program utilization were no different (p=0.172, p=0.127, p=0.659). There was no significant difference in pharmacist’s group, health care team’s group and physician’s group (p=0.329, p=0.070, p=0.040). Times of intervention at 1 month and 6 months improved medication adherence significantly (p= 0.0001, p=0.013). There was significantly improved adherence in single intervention (p=0.027) but no different in multiple interventions (p=0.154). When we analyzed medication adherence with the mean score, no improved adherence was found, not relevant with who gives the intervention and times to intervention. However, the multiple interventions group was statistically significant improved medication adherence (p=0.040). Phone call and the physician’s group were statistically significant improved clinical outcomes in number of improved patients (0.025 and 0.020, respectively). But in the pharmacist’s group and physician’s group were not found difference in the mean score of clinical outcomes (p=0.993, p=0.120, respectively). Times to intervention and number of intervention were not significant difference than usual care. The overall intervention can increase antidepressant adherence, especially the printing media, and the appropriate timing of the intervention is at least 6 months. For effective treatment, the provider should have experience and expert in caring for patients with depressive disorders, such as a psychiatrist. Medical personnel should have knowledge in caring for these patients also.

Keywords: depression, medication adherence, clinical outcomes, systematic review, meta-analysis

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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

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Authors: Giulia Colonna, Jocelyn Hoye, Bart de Laat, Gelsina Stanley, Jose Key, Alaaddin Ibrahimy, Sule Tinaz, Evan D. Morris

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Parkinson’s disease (PD) is the second most common neurodegenerative disease and affects approximately 1% of the world’s population. Increasing evidence suggests that aerobic physical exercise can be beneficial in mitigating both motor and non-motor symptoms of the disease. In a recent pilot study of the role of exercise on PD, we sought to confirm exercise intensity by monitoring heart rate (HR). For this purpose, we asked participants to wear a chest strap heart rate monitor (Polar Electro Oy, Kempele). The device sometimes proved uncomfortable. Looking forward to larger clinical trials, it would be convenient to employ a more comfortable and user friendly device. The Fitbit Charge 4 (Fitbit Inc) is a potentially comfortable, user-friendly solution since it is a wrist-worn heart rate monitor. Polar H10 has been used in large trials, and for our purposes, we treated it as the gold standard for the beat-to-beat period (R-R interval) assessment. In previous literature, it has been shown that Fitbit Charge 4 has comparable accuracy to Polar H10 in healthy subjects. It has yet to be determined if the Fitbit is as accurate as the Polar H10 in subjects with PD or in clinical populations, generally. Goal: To compare the Fitbit Charge 4 to the Polar H10 for monitoring HR in PD subjects engaging in an intensive exercise program. Methods: A total of 596 exercise sessions from 11 subjects (6 males) were collected simultaneously by both devices. Subjects with early-stage PD (Hoehn & Yahr <=2) were enrolled in a 6 months exercise training program designed for PD patients. Subjects participated in 3 one-hour exercise sessions per week. They wore both Fitbit and Polar H10 during each session. Sessions included rest, warm-up, intensive exercise, and cool-down periods. We calculated the bias in the HR via Fitbit under rest (5min) and intensive exercise (20min) by comparing the mean HR during each of the periods to the respective means measured by the Polar (HRFitbit – HRPolar). We also measured the sensitivity and specificity of Fitbit for detecting HRs that exceed the threshold for intensive exercise, defined as 70% of an individual’s theoretical maximum HR. Different types of correlation between the two devices were investigated. Results: The mean bias was 1.68 bpm at rest and 6.29 bpm during high intensity exercise, with an overestimation by Fitbit in both conditions. The mean bias of Fitbit across both rest and intensive exercise periods was 3.98 bpm. The sensitivity of the device in identifying high intensity exercise sessions was 97.14 %. The correlation between the two devices was non-linear, suggesting a saturation tendency of Fitbit to saturate at high values of HR. Conclusion: The performance of Fitbit Charge 4 is comparable to Polar H10 for assessing exercise intensity in a cohort of PD subjects. The device should be considered a reasonable replacement for the more cumbersome chest strap technology in future similar studies of clinical populations.

Keywords: fitbit, heart rate measurements, parkinson’s disease, wrist-wearable devices

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Authors: Osk Dagsdottir

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Background—Gait classifying allows clinicians to differentiate gait patterns into clinically important categories that help in clinical decision making. Reliable comparison of gait data between normal and patients requires knowledge of the gait parameters of normal children's specific age group. However, there is still a lack of the gait database for normal children of different ages. Objectives—This study aims to investigate the kinematics of the lower limb joints during gait for normal children in different age groups. Methods—Fifty-three normal children (34 boys, 19 girls) were recruited in this study. All the children were aged between 5 to 16 years old. Age groups were defined as three types: young child aged (5-7), child (8-11), and adolescent (12-16). When a participant agreed to take part in the project, their parents signed a consent form. Vicon® motion capture system was used to collect gait data. Participants were asked to walk at their comfortable speed along a 10-meter walkway. Each participant walked up to 20 trials. Three good trials were analyzed using the Vicon Plug-in-Gait model to obtain parameters of the gait, e.g., walking speed, cadence, stride length, and joint parameters, e.g., joint angle, force, moments, etc. Moreover, each gait cycle was divided into 8 phases. The range of motion (ROM) angle of pelvis, hip, knee, and ankle joints in three planes of both limbs were calculated using an in-house program. Results—The temporal-spatial variables of three age groups of normal children were compared between each other; it was found that there was a significant difference (p < 0.05) between the groups. The step length and walking speed were gradually increasing from young child to adolescent, while cadence was gradually decreasing from young child to adolescent group. The mean and standard deviation (SD) of the step length of young child, child and adolescent groups were 0.502 ± 0.067 m, 0.566 ± 0.061 m and 0.672 ± 0.053 m, respectively. The mean and SD of the cadence of the young child, child and adolescent groups were 140.11±15.79 step/min, 129±11.84 step/min, and a 115.96±6.47 step/min, respectively. Moreover, it was observed that there were significant differences in kinematic parameters, either whole gait cycle or each phase. For example, RoM of knee angle in the sagittal plane in the whole cycle of young child group is (65.03±0.52 deg) larger than child group (63.47±0.47 deg). Conclusion—Our result showed that there are significant differences between each age group in the gait phases and thus children walking performance changes with ages. Therefore, it is important for the clinician to consider the age group when analyzing the patients with lower limb disorders before any clinical treatment.

Keywords: action research, creative learning, mathematics education, professional development

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Authors: Teklay Gebrecherkos

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Background: Serological testing for SARS-CoV-2 plays an important role in epidemiological studies, in aiding the diagnosis of COVID-19 and assess vaccine responses. Little is known about the dynamics of SARS-CoV-2 serology in African settings. Here, we aimed to characterize the longitudinal antibody response profile to SARS-CoV-2 in Ethiopia. Methods: In this prospective study, a total of 102 PCR-confirmed COVID-19 patients were enrolled. We obtained 802 plasma samples collected serially. SARS-CoV-2 antibodies were determined using four lateral flow immune assays (LFIAs) and an electrochemiluminescent immunoassay. We determined longitudinal antibody response to SARS-CoV-2 as well as seroconversion dynamics. Results: Serological positivity rate ranged between 12%-91%, depending on timing after symptom onset. There was no difference in the positivity rate between severe and non-severe COVID-19 cases. The specificity ranged between 90%-97%. Agreement between different assays ranged between 84%-92%. The estimated positive predictive value (PPV) for IgM or IgG in a scenario with seroprevalence at 5% varies from 33% to 58%. Nonetheless, when the population seroprevalence increases to 25% and 50%, there is a corresponding increase in the estimated PPVs. The estimated negative-predictive value (NPV) in a low seroprevalence scenario (5%) is high (>99%). However, the estimated NPV in a high seroprevalence scenario (50%) for IgM or IgG is reduced significantly from 80% to 85%. Overall, 28/102 (27.5%) seroconverted by one or more assays tested within a median time of 11 (IQR: 9–15) days post symptom onset. The median seroconversion time among symptomatic cases tended to be shorter when compared to asymptomatic patients [9 (IQR: 6–11) vs. 15 (IQR: 13–21) days; p = 0.002]. Overall, seroconversion reached 100% 5.5 weeks after the onset of symptoms. Notably, of the remaining 74 COVID-19 patients included in the cohort, 64 (62.8%) were positive for antibodies at the time of enrollment, and 10 (9.8%) patients failed to mount a detectable antibody response by any of the assays tested during follow-up. Conclusions: Longitudinal assessment of antibody response in African COVID-19 patients revealed heterogeneous responses. This underscores the need for a comprehensive evaluation of serum assays before implementation. Factors associated with failure to seroconvert need further research.

Keywords: COVID-19, antibody, rapid diagnostic tests, ethiopia

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Authors: Carlos M. Parra, Matthew Sutherland, Ranjita Poudel

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Reduced mental-bandwidth related to low socioeconomic status (low-SES) might lead to impulsivity and risk-taking behavior, which poses as a major hurdle towards asset building (savings) behavior. Understanding the relationship between risk-related personality metrics as well as laboratory risk behavior and real-life savings behavior can help facilitate the development of effective asset building programs, which are vital for mitigating financial vulnerability and income inequality. As such, this study explored the relationship between personality metrics, laboratory behavior in a risky decision-making task and real-life asset building (savings) behaviors among individuals with low-SES from Miami, Florida (FL). Study participants (12 male, 15 female) included racially and ethnically diverse adults (mean age 41.22 ± 12.65 years), with incomplete higher education (18% had High School Diploma, 30% Associates, and 52% Some College), and low annual income (mean $13,872 ± $8020.43). Participants completed eight self-report surveys and played a widely used risky decision-making paradigm called the Balloon Analogue Risk Task (BART). Specifically, participants played three runs of BART (20 trials in each run; total 60 trials). In addition, asset building behavior data was collected for 24 participants who opened and used savings accounts and completed a 6-month savings program that involved monthly matches, and a final reward for completing the savings program without any interim withdrawals. Each participant’s total savings at the end of this program was the main asset building indicator considered. In addition, a new effective use of average pump bet (EUAPB) indicator was developed to characterize each participant’s ability to place winning bets. This indicator takes the ratio of each participant’s total BART earnings to average pump bet (APB) in all 60 trials. Our findings indicated that EUAPB explained more than a third of the variation in total savings among participants. Moreover, participants who managed to obtain BART earnings of at least 30 cents out of their APB, also tended to exhibit better asset building (savings) behavior. In particular, using this criterion to separate participants into high and low EUAPB groups, the nine participants with high EUAPB (mean BART earnings of 35.64 cents per APB) ended up with higher mean total savings ($255.11), while the 15 participants with low EUAPB (mean BART earnings of 22.50 cents per APB) obtained lower mean total savings ($40.01). All mean differences are statistically significant (2-tailed p  .0001) indicating that the relation between higher EUAPB and higher total savings is robust. Overall, these findings can help refine asset building interventions implemented by policy makers and practitioners interested in reducing financial vulnerability among low-SES population. Specifically, by helping identify individuals who are likely to readily take advantage of savings opportunities (such as matched savings programs) and avoiding the stipulation of unnecessary and expensive financial coaching programs to these individuals. This study was funded by J.P. Morgan Chase (JPMC) and carried out by scientists from Florida International University (FIU) in partnership with Catalyst Miami.

Keywords: balloon analogue risk task (BART), matched savings programs, asset building capability, low-SES participants

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Authors: Maria Monica D. Espinosa

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This study aimed to identify and examine the characteristics of an effective leader in a Hospital institution from the perspectives of military nurse-managers. The researcher extracted the different facets of leadership from the stories of six nurse- managers from a military hospital. The stories which are in pre-reflective stage convey an unbiased perspective from which clinical leadership may be defined. Using Phenomenology as a method of Research, the lived experiences of the military nurse-managers served as empirical data which were reflected upon until the formulation of insights. The information from the co-researchers became gallows from which the characteristics of effective leadership in the clinical area were drawn. These insights were synthesized through layers of reflection that resulted to the knowledge about clinical leadership. The reflections are the following, (a) Clinical leaders develop their skills through experiences and hardwork; (b) Clinical leaders are devoted; (c) Clinical leaders are focused; (d) Clinical leaders are good in interpersonal relationship; (e) Clinical leaders are mentors; (f) Clinical leaders seek affirmation and recognition; and (g) Clinical leaders are responsible and dependable. The common themes that emerged from the nurse manager’s stories showed that clinical leadership maybe attained if leaders possessed the following traits, (a) The gift to establish a steadfast and firm management; (b) The proficiency to guide and encourage others towards the achievement of their goals and objectives; (c) The ability to instigate participative and collaborative work among his/her subordinates and (d) The aptitude and skill to address the institutional concerns in their unit. In the future, Clinical leaders should continually adapt an evaluation program on how they can relate socially with their subordinates, the result of which can be used as a basis in developing strategies on relationship enhancement. Moreover, they should empower the nurses by allowing them to voice out their opinions and concerns regarding assignments, role expectations, and workload issues to improve and strengthen the relationships among nurses. Lastly, they can incorporate a collaborative strategy to promote professional socialization attitudes of nurse managers who work with staff nurses to improve the quality of their proficiencies and enhance a positive clinical environment.

Keywords: clinical leadership, experiences, implications, military nurse - managers, phenomenology

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Authors: Asadullah I. Qazi, Mansoor Ahsan, Zahir Ashraf, Uzair Ahmad

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System identification of an Unmanned Aerial Vehicle (UAV), to acquire its mathematical model, is a significant step in the process of aircraft flight automation. The need for reliable mathematical model is an established requirement for autopilot design, flight simulator development, aircraft performance appraisal, analysis of aircraft modifications, preflight testing of prototype aircraft and investigation of fatigue life and stress distribution etc.  This research is aimed at system identification of a fixed wing UAV by means of specifically designed flight experiment. The purposely designed flight maneuvers were performed on the UAV and aircraft states were recorded during these flights. Acquired data were preprocessed for noise filtering and bias removal followed by parameter estimation of longitudinal dynamics transfer functions using MATLAB system identification toolbox. Black box identification based transfer function models, in response to elevator and throttle inputs, were estimated using least square error   technique. The identification results show a high confidence level and goodness of fit between the estimated model and actual aircraft response.

Keywords: fixed wing UAV, system identification, black box modeling, longitudinal dynamics, least square error

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Authors: Saul A. Torres Z., Eduardo Liceaga C., Alfredo Arias M.

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We seek to develop a UAV for agricultural spraying at a maximum altitude of 5000 meters above sea level, with a payload of 100 liters of fumigant. For the developing the aerodynamic design of the aircraft is using computational tools such as the "Vortex Lattice Athena" software, "MATLAB", "ANSYS FLUENT", "XFoil" package among others. Also methods are being used structured programming, exhaustive analysis of optimization methods and search. The results have a very low margin of error, and the multi-objective problems can be helpful for future developments. Also we developed method for Stability Analysis (Lateral-Directional and Longitudinal).

Keywords: aerodynamics design, optimization, algorithm genetic, multi-objective problem, longitudinal stability, lateral-directional stability

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Authors: K. Ebrahimi, Sh. Shahid, M. Mohammadi Ghaleni, M. H. Omid

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The longitudinal dispersion coefficient is a crucial parameter for 1-D water quality analysis of riverine flows. So far, different types of empirical equations for estimation of the coefficient have been developed, based on various case studies. The main objective of this paper is to develop an empirical equation for estimation of the coefficient for a riverine flow. For this purpose, a set of tracer experiments was conducted, involving salt tracer, at three sections located in downstream of a lengthy canal. Tracer data were measured in three mixing lengths along the canal including; 45, 75 and 100m. According to the results, the obtained coefficients from new developed empirical equation gave an encouraging level of agreement with the theoretical values.

Keywords: coefficients, dispersion, river, tracer, water quality

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Authors: Ranjit Biswas

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The existing subject Algebra is incomplete to support mathematical computations being done by scientists of all areas: Mathematics, Physics, Statistics, Chemistry, Space Science, Cosmology etc. even starting from the era of great Einstein. A huge hidden gap in the subject ‘Algebra’ is unearthed. All the scientists today, including mathematicians, physicists, chemists, statisticians, cosmologists, space scientists, and economists, even starting from the great Einstein, are lucky that they got results without facing any contradictions or without facing computational errors. Most surprising is that the results of all scientists, including Nobel Prize winners, were proved by them by doing experiments too. But in this paper, it is rigorously justified that they all are lucky. An algebraist can define an infinite number of new algebraic structures. The objective of the work in this paper is not just for the sake of defining a distinct algebraic structure, but to recognize and identify a major gap of the subject ‘Algebra’ lying hidden so far in the existing vast literature of it. The objective of this work is to fix the unearthed gap. Consequently, a different algebraic structure called ‘Region’ has been introduced, and its properties are studied.

Keywords: region, ROR, RORR, region algebra

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Authors: Ayon Mukherjee

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

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

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Authors: Ramy Shaaban

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The purpose of this study was to examine the difference in clinical reasoning skills of students when using virtual audiology cases with and without collaborative assistance from major learning approaches important to clinical reasoning skills and computer-based learning models: Situated Learning Theory, Social Development Theory, Scaffolding, and Collaborative Learning. A quasi-experimental design was conducted at two United States universities to examine whether there is a significant difference in clinical reasoning skills between three treatment groups using IUP Audiosim software. Two computer-based audiology case simulations were developed, and participants were randomly placed into the three groups: no collaboration, virtual collaboration, and live collaboration. The clinical reasoning data were analyzed using One-Way ANOVA and Tukey posthoc analyses. The results show that there was a significant difference in clinical reasoning skills between the three treatment groups. The score obtained by the no collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups. Collaboration, whether virtual or in person, has a positive effect on students’ clinical reasoning. These results with audiology students indicate that combining collaboration models with scaffolding and embedding situated learning and social development theories into the design of future virtual patients has the potential to improve students’ clinical reasoning skills.

Keywords: clinical reasoning, virtual patients, collaborative learning, scaffolding

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Authors: Sheeraz Memon, Namunu C. Maddage, Margaret Lech, Nicholas Allen

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The effect of a clinical environment on the accuracy of the speaker verification was tested. The speaker verification tests were performed within homogeneous environments containing clinically depressed speakers only, and non-depresses speakers only, as well as within mixed environments containing different mixtures of both climatically depressed and non-depressed speakers. The speaker verification framework included the MFCCs features and the GMM modeling and classification method. The speaker verification experiments within homogeneous environments showed 5.1% increase of the EER within the clinically depressed environment when compared to the non-depressed environment. It indicated that the clinical depression increases the intra-speaker variability and makes the speaker verification task more challenging. Experiments with mixed environments indicated that the increase of the percentage of the depressed individuals within a mixed environment increases the speaker verification equal error rates.

Keywords: speaker verification, GMM, EM, clinical environment, clinical depression

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Authors: Vasoontara Yiengprugsawan, Sam-ang Seubsman

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As Thais live longer, caregivers will become even more important to social and healthcare systems. Commonly reported in many low and middle‐income countries in Asia, formal social welfare services to support caregivers are lacking and informal family support will be required for all levels of care. In 2005, 87,151 open‐university adults were recruited to the Thai Cohort Study, with the majority aged between 25 and 39 years, and residing nationwide. At the 4‐year follow up in 2009 (n=60569) and the 8‐year follow‐up in 2013 (n=42785), prospective cohort participants were asked if they provide care for chronically ill, disabled, or frail family members. Among Thai cohort members reporting between 2009 and 2013, approximately 56% were not caregivers in either year, 24.5% reported providing care in 2009 only, 8.6% in 2013 only, and 10.6% reported providing care at both time points. Caregivers in the cohort reported providing financial support, help with shopping, emotional support, and assist with daily activities. Kessler 6 psychological distress scale, measured in both 2009 and 2013, was used as the primary outcome of a relationship between caregiving status and mental health. Using multivariate logistic regression, our 4‐year longitudinal findings revealed that cohort members who reported providing care at both time points were 1.4 to 1.6 times more likely to report high psychological distress than non‐caregivers, after accounting for potential covariates. With increasing needs for informal care provided by family members, the future health and social welfare system will need to provide adequate support to caregivers (e.g., respite care, clinical support and information for the family, and awareness of mental health among caregivers).

Keywords: family caregivers, psychological distress, prospective cohort, longitudinal study, Thailand

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Authors: Pei-Ru Yang, Yu-Chen Lin, Jia-Min Wu

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Background: A 58-year-old man with a history of osteoporosis and diabetes presented with chronic pain in his left knee due to severe knee joint degeneration. The knee replacement surgery was recommended by the doctor. But the patient suffered from low pain tolerance and wondered if virtual reality could relieve acute postoperative wound pain. Methods: We used the PICO (patient, intervention, comparison, and outcome) approach to generate indexed keywords and searched systematic review articles from 2017 to 2021 on the Cochran Library, PubMed, and Clinical Key databases. Results: The initial literature results included 38 articles, including 12 Cochrane library articles and 26 PubMed articles. One article was selected for further analysis after removing duplicates and off-topic articles. The eight trials included in this article were published between 2013 and 2019 and recruited a total of 723 participants. The studies, conducted in India, Lebanon, Iran, South Korea, Spain, and China, included adults who underwent hemorrhoidectomy, dental surgery, craniotomy or spine surgery, episiotomy repair, and knee surgery, with a mean age (24.1 ± 4.1 to 73.3 ± 6.5). Virtual reality is an emerging non-drug postoperative analgesia method. The findings showed that pain control was reduced by a mean of 1.48 points (95% CI: -2.02 to -0.95, p-value < 0.0001) in minor surgery and 0.32 points in major surgery (95% CI: -0.53 to -0.11, p-value < 0.03), and the overall postoperative satisfaction has improved. Discussion: Postoperative pain is a common clinical problem in surgical patients. Research has confirmed that virtual reality can create an immersive interactive environment, communicate with patients, and effectively relieve postoperative pain. However, virtual reality requires the purchase of hardware and software and other related computer equipment, and its high cost is a disadvantage. We selected the best literature based on clinical questions to answer the patient's question and used share decision making (SDM) to help the patient make decisions based on the clinical situation after knee replacement surgery to improve the quality of patient-centered care.

Keywords: knee replacement surgery, postoperative pain, share decision making, virtual reality

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Authors: Luca Martignoni

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The increasing usage of clinical decision support systems in healthcare and the demand for software that enables doctors to take informed decisions is changing everyday clinical practice. However, as technology advances not only are the benefits of technology growing, but so are the potential risks. A growing danger is the doctors’ over-reliance on the proposed decision of the clinical decision support system, leading towards deskilling and rash decisions by doctors. In that regard, identifying doctors' requirements for software and developing approaches to prevent technological over-reliance is of utmost importance. In this paper, we report the results of a design science research study, focusing on the requirements and design principles of ultrasound software. We conducted a total of 15 interviews with experts about poten-tial ultrasound software functions. Subsequently, we developed meta-requirements and design principles to design future clinical decision support systems efficiently and as free from the occur-rence of technological over-reliance as possible.

Keywords: clinical decision support systems, technological over-reliance, design principles, design science research

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Authors: Dhananjoy Shaw, Seema Sharma (Kaushik)

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Anthropometry helps in associating the physical properties of an individual with their racial, cultural, and psychological attributes. Numerous research studies have included different skeletal diameters as a variable. However, most of the studies suggest their inclusion describing specific characteristics/traits of the body. However, there seems to be a scarcity of literature related to the effect of any kind of longitudinal physical training on human skeletal diameters. Hence, the present investigation was conducted to study the variability of covariance of selected skeletal diameters of females in a longitudinal physical training programme. The sample for the study was 78 college going students of the University of Delhi, classified equally in three groups, i.e. viz. (a) Progressive load of training or conditioning group coded as PLT; (b) Constant load of training or non-conditioning group coded as CLT; and (c) No-load or control or sedentary group coded as NL. Collectively, mean age of the sample was 19.54±1.79 years. The randomly selected samples were given maximum consideration to maintain their homogeneity. The variables included biacromial diameter, biiliocristal diameter, bitrochantaerion diameter, humeral bicondylar, femoral bicondylar, wrist diameter, ankle diameter, and foot breadth. Multi-group repeated measure design was adopted for the experimentation. Each group was measured four times after completion of each of the three meso-cycles of six-weeks duration. The measurements were taken following the standard landmarks and procedures. Mean, standard deviation, analysis of co-variance and its post-hoc analysis were computed to analyze the data statistically. The study concluded that both the progressive and constant load of physical training bring changes in the selected skeletal diameters of females. It also reflected the increase due to growth also along with training.

Keywords: longitudinal, physical training, skeletal diameters, step progression load

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Authors: Olayiwola Moruf Oyedunsi

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This paper discusses the Modified Variational Iteration Method (MVIM) for the solution of nonlinear Burgers’ equation arising in longitudinal dispersion phenomena in fluid flow through porous media. The method is an elegant combination of Taylor’s series and the variational iteration method (VIM). Using Maple 18 for implementation, it is observed that the procedure provides rapidly convergent approximation with less computational efforts. The result shows that the concentration C(x,t) of the contaminated water decreases as distance x increases for the given time t.

Keywords: modified variational iteration method, Burger’s equation, porous media, partial differential equation

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Authors: Yu-Chieh Huang, Pei-Shih Chen, Tao-Hsin Tung

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Background: Urinary tract infection is the most common bacterial infection to our best knowledge. Objective: This study is to investigate whether cranberry ingesting could improve the urinary tract infection. Methods: We searched the PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 9 March 1994 and June 30, 2017, with a priori defined inclusion and exclusion criteria. The search terms included (cranberry OR Vaccinium macrocarpon OR Vaccinium oxy-coccus OR Vaccinium microcarpum OR Vaccinium erythrocarpum OR Vaccinium) AND (urinary tract infection OR bacteriuria OR pyuria) AND (effect OR effective-ness OR efficacy) AND (random OR randomized). Results: There were 26 studies met the selection criteria included among 4709 eligible participants. We analyzed all trials in meta-analysis. The random-effects pooled risk ratio (RR) for the group using cranberry versus using placebo was 0.75; 95%CI[0.63, 0.880]; p-value=0.0002) and heterogeneity was 56%. Furthermore, we divided the subjects into different subgroup to analysis. Ingesting cranberry seemed to be more effective in some subgroups, including the patients with recurrent UTI (RR, 0.71; 95%CI[0.54,0.93]; p-value=0.002) (I²= 65%) and female population (RR, 0.73, 95%CI[0.58,0.92]; p-value=0.002) (I²= 59%). The prevention effect was not different between cranberry and trimethoprim (RR, 1.25, 95%CI[0.67, 2.33]; p-value=0.49) (I²= 68%). No matter the forms of cranberry were capsules or juice, the efficacy was useful. Conclusions: It is showed that cranberry ingesting is usefully associated with prevention UTI. There are more effective in prevention of UTI in some groups.

Keywords: cranberry, effectiveness, prevention, urinary tract infect

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Authors: Natchaphon Auampradit, Patama Vapattanawong, Sureeporn Punpuing, Malee Sunpuwan, Tawanchai Jirapramukpitak

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Longitudinal studies related to cognitive impairment in elderly are necessary for health promotion and development. The purposes of this study were (1) to examine changes in cognition of elderly over time and (2) to examine the impacts of changes in social determinants of health (SDH) toward changes in cognition of elderly by using the secondary data derived from the Kanchanaburi Demographic Surveillance System (KDSS) by the Institute for Population and Social Research (IPSR) which contained longitudinal data on individuals, households, and villages. Two selected projects included the Health and Social Support for Elderly in KDSS in 2007 and the Population, Economic, Social, Cultural, and Long-term Care Surveillance for Thai Elderly People’s Health Promotion in 2011. The samples were 586 elderly participated in both projects. SDH included living arrangement, social relationships with children, relatives, and friends, household asset-based wealth index, household monthly income, loans for livings, loans for investment, and working status. Cognitive impairment was measured by category fluency and delayed recall. This study employed Generalized Estimating Equation (GEE) model to investigate changes in cognition by taking SDH and other variables such as age, gender, marital status, education, and depression into the model. The unstructured correlation structure was selected to use for analysis. The results revealed that 24 percent of elderly had cognitive impairment at baseline. About 13 percent of elderly still had cognitive impairment during 2007 until 2011. About 21 percent and 11 percent of elderly had cognitive decline and cognitive improvement, respectively. The cross-sectional analysis showed that household asset-based wealth index, social relationship with friends, working status, age, marital status, education, and depression were significantly associated with cognitive impairment. The GEE model revealed longitudinal effects of household asset-based wealth index and working status against cognition during 2007 until 2011. There was no longitudinal effect of social conditions against cognition. Elderly living with richer household asset-based wealth index, still being employed, and being younger were less likely to have cognitive impairment. The results strongly suggested that poorer household asset-based wealth index and being unemployed were served as a risk factor for cognitive impairment over time. Increasing age was still the major risk for cognitive impairment as well.

Keywords: changes in cognition, cognitive impairment, elderly, KDSS, longitudinal study

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Authors: Hammache Nadir

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The scientific study of human learning and memory is now more than 125 years old. Psychologists have conducted thousands of experiments, correlational analyses, and field studies during this time, in addition to other research conducted by those from neighboring fields. A huge knowledge base has been carefully built up over the decades. Given this backdrop, we may ask ourselves: What great changes in education have resulted from this huge research base? How has the scientific study of learning and memory changed practices in education from those of, say, a century ago? Have we succeeded in building a translational educational science to rival medical science (in which biological knowledge is translated into medical practice) or types of engineering (in which, e.g., basic knowledge in chemistry is translated into products through chemical engineering)? The answer, I am afraid, is rather mixed. Psychologists and psychological research have influenced educational practice, but in fits and starts. After all, some of the great founders of American psychology—William James, Edward L. Thorndike, John Dewey, and others—are also revered as important figures in the history of education. And some psychological research and ideas have made their way into education—for instance, computer-based cognitive tutors for some specific topics have been developed in recent years—and in years past, such practices as teaching machines, programmed learning, and, in higher education, the Keller Plan were all important. These older practices have not been sustained. Was that because they failed or because of a lack of systematic research showing they were effective? At any rate, in 2012, we cannot point to a well-developed translational educational science in which research about learning and memory, thinking and reasoning, and related topics is moved from the lab into controlled field trials (like clinical trials in medicine) and the tested techniques, if they succeed, are introduced into broad educational practice. We are just not there yet, and one question that arises is how we could achieve a translational educational science.

Keywords: affective, education, cognition, pshychology

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Authors: Taisuke Sakaki, Toshihiko Shimokawa, Nobuhiro Ushimi, Koji Murakami, Yong-Kwun Lee, Kazuhiro Tsuruta, Kanta Aoki, Kaoru Fujiie, Ryuji Katamoto, Atsushi Sugyo

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Recently attention has been focused on incomplete spinal cord injuries (SCI) to the central spine caused by pressure on parts of the white matter conduction pathway, such as the pyramidal tract. In this paper, we focus on a training robot designed to assist with primary walking-pattern training. The target patient for this training robot is relearning the basic functions of the usual walking pattern; it is meant especially for those with incomplete-type SCI to the central spine, who are capable of standing by themselves but not of performing walking motions. From the perspective of human engineering, we monitored the operator’s actions to the robot and investigated the movement of joints of the lower extremities, the circumference of the lower extremities, and exercise intensity with the machine. The concept of the device was to provide mild training without any sudden changes in heart rate or blood pressure, which will be particularly useful for the elderly and disabled. The mechanism of the robot is modified to be simple and lightweight with the expectation that it will be used at home.

Keywords: training, rehabilitation, SCI patient, welfare, robot

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Authors: Pedro Cabrales, Scott Caroen, Tony R. Reid, Bryan Oronsky

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Introduction and Purpose RRx-001 is an NLRP3 inhibitor and Nrf2 agonist in Phase 3 trials for the treatment of cancer. The purpose of this study was to examine whether treatment with RRx-001, given itsanti-inflammatory and antioxidant properties, improvedexercise and skeletal muscle oxidative capacity in mice on the generalpremiss that better health outcomes correlatewith more activity. Material and Methods Male and female adult mice (n=6 per group) were subjected to an endurance exercise capacity (EEC)test until exhaustion on a motorized treadmill after 3 once weekly doses of either RRx-001 5 mg/kg, RRx-001 2 mg/kg, or vehicle. The EEC protocol consisted of a treadmill velocity of 30meters per min at an uphill inclination (slope of 10%) until the mice reached fatigue, which was defined as the inability of the mice to maintain the appropriate pace despitecontinuous hand stimulation for 1 min. The concentration of malondialdehyde (MDA), an indicator of lipid peroxidation, and creatine kinase (CK), an indicator of muscle damage, in the blood samples collected immediately after the acute exercise was determined with a commercial ELISA assay kit. ResultsThe exhaustive exercise times of the RRx-001 groups were significantly longer than that of the vehicle group (p<0.05) by weeks 2 and 3. In addition, MDA levels in the gastrocnemius, soleus, and extensor digitorum longus muscles were significantly lower than those of the vehicle group were (p<0.05), as were the serum CK levels(p<0.05). ConclusionsIn conclusion, this study found that RRx-001 has anti-fatigue properties, as evidenced by an increase in exercise capacity with RRx-001 treatment, and protects against strenuous exercise-induced muscle damage and lipid peroxidation. This data potentially supports the use of RRx-001 in the clinic to improve exercise performance and reduce physical fatigue.

Keywords: RRx-001, anti-fatigue, muscle protection, increased exercise tolerance, lipid peroxidation

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Authors: Selena Ferrian, Erin Mccaffrey, Toshie Saito, Aiqin Cao, Noah Greenwald, Mark Robert Nicolls, Trevor Bruce, Roham T. Zamanian, Patricia Del Rosario, Marlene Rabinovitch, Michael Angelo

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Recent experimental and clinical observations are advancing immunotherapies to clinical trials in pulmonary arterial hypertension (PAH). However, comprehensive mapping of the immune landscape in pulmonary arteries (PAs) is necessary to understand how immune cell subsets interact to induce pulmonary vascular pathology. We used multiplexed ion beam imaging by time-of-flight (MIBI-TOF) to interrogate the immune landscape in PAs from idiopathic (IPAH) and hereditary (HPAH) PAH patients. Massive immune infiltration in I/HPAH was observed with intramural infiltration linked to PA occlusive changes. The spatial context of CD11c+DCs expressing SAMHD1, TIM-3 and IDO-1 within immune-enriched microenvironments and neutrophils were associated with greater immune activation in HPAH. Furthermore, CD11c-DC3s (mo-DC-like cells) within a smooth muscle cell (SMC) enriched microenvironment were linked to vessel score, proliferating SMCs, and inflamed endothelial cells. Experimental data in cultured cells reinforced a causal relationship between neutrophils and mo-DCs in mediating pulmonary arterial SMC proliferation. These findings merit consideration in developing effective immunotherapies for PAH.

Keywords: pulmonary arterial hypertension, vascular remodeling, indoleamine 2-3-dioxygenase 1 (IDO-1), neutrophils, monocyte-derived dendritic cells, BMPR2 mutation, interferon gamma (IFN-γ)

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Authors: Philip Friedlander, John Rutledge, Jason Suh

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Inhibition of programmed death-1 (PD-1) or its ligand PD-L1 confers therapeutic efficacy in a wide range of solid tumor malignancies. Primary or acquired resistance can develop through activation of immunosuppressive immune cells such as tumor-associated macrophages. The renin angiotensin system (RAS) systemically regulates fluid and sodium hemodynamics, but components are expressed on and regulate the activity of immune cells, particularly of myeloid lineage. We hypothesized that inhibition of RAS would improve the efficacy of PD-1/PD-L-1 treatment. A retrospective analysis was performed through a chart review of patients with solid metastatic malignancies treated with a PD-1/PD-L1 inhibitor between 1/2013 and 6/2019 at Valley Hospital, a community hospital in New Jersey, USA. Efficacy was determined by medical oncologist documentation of clinical benefit in visit notes and by the duration of time on immunotherapy treatment. The primary endpoint was the determination of efficacy differences in patients treated with an inhibitor of RAS ( ace inhibitor, ACEi, or angiotensin blocker, ARB) compared to patients not treated with these inhibitors. To control for broader antihypertensive effects, efficacy as a function of treatment with beta blockers was assessed. 173 patients treated with PD-1/PD-L-1 inhibitors were identified of whom 52 were also treated with an ACEi or ARB. Chi-square testing revealed a statistically significant relationship between being on an ACEi or ARB and efficacy to PD-1/PD-L-1 therapy (p=0.001). No statistically significant relationship was seen between patients taking or not taking beta blocker antihypertensives (p= 0.33). Kaplan-Meier analysis showed statistically significant improvement in the duration of therapy favoring patients concomitantly treated with ACEi or ARB compared to patients not exposed to antihypertensives and to those treated with beta blockers. Logistic regression analysis revealed that age, gender, and cancer type did not have significant effects on the odds of experiencing clinical benefit (p=0.74, p=0.75, and p=0.81, respectively). We conclude that retrospective analysis of the treatment of patients with solid metastatic tumors with anti-PD-1/PD-L1 in a community setting demonstrates greater clinical benefit in the context of concomitant ACEi or ARB inhibition, irrespective of gender or age. This data supports the development of prospective assessment through randomized clinical trials.

Keywords: angiotensin, cancer, immunotherapy, PD-1, efficacy

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Authors: Elena K. Schneider, Johnny X. Huang, Vincenzo Carbone, Mark Baker, Mohammad A. K. Azad, Matthew A. Cooper, Jian Li, Tony Velkov

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Ivacaftor is a novel CF trans-membrane conductance regulator (CFTR) potentiator that improves the pulmonary function for cystic fibrosis patients bearing a G551D CFTR-protein mutation. Because ivacaftor is highly bound (>97%) to plasma proteins, there is the strong possibility that co-administered CF drugs that compete for the same plasma protein binding sites and impact the free drug concentration. This in turn could lead to drastic changes in the in vivo efficacy of ivacaftor and therapeutic outcomes. This study compares the binding affinity of ivacaftor and co-administered CF drugs for human serum albumin (HSA) and α1-acid glycoprotein (AGP) using surface plasmon resonance and fluorimetric binding assays that measure the displacement of site selective probes. Due to their high plasma protein binding affinities, drug-drug interactions between ivacaftor are to be expected with ducosate, montelukast, ibuprofen, dicloxacillin, omeprazole and loratadine. The significance of these drug-drug interactions is interpreted in terms of the pharmacodynamic/pharmacokinetic parameters and molecular docking simulations. The translational outcomes of the data are presented as recommendations for a staggered treatment regimen for future clinical trials which aims to maximize the effective free drug concentration and clinical efficacy of ivacaftor.

Keywords: human α-1-acid glycoprotein, binding affinity, human serum albumin, ivacaftor, cystic fibrosis

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Authors: Philippe Dillien, Patrice Forget, Harald Engel, Olivier Cornu, Marc De Kock, Jean Cyr Yombi

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Introduction: Hip fracture precedes commonly death in elderly people. Identification of high-risk patients may contribute to target patients in whom optimal management, resource allocation and trials efficiency is needed. The aim of this study is to construct a predictive score of mortality after hip fracture on the basis of the objective prognostic factors available: Neutrophil-to-lymphocyte ratio (NLR), age, and sex. C-Reactive Protein (CRP), is also considered as an alternative to the NLR. Patients and methods: After the IRB approval, we analyzed our prospective database including 286 consecutive patients with hip fracture. A score was constructed combining age (1 point per decade above 74 years), sex (1 point for males), and NLR at postoperative day+5 (1 point if >5). A receiver-operating curve (ROC) curve analysis was performed. Results: From the 286 patients included, 235 were analyzed (72 males and 163 females, 30.6%/69.4%), with a median age of 84 (range: 65 to 102) years, mean NLR values of 6.47+/-6.07. At one year, 82/280 patients died (29.3%). Graphical analysis and log-rank test confirm a highly statistically significant difference (P<0.001). Performance analysis shows an AUC of 0.72 [95%CI 0.65-0.79]. CRP shows no advantage on NLR. Conclusion: We have developed a score based on age, sex and the NLR to predict the risk of mortality at one year in elderly patients after surgery for a hip fracture. After external validation, it may be included in clinical practice as in clinical research to stratify the risk of postoperative mortality.

Keywords: neutrophil-to-lymphocyte ratio, hip fracture, postoperative mortality, medical and health sciences

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Authors: Zakia Belhadj, Bing He, Hua Zhang, Xueqing Wang, Wenbing Dai, Qiang Zhang

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Mononuclear phagocyte system (MPS) forms an abominable obstacle hampering the tumor delivery efficiency of nanoparticles. Passively targeted nanocarriers have received clinical approval over the past 20 years. However, none of the actively targeted nanocarriers have entered clinical trials. Thus it is important to endue effective targeting ability to actively targeted approaches by overcoming biological barriers to nanoparticle drug delivery. Here, it presents that an Esomeprazole-based preconditioning strategy for regulating nanocarrier-MPS interaction to substantially prolong circulation time and enhance tumor targeting of nanoparticles. In vitro, the clinically approved proton pump inhibitor Esomeprazole “ESO” was demonstrated to reduce interactions between macrophages and subsequently injected targeted vesicles by interfering with their lysosomal trafficking. Of note, in vivo studies demonstrated that ESO pretreatment greatly decreased the liver and spleen uptake of c(RGDm7)-modified vesicles, highly enhanced their tumor accumulation, thereby provided superior therapeutic efficacy of c(RGDm7)-modified vesicles co-loaded with Doxorubicin (DOX) and Gefitinib (GE). This MPS-preconditioning strategy using ESO provides deeper insights into regulating nanoparticles interaction with the phagocytic system and enhancing their cancer cells' accessibility for anticancer therapy.

Keywords: esomeprazole (ESO), mononuclear phagocyte system (MPS), preconditioning strategy, targeted lipid vesicles

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Authors: Modi Alsubaie, Willem Kuyken, Rebecca Abbott, Barnaby Dunn, Chris Dickens, Tina Keil, William Henley

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Background: Recently, there has been an increased interest in studying the effects of mindfulness-based interventions for people with psychological and physical problems. However, the mechanisms of action in these interventions that lead to beneficial physical and psychological outcomes have yet to be clearly identified. Purpose: The aim of this paper is to review, systematically, the evidence to date on the mechanisms of action in mindfulness interventions in populations with physical and/or psychological conditions. Method: Searches of seven databases (PsycINFO, Medline (Ovid), Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, AMED, ClinicalTrials.gov) were undertaken in June 2014 and July 2015. We evaluated to what extent the studies we identified met the criteria suggested by Kazdin for establishing mechanisms of action within a psychological treatment (2007, 2009). Results: We identified four trials examining mechanisms of mindfulness interventions in those with comorbid psychological and physical health problems and 14 in those with psychological conditions. These studies examined a diverse range of potential mechanisms, including mindfulness and rumination. Of these candidate mechanisms, the most consistent finding was that greater self-reported change in mindfulness mediated superior clinical outcomes. However, very few studies fully met the Kazdin criteria for examining treatment mechanisms. Conclusion: There was evidence that global changes in mindfulness are linked to better outcomes. This evidence pertained more to interventions targeting psychological rather than physical health conditions. While there is promising evidence that MBCT/MBSR intervention effects are mediated by hypothesised mechanisms, there is a lack of methodological rigour in the field of testing mechanisms of action for both MBCT and MBSR, which precludes definitive conclusions.

Keywords: MBCT, MBSR, mechanisms, physical conditions, psychological conditions, systematic review

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