Miracle-dz/UniFAR-FTUs huggingface dataset:
Statistical considerations regarding correlated lots in analytical biosimilar equivalence test

ABSTRACT In the evaluation of the analytical similarity data, an equivalence testing approach for most critical and quantitative quality attributes, which are assigned to Tier 1 in their proposed three-tier approach, was proposed. The Food and Drug Administration (FDA) has recommended the proposed equivalence testing approach to sponsors through meeting comments for Pre-Investigational New Drug Applications (PINDs) and Investigational New Drug Applications (INDs) since 2014. The FDA has received some feedback on the statistical issues of potentially correlated reference lot values subjected to equivalence testing since independent and identical observations (lot values) from the proposed biosimilar product and the reference product are assumed. In this article, we describe one method for correcting the estimation bias of the reference variability so as to increase the equivalence margin and its modified versions for increasing the equivalence margin and correcting the standard errors in the confidence intervals, assuming that the lot values are correlated under a few known correlation matrices. Our comparisons between these correcting methods and no correction for bias in the reference variability under several assumed correlation structures indicate that all correcting methods would increase the type I error rate dramatically but only improve the power slightly for most of the simulated scenarios. For some particular simulated cases, the type I error rate can be extremely large (e.g., 59%) if the guessed correlation is larger than the assumed correlation. Since the source of a reference drug product lot is unknown in nature, correlation between lots is a design issue. Hence, to obtain independent reference lot values by purchasing the reference lots at a wide time window often is a design remedy for correlated reference lot values.
Probiotic E.faecalis — adjuvant therapy in children with recurrent rhinosinusitis

Sinusitis is a frequent complication of respiratory tract infections. Probiotics are perceived to be useful in infections, allergies, and inflammations. Our prospective trial stratified 204 children with recurrent rhinosinusitis by age (2–11 years, 54m:64f; 12–18 years, 39m:47f) and assigned them to standard treatment (antibiotics, anticongestants) or additional 60 days Symbioflor-1 (SF1; Enterococcus faecalis 1.5–4.5x107 CFU). The number of sinusitis episodes was lower in SF1-treated patients (2.52±0.91) than among controls (3.27±1.36; p=0.01). Mean duration of the first sinusitis episode was 11.9±8.6 days with SF1, whereas it was 16.1±12.9 days in the younger controls (p=0.023) and 9.86±5.05 days in the elder controls (n.s.). Duration of subsequent sinusitis episodes was also shorter in SF1 patients (15.2±13.6 days) compared with controls (22.7±14.8 days; p=0.030). No adverse events were observed. Probiotic Enterococcus faecalis adjuvant to conventional therapy can reduce the number and duration of rhinosinusitis episodes in children and adolescents.
Group‐Based Trajectory Models: Assessing Adherence to Antihypertensive Medication in Older Adults in a Community Pharmacy Setting

Antihypertensive medication nonadherence is highly prevalent, leading to uncontrolled blood pressure. Methods that facilitate the targeting and tailoring of adherence interventions in clinical settings are required. Group‐Based Trajectory Modeling (GBTM) is a newer method to evaluate adherence using pharmacy dispensing (refill) data that has advantages over traditional refill adherence metrics (e.g. Proportion of Days Covered) by identifying groups of patients who may benefit from adherence interventions, and identifying patterns of adherence behavior over time that may facilitate tailoring of an adherence intervention. We evaluated adherence to antihypertensive medication in 905 patients over a 12‐month period in a community pharmacy setting using GBTM, identifying three subgroups of adherence patterns: 52.8%, 40.7%, and 6.5% had very high, high, and low adherence, respectively. However, GBTM failed to demonstrate predictive validity with blood pressure at 12 months. Further research on the validity of adherence measures that facilitate interventions in clinical settings is required.
Psychological Distress Patterns of Women and Mothers Presenting for HIV-Related Mental Health Care

ABSTRACT Over a seven year period, data were collected from 228 women living with HIV upon their self-enrollment into mental health care at an HIV-related mental health clinic. Analyses were conducted to explore the symptoms of mental health distress being presented by women upon their enrollment into care and, in particular, associations between these symptoms and characteristics of motherhood. Findings suggest that women living with HIV present for care with significant levels of psychological distress symptoms and that factors related to parenthood are associated with diverse clinical presentations. As an increasingly prevalent component of the HIV social services system, women living with HIV are in need of access to services that are responsive to their unique mental health issues and that are based upon an understanding of the extent to which familial variables influence psychological distress.
Process Improvement for Maximized Therapeutic Innovation Outcome

Deconvoluting key biological mechanisms forms the framework for therapeutic discovery. Strategies that enable effective translation of those insights along the development and regulatory path ultimately drive validated clinical application in patients and populations. Accordingly, parity in What vs. How we transform novel mechanistic insights into therapeutic paradigms is essential in achieving success. Aligning molecular discovery with innovations in structures and processes along the discovery–development–regulation–utilization continuum maximizes the return on public and private investments for next‐generation solutions in managing health and disease.
Predictors of Sleep Quality in Community-Dwelling Older Adults in Northern Taiwan

Background: Poor sleep quality may have a significant and negative impact on physical and mental health. Poor sleep quality also increases the risk of all-cause mortality. Few studies have explored the sleep quality of community-dwelling older adults in Taiwan. Purpose: This study examined the prevalence of sleep disturbance and potential factors of influence in community-dwelling older people in Taiwan. Methods: We used a cross-sectional design to recruit a total of 160 individuals 60 years of age or older from an urban area in northern Taiwan. All subjects completed a structured questionnaire that included demographic data, physical health status, a social activity/habit survey, as well as the Chinese versions of Barthel’s index, Pittsburgh Sleep Quality Index, short form of the Geriatric Depression Scale, the SF-36 Health-Related Quality of Life Survey, and the Physical Activity Scale for the Elderly. Results: Participants reported a rate of sleep disturbance of 41.9%. Sleep disturbance was associated with nocturia and dizziness, hypertension, increased use of medications such as antihypertensives and gastric medicines, poor self-reported functional status, depression, and sedentary lifestyle. Logistic regression showed nocturia, sedentary lifestyle, and mental component summary score as significant predictors of sleep disturbance. Conclusions/Implications for Practice: Sleep disturbance should be examined within the context of an individual’s physical, mental, and social status. Symptom management education and an active lifestyle are necessary to promote sleep quality in older people.
3D Differentiation of LUHMES Cell Line to Study Recovery and Delayed Neurotoxic Effects

Current neurotoxicity testing and the study of molecular mechanisms in neurodegeneration in vitro usually focuses on acute exposures to compounds. 3D Lund human mesencephalic (LUHMES) cells allow long‐term treatment or pulse exposure in combination with compound washout to study delayed neurotoxic effects as well as recovery and neurodegeneration pathways. In this unit we describe 3D LUHMES culture and characterization. Characterization of the model involves immunocytochemistry, flow cytometry, and qPCR measurements. Studying the delayed effects of compounds is more relevant to human exposures and neurodegenerative diseases with a strong genetic or environmental component. Most assays for molecular endpoints have been developed for monolayer cell culture and therefore need to be adapted for 3D models. In this unit, we further describe toxicological assays for molecular endpoints such as ATP levels, mitochondrial viability, and neurite outgrowth, which have been adapted for use in 3D LUHMES cultures. © 2017 by John Wiley & Sons, Inc.
Alcohol Use Reduction Program in Methadone Maintained Individuals with Hepatitis C Virus Infection

ABSTRACT The purpose of this article was to investigate the personal and social barriers experienced by methadone maintained clients when seeking treatment for alcohol abuse along with strategies for engaging such clients in treatment programs. A qualitative design using semi-structured focus groups was used to obtain the perspectives of 41 methadone-maintained clients in Los Angeles, California. Sessions were recorded, transcribed, and content-analyzed. Attitudes of health care providers were considered critical factors for engaging clients in treatment programs. Other facilitators included incentives and forms of support (emotional, financial, or material aid), whereas barriers consisted of lack of provider knowledge and insensitivity to acquiring needed resources. Clients also discussed the importance of personal attributes in achieving successful behavioral change, such as personal motivation. The findings suggest that healthcare providers' strategies designed to boost motivation, combined with various types of support, may prove successful in alcohol reduction among methadone-maintained clients.
CuI versus RuII: dye-sensitized solar cells and beyond.

Ru(II) complexes have long played the central role in photochemical conversion of sunlight leading to dye-sensitised solar cells with high power conversion efficiencies. Cu(I) complexes have been recognised as possessing comparable photophysical and electrochemical properties offering similar function with a cheaper and more abundant metal. DSSCs with significant power conversion efficiency using a Cu(I)-polypyridyl sensitiser have recently emerged and future strategies for further improving performance of these is discussed.
Exploring the Focus and Experiences of Smartphone Applications for Addiction Recovery

Addiction recovery Smartphone applications (apps) (n = 87) identified on the Google Play store in 2012 were coded, along with app user reviews, to explore functions, foci, and user experiences. Content analysis revealed that apps typically provided information on recovery, as well as content to enhance motivation, promote social support and tools to monitor progress. App users commented that the apps helped to inform them, keep them focussed, inspire them, and connect them with other people and groups. Because few addiction recovery apps appear to have been formally evaluated, further research is needed to ascertain their effectiveness as stand-alone or adjunctive interventions.
Spectral discrimination of serum from liver cancer and liver cirrhosis using Raman spectroscopy

In this paper, Raman spectra of human serum were measured using Raman spectroscopy, then the spectra was analyzed by multivariate statistical methods of principal component analysis (PCA). Then linear discriminant analysis (LDA) was utilized to differentiate the loading score of different diseases as the diagnosing algorithm. Artificial neural network (ANN) was used for cross-validation. The diagnosis sensitivity and specificity by PCA-LDA are 88% and 79%, while that of the PCA-ANN are 89% and 95%. It can be seen that modern analyzing method is a useful tool for the analysis of serum spectra for diagnosing diseases.
A Comparison of Random and Post-Accident Urine Opiate and Opioid Tests

Opioid use is associated with poor reaction time, attention, balance and memory posing a potential threat to workplace safety. The purpose of this study is to determine if there is a statistical association between opiate/opioid use and work related accidents as measured by urine drug tests by comparing the proportion of opiate/opioid laboratory positive urine specimens for postaccident verses random samples. The prevalence of laboratory positive opiate/opioid tests, the odds ratio, Fisher's exact probability test and the population attributable risk were calculated for each comparison. This study found a statistically significant difference for opiate/opioid results favoring the post-accident group.
Triaging Patients for Allied Health Services: A Systematic Review of the Literature

Occupational therapists and other allied health clinicians often need to make decisions about the relative urgency of referrals, which patients should be seen first and, in some cases, whether patients require services at all. A systematic review of the literature was conducted to investigate the properties and outcomes of triage systems applied to patients referred to allied health services. Literature was searched through the CINAHL, EMBASE and MEDLINE databases (until March 2008), combining the key elements of ‘allied health’ and ‘triage’. Seven articles were identified that met the inclusion and exclusion criteria, and these were assessed against quality criteria and a process of descriptive synthesis applied for the purpose of analysis and comparison. The findings indicate that there has been little investigation of the outcomes of allied health triage systems. Studies that have assessed triage systems have focused largely on measurement properties and the majority of these have indicated poor to fair reliability. A first step in introducing allied health triage systems is to establish reliability, involving the patient directly in the assessment process. There is not yet sufficient evidence to recommend any particular triage system for application to allied health services.
Raltegravir Potassium

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to your Pharmacy & Therapeutics Committee. Subscribers also receive monthly 1-page summary monographs on the agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and are also available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I. X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I. X. , call The Formulary at 800-322-4349. The February 2008 monograph topics are nilotinib, sapropterin dihydrochloride, asenapine, bendamustine hydrochloride, and lacosamide. The DUE is on oral therapy for pulmonary hypertension.
Further Trends in Work-Related Musculoskeletal Disorders: A Comparison of Risk Factors for Symptoms Using Quality of Work Life Data From the 2002, 2006, and 2010 General Social Survey

Objective: To report trends for the risk of musculoskeletal disorders. Methods: Three Quality of Work Life surveys examine the risk factors for musculoskeletal disorders. Results: Findings similar for several risk factors, but differences across the reporting years may reflect economic conditions. Respondent numbers in 2010 were reduced, some risk factors had pattern changes, and there were sex and age differences. Trend analysis showed most significant changes were for the “work fast” risk factor. New 2010 “physical effort” item showed sex differences, and items reflective of total worker health showed strong associations with “back pain” and “pain in arms. ” Conclusions: Intervention strategies should focus on physical exposures and psychosocial risk factors (work stress, safety climate, job satisfaction, supervisor support, work fast, work freedom, work time) that have been consistently related to reports of musculoskeletal disorders. Economic conditions will influence some psychosocial risk factors.
Associations between anthropometric parameters and serum lipids in preadolescent and adolescent girls and boys

Abstract Aim: The purpose of this study was to investigate the relationship between anthropometric parameters and serum lipid concentrations in both preadolescent and adolescent girls and boys. Materials & Methods: Basic lipid status parameters were determined in fasting venous blood from 186 preadolescents and adolescents. Atherogenic indices were calculated. Results: Two-way analysis of variance showed significant interactions between age and BMI subgroups in girls at the level of HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), non-HDL-C, total cholesterol/HDL-C and LDL-C/HDL-C. Ordinal regression analysis showed that increasing age in both genders reduced the probability of higher HDL-C concentrations. Conclusion: Age was an independent predictor for lower HDL-C concentration in both genders. BMI was the most significant independent predictor for most lipid parameters in girls.
ACUTE APLASTIC ANEMIA COMPLICATING ARSPHENAMINE THERAPY: REPORT OF A CASE TREATED FOR SYPHILIS COINCIDENT WITH TUBERCULOSIS

The first to give a clinical description of aplastic anemia was Ehrlich,1in 1888, whose patient developed this disease condition following a severe uterine hemorrhage. Many case reports followed with speculative discussions as to whether this form of anemia is a distinct disease entity or a symptom-complex of purpura hemorrhagica. Duke2emphasizes that the course and symptoms of this disease depend in the main on which of the three principal blood-forming elements of the bone marrow is mostly affected. The usual symptoms of progressive anemia will predominate when the erythropoietic tissue is chiefly affected; agranulocytosis with subsequent infection, notably angina, when there is failure of regeneration of leukocytes, and purpura with hemorrhage when there occurs a considerable diminution in the blood platelets. This valuable conception is important to bear in mind, since it helps to give a proper appraisal of some of the blood dyscrasias which occasionally follow
Importance of Recording Pulmonary Venous Flow Velocities With Transthoracic or Transesophagea1 Echocartiography

The recording of pulmonary venous flow velocities during Doppler ecgicardiography has not received sufficient attention. This review emphasizes the importance of recording pulmonary venous flow velocities (systolic, diastolic, and atrial reversal components) during transthoracic or transesophageal echocardiography. Clinical conditions that increase left atrial pressure, such as congestive heart failure, or that alter left atrial contraction (i.e., atrial fibrillation) result in diminished systolic pulmonary venous inflow and relatively increased diastolic pulmonary venous inflow. When moderate or severe mitral regurgitation is present or suspected by color Doppler imaging, pulmonary venous systolic flow will be blunted or exhibit systolic revetrsal. Distinctive patterns of respiratory variation in systolic and diastolic pulmonary venous velocities can be observed in patients with constrictive heart failure and elevated left ventricular end diastolic pressures but with normal mitral inflow patterns have abnormal pulmonary venous flow characteristics. Stenosis of the pulmonary may demonsterate increased pulmonary venous velocities or flow disturbances after postoperative repair. Pulmonary venous flow characteristics provide hemodynamic infomation not provided by other Doppler monalities or echocardiographic imaging.
What Are the Prebiotics, and What Are Not -

Prebiotics are dietary components in the form of indigestible carbohydrate targeting intestinal flora in humans. In the literature there has been a number of in vivo and vitro studies on prebiotics conducted since 1995. The effect of prebiotics on the intestinal health is an area in food science in which more intensive studies were conducted. The purpose of this review article is to bring together and interpret the results of the studies investigating the physiological and bifidogenic effects of prebiotics on the intestinal health and to shed light on new studies.
Attitudes, Knowledge, Behavior in the Context of HIV/AIDS Stigma

The traditional trio of attitudes, knowledge, and behavior still comprises a good framework to understand the realities of people living with HIV, HIV-affected individuals, and HIV/AIDS service providers– all of whom must negotiate aspects of marginalization related to HIV/ AIDS. Indeed, one of the universals in the HIV epidemic continues to be the contextual HIV stigma (Herek & Glunt, 1988), which is pervasive throughout the world. Although the actual and perceived stigma varies across and within affected groups, the social policy environment, cultural differences, as well as discrimination, and bias impact the quality of life, mental health, and engagement in care for people living with HIV. While stigma, grief, social distancing, and reactions have been recognized since the beginning of the epidemic, continual exploration and documentation of how HIV-related stigma interacts with social motivation among HIV-affected individuals and service providers remain critical to effective social service provision. In the early 1990s, Weiner’s (1993) attributional model of social motivation sought to explain the links between perceptions of control, responsibility, and affective and prosocial responses toward stigmatized victims. As such, judgments about people’s personal responsibility for contracting the disease or spreading the disease are linked to the societal reactions to HIVaffected populations, people’s willingness to serve this population, and, further, to particular strategies used in prevention services. This issue includes several articles exploring themes of stigma, societal attitudes,
On the solution of complementarity problems arising in American options pricing

In the Black–Scholes–Merton model, as well as in more general stochastic models in finance, the price of an American option solves a parabolic variational inequality. When the variational inequality is discretized, one obtains a linear complementarity problem (LCP) that must be solved at each time step. This paper presents an algorithm for the solution of these types of LCPs that is significantly faster than the methods currently used in practice. The new algorithm is a two-phase method that combines the active-set identification properties of the projected successive over relaxation (SOR) iteration with the second-order acceleration of a (recursive) reduced-space phase. We show how to design the algorithm so that it exploits the structure of the LCPs arising in these financial applications and present numerical results that show the effectiveness of our approach.