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quality by design

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https://www.readbyqxmd.com/read/29783113/automated-uhplc-separation-of-10-pharmaceutical-compounds-using-software-modeling
#1
A Zöldhegyi, H-J Rieger, I Molnár, L Fekhretdinova
Human mistakes are still one of the main reasons of underlying regulatory affairs that in a compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) must be eliminated. To develop smooth, fast and robust methods that are free of human failures, a state-of-the-art automation was presented. For the scope of this study, a commercial software (DryLab) and a model mixture of 10 drugs were subjected to testing. Following AQbD-principles, the best available working point was selected and conformational experimental runs, i...
March 20, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29783091/mind-at-home-streamlined-study-protocol-for-a-randomized-trial-of-home-based-care-coordination-for-persons-with-dementia-and-their-caregivers
#2
Quincy M Samus, Betty Smith Black, Melissa Reuland, Jeannie-Marie S Leoutsakos, Laura Pizzi, Kevin D Frick, David L Roth, Laura N Gitlin, Constantine G Lyketsos, Deirdre Johnston
BACKGROUND: Dementia is associated with high health care costs, premature long-term care (LTC) placement, medical complications, reduced quality of life, and caregiver burden. Most health care providers and systems are not yet organized or equipped to provide comprehensive long-term care management for dementia, although a range of effective symptoms and supportive care approaches exist. The Maximizing Independence at Home-Streamlined (MIND-S) is a promising model of home-based dementia care coordination designed to efficiently improve person-centered outcomes, while reducing care costs...
May 18, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29783065/participation-in-daily-life-influence-on-quality-of-life-in-ambulatory-children-with-cerebral-palsy
#3
Jaclyn Omura, Molly Fuentes, Kristie Bjornson
BACKGROUND: Cerebral palsy is a chronic condition which affects children and has an impact on social and physical activity, as well as participation in daily life. Participation and quality of life are two important measures of successful rehabilitation that have not been well studied in children with cerebral palsy. OBJECTIVE: To report levels of participation and examine the relationship of participation to quality of life (QOL) in ambulatory children with cerebral palsy (CP) DESIGN: Secondary analysis, cross-sectional cohort study SETTING: Regional pediatric specialty care center PARTICIPANTS: A cohort of 128 ambulatory children with CP, Gross Motor Function Classification System (GMFCS) levels I-III, age 2-9 years INTERVENTIONS: Not Applicable MAIN OUTCOME MEASURES: Pediatric Quality of Life Inventory (PedsQL); Assessment of Life Habits (LIFE-H); Children's Assessment of Participation and Enjoyment and Assessment of Preschool Children's Participation (CAPE/APCP)...
May 18, 2018: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/29782615/feasibility-study-applying-a-parametric-model-as-the-design-generator-for-3d-printed-orthosis-for-fracture-immobilization
#4
Jianyou Li, Hiroya Tanaka
Background: Applying 3D printing technology for the fabrication of custom-made orthoses provides significant advantages, including increased ventilation and lighter weights. Currently, the design of such orthoses is most often performed in the CAD environment, but creating the orthosis model is a time-consuming process that requires significant CAD experience. This skill gap limits clinicians from applying this technology in fracture treatment. The purpose of this study is to develop a parametric model as the design generator for 3D-printed orthoses for an inexperienced CAD user and to evaluate its feasibility and ease of use via a training and design exercise...
2018: 3D Print Med
https://www.readbyqxmd.com/read/29782182/a-specifically-designed-multispecies-probiotic-supplement-relieves-seasonal-allergic-rhinitis-symptoms
#5
Annabelle M Watts, Amanda J Cox, Peter K Smith, Isolde Besseling-van der Vaart, Allan W Cripps, Nicholas P West
BACKGROUND: Probiotics are purported to reduce symptoms of allergic rhinitis. This study sought to determine the proportion of participants with an improvement in the mini Rhinoconjunctivitis Quality of Life Questionnaire (mRQLQ) in response to a multispecies probiotic supplement with a Simon Two-Stage design. METHODS: This study was based on a Simon Two-Stage Design for p1 -p0  = 0.18 to account for seasonal variation in symptoms. Under this design, ≥10 patients are required to exhibit an improvement in quality-of-life scores to determine that there was sufficient activity for the supplement to be considered effective...
May 21, 2018: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/29781702/first-language-raters-opinions-when-validating-word-recordings-for-a-newly-developed-speech-reception-threshold-test
#6
Seema Panday, Harsha Kathard, Mershen Pillay, Wayne Wilson
 The purpose of this study was to consider the value of adding first-language speaker ratings to the process of validating word recordings for use in a new speech reception threshold (SRT) test in audiology. Previous studies had identified 28 word recordings as being suitable for use in a new SRT test. These word recordings had been shown to satisfy the linguistic criteria of familiarity, phonetic dissimilarity and tone, and the psychometric criterion of homogeneity of audibility. Objectives: The aim of the study was to consider the value of adding first-language speakers' ratings when validating word recordings for a new SRT test...
March 29, 2018: South African Journal of Communication Disorders. die Suid-Afrikaanse Tydskrif Vir Kommunikasieafwykings
https://www.readbyqxmd.com/read/29781698/a-middle-range-model-for-improving-quality-of-nursing-education-in-malawi
#7
Thokozani M Bvumbwe, Ntombifikile G Mtshali
BACKGROUND:  Despite a global consensus that nurses and midwives constitute the majority and are a backbone of any country's health workforce system, productive capacity of training institutions remains low and still needs more guidance. This study aimed at developing a middle-range model to guide efforts in nursing education improvements. OBJECTIVE:  To explore challenges facing nursing education in Malawi and to describe efforts that are being put in place to improve nursing education and the process of development of a model to improve nursing education in Malawi...
March 22, 2018: Curationis
https://www.readbyqxmd.com/read/29781509/comparative-analgesic-efficacy-of-pregabalin-administered-according-to-either-a-prevention-protocol-or-an-intervention-protocol-in-rats-with-cisplatin-induced-peripheral-neuropathy
#8
F Y Han, A Kuo, J R Nicholson, L Corradinni, M T Smith
Chemotherapy-induced peripheral neuropathy (CIPN) is a type of peripheral neuropathic pain that may be dose-limiting in patients administered potentially curative cancer chemotherapy dosing regimens. In cancer survivors, persistent CIPN adversely affects patient quality of life and so adjuvant drugs (anticonvulsants e.g. pregabalin or antidepressants e.g. amitriptyline) are recommended for the relief of CIPN. However, most studies in rodent models of CIPN involve administration of single bolus doses of adjuvant drugs to assess pain-relieving efficacy...
May 21, 2018: Clinical and Experimental Pharmacology & Physiology
https://www.readbyqxmd.com/read/29781504/epidural-versus-non-epidural-or-no-analgesia-for-pain-management-in-labour
#9
REVIEW
Millicent Anim-Somuah, Rebecca Md Smyth, Allan M Cyna, Anna Cuthbert
BACKGROUND: Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review (Epidural versus non-epidural or no analgesia in labour), last published in 2011. OBJECTIVES: To assess the effectiveness and safety of all types of epidural analgesia, including combined-spinal-epidural (CSE) on the mother and the baby, when compared with non-epidural or no pain relief during labour...
May 21, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29781464/psychosocial-distress-screening-an-educational-program-s-impact-on-participants-goals-for-screening-implementation-in-routine-cancer-care
#10
Mark Lazenby, Elizabeth Ercolano, Andrea Knies, Nick Pasacreta, Marcia Grant, Jimmie C Holland, Paul B Jacobsen, Terry Badger, Devika R Jutagir, Ruth McCorkle
BACKGROUND: Psychosocial distress screening is a quality care standard in cancer care. Screening implementation may be facilitated by an educational program that uses goals to evaluate progress over time. OBJECTIVES: This article describes the content and design of the Screening for Psychosocial Distress Program (SPDP), reports on its delivery to 36 paired participants, and evaluates its effects on distress screening activities and goals. METHODS: The SPDP used a one-group pre-/post-test design...
June 1, 2018: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/29781395/judicialization-2-0-understanding-right-to-health-litigation-in-real-time
#11
João Biehl, Mariana P Socal, Varun Gauri, Debora Diniz, Marcelo Medeiros, Gabriela Rondon, Joseph J Amon
Over the past two decades, debate over the whys, the hows, and the effects of the ever-expanding phenomenon of right-to-health litigation ('judicialization') throughout Latin America have been marked by polarised arguments and limited information. In contrast to claims of judicialization as a positive or negative trend, less attention has been paid to ways to better understand the phenomenon in real time. In this article, we propose a new approach-Judicialization 2.0-that recognises judicialization as an integral part of democratic life...
May 21, 2018: Global Public Health
https://www.readbyqxmd.com/read/29781149/supporting-advanced-dementia-in-people-with-down-syndrome-and-other-intellectual-disability-consensus-statement-of-the-international-summit-on-intellectual-disability-and-dementia
#12
M McCarron, P McCallion, A Coppus, J Fortea, S Stemp, M Janicki, K Wtachman
BACKGROUND: The International Summit on Intellectual Disability and Dementia (Glasgow, Scotland; October 2016) noted that advanced dementia can be categorised as that stage of dementia progression characterised by significant losses in cognitive and physical function, including a high probability of further deterioration and leading to death. METHOD: The question before the Summit was whether there were similarities and differences in expressions of advanced dementia between adults with intellectual disability (ID) and adults in the general population...
May 20, 2018: Journal of Intellectual Disability Research: JIDR
https://www.readbyqxmd.com/read/29780863/a-novel-cognitive-functional-composite-measure-to-detect-changes-in-early-alzheimer-s-disease-test-retest-reliability-and-feasibility
#13
Roos J Jutten, John Harrison, Philippe R Lee Meeuw Kjoe, Esther M Opmeer, Niki S M Schoonenboom, Frank Jan de Jong, Craig W Ritchie, Philip Scheltens, Sietske A M Sikkes
Introduction: To improve the detection of changes in Alzheimer's disease (AD), we designed the cognitive-functional composite (CFC). As a first validation step, we investigated its test-retest reliability and feasibility of use. Methods: We performed a test-retest study with 2-3 weeks between assessments, including patients with mild cognitive impairment (MCI) or mild AD dementia and cognitively healthy participants. We calculated intraclass correlation coefficients (ICCs) type absolute agreement for all CFC measures and compared baseline and retest scores using paired-samples t -tests...
2018: Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring
https://www.readbyqxmd.com/read/29780402/dark-septate-endophytic-fungi-increase-green-manure-15-n-recovery-efficiency-n-contents-and-micronutrients-in-rice-grains
#14
Carlos Vergara, Karla E C Araujo, Segundo Urquiaga, Claudete Santa-Catarina, Nivaldo Schultz, Ednaldo da Silva Araújo, Fabiano de Carvalho Balieiro, Gustavo R Xavier, Jerri É Zilli
An understanding of the interaction between rice and dark septate endophytic (DSE) fungi, under green fertilization, may lead to sustainable agricultural practices. Nevertheless, this interaction is still poorly understood. Therefore, in this study, we aimed to evaluate the accumulation of macro- and micronutrients, dry matter, and protein and N recovery efficiency from Canavalia ensiformis (L.)-15 N in rice inoculated with DSE fungi. An experiment under greenhouse conditions was conducted in a randomized complete block design comprising split-plots, with five replicates of rice plants potted in non-sterilized soil...
2018: Frontiers in Plant Science
https://www.readbyqxmd.com/read/29780400/led-lighting-modification-of-growth-metabolism-yield-and-flour-composition-in-wheat-by-spectral-quality-and-intensity
#15
István Monostori, Márk Heilmann, Gábor Kocsy, Marianna Rakszegi, Mohamed Ahres, Susan B Altenbach, Gabriella Szalai, Magda Pál, Dávid Toldi, Livia Simon-Sarkadi, Noémi Harnos, Gábor Galiba, Éva Darko
The use of light-emitting diode (LED) technology for plant cultivation under controlled environmental conditions can result in significant reductions in energy consumption. However, there is still a lack of detailed information on the lighting conditions required for optimal growth of different plant species and the effects of light intensity and spectral composition on plant metabolism and nutritional quality. In the present study, wheat plants were grown under six regimens designed to compare the effects of LED and conventional fluorescent lights on growth and development, leaf photosynthesis, thiol and amino acid metabolism as well as grain yield and flour quality of wheat...
2018: Frontiers in Plant Science
https://www.readbyqxmd.com/read/29779953/a-quality-assurance-device-for-measuring-afterloader-performance-and-transit-dose-for-nasobiliary-high-dose-rate-brachytherapy
#16
Christopher L Deufel, John P Mullins, Mark J Zakhary
PURPOSE: Nasobiliary high-dose-rate (HDR) brachytherapy has emerged as an effective tool to boost the radiation dose for patients with unresectable perihilar cholangiocarcinoma. This work describes a quality assurance (QA) tool for measuring the HDR afterloader's performance, including the transit dose, when the source wire travels through a tortuous nasobiliary catheter path. METHODS AND MATERIALS: The nasobiliary QA device was designed to mimic the anatomical path of a nasobiliary catheter, including the nasal, stomach, duodenum, and bile duct loops...
May 17, 2018: Brachytherapy
https://www.readbyqxmd.com/read/29779466/a-systematic-review-of-shock-attenuating-componentry-for-lower-limb-amputees
#17
Mitchell Farrar, Emma Thomas
BACKGROUND: Shock-attenuating pylons are commonly fitted to prostheses in order to compensate for the anatomical and biomechanical shock-absorbing features of the lower limb removed upon amputation. However, studies concerning their shock-attenuating capacity are highly variable and, to date, have not yet been reviewed, making them difficult to interpret and apply in clinical practice. OBJECTIVES: To synthesise and appraise the available literature examining the effectiveness of shock-attenuating pylons in attenuating shock upon limb loading compared to rigid pylons among lower limb amputees...
May 1, 2018: Prosthetics and Orthotics International
https://www.readbyqxmd.com/read/29779452/a-systematic-review-of-reviews-of-the-outcome-of-severe-neglect-in-underresourced-childcare-institutions
#18
Alan Carr, Hollie Duff, Fiona Craddock
The aim of the systematic review described in this article was to determine the outcomes for individuals exposed to severe neglect in congregate care institutions such as orphanages. In this context, severe neglect refers to failure to meet children's basic physical, developmental, and emotional needs due to inadequate resources. In this systematic review of previous systematic reviews and meta-analyses, searches of 10 databases were conducted, 18 papers that met inclusion and exclusion criteria were selected for review, their quality was assessed, and data were extracted and synthesized...
January 1, 2018: Trauma, Violence & Abuse
https://www.readbyqxmd.com/read/29779024/a-randomized-clinical-trial-of-metformin-to-treat-autosomal-dominant-polycystic-kidney-disease
#19
Stephen L Seliger, Kaleab Z Abebe, Kenneth R Hallows, Dana C Miskulin, Ronald D Perrone, Terry Watnick, Kyongtae Tae Bae
BACKGROUND: Metformin inhibits cyclic AMP generation and activates AMP-activated protein kinase (AMPK), which inhibits the cystic fibrosis transmembrane conductance regulator and Mammalian Target of Rapamycin pathways. Together these effects may reduce cyst growth in autosomal dominant polycystic kidney disease (ADPKD). METHODS: A phase II, double-blinded randomized placebo-controlled trial of 26 months duration. Participants will include nondiabetic adults (n = 96) aged 18-60 years, with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1...
May 18, 2018: American Journal of Nephrology
https://www.readbyqxmd.com/read/29778755/development-and-acceptability-assessment-of-a-self-management-intervention-to-prevent-acute-to-chronic-pain-transition-after-major-lower-extremity-trauma
#20
Mélanie Bérubé, Céline Gélinas, Géraldine Martorella, Nancy Feeley, José Côté, George-Yves Laflamme, Dominique M Rouleau, Manon Choinière
Transition from acute to chronic pain often occurs after major lower extremity trauma. Chronic pain has been found to negatively affect daily functioning, including the capacity to work and quality of life. Empirical data and an acceptability assessment were used to develop a self-management intervention aimed at preventing acute to chronic pain transition after major lower extremity trauma (i.e., iPACT-E-Trauma). Evidence from previous studies on preventive self-management interventions, combined with a biopsychosocial conceptual framework and clinical knowledge, helped define the key features of the preliminary version...
May 16, 2018: Pain Management Nursing: Official Journal of the American Society of Pain Management Nurses
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