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https://www.readbyqxmd.com/read/29047193/unlicensed-pharmaceutical-preparations-for-clinical-patient-care-ensuring-safety
#1
REVIEW
Sofieke de Wilde, Maria G H de Jong, Paul P H Le Brun, Henk-Jan Guchelaar, Kirsten J M Schimmel
Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient...
October 19, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29044446/social-cognition-in-schizophrenia-unaffected-relatives-and-ultra-high-risk-for-psychosis-what-do-we-currently-know
#2
Alejandra Mondragón-Maya, Daniela Ramos-Mastache, Pedro D Román, Guillermina Yáñez-Téllez
INTRODUCTION: Schizophrenia patients show impairments in social cognition (SC), which is a set of cognitive processes that underlie social interactions. The research about SC in schizophrenia has identified four main domains: Theory of mind (ToM), social perception, attributional style and emotional processing. The present review aims to summarize the most recent and consistent findings about SC in patients with schizophrenia, unaffected relatives and ultra-high risk for psychosis individuals (UHR), as well as its association with clinical variables and functional outcome...
September 2017: Actas Españolas de Psiquiatría
https://www.readbyqxmd.com/read/29042899/evidence-for-hypothalamus-pituitary-adrenal-axis-and-immune-alterations-at-prodrome-of-psychosis-in-males
#3
Evangelos Karanikas, Evangelos Ntouros, Dimitrios Oikonomou, Georgios Floros, Ioannis Griveas, Georgios Garyfallos
We aimed to investigate the inflammatory substrate in psychosis by evaluating both the Hypothalamus-Pituitary-Adrenal axis function and immune state at prodrome. This involved the recruitment of Ultra High Risk (UHR) of Psychosis subjects, Healthy Controls (HC) and patients with established Schizophrenia (CHRON). Serum cortisol at 3 different times throughout the day was measured. The Dexamethasone Suppression Test was performed plus 12 circulating cytokines were measured. The UHR subjects presented increased IL-4 levels compared with both the HC and CHRON patients...
September 2017: Psychiatry Investigation
https://www.readbyqxmd.com/read/29042877/impaired-social-and-role-function-in-ultra-high-risk-for-psychosis-and-first-episode-schizophrenia-its-relations-with-negative-symptoms
#4
So Jung Lee, Kyung Ran Kim, Su Young Lee, Suk Kyoon An
OBJECTIVE: Psychosocial dysfunction was a nettlesome problem of schizophrenia even in their prodromal phase as well as in their first-episode. In addition, its relations with psychopathology were not determined. The aim of the present study was to examine whether the social and role function impairment was found in ultra-high risk for psychosis (UHR) individuals as well as first-episode schizophrenia patients and to explore its relations with psychopathology. METHODS: Thirty-seven normal controls, 63 UHR participants and 28 young, first-episode schizophrenia patients were recruited...
September 2017: Psychiatry Investigation
https://www.readbyqxmd.com/read/29033468/the-aviation-paradox-why-we-can-know-jetliners-but-not-reactors
#5
John Downer
Publics and policymakers increasingly have to contend with the risks of complex, safety-critical technologies, such as airframes and reactors. As such, 'technological risk' has become an important object of modern governance, with state regulators as core agents, and 'reliability assessment' as the most essential metric. The Science and Technology Studies (STS) literature casts doubt on whether or not we should place our faith in these assessments because predictively calculating the ultra-high reliability required of such systems poses seemingly insurmountable epistemological problems...
2017: Minerva
https://www.readbyqxmd.com/read/29030041/the-application-of-chiral-ultra-high-performance-liquid-chromatography-tandem-mass-spectrometry-to-the-separation-of-the-zoxamide-enantiomers-and-the-study-of-enantioselective-degradation-process-in-agricultural-plants
#6
Xinglu Pan, Fengshou Dong, Zenglong Chen, Jun Xu, Xingang Liu, Xiaohu Wu, Yongquan Zheng
In this study, an effective and sensitive chiral analytical method was developed to detect zoxamide enantiomers in vegetables, fruits and environmental matrices using ultra-high-performance liquid chromatography-tandem mass spectrometry. Optimal separation conditions were achieved with Lux Amylose-2 chiral column using acetonitrile/water (70:30v/v) as mobile phase with a flow rate and column temperature of 0.5mL/min and 25°C. The absolute configuration, optical rotation and elution order were confirmed for the first time...
October 6, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/29026200/simultaneous-quantification-of-nine-aconitum-alkaloids-in-aconiti-lateralis-radix-praeparata-and-related-products-using-uhplc-qqq-ms-ms
#7
Fan He, Can-Jian Wang, Ying Xie, Chun-Song Cheng, Zhong-Qiu Liu, Liang Liu, Hua Zhou
Aconiti Lateralis Radix Praeparata (Fuzi) is obtained from processed daughter roots of Aconitum carmichaeli, a toxic plant with a high medical value well known in Chinese medicine. In addition to the known toxic alkaloids (aconitine, mesaconitine, and hypaconitine) and bioactive alkaloids (benzoylaconine, benzoylmesaconine, and benzoylhypaconine), three rarely found alkaloids have been previously reported in Fuzi, i.e., yunaconitine, 8-deacetyl-yunaconitine, and crassicauline A, and they were reported in recent years to cause potential risk to patients who took Fuzi or related products...
October 12, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29020419/cortical-gaba-in-subjects-at-ultra-high-risk-of-psychosis-relationship-to-negative-prodromal-symptoms
#8
Gemma Modinos, Fatma Simsek, Jamie Horder, Matthijs Bossong, Ilaria Bonoldi, Matilda Azis, Jesus Perez, Matthew Broome, David J Lythgoe, James M Stone, Oliver D Howes, Declan G Murphy, Anthony A Grace, Paul Allen, Philip McGuire
Background: Whilst robust preclinical and postmortem evidence suggests that altered GABAergic function is central to the development of psychosis, little is known about whether it is altered in subjects at ultra-high risk of psychosis, or its relationship to prodromal symptoms. Methods: Twenty-one anti-psychotic naïve UHR individuals and 20 healthy volunteers underwent proton magnetic resonance imaging at 3T. GABA levels were obtained from the medial prefrontal cortex (MPFC) using MEGA-PRESS, and expressed as peak-area ratios relative to the synchronously-acquired creatine signal...
August 19, 2017: International Journal of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28986006/association-between-mismatch-negativity-and-global-functioning-is-specific-to-duration-deviance-in-early-stages-of-psychosis
#9
Daisuke Koshiyama, Kenji Kirihara, Mariko Tada, Tatsuya Nagai, Mao Fujioka, Shinsuke Koike, Motomu Suga, Tsuyoshi Araki, Kiyoto Kasai
BACKGROUND: Mismatch negativity (MMN) is a candidate biomarker for early stages of psychosis. Although an association among duration MMN (dMMN), cognitive deficits, and functional outcome in chronic schizophrenia has been shown by a large-scale study, the effects of deviant type and clinical stages have not been investigated. METHODS: We investigated the relationships among dMMN, frequency MMN (fMMN), global functioning, and cognitive function in early stages of psychosis...
October 3, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28985322/chemical-evaluation-of-electronic-cigarettes-multicomponent-analysis-of-liquid-refills-and-their-corresponding-aerosols
#10
Nicolas Beauval, Sébastien Antherieu, Mélissa Soyez, Nicolas Gengler, Nathalie Grova, Michael Howsam, Emilie M Hardy, Marc Fischer, Brice M R Appenzeller, Jean-François Goossens, Delphine Allorge, Guillaume Garçon, Jean-Marc Lo-Guidice, Anne Garat
Electronic cigarette use has raised concern worldwide regarding potential health risks and its position in tobacco cessation strategies. As part of any toxicity assessment, the chemical characterization of e-liquids and their related vapors are among fundamental data to be determined. Considering the lack of available reference methods, we developed and validated several analytical procedures in order to conduct a multicomponent analysis of six e-liquid refills and their resultant vapor emissions (generated by a smoking machine), and compared them with tobacco smoke...
July 14, 2017: Journal of Analytical Toxicology
https://www.readbyqxmd.com/read/28984077/broad-clinical-high-risk-mental-state-charms-methodology-of-a-cohort-study-validating-criteria-for-pluripotent-risk
#11
Jessica A Hartmann, Barnaby Nelson, Rachael Spooner, G Paul Amminger, Andrew Chanen, Christopher G Davey, Meredith McHugh, Aswin Ratheesh, Devi Treen, Hok Pan Yuen, Patrick D McGorry
AIM: The development of the ultra-high risk (UHR) criteria for psychosis created a new paradigm for the prevention research in psychiatry. Since (1) prevention research faces the challenge of achieving adequate statistical power when focusing on single low-incidence syndromes and (2) early clinical phenotypes are overlapping and non-specific, this study broadens the UHR state beyond psychosis as an outcome. The CHARMS (clinical high at-risk mental state) study aims to prospectively validate a set of trans-diagnostic criteria to identify help-seeking young people at risk of developing a range of serious mental illnesses...
October 5, 2017: Early Intervention in Psychiatry
https://www.readbyqxmd.com/read/28972591/altered-activation-and-connectivity-in-a-hippocampal-basal-ganglia-midbrain-circuit-during-salience-processing-in-subjects-at-ultra-high-risk-for-psychosis
#12
T Winton-Brown, A Schmidt, J P Roiser, O D Howes, A Egerton, P Fusar-Poli, N Bunzeck, A A Grace, E Duzel, S Kapur, P McGuire
Animal models of psychosis propose that abnormal hippocampal activity drives increased subcortical dopamine function, which is thought to contribute to aberrant salience processing and psychotic symptoms. These effects appear to be mediated through connections between the hippocampus, ventral striatum/pallidum and the midbrain. The aim of the present study was to examine the activity and connectivity in this pathway in people at ultra high risk (UHR) for psychosis. Functional magnetic resonance imaging was used to compare neural responses in a hippocampal-basal ganglia-midbrain network during reward, novelty and aversion processing between 29 UHR subjects and 32 healthy controls...
October 3, 2017: Translational Psychiatry
https://www.readbyqxmd.com/read/28968651/kinome-expression-profiling-of-human-neuroblastoma-tumors-identifies-potential-drug-targets-for-ultra-high-risk-patients
#13
Roberta Russo, Flora Cimmino, Lucia Pezone, Francesco Manna, Marianna Avitabile, Concetta Langella, Jan Koster, Fiorina Casale, Maddalena Raia, Giampietro Viola, Matthias Fischer, Achille Iolascon, Mario Capasso
Neuroblastoma (NBL) accounts for >7% of malignancies in patients younger than 15 years. Low- and intermediate-risk patients exhibit excellent or good prognosis after treatment, whereas for high-risk (HR) patients, the estimated 5-year survival rates is still <40%. The ability to stratify HR patients that will not respond to standard treatment strategies is critical for informed treatment decisions. In this study, we have generated a specific kinome gene signature, named Kinome-27, which is able to identify a subset of HR-NBL tumors, named ultra-HR NBL, with highly aggressive clinical behavior that not adequately respond to standard treatments...
August 29, 2017: Carcinogenesis
https://www.readbyqxmd.com/read/28968296/sentinel-lymph-node-ultra-staging-as-a-supplement-for-endometrial-cancer-intraoperative-frozen-section-deficiencies
#14
Morgan Blakely, Yuxin Liu, Jamal Rahaman, Monica Prasad-Hayes, Mikhail Tismenetsky, Xiaofei Wang, Navya Nair, Karen A Dresser, Nimesh Nagarsheth, Tamara Kalir
For endometrial cancer (EC), most surgeons rely on intraoperative frozen section (IFS) to determine the risk of nodal metastasis and necessity of lymphadenectomy. IFS remains a weak link in this practice due to its susceptibility to diagnostic errors. As a less invasive alternative, sentinel lymph node (SLN) mapping and ultra-staging have gradually gained acceptance for EC. We aimed to establish the SLN success rate, negative predictive value, and whether SLNs provide useful information for cases misdiagnosed on IFS...
September 29, 2017: International Journal of Gynecological Pathology
https://www.readbyqxmd.com/read/28965698/comparison-of-a-sentinel-lymph-node-mapping-algorithm-and-comprehensive-lymphadenectomy-in-the-detection-of-stage-iiic-endometrial-carcinoma-at-higher-risk-for-nodal-disease
#15
Jennifer A Ducie, Ane Gerda Zahl Eriksson, Narisha Ali, Michaela E McGree, Amy L Weaver, Giorgio Bogani, William A Cliby, Sean C Dowdy, Jamie N Bakkum-Gamez, Robert A Soslow, Gary L Keeney, Nadeem R Abu-Rustum, Andrea Mariani, Mario M Leitao
OBJECTIVE: To determine if a sentinel lymph node (SLN) mapping algorithm will detect metastatic nodal disease in patients with intermediate-/high-risk endometrial carcinoma. METHODS: Patients were identified and surgically staged at two collaborating institutions. The historical cohort (2004-2008) at one institution included patients undergoing complete pelvic and paraaortic lymphadenectomy to the renal veins (LND cohort). At the second institution an SLN mapping algorithm, including pathologic ultra-staging, was performed (2006-2013) (SLN cohort)...
September 28, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28952616/a-glass-fibre-membrane-platform-for-ultra-sensitive-detection-of-cardiac-troponin-t
#16
Keum-Soo Song, Satish Balasaheb Nimse, Mukesh Digambar Sonawane, Yahui Lin, Zhou Zhou, Taisun Kim
A glass fibre membrane platform that allows quantification of circulating cTnT with a LoD of 0.87 pg mL(-1) is described. The proposed platform uses a glass fibre membrane, DNA-guided detection method, and antibody-conjugated fluorescent beads for the quantification of cTnT in the analytical detection range of 1-120 pg mL(-1) at room temperature in 30 min. Glass fibre membranes were chemically modified to immobilize the oligonucleotide probes that catch a biomolecular complex (FB-dAB-cTnT-cAB-DNA) containing complementary oligonucleotides...
September 27, 2017: Analyst
https://www.readbyqxmd.com/read/28948212/dna-repair-deficiency-biomarkers-and-the-70-gene-ultra-high-risk-signature-as-predictors-of-veliparib-carboplatin-response-in-the-i-spy-2-breast-cancer-trial
#17
Denise M Wolf, Christina Yau, Ashish Sanil, Annuska Glas, Emanuel Petricoin, Julia Wulfkuhle, Tesa M Severson, Sabine Linn, Lamorna Brown-Swigart, Gillian Hirst, Meredith Buxton, Angela DeMichele, Nola Hylton, Fraser Symmans, Doug Yee, Melissa Paoloni, Laura Esserman, Don Berry, Hope Rugo, Olufunmilayo Olopade, Laura van 't Veer
Veliparib combined with carboplatin (VC) was an experimental regimen evaluated in the biomarker-rich neoadjuvant I-SPY 2 trial for breast cancer. VC showed improved efficacy in the triple negative signature. However, not all triple negative patients achieved pathologic complete response and some HR+HER2- patients responded. Pre-specified analysis of five DNA repair deficiency biomarkers (BRCA1/2 germline mutation; PARPi-7, BRCA1ness, and CIN70 expression signatures; and PARP1 protein) was performed on 116 HER2- patients (VC: 72 and concurrent controls: 44)...
2017: NPJ Breast Cancer
https://www.readbyqxmd.com/read/28941595/lipidome-as-a-predictive-tool-in-progression-to-type-2-diabetes-in-finnish-men
#18
Tommi Suvitaival, Isabel Bondia-Pons, Laxman Yetukuri, Päivi Pöhö, John J Nolan, Tuulia Hyötyläinen, Johanna Kuusisto, Matej Orešič
BACKGROUND: There is a need for early markers to track and predict the development of type 2 diabetes mellitus (T2DM) from the state of normal glucose tolerance through prediabetes. In this study we tested whether the plasma molecular lipidome has biomarker potential to predicting the onset of T2DM. METHODS: We applied global lipidomic profiling on plasma samples from well-phenotyped men (107 cases, 216 controls) participating in the longitudinal METSIM study at baseline and at five-year follow-up...
September 20, 2017: Metabolism: Clinical and Experimental
https://www.readbyqxmd.com/read/28926270/an-ultrathin-nanoporous-membrane-evaporator
#19
Zhengmao Lu, Kyle L Wilke, Daniel J Preston, Ikuya Kinefuchi, Elizabeth Chang-Davidson, Evelyn N Wang
Evaporation is a ubiquitous phenomenon found in nature and widely used in industry. Yet a fundamental understanding of interfacial transport during evaporation remains limited to date owing to the difficulty of characterizing the heat and mass transfer at the interface, especially at high heat fluxes (>100 W/cm(2)). In this work, we elucidated evaporation into an air ambient with an ultrathin (≈200 nm thick) nanoporous (≈130 nm pore diameter) membrane. With our evaporator design, we accurately monitored the temperature of the liquid-vapor interface, reduced the thermal-fluidic transport resistance, and mitigated the clogging risk associated with contamination...
October 11, 2017: Nano Letters
https://www.readbyqxmd.com/read/28903120/opening-the-black-box-of-cognitive-behavioural-case-management-in-clients-with-ultra-high-risk-for-psychosis
#20
Jessica A Hartmann, Patrick D McGorry, Stefanie J Schmidt, G Paul Amminger, Hok Pan Yuen, Connie Markulev, Gregor E Berger, Eric Y H Chen, Lieuwe de Haan, Ian B Hickie, Suzie Lavoie, Meredith J McHugh, Nilufar Mossaheb, Dorien H Nieman, Merete Nordentoft, Anita Riecher-Rössler, Miriam R Schäfer, Monika Schlögelhofer, Stefan Smesny, Andrew Thompson, Swapna Kamal Verma, Alison R Yung, Barnaby Nelson
BACKGROUND: Cognitive-behavioural therapy (CBT) is the first-choice treatment in clients with ultra-high risk (UHR) for psychosis. However, CBT is an umbrella term for a plethora of different strategies, and little is known about the association between the intensity and content of CBT and the severity of symptomatic outcome. METHODS: A sample of 268 UHR participants received 6 months of CBT with case management (CBCM) in the context of the multi-centre NEURAPRO trial with monthly assessments of attenuated psychotic symptoms (APS)...
2017: Psychotherapy and Psychosomatics
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