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Clinical analytics

Matthew A Psioda, Joseph G Ibrahim
We consider the problem of Bayesian sample size determination for a clinical trial in the presence of historical data that inform the treatment effect. Our broadly applicable, simulation-based methodology provides a framework for calibrating the informativeness of a prior while simultaneously identifying the minimum sample size required for a new trial such that the overall design has appropriate power to detect a non-null treatment effect and reasonable type I error control. We develop a comprehensive strategy for eliciting null and alternative sampling prior distributions which are used to define Bayesian generalizations of the traditional notions of type I error control and power...
March 14, 2018: Biostatistics
Cristan Farmer, Margo Thienemann, Collin Leibold, Gabrielle Kamalani, Bethany Sauls, Jennifer Frankovich
Objectives: To establish the psychometric properties of the Caregiver Burden Inventory (CBI) in patients with Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), which is characterized by the abrupt onset of obsessive-compulsive disorder and/or restricted eating and at least two additional psychiatric symptoms. Parents of patients with PANS have reported high caregiver burden. However, no validated instrument of burden exists for this population. Methods: Study took place at a community-based PANS clinic where the CBI is administered as part of routine clinical care...
March 14, 2018: Journal of Pediatric Psychology
Amaris Castanon, Grant Pierre, Rohan Willis, E Nigel Harris, Elizabeth Papalardo, Zurina Romay-Penabad, Alvaro Schleh, Praveen Jajoria, Monica Smikle, Karel DeCeulaer, Anne Tebo, Troy Jaskowski, Marta M Guerra, D Ware Branch, Jane E Salmon, Michelle Petri, Emilio B Gonzalez
Objectives: We evaluate the performance characteristics of antiphosphatidylserine (anti-PS), antiphosphatidylinositol (anti-PI), and antiphospholipid mixture (APhL) enzyme-linked immunosorbent assays (ELISAs) compared with anticardiolipin (aCL) and anti-β2 glycoprotein I (anti-β2GPI) in a large group of patients with antiphospholipid (aPL)-related diseases. Methods: Serum samples from 548 patients from the Hopkins and Jamaican systemic lupus erythematosus cohorts, the PROMISSE cohort, and the Antiphospholipid Standardization Laboratory were examined for immunoglobulin G (IgG)/immunoglobulin M (IgM) positivity in aCL, anti-β2GPI, anti-PS, anti-PI, and APhL ELISA assays...
March 14, 2018: American Journal of Clinical Pathology
Brenda Deliz, Kathya Ramos, Cynthia M Pérez
OBJECTIVE: To evaluate the sociodemographic characteristics and clinical and functional profile of amyotrophic lateral sclerosis (ALS) patients evaluated at Puerto Rico's Muscular Dystrophy Association-supported (MDA) clinics. METHODS: A retrospective review of 76 medical records of ALS patients evaluated at any of four MDA-sponsored clinics in Puerto Rico. RESULTS: The mean age of diagnosis was 57.4 ± 11.1 yrs. Most of the patients (52.3%) were women...
March 2018: Puerto Rico Health Sciences Journal
Davina Gale, Andrew R J Lawson, Karen Howarth, Mikidache Madi, Bradley Durham, Sarah Smalley, John Calaway, Shannon Blais, Greg Jones, James Clark, Peter Dimitrov, Michelle Pugh, Samuel Woodhouse, Michael Epstein, Ana Fernandez-Gonzalez, Alexandra S Whale, Jim F Huggett, Carole A Foy, Gerwyn M Jones, Hadas Raveh-Amit, Karin Schmitt, Alison Devonshire, Emma Green, Tim Forshew, Vincent Plagnol, Nitzan Rosenfeld
INTRODUCTION: Detection and monitoring of circulating tumor DNA (ctDNA) is rapidly becoming a diagnostic, prognostic and predictive tool in cancer patient care. A growing number of gene targets have been identified as diagnostic or actionable, requiring the development of reliable technology that provides analysis of multiple genes in parallel. We have developed the InVision™ liquid biopsy platform which utilizes enhanced TAm-Seq™ (eTAm-Seq™) technology, an amplicon-based next generation sequencing method for the identification of clinically-relevant somatic alterations at low frequency in ctDNA across a panel of 35 cancer-related genes...
2018: PloS One
Fernando Martínez, Núria Alegret, Federico Carol, M Jesús Laso, Juanjo Zancajo, Esteban García, Vanesa Ros
OBJECTIVES: The main objective of this study was to identify demographic, clinical, analytical factors or injuries associated with 30-day mortality in patients with pelvic fractures. MATERIAL AND METHODS: Prospective observational study of patients with multiple injuries including pelvic fractures between January 2009 and January 2017. We recorded demographic, clinical, and laboratory data on arrival at the emergency department; type of pelvic fracture; treatments; associated lesions; and 30-day mortality...
2018: Emergencias: Revista de la Sociedad Española de Medicina de Emergencias
Rafiq Ahmad, Nirmalya Tripathy, Min-Sang Ahn, Jin-Young Yoo, Yoon-Bong Hahn
Seed layer plays a crucial role to achieve high electrical conductivity and ensure higher performance of the devices. In this study, we report fabrication of a solution-gated field-effect transistor (FET) sensor based on zinc oxide nanorods (ZnO NRs) modified iron oxide nanoparticles (α-Fe2O3 NPs) grown on a highly conductive sandwich-like seed layer (ZnO seed layer/Ag nanowires/ZnO seed layer). The sandwich-like seed layer and ZnO NRs modification with α-Fe2O3 NPs provide excellent conductivity and prevent possible ZnO NRs surface damage from low pH enzyme immobilization, respectively...
March 16, 2018: ACS Sensors
Alicia Algeciras-Schimnich
The post-operative management of patients with differentiated thyroid carcinoma (DTC) relies on serial measurements of serum thyroglobulin. Current methodologies for thyroglobulin quantitation vary in their analytical and clinical performance. For years, thyroglobulin radioimmunoassays (RIA) and immunometric assays (IMA) have been used despite analytical interferences from anti-thyroglobulin autoantibodies (TgAb) as well as heterophile antibodies (HAb). TgAb interference limits Tg utility as a tumor marker in ∼30% of TgAb-positive patients...
March 16, 2018: Critical Reviews in Clinical Laboratory Sciences
Khairunnisa Amreen, Sivakumar Nisha, Annamalai Senthil Kumar
Direct sensing of uric acid (UA) in an undiluted whole blood sample is reported here taking human whole blood as an analyte and a self-supporting electrolyte. Among various solid electrodes (Pt, Au, GCE, and GCE/Nafion) and carbon nanomaterials (carbon nanofibers, graphene oxide, graphite nanopowder, graphitized mesoporous carbon (GMC), single-walled carbon nanotubes, and multiwalled carbon nanotubes) tested, a GMC-modified glassy carbon electrode, designated as GCE/GMC, showed a remarkable response towards direct electrochemical oxidation of blood uric acid at ∼0...
March 16, 2018: Analyst
Shuangshuang Lu, Jiayi Wu, Yan Fang, Wei Wang, Yu Zong, Xiaosong Chen, Ou Huang, Jian-Rong He, Weiguo Chen, Yafen Li, Kunwei Shen, Li Zhu
Introduction: Approximately 5% of primary breast cancer patients present de novo stage IV breast cancer, for whom systematic therapy is the mainstream treatment. The role of surgical excision of the primary tumor has been controversial due to inconsistent results of relevant studies. Recently, with the reports of some relevant preclinical data, retrospective studies and randomized clinical trials, we've got more evidence to reexamine the issue. Based on those above, a literature review and meta-analysis was performed to determine whether surgery of the primary tumor could improve overall survival in the setting of stage IV breast cancer...
February 20, 2018: Oncotarget
Sanghamitra Mohanty, Prasant Mohanty, Chintan Trivedi, Carola Gianni, Domenico G Della Rocca, Luigi Di Biase, Andrea Natale
BACKGROUND: This meta-analysis systematically evaluated the outcome of pulmonary vein isolation (PVI) with and without focal impulse and rotor modulation (FIRM) ablation in patients with atrial fibrillation. METHODS AND RESULTS: Extensive literature search was performed for studies reporting outcomes of PVI alone and PVI+FIRM procedures. For PVI alone, only randomized trials conducted in the past 3 years reporting single-procedure off-antiarrhythmic drugs success rate at ≥12-month follow-up were included...
March 2018: Circulation. Arrhythmia and Electrophysiology
Leontine Mulder, Renate van der Molen, Carin Koelman, Ester van Leeuwen, Anja Roos, Jan Damoiseaux
ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity...
March 12, 2018: Autoimmunity Reviews
Dmitry S Novikov, Jelle Veraart, Ileana O Jelescu, Els Fieremans
We develop a general analytical and numerical framework for estimating intra- and extra-neurite water fractions and diffusion coefficients, as well as neurite orientational dispersion, in each imaging voxel. By employing a set of rotational invariants and their expansion in the powers of diffusion weighting, we analytically uncover the nontrivial topology of the parameter estimation landscape, showing that multiple branches of parameters describe the measurement almost equally well, with only one of them corresponding to the biophysical reality...
March 12, 2018: NeuroImage
Bakary Sanneh, Alhagie Papa Sey, Minesh Shah, Jacqueline Tate, Mariama Sonko, Sheriffo Jagne, ModouLamin Jarju, Dawda Sowe, Makie Taal, Adam Cohen, Umesh Parashar, Jason M Mwenda
INTRODUCTION: Rotavirus vaccines protect against the leading cause of severe childhood diarrhoea, and have been introduced in many low-income African countries. The Gambia introducedRotateq® (RV5) into their national immunization program in 2013. We revieweddata from an active rotavirus sentinel surveillancesitefor early evidence of vaccine impact. METHODS: We compared rotavirus prevalence in diarrhoeal stool in children< 5 years of age admittedat the Edward Francis Small Teaching Hospital sentinel surveillance site before (2013) andafterRV5 introduction (2015-2016) in the Gambia...
March 12, 2018: Vaccine
Tao Liu, Karin D Rodland, Richard D Smith
Aberrant degradation of proteins is associated with many pathological states, including cancers. Mass spectrometric analysis of the tumor peptidome has the potential to provide biological insights on proteolytic processing in cancer. However, attempts to use the tumors peptidome information in cancer research have been fairly limited to date, largely due to the lack of effective approaches for robust peptidomics identification and quantification, and the prevalence of confounding factors and biases associated with sample handling and processing...
2018: Vitamins and Hormones
Evelina Cardoso, Thomas Mercier, Anna Dorothea Wagner, Krisztian Homicsko, Olivier Michielin, Kim Ellefsen-Lavoie, Laurène Cagnon, Manuel Diezi, Thierry Buclin, Nicolas Widmer, Chantal Csajka, Laurent Decosterd
A sensitive and selective method of high performance liquid chromatography (HPLC) coupled to tandem mass spectrometry (MS/MS) has been developed for the simultaneous quantification of six anticancer protein kinase inhibitors (PKIs), dabrafenib, trametinib, vemurafenib, cobimetinib, pazopanib, regorafenib, and two active metabolites (regorafenib-M2 and regorafenib-M5) in human plasma. Plasma protein precipitation with methanol enables the sample extraction of 100 μL aliquot of plasma. Analytes are detected by electrospray triple-stage quadrupole mass spectrometry and quantified using the calibration curves with stable isotope-labeled internal standards...
February 8, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Taylor McLinden, Erica E M Moodie, Anne-Marie Hamelin, Sam Harper, Carmine Rossi, Sharon L Walmsley, Sean B Rourke, Curtis Cooper, Marina B Klein, Joseph Cox
BACKGROUND: Severe food insecurity (FI) is common among individuals living with HIV-hepatitis C virus (HCV) co-infection. We hypothesize that the injection of opioids is partly responsible for the association between injection drug use and severe FI. Therefore, this analysis examines whether methadone maintenance treatment for opioid dependence is associated with a lower risk of severe FI. METHODS: We used biannual data from the Canadian Co-infection Cohort (N = 608, 2012-2015)...
February 20, 2018: Drug and Alcohol Dependence
Rafał Podgórski, David Aebisher, Monika Stompor, Dominika Podgórska, Artur Mazur
The aim of this paper is a straightforward presentation of the steroidogenesis process and the most common type of congenital adrenal hyperplasia (CAH) - 21-hydroxylase deficiency - as well as the analytical diagnostic methods that are used to recognize this disease. CAH is a family of common autosomal recessive disorders characterized by impaired adrenal cortisol biosynthesis with associated androgen excess due to a deficiency of one or more enzymes in the steroidogenesis process within the adrenal cortex...
March 15, 2018: Acta Biochimica Polonica
Cheng-Han Wu, Bang-Hung Yang, Yuan-Hwa Chou, Shyh-Jen Wang, Jyh-Cheng Chen
99mTc-TRODAT-1 is a type of drug that can bind to dopamine transporters in living organisms and is often used in SPCT imaging for observation of changes in the activity uptake of dopamine in the striatum. Therefore, it is currently widely used in studies on clinical diagnosis of Parkinson's disease (PD) and movement-related disorders. In conventional 99mTc-TRODAT-1 SPECT image evaluation, visual inspection or manual selection of ROI for semiquantitative analysis is mainly used to observe and evaluate the degree of striatal defects...
2018: PloS One
Vincent Plagnol, Samuel Woodhouse, Karen Howarth, Stefanie Lensing, Matt Smith, Michael Epstein, Mikidache Madi, Sarah Smalley, Catherine Leroy, Jonathan Hinton, Frank de Kievit, Esther Musgrave-Brown, Colin Herd, Katherine Baker-Neblett, Will Brennan, Peter Dimitrov, Nathan Campbell, Clive Morris, Nitzan Rosenfeld, James Clark, Davina Gale, Jamie Platt, John Calaway, Greg Jones, Tim Forshew
Circulating tumor DNA (ctDNA) analysis is being incorporated into cancer care; notably in profiling patients to guide treatment decisions. Responses to targeted therapies have been observed in patients with actionable mutations detected in plasma DNA at variant allele fractions (VAFs) below 0.5%. Highly sensitive methods are therefore required for optimal clinical use. To enable objective assessment of assay performance, detailed analytical validation is required. We developed the InVisionFirst™ assay, an assay based on enhanced tagged amplicon sequencing (eTAm-Seq™) technology to profile 36 genes commonly mutated in non-small cell lung cancer (NSCLC) and other cancer types for actionable genomic alterations in cell-free DNA...
2018: PloS One
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