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https://www.readbyqxmd.com/read/28644367/oral-cholic-acid-is-efficacious-and-well-tolerated-in-patients-with-bile-acid-synthesis-and-zellweger-spectrum-disorders
#1
James E Heubi, Kevin E Bove, Kenneth D R Setchell
BACKGROUND/AIMS: Patients with bile acid synthesis disorders (BASD) due to single enzyme defects (SED) or Zellweger spectrum disorders (ZSD) accumulate hepatotoxic atypical bile acids resulting in potentially fatal progressive liver disease. We evaluated the efficacy and safety of oral cholic acid in patients with BASD. METHODS: In this phase 3, open-label, single-arm, nonrandomized, noncomparative study conducted over 18 years, patients were administered cholic acid orally 10 to 15 mg/kg/day...
June 21, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28644160/calcitonin-gene-related-peptide-targeted-therapies-for-migraine-and-cluster-headache-a-review
#2
Nathaniel M Schuster, Alan M Rapoport
Calcitonin gene-related peptide (CGRP) is a signaling neuropeptide released from activated trigeminal sensory afferents in headache and facial pain disorders. There are a handful of CGRP-targeted therapies currently in phase 3 studies for migraine acute treatment or prevention. Currently, 4 monoclonal antibodies targeting either the CGRP ligand or receptor are being studied for migraine prevention: ALD403 (eptinezumab), AMG 334 (erenumab), LY2951742 (galcanezumab), and TEV-48125 (fremanezumab). Meanwhile, 1 small-molecule CGRP receptor antagonist (ubrogepant, MK-1602) is currently in phase 3 studies for the acute treatment of migraine...
June 21, 2017: Clinical Neuropharmacology
https://www.readbyqxmd.com/read/28644114/midostaurin-plus-chemotherapy-for-acute-myeloid-leukemia-with-a-flt3-mutation
#3
Richard M Stone, Sumithra J Mandrekar, Ben L Sanford, Kristina Laumann, Susan Geyer, Clara D Bloomfield, Christian Thiede, Thomas W Prior, Konstanze Döhner, Guido Marcucci, Francesco Lo-Coco, Rebecca B Klisovic, Andrew Wei, Jorge Sierra, Miguel A Sanz, Joseph M Brandwein, Theo de Witte, Dietger Niederwieser, Frederick R Appelbaum, Bruno C Medeiros, Martin S Tallman, Jürgen Krauter, Richard F Schlenk, Arnold Ganser, Hubert Serve, Gerhard Ehninger, Sergio Amadori, Richard A Larson, Hartmut Döhner
Background Patients with acute myeloid leukemia (AML) and a FLT3 mutation have poor outcomes. We conducted a phase 3 trial to determine whether the addition of midostaurin - an oral multitargeted kinase inhibitor that is active in patients with a FLT3 mutation - to standard chemotherapy would prolong overall survival in this population. Methods We screened 3277 patients, 18 to 59 years of age, who had newly diagnosed AML for FLT3 mutations. Patients were randomly assigned to receive standard chemotherapy (induction therapy with daunorubicin and cytarabine and consolidation therapy with high-dose cytarabine) plus either midostaurin or placebo; those who were in remission after consolidation therapy entered a maintenance phase in which they received either midostaurin or placebo...
June 23, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28642717/the-lactate-minimum-test-concept-methodological-aspects-and-insights-for-future-investigations-in-human-and-animal-models
#4
REVIEW
Leonardo H D Messias, Claudio A Gobatto, Wladimir R Beck, Fúlvia B Manchado-Gobatto
In 1993, Uwe Tegtbur proposed a useful physiological protocol named the lactate minimum test (LMT). This test consists of three distinct phases. Firstly, subjects must perform high intensity efforts to induce hyperlactatemia (phase 1). Subsequently, 8 min of recovery are allowed for transposition of lactate from myocytes (for instance) to the bloodstream (phase 2). Right after the recovery, subjects are submitted to an incremental test until exhaustion (phase 3). The blood lactate concentration is expected to fall during the first stages of the incremental test and as the intensity increases in subsequent stages, to rise again forming a "U" shaped blood lactate kinetic...
2017: Frontiers in Physiology
https://www.readbyqxmd.com/read/28642059/new-trends-on-obesity-and-nafld-in-asia
#5
REVIEW
Jian-Gao Fan, Seung-Up Kim, Vincent Wai-Sun Wong
Traditionally, obesity and its related diseases are considered problems in Western countries. However, in the past two decades, urbanization in many Asian countries has led to sedentary lifestyle and overnutrition, and has set the stage for the epidemic of obesity. This article reviews the epidemiological trend of obesity in Asia with special emphasis on the emerging condition of non-alcoholic fatty liver disease (NAFLD). Currently, the population prevalence of NAFLD in Asia is around 25%, similar to that in many Western countries...
June 19, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28642008/concurrent-once-daily-versus-twice-daily-chemoradiotherapy-in-patients-with-limited-stage-small-cell-lung-cancer-convert-an-open-label-phase-3-randomised-superiority-trial
#6
Corinne Faivre-Finn, Michael Snee, Linda Ashcroft, Wiebke Appel, Fabrice Barlesi, Adityanarayan Bhatnagar, Andrea Bezjak, Felipe Cardenal, Pierre Fournel, Susan Harden, Cecile Le Pechoux, Rhona McMenemin, Nazia Mohammed, Mary O'Brien, Jason Pantarotto, Veerle Surmont, Jan P Van Meerbeeck, Penella J Woll, Paul Lorigan, Fiona Blackhall
BACKGROUND: Concurrent chemoradiotherapy is the standard of care in limited-stage small-cell lung cancer, but the optimal radiotherapy schedule and dose remains controversial. The aim of this study was to establish a standard chemoradiotherapy treatment regimen in limited-stage small-cell lung cancer. METHODS: The CONVERT trial was an open-label, phase 3, randomised superiority trial. We enrolled adult patients (aged ≥18 years) who had cytologically or histologically confirmed limited-stage small-cell lung cancer, Eastern Cooperative Oncology Group performance status of 0-2, and adequate pulmonary function...
June 19, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28641970/the-interaction-of-caseload-and-usage-in-determining-outcomes-of-unicompartmental-knee-arthroplasty-a-meta-analysis
#7
Thomas W Hamilton, James M Rizkalla, Leonidas Kontochristos, Barbara E Marks, Stephen J Mellon, Christopher A F Dodd, Hemant G Pandit, David W Murray
BACKGROUND: Outcomes after unicompartmental knee arthroplasty (UKA) are variable and influenced by caseload (UKA/y) and usage (percentage of knee arthroplasty that are UKA), which relates to indications. This meta-analysis assesses the relative importance of these factors. METHODS: MEDLINE (Ovid), Embase (Ovid), and Web of Science (ISI) were searched for consecutive series of cemented Phase 3 Oxford medial UKA. The primary outcome was revision rate/100 observed component years (% pa) with subgroup analysis based on caseload and usage...
May 11, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28640926/clinimetric-properties-of-hip-abduction-strength-measurements-obtained-using-a-handheld-dynamometer-in-individuals-with-a-lower-extremity-amputation
#8
Ruud A Leijendekkers, Gerben van Hinte, Amy D Sman, J Bart Staal, Maria W G Nijhuis-van der Sanden, Thomas J Hoogeboom
INTRODUCTION: Suitable handheld dynamometer (HHD)-techniques to test hip abduction strength in individuals with a lower extremity amputation, irrespective of their amputation level are absent. The aim of this study was to optimise a HHD-technique and to test its reproducibility and validity. METHODS: This study involved three phases, in which two techniques were evaluated. Both HHD-techniques used a lever-arm of 22 centimetre. HHD-technique 1 used a break-technique...
2017: PloS One
https://www.readbyqxmd.com/read/28639998/the-new-parent-checklist-a-tool-to-promote-parental-reflection
#9
Elizabeth M Keys, Deborah A McNeil, Donna A Wallace, Jason Bostick, A Jocelyn Churchill, Maureen M Dodd
PURPOSE: To design and establish content and face validity of an evidenceinformed tool that promotes parental self-reflection during the transition to parenthood. STUDY DESIGN AND METHODS: The New Parent Checklist was developed using a three-phase sequential approach: (Phase 1) a scoping review and expert consultation to develop and refine a prototype tool; (Phase 2) content analysis of parent focus groups; and (Phase 3) assessment of utility in a cross-sectional sample of parents completing the New Parent Checklist and a questionnaire...
June 20, 2017: MCN. the American Journal of Maternal Child Nursing
https://www.readbyqxmd.com/read/28637744/group-clinics-for-young-adults-with-diabetes-in-an-ethnically-diverse-socioeconomically-deprived-setting-together-study-protocol-for-a-realist-review-co-design-and-mixed-methods-participatory-evaluation-of-a-new-care-model
#10
Chrysanthi Papoutsi, Dougal Hargreaves, Grainne Colligan, Ann Hagell, Anita Patel, Desirée Campbell-Richards, Russell M Viner, Shanti Vijayaraghavan, Martin Marshall, Trisha Greenhalgh, Sarah Finer
INTRODUCTION: Young adults with diabetes often report dissatisfaction with care and have poor diabetes-related health outcomes. As diabetes prevalence continues to rise, group-based care could provide a sustainable alternative to traditional one-to-one consultations, by engaging young people through life stage-, context- and culturally-sensitive approaches. In this study, we will co-design and evaluate a group-based care model for young adults with diabetes and complex health and social needs in socioeconomically deprived areas...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28637515/current-globalization-of-drug-interventional-clinical-trials-characteristics-and-associated-factors-2011-2013
#11
Sohyun Jeong, Minji Sohn, Jae Hyun Kim, Minoh Ko, Hee-Won Seo, Yun-Kyoung Song, Boyoon Choi, Nayoung Han, Han-Sung Na, Jong Gu Lee, In-Wha Kim, Jung Mi Oh, Euni Lee
BACKGROUND: Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. METHODS: The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials...
June 21, 2017: Trials
https://www.readbyqxmd.com/read/28637104/-treatment-options-in-non-alcoholic-fatty-liver-disease
#12
REVIEW
Won Kim
The prevalence of non-alcoholic fatty liver disease (NAFLD) has sharply increased over the past several decades in Korea. In most cases of NAFLD, metabolic stress and cellular apoptosis are often driven by metabolic abnormality, eventually leading to inflammation and fibrosis . Along with a dramatic surge in the obesity epidemic, 10-20% of NAFLD patients ultimately progress to non-alcoholic steatohepatitis (NASH), a precursor to cirrhosis and hepatocellular carcinoma, as well as multi-organ systemic diseases...
June 25, 2017: Korean Journal of Gastroenterology, Taehan Sohwagi Hakhoe Chi
https://www.readbyqxmd.com/read/28636851/first-line-nivolumab-in-stage-iv-or-recurrent-non-small-cell-lung-cancer
#13
COMMENT
David P Carbone, Martin Reck, Luis Paz-Ares, Benjamin Creelan, Leora Horn, Martin Steins, Enriqueta Felip, Michel M van den Heuvel, Tudor-Eliade Ciuleanu, Firas Badin, Neal Ready, T Jeroen N Hiltermann, Suresh Nair, Rosalyn Juergens, Solange Peters, Elisa Minenza, John M Wrangle, Delvys Rodriguez-Abreu, Hossein Borghaei, George R Blumenschein, Liza C Villaruz, Libor Havel, Jana Krejci, Jesus Corral Jaime, Han Chang, William J Geese, Prabhu Bhagavatheeswaran, Allen C Chen, Mark A Socinski
BACKGROUND: Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC. METHODS: We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles)...
June 22, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28636292/-head-and-neck-cancer-promising-results-of-immunotherapy
#14
Aurélie Sivade, Djamila Bensaid, Yan Monnier, Keyvan Shabafrouz, Hanan Bouchaab, Valérie Cristina
Immunotherapy, especially checkpoint inhibitors such as anti-PD1 and anti-PDL1 antibodies, has changed the standard of care and the prognosis of melanoma, but also more recently of lung cancer, renal cancer and Hodgkin lymphoma. Results of preliminary studies in head and neck squamous cell carcinoma (HNSCC) as well as in less frequent tumors of the region, such as nasopharyngeal carcinoma and high grade salivary gland carcinoma, are also promising. Indeed, in a recent phase 3 study, the PD1 inhibitor nivolumab has recently demonstrated a significant improvement in overall survival for platin-resistant recurrent and/or metastatic HNSCC...
May 17, 2017: Revue Médicale Suisse
https://www.readbyqxmd.com/read/28634649/assessment-of-cabozantinib-treatment-on-qt-interval-in-a-phase-3-study-in-medullary-thyroid-cancer-evaluation-of-indirect-qt-effects-mediated-through-treatment-induced-changes-in-serum-electrolytes
#15
Dale R Miles, Steven A Lacy, David R Wada, Steve Milwee, Yifah Yaron, Linh T Nguyen
PURPOSE: This study evaluated factors impacting QTc interval in a phase 3 trial of cabozantinib in progressive, metastatic, medullary thyroid cancer (MTC). METHODS: Electrocardiogram (12-lead ECG) measurements were obtained at screening, and at pre-dose, and 2, 4, and 6 h post-dose on Days 1 and 29 in a phase 3 study in patients with MTC treated with cabozantinib (140 mg/day). Central tendency analyses were conducted on baseline-corrected QTc values. Linear and nonlinear mixed-effects models were used to evaluate potential factors affecting the QTc interval, including serum electrolytes, patient demographics, and cabozantinib concentration...
June 20, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28634000/dose-dependent-effects-of-abobotulinumtoxina-dysport%C3%A2-on-spasticity-and-active-movements-in-adults-with-upper-limb-spasticity-secondary-analysis-of-a-phase-3-study
#16
Michael W O'Dell, Allison Brashear, Robert Jech, Thierry Lejeune, Philippe Marque, Djamel Bensmail, Ziyad Ayyoub, David M Simpson, Magali Volteau, Claire Vilain, Philippe Picaut, Jean Michel Gracies
BACKGROUND: AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. OBJECTIVE: To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DESIGN: Secondary analysis of a phase 3 study (NCT01313299). SETTING: Multi-center, international, double-blind, placebo-controlled clinical trial...
June 17, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28633953/reversal-learning-and-resurgence-of-operant-behavior-in-zebrafish-danio-rerio
#17
Toshikazu Kuroda, Yuto Mizutani, Carlos R X Cançado, Christopher A Podlesnik
Zebrafish are used extensively as vertebrate animal models in biomedical research for having such features as a fully sequenced genome and transparent embryo. Yet, operant-conditioning studies with this species are scarce. The present study investigated reversal learning and resurgence of operant behavior in zebrafish. A target response (approaching a sensor) was reinforced in Phase 1. In Phase 2, the target response was extinguished while reinforcing an alternative response (approaching a different sensor)...
June 17, 2017: Behavioural Processes
https://www.readbyqxmd.com/read/28631497/cost-effectiveness-of-blinatumomab-versus-salvage-chemotherapy-in-relapsed-or-refractory-philadelphia-chromosome-negative-b-precursor-acute-lymphoblastic-leukemia-from-a-us-payer-perspective
#18
Thomas E Delea, Jordan Amdahl, Diana Boyko, May Hagiwara, Zachary F Zimmerman, Janet L Franklin, Ze Cong, Guy Hechmati, Anthony Stein
Objective To evaluate the cost-effectiveness of blinatumomab (Blincyto) versus standard of care (SOC) chemotherapy in adults with relapsed or refractory (R/R) Philadelphia-chromosome-negative (Ph-) B-precursor acute lymphoblastic leukemia (ALL) based on the results of the phase 3 TOWER study from a US healthcare payer perspective. Methods The Blincyto Global Economic Model (B-GEM), a partitioned survival model, was used to estimate the incremental cost-effectiveness ratio (ICER) of blinatumomab versus SOC. Response rates, event free survival (EFS), overall survival (OS), numbers of cycles of blinatumomab and SOC, and transplant rates were estimated from TOWER...
June 20, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28630189/in-vitro-activity-of-delafloxacin-and-microbiological-response-against-fluoroquinolone-susceptible-and-non-susceptible-s-aureus-isolates-from-two-phase-3-studies-of-acute-bacterial-skin-and-skin-structure-infections-absssi
#19
S McCurdy, L Lawrence, M Quintas, L Woosley, R Flamm, C Tseng, S Cammarata
Delafloxacin is an investigational anionic fluoroquinolone antibiotic with broad spectrum in vitro activity, including Gram-positive organisms, Gram-negative organisms, atypical organisms, and anaerobes. The in vitro activity of delafloxacin and percent microbiological response in subjects infected with fluoroquinolone susceptible and non-susceptible S. aureus isolates was determined from two global Phase 3 studies of delafloxacin versus vancomycin plus aztreonam in ABSSSI. Patients were enrolled in 23 countries predominately in the US but also Eastern Europe, South America and Asia...
June 19, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28626439/attentive-observation-is-essential-for-the-misattribution-of-agency-to-self-performance
#20
Shiho Kashihara, Noriaki Kanayama, Makoto Miyatani, Takashi Nakao
Recent studies have repeatedly demonstrated a false memory phenomenon in which people falsely remember having performed an action by oneself when in fact they have only observed the action by another person. We investigated the attentional effect to the action itself on the observation inflation. Fifty-four participants first performed and read actions (Phase 1); then, they observed the action video that showed another's actions (Phase 2), some of which they had not performed in Phase 1. In the Phase 2, they were required to focus on either the actor's performance (i...
2017: Frontiers in Psychology
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