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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
#1
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/28637104/-treatment-options-in-non-alcoholic-fatty-liver-disease
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
https://www.readbyqxmd.com/read/28626220/a-phase-3-randomized-placebo-controlled-trial-of-darbepoetin-alfa-in-patients-with-anemia-and-lower-risk-myelodysplastic-syndromes
#11
U Platzbecker, A Symeonidis, E N Oliva, J S Goede, M Delforge, J Mayer, B Slama, S Badre, E Gasal, B Mehta, J Franklin
Use of darbepoetin alfa to treat anemia in patients with lower-risk myelodysplastic syndromes (MDS) was evaluated in a phase 3 trial. Eligible patients had low/intermediate-1 risk MDS, hemoglobin ⩽10 g/dl, low transfusion burden, and serum erythropoietin ⩽500 mU/ml. Patients were randomized 2:1 to receive 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin alfa. A total of 147 patients were randomized, with median hemoglobin of 9...
June 19, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28625627/a-multicenter-randomized-phase-3-trial-comparing-fixed-dose-versus-toxicity-adjusted-dose-of-cisplatin-etoposide-in-extensive-small-cell-lung-cancer-sclc-patients-the-small-cell-lung-cancer-toxicity-adjusted-dosing-stad-1-trial
#12
Alessandro Morabito, Gennaro Daniele, Raffaele Costanzo, Adolfo Gino Favaretto, Virgilio Filipazzi, Antonio Rossi, Vittorio Gebbia, Federico Castiglione, Luigi Cavanna, Evaristo Maiello, Claudia Sandomenico, Laura Bonanno, Elena Piazza, Paolo Maione, Maria Carmela Piccirillo, Massimo Di Maio, Gaetano Rocco, Ciro Gallo, Francesco Perrone, Cesare Gridelli
OBJECTIVES: Data supporting the prognostic role of chemotherapy induced haematological toxicity suggest that toxicity-adjusted-dosing (TAD) of chemotherapy might improve treatment efficacy. We tested whether TAD of the cisplatin-etoposide combination might improve the response rate, in previously untreated extensive stage disease (ED)-SCLC patients, as compared with standard fixed-dosing (FD). METHODS: Patients with ED-SCLC were randomized to receive either TAD or FD of cisplatin-etoposide as first-line treatment...
June 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28625615/efficacy-and-safety-of-abobotulinumtoxina-dysport%C3%A2-for-the-treatment-of-hemiparesis-in-adults-with-upper-limb-spasticity-previously-treated-with-botulinum-toxin-sub-analysis-from-a-phase-3-randomized-controlled-trial
#13
Christina Marciniak, Peter McAllister, Heather Walker, Allison Brashear, Steven Edgley, Thierry Deltombe, Svetlana Khatkova, Marta Banach, Fatma Gul, Claire Vilain, Philippe Picaut, Anne-Sophie Grandoulier, Jean-Michel Gracies
OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). DESIGN: A post-hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study SETTING: 34 neurology or rehabilitation clinics in nine countries. PARTICIPANTS: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n=105 of 243 in the total trial population) in the affected limb...
June 15, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28625368/effect-of-aspirin-on-renal-disease-progression-in-patients-with-type-2-diabetes-a-multicenter-double-blind-placebo-controlled-randomized-trial-the-renal-disease-progression-by-aspirin-in-diabetic-patients-leda-trial-rationale-and-study-design
#14
Francesco Violi, Giovanni Targher, Annarita Vestri, Roberto Carnevale, Maurizio Averna, Alessio Farcomeni, Andrea Lenzi, Francesco Angelico, Francesco Cipollone, Daniele Pastori
Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic kidney disease and kidney failure. It has been estimated that the annual decline of estimated glomerular filtration rate (eGFR) among patients with T2DM is approximately 2.0-2.5mL min(-1) y(-1). Cyclooxygenase-dependent eicosanoids, such as 11-dehydro-thromboxane (Tx)B2, are increased in T2DM patients and are potentially involved in the regulation of renal blood flow. Animal models showed that cyclooxygenase inhibitors, such as aspirin, are associated with improvements in renal plasma flow and eGFR values...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28625204/effect-of-aripiprazole-lauroxil-in-patients-with-acute-schizophrenia-as-assessed-by-the-positive-and-negative-syndrome-scale-supportive-analyses-from-a-phase-3-study
#15
Leslie Citrome, Robert Risinger, Andrew J Cutler, Yangchun Du, Jacqueline Zummo, Henry A Nasrallah, Bernard L Silverman
OBJECTIVE: Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic that was evaluated for the treatment of schizophrenia in a randomized, placebo-controlled, Phase 3 study. Here, we present exploratory analyses of supportive efficacy endpoints. METHODS: Patients experiencing an acute exacerbation of schizophrenia received AL 441 mg intramuscularly (IM), AL 882 mg IM, or matching placebo IM monthly. Supportive endpoints included changes from baseline at subsequent time points in Clinical Global Impression-Severity (CGI-S) scale score; Positive and Negative Syndrome Scale (PANSS) Total score; PANSS Positive, Negative, and General Psychopathology subscale scores; PANSS Marder factors (post hoc); and PANSS responder rate...
June 19, 2017: CNS Spectrums
https://www.readbyqxmd.com/read/28624096/a-multiregional-randomized-evaluation-of-the-lipid-modifying-efficacy-and-tolerability-of-anacetrapib-added-to-ongoing-statin-therapy-in-patients-with-hypercholesterolemia-or-low-high-density-lipoprotein-cholesterol
#16
Christie M Ballantyne, Sukrut Shah, Aditi Sapre, Tanya B Ashraf, Sandra C Tobias, Tayfun Sahin, Ping Ye, Yugang Dong, Wayne Huey-Heng Sheu, Duk-Hyun Kang, Paulo Roberto Ferreira Rossi, Yulia Moiseeva, Ignacio Rodriguez Briones, Amy O Johnson-Levonas, Yale B Mitchel
This phase 3, multiregional, randomized, double-blind, placebo-controlled study assessed the efficacy/safety profile of anacetrapib added to ongoing therapy with statin ± other lipid-modifying therapies in patients with hypercholesterolemia who were not at their low-density lipoprotein (LDL-C) goal (as per the National Cholesterol Education Program Adult Treatment Panel III guidelines) and in those with low high-density lipoprotein cholesterol (HDL-C). Patients on a stable dose of statin ± other lipid-modifying therapies and with LDL-C ≥70 to <115, ≥100 to <145, ≥130, or ≥160 mg/dl for very high, high, moderate, or low CHD risk or at LDL-C goal (per CHD risk category) with HDL-C ≤40 mg/dl were randomized in a ratio of 1:1 to anacetrapib 100 mg (n = 290) or placebo (n = 293) for 24 weeks, followed by a 12-week off-drug phase...
April 12, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28623954/efficacy-and-safety-of-alirocumab-in-patients-with-hypercholesterolemia-not-adequately-controlled-with-non-statin-lipid-lowering-therapy-or-the-lowest-strength-of-statin-odyssey-nippon-study-design-and-rationale
#17
Tamio Teramoto, Akira Kondo, Arihiro Kiyosue, Mariko Harada-Shiba, Yasushi Ishigaki, Kimimasa Tobita, Yumiko Kawabata, Asuka Ozaki, Marie T Baccara-Dinet, Masataka Sata
BACKGROUND: Statins are generally well-tolerated and serious side effects are infrequent, but some patients experience adverse events and reduce their statin dose or discontinue treatment altogether. Alirocumab is a highly specific, fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), which can produce substantial and sustained reductions of low-density lipoprotein cholesterol (LDL-C). METHODS: The randomized, double-blind, placebo-controlled, parallel-group, phase 3 ODYSSEY NIPPON study will explore alirocumab 150 mg every 4 weeks (Q4W) in 163 Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin (5 mg/day) or are receiving a non-statin lipid-lowering therapy (LLT) (fenofibrate, bezafibrate, ezetimibe, or diet therapy alone)...
June 17, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28623614/abobotulinumtoxina-a-review-in-pediatric-lower-limb-spasticity
#18
Yahiya Y Syed
AbobotulinumtoxinA (Dysport(®)) is currently the only botulinum toxin A formulation approved by the US FDA for the treatment of lower limb spasticity in pediatric patients aged ≥2 years. Intramuscular abobotulinumtoxinA was approved based on the results of a pivotal phase 3 trial in children with lower limb spasticity due to cerebral palsy. In this trial, a single treatment cycle with abobotulinumtoxinA 10-15 U/kg/leg injected into the gastrocnemius and soleus muscles significantly improved ankle plantar flexor muscle tone (primary endpoint), with abobotulinumtoxinA recipients showing a significant response to treatment relative to placebo...
June 16, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28622913/targeting-urate-to-reduce-oxidative-stress-in-parkinson-disease
#19
REVIEW
Grace F Crotty, Alberto Ascherio, Michael A Schwarzschild
Oxidative stress has been implicated as a core contributor to the initiation and progression of multiple neurological diseases. Genetic and environmental factors can produce oxidative stress through mitochondrial dysfunction leading to the degeneration of dopaminergic and other neurons underlying Parkinson disease (PD). Although clinical trials of antioxidants have thus far failed to demonstrate slowed progression of PD, oxidative stress remains a compelling target. Rather than prompting abandonment of antioxidant strategies, these failures have raised the bar for justifying drug and dosing selections and for improving study designs to test for disease modification by antioxidants...
June 13, 2017: Experimental Neurology
https://www.readbyqxmd.com/read/28620346/primary-progressive-multiple-sclerosis-putting-together-the-puzzle
#20
REVIEW
Ahmed Abdelhak, Martin S Weber, Hayrettin Tumani
The focus of multiple sclerosis research has recently turned to the relatively rare and clearly more challenging condition of primary progressive multiple sclerosis (PPMS). Many risk factors such as genetic susceptibility, age, and Epstein-Barr virus (EBV) infection may interdepend on various levels, causing a complex pathophysiological cascade. Variable pathological mechanisms drive disease progression, including inflammation-associated axonal loss, continuous activation of central nervous system resident cells, such as astrocytes and microglia as well as mitochondrial dysfunction and iron accumulation...
2017: Frontiers in Neurology
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