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https://www.readbyqxmd.com/read/28230615/the-effect-of-intravenous-acetaminophen-on-postoperative-pain-and-narcotic-consumption-after-vaginal-reconstructive-surgery-a-double-blind-randomized-placebo-controlled-trial
#1
Catrina C Crisp, Madiha Khan, Donna L Lambers, Lauren B Westermann, Donna M Mazloomdoost, Jennifer J Yeung, Steven D Kleeman, Rachel N Pauls
OBJECTIVE: This study aimed to determine the effect of intravenous acetaminophen versus placebo on postoperative pain, satisfaction with pain control, and narcotic use after vaginal reconstructive surgery. METHODS: This was an institutional review board-approved, double-blind placebo-controlled randomized trial. Women scheduled for reconstructive surgery including vaginal hysterectomy and vaginal vault suspension were enrolled. Subjects received 1000 mg of intravenous acetaminophen or 100 mL placebo every 6 hours for 24 hours...
March 2017: Female Pelvic Medicine & Reconstructive Surgery
https://www.readbyqxmd.com/read/28230262/evaluation-of-the-immunogenicity-of-the-dabigatran-reversal-agent-idarucizumab-during-phase-i-studies
#2
Stephen Norris, Steven Ramael, Ippei Ikushima, Wouter Haazen, Akiko Harada, Viktoria Moschetti, Susumu Imazu, Paul A Reilly, Benjamin Lang, Joachim Stangier, Stephan Glund
AIMS: Idarucizumab, a humanized monoclonal anti-dabigatran antibody fragment, is effective in emergency reversal of dabigatran anticoagulation. Pre-existing and treatment-emergent anti-idarucizumab antibodies (antidrug antibodies; ADA) may affect the safety and efficacy of idarucizumab. This analysis characterized the pre-existing and treatment-emergent ADA and assessed their impact on the pharmacokinetics and pharmacodynamics (PK/PD) of idarucizumab. METHODS: Data were pooled from three phase I, randomized, double-blind idarucizumab studies in healthy Caucasian; elderly, renally impaired subjects; and healthy Japanese subjects...
February 23, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28230252/randomized-double-blind-placebo-controlled-phase-2-study-of-ganaxolone-as-add-on-therapy-in-adults-with-uncontrolled-partial-onset-seizures
#3
Michael R Sperling, Pavel Klein, Julia Tsai
OBJECTIVE: To evaluate the efficacy and safety of ganaxolone as adjunctive therapy in adults with uncontrolled partial-onset seizures despite taking up to three concomitant antiepileptic drugs (AEDs). METHODS: Adults aged 18-69 years and refractory to conventional AEDs were enrolled in a multicenter, double-blind, placebo-controlled trial. After an 8-week baseline period, patients were randomized 2:1 to ganaxolone 1,500 mg/day or placebo for a 10-week treatment period (2-week forced titration and 8-week maintenance) followed by either tapering or entry into an open-label extension study...
February 23, 2017: Epilepsia
https://www.readbyqxmd.com/read/28229893/safety-and-efficacy-of-natalizumab-in-patients-with-acute-ischaemic-stroke-action-a-randomised-placebo-controlled-double-blind-phase-2-trial
#4
Jacob Elkins, Roland Veltkamp, Joan Montaner, S Claiborne Johnston, Aneesh B Singhal, Kyra Becker, Maarten G Lansberg, Weihua Tang, Ih Chang, Kumar Muralidharan, Sarah Gheuens, Lahar Mehta, Mitchell S V Elkind
BACKGROUND: In animal models of acute ischaemic stroke, blocking of the leukocyte-endothelium adhesion by antagonism of α4 integrin reduces infarct volumes and improves outcomes. We assessed the effect of one dose of natalizumab, an antibody against the leukocyte adhesion molecule α4 integrin, in patients with acute ischaemic stroke. METHODS: In this double-blind, phase 2 study, patients with acute ischaemic stroke (aged 18-85 years) from 30 US and European clinical sites were randomly assigned (1:1) to 300 mg intravenous natalizumab or placebo with stratification by treatment window and baseline infarct size...
March 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28229892/safety-and-efficacy-of-opicinumab-in-acute-optic-neuritis-renew-a-randomised-placebo-controlled-phase-2-trial
#5
Diego Cadavid, Laura Balcer, Steven Galetta, Orhan Aktas, Tjalf Ziemssen, Ludo Vanopdenbosch, Jette Frederiksen, Mark Skeen, Glenn J Jaffe, Helmut Butzkueven, Focke Ziemssen, Luca Massacesi, Yi Chai, Lei Xu, Stefanie Freeman
BACKGROUND: The human monoclonal antibody opicinumab (BIIB033, anti-LINGO-1) has shown remyelinating activity in preclinical studies. We therefore assessed the safety and tolerability, and efficacy of opicinumab given soon after a first acute optic neuritis episode. METHODS: This randomised, double-blind, placebo-controlled, phase 2 study (RENEW) was done at 33 sites in Australia, Canada, and Europe in participants (aged 18-55 years) with a first unilateral acute optic neuritis episode within 28 days from study baseline...
March 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28229572/coenzyme-q10-does-not-prevent-exercise-induced-muscle-damage-and-oxidative-stress-in-sedentary-men
#6
Nilsel Okudan, Muaz Belviranli, Savaş Torlak
BACKGROUND: The objective of this study was to examine the effects of coenzyme Q10 (CoQ10) supplementation on exercise-induced muscle damage and oxidative stress in sedentary young men. In this study, a total of twenty one sedentary and healthy young men participated. METHODS: Participants were assigned at random to a CoQ10 or a placebo group employing a double-blind method. Those in the CoQ10 group ingested 200 mg CoQ10 per day for 4 weeks. Those in the placebo group ingested the same dosage of a placebo...
February 22, 2017: Journal of Sports Medicine and Physical Fitness
https://www.readbyqxmd.com/read/28229548/oligofructose-decreases-serum-lipopolysaccharide-and-plasminogen-activator-inhibitor-1-in-adults-with-overweight-obesity
#7
Jill A Parnell, Teja Klancic, Raylene A Reimer
OBJECTIVE: To determine the effect of prebiotic supplementation on metabolic endotoxemia and systemic inflammation in adults with overweight and obesity. METHODS: Samples from a previously conducted randomized, double-blind, placebo-controlled trial were used for analysis. Participants were randomized to 21 g of oligofructose (n = 20; BMI 30.4 kg/m(2) ) or a maltodextrin placebo (n = 17; BMI 29.5 kg/m(2) ) for 12 weeks. A total of 37 participants had samples available for the current analysis...
March 2017: Obesity
https://www.readbyqxmd.com/read/28228782/safety-and-effectiveness-of-teriparatide-vs-alendronate-in-postmenopausal-osteoporosis-a-prospective-non-randomized-clinical-study
#8
Gianfilippo Caggiari, Paolo Tranquilli Leali, Giulia Raffaella Mosele, Leonardo Puddu, Francesca Badessi, Carlo Doria
In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤-2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer...
September 2016: Clinical Cases in Mineral and Bone Metabolism
https://www.readbyqxmd.com/read/28228781/denosumab-is-really-effective-in-the-treatment-of-osteoporosis-secondary-to-hypogonadism-in-prostate-carcinoma-patients-a-prospective-randomized-multicenter-international-study
#9
Carlo Doria, Paolo Tranquilli Leali, Federico Solla, Gianluca Maestretti, Massimo Balsano, Robero Mario Scarpa
INTRODUCTION: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone...
September 2016: Clinical Cases in Mineral and Bone Metabolism
https://www.readbyqxmd.com/read/28228695/accessory-joint-and-neural-mobilizations-for-shoulder-range-of-motion-restriction-after-breast-cancer-surgery-a-pilot-randomized-clinical-trial
#10
Irene de la Rosa Díaz, María Torres Lacomba, Ester Cerezo Téllez, Cristina Díaz Del Campo Gómez-Rico, Carlos Gutiérrez Ortega
OBJECTIVE: The aim of this study was to assess the methods to conduct a substantive clinical trial to evaluate the effects of accessory joint mobilization (AJM) vs neural mobilization (NM) techniques for shoulder motion restriction after breast cancer surgery. METHODS: This pilot study was a prospective randomized and double-blind clinical trial in which 18 women who underwent unilateral breast cancer surgery and axillary lymph node dissection participated. The study was conducted at the Women's Health Research Group at the Physical Therapy Department of Alcalá University, Madrid, Spain...
March 2017: Journal of Chiropractic Medicine
https://www.readbyqxmd.com/read/28228578/proof-of-concept-randomized-trial-of-the-monoclonal-antibody-gsk249320-versus-placebo-in-stroke-patients
#11
Steven C Cramer, Lori A Enney, Colleen K Russell, Monica Simeoni, Thomas R Thompson
BACKGROUND AND PURPOSE: One class of poststroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein. The purpose of the current study was to extend preclinical and clinical findings of GSK249320, a humanized monoclonal antibody to myelin-associated glycoprotein with disabled Fc region, to explore effects on motor outcomes post-stroke. METHODS: In this phase IIb double-blind, randomized, placebo-controlled study, patients at 30 centers with ischemic stroke 24 to 72 hours prior and gait deficits were randomized to 2 IV infusions of GSK249320 or placebo...
February 22, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28228504/the-dynamics-of-gastric-emptying-and-self-reported-feelings-of-satiation-are-better-predictors-than-gastrointestinal-hormones-of-the-effects-of-lipid-emulsion-structure-on-fat-digestion-in-healthy-adults-a-bayesian-inference-approach
#12
Andreas Steingoetter, Simon Buetikofer, Jelena Curcic, Dieter Menne, Jens F Rehfeld, Michael Fried, Werner Schwizer, Tim J Wooster
Background: Limited information exists on the relation between fat emulsion structure and its effect on the release of gastrointestinal hormones and feelings of satiation.Objective: We investigated the impact of fat emulsion droplet size, gravitational and acid stability, and redispersibility on gastrointestinal responses and sought to deduce the relative importance of the hormones ghrelin, cholecystokinin, glucagon-like peptide-1, and peptide YY (PYY) in controlling fat emptying and related satiation.Methods: Within a randomized, double-blind, 4-armed crossover study, an extensive data set was generated by MRI of gastric function, analysis of hormone profiles, and ratings of satiation in healthy participants [10 women and 7 men with a mean ± SD age of 25 ± 7 y and body mass index (in kg/m(2)) of 22 ± 1] after intake of 4 different fat emulsions...
February 22, 2017: Journal of Nutrition
https://www.readbyqxmd.com/read/28228426/probiotics-lactobacillus-gasseri-ks-13-bifidobacterium-bifidum-g9-1-and-bifidobacterium-longum-mm-2-improve-rhinoconjunctivitis-specific-quality-of-life-in-individuals-with-seasonal-allergies-a-double-blind-placebo-controlled-randomized-trial
#13
Jennifer C Dennis-Wall, Tyler Culpepper, Carmelo Nieves, Cassie C Rowe, Alyssa M Burns, Carley T Rusch, Ashton Federico, Maria Ukhanova, Sheldon Waugh, Volker Mai, Mary C Christman, Bobbi Langkamp-Henken
Background: Rhinoconjunctivitis-specific quality of life is often reduced during seasonal allergies. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MRQLQ) is a validated tool used to measure quality of life in people experiencing allergies (0 = not troubled to 6 = extremely troubled). Probiotics may improve quality of life during allergy season by increasing the percentage of regulatory T cells (Tregs) and inducing tolerance.Objective: The objective of this study was to determine whether consuming Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and B...
February 22, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28228425/prebiotic-supplementation-improves-appetite-control-in-children-with-overweight-and-obesity-a-randomized-controlled-trial
#14
Megan P Hume, Alissa C Nicolucci, Raylene A Reimer
Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk...
February 22, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28228418/folic-acid-supplementation-increases-cutaneous-vasodilator-sensitivity-to-sympathetic-nerve-activity-in-older-adults
#15
Anna E Stanhewicz, Jody L Greaney, Lacy M Alexander, W Larry Kenney
During heat stress, blunted increases in skin sympathetic nervous system activity (SSNA) and reductions in end-organ vascular responsiveness contribute to the age-related reduction in reflex cutaneous vasodilation. In older adults, folic acid supplementation improves the cutaneous vascular conductance (CVC) response to passive heating; however, the influence of folic acid supplementation on SSNA:CVC transduction is unknown. Fourteen older adults (66±1yrs, 8M/6F) ingested folic acid (5mg·day(-1)) or placebo for 6 weeks in a randomized, double-blind, crossover design...
February 22, 2017: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
https://www.readbyqxmd.com/read/28228148/the-effect-of-melatonin-on-depressive-symptoms-anxiety-circadian-and-sleep-disturbances-in-patients-after-acute-coronary-syndrome-medacis-study-protocol-for-a-randomized-controlled-trial
#16
Michael Tvilling Madsen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur
BACKGROUND: Depression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressive symptoms are even more frequent. Furthermore, anxiety symptoms and sleep-wake disturbances are frequent. The objective of the MEDACIS trial is to investigate whether prophylactic treatment with melatonin has a preventive effect on depression, depressive and anxiety symptoms, sleep, and circadian disturbances following ACS...
February 23, 2017: Trials
https://www.readbyqxmd.com/read/28228137/erratum-to-randomized-double-blind-clinical-trial-on-the-effect-of-oral-%C3%AE-cyclodextrin-on-serum-lipids
#17
Marcelo J A Amar, Maryann Kaler, Amber B Courville, Robert Shamburek, Maureen Sampson, Anna Wolska, Alan T Remaley
No abstract text is available yet for this article.
February 22, 2017: Lipids in Health and Disease
https://www.readbyqxmd.com/read/28228114/efficacy-of-1-5-and-20%C3%A2-mg-oral-sildenafil-in-the-treatment-of-adults-with-pulmonary-arterial-hypertension-a-randomized-double-blind-study-with-open-label-extension
#18
Carmine Dario Vizza, B K S Sastry, Zeenat Safdar, Lutz Harnisch, Xiang Gao, Min Zhang, Manisha Lamba, Zhi-Cheng Jing
BACKGROUND: In a previous study, 6-minute walk distance (6MWD) improvement with sildenafil was not dose dependent at the 3 doses tested (20, 40, and 80 mg 3 times daily [TID]). This study assessed whether lower doses were less effective than the approved 20-mg TID dosage. METHODS: Treatment-naive patients with pulmonary arterial hypertension were randomized to 12 weeks of double-blind sildenafil 1, 5, or 20 mg TID; 12 weeks of open-label sildenafil 20 mg TID followed...
February 23, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/28228106/long-term-treatment-with-ruxolitinib-for-patients-with-myelofibrosis-5-year-update-from-the-randomized-double-blind-placebo-controlled-phase-3-comfort-i-trial
#19
Srdan Verstovsek, Ruben A Mesa, Jason Gotlib, Vikas Gupta, John F DiPersio, John V Catalano, Michael W N Deininger, Carole B Miller, Richard T Silver, Moshe Talpaz, Elliott F Winton, Jimmie H Harvey, Murat O Arcasoy, Elizabeth O Hexner, Roger M Lyons, Ronald Paquette, Azra Raza, Mark Jones, Deanna Kornacki, Kang Sun, Hagop Kantarjian
BACKGROUND: The randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial evaluated the JAK1/JAK2 inhibitor ruxolitinib in patients with intermediate-2/high-risk myelofibrosis. The primary and planned 3-year analyses of COMFORT-I data demonstrated that ruxolitinib-the first myelofibrosis-approved therapy-reduced splenomegaly and prolonged overall survival versus placebo. Here, we present the final 5-year results. METHODS: Patients managed in Australia, Canada, and the USA were randomized centrally (interactive voice response system) 1:1 to oral ruxolitinib twice daily (15 or 20 mg per baseline platelet counts) or placebo...
February 22, 2017: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/28226340/oral-oxycodone-for-acute-postoperative-pain-a-review-of-clinical-trials
#20
Chi Wai Cheung, Stanley Sau Ching Wong, Qiu Qiu, Xianyu Wang
BACKGROUND: Opioids are the mainstay of pain management for acute postsurgical pain. Oral oxycodone is an opioid that can provide effective acute postoperative pain relief. OBJECTIVES: To evaluate the use of oral oxycodone for acute postoperative pain management. STUDY DESIGN: This is a narrative review based on published articles searched in PubMed and Medline from 2003 to 2015 on oral oxycodone for acute postoperative pain management. METHODS: Clinical trials related to the use of oral oxycodone for acute postoperative pain management were searched via PubMed and Medline from 2003 to 2015...
February 2017: Pain Physician
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