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Randomized placebo controlled double blind

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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/28230252/randomized-double-blind-placebo-controlled-phase-2-study-of-ganaxolone-as-add-on-therapy-in-adults-with-uncontrolled-partial-onset-seizures
#2
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
#3
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/28229548/oligofructose-decreases-serum-lipopolysaccharide-and-plasminogen-activator-inhibitor-1-in-adults-with-overweight-obesity
#4
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/28228578/proof-of-concept-randomized-trial-of-the-monoclonal-antibody-gsk249320-versus-placebo-in-stroke-patients
#5
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/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
#6
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
#7
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/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
#8
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/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
#9
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
#10
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
https://www.readbyqxmd.com/read/28225996/effect-of-diacerein-as-an-add-on-to-metformin-in-patients-with-type-2-diabetes-mellitus-and-inadequate-glycemic-control
#11
Miriam Méndez-Del Villar, Esperanza Martínez-Abundis, Rafael O Preciado-Márquez, Manuel González-Ortiz
Objective: To evaluate the effect of diacerein as an add-on to metformin in patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control. Materials and methods: A randomized, double-blind, placebo-controlled clinical trial was carried out on 12 patients with T2DM and inadequate glycemic control [glycated hemoglobin A1c (A1C) ≥ 7%] with metformin as monotherapy (≥ 1500 mg per day) for at least the previous 90 days. Fasting and postprandial glucose were measured before and after the pharmacological intervention...
February 13, 2017: Archives of Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28225674/inhibiting-plasma-kallikrein-for-hereditary-angioedema-prophylaxis
#12
Aleena Banerji, Paula Busse, Mustafa Shennak, William Lumry, Mark Davis-Lorton, Henry J Wedner, Joshua Jacobs, James Baker, Jonathan A Bernstein, Richard Lockey, H Henry Li, Timothy Craig, Marco Cicardi, Marc Riedl, Ahmad Al-Ghazawi, Carolyn Soo, Ryan Iarrobino, Daniel J Sexton, Christopher TenHoor, Jon A Kenniston, Ryan Faucette, J Gordon Still, Harvey Kushner, Robert Mensah, Chris Stevens, Joseph C Biedenkapp, Yung Chyung, Burt Adelman
Background Hereditary angioedema with C1 inhibitor deficiency is characterized by recurrent, unpredictable swelling episodes caused by uncontrolled plasma kallikrein generation and excessive bradykinin release resulting from cleavage of high-molecular-weight kininogen. Lanadelumab (DX-2930) is a new kallikrein inhibitor with the potential for prophylactic treatment of hereditary angioedema with C1 inhibitor deficiency. Methods We conducted a phase 1b, multicenter, double-blind, placebo-controlled, multiple-ascending-dose trial...
23, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28225506/effects-of-single-dose-preemptive-intravenous-ibuprofen-on-postoperative-opioid-consumption-and-acute-pain-after-laparoscopic-cholecystectomy
#13
Elif Oral Ahiskalioglu, Ali Ahiskalioglu, Pelin Aydin, Ahmet Murat Yayik, Ayetullah Temiz
BACKGROUND: Although studies involving intravenous (IV) ibuprofen are still limited, it has been shown to have a potential role in the treatment of postoperative pain. The primary objective of this study was to investigate the effects of preemptive IV ibuprofen on postoperative 24 hour opioid consumption and postoperative pain in patients undergoing laparoscopic cholecystectomy. METHODS: Following ethical committee approval, 60 patients aged 18 to 65, American Society of Anesthesiology (ASA) I-II, and scheduled for laparoscopic cholecystectomy were included in this prospective, randomized, double-blinded study...
February 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28225220/efficacy-of-ruscus-extract-hmc-and-vitamin-c-constituents-of-cyclo-3-fort%C3%A2-on-improving-individual-venous-symptoms-and-edema-a-systematic-review-and-meta-analysis-of-randomized-double-blind-placebo-controlled-trials
#14
Stavros K Kakkos, François A Allaert
INTRODUCTION: Venoactive drugs (VADs) are considered an important component of the medical (conservative) treatment of chronic venous disorders (CVDs). However, the efficacy of certain VADs on one or more individual leg symptoms may have not been extensively studied to justify a high level or grade of recommendation in guidelines on CVD. The aim of the present systematic review and meta-analysis was to study the effectiveness of VADs containing Ruscus across the spectrum of defined venous symptoms...
April 2017: International Angiology: a Journal of the International Union of Angiology
https://www.readbyqxmd.com/read/28225185/preventive-effects-of-topical-washing-with-miconazole-nitrate-containing-soap-to-diaper-candidiasis-in-hospitalized-elderly-patients-a-prospective-double-blind-placebo-controlled-study
#15
Hidenori Takahashi, Noritaka Oyama, Izumi Tanaka, Michiko Hasegawa, Kaori Hirano, Chieko Shimada, Minoru Hasegawa
The objective of the present randomized, double-blind trial was to evaluate the efficacy and safety of daily washing with miconazole nitrate-containing soap for candidiasis at diaper-covered sites in elderly subjects under long-term inpatient care. To confirm the onset and disappearance of candidiasis, we microscopically evaluated the existence of the pseudohyphae and/or blastoconidia of Candida spp. We enrolled 75 elderly patients who wore diapers all day in the hospital or nursing home. Patients were randomly assigned to receive treatment with either miconazole soap or miconazole-free placebo soap, and 28 patients in the miconazole group and 27 patients in the placebo group were followed for 4 weeks...
February 22, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28224644/clinical-effect-of-intratympanic-dexamethasone-injection-in-acute-unilateral-tinnitus-a-prospective-placebo-controlled-multicenter-study
#16
Hyun-Jin Lee, Min-Beom Kim, Shin-Young Yoo, Shi Nae Park, Eui-Cheol Nam, In Seok Moon, Ho-Ki Lee
OBJECTIVE: The purpose of this study was to investigate the effectiveness of intratympanic dexamethasone injection (ITDI) in acute tinnitus of presumed cochlear origin. STUDY DESIGN: A prospective, randomized, placebo-controlled, double-blinded, multicenter study. METHODS: Between August 2013 and December 2015, 54 patients with unilateral tinnitus were enrolled at four different centers. Patients were assigned either to an ITDI (n = 27) or an intratympanic normal saline injection (ITNI; n = 27) group through block randomization...
February 22, 2017: Laryngoscope
https://www.readbyqxmd.com/read/28224232/effects-of-traumeel-tr14-on-recovery-and-inflammatory-immune-response-after-repeated-bouts-of-exercise-a-double-blind-rct
#17
Kerstin Muders, Christian Pilat, Vanessa Deuster, Torsten Frech, Karsten Krüger, Jörn Pons-Kühnemann, Frank-Christoph Mooren
PURPOSE: The purpose of this double-blind, randomized, placebo-controlled clinical trial was to investigate the effects of the natural combination medicine Traumeel (Tr14) consisting of 14 diluted biological and mineral components on the inflammatory immune response and recovery up to 72 h after repetitive bouts of bicycle tests. METHODS: Antigen-stimulated IL-1ra and IL-6 were defined as primary outcome measures. Moreover, various immunological and serum muscle damage markers were investigated...
February 21, 2017: European Journal of Applied Physiology
https://www.readbyqxmd.com/read/28223381/a-phase-i-randomized-double-blinded-placebo-and-moxifloxacin-controlled-4-period-crossover-study-to-evaluate-the-effect-of-gepotidacin-on-cardiac-conduction-as-assessed-by-12-lead-electrocardiogram-in-healthy-volunteers
#18
Mohammad Hossain, Meijian Zhou, Courtney Tiffany, Etienne Dumont, Borje Darpo
Gepotidacin is a novel, first in class triazaacenaphthylene antibiotic in development for treatment of conventional and biothreat infections. This was a single-dose, cross-over thorough QT study in healthy subjects who were administered an IV gepotidacin as a therapeutic (1000 mg), and supra-therapeutic (1800 mg) dose, placebo and 400 mg oral moxifloxacin in 4 separate treatment periods.Gepotidacin caused a mild effect on heart rate with a largest placebo-corrected change-from-baseline HR of 7 and 10 bpm at the end of the 1000 mg and 1800 mg infusion, respectively...
February 21, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28222801/a-new-method-for-treating-fecal-incontinence-by-implanting-stem-cells-derived-from-human-adipose-tissue-preliminary-findings-of-a-randomized-double-blind-clinical-trial
#19
Arash Sarveazad, Graham L Newstead, Rezvan Mirzaei, Mohammad Taghi Joghataei, Mehrdad Bakhtiari, Asrin Babahajian, Bahar Mahjoubi
BACKGROUND: Anal sphincter defects are a major cause of fecal incontinence causing negative effects on daily life, social interactions, and mental health. Because human adipose-derived stromal/stem cells (hADSCs) are easier and safer to access, secrete high levels of growth factor, and have the potential to differentiate into muscle cells, we investigated the ability of hADSCs to improve anal sphincter incontinence. METHODS: The present randomized double-blind clinical trial was performed on patients with sphincter defects...
February 21, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/28222674/administration-of-hes-in-elderly-patients-undergoing-hip-arthroplasty-under-spinal-anesthesia-is-not-associated-with-an-increase-in-renal-injury
#20
Yuanyuan Zhang, Yonghao Yu, Junya Jia, Wenli Yu, Rubin Xu, Licheng Geng, Ying Wei
BACKGROUND: Hydroxyethyl starch (HES) is applied to achieve volume expansion during surgery; however, nephrotoxicity may be induced in patients with sepsis. Simultaneously, neutrophil gelatinase-associated lipocalin (NGAL) and IL-18 have been illustrated as pivotal indicators to diagnose the acute kidney injury (AKI) early. This multi-center, randomized, double-blinded, placebo-controlled study aimed to investigate whether 6% HES 130/0.4 administration caused postoperative AKI, which can be revealed by urinary and plasma NGAL and IL-18 estimations in elderly patients with normal renal function undergoing hip arthroplasty under spinal anesthesia...
February 21, 2017: BMC Anesthesiology
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