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randomized, double-blind, trial

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https://www.readbyqxmd.com/read/28323989/preconception-low-dose-aspirin-restores-diminished-pregnancy-and-live-birth-rates-in-women-with-low-grade-inflammation-a-secondary-analysis-of-a-randomized-trial
#1
Lindsey A Sjaarda, Rose G Radin, Robert M Silver, Emily Mitchell, Sunni L Mumford, Brian Wilcox, Noya Galai, Neil J Perkins, Jean Wactawski-Wende, Joseph B Stanford, Enrique F Schisterman
Context: Inflammation is linked to causes of infertility. Low dose aspirin (LDA) may improve reproductive success in women with chronic, low-grade inflammation. Objective: To investigate the effect of preconception-initiated LDA on pregnancy rate, pregnancy loss, live birth rate, and inflammation during pregnancy. Design: Stratified secondary analysis of a multi-center, block-randomized, double-blind, placebo-controlled trial. Setting: Four U...
February 3, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323986/chronic-intranasal-insulin-does-not-affect-hepatic-lipids-but-lowers-circulating-bcaas-in-healthy-male-subjects
#2
Thomas Scherer, Peter Wolf, Sabina Smajis, Melania Gaggini, Martina Hackl, Amalia Gastaldelli, Peter Klimek, Elisa Einwallner, Rodrig Marculescu, Anton Luger, Clemens Fürnsinn, Siegfried Trattnig, Christoph Buettner, Martin Krššák, Michael Krebs
Context: Non-alcoholic fatty liver disease and elevated circulating branched-chain amino acids (BCAAs) are common characteristics of obesity and type 2 diabetes. In rodents, brain insulin signaling controls both hepatic triglyceride secretion and BCAA catabolism. Whether brain insulin signaling controls similar metabolic pathways in humans is unknown. Objective: Here we assessed if intranasal insulin, a method to preferentially deliver insulin to the central nervous system, is able to modulate hepatic lipid content and plasma BCAAs in humans...
January 16, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323947/effects-of-mixed-carotenoids-on-adipokines-and-abdominal-adiposity-in-children-a-pilot-study
#3
J Atilio Canas, Amanda Lochrie, Amy Galena McGowan, Jobayer Hossain, Christopher Schettino, P Babu Balagopal
Context: Carotenoids have been implicated in the regulation of adipocyte metabolism. Objective: To compare the effects of mixed-carotenoid supplementation (MCS) vs. placebo on adipokines and the accrual of abdominal adiposity in children with obesity. Design and Setting: Randomized (1:1) double-blind, placebo-controlled intervention trial to evaluate the effects of MCS over 6 months in a subspecialty clinic. Participants: Twenty (6 male and 14 female) children with simple obesity (BMI > 90%); age: 10...
March 13, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28323838/bupropion-for-the-treatment-of-apathy-in-huntington-s-disease-a-multicenter-randomised-double-blind-placebo-controlled-prospective-crossover-trial
#4
Harald Gelderblom, Torsten Wüstenberg, Tim McLean, Lisanne Mütze, Wilhelm Fischer, Carsten Saft, Rainer Hoffmann, Sigurd Süssmuth, Peter Schlattmann, Erik van Duijn, Bernhard Landwehrmeyer, Josef Priller
OBJECTIVE: To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington's disease (HD). METHODS: In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy-Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant...
2017: PloS One
https://www.readbyqxmd.com/read/28323806/improving-pain-management-and-long-term-outcomes-following-high-energy-orthopaedic-trauma-pain-study
#5
Renan C Castillo, Srinivasa N Raja, Katherine P Frey, Heather A Vallier, Paul Tornetta, Todd Jaeblon, Brandon J Goff, Allan Gottschalk, Daniel O Scharfstein, Robert V OʼToole
Poor pain control after orthopaedic trauma is a predictor of physical disability and numerous negative long-term outcomes. Despite increased awareness of the negative consequences of poorly controlled pain, analgesic therapy among hospitalized patients after orthopaedic trauma remains inconsistent and often inadequate. The Pain study is a 3 armed, prospective, double-blind, multicenter randomized trial designed to evaluate the effect of standard pain management versus standard pain management plus perioperative nonsteroidal anti-inflammatory drugs or pregabalin in patients of ages 18-85 with extremity fractures...
April 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28323798/supplemental-perioperative-oxygen-to-reduce-surgical-site-infection-after-high-energy-fracture-surgery-oxygen-study
#6
Robert V OʼToole, Manjari Joshi, Anthony R Carlini, Robert A Sikorski, Armagan Dagal, Clinton K Murray, Michael J Weaver, Ebrahim Paryavi, Alec C Stall, Daniel O Scharfstein, Julie Agel, Mary Zadnik, Michael J Bosse, Renan C Castillo
Supplemental perioperative oxygen (SPO) therapy has been proposed as one approach for reducing the risk of surgical site infection (SSI). Current data are mixed regarding efficacy in decreasing SSI rates and hospital inpatient stays in general and few data exist for orthopaedic trauma patients. This study is a phase III, double-blind, prospective randomized clinical trial with a primary goal of assessing the efficacy of 2 different concentrations of perioperative oxygen in the prevention of SSIs in adults with tibial plateau, pilon (tibial plafond), or calcaneus fractures at higher risk of infection and definitively treated with plate and screw fixation...
April 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28319997/intradiscal-glucocorticoid-injection-for-patients-with-chronic-low-back-pain-associated-with-active-discopathy-a-randomized-trial
#7
Christelle Nguyen, Isabelle Boutron, Gabriel Baron, Katherine Sanchez, Clémence Palazzo, Raphaël Benchimol, Guillaume Paris, Étienne James-Belin, Marie-Martine Lefèvre-Colau, Johann Beaudreuil, Jean-Denis Laredo, Anne Béra-Louville, Anne Cotten, Jean-Luc Drapé, Antoine Feydy, Philippe Ravaud, François Rannou, Serge Poiraudeau
Background: Active discopathy is associated with a specific phenotype of chronic low back pain (LBP). Local inflammation has a role in active discopathy-associated symptoms. Objective: To assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in patients with chronic LBP with active discopathy. Design: Prospective, parallel-group, double-blind, randomized, controlled study. (ClinicalTrials.gov: NCT00804531). Setting: 3 tertiary care centers in France...
March 21, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28319947/effects-of-capsaicin-on-older-patients-with-oropharyngeal-dysphagia-a-double-blind-placebo-controlled-crossover-study
#8
Rui Nakato, Noriaki Manabe, Sayako Shimizu, Kozo Hanayama, Akiko Shiotani, Jiro Hata, Ken Haruma
BACKGROUND/AIMS: The standard of care for older patients with oropharyngeal dysphagia (OD) is poor. Stimulation of transient receptor potential vanilloid 1 might become a pharmacological strategy for these patients. This study aimed to compare the therapeutic effect of film food containing 0.75 µg of capsaicin in these patients. METHODS: In a crossover, randomized trial, 49 patients with OD were provided capsaicin or identical placebo at least 7 days apart. Patients' reported symptoms during repeated swallowing, the volume, pH and substance P (SP) concentrations in saliva, and cervical esophageal wall motion evaluated by ultrasonographic tissue Doppler imaging were obtained before and after capsaicin or placebo administration...
March 21, 2017: Digestion
https://www.readbyqxmd.com/read/28319848/treatment-of-premenstrual-dysphoric-disorder-with-the-gabaa-receptor-modulating-steroid-antagonist-sepranolone-uc1010-a-randomized-controlled-trial
#9
Marie Bixo, Karin Ekberg, Inger Sundström Poromaa, Angelica Lindén Hirschberg, Aino Fianu Jonasson, Lotta Andréen, Erika Timby, Marianne Wulff, Agneta Ehrenborg, Torbjörn Bäckström
CONTEXT: Allopregnanolone is a metabolite from progesterone and a positive modulator of the GABAA receptor. This endogenous steroid may induce negative mood in sensitive women when present in serum levels comparable to the premenstrual phase. Its endogenous isomer, isoallopregnanolone, has been shown to antagonize allopregnanolone effects in experimental animal and human models. OBJECTIVE: The objective was to test whether inhibition of allopregnanolone by treatment with the GABAA modulating steroid antagonist (GAMSA) Sepranolone (UC1010) during the premenstrual phase could reduce symptoms of the premenstrual dysphoric disorder (PMDD)...
March 1, 2017: Psychoneuroendocrinology
https://www.readbyqxmd.com/read/28319467/effects-of-iv-acetaminophen-on-core-body-temperature-and-hemodynamic-responses-in-febrile-critically-ill-adults-a-randomized-controlled-trial
#10
Hildy M Schell-Chaple, Kathleen D Liu, Michael A Matthay, Daniel I Sessler, Kathleen A Puntillo
OBJECTIVE: To determine the effects of IV acetaminophen on core body temperature, blood pressure, and heart rate in febrile critically ill patients. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Three adult ICUs at a large, urban, academic medical center. PATIENTS: Forty critically ill adults with fever (core temperature, ≥ 38.3°C). INTERVENTION: An infusion of acetaminophen 1 g or saline placebo over 15 minutes...
March 17, 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28319243/association-of-antioxidant-supplement-use-and-dementia-in-the-prevention-of-alzheimer-s-disease-by-vitamin-e-and-selenium-trial-preadvise
#11
Richard J Kryscio, Erin L Abner, Allison Caban-Holt, Mark Lovell, Phyllis Goodman, Amy K Darke, Monica Yee, John Crowley, Frederick A Schmitt
Importance: Oxidative stress is an established dementia pathway, but it is unknown if the use of antioxidant supplements can prevent dementia. Objective: To determine if antioxidant supplements (vitamin E or selenium) used alone or in combination can prevent dementia in asymptomatic older men. Design, Setting, and Participants: The Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADViSE) trial began as a double-blind randomized clinical trial in May 2002, which transformed into a cohort study from September 2009 to May 2015...
March 20, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28318926/effectiveness-of-tranexamic-acid-for-reducing-intraoperative-bleeding-in-palatoplasties-a-randomized-clinical-trial
#12
Guilherme C Arantes, Rui Manoel R Pereira, Daniela B de Melo, Nivaldo Alonso, Maria do Carmo M B Duarte
BACKGROUND: Few data are available regarding blood loss during cleft palate surgery. This study assessed the effect of using tranexamic acid in the reduction of intraoperative bleeding. METHODS: A double-blind, randomized clinical trial compared intraoperative bleeding and the incidence of oronasal fistulas after palatoplasties in a control group that was given placebo and an intervention group that was given 10 mg/kg tranexamic acid followed by a continuous infusion of 1 mg/kg/h of the same until the end of surgery...
December 30, 2016: Journal of Cranio-maxillo-facial Surgery
https://www.readbyqxmd.com/read/28318850/safety-and-efficacy-of-hyperosmolar-irrigation-solution-in-shoulder-arthroscopy
#13
Nicholas M Capito, James L Cook, Bernardo Yahuaca, Marie D Capito, Seth L Sherman, Matthew J Smith
BACKGROUND: A hyperosmolar irrigation solution has been reported to be safe and have potential benefits for use during shoulder arthroscopy in an animal model study. In this study, the clinical effects of a hyperosmolar solution were compared with a standard isotonic solution when used for shoulder arthroscopy. METHODS: A prospective, double-blind, randomized controlled trial was performed to compare isotonic (273 mOsm/L) and hyperosmolar (593 mOsm/L) irrigation solutions used for arthroscopic rotator cuff repair...
March 15, 2017: Journal of Shoulder and Elbow Surgery
https://www.readbyqxmd.com/read/28317885/efficacy-of-alginate-based-reflux-suppressant-and-magnesium-aluminium-antacid-gel-for-treatment-of-heartburn-in-pregnancy-a-randomized-double-blind-controlled-trial
#14
Pontip Meteerattanapipat, Vorapong Phupong
The aim of this study was to compare the therapeutic efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. A double-blinded, randomized, controlled trial was conducted. One hundred pregnant women at less than 36 weeks gestation with heartburn at least twice per week were randomized to either alginate-based reflux suppressant or to magnesium-aluminium antacid gel. Details of heartburn were recorded before beginning the treatment and the second week of study...
March 20, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28317321/development-of-a-home-based-auditory-training-to-improve-speech-recognition-on-the-telephone-for-patients-with-cochlear-implants-a-randomized-trial
#15
Friedrich Ihler, Jenny Blum, Gino Steinmetz, Bernhard G Weiss, Stefan Zirn, Martin Canis
OBJECTIVES: Speech recognition on the telephone poses a challenge for patients with cochlear implants due to a reduced bandwidth of transmission. This trial evaluates a home-based auditory training with telephone-specific filtered speech material to improve sentence recognition. DESIGN: Randomized controlled parallel double-blind. SETTING: One tertiary referral center. PARTICIPANTS: 20 postlingually deafened patients with cochlear implants...
March 20, 2017: Clinical Otolaryngology
https://www.readbyqxmd.com/read/28316174/-efficacy-and-safety-analysis-of-ivabradine-hydrochloride-treatment-of-chinese-patients-with-chronic-heart-failure-subgroup-analysis-of-chinese-patients-in-the-shift-study
#16
D Y Hu, D J Huang, Z Y Yuan, R P Zhao, X W Yan, M H Wang
Objective: To evaluate the efficacy and safety of ivabradine for the treatment of Chinese patients with chronic heart failure based on the Chinese subgroup data of the systolic heart failure treatment with the I(f) inhibitor ivabradine trial (SHIFT). Method: A total of 6 558 stable outpatients who presented symptoms of heart failure, with a left ventricular ejection fraction (LVEF) ≤35%, sinus rhythms with a heart rate ≥70 bpm participated in the randomized, double-blind, placebo-controlled, international multicenter clinical study...
March 24, 2017: Zhonghua Xin Xue Guan Bing za Zhi
https://www.readbyqxmd.com/read/28315576/control-of-lower-extremity-edema-in-patients-with-diabetes-double-blind-randomized-controlled-trial-assessing-the-efficacy-of-mild-compression-diabetic-socks
#17
Stephanie C Wu, Ryan T Crews, Melissa Skratsky, Julia Overstreet, Sai V Yalla, Michelle Winder, Jacquelyn Ortiz, Charles A Andersen
AIMS: Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. METHODS: Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18-25mmHg) or non-compression knee high diabetic socks...
February 27, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28315010/comparison-of-efficacy-of-meperidine-and-fentanyl-in-terms-of-pain-management-and-quality-of-life-in-patients-with-cervical-cancer-receiving-intracavitary-brachytherapy-a-double-blind-randomized-controlled-trial
#18
Saengrawee Thanthong, Sirikorn Rojthamarat, Wipra Worasawate, Phongthara Vichitvejpaisal, Danupon Nantajit, Nantakarn Ieumwananontachai
OBJECTIVE: The aim of this study was to compare the effectiveness of two sedative regimens, a benzodiazepine with either meperidine or fentanyl, in relieving pain in patients with cervical cancer undergoing intracavitary brachytherapy in terms of pain score and quality of life. METHODS: Forty unselected outpatients undergoing brachytherapy (160 fractions) were enrolled with informed consent and randomized to receive a benzodiazepine with either meperidine or fentanyl...
March 18, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28314382/erratum-to-a-randomized-double-blind-placebo-controlled-clinical-trial-of-fluoride-varnish-in-preventing-dental-caries-of-sj%C3%A3-gren-s-syndrome-patients
#19
Weini Xin, Katherine Chiu Man Leung, Edward Chin Man Lo, Mo Yin Mok, Moon Ho Leung
No abstract text is available yet for this article.
March 17, 2017: BMC Oral Health
https://www.readbyqxmd.com/read/28306636/blood-pressure-lowering-efficacy-and-safety-of-perindopril-indapamide-amlodipine-single-pill-combination-in-patients-with-uncontrolled-essential-hypertension-a-multicenter-randomized-double-blind-controlled-trial
#20
Jean-Jacques Mourad, Celso Amodeo, Martine de Champvallins, Romualda Brzozowska-Villatte, Roland Asmar
OBJECTIVES: This 4-month, double-blind, randomized, controlled trial was designed to demonstrate the superiority of perindopril/indapamide/amlodipine single pill over perindopril/indapamide after 1 month and to determine further up-titration efficacy and safety in patients with mild-to-moderate hypertension. METHODS: After a 1-month run-in period on perindopril/indapamide 5/1.25 mg, patients with SBP/DBP at least 150/95 mmHg and no diabetes or renal insufficiency received perindopril/indapamide/amlodipine 5/1...
March 16, 2017: Journal of Hypertension
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