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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/28528475/effects-of-selenium-supplementation-on-gene-expression-levels-of-inflammatory-cytokines-and-vascular-endothelial-growth-factor-in-patients-with-gestational-diabetes
#1
Mehri Jamilian, Mansooreh Samimi, Faraneh Afshar Ebrahimi, Esmat Aghadavod, Robabeh Mohammadbeigi, Maryam Rahimi, Zatollah Asemi
Selenium is known to exert multiple beneficial effects including anti-inflammatory actions. The aim of the study was to evaluate the effects of selenium supplementation on gene expression levels of inflammatory cytokines and vascular endothelial growth factor (VEGF) in women with gestational diabetes (GDM). This randomized double-blind, placebo-controlled trial was carried out among 40 subjects diagnosed with GDM aged 18-40 years old. Subjects were randomly allocated into two groups to receive either 200 μg/day selenium supplements (n = 20) or placebo (n = 20) for 6 weeks...
May 21, 2017: Biological Trace Element Research
https://www.readbyqxmd.com/read/28528342/an-insight-into-the-changes-in-skin-texture-and-properties-following-dietary-intervention-with-a-nutricosmeceutical-containing-a-blend-of-collagen-bioactive-peptides-and-antioxidants
#2
Licia Genovese, Andrea Corbo, Sara Sibilla
BACKGROUND: Skin aging is a multifactorial phenomenon which causes alterations in skin physiological functions and, most visibly, phenotypic changes. In particular, during the aging process, hyaluronic acid, collagen, and elastin fibers undergo structural and functional changes. AIMS: This study aimed to give an insight into the photo-protective benefits and efficacy of an oral liquid nutricosmeceutical containing collagen bioactive peptides and antioxidants to counteract the signs of aging...
May 20, 2017: Skin Pharmacology and Physiology
https://www.readbyqxmd.com/read/28528242/efficacy-and-safety-of-celecoxib-monotherapy-for-mild-to-moderate-depression-in-patients-with-colorectal-cancer-a-randomized-double-blind-placebo-controlled-trial
#3
Maryam Alamdarsaravi, Alireza Ghajar, Ahmad-Ali Noorbala, Mohammad Arbabi, Amirhossein Emami, Farhad Shahei, Mehrzad Mirzania, Morteza Jafarinia, Mohsen Afarideh, Shahin Akhondzadeh
Cancer-related inflammation is an essential process in malignancies. Celecoxib, a nonsteroidal anti-inflammatory drug that acts via the selective inhibition of cyclooxygenase (COX)-2, has shown favorable effects in several psychiatric disorders. The present study aimed to assess the safety and efficacy of celecoxib single therapy on depressive symptoms of patients with colorectal cancer who underwent chemotherapy. The study was conducted as a 6-week, parallel-group, randomized, double-blind, placebo-controlled trial...
May 17, 2017: Psychiatry Research
https://www.readbyqxmd.com/read/28527821/impact-of-sodium-bicarbonate-buffered-lidocaine-on-patient-pain-during-image-guided-breast-biopsy
#4
Alison Vasan, Jay A Baker, Rebecca A Shelby, Mary Scott C Soo
PURPOSE: This randomized, double-blind controlled study evaluated the effectiveness of sodium bicarbonate-buffered lidocaine on reducing pain during imaging-guided breast biopsies. MATERIALS AND METHODS: This prospective, HIPAA-compliant study randomly assigned 85 women undergoing ultrasound- or stereotactic-guided core-needle breast biopsies to receive intradermally and intraparenchymally either 1% lidocaine buffered with sodium bicarbonate (9:1 ratio) (bicarbonate study group) or 1% lidocaine alone (control group)...
May 17, 2017: Journal of the American College of Radiology: JACR
https://www.readbyqxmd.com/read/28527704/anti-madcam-antibody-pf-00547659-for-ulcerative-colitis-turandot-a-phase-2-randomised-double-blind-placebo-controlled-trial
#5
Séverine Vermeire, William J Sandborn, Silvio Danese, Xavier Hébuterne, Bruce A Salzberg, Maria Klopocka, Dino Tarabar, Tomas Vanasek, Miloš Greguš, Paul A Hellstern, Joo Sung Kim, Miles P Sparrow, Kenneth J Gorelick, Michelle Hinz, Alaa Ahmad, Vivek Pradhan, Mina Hassan-Zahraee, Robert Clare, Fabio Cataldi, Walter Reinisch
BACKGROUND: PF-00547659 is a fully human monoclonal antibody that binds to human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) to selectively reduce lymphocyte homing to the intestinal tract. We aimed to assess the efficacy and safety of PF-00547659 in patients with moderate to severe ulcerative colitis. METHODS: This phase 2, randomised, double-blind, placebo-controlled clinical trial recruited patients aged 18-65 years from 105 centres in 21 countries, with a history (≥3 months) of active ulcerative colitis extending more than 15 cm beyond the anal verge (with a total Mayo score ≥6 and a Mayo endoscopic subscore ≥2) who had failed or were intolerant to at least one conventional therapy...
May 17, 2017: Lancet
https://www.readbyqxmd.com/read/28527545/comparing-effects-of-two-different-types-of-nei-guan-acupuncture-stimulation-devices-in-reducing-postoperative-nausea-and-vomiting
#6
Hanna Oh, Bo Hwan Kim
PURPOSE: To compare the effects of a relief band using transcutaneous electrical nerve stimulation with a wrist band using acupressure on the Nei-Guan acupuncture point to relieve postoperative nausea and vomiting (PONV) in patients who had undergone gynecologic surgery. DESIGN: A double-blinded randomized controlled trial. METHODS: In total, 54 patients scheduled for gynecologic surgery under general anesthesia were included in this study...
June 2017: Journal of Perianesthesia Nursing: Official Journal of the American Society of PeriAnesthesia Nurses
https://www.readbyqxmd.com/read/28527421/a-phase-iii-randomized-multi-center-double-blind-placebo-controlled-study-of-safety-and-efficacy-of-lofexidine-for-relief-of-symptoms-in-individuals-undergoing-inpatient-opioid-withdrawal
#7
Charles W Gorodetzky, Sharon L Walsh, Peter R Martin, Andrew J Saxon, Kristen L Gullo, Kousick Biswas
BACKGROUND: Lofexidine is an alpha-2-adrenergic receptor agonist approved in the United Kingdom (UK) for the treatment of opioid withdrawal symptoms. Lofexidine has demonstrated better efficacy than placebo for reducing opioid withdrawal symptoms in patients undergoing opioid withdrawal with less reported hypotension than clonidine. METHODS: Designed as an FDA registration trial, this 8-day, randomized, double-blind, placebo-controlled, parallel-group study in 264 patients dependent on short-acting opioids evaluated the efficacy of lofexidine hydrochloride in reducing withdrawal symptoms in patients undergoing opioid withdrawal...
May 10, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28526386/the-effects-of-folic-acid-and-pyridoxine-supplementation-on-characteristics-of-migraine-attacks-in-migraine-patients-with-aura-a-double-blind-randomized-placebo-controlled-clinical-trial
#8
Gholamreza Askari, Morteza Nasiri, Hassan Mozaffari-Khosravi, Masod Rezaie, Mahdieh Bagheri-Bidakhavidi, Omid Sadeghi
OBJECTIVE: The aim of this study was to assess the effects of folic acid alone and in combination with pyridoxine on characteristics of migraine attacks in adult migraine patients with aura. METHODS: This double-blind, randomized placebo-controlled, clinical trial was conducted on 95 migraine patients with aura (age range 18-65 y) in Isfahan, Islamic Republic of Iran, in 2014. Patients were randomly allocated to receive folic acid (5 mg/d) plus pyridoxine (80 mg/d) or folic acid alone (5 mg/d) or placebo (lactose) for 3 mo...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28526381/medium-term-effect-of-sublingual-l-glutathione-supplementation-on-flow-mediated-dilation-in-subjects-with-cardiovascular-risk-factors
#9
Jonica Campolo, Stefano Bernardi, Lorena Cozzi, Silvia Rocchiccioli, Cinzia Dellanoce, Antonella Cecchettini, Annamaria Tonini, Marina Parolini, Benedetta De Chiara, Gianpaolo Micheloni, Gualtiero Pelosi, Claudio Passino, Cristina Giannattasio, Oberdan Parodi
OBJECTIVE: Supplementation of glutathione (GSH) may be a positive strategy to improve the endogenous antioxidant defense required to counteract many acute and chronic diseases. However, the efficacy of GSH treatment seems to be closely related to type of administration, degree of absorption, and increase of its concentrations. The aim of this study was to test a new sublingual formulation of L-GSH, which enters directly the systemic circulation, to assess its efficacy on circulating biochemical markers of hepatic metabolism, lipid profile, and oxidative stress and on peripheral vascular function compared with placebo in patients with cardiovascular risk factors (CVRF)...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28526374/impact-of-high-dose-vitamin-d3-on-plasma-free-25-hydroxyvitamin-d-concentrations-and-antimicrobial-peptides-in-critically-ill-mechanically-ventilated-adults
#10
Jenny E Han, Jessica A Alvarez, Jennifer L Jones, Vin Tangpricha, Mona A Brown, Li Hao, Lou Ann S Brown, Greg S Martin, Thomas R Ziegler
OBJECTIVES: High-dose vitamin D3 increases plasma total 25-hydroxyvitamin D [25(OH)D] in critically ill, ventilated patients; however, to our knowledge, the effect on plasma levels of free (nonprotein-bound) 25(OH)D has not been investigated in critical illness. Moreover, the relationship of free 25(OH)D and the regulation of endogenous antimicrobial peptides (AMPs) remains unknown. The aims of this study were to determine in critically ill adults with respiratory failure the effect of previous high-dose regimens of vitamin D3 on free 25(OH)D concentrations, the relationship of free 25(OH)D with circulating cathelicidin (LL-37) and human beta-defensin-2 (hBD-2), and the associations between plasma levels of free 25(OH)D and these AMPs to alveolar macrophage phagocytosis function...
June 2017: Nutrition
https://www.readbyqxmd.com/read/28526048/men-s-and-women-s-response-to-treatment-and-perceptions-of-outcomes-in-a-randomized-controlled-trial-of-injectable-opioid-assisted-treatment-for-severe-opioid-use-disorder
#11
Heather Palis, Kirsten Marchand, Daphne Guh, Suzanne Brissette, Kurt Lock, Scott MacDonald, Scott Harrison, Aslam H Anis, Michael Krausz, David C Marsh, Martin T Schechter, Eugenia Oviedo-Joekes
BACKGROUND: To test whether there are gender differences in treatment outcomes among patients receiving injectable opioids for the treatment of long-term opioid-dependence. The study additionally explores whether men and women have different perceptions of treatment effectiveness. METHODS: This study is a secondary analysis from SALOME, a double-blind, phase III, randomized controlled trial testing the non-inferiorirty of injectable hydromorphone to injectable diacetylmorphine among 202 long-term street opioid injectors in Vancouver (Canada)...
May 19, 2017: Substance Abuse Treatment, Prevention, and Policy
https://www.readbyqxmd.com/read/28525632/effect-of-baseline-characteristics-on-the-pain-response-to-pregabalin-in-fibromyalgia-patients-with-comorbid-depression
#12
Stuart L Silverman, Miroslav Backonja, Lynne Pauer, Jaren Landen, Pritha Bhadra Brown, Joseph M Scavone, Richard Vissing, Andrew Clair
Objective. : To evaluate the effect of baseline characteristics on the treatment response to pregabalin in fibromyalgia (FM) patients with depression. Design. : Post hoc analysis from a randomized, double-blind, placebo-controlled, two-way crossover study of pregabalin (300 or 450 mg/day, twice daily). Subjects. : A total of 193 FM patients taking an antidepressant for comorbid depression. Methods. : The effect of patient baseline characteristics on the treatment response to pregabalin vs placebo was assessed for the primary efficacy end point (mean pain score on an 11-point numeric rating scale)...
May 19, 2017: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/28524639/high-dose-intravenous-steroid-pulse-therapy-in-ocular-involvement-of-behcet-s-disease-a-pilot-double-blind-control-study
#13
Mastaneh Mohammadi, Farhad Shahram, Hormoz Shams, Massoomeh Akhlaghi, Farimah Ashofteh, Fereydoun Davatchi
AIM: To evaluate the efficacy of intravenous high-dose pulses of methylprednisolone (IVPM) for treatment of ocular involvement in Behcet's disease (BD). METHOD: In a double-blind control study, we randomized BD patients with posterior uveitis (PU) and/or retinal vasculitis (RV) into two groups. They received either IVPM (1000 mg methylprednisolone) or placebo for 3 consecutive days. Both groups received combination therapy with IV cyclophosphamide, azathioprine and prednisolone for 6 months...
May 19, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28523945/prevention-of-postmenopausal-osteoporosis-in-chinese-women-a-5-year-double-blind-randomized-parallel-placebo-controlled-study
#14
S Y Ran, Q Yu, Y Chen, S Q Lin
OBJECTIVES: To observe the effectiveness and safety of menopause-related hormone therapy (MHT) to prevent bone loss in Chinese women during the menopausal transition and early menopause, as well as to evaluate the effects of 5-year MHT on overall health to add Level I evidence for the prevention of osteoporosis using MHT. DESIGN: This clinical study was a prospective, double-blind, randomized, parallel placebo-controlled study. Chinese women in the menopausal transition and early menopause were randomly allocated to the MHT group or the placebo group...
May 19, 2017: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/28523393/flavored-anesthetic-masks-for-inhalational-induction-in-children
#15
Aakriti Gupta, Preethy Joseph Mathew, Neerja Bhardwaj
OBJECTIVES: To evaluate the clinical efficacy of masking the odor of inhalational agents using fruit flavors on the anxiety behavior and compliance of children for inhalational induction. METHODS: A prospective randomized double blind, placebo controlled study was conducted on 60 unpremedicated children in the age group of 4-12 y. Thirty children received anesthetic masks smeared with a flavor of child's choice while the other 30 children were induced using masks without flavor...
May 19, 2017: Indian Journal of Pediatrics
https://www.readbyqxmd.com/read/28522675/effects-of-sodium-glucose-cotransporter-2-inhibitors-on-24-hour-ambulatory-blood-pressure-a-systematic-review-and-meta-analysis
#16
REVIEW
William L Baker, Leo F Buckley, Michael S Kelly, John D Bucheit, Eric D Parod, Roy Brown, Salvatore Carbone, Antonio Abbate, Dave L Dixon
BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a novel class of antihyperglycemic agents that improve glycemic control by increasing glycosuria. Additional benefits beyond glucose lowering include significant improvements in seated clinic blood pressure (BP), partly attributed to their diuretic-like actions. Less known are the effects of this class on 24-hour ambulatory BP, which is a better predictor of cardiovascular risk than seated clinic BP. METHODS AND RESULTS: We performed a meta-analysis of randomized, double-blind, placebo-controlled trials to investigate the effects of SGLT2 inhibitors on 24-hour ambulatory BP...
May 18, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28522646/mr-spectroscopy-of-hepatic-fat-and-adiponectin-and-leptin-levels-during-testosterone-therapy-in-type-2-diabetes-a-randomized-double-blinded-placebo-controlled-trial
#17
Line Velling Magnussen, Poul Erik Andersen, Anabel Diaz, Jelena Markovic Ostojic, Kurt Højlund, David M Hougaard, Anders Nymark Christensen, Torben Leo Nielsen, Marianne Skovsager Andersen
BACKGROUND: Men with type 2 diabetes mellitus (T2D) often have lowered testosterone levels and an increased risk of cardiovascular disease (CVD). Ectopic fat increases the risk of CVD, whereas subcutaneous gluteofemoral fat protects against CVD and has a beneficial adipokine secreting profile. HYPOTHESIS: Testosterone replacement therapy (TRT) may reduce the content of ectopic fat and improve the adipokine profile in men with T2D. DESIGN AND METHODS: A randomized, double-blinded, placebo-controlled study in 39 men aged 50-70 years with T2D and bioavailable testosterone levels <7...
May 18, 2017: European Journal of Endocrinology
https://www.readbyqxmd.com/read/28522181/safety-and-efficacy-of-edaravone-in-well-defined-patients-with-amyotrophic-lateral-sclerosis-a-randomised-double-blind-placebo-controlled-trial
#18
(no author information available yet)
BACKGROUND: In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population...
May 15, 2017: Lancet Neurology
https://www.readbyqxmd.com/read/28521880/pharmacokinetics-of-oral-hydrocortisone-results-and-implications-from-a-randomized-controlled-trial
#19
Jorien Werumeus Buning, Daan J Touw, Pauline Brummelman, Robin P F Dullaart, Gerrit van den Berg, Melanie M van der Klauw, Jasper Kamp, Bruce H R Wolffenbuttel, André P van Beek
CONTEXT AND OBJECTIVE: This study aimed at comparing pharmacokinetics of two different doses of hydrocortisone (HC) in patients with secondary adrenal insufficiency (SAI). DESIGN, SETTING AND PATIENTS: Forty-six patients with SAI participated in this randomized double-blind crossover study. INTERVENTION: Patients received two different doses of HC (0.2-0.3mg HC/kg body weight/day and 0.4-0.6mg HC/kg body weight/day). MAIN OUTCOME MEASURES: One- and two-compartment population models for plasma free cortisol, plasma total cortisol and salivary cortisol were parameterized...
June 2017: Metabolism: Clinical and Experimental
https://www.readbyqxmd.com/read/28521846/measures-of-suicidality-in-phase-3-clinical-trials-of-levomilnacipran-er-in-adults-with-major-depressive-disorder
#20
Michael E Thase, Carl Gommoll, Changzheng Chen, Kenneth Kramer, Arif Khan, Suresh Durgam
OBJECTIVE: To evaluate the effects of levomilnacipran extended-release (ER) on suicidal ideation and behavior in adults with major depressive disorder (MDD). METHODS: Post hoc analyses were conducted in patients from 4 randomized, double-blind, placebo-controlled trials and a long-term, open-label extension study of levomilnacipran ER (40-120 mg/d) in adults with MDD. Analyses included incidence of suicide-related treatment-emergent adverse events (TEAEs); incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation (score=1-5) and behavior (score=6-10); percent of patients who shifted from no C-SSRS suicidal ideation/behavior at baseline to suicidal ideation during treatment (worsened from score=0 to score=1-5), or vice-versa (improved from score=1-5 to score=0)...
May 19, 2017: CNS Spectrums
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