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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/29667940/the-importance-of-the-saphenous-nerve-block-for-analgesia-following-major-ankle-surgery-a-randomized-controlled-double-blind-study
#1
Siska Bjørn, Wan Yi Wong, Jørgen Baas, Kristian K Nielsen, Jens Børglum, Rasmus Wulff Hauritz, Thomas Fichtner Bendtsen
BACKGROUND AND OBJECTIVES: Major ankle surgery causes intense postoperative pain, and whereas the importance of a sciatic nerve block is well established, the clinical significance of a supplemental saphenous nerve block has never been determined in a prospective, randomized, double-blind, placebo-controlled trial. We hypothesized that a saphenous nerve block reduces the proportion of patients experiencing significant clinical pain after major ankle surgery. METHODS: Eighteen patients were enrolled and received a popliteal sciatic nerve block...
March 26, 2018: Regional Anesthesia and Pain Medicine
https://www.readbyqxmd.com/read/29667144/efficacy-and-safety-of-zofenopril-versus-ramipril-in-the-treatment-of-myocardial-infarction-and-heart-failure-a-review-of-the-published-and-unpublished-data-of-the-randomized-double-blind-smile-4-study
#2
REVIEW
Claudio Borghi, Stefano Omboni, Salvatore Novo, Dragos Vinereanu, Giuseppe Ambrosio, Ettore Ambrosioni
Zofenopril is a lipophilic, sulfhydryl group-containing angiotensin-converting enzyme (ACE)-inhibitor, characterized by wide tissue distribution, long duration of action, and pleiotropic effects on endothelial dysfunction. Its clinical efficacy and safety have been described in the four randomized controlled trials of the SMILE program, which globally enrolled more than 3600 patients in post-acute myocardial infarction (AMI) setting. The SMILE-4 study specifically selected patients with left ventricular dysfunction at admission, and compared the effects of zofenopril or ramipril in combination with acetylsalicylic acid (ASA)...
April 17, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29665840/effects-of-cyclosporine-a-pretreatment-of-deceased-organ-donors-on-kidney-graft-function-cis-a-rein-study-protocol-for-a-randomized-controlled-trial
#3
Jean-Christophe Orban, Eric Fontaine, Elisabeth Cassuto, Karine Baumstarck, Marc Leone, Jean-Michel Constantin, Carole Ichai
BACKGROUND: Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmacological interventions aiming to prevent ischemia-reperfusion injuries failed to reduce the rate of DGF. We hypothesize that cyclosporine as an early preconditioning procedure in donors would be associated with decreased DGF...
April 17, 2018: Trials
https://www.readbyqxmd.com/read/29665762/effects-of-vitamin-b6-pyridoxine-and-a-b-complex-preparation-on-dreaming-and-sleep
#4
Denholm J Aspy, Natasha A Madden, Paul Delfabbro
Anecdotal evidence indicates that supplementation with vitamin B6 (pyridoxine) before bed can enhance dream vividness and recall. In a single pilot study, Ebben, Lequerica, and Spielman (2002) found that vitamin B6 had a dose-dependent effect of increasing scores on a composite measure of dream vividness, bizarreness, emotionality, and color. The present research replicated this study using a larger and more diverse sample of 100 participants from across Australia. We conducted a randomized, double-blind, placebo-controlled investigation of the effects on dreaming and sleep of ingesting 240 mg vitamin B6 (pyridoxine hydrochloride) before bed for five consecutive days...
January 1, 2018: Perceptual and Motor Skills
https://www.readbyqxmd.com/read/29665351/neuroendocrine-response-to-gaba-b-receptor-agonism-in-alcohol-dependent-individuals-results-from-a-combined-outpatient-and-human-laboratory-experiment
#5
Mehdi Farokhnia, Mikela B Sheskier, Mary R Lee, April N Le, Erick Singley, Sofia Bouhlal, Timmy Ton, Zhen Zhao, Lorenzo Leggio
Gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the nervous system, plays an important role in biobehavioral processes that regulate alcohol seeking, food intake, and stress response. The metabotropic GABA-B receptor has been investigated as a potential therapeutic target for alcohol use disorder, by using orthosteric agonists (e.g., baclofen) and positive allosteric modulators. Whether and how pharmacological manipulation of the GABA-B receptor, in combination with alcohol intake, may affect feeding- and stress-related neuroendocrine pathways remains unknown...
April 14, 2018: Neuropharmacology
https://www.readbyqxmd.com/read/29665158/peanut-gastro-intestinal-delivery-oral-immunotherapy-in-adolescents-results-of-the-build-up-phase-of-a-randomized-double-blind-placebo-controlled-trial-pita-study
#6
Jean-Luc Fauquert, Elodie Michaud, Bruno Pereira, Lise Bernard, Nelly Gourdon-Dubois, Paul-Olivier Rouzaire, Emmanuelle Rochette, Etienne Merlin, Bertrand Evrard
BACKGROUND: Oral immunotherapy to peanut is effective in desensitizing patients but has significant side effects including anaphylaxis and gastro-intestinal symptoms. In most protocols peanut is administered in a vehicle food. OBJECTIVE: In an exclusively adolescent population, we tested a new approach using sealed capsules of peanut (Gastro-Intestinal Delivery Oral Immunotherapy or GIDOIT) in order to bypass the upper gastro-intestinal tract. The primary aim was to assess the efficacy of the oral build-up phase of GIDOIT and the secondary aim to analyse its safety...
April 17, 2018: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29665109/improving-the-performance-time-and-accuracy-of-ultrasound-guided-interventions-a-randomized-controlled-double-blind-trial-of-the-line-of-sight-approach-and-the-apples-mnemonic
#7
John W Norbury, Natalie C Karr, Vivek Sindhi, Kimberly M Rathbun, Stephen C Charles, Michael B McIver, Eric J Morrison
OBJECTIVES: To determine whether the line-of-sight approach improved the performance time and accuracy of ultrasound (US)-guided needle placement targeting the subdeltoid bursa in a cadaver among novice operators compared to the side approach. A secondary objective was to determine whether participants thought the APPLES (angle, position, perpendicular, line up, entry, sweep) mnemonic was a helpful guide for performing the procedure. METHODS: Medical students and residents were randomized into either a line-of-sight or side approach group and then crossed over to the other group...
April 17, 2018: Journal of Ultrasound in Medicine: Official Journal of the American Institute of Ultrasound in Medicine
https://www.readbyqxmd.com/read/29664865/do-these-crystals-really-sparkle-commentary-on-an-article-by-philip-g-conaghan-mbbs-phd-fracp-frcp-et-al-effects-of-a-single-intra-articular-injection-of-a-microsphere-formulation-of-triamcinolone-acetonide-on-knee-osteoarthritis-pain-a-double-blinded-randomized
#8
https://www.readbyqxmd.com/read/29664853/effects-of-a-single-intra-articular-injection-of-a-microsphere-formulation-of-triamcinolone-acetonide-on-knee-osteoarthritis-pain-a-double-blinded-randomized-placebo-controlled-multinational-study
#9
Philip G Conaghan, David J Hunter, Stanley B Cohen, Virginia B Kraus, Francis Berenbaum, Jay R Lieberman, Deryk G Jones, Andrew I Spitzer, David S Jevsevar, Nathaniel P Katz, Diane J Burgess, Joelle Lufkin, James R Johnson, Neil Bodick
BACKGROUND: Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs. METHODS: In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg)...
April 18, 2018: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/29664714/randomized-phase-ii-trial-of-fulvestrant-plus-everolimus-or-placebo-in-postmenopausal-women-with-hormone-receptor-positive-human-epidermal-growth-factor-receptor-2-negative-metastatic-breast-cancer-resistant-to-aromatase-inhibitor-therapy-results-of-pre0102
#10
Noah Kornblum, Fengmin Zhao, Judith Manola, Paula Klein, Bhuvaneswari Ramaswamy, Adam Brufsky, Phillip J Stella, Brian Burnette, Melinda Telli, Della F Makower, Puneet Cheema, Cristina I Truica, Antonio C Wolff, Gamini S Soori, Barbara Haley, Timothy R Wassenaar, Lori J Goldstein, Kathy D Miller, Joseph A Sparano
Purpose The mammalian target of rapamycin inhibitor everolimus targets aberrant signaling through the PI3K/AKT/mammalian target of rapamycin pathway, a mechanism of resistance to anti-estrogen therapy in estrogen receptor (ER)-positive breast cancer. We hypothesized that everolimus plus the selective ER downregulator fulvestrant would be more efficacious than fulvestrant alone in ER-positive metastatic breast cancer resistant to aromatase inhibitor (AI) therapy. Patients and Methods This randomized, double-blind, placebo-controlled, phase II study included 131 postmenopausal women with ER-positive, human epidermal growth factor receptor 2-negative, AI-resistant metastatic breast cancer randomly assigned to fulvestrant (500 mg days 1 and 15 of cycle 1, then day 1 of cycles 2 and beyond) plus everolimus or placebo...
April 17, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29663714/a-randomized-placebo-controlled-double-blind-study-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-and-repeated-doses-of-mirogabalin-in-healthy-asian-volunteers
#11
Mendel Jansen, Steven Warrington, Victor Dishy, Shoichi Ohwada, Lisa Johnson, Karen Brown, Hitoshi Ishizuka
Mirogabalin is a novel, preferentially selective α2 δ-1 ligand under investigation to treat neuropathic pain. The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of various doses of mirogabalin in healthy subjects of different ethnicities. This randomized, placebo-controlled, double-blind, sequential, ascending-dose study evaluated single (10-40 mg) and repeated (10, 15 mg twice a day) doses of mirogabalin in Japanese subjects, and a single dose of mirogabalin in Korean, Chinese, and white subjects...
April 17, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29662734/effect-of-a-water-extract-of-curcuma-longa-on-emotional-states-in-healthy-participants
#12
Kengo Kawasaki, Koutarou Muroyama, Shinji Murosaki
Physiological symptoms of mood disturbances, such as fatigue or anxiety, are closely related to inflammation in the central nervous system or the whole body. Curcuma longa is widely used as a dietary spice and has been reported to have anti-inflammatory activity. To investigate the effect of a water extract of C. longa (WEC) on emotional states, a randomized, double-blind, placebo-controlled, parallel-group study was conducted with healthy participants. Forty-eight participants were randomly assigned to receive five tablets containing 150 mg WEC and 0...
2018: Bioscience of Microbiota, Food and Health
https://www.readbyqxmd.com/read/29662493/age-related-changes-in-the-natural-killer-cell-response-to-seasonal-influenza-vaccination-are-not-influenced-by-a-synbiotic-a-randomised-controlled-trial
#13
Agnieszka Przemska-Kosicka, Caroline E Childs, Catherine Maidens, Honglin Dong, Susan Todd, Margot A Gosney, Kieran Michael Tuohy, Parveen Yaqoob
Natural killer (NK) cells are an important component of the immune response to influenza infection, but are subject to alteration during aging, which may play a role in impaired response to infection and vaccination in older people. Enhancement of NK cell activity could, therefore, present a means to improve the immune response to vaccination in older subjects, and pre- and probiotics offer an opportunity to modulate antiviral defenses via alteration of the gut microbiota. This study investigated the effect of a novel probiotic, Bifidobacterium longum bv...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29661905/randomized-study-of-adjunctive-belimumab-in-participants-with-generalized-myasthenia-gravis
#14
Karen Hewett, Donald B Sanders, Richard A Grove, Christine L Broderick, Todd J Rudo, Ashlyn Bassiri, Marina Zvartau-Hind, Vera Bril
OBJECTIVE: To investigate the efficacy and safety of belimumab, a fully human immunoglobulin G1λ monoclonal antibody against B-lymphocyte stimulator, in participants with generalized myasthenia gravis (MG) who remained symptomatic despite standard of care (SoC) therapy. METHODS: Eligible participants with MG were randomized 1:1 to receive IV belimumab 10 mg/kg or placebo in this phase II, placebo-controlled, multicenter, double-blind study (NCT01480596; BEL115123)...
April 17, 2018: Neurology
https://www.readbyqxmd.com/read/29661838/chronic-supplementation-with-a-mitochondrial-antioxidant-mitoq-improves-vascular-function-in-healthy-older-adults
#15
Matthew J Rossman, Jessica R Santos-Parker, Chelsea A C Steward, Nina Z Bispham, Lauren M Cuevas, Hannah L Rosenberg, Kayla A Woodward, Michel Chonchol, Rachel A Gioscia-Ryan, Michael P Murphy, Douglas R Seals
Excess reactive oxygen species production by mitochondria is a key mechanism of age-related vascular dysfunction. Our laboratory has shown that supplementation with the mitochondrial-targeted antioxidant MitoQ improves vascular endothelial function by reducing mitochondrial reactive oxygen species and ameliorates arterial stiffening in old mice, but the effects in humans are unknown. Here, we sought to translate our preclinical findings to humans and determine the safety and efficacy of MitoQ. Twenty healthy older adults (60-79 years) with impaired endothelial function (brachial artery flow-mediated dilation <6%) underwent 6 weeks of oral supplementation with MitoQ (20 mg/d) or placebo in a randomized, placebo-controlled, double-blind, crossover design study...
April 16, 2018: Hypertension
https://www.readbyqxmd.com/read/29661657/reprint-of-the-effect-of-n-acetylcysteine-and-working-memory-training-on-cocaine-use-craving-and-inhibition-in-regular-cocaine-users-correspondence-of-lab-assessments-and-ecological-momentary-assessment
#16
Mieke H J Schulte, Reinout W Wiers, Wouter J Boendermaker, Anna E Goudriaan, Wim van den Brink, Denise S van Deursen, Malte Friese, Emily Brede, Andrew J Waters
INTRODUCTION: Effective treatment for cocaine use disorder should dampen hypersensitive cue-induced motivational processes and/or strengthen executive control. Using a randomized, double-blind, placebo-controlled intervention, the primary aim of this study was to investigate the effect of N-Acetylcysteine (NAC) and working memory (WM)-training to reduce cocaine use and craving and to improve inhibition assessed in the laboratory and during Ecological Momentary Assessment (EMA). The second aim was to examine correspondence between laboratory and EMA data...
March 26, 2018: Addictive Behaviors
https://www.readbyqxmd.com/read/29660425/certolizumab-pegol-for-the-treatment-of-chronic-plaque-psoriasis-results-through-48-weeks-of-a-phase-3-multicenter-randomized-double-blinded-etanercept-and-placebo-controlled-study-cimpact
#17
Mark Lebwohl, Andrew Blauvelt, Carle Paul, Howard Sofen, Jolanta Węgłowska, Vincent Piguet, Daniel Burge, Robert Rolleri, Janice Drew, Luke Peterson, Matthias Augustin
BACKGROUND: Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity. OBJECTIVE: Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. METHODS: Patients were randomized 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks. Certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 were re-randomized to certolizumab or placebo for 32 weeks...
April 13, 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29660421/certolizumab-pegol-for-the-treatment-of-chronic-plaque-psoriasis-results-through-48-weeks-from-two-phase-3-multicenter-randomized-double-blinded-placebo-controlled-studies-cimpasi-1-and-cimpasi-2
#18
Alice B Gottlieb, Andrew Blauvelt, Diamant Thaçi, Craig L Leonardi, Yves Poulin, Janice Drew, Luke Peterson, Catherine Arendt, Daniel Burge, Kristian Reich
BACKGROUND: Certolizumab pegol, the only Fc-Free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements and suggested a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. OBJECTIVE: Assess certolizumab efficacy and safety versus placebo in phase 3 studies. METHODS: Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks...
April 13, 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29660190/safety-and-immunogenicity-of-hbai20-hepatitis-b-vaccine-in-healthy-na%C3%A3-ve-and-non-responding-adults
#19
Özgür M Koc, Paul H M Savelkoul, Inge H M van Loo, Andrea Peeters, Astrid M L Oude Lashof
Approximately 5% of the healthy adult population respond inadequately to the commercial recombinant hepatitis B vaccines. As the recombinant vaccines all have an aluminum-based adjuvant, we tried to enhance the immune response by adding a cytokine-based adjuvant. This new adjuvant AI20, containing 20μg recombinant human IL-2 attached to 20μg aluminum hydroxide, was added to HBVaxPro©-10μg (HBAI20). In a double-blind randomized controlled trial (RCT), 24 naïve subjects were randomized to receive either HBAI20 or commercial HBVaxPro©-10μg vaccine...
April 16, 2018: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29660034/e-cigarettes-may-support-smokers-with-high-smoking-related-risk-awareness-to-stop-smoking-in-the-short-run-preliminary-results-by-randomized-controlled-trial
#20
Marianna Masiero, Claudio Lucchiari, Ketti Mazzocco, Giulia Veronesi, Patrick Maisonneuve, Costantino Jemos, Emanuela Omodeo Salè, Stefania Spina, Raffaella Bertolotti, Gabriella Pravettoni
Introduction: E-cigarettes may be positively used in tobacco cessation treatments. However, neither the World Health Organization nor the American Food and Drug Administration has recognized them as effective cessation aids. Data about the efficacy and safety of e-cigarettes are still limited and controversial. Methods: This was a double-blind randomized controlled study. The main aim was to assess the efficacy of the use of e-cigarettes in a tobacco cessation program with a group of chronic smokers voluntarily involved in long-term lung cancer screening...
April 11, 2018: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
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