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https://www.readbyqxmd.com/read/28550255/sembragiline-in-moderate-alzheimer-s-disease-results-of-a-randomized-double-blind-placebo-controlled-phase-ii-trial-mayflower-road
#1
Stephane Nave, Rachelle S Doody, Mercè Boada, Timo Grimmer, Juha-Matti Savola, Paul Delmar, Meike Pauly-Evers, Tania Nikolcheva, Christian Czech, Edilio Borroni, Benedicte Ricci, Juergen Dukart, Marie Mannino, Tracie Carey, Emma Moran, Inma Gilaberte, Nicoletta Milani Muelhardt, Irene Gerlach, Luca Santarelli, Susanne Ostrowitzki, Paulo Fontoura
BACKGROUND: Sembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer's disease (AD). OBJECTIVE: To evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD. METHODS: In this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13-20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg, or placebo once daily orally for 52 weeks...
May 26, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28550195/dipeptidyl-peptidase-4-inhibition-stimulates-distal-tubular-natriuresis-and-increases-in-circulating-sdf-1%C3%AE-1-67-in-patients-with-type-2-diabetes
#2
Julie A Lovshin, Harindra Rajasekeran, Yulyia Lytvyn, Leif E Lovblom, Shajiha Khan, Robel Alemu, Amy Locke, Vesta Lai, Huaibing He, Lucinda Hittle, Weixun Wang, Daniel J Drucker, David Z I Cherney
OBJECTIVE: Antihyperglycemic agents, such as empagliflozin, stimulate proximal tubular natriuresis and improve cardiovascular and renal outcomes in patients with type 2 diabetes. Because dipeptidyl peptidase 4 (DPP-4) inhibitors are used in combination with sodium-glucose cotransporter 2 (SGLT-2) inhibitors, we examined whether and how sitagliptin modulates fractional sodium excretion and renal and systemic hemodynamic function. RESEARCH DESIGN AND METHODS: We studied 32 patients with type 2 diabetes in a prospective, double-blind, randomized, placebo-controlled trial...
May 26, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28550081/randomized-controlled-trial-for-the-effect-of-vitamin-d-supplementation-on-vascular-stiffness-in-ckd
#3
Adeera Levin, Mila Tang, Taylor Perry, Nadia Zalunardo, Monica Beaulieu, Joshua A Dubland, Kelly Zerr, Ognjenka Djurdjev
BACKGROUND AND OBJECTIVES: Vitamin D is implicated in vascular health in CKD. This study compared placebo, calcifediol, and calcitriol treatment with changes in vascular stiffness, BP, proteinuria, mineral metabolism parameters, C-reactive protein, and fibroblast growth factor 23 in patients with stable CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a double-blind, randomized controlled trial in outpatient CKD clinics in Vancouver, Canada, from February of 2011 to August of 2014, enrolling 119 patients with an eGFR of 15-45 ml/min per 1...
May 26, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/28550071/tubular-discectomy-versus-conventional-microdiscectomy-for-the-treatment-of-lumbar-disc-herniation-long-term-results-of-a-randomised-controlled-trial
#4
Gijsbert M Overdevest, Wilco C Peul, Ronald Brand, Bart W Koes, Ronald Hma Bartels, Wee F Tan, Mark P Arts
BACKGROUND: The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up...
May 26, 2017: Journal of Neurology, Neurosurgery, and Psychiatry
https://www.readbyqxmd.com/read/28549430/reduction-of-the-serum-levels-of-a-specific-biomarker-of-cartilage-degradation-coll2-1-by-hyaluronic-acid-kartilage%C3%A2-cross-compared-to-placebo-in-painful-knee-osteoarthritis-patients-the-epikart-study-a-pilot-prospective-comparative-randomized-double-blind
#5
Yves Henrotin, Francis Berenbaum, Xavier Chevalier, Marc Marty, Pascal Richette, François Rannou
BACKGROUND: Viscosupplementation is a symptomatic treatment of the knee osteoarthritis based on the intra-articular injection of hyaluronic acid (IAHA). Although many studies have investigated its effect on symptoms, few clinical studies have focused on its effects on biologicals markers of cartilage metabolism. In this study, we assessed the effect of an intra-articular injection of a reticulated hyaluronic acid compound on the level of a specific biomarker of type II collagen degradation...
May 26, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28549145/six-month-safety-data-of-recombinant-vesicular-stomatitis-virus-zaire-ebola-virus-envelope-glycoprotein-vaccine-in-a-phase-3-double-blind-placebo-controlled-randomized-study-in-healthy-adults
#6
Scott A Halperin, Jose R Arribas, Richard Rupp, Charles P Andrews, Laurence Chu, Rituparna Das, Jakub K Simon, Matthew T Onorato, Kenneth Liu, Jason Martin, Frans A Helmond
Background.: This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Methods.: Overall, 1197 subjects were randomized 2:2:2:2:1; 1194 were vaccinated with 1 dose of 1 of 3 lots of rVSVΔG- ZEBOV-GP (2 × 107 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 108 pfu, n = 264; high-dose group), or placebo (n = 133)...
May 26, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28548228/skin-reactions-after-photodynamic-therapy-are-unaffected-by-839%C3%A2-nm-photobiomodulation-therapy-a-randomized-double-blind-placebo-controlled-clinical-trial
#7
Christiane Bay, Anne-Cathrine Vissing, Daniel Thaysen-Petersen, Catharina Margrethe Lerche, Katrine Togsverd-Bo, Jakob Heydenreich, Merete Haedersdal
BACKGROUND AND OBJECTIVE: Photodynamic therapy (PDT) is associated with erythema and edema. Photobiomodulation (PBM) therapy may stimulate the skin recovery process. We investigated the potential of PBM to reduce PDT-induced skin reactions. STUDY DESIGN AND METHODS: Healthy volunteers (n = 20) were randomized to receive left- or right side PBM (near-infrared 839/595 nm) or placebo-PBM (595 nm) on their buttocks. Corresponding test areas were exposed to standardized PDT reactions, using ablative fractional laser-assisted PDT (AFXL-PDT) with methyl-aminolevulinate (MAL) incubated for 30, 90, and 180 minutes before red-light illumination...
May 26, 2017: Lasers in Surgery and Medicine
https://www.readbyqxmd.com/read/28548024/a-randomized-double-blind-non-inferiority-trial-evaluating-the-efficacy-and-safety-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-or-glimepiride-in-patients-with-type-2-diabetes-inadequately-controlled-on-metformin-monotherapy
#8
Yehuda Handelsman, Brett Lauring, Ira Gantz, Carol Iredale, Edward A O'Neill, Ziwen Wei, Shailaja Suryawanshi, Keith D Kaufman, Samuel S Engel, Eseng Lai
OBJECTIVE: To evaluate the efficacy and safety of adding the once-weekly DPP-4 inhibitor omarigliptin or the sulfonylurea glimepiride to the treatment regimen of patients with type 2 diabetes (T2DM) and inadequate glycemic control on metformin monotherapy. METHODS: Patients with T2DM and HbA1c ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500 mg/day) were randomized to omarigliptin 25 mg once-weekly (N = 376) or glimepiride up to 6 mg once-daily (N = 375) for 54 weeks...
May 26, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28547998/a-randomized-clinical-trial-evaluating-the-efficacy-and-safety-of-the-once-weekly-dipeptidyl-peptidase-4-inhibitor-omarigliptin-in-patients-with-type-2-diabetes-inadequately-controlled-on-metformin-monotherapy
#9
R Ravi Shankar, Silvio E Inzucchi, Victoria Scarabello, Ira Gantz, Keith D Kaufman, Eseng Lai, Paulette Ceesay, Shailaja Suryawanshi, Samuel S Engel
OBJECTIVE: To examine the efficacy and safety of the once-weekly (q.w.) dipeptidyl peptidase-4 inhibitor, omarigliptin, in patients with type 2 diabetes (T2DM) and inadequate glycemic control on metformin monotherapy. METHODS: In a randomized, double-blind trial, patients with T2DM on a stable dose of metformin monotherapy (≥1500 mg/day) with glycated hemoglobin (HbA1c) of 7.0% to 10.5% were randomized to omarigliptin 25 mg q.w. or matching placebo (N = 201 in both) for 24 weeks (primary timepoint) followed by an additional 80-week treatment period...
May 26, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28546768/effectiveness-of-various-formulations-of-local-anesthetics-and-additives-for-topical-anesthesia-a-prospective-randomized-double-blind-placebo-controlled-study
#10
Christian Weilbach, Christian Hoppe, Matthias Karst, Michael Winterhalter, Konstantinos Raymondos, Arthur Schultz, Niels Rahe-Meyer
BACKGROUND: Topical anesthesia is used to control pain associated with many procedures in medicine. Today, the product most commonly applied for topical anesthesia in Germany is EMLA(®) (lidocaine/prilocaine). However, since prilocaine is a methemoglobin-inducing agent, there are limitations to its use, especially in neonates and infants. The aim of this study was to evaluate the effect of prilocaine and lidocaine as well as propylene glycol, a penetration enhancer, and trometamol, a buffer substance, in anesthetic creams...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28546097/10-years-of-denosumab-treatment-in-postmenopausal-women-with-osteoporosis-results-from-the-phase-3-randomised-freedom-trial-and-open-label-extension
#11
Henry G Bone, Rachel B Wagman, Maria L Brandi, Jacques P Brown, Roland Chapurlat, Steven R Cummings, Edward Czerwiński, Astrid Fahrleitner-Pammer, David L Kendler, Kurt Lippuner, Jean-Yves Reginster, Christian Roux, Jorge Malouf, Michelle N Bradley, Nadia S Daizadeh, Andrea Wang, Paula Dakin, Nicola Pannacciulli, David W Dempster, Socrates Papapoulos
BACKGROUND: Long-term safety and efficacy of osteoporosis treatment are important because of the chronic nature of the disease. We aimed to assess the long-term safety and efficacy of denosumab, which is widely used for the treatment of postmenopausal women with osteoporosis. METHODS: In the multicentre, randomised, double-blind, placebo-controlled, phase 3 FREEDOM trial, postmenopausal women aged 60-90 years with osteoporosis were enrolled in 214 centres in North America, Europe, Latin America, and Australasia and were randomly assigned (1:1) to receive 60 mg subcutaneous denosumab or placebo every 6 months for 3 years...
May 22, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28546090/safety-and-tolerability-of-long-acting-cabotegravir-injections-in-hiv-uninfected-men-eclair-a-multicentre-double-blind-randomised-placebo-controlled-phase-2a-trial
#12
Martin Markowitz, Ian Frank, Robert M Grant, Kenneth H Mayer, Richard Elion, Deborah Goldstein, Chester Fisher, Magdalena E Sobieszczyk, Joel E Gallant, Hong Van Tieu, Winkler Weinberg, David A Margolis, Krischan J Hudson, Britt S Stancil, Susan L Ford, Parul Patel, Elizabeth Gould, Alex R Rinehart, Kimberly Y Smith, William R Spreen
BACKGROUND: Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection. METHODS: We did this multicentre, double-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA...
May 22, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28546012/-a-prospective-randomized-double-blinded-control-study-on-comparison-of-tramadol-clonidine-and-dexmedetomidine-for-post-spinal-anesthesia-shivering
#13
Rajagopalan Venkatraman, Krishnamoorthy Karthik, Anand Pushparani, Annadurai Mahalakshmi
INTRODUCTION: Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. METHODS: This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia...
May 22, 2017: Revista Brasileira de Anestesiologia
https://www.readbyqxmd.com/read/28545978/benralizumab-for-patients-with-mild-to-moderate-persistent-asthma-bise-a-randomised-double-blind-placebo-controlled-phase-3-trial
#14
Gary T Ferguson, J Mark FitzGerald, Eugene R Bleecker, Michel Laviolette, David Bernstein, Craig LaForce, Lyndon Mansfield, Peter Barker, Yanping Wu, Maria Jison, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, anti-interleukin 5 receptor α monoclonal antibody that directly and rapidly depletes eosinophils, reduces asthma exacerbations, and improves lung function for patients with severe eosinophilic asthma. The objective of this trial was to assess the safety and efficacy of benralizumab for patients with mild to moderate, persistent asthma. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients aged 18-75 years, weighing at least 40 kg, and with a postbronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of at least 12% at screening, from 52 clinical research centres in six countries...
May 22, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28545804/knemometry-assessment-of-short-term-growth-in-children-with-asthma-receiving-fluticasone-furoate-for-2-weeks-a-randomized-placebo-controlled-crossover-trial
#15
Ole D Wolthers, Sally Stone, Philippe Bareille, Susan Tomkins, Sanjeev Khindri
PURPOSE: A dry powder inhaler formulation of the inhaled corticosteroid fluticasone furoate (FF) is being evaluated for use in children. An important potential risk associated with the use of inhaled corticosteroids in children is growth suppression. Therefore, the aim of this study was to assess the short-term lower leg growth in children with asthma treated for 2 weeks with inhaled FF versus placebo from the ELLIPTA inhaler. METHODS: Prepubertal children with persistent asthma (n = 60; aged 5 to <12 years) were recruited into a randomized, double-blind, placebo-controlled, 2-way crossover, noninferiority study...
May 22, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28545589/gastrointestinal-tolerance-of-low-fodmap-oral-nutrition-supplements-in-healthy-human-subjects-a-randomized-controlled-trial
#16
Jennifer Erickson, Renee Korczak, Qi Wang, Joanne Slavin
BACKGROUND: There has been increasing interest in utilizing a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) for the treatment of irritable bowel syndrome (IBS), a functional gastrointestinal disease. While studies have indicated that this diet can be effective at symptom reduction, it is a restrictive diet and patients may find it challenging to find low FODMAP products to meet their nutrient needs. The primary objective of this study was to assess the gastrointestinal (GI) tolerance of three low FODMAP oral nutrition supplements (ONS) in healthy adults...
May 25, 2017: Nutrition Journal
https://www.readbyqxmd.com/read/28545508/open-label-versus-double-blind-placebo-treatment-in-irritable-bowel-syndrome-study-protocol-for-a-randomized-controlled-trial
#17
Sarah Ballou, Ted J Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T Hall, John M Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson, Lisa Conboy, Anthony Lembo, Roger B Davis
BACKGROUND: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo...
May 25, 2017: Trials
https://www.readbyqxmd.com/read/28544917/effective-and-safe-mannitol-administration-in-patients-undergoing-supratentorial-tumor-surgery-a-prospective-randomized-and-double-blind-study
#18
Eren Fatma Akcil, Ozlem Korkmaz Dilmen, Esra Sultan Karabulut, Serdar Selcuk Koksal, Fatis Altindas, Yusuf Tunali
OBJECTIVES: Although osmotic diuresis with mannitol is commonly used to provide brain relaxation, there is no consensus regarding its optimal dose and combination with loop diuretics. The aim of the present study is to evaluate the effects of mannitol and combination of furosemide with different doses of mannitol on brain relaxation and on blood electrolytes, lactate level, urine output, fluid balance and blood osmolarity in patients undergoing supratentorial tumor surgery. PATIENTS AND METHODS: This prospective, randomized, double blind, placebo-controlled study included 51 patients (ASA I-III) scheduled for elective supratentorial craniotomy...
May 15, 2017: Clinical Neurology and Neurosurgery
https://www.readbyqxmd.com/read/28544610/phenol-enriched-olive-oils-modify-paraoxonase-related-variables-a-randomized-crossover-controlled-trial
#19
Sara Fernández-Castillejo, Ana-Isabel García-Heredia, Rosa Solà, Jordi Camps, Maria-Carmen López de la Hazas, Marta Farràs, Anna Pedret, Úrsula Catalan, Laura Rubió, Maria-José Motilva, Olga Castañer, María-Isabel Covas, Rosa-Maria Valls
SCOPE: Low paraoxonase (PON)1 activities, and high PON1 and low PON3 protein levels are characteristic of cardiovascular disease. Our aim was to assess short and long-term effects of virgin olive oils (VOO), enriched with their own phenolic compounds (PC; FVOO) or with them plus complementary PC from thyme (FVOOT), on PON-related variables and the mechanisms involved. METHODS AND RESULTS: Two randomized, controlled, double-blind, and crossover interventions were conducted...
May 25, 2017: Molecular Nutrition & Food Research
https://www.readbyqxmd.com/read/28544422/assessment-of-clinically-relevant-bleeding-as-a-surrogate-outcome-for-major-bleeding-validation-by-meta-analysis-of-randomized-controlled-trials
#20
S Laporte, C Chapelle, L Bertoletti, E Ollier, P Zufferey, J-C Lega, A Merah, H Décousus, S Schulman, G Meyer, M Cucherat, P Mismetti
BACKGROUND: Clinically relevant bleeding (CRB), comprising major bleeding and clinically relevant non-major bleeding, has been used as a surrogate for major bleeding in most anticoagulant trials, but its validity for estimating compromise between thrombotic and bleeding events has never been assessed. METHODS: We systematically reviewed randomized phase III trials comparing new anticoagulants with standard of care for venous thromboembolism prevention following major orthopedic surgery, venous thromboembolism (VTE) treatment, or stroke and systemic embolism prevention in atrial fibrillation (AF), and reporting both major bleeding and CRB rates...
May 20, 2017: Journal of Thrombosis and Haemostasis: JTH
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