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https://www.readbyqxmd.com/read/29933364/pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-single-dose-denosumab-in-healthy-chinese-volunteers-a-randomized-single-blind-placebo-controlled-study
#1
Qian Chen, Chaoying Hu, Yanmei Liu, Rong Song, Wenjing Zhu, Hongxin Zhao, Antonio Nino, Fan Zhang, Yun Liu
BACKGROUND: Denosumab is a fully human monoclonal antibody against receptor activator of nuclear factor kappa-B ligand, a cytokine essential for the formation, function and survival of osteoclasts. This study assessed the pharmacokinetics, pharmacodynamics, safety and tolerability of single-dose denosumab (60 and 120 mg) in healthy Chinese volunteers. METHODS: This randomized (3:3:2), single-blind, placebo-controlled study enrolled healthy Chinese volunteers to receive single subcutaneous injection of denosumab 60 mg, 120 mg, or placebo...
2018: PloS One
https://www.readbyqxmd.com/read/29933277/phototherapy-on-management-of-creatine-kinase-activity-in-general-versus-localized-exercise-a-systematic-review-and-meta-analysis
#2
Aryane Flauzino Machado, Jéssica Kirsch Micheletti, Jaqueline Santos Silva Lopes, Franciele Marques Vanderlei, Ernesto Cesar Pinto Leal-Junior, Jayme Netto Junior, Carlos Marcelo Pastre
OBJECTIVE: The main focus of this systematic review was to determine the efficacy of phototherapy in the management of creatine kinase (CK) activity after exercise and furthermore to identify for which exercise model protocol phototherapy provides the best results. DESIGN: Meta-analysis comparing phototherapy with a control condition. SETTING: The MEDLINE, EMBASE, SPORTDiscus, PEDro, and CENTRAL databases were searched from their earliest records to October 03, 2016...
June 21, 2018: Clinical Journal of Sport Medicine: Official Journal of the Canadian Academy of Sport Medicine
https://www.readbyqxmd.com/read/29932311/rationale-and-design-of-a-multicentre-randomized-placebo-controlled-trial-of-mirabegron-a-beta3-adrenergic-receptor-agonist-on-left-ventricular-mass-and-diastolic-function-in-patients-with-structural-heart-disease-beta3-left-ventricular-hypertrophy-beta3-lvh
#3
Anne-Catherine Pouleur, Stefan Anker, Dulce Brito, Oana Brosteanu, Dirk Hasenclever, Barbara Casadei, Frank Edelmann, Gerasimos Filippatos, Damien Gruson, Ignatios Ikonomidis, Renaud Lhommel, Masliza Mahmod, Stefan Neubauer, Alexandre Persu, Bernhard L Gerber, Stefan Piechnik, Burkert Pieske, Elisabeth Pieske-Kraigher, Fausto Pinto, Piotr Ponikowski, Michele Senni, Jean-Noël Trochu, Nancy Van Overstraeten, Rolf Wachter, Jean-Luc Balligand
AIMS: Progressive left ventricular (LV) remodelling with cardiac myocyte hypertrophy, myocardial fibrosis, and endothelial dysfunction plays a key role in the onset and progression of heart failure with preserved ejection fraction. The Beta3-LVH trial will test the hypothesis that the β3 adrenergic receptor agonist mirabegron will improve LV hypertrophy and diastolic function in patients with hypertensive structural heart disease at high risk for developing heart failure with preserved ejection fraction...
June 22, 2018: ESC Heart Failure
https://www.readbyqxmd.com/read/29932239/efficacy-of-different-drugs-in-the-treatment-of-minimal-hepatic-encephalopathy-a-network-meta-analysis-involving-826-patients-based-on-10-randomized-controlled-trials
#4
Xiao-Jun Cai, Lei Wang, Chun-Mei Hu
Minimal hepatic encephalopathy (MHE), a complex neuropsychological complication of cirrhosis, is characterized by delayed reaction time and the inhibition of abnormal response. This network meta-analysis (NMA) was adopted to compare the efficacy of five drugs including lactulose, probiotics, rifaximin, acetyl-L-carnitine (ALC), and L-Ornithine L-aspartate (LOLA) in the treatment of MHE. The Cochrane Library, PubMed, and Embase databases were searched for any existing entail on these five drugs from the inception to February 2018, including Randomized controlled trials (RCTs)...
June 22, 2018: Journal of Cellular Biochemistry
https://www.readbyqxmd.com/read/29932230/effects-of-selenium-supplementation-on-expression-of-sepp1-in-mrna-and-protein-levels-in-subjects-with-and-without-metabolic-syndrome-suffering-from-coronary-artery-disease-selenegene-study-a-double-blind-randomized-controlled-trial
#5
Mojgan Gharipour, Khadija Ouguerram, El-Hassane Nazih, Mansour Salehi, Mehrdad Behmanesh, Hamidreza Roohafza, Syed Mohsen Hosseini, Pouya Nezafati, Minoo Dianatkhah, Amin Gharipour, Shaghayegh Haghjoo, Nizal Sarrafzadegan, Masoumeh Sadeghi
Selenoprotein P (SePP) is involved in the protection against diseases. The present study is the first investigation of the effect of selenium supplementation on plasma selenium and expression of SEPP1 in mRNA and protein levels based on metabolic syndrome (MetS), in individuals suffering from coronary artery diseases. In this clinical trial, 160 patients with angiographically documented stenosis of more than 75% in each vessel were enrolled. Patients received either 200-mg selenium yeast tablets or placebo tablets orally after a meal, once daily for 60 days...
June 22, 2018: Journal of Cellular Biochemistry
https://www.readbyqxmd.com/read/29932001/locally-administered-bisphosphonate-in-hip-stem-revisions-using-the-bone-impaction-grafting-technique-a-randomised-placebo-controlled-study-with-dxa-and-five-year-rsa-follow-up
#6
Ola Belfrage, Magnus Tägil, Martin Sundberg, Uldis Kesteris, Gunnar Flivik
BACKGROUND: Bisphosphonates have previously been shown to increase the density of impacted graft bone. In the present study we hypothesise that bisphosphonates also reduce early stem subsidence. We examined the effect of locally applied bisphosphonate to allografts on prosthetic micromotion and bone density in femoral stem revision with impaction grafting. METHODS: 37 patients were randomised to either clodronate or saline as local adjunct to the morsellised allograft bone...
June 1, 2018: Hip International: the Journal of Clinical and Experimental Research on Hip Pathology and Therapy
https://www.readbyqxmd.com/read/29931657/vitamin-d-supplementation-to-persistent-carriers-of-mrsa-a-randomized-and-placebo-controlled-clinical-trial
#7
Linda Björkhem-Bergman, Catharina Missailidis, John Karlsson-Valik, Ann Tammelin, Lena Ekström, Matteo Bottai, Ulf Hammar, Gudrun Lindh, Peter Bergman
Methicillin-resistant Staphylococcus aureus (MRSA) is resistant to all beta-lactam antibiotics and can cause severe infections that are difficult to treat. Eradication strategies with conventional antibiotics are not always effective and alternative approaches are warranted. Here, we tested the hypothesis that daily supplementation with vitamin D for 12 months would reduce MRSA carriage rates among a group of persistent carriers. This was a double-blind, placebo-controlled randomized trial with n = 65 persistent MRSA carriers with 25-hydroxy vitamin D3 (25OHD) < 75 nmol/L, who were followed up with bacterial cultures at baseline and every 3 months for 1 year...
June 21, 2018: European Journal of Clinical Microbiology & Infectious Diseases
https://www.readbyqxmd.com/read/29931594/telotristat-ethyl-a-review-in-carcinoid-syndrome-diarrhoea
#8
Katherine A Lyseng-Williamson
Telotristat ethyl (Xermelo® ), a first-in-class peripheral tryptophan hydroxylase (TPH) inhibitor, is approved to treat carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy alone. Some neuroendocrine tumours secrete serotonin (5-HT) into the blood, resulting in frequent bowel movements (BMs) and other symptoms. Telotristat ethyl inhibits TPH, thereby reducing the production of 5-HT and improving carcinoid syndrome diarrhoea. In the 12-week placebo-controlled phase of randomized trials in patients with carcinoid syndrome diarrhoea (most of whom were receiving SSA therapy), the addition of oral telotristat ethyl 250 three times daily provided significant reductions in the frequency of BMs and levels of urinary 5-hydroxyindolacetic acid (u5-HIAA; a metabolite of 5-HT) relative to placebo...
June 2018: Drugs
https://www.readbyqxmd.com/read/29931592/sarilumab-a-review-in-moderate-to-severe-rheumatoid-arthritis
#9
Yvette N Lamb, Emma D Deeks
Sarilumab (Kevzara® ), a monoclonal antibody against the interleukin-6 (IL-6) receptor, is approved in various countries, including the USA, those of the EU, and Japan, as a subcutaneous treatment administered every 2 weeks for moderately to severely active rheumatoid arthritis (RA) in adults who have responded inadequately to, or are intolerant of, one or more DMARDs. In placebo-controlled trials, sarilumab improved the signs and symptoms of RA, as well as physical function and health-related quality-of-life (HR-QOL), when administered in combination with conventional synthetic DMARD (csDMARD) therapy in patients with an inadequate response to methotrexate or an inadequate response to, or intolerance of, at least one tumour necrosis factor (TNF) inhibitor; benefits were sustained over ≤ 3 years' therapy in an open-label extension...
June 2018: Drugs
https://www.readbyqxmd.com/read/29931588/low-level-laser-therapy-combined-to-functional-exercise-on-treatment-of-fibromyalgia-a-double-blind-randomized-clinical-trial
#10
Daniel Germano Maciel, Marianne Trajano da Silva, José Antônio Rodrigues, João Batista Viana Neto, Ingrid Martins de França, Ana Beatriz Medeiros Melo, Therence Yves Pereira Barros da Silva, Wouber Hérickson de Brito Vieira
This study aims to investigate the effects of low-level laser therapy (LLLT) combined to a functional exercise program on treatment of FM. A double-blind and placebo-controlled randomized clinical trial composed of 22 women divided into two groups: placebo group (functional exercise program associated with placebo phototherapy n = 11) and laser group (same exercise program associated with active phototherapy; n = 11). Each session lasted from 40 to 60 min and was performed three times a week for 8 weeks...
June 21, 2018: Lasers in Medical Science
https://www.readbyqxmd.com/read/29931555/uric-acid-and-progression-of-chronic-kidney-disease
#11
Donald J Weaver
The association between serum uric acid levels and human disease has garnered intense interest over the last decade including chronic kidney disease. Animal studies have provided evidence for a potential mechanistic role of uric acid in promoting progression of chronic kidney disease. Epidemiologic studies have also suggested an association between elevated serum uric acid levels and worsening renal function in the general population as well as in patients with chronic kidney disease. However, there is currently insufficient evidence to recommend the use of uric acid-lowering therapy to delay progression of chronic kidney disease in this patient population...
June 21, 2018: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/29931459/effects-of-vitamin-d3-supplementation-on-muscle-strength-mass-and-physical-performance-in-women-with-vitamin-d-insufficiency-a-randomized-placebo-controlled-trial
#12
Lise Sofie Bislev, Lene Langagergaard Rødbro, Lars Rolighed, Tanja Sikjaer, Lars Rejnmark
Vitamin D insufficiency and hyperparathyroidism have been associated with reduced muscle strength, physical performance, postural stability, well-being, and quality of life. In a double-blinded, randomized placebo-controlled trial, we aimed to investigate effects of vitamin D3 supplementation on above-mentioned outcomes in healthy community-dwelling postmenopausal women with plasma levels of 25-hydroxyvitamin D (25(OH)D) below < 50 nmol/l and high parathyroid hormone (PTH) levels. Participants (N = 81) were 1:1 treated with vitamin D3, 70 µg (2800 IU)/day or identical placebo for three months during wintertime (56°N)...
June 21, 2018: Calcified Tissue International
https://www.readbyqxmd.com/read/29931423/the-effects-of-probiotics-and-synbiotic-supplementation-on-glucose-and-insulin-metabolism-in-adults-with-prediabetes-a-double-blind-randomized-clinical-trial
#13
Nazila Kassaian, Awat Feizi, Ashraf Aminorroaya, Parvaneh Jafari, Maryam Tajabadi Ebrahimi, Masoud Amini
AIMS: Probiotics and/or prebiotics could be a promising approach to improve metabolic disorders by favorably modifying the gut microbial composition. OBJECTIVES: To assess the effects of probiotics and synbiotic on glycemic indices in prediabetic individuals who are at risk of type 2 diabetes and its complications. METHODS: In a double-blind, randomized, placebo-controlled parallel-group clinical trial, 120 prediabetic adults participated and were randomly allocated to receive either probiotics or synbiotic or placebo supplements for 24 weeks...
June 22, 2018: Acta Diabetologica
https://www.readbyqxmd.com/read/29931320/a-dose-escalating-study-with-the-fetal-estrogen-estetrol-in-healthy-males
#14
Herjan J T Coelingh Bennink, Yvette Zimmerman, Carole Verhoeven, Alice E Dutman, Tjeert Mensinga, Cornelis Kluft, Yacov Reisman, Frans M J Debruyne
Context: Luteinizing hormone-releasing hormone (LHRH) agonists replaced estrogens for endocrine treatment of advanced prostate cancer (PC) because of cardiovascular side effects. The fetal estrogen estetrol (E4) may be safer for PC treatment and is expected to decrease testosterone (T) and prevent estrogen deficiency. Objective: To investigate the safety and T suppressive effect of E4 in healthy males. Design: Double-blind, randomized, placebo-controlled, dose-escalating study...
June 20, 2018: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29931216/a-phase-3-randomized-placebo-controlled-trial-to-evaluate-efficacy-and-safety-of-romosozumab-in-men-with-osteoporosis
#15
E Michael Lewiecki, Tomasz Blicharski, Stefan Goemaere, Kurt Lippuner, Paul D Meisner, Paul D Miller, Akimitsu Miyauchi, Judy Maddox, Li Chen, Stephane Horlait
Context: Globally, one in five men over 50 years of age is predicted to experience an osteoporotic fracture. Because of the treatment gap in osteoporosis and paucity of bone-forming agents for men, there is need for new osteoporosis treatments. Objective: Evaluate the safety and efficacy of romosozumab in men with osteoporosis. Design: Phase 3 randomized placeBo-contRolled double-blind study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE; NCT02186171) for 12 months...
June 20, 2018: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29931143/oxandrolone-treatment-results-in-an-increased-risk-of-gonadarche-in-prepubertal-boys-with-klinefelter-syndrome
#16
Shanlee M Davis, Najiba Lahlou, Matthew Cox-Martin, Karen Kowal, Philip S Zeitler, Judith L Ross
Context: Klinefelter syndrome (KS) is a common genetic condition in which males have an extra X chromosome. KS is associated with testosterone deficiency, neurodevelopmental delays, and cardiometabolic disorders. There has been recent interest in prepubertal androgen treatment, however the effects on puberty and gonadal function are unknown. Objective: To compare onset of puberty and testicular function in pre-pubertal boys treated with two years of oxandrolone versus placebo...
June 20, 2018: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29931076/effect-of-adding-motolimod-to-standard-combination-chemotherapy-and-cetuximab-treatment-of-patients-with-squamous-cell-carcinoma-of-the-head-and-neck-the-active8-randomized-clinical-trial
#17
Robert L Ferris, Nabil F Saba, Barbara J Gitlitz, Robert Haddad, Ammar Sukari, Prakash Neupane, John C Morris, Krzysztof Misiukiewicz, Julie E Bauman, Moon Fenton, Antonio Jimeno, Douglas R Adkins, Charles J Schneider, Assuntina G Sacco, Keisuke Shirai, Daniel W Bowles, Michael Gibson, Tobenna Nwizu, Raphael Gottardo, Kristi L Manjarrez, Gregory N Dietsch, James Kyle Bryan, Robert M Hershberg, Ezra E W Cohen
Importance: Immunotherapy for recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) is promising. The toll-like receptor 8 (TLR8) agonist motolimod may stimulate innate and adaptive immunity. Objective: To determine whether motolimod improves outcomes for R/M SCCHN when combined with standard therapy. Design, Setting, and Participants: The Active8 study was a multicenter, randomized, double-blind, placebo-controlled clinical trial enrolling adult patients (age ≥18 years) with histologically confirmed R/M SCCHN of the oral cavity, oropharynx, hypopharynx, or larynx between October 2013 and August 2015...
June 21, 2018: JAMA Oncology
https://www.readbyqxmd.com/read/29930930/the-effect-of-atorvastatin-on-obsessive-compulsive-symptoms-of-refractory-obsessive-compulsive-disorder-add-on-therapy
#18
Shahla Akouchekian, Victoria Omranifard, Parivash Moshfegh, Mohammad Reza Maracy, Asiyeh Almasi
Background: Considering the effect of statins on the regulation of dopamine neurotransmitters and glutamates and importance of the treatment of obsessive-compulsive disorder (OCD) due to its relatively high prevalence and disability of available drugs in treatment of many patients, we came to the point to examine effectiveness of statins in patients with OCD. Materials and Methods: This study is a double-blind randomized clinical trial, which is done in OCD clinic of Isfahan Shariati in 2014 for 1 year...
2018: Advanced Biomedical Research
https://www.readbyqxmd.com/read/29930521/how-placebo-needles-differ-from-placebo-pills
#19
REVIEW
Younbyoung Chae, Ye-Seul Lee, Paul Enck
Because acupuncture treatment is defined by the process of needles penetrating the body, placebo needles were originally developed with non-penetrating mechanisms. However, whether placebo needles are valid controls in acupuncture research is subject of an ongoing debate. The present review provides an overview of the characteristics of placebo needles and how they differ from placebo pills in two aspects: (1) physiological response and (2) blinding efficacy. We argue that placebo needles elicit physiological responses similar to real acupuncture and therefore provide similar clinical efficacy...
2018: Frontiers in Psychiatry
https://www.readbyqxmd.com/read/29930370/taste-disturbances-are-there-any-effective-treatments
#20
Michelle Michelson, Analia Veitz-Keenan
Data sourcesSeveral electronic databases were searched such as Cochrane Oral Health's Trials, Cochrane Library, Medline Ovid, CINAHL EBSCO and AMED Ovid and ongoing registered clinical trials in clinicaltrials.gov and in the World Health Organization International Clinical Trials Registry Platform. No restriction was placed on language and date of publication.Study selectionThe authors included randomised clinical trials (RCTs) and cross-over trials comparing any pharmacological intervention or any non-pharmacological agent with a control intervention...
June 2018: Evidence-based Dentistry
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