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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/27914656/chronic-oral-study-of-myosin-activation-to-increase-contractility-in-heart-failure-cosmic-hf-a-phase-2-pharmacokinetic-randomised-placebo-controlled-trial
#1
John R Teerlink, G Michael Felker, John J V McMurray, Scott D Solomon, Kirkwood F Adams, John G F Cleland, Justin A Ezekowitz, Assen Goudev, Peter Macdonald, Marco Metra, Veselin Mitrovic, Piotr Ponikowski, Pranas Serpytis, Jindrich Spinar, János Tomcsányi, Hans J Vandekerckhove, Adriaan A Voors, Maria Laura Monsalvo, James Johnston, Fady I Malik, Narimon Honarpour
BACKGROUND: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil. METHODS: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks...
November 30, 2016: Lancet
https://www.readbyqxmd.com/read/27914492/ticagrelor-with-aspirin-or-alone-in-high-risk-patients-after-coronary-intervention-rationale-and-design-of-the-twilight-study
#2
Usman Baber, George Dangas, David J Cohen, C Michael Gibson, Shamir R Mehta, Dominick J Angiolillo, Stuart J Pocock, Mitchell W Krucoff, Adnan Kastrati, E Magnus Ohman, Philippe Gabriel Steg, Juan Badimon, M Urooj Zafar, Jaya Chandrasekhar, Samantha Sartori, Melissa Aquino, Roxana Mehran
BACKGROUND: Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT. METHODS: TWILIGHT is a randomized, double-blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES...
December 2016: American Heart Journal
https://www.readbyqxmd.com/read/27914210/randomized-controlled-trial-of-oral-immunotherapy-for-egg-allergy-in-japanese-patients
#3
Masayuki Akashi, Hiroki Yasudo, Masami Narita, Ichiro Nomura, Akira Akasawa, Motohiro Ebisawa, Takao Takahashi, Yukihiro Ohya
BACKGROUND: Egg allergy is one of the most common food allergies in young child. While oral immunotherapy (OIT) is not routinely recommended in current guidelines, it has been considered as a potential alternative treatment strategy. Studies on OIT for food allergies have been explored; however, no studies with control group have been reported in Japan. METHODS: The first oral food challenge test (OFC) was performed on participants before treatment to ensure the diagnosis and evaluate the threshold dose for egg by the way of double-blind, placebo-controlled food challenge (DBPCFC)...
December 3, 2016: Pediatrics International: Official Journal of the Japan Pediatric Society
https://www.readbyqxmd.com/read/27914176/prophylactic-rectal-indomethacin-may-be-ineffective-for-preventing-post-ercp-pancreatitis-in-general-patients-a-meta-analysis
#4
REVIEW
Yunlu Feng, Udayakumar Navaneethan, Xiang Zhu, Shyam Varadarajulu, Ingrid Schwartz, Robert H Hawes, Muhammad K Hasan, Aiming Yang
BACKGROUND AND AIMS: The efficacy of prophylactic indomethacin for prevention of post-ERCP pancreatitis (PEP) in general patients remains controversial. To address this, we therefore conducted a meta-analysis of clinical trials specifically on rectal indomethacin in prevention of PEP in consecutive patients undergoing ERCP. METHODS: We searched MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases to identify randomized, double-blinded, controlled clinical trials on rectal indomethacin in prevention of PEP in consecutive patients undergoing ERCP...
December 3, 2016: Digestive Endoscopy: Official Journal of the Japan Gastroenterological Endoscopy Society
https://www.readbyqxmd.com/read/27914033/l-carnitine-simvastatin-reduces-lipoprotein-a-levels-compared-with-simvastatin-monotherapy-a-randomized-double-blind-placebo-controlled-study
#5
M Florentin, M S Elisaf, C V Rizos, V Nikolaou, E Bilianou, C Pitsavos, E N Liberopoulos
Lipoprotein (a) [Lp(a)] is an independent risk factor for cardiovascular disease. There are currently limited therapeutic options to lower Lp(a) levels. L-Carnitine has been reported to reduce Lp(a) levels. The aim of this study was to compare the effect of L-carnitine/simvastatin co-administration with that of simvastatin monotherapy on Lp(a) levels in subjects with mixed hyperlipidemia and elevated Lp(a) concentration. Subjects with levels of low-density lipoprotein cholesterol (LDL-C) >160 mg/dL, triacylglycerol (TAG) >150 mg/dL and Lp(a) >20 mg/dL were included in this study...
December 2, 2016: Lipids
https://www.readbyqxmd.com/read/27913872/treatment-for-6%C3%A2-months-with-fish-oil-derived-n-3-polyunsaturated-fatty-acids-has-neutral-effects-on-glycemic-control-but-improves-dyslipidemia-in-type-2-diabetic-patients-with-abdominal-obesity-a-randomized-double-blind-placebo-controlled-trial
#6
Feng Wang, Yanyan Wang, Yan Zhu, Xiaosong Liu, Hui Xia, Xian Yang, Guiju Sun
PURPOSE: This study aimed to determine the effects of fish oil-derived n-3 PUFA on glycemic control and lipid profiles in type 2 diabetic patients with abdominal obesity. METHODS: In a randomized, double-blind, placebo-controlled trial, 100 type 2 diabetic patients with abdominal obesity were randomized into two groups including 4 g/day of fish oil (2.4 g n-3 PUFA) or placebo (corn oil) for 6 months. Serum fatty acid, body composition, as well as markers of glucose regulation and lipid parameters were measured before and after intervention...
December 2, 2016: European Journal of Nutrition
https://www.readbyqxmd.com/read/27913695/a-randomized-double-blind-placebo-controlled-trial-of-coenzyme-q10-in-huntington-disease
#7
Andrew McGarry, Michael McDermott, Karl Kieburtz, Elisabeth A de Blieck, Flint Beal, Karen Marder, Christopher Ross, Ira Shoulson, Peter Gilbert, William M Mallonee, Mark Guttman, Joanne Wojcieszek, Rajeev Kumar, Mark S LeDoux, Mary Jenkins, H Diana Rosas, Martha Nance, Kevin Biglan, Peter Como, Richard M Dubinsky, Kathleen M Shannon, Padraig O'Suilleabhain, Kelvin Chou, Francis Walker, Wayne Martin, Vicki L Wheelock, Elizabeth McCusker, Joseph Jankovic, Carlos Singer, Juan Sanchez-Ramos, Burton Scott, Oksana Suchowersky, Stewart A Factor, Donald S Higgins, Eric Molho, Fredy Revilla, John N Caviness, Joseph H Friedman, Joel S Perlmutter, Andrew Feigin, Karen Anderson, Ramon Rodriguez, Nikolaus R McFarland, Russell L Margolis, Eric S Farbman, Lynn A Raymond, Valerie Suski, Sandra Kostyk, Amy Colcher, Lauren Seeberger, Eric Epping, Sherali Esmail, Nancy Diaz, Wai Lun Alan Fung, Alan Diamond, Samuel Frank, Philip Hanna, Neal Hermanowicz, Leon S Dure, Merit Cudkowicz
OBJECTIVE: To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD. METHODS: We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months...
December 2, 2016: Neurology
https://www.readbyqxmd.com/read/27913576/empagliflozin-as-add-on-therapy-in-patients-with-type-2-diabetes-inadequately-controlled-with-linagliptin-and-metformin-a-24-week-randomized-double-blind-parallel-group-trial
#8
Eirik Søfteland, Juris J Meier, Bente Vangen, Robert Toorawa, Mario Maldonado-Lutomirsky, Uli C Broedl
OBJECTIVE: To evaluate the efficacy and safety of empagliflozin versus placebo as add-on therapy in patients with type 2 diabetes and inadequate glycemic control with linagliptin and metformin. RESEARCH DESIGN AND METHODS: Patients with HbA1c ≥8.0% and ≤10.5% (≥64 and ≤91 mmol/mol) while receiving stable-dose metformin received open-label linagliptin 5 mg (n = 606) for 16 weeks. Subsequently, those with HbA1c ≥7.0 and ≤10.5% (≥53 and ≤91 mmol/mol) were randomized to receive double-blind, double-dummy treatment with empagliflozin 10 mg (n = 112), empagliflozin 25 mg (n = 111), or placebo (n = 110) for 24 weeks; all patients continued treatment with metformin and linagliptin 5 mg...
December 2, 2016: Diabetes Care
https://www.readbyqxmd.com/read/27912953/evaluating-the-effect-of-matricaria-recutita-and-mentha-piperita-herbal-mouthwash-on-management-of-oral-mucositis-in-patients-undergoing-hematopoietic-stem-cell-transplantation-a-randomized-double-blind-placebo-controlled-clinical-trial
#9
Maria Tavakoli Ardakani, Sara Ghassemi, Mahshid Mehdizadeh, Faraz Mojab, Jamshid Salamzadeh, Samaneh Ghassemi, Abbas Hajifathali
OBJECTIVES: To investigate the effects of Matricaria recutita and Mentha piperita on oral mucositis (OM) in patients undergoing hematopoietic stem cell transplantation (HSCT). DESIGN: Randomized double blind placebo controlled clinical trial. SETTING: Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, and Bone Marrow Transplantation Center at Taleghani Teaching Hospital, Tehran, Iran. PARTICIPANTS: Sixty patients undergoing HSCT were randomly assigned to two groups: placebo (n=33), and herbal mouthwash group (n=27)...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912950/a-randomized-placebo-controlled-trial-of-traditional-chinese-medicine-as-an-add-on-therapy-to-oral-montelukast-in-the-treatment-of-mild-persistent-asthma-in-children
#10
Pak-Hong Chan, Ching-Yee To, Eric Yat-Tung Chan, Handong Li, Xiuxia Zhang, Pok-Yu Chow, Po-Ling Liu, Shuk-Yu Leung, Chung-Hong Chan, Ka-Yan Chan, Johnny Yick-Chun Chan, Jonathan Pak-Heng Ng, Daniel Kwok-Keung Ng
OBJECTIVES: Traditional Chinese medicine are commonly used for treatment of asthma. However, there are only very limited data about its efficacy in children. Therefore, we aimed to determine the efficacy of augmented Yu Ping Feng San (aYPFS) as an add-on to oral montelukast compared with montelukast alone for treatment of mild persistent asthma in children. DESIGN: A single centre, placebo-controlled, double-blinded, randomized control trial was carried out. Participants with age 6-18 years who had mild persistent asthma were randomized according to random number list to receive either aYPFS plus montelukast for 24 weeks or placebo plus montelukast for 24 weeks...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912940/panax-ginseng-and-salvia-miltiorrhiza-supplementation-during-eccentric-resistance-training-in-middle-aged-and-older-adults-a-double-blind-randomized-control-trial
#11
Hsin-Fu Lin, Chun-Chung Chou, Hsiao-Han Chao, Hirofumi Tanaka
BACKGROUND: Muscle damage induced by an acute bout of eccentric exercise results in transient arterial stiffening. In this study, we sought to determine the effects of progressive eccentric resistance exercise training on vascular functions, and whether herb supplementation would enhance training adaptation by ameliorating the arterial stiffening effects. METHODS: By using a double-blinded randomized placebo-controlled design, older adults were randomly assigned to either the Panax ginseng and Salvia miltiorrhiza supplementation group (N=12) or the placebo group (N=11)...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912935/multi-dimensional-analysis-on-parkinson-s-disease-questionnaire-39-in-parkinson-s-patients-treated-with-bushen-huoxue-granule-a-multicenter-randomized-double-blinded-and-placebo-controlled-trial
#12
Min Li, Hui Ming Yang, Dong Xiao Luo, Jian Zong Chen, Heng Jun Shi
OBJECTIVES: To preliminarily assess the effects of Bushen Huoxue Granule (BHG) on Parkinson's Patients with Parkinson's Disease Questionnaire-39 (PDQ-39)and to provide data for further research. DESIGN: A randomized, double-blinded, placebo controlled study with a 3-month intervention period and a 6-month follow-up. INTERVENTIONS: Participants were patients with Parkinson's Disease (PD) of age ranging from 50 to 80 years and Hoehn and Yahr (H-Y) stage I-IV of the disease...
December 2016: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/27912875/long-term-chamomile-matricaria-chamomilla-l-treatment-for-generalized-anxiety-disorder-a-randomized-clinical-trial
#13
Jun J Mao, Sharon X Xie, John R Keefe, Irene Soeller, Qing S Li, Jay D Amsterdam
BACKGROUND: Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects. PURPOSE: To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse. METHODS: Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center...
December 15, 2016: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
https://www.readbyqxmd.com/read/27912207/clinical-adverse-effects-of-endothelin-receptor-antagonists-insights-from-the-meta-analysis-of-4894-patients-from-24-randomized-double-blind-placebo-controlled-clinical-trials
#14
Anhua Wei, Zhichun Gu, Juan Li, Xiaoyan Liu, Xiaofan Wu, Yi Han, Jun Pu
BACKGROUND: Evidence of the clinical safety of endothelin receptor antagonists (ERAs) is limited and derived mainly from individual trials; therefore, we conducted a meta-analysis. METHODS AND RESULTS: After systematic searches of the Medline, Embase, and Cochrane Library databases and the ClinicalTrials.gov website, randomized controlled trials with patients receiving ERAs (bosentan, macitentan, or ambrisentan) in at least 1 treatment group were included. All reported adverse events of ERAs were evaluated...
October 26, 2016: Journal of the American Heart Association
https://www.readbyqxmd.com/read/27911471/the-effects-of-coenzyme-q10-supplementation-on-glucose-metabolism-and-lipid-profiles-in-women-with-polycystic-ovary-syndrome-a-randomized-double-blind-placebo-controlled-trial
#15
Mansooreh Samimi, Maryam Zarezade Mehrizi, Fatemeh Foroozanfard, Hossein Akbari, Mehri Jamilian, Shahnaz Ahmadi, Zatollah Asemi
BACKGROUND: Data on the effects of coenzyme Q10 (CoQ10) supplementation on metabolic profiles among subjects with polycystic ovary syndrome (PCOS) are scarce. OBJECTIVE: This study was done to evaluate the effects of CoQ10 supplementation on glucose metabolism and lipid profiles in subjects with PCOS. DESIGN, PATIENTS AND MEASUREMENTS: This randomized double-blind, placebo-controlled trial was conducted on 60 women diagnosed with PCOS. Subjects were randomly assigned into two groups to intake either 100 mg CoQ10 supplements (N=30) or placebo (N=30) per day for 12 weeks...
December 2, 2016: Clinical Endocrinology
https://www.readbyqxmd.com/read/27910156/ixekizumab-treatment-improves-fingernail-psoriasis-in-patients-with-moderate-to-severe-psoriasis-results-from-the-randomized-controlled-and-open-label-phases-of-uncover-3
#16
P van de Kerkhof, L Guenther, A B Gottlieb, M Sebastian, J J Wu, P Foley, A Morita, O Goldblum, L Zhang, J Erickson, S Ball, P Rich
BACKGROUND: Fingernail psoriasis is difficult to treat. OBJECTIVE: The objective was to evaluate the effect of ixekizumab, a monoclonal antibody selectively targeting IL-17A, on fingernail psoriasis. METHODS: This Phase 3, double-blind trial (UNCOVER-3) randomized patients to placebo, etanercept (50-mg twice weekly), or 80 mg ixekizumab as one injection every 4 (IXE Q4W) or 2 weeks (IXE Q2W) after a 160-mg starting dose. At Week 12, ixekizumab patients received open-label IXE Q4W through Week 60; placebo patients received a 160-mg starting ixekizumab dose and etanercept patients a 4-week placebo washout before starting IXE Q4W...
November 5, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/27909164/rapid-and-sustained-symptom-reduction-following-psilocybin-treatment-for-anxiety-and-depression-in-patients-with-life-threatening-cancer-a-randomized-controlled-trial
#17
Stephen Ross, Anthony Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara Malone, Barry Cohen, Sarah E Mennenga, Alexander Belser, Krystallia Kalliontzi, James Babb, Zhe Su, Patricia Corby, Brian L Schmidt
BACKGROUND: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. METHODS: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0...
December 2016: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/27909139/safety-and-efficacy-of-sbi-087-a-subcutaneous-agent-for-b-cell-depletion-in-patients-with-active-rheumatoid-arthritis-results-from-a-phase-ii-randomized-double-blind-placebo-controlled-study
#18
Nemanja Damjanov, Malgorzata Tlustochowicz, Jacob Aelion, Maria Greenwald, Annette Diehl, Indranil Bhattacharya, Elena Peeva, Sandeep Menon, Ian Gourley
OBJECTIVE: To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA). METHODS: A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate...
December 2016: Journal of Rheumatology
https://www.readbyqxmd.com/read/27906839/endothelin-contributes-to-the-blood-pressure-rise-triggered-by-hypoxia-in-severe-obstructive-sleep-apnea
#19
Christophe Janssen, Atul Pathak, Guido Grassi, Philippe van de Borne
BACKGROUND: Obstructive sleep apnea (OSA) is strongly correlated with an increased risk of systemic hypertension. However, the link between systemic hypertension and nocturnal apneas remains incompletely understood. Animal studies suggest an implication of the endothelin system. The aim of the present study is to determine if endogenous endothelin plays a role in the increase in blood pressure observed during hypoxic episodes in OSA patients, in addition to peripheral chemoreflex and neural sympathetic activation...
January 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/27906800/lactobacillus-reuteri-dsm-17938-in-the-treatment-of-functional-abdominal-pain-in-children-rct-study
#20
Oleg Jadrešin, Iva Hojsak, Zrinjka Mišak, Alemka Jaklin Kekez, Tena Trbojević, Lana Ivković, Sanja Kolaček
OBJECTIVES: Beneficial therapeutic effect of probiotics has been reported in children with the irritable bowel syndrome (IBS) but not consistently in other functional abdominal pain-related disorders. The aim of this study was to investigate the effect of Lactobacillus (L.) reuteri DSM 17938 in the treatment of functional abdominal pain (FAP) and IBS in children. METHODS: Children (age 4-18 years) referred to pediatric gastroenterologist at Children's Hospital Zagreb from May 2012 to December 2014, diagnosed as FAP or IBS, were randomized to receive L...
November 30, 2016: Journal of Pediatric Gastroenterology and Nutrition
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