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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/29913528/blood-pressure-and-cognitive-performance-after-a-single-administration-of-a-camphor-crataegus-combination-in-adolescents-with-low-blood-pressure
#1
Rainer Schandry, Daniela Lindauer, Matthias Mauz
Low blood pressure is rather widespread among adolescents and frequently accompanied by complaints. Two single-center, double-blinded, randomized, and placebo-controlled trials were performed with adolescent participants in the age range of 14 - 17 y having a systolic blood pressure below 118 mmHg (boys) or 110 mmHg (girls). They received a single dose of 20 drops of a fixed combination of natural D-camphor and an ethanolic extract from fresh Crataegus berries (CCC) or of an ethanolic placebo. The efficacy of CCC (commercial name Korodin) has proven its efficacy in the treatment of low blood pressure in adults of all ages, although related placebo-controlled, double-blind studies for adolescents following European (EU) pediatric regulations are lacking...
June 18, 2018: Planta Medica
https://www.readbyqxmd.com/read/29913256/the-effect-of-glucocorticoids-on-bone-mineral-density-in-patients-with-rheumatoid-arthritis-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#2
Anne-Birgitte Blavnsfeldt, Annette de Thurah, Malissa Dawn Thomsen, Simon Tarp, Bente Langdahl, Ellen-Margrethe Hauge
PURPOSE: The role of glucocorticoids in the treatment of rheumatoid arthritis (RA) is widely debated. Impairment of bone formation may be counter-balanced by reduced systemic inflammation. This review aims to assess the effect of prednisolone/prednisone on bone mineral density (BMD) in patients with RA analyzed in randomized, controlled trials. METHODS: We performed a systematic literature search and identified randomized, double-blinded placebo-controlled studies including patients with RA and using prednisolone or prednisone as the intervention...
June 15, 2018: Bone
https://www.readbyqxmd.com/read/29913020/effect-of-tamsulosin-on-passage-of-symptomatic-ureteral-stones-a-randomized-clinical-trial
#3
Andrew C Meltzer, Pamela Katzen Burrows, Allan B Wolfson, Judd E Hollander, Michael Kurz, Ziya Kirkali, John W Kusek, Patrick Mufarrij, Stephen V Jackman, Jeremy Brown
Importance: Urinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage. Objective: To determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients. Design, Setting, and Participants: We conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase)...
June 18, 2018: JAMA Internal Medicine
https://www.readbyqxmd.com/read/29913017/safety-and-tolerability-of-multiple-ascending-doses-of-prx002-rg7935-an-anti-%C3%AE-synuclein-monoclonal-antibody-in-patients-with-parkinson-disease-a-randomized-clinical-trial
#4
Joseph Jankovic, Ira Goodman, Beth Safirstein, Tonya K Marmon, Dale B Schenk, Martin Koller, Wagner Zago, Daniel K Ness, Sue G Griffith, Michael Grundman, Jay Soto, Susanne Ostrowitzki, Frank G Boess, Meret Martin-Facklam, Joseph F Quinn, Stuart H Isaacson, Omid Omidvar, Aaron Ellenbogen, Gene G Kinney
Importance: Aggregated α-synuclein is believed to be central to the pathogenesis of Parkinson disease (PD). PRX002/RG7935 (PRX002) is a humanized monoclonal antibody designed to target aggregated forms of α-synuclein, thereby inhibiting neuron-to-neuron transfer of presumed pathogenic forms of α-synuclein, potentially resulting in neuronal protection and slowing disease progression. Objective: To evaluate the safety and tolerability of multiple intravenous infusions of PRX002 in patients with idiopathic PD...
June 18, 2018: JAMA Neurology
https://www.readbyqxmd.com/read/29913015/comparison-of-safety-and-efficacy-of-methadone-vs-morphine-for-treatment-of-neonatal-abstinence-syndrome-a-randomized-clinical-trial
#5
Jonathan M Davis, Jeffrey Shenberger, Norma Terrin, Janis L Breeze, Mark Hudak, Elisha M Wachman, Peter Marro, Erica L Oliveira, Karen Harvey-Wilkes, Adam Czynski, Barbara Engelhardt, Karen D'Apolito, Debra Bogen, Barry Lester
Importance: Although opioids are used to treat neonatal abstinence syndrome (NAS), the best pharmacologic treatment has not been established. Objective: To compare the safety and efficacy of methadone and morphine in NAS. Design, Setting, and Participants: In this randomized, double-blind, intention-to-treat trial, term infants from 8 US newborn units whose mothers received buprenorphine, methadone, or opioids for pain control during pregnancy were eligible...
June 18, 2018: JAMA Pediatrics
https://www.readbyqxmd.com/read/29912858/effect-of-caffeine-on-sprint-cycling-in-experienced-cyclists
#6
Dawn E Anderson, Sarah E LeGrand, Reece D McCart
Anderson, DE, LeGrand, SE, and McCart, RD. Effect of caffeine on sprint cycling in experienced cyclists. J Strength Cond Res XX(X): 000-000, 2018-Research regarding the ergogenic effects of caffeine (CAF) in anaerobic activity remains inconclusive. However, some researchers have found significant improvements in anaerobic performance when testing specifically trained athletes. A double-blind, placebo-controlled, counterbalanced, cross-over design was implemented to assess the impact of CAF on a 30-second Wingate Anaerobic Test (WAnT) in experienced cyclists...
June 15, 2018: Journal of Strength and Conditioning Research
https://www.readbyqxmd.com/read/29912799/adjunct-aripiprazole-reduces-prolactin-and-prolactin-related-adverse-effects-in-premenopausal-women-with-psychosis-results-from-the-daamsel-clinical-trial
#7
Deanna L Kelly, Megan M Powell, Heidi J Wehring, MacKenzie A Sayer, Ann Marie Kearns, Ann L Hackman, Robert W Buchanan, Rebecca B Nichols, Heather A Adams, Charles M Richardson, Gopal Vyas, Robert P McMahon, Amber K Earl, Kelli M Sullivan, Fang Liu, Sarah E Luttrell, Faith B Dickerson, Stephanie M Feldman, Supriya Narang, Maju M Koola, Peter F Buckley, Jill A RachBeisel, Joseph P McEvoy
PURPOSE/BACKGROUND: Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness. Treating these adverse effects may improve treatment acceptability, adherence, and long-term outcomes. METHODS/PROCEDURES: Premenopausal women with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder were recruited for a randomized, double-blind, placebo-controlled 16-week trial of adjunct aripiprazole (5-15 mg/d)...
June 15, 2018: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/29912570/the-use-of-a-stem-and-leaf-aqueous-extract-of-cissus-quadrangularis-cqr-300-to-reduce-body-fat-and-other-components-of-metabolic-syndrome-in-overweight-participants
#8
Robert Nash, Boris Azantsa, Dieudonne Kuate, Harrinder Singh, Julius Oben
BACKGROUND: Previous work had shown the ability of an aqueous leaf and stem extract of Cissus quandrangularis (300 mg of CQR, CQR-300) to improve components of metabolic syndrome (MS) in overweight individuals. OBJECTIVE: This small pilot study aimed to confirm the efficacy of CQR-300 in reducing the percentage body fat measured using two different methods-bioelectrical impedance assay versus dual-energy X-ray absorptiometry (DEXA). DESIGN: The study was an 8-week double-blind, placebo-controlled pilot trial on 67 individuals who were requested by a dietary counselor to maintain their normal exercise and dietary routines...
June 18, 2018: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/29912318/bayesian-inference-for-network-meta-regression-using-multivariate-random-effects-with-applications-to-cholesterol-lowering-drugs
#9
Hao Li, Ming-Hui Chen, Joseph G Ibrahim, Sungduk Kim, Arvind K Shah, Jianxin Lin, Andrew M Tershakovec
Low-density lipoprotein cholesterol (LDL-C) has been identified as a causative factor for atherosclerosis and related coronary heart disease, and as the main target for cholesterol- and lipid-lowering therapy. Statin drugs inhibit cholesterol synthesis in the liver and are typically the first line of therapy to lower elevated levels of LDL-C. On the other hand, a different drug, Ezetimibe, inhibits the absorption of cholesterol by the small intestine and provides a different mechanism of action. Many clinical trials have been carried out on safety and efficacy evaluation of cholesterol lowering drugs...
April 18, 2018: Biostatistics
https://www.readbyqxmd.com/read/29912061/a-single-low-dose-of-hydrocortisone-enhances-cognitive-functioning-in-hiv-infected-women
#10
Leah H Rubin, K Luan Phan, Sheila M Keating, Pauline M Maki
OBJECTIVE: Low-dose hydrocortisone (LDH) enhances aspects of learning and memory in select populations including patients with PTSD and HIV-infected men. HIV-infected women show impairments in learning and memory, but the cognitive effects of LDH in HIV-infected women are unknown. DESIGN: Double-blind, placebo-controlled, cross-over study examining the time-dependent effects of a single low-dose administration of hydrocortisone (10 mg oral) on cognition in 36 HIV-infected women...
June 14, 2018: AIDS
https://www.readbyqxmd.com/read/29910440/red-spinach-extract-increases-ventilatory-threshold-during-graded-exercise-testing
#11
Angelique N Moore, Cody T Haun, Wesley C Kephart, Angelia M Holland, Christopher B Mobley, David D Pascoe, Michael D Roberts, Jeffrey S Martin
Background: We examined the acute effect of a red spinach extract (RSE) (1000 mg dose; ~90 mg nitrate (NO 3 - )) on performance markers during graded exercise testing (GXT). Methods: For this randomized, double-blind, placebo (PBO)-controlled, crossover study, 15 recreationally-active participants (aged 23.1 ± 3.3 years; BMI: 27.2 ± 3.7 kg/m²) reported >2 h post-prandial and performed GXT 65⁻75 min post-RSE or PBO ingestion. Blood samples were collected at baseline (BL), pre-GXT (65⁻75 min post-ingestion; PRE), and immediately post-GXT (POST)...
October 16, 2017: Sports (Basel)
https://www.readbyqxmd.com/read/29910056/rationale-and-design-of-the-seneca-stem-cell-injection-in-cancer-survivors-trial
#12
Roberto Bolli, Joshua M Hare, Timothy D Henry, Carrie G Lenneman, Keith L March, Kathy Miller, Carl J Pepine, Emerson C Perin, Jay H Traverse, James T Willerson, Phillip C Yang, Adrian P Gee, João A Lima, Lem Moyé, Rachel W Vojvodic, Shelly L Sayre, Judy Bettencourt, Michelle Cohen, Ray F Ebert, Robert D Simari
OBJECTIVES: SENECA (StEm cell iNjECtion in cAncer survivors) is a phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and feasibility of delivering allogeneic mesenchymal stromal cells (allo-MSCs) transendocardially in subjects with anthracycline-induced cardiomyopathy (AIC). BACKGROUND: AIC is an incurable and often fatal syndrome, with a prognosis worse than that of ischemic or nonischemic cardiomyopathy. Recently, cell therapy with MSCs has emerged as a promising new approach to repair damaged myocardium...
July 2018: American Heart Journal
https://www.readbyqxmd.com/read/29910047/design-and-rationale-of-the-fontan-udenafil-exercise-longitudinal-fuel-trial
#13
David J Goldberg, Victor Zak, Bryan H Goldstein, Brian W McCrindle, Shaji C Menon, Kurt R Schumacher, R Mark Payne, Jonathan Rhodes, Kimberly E McHugh, Daniel J Penny, Felicia Trachtenberg, Michelle S Hamstra, Marc E Richmond, Peter C Frommelt, Matthew D Files, James L Yeager, Victoria L Pemberton, Mario P Stylianou, Gail D Pearson, Stephen M Paridon
The Fontan operation creates a circulation characterized by elevated central venous pressure and low cardiac output. Over time, these characteristics result in a predictable and persistent decline in exercise performance that is associated with an increase in morbidity and mortality. A medical therapy that targets the abnormalities of the Fontan circulation might, therefore, be associated with improved outcomes. Udenafil, a phosphodiesterase type 5 inhibitor, has undergone phase I/II testing in adolescents who have had the Fontan operation and has been shown to be safe and well tolerated in the short term...
July 2018: American Heart Journal
https://www.readbyqxmd.com/read/29910042/belimumab-in-kidney-transplantation-an-experimental-medicine-randomised-placebo-controlled-phase-2-trial
#14
Gemma D Banham, Shaun M Flint, Nicholas Torpey, Paul A Lyons, Don N Shanahan, Adele Gibson, Christopher J E Watson, Ann-Marie O'Sullivan, Joseph A Chadwick, Katie E Foster, Rachel B Jones, Luke R Devey, Anna Richards, Lars-Peter Erwig, Caroline O Savage, Kenneth G C Smith, Robert B Henderson, Menna R Clatworthy
BACKGROUND: B cells produce alloantibodies and activate alloreactive T cells, negatively affecting kidney transplant survival. By contrast, regulatory B cells are associated with transplant tolerance. Immunotherapies are needed that inhibit B-cell effector function, including antibody secretion, while sparing regulators and minimising infection risk. B lymphocyte stimulator (BLyS) is a cytokine that promotes B-cell activation and has not previously been targeted in kidney transplant recipients...
June 14, 2018: Lancet
https://www.readbyqxmd.com/read/29910030/efficacy-and-safety-of-bempedoic-acid-added-to-ezetimibe-in-statin-intolerant-patients-with-hypercholesterolemia-a-randomized-placebo-controlled-study
#15
Christie M Ballantyne, Maciej Banach, G B John Mancini, Norman E Lepor, Jeffrey C Hanselman, Xin Zhao, Lawrence A Leiter
BACKGROUND AND AIMS: Patients with hyperlipidemia who are unable to tolerate optimal statin therapy are at increased cardiovascular risk due to ongoing elevations in low-density lipoprotein cholesterol (LDL-C). The objective of CLEAR Tranquility (NCT03001076) was to evaluate the efficacy and safety of bempedoic acid when added to background lipid-modifying therapy in patients with a history of statin intolerance who require additional LDL-C lowering. METHODS: This phase 3, multicenter, randomized, double-blind, placebo-controlled study enrolled patients with a history of statin intolerance and an LDL-C ≥100 mg/dL while on stable lipid-modifying therapy...
June 12, 2018: Atherosclerosis
https://www.readbyqxmd.com/read/29910009/lofexidine-versus-diazepam-for-the-treatment-of-opioid-withdrawal-syndrome-a-double-blind-randomized-clinical-trial-in-singapore
#16
Song Guo, Victoria Manning, Yi Yang, Puay Kee Koh, Edwin Chan, Nurun Nisa de Souza, Pryseley Nkouibert Assam, Rehena Sultana, Ruki Wijesinghe, Julius Pangjaya, Gomathinayagam Kandasami, Christopher Cheok, Kae Meng Lee, Kim Eng Wong
BACKGROUND: Many individuals leave costly inpatient detoxification programs prematurely because of the severity of withdrawal symptoms experienced. In the absence of opioid-assisted detoxification in Singapore, diazepam is used to manage withdrawal. However since diazepam is addictive, there is a need to explore the effectiveness of alternative medications. DESIGN AND PROCEDURES: The study aimed to examine the safety and efficacy of lofexidine, a non-opiate, non-addictive, alpha 2-adrenergic agonist in assisting opioid detoxification in Singapore, using a randomized, double-blind, investigator-initiated placebo-controlled trial comparing lofexidine against diazepam...
August 2018: Journal of Substance Abuse Treatment
https://www.readbyqxmd.com/read/29909463/correction-to-the-effects-of-resveratrol-on-markers-of-oxidative-stress-in-patients-with-type-2-diabetes-a-randomized-double-blind-placebo-controlled-clinical-trial
#17
ShadiSadat Seyyedebrahimi, Hadi Khodabandehloo, Ensieh Nasli Esfahani, Reza Meshkani
Oxidative stress plays a pivotal role in the pathogenesis of type 2 diabetes (T2D). In vitro and animal studies have shown that resveratrol exerts an antioxidant effect, but clinical trials addressing this effect in patients with T2D are limited. The aim of this study was to determine whether resveratrol supplementation affects oxidative stress markers in a randomized, placebo-controlled, double-blind clinical trial.
June 16, 2018: Acta Diabetologica
https://www.readbyqxmd.com/read/29909285/efficacy-of-dexamethasone-in-preventing-acute-mountain-sickness-in-copd-patients-randomized-trial
#18
Michael Furian, Mona Lichtblau, Sayaka S Aeschbacher, Bermet Estebesova, Berik Emilov, Ulan Sheraliev, Nuriddin H Marazhapov, Maamed Mademilov, Batyr Osmonov, Maya Bisang, Stefanie Ulrich, Tsogyal D Latshang, Silvia Ulrich, Talant M Sooronbaev, Konrad E Bloch
BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) may experience acute mountain sickness (AMS) and other altitude-related adverse health effects (ARAHE) when travelling to high altitude. We evaluated whether dexamethasone, a drug used for AMS prevention in healthy individuals, would prevent AMS/ARAHE in COPD. METHODS: In this placebo-controlled, double-blind, parallel-design trial COPD patients, GOLD grade 1-2, living below 800m, were randomized to receive dexamethasone (8mg/day) or placebo starting on the day before ascent and while staying in a high altitude clinic at 3100m for 2 days...
June 14, 2018: Chest
https://www.readbyqxmd.com/read/29908991/mage-a3-immunotherapeutic-as-adjuvant-therapy-for-patients-with-resected-mage-a3-positive-stage-iii-melanoma-derma-a-double-blind-randomised-placebo-controlled-phase-3-trial
#19
Brigitte Dreno, John F Thompson, Bernard Mark Smithers, Mario Santinami, Thomas Jouary, Ralf Gutzmer, Evgeny Levchenko, Piotr Rutkowski, Jean-Jacques Grob, Sergii Korovin, Kamil Drucis, Florent Grange, Laurent Machet, Peter Hersey, Ivana Krajsova, Alessandro Testori, Robert Conry, Bernard Guillot, Wim H J Kruit, Lev Demidov, John A Thompson, Igor Bondarenko, Jaroslaw Jaroszek, Susana Puig, Gabriela Cinat, Axel Hauschild, Jelle J Goeman, Hans C van Houwelingen, Fernando Ulloa-Montoya, Andrea Callegaro, Benjamin Dizier, Bart Spiessens, Muriel Debois, Vincent G Brichard, Jamila Louahed, Patrick Therasse, Channa Debruyne, John M Kirkwood
BACKGROUND: Despite newly approved treatments, metastatic melanoma remains a life-threatening condition. We aimed to evaluate the efficacy of the MAGE-A3 immunotherapeutic in patients with stage IIIB or IIIC melanoma in the adjuvant setting. METHODS: DERMA was a phase 3, double-blind, randomised, placebo-controlled trial done in 31 countries and 263 centres. Eligible patients were 18 years or older and had histologically proven, completely resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma with macroscopic lymph node involvement and an Eastern Cooperative Oncology Group performance score of 0 or 1...
June 13, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29908682/the-effects-of-melissa-officinalis-supplementation-on-depression-anxiety-stress-and-sleep-disorder-in-patients-with-chronic-stable-angina
#20
Habib Haybar, Ahmad Zare Javid, Mohammad Hosein Haghighizadeh, Einollah Valizadeh, Seyede Marjan Mohaghegh, Assieh Mohammadzadeh
BACKGROUND: Despite advances in the treatment of cardiovascular diseases in recent decades, patients experience high levels of depression, anxiety, stress, and insomnia. Since the calming effect of Melissa officinalis (MO) has been known, this study aimed to determine the effects of MO supplementation on depression, anxiety, stress, and sleep disturbances in patients with chronic stable angina (CSA). METHODS: In this double-blind placebo-controlled clinical trial, 80 patients with CSA were divided randomly into two groups (taking 3 g MO supplement or placebo daily for 8 weeks)...
August 2018: Clinical Nutrition ESPEN
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