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https://www.readbyqxmd.com/read/28641022/a-randomized-single-dose-parallel-study-on-enhancement-of-nitric-oxide-in-serum-and-saliva-with-the-use-of-natural-sports-supplement-in-healthy-adults
#1
Joby Jacob, Sreeraj Gopi, Chandradhara Divya
Sports supplements that stimulate the production of nitric oxide (NO) are widely promoted agents in the sports nutrition domain, and nitric oxide plays an important role to enhance the cardiovascular and physical fitness of the sports participants. The purpose of the study is to investigate whether oral intake of a sports nutritional supplement (Fitnox) is able to increase nitrate (NO3(-)) and nitrite (NO2(-)) levels in blood serum and saliva of healthy adults. Fitnox is a unique blend of Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins...
June 22, 2017: Journal of Dietary Supplements
https://www.readbyqxmd.com/read/28640990/opiate-antagonists-do-not-interfere-with-the-clinical-benefits-of-stimulants-in-adhd-a-double-blind-placebo-controlled-trial-of-the-mixed-opioid-receptor-antagonist-naltrexone
#2
Thomas J Spencer, Pradeep Bhide, Jinmin Zhu, Stephen V Faraone, Maura Fitzgerald, Amy M Yule, Mai Uchida, Andrea E Spencer, Anna M Hall, Ariana J Koster, Joseph Biederman
OBJECTIVE: Methylphenidate activates μ-opioid receptors, which are linked to euphoria. μ-Opioid antagonists, such as naltrexone, may attenuate the euphoric effects of stimulants, thereby minimizing their abuse potential. This study assessed whether the combination of naltrexone with methylphenidate is well-tolerated while preserving the clinical benefits of stimulants in subjects with attention-deficit/hyperactivity disorder (ADHD). METHODS: We conducted a 6-week, double-blind, placebo-controlled, randomized clinical trial of naltrexone in adults with DSM-IV ADHD receiving open treatment with a long-acting formulation of methylphenidate from January 2013 to July 2015...
June 20, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28640988/does-half-life-matter-after-antipsychotic-discontinuation-a-relapse-comparison-in-schizophrenia-with-3-different-formulations-of-paliperidone
#3
Peter J Weiden, Edward Kim, Jason Bermak, Ibrahim Turkoz, Srihari Gopal, Joris Berwaerts
OBJECTIVE: To evaluate the effect of 1 oral and 2 distinct long-acting injectable (LAI) formulations of the same antipsychotic on times to relapse following medication discontinuation. METHODS: Data were drawn from 3 similarly designed, multicenter, double-blind, placebo-controlled, randomized-withdrawal studies of paliperidone in adults with a schizophrenia diagnosis (according to DSM-IV criteria for ≥ 1 year before screening): once-daily extended-release oral paliperidone (ORAL paliperidone), once-monthly paliperidone palmitate (PP1M), and once-every-3-months paliperidone palmitate (PP3M)...
June 20, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28640576/the-effect-of-aromatherapy-on-insomnia-and-other-common-symptoms-among-patients-with-acute-leukemia
#4
Lisa Blackburn, Sara Achor, Betty Allen, Nicole Bauchmire, Danielle Dunnington, Rebecca Klisovic, Steven Naber, Kirsten Roblee, Angela Samczak, Kelly Tomlinson-Pinkham, Esther Chipps
Purpose/Objectives: To determine if the use of aromatherapy improves insomnia and other common symptoms in hospitalized patients with newly diagnosed acute leukemia. Design: A randomized, crossover, washout trial. Setting: An inpatient acute leukemia unit at the Arthur G. James Cancer Hospital and Richard L. Solove Research Institute of the Wexner Medical Center at Ohio State University in Columbus. Sample: 50 patients who were newly diagnosed with acute leukemia and hospitalized to receive their initial four weeks of intensive induction chemotherapy...
June 16, 2017: Oncology Nursing Forum
https://www.readbyqxmd.com/read/28637064/safety-and-efficacy-of-glycopyrrolate-as-a-premedication-for-endoscopic-submucosal-dissection-a-randomized-double-blind-placebo-controlled-study
#5
Eui Joo Kim, Min Young Um, Kyoung Oh Kim, Jung Ho Kim, Su Young Kim, Dong Kyun Park, Kwang An Kwon, Jun Won Chung, Yoon Jae Kim
Background and study aims Anticholinergic premedication has not been validated for endoscopic submucosal dissection (ESD). In this randomized, double-blind, placebo-controlled trial, we investigated the efficacy and safety of glycopyrrolate as a premedication for ESD. Methods A total of 196 patients undergoing ESD at a single tertiary medical center between December 2014 and February 2016 were randomly allocated to receive one of the following two premedications: glycopyrrolate (0.004 mg/kg intramuscularly [IM]) or placebo (2...
June 21, 2017: Endoscopy
https://www.readbyqxmd.com/read/28636754/linagliptin-and-its-effects-on-hyperglycaemia-and-albuminuria-in-patients-with-type-2-diabetes-and-renal-dysfunction-the-randomized-marlina-t2d%C3%A2-trial
#6
P-H Groop, M E Cooper, V Perkovic, B Hocher, K Kanasaki, M Haneda, G Schernthaner, K Sharma, R C Stanton, R Toto, J Cescutti, M Gordat, T Meinicke, A Koitka-Weber, S Thiemann, M von Eynatten
AIMS: The MARLINA-T2D™ study (ClinicalTrials.gov, NCT01792518) was designed to investigate the glycaemic and renal effects of linagliptin added to standard-of-care in individuals with type 2 diabetes and albuminuria. METHODS: 360 individuals with type 2 diabetes, HbA1c 6.5 - 10.0% (48 - 86 mmol/mol), estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m(2) , and urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g despite single agent renin-angiotensin-system blockade were randomized to double-blind linagliptin (n = 182) or placebo (n = 178) for 24 weeks...
June 21, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28636694/placebo-response-and-practice-effects-in-schizophrenia-cognition-trials
#7
Richard S E Keefe, Vicki G Davis, Philip D Harvey, Alexandra S Atkins, George M Haig, Owen Hagino, Stephen Marder, Dana C Hilt, Daniel Umbricht
Importance: Patients' previous experience with performance-based cognitive tests in clinical trials for cognitive impairment associated with schizophrenia can create practice-related improvements. Placebo-controlled trials for cognitive impairment associated with schizophrenia are at risk for these practice effects, which can be difficult to distinguish from placebo effects. Objectives: To conduct a systematic evaluation of the magnitude of practice effects on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) in cognitive impairment associated with schizophrenia and to examine which demographic, clinical, and cognitive characteristics were associated with improvement in placebo conditions...
June 21, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/28636208/a-phase-i-trial-of-prn1008-a-novel-reversible-covalent-inhibitor-of-bruton-s-tyrosine-kinase-in-healthy-volunteers
#8
Patrick F Smith, Janakan Krishnarajah, Philip A Nunn, Ron J Hill, Dane Karr, D Tam, Mohammad Masjedizadeh, Jens O Funk, Steve G Gourlay
AIM: To evaluate the safety, tolerability, and PK/PD of PRN1008, a novel BTK inhibitor, in healthy volunteers, and thus determine the dose range for future clinical studies. METHODS: This was a two-part randomized, placebo controlled study in healthy volunteers using a liquid formulation. Part I was a single ascending dose design with dose levels of 50 to 1200 mg (n=6 active, 2 placebo per cohort); Part II was a multiple ascending dose design, with dose regimens ranging from 300 mg to 900 mg daily, either qd or bd for 10 days...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28635331/network-meta-analysis-of-liraglutide-versus-dpp-4-inhibitors-for-the-treatment-of-type-2-diabetes-in-japanese-patients
#9
Dieter Ayers, Steve Kanters, Rachel Goldgrub, Monica Hughes, Ryo Kato, Nana Kragh
AIMS: To determine the comparative efficacy and safety of liraglutide and dipeptidyl peptidiase-4 (DPP-4) inhibitors as antidiabetics for Japanese patients with uncontrolled type 2 diabetes (T2DM). METHODS AND MATERIALS: We searched for randomized-controlled trials (RCTs) evaluating outcomes among Japanese adults with uncontrolled T2DM and including liraglutide or DPP-4 inhibitors up to August 2016. We extracted data on trial and patient characteristics, and the following outcomes: HbA1c, weight, patients meeting HbA1c <7%, patients experiencing hypoglycemic events, microalbuminuria, estimated glomerular filtration rate (eGFR) and creatinine...
June 21, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28635182/the-effect-of-flaxseed-supplementation-on-body-weight-and-body-composition-a-systematic-review-and-meta-analysis-of-45-randomized-placebo-controlled-trials
#10
REVIEW
M Mohammadi-Sartang, Z Mazloom, H Raeisi-Dehkordi, R Barati-Boldaji, N Bellissimo, J O Totosy de Zepetnek
Flaxseed consumption may be inversely associated with obesity; however, findings of available randomized controlled trials (RCTs) are conflicting. The present study aimed to systematically review and analyse RCTs assessing the effects of flaxseed consumption on body weight and body composition. PubMed, Medline via Ovid, SCOPUS, EMBASE and ISI Web of Sciences databases were searched up to November 2016. Mean changes in body composition indices including body weight, body mass index (BMI) and waist circumference were extracted...
June 21, 2017: Obesity Reviews: An Official Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/28635153/topical-silymarin-administration-for-prevention-of-capecitabine-induced-hand-foot-syndrome-a-randomized-double-blinded-placebo-controlled-clinical-trial
#11
Sepideh Elyasi, Farzaneh Sadat Rezazadeh Shojaee, Abolghasem Allahyari, Gholamreza Karimi
Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of capecitabine in patient with gastrointestinal cancers. Silymarin is a polyphenolic flavonoid extracted from the Silybum marianum that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluated silymarin efficacy in prevention of capecitabine-induced HFS in patients with gastrointestinal cancers, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of silymarin gel 1%, which is applied on the palms and soles twice daily starting at the first day of chemotherapy for 9 weeks, on HFS occurrence was assessed...
June 21, 2017: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/28634748/exposure-response-relationship-of-ramucirumab-in-east-asian-patients-from-rainbow-a-randomized-clinical-trial-in-second-line-treatment-of-gastric-cancer
#12
Tae You Kim, Chia-Jui Yen, Salah-Eddin Al-Batran, David Ferry, Ling Gao, Yanzhi Hsu, Rebecca Cheng, Mauro Orlando, Atsushi Ohtsu
BACKGROUND: Ramucirumab is a recombinant human IgG1 neutralizing monoclonal antibody specific for vascular endothelial growth factor receptor-2. Second-line ramucirumab, in conjunction with paclitaxel (ramucirumab 8 mg/kg or placebo in combination with 80 mg/m(2) paclitaxel), has been shown to be effective and safe in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in RAINBOW, a global phase III randomized clinical trial. We conducted an exploratory exposure-response analysis of efficacy and safety of ramucirumab in East Asian patients from the RAINBOW trial...
June 20, 2017: Gastric Cancer
https://www.readbyqxmd.com/read/28634650/a-randomized-phase-ii-study-of-gemcitabine-plus-z-360-a-cck2-receptor-selective-antagonist-in-patients-with-metastatic-pancreatic-cancer-as-compared-with-gemcitabine-plus-placebo
#13
Makoto Ueno, Chung Pin Li, Masafumi Ikeda, Hiroshi Ishii, Nobumasa Mizuno, Taketo Yamaguchi, Tatsuya Ioka, Do Youn Oh, Wataru Ichikawa, Takuji Okusaka, Yutaka Matsuyama, Daichi Arai, Li Tzong Chen, Young Suk Park, Junji Furuse
BACKGROUND: We investigated the efficacy and safety of 60, 120, or 240 mg of Z-360, which is a highly potent cholecystokinin2-receptor-selective antagonist, combined with gemcitabine in patients with metastatic pancreatic cancer. METHODS: Patients were randomly assigned in a 1:1:1:1 ratio to one of four treatment groups. Patients received 1000 mg/m(2) gemcitabine for each cycle and Z-360 tablets of 60 mg (GZ 60 mg group), 120, 240 mg or placebo tablets (Gem group) orally twice daily...
June 20, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28634219/early-use-of-n-acetylcysteine-nac-with-nitrate-therapy-in-patients-undergoing-primary-percutaneous-coronary-intervention-for-st-segment-elevation-myocardial-infarction-reduces-myocardial-infarct-size-the-naciam-trial
#14
Sivabaskari Pasupathy, Rosanna Tavella, Suchi Grover, Betty Raman, Nathan E K Procter, Yang T Du, Gnanadevan Mahadavan, Irene Stafford, Tamila Heresztyn, Andrew Holmes, Christopher Zeitz, Margaret Arstall, Joseph B Selvanayagam, John D Horowitz, John F Beltrame
Background -Contemporary ST-elevation myocardial infarction (STEMI) management involves primary percutaneous coronary intervention (PCI) with on-going studies focusing on infarct size reduction utilizing ancillary therapies. N-acetylcysteine (NAC) is an antioxidant with reactive oxygen species scavenging properties that also potentiates the effects of nitroglycerin (NTG) and thus represents a potentially beneficial ancillary therapy in primary PCI. The NACIAM (NACIn Acute Myocardial infarction) trial examined the effects of NAC on infarct size in STEMI patients undergoing PCI...
June 20, 2017: Circulation
https://www.readbyqxmd.com/read/28634136/tongxie-formula-reduces-symptoms-of-irritable-bowel-syndrome
#15
Heng Fan, Liang Zheng, Yaoliang Lai, Weimin Lu, Zhixiang Yan, Qi Xiao, Baiwen Li, Min Tang, Dawei Huang, Yuanyuan Wang, Zhen Li, Yuwei Mei, Zhengyan Jiang, Xingxing Liu, Qing Tang, Dongmei Zuo, Jingyi Ye, Yongqiang Yang, Huisuo Huang, Zongxiang Tang, Jun Xiao
BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal disorder, yet few drugs are effective in reducing symptoms. Approximately 50% of patients with IBS attempt herbal therapy at least once. We performed a randomized controlled trial to compare the efficacy of the herb formulation tongxie vs placebo or pinaverium (an antispasmodic agent) in reducing symptoms of IBS. METHODS: We performed a trial of 1044 adult patients with IBS (based on Rome III criteria) at 5 hospitals in China, from August 2012 through January 2015...
June 17, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28634037/clinical-benefit-of-drugs-targeting-mitochondrial-function-as-an-adjunct-to-reperfusion-in-st-segment-elevation-myocardial-infarction-a-meta-analysis-of-randomized-clinical-trials
#16
Gianluca Campo, Rita Pavasini, Giampaolo Morciano, A Michael Lincoff, C Michael Gibson, Masafumi Kitakaze, Jacob Lonborg, Amrita Ahluwalia, Hideki Ishii, Michael Frenneaux, Michel Ovize, Marcello Galvani, Dan Atar, Borja Ibanez, Giampaolo Cerisano, Simone Biscaglia, Brandon J Neil, Masanori Asakura, Thomas Engstrom, Daniel A Jones, Dana Dawson, Roberto Ferrari, Paolo Pinton, Filippo Ottani
AIMS: To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. METHODS: Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo...
June 13, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28634000/dose-dependent-effects-of-abobotulinumtoxina-dysport%C3%A2-on-spasticity-and-active-movements-in-adults-with-upper-limb-spasticity-secondary-analysis-of-a-phase-3-study
#17
Michael W O'Dell, Allison Brashear, Robert Jech, Thierry Lejeune, Philippe Marque, Djamel Bensmail, Ziyad Ayyoub, David M Simpson, Magali Volteau, Claire Vilain, Philippe Picaut, Jean Michel Gracies
BACKGROUND: AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited. OBJECTIVE: To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS. DESIGN: Secondary analysis of a phase 3 study (NCT01313299). SETTING: Multi-center, international, double-blind, placebo-controlled clinical trial...
June 17, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28633650/effects-of-tolvaptan-in-patients-with-acute-heart-failure-a-systematic-review-and-meta-analysis
#18
Chunbin Wang, Bo Xiong, Lin Cai
BACKGROUND: Acute heart failure, which requires urgent evaluation and treatment, is a leading cause for admission to the emergency department. The aim of this meta-analysis was to evaluate the effects of tolvaptan on acute heart failure and compare them with the effects of conventional therapy or placebo. METHODS: The electronic databases PubMed, EMBASE, and the Cochrane Controlled Trial registry were searched from their starting dates to October 24, 2016. Two authors independently read the trials and extracted related information from the included studies...
June 20, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28633600/direct-comparison-of-tricyclic-and-serotonin-reuptake-inhibitor-antidepressants-in-randomized-head-to-head-trials-in-acute-major-depression-systematic-review-and-meta-analysis
#19
Juan Undurraga, Ross J Baldessarini
BACKGROUND: A comparison across trials conducted over several decades suggested superior efficacy of tricyclic antidepressants (TCAs) over selective serotonin-reuptake inhibitors (SSRIs). However, this outcome may reflect a selective secular decline of responses after randomization to placebo. Remaining uncertainty encouraged direct comparison of the drug-types in trials involving randomized, head-to-head comparisons. METHODS: We systematically identified reports of randomized trials of TCAs versus SSRIs for major depression in several digital databases, and applied standard meta-analytic and multiple-factor regression methods to analyze and pool the findings...
June 1, 2017: Journal of Psychopharmacology
https://www.readbyqxmd.com/read/28633147/tranexamic-acid-safely-reduced-blood-loss-in-hemi-and-total-hip-arthroplasty-for-acute-femoral-neck-fracture-a-randomized-clinical-trial
#20
Chad D Watts, Matthew T Houdek, S Andrew Sems, William W Cross, Mark W Pagnano
OBJECTIVES: We aimed to determine whether (1) tranexamic acid (TXA) reduces the incidence of transfusion (2) TXA reduces the calculated blood loss, and (3) there are any observable differences in 30- and 90-day complications with TXA administration during arthroplasty for femoral neck fracture (FNF). DESIGN: Prospective, double-blinded, randomized controlled trial. SETTING: Level 1 Academic Trauma Center. PATIENTS/PARTICIPANTS: One hundred thirty-eight patients who presented with a low-energy, isolated, FNF (AO 31B) treated with either hemi- or total hip arthroplasty within 72 hours of injury were randomized to either the TXA group (69 patients) or placebo group (69 patients)...
July 2017: Journal of Orthopaedic Trauma
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