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Randomized double blinded controlled studies

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https://www.readbyqxmd.com/read/29053851/escitalopram-ameliorates-hypercortisolemia-and-insulin-resistance-in-low-birth-weight-men-with-limbic-brain-alterations
#1
Christian Selmer Buhl, Hans Stødkilde-Jørgensen, Poul Videbech, Allan Vaag, Niels Møller, Sten Lund, Esben Selmer Buhl
CONTEXT: Low birth weight (LBW, <2500 g) is linked to development of insulin resistance and limbic-hypothalamic-pituitary-adrenal (LHPA)-axis hyperactivity. OBJECTIVE: First aim was to study insulin action, LHPA-axis function and limbic brain structures in young, healthy LBW-men vs. normal birth weight controls (NBW) (Part 1). Second aim was to investigate the effects of Escitalopram vs. placebo treatment in LBW with regards to LHPA-axis and insulin sensitivity (Part 2)...
October 18, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29052805/sublingual-buprenorphine-efficacy-in-renal-colic-pain-relief-a-randomized-placebo-controlled-clinical-trial
#2
Javad Mozafari, Kambiz Masoumi, Arash Forouzan, Hassan Motamed, Malehi Amal Saki, Marzieh Dezham
INTRODUCTION: This study was designed to compare the analgesic efficacy of sublingual (SL) buprenorphine and intravenous (IV) ketorolac for renal colic pain relief. METHODS: The present study was carried out as a double-blind, double-dummy randomized clinical trial in patients diagnosed with acute renal colic attending the emergency department. The study subjects were 63 patients with confirmed renal stones. The subjects were randomly divided into two groups. One group, which included 32 patients, received SL buprenorphine tablets (2 mg) with an IV placebo, and another group, including 31 patients, received ketorolac tromethamine (30 mg) with a SL placebo...
October 20, 2017: Pain and Therapy
https://www.readbyqxmd.com/read/29052559/efficacy-and-safety-of-niaoduqing-particles-for-delaying-moderate-to-severe-renal-dysfunction-a-randomized-double-blind-placebo-controlled-multicenter-clinical-study
#3
Ying Zheng, Guang-Yan Cai, Li-Qun He, Hong-Li Lin, Xiao-Hong Cheng, Nian-Song Wang, Gui-Hua Jian, Xu-Sheng Liu, Yu-Ning Liu, Zhao-Hui Ni, Jing-Ai Fang, Han-Lu Ding, Wang Guo, Ya-Ni He, Li-Hua Wang, Ya-Ping Wang, Hong-Tao Yang, Zhi-Ming Ye, Ren-Huan Yu, Li-Juan Zhao, Wen-Hua Zhou, Wen-Ge Li, Hui-Juan Mao, Yong-Li Zhan, Zhao Hu, Chen Yao, Ri-Bao Wei, Xiang-Mei Chen
BACKGROUND: Chronic kidney disease (CKD) with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, Niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 CKD. METHODS: The present study was a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial...
October 20, 2017: Chinese Medical Journal
https://www.readbyqxmd.com/read/29052245/the-longitudinal-impact-of-probiotic-and-peanut-oral-immunotherapy-ppoit-on-health-related-quality-of-life-hrql
#4
Audrey Dunn Galvin, Suzanne McMahon, Anne-Louise Ponsonby, Kuang-Chih Hsiao, Mimi L K Tang
BACKGROUND: We previously reported that Probiotic and Peanut Oral Immunotherapy (PPOIT) was effective at inducing sustained unresponsiveness compared with placebo in a double-blind, placebo-controlled randomized trial. This study evaluated the impact of PPOIT on health related quality of life (HRQL). METHOD: Fifty-one participants (PPOIT 24; Placebo 27) from the PPOIT trial completed Food Allergy Quality of Life Questionnaire (FAQLQ-PF) and Food Allergy Independent Measure (FAIM) at pre-treatment, end-of-treatment and 3-months after end-of-treatment...
October 20, 2017: Allergy
https://www.readbyqxmd.com/read/29051184/novel-use-of-hydroxyurea-in-an-african-region-with-malaria-noharm-a-trial-for-children-with-sickle-cell-anemia
#5
Robert O Opoka, Christopher M Ndugwa, Teresa S Latham, Adam Lane, Heather A Hume, Phillip Kasirye, James S Hodges, Russell E Ware, Chandy C John
Hydroxyurea treatment is recommended for children with sickle cell anemia (SCA) living in high-resource malaria-free regions, but its safety and efficacy in malaria-endemic sub-Saharan Africa, where the greatest sickle cell burden exists, remain unknown. In vitro studies suggest hydroxyurea could increase malaria severity, and hydroxyurea-associated neutropenia could worsen infections. NOHARM was a randomized, double-blinded, placebo-controlled trial conducted in malaria-endemic Uganda, comparing hydroxyurea to placebo at 20 ± 2...
October 19, 2017: Blood
https://www.readbyqxmd.com/read/29050992/the-impact-of-13-valent-pneumococcal-conjugate-vaccination-on-virus-associated-community-acquired-pneumonia-in-elderly
#6
Susanne M Huijts, Frank E J Coenjaerts, Marieke Bolkenbaas, Cornelis H van Werkhoven, Diederick E Grobbee, Marc J M Bonten
OBJECTIVES: Our objective was to evaluate whether vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) prevents the incidence of community-acquired pneumonia (CAP) caused by influenza (Influenza-Associated CAP, IA-CAP) or other respiratory viruses in elderly. METHODS: This analysis was part of the Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA); a double blind, randomized, placebo-controlled trial in 84,496 immunocompetent individuals aged ≥65 years...
October 16, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29050397/the-antimyotonic-effect-of-lamotrigine-in-non-dystrophic-myotonias-a-double-blind-randomized-study
#7
Grete Andersen, Gitte Hedermann, Nanna Witting, Morten Duno, Henning Andersen, John Vissing
Mexiletine is the only drug with proven effect for treatment of non-dystrophic myotonia, but mexiletine is expensive, has limited availability and several side effects. There is therefore a need to identify other pharmacological compounds that can alleviate myotonia in non-dystrophic myotonias. Like mexiletine, lamotrigine is a sodium channel blocker, but unlike mexiletine, lamotrigine is available, inexpensive, and well tolerated. We investigated the potential of using lamotrigine for treatment of myotonia in patients with non-dystrophic myotonias...
September 1, 2017: Brain: a Journal of Neurology
https://www.readbyqxmd.com/read/29050384/stimulating-thought-a-functional-mri-study-of-transcranial-direct-current-stimulation-in-schizophrenia
#8
Natasza D Orlov, Owen O'Daly, Derek K Tracy, Yusuf Daniju, John Hodsoll, Lorena Valdearenas, John Rothwell, Sukhi S Shergill
Individuals with schizophrenia typically suffer a range of cognitive deficits, including prominent deficits in working memory and executive function. These difficulties are strongly predictive of functional outcomes, but there is a paucity of effective therapeutic interventions targeting these deficits. Transcranial direct current stimulation is a novel neuromodulatory technique with emerging evidence of potential pro-cognitive effects; however, there is limited understanding of its mechanism. This was a double-blind randomized sham controlled pilot study of transcranial direct current stimulation on a working memory (n-back) and executive function (Stroop) task in 28 individuals with schizophrenia using functional magnetic resonance imaging...
September 1, 2017: Brain: a Journal of Neurology
https://www.readbyqxmd.com/read/29049653/effect-of-oral-semaglutide-compared-with-placebo-and-subcutaneous-semaglutide-on-glycemic-control-in-patients-with-type-2-diabetes-a-randomized-clinical-trial
#9
Melanie Davies, Thomas R Pieber, Marie-Louise Hartoft-Nielsen, Oluf K H Hansen, Serge Jabbour, Julio Rosenstock
Importance: Glucagon-like peptide-1 (GLP-1) receptor agonists are effective therapies for the treatment of type 2 diabetes and are all currently available as an injection. Objectives: To compare the effects of oral semaglutide with placebo (primary) and open-label subcutaneous semaglutide (secondary) on glycemic control in patients with type 2 diabetes. Design, Setting, and Patients: Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014...
October 17, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29048765/ageratum-conyzoides-l-inhibits-5-alpha-reductase-gene-expression-in-human-prostate-cells-and-reduces-symptoms-of-benign-prostatic-hypertrophy-in-otherwise-healthy-men-in-a-double-blind-randomized-placebo-controlled-clinical-study
#10
Matthew Detering, Elizabeth Steels, Sundar Rao Koyyalamudi, Elena Allifranchini, Elena Bocchietto, Luis Vitetta
A double-blind, randomized, placebo-controlled clinical trial assessed the efficacy and safety of Ageratum conyzoides in treating benign prostatic hypertrophy (BPH). In this study, 109 men with medically diagnosed BPH, aged 41-76 years, were administered the investigational product, A. conyzoides extract at a dose of 250 mg/d or placebo, q.d. for 12 weeks. The primary outcome measures were the International Prostate Symptom Score (IPSS), daily urinary frequency and safety evaluations. The secondary outcome measures were testosterone, dihydrotestosterone, oestradiol, sex hormone binding globulin (SHBG), Dehydroepiandrosterone sulfate (DHEA-S) and cortisol levels, and prostate specific antigen (PSA), lipids, blood glucose, the Aging Male's Symptom (AMS) Score and sexual function assessed by Derogatis Interview for Sexual Functioning-Self Report (DISF-SR)...
October 19, 2017: BioFactors
https://www.readbyqxmd.com/read/29048132/comparison-of-the-efficiency-of-ultrasound-guided-injections-of-the-rhomboid-major-and-trapezius-muscles-in-myofascial-pain-syndrome-a-prospective-randomized-controlled-double-blind-study
#11
Burcu Metin Ökmen, Korgün Ökmen, Lale Altan
OBJECTIVES: We aimed to investigate the effect of ultrasound (US)-guided injections of the rhomboid major (deep) and trapezius (superficial) muscles on pain, disability, and quality of life in patients with myofascial pain syndrome. METHODS: In this prospective randomized controlled double-blind study, 65 patients with a diagnosis of myofascial pain syndrome were randomized into 2 groups. In group 1 (n = 33), US-guided rhomboid major muscle injection was performed, and in group 2 (n = 32), US-guided trapezius muscle injection was performed...
October 19, 2017: Journal of Ultrasound in Medicine: Official Journal of the American Institute of Ultrasound in Medicine
https://www.readbyqxmd.com/read/29047408/the-efficacy-of-the-kampo-medicine-rikkunshito-for-chemotherapy-induced-anorexia-rich-trial-study-protocol-for-a-randomized-controlled-trial
#12
Takuya Inoue, Hironori Takagi, Yuki Owada, Yuzuru Watanabe, Takumi Yamaura, Mitsuro Fukuhara, Satoshi Muto, Naoyuki Okabe, Yuki Matsumura, Takeo Hasegawa, Jun Osugi, Mika Hoshino, Mitsunori Higuchi, Yutaka Shio, Hiroshi Yokouchi, Kenya Kanazawa, Katsuya Ohbuchi, Takahisa Fukushima, Mitsuru Munakata, Hiroyuki Suzuki
BACKGROUND: Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement...
October 18, 2017: Trials
https://www.readbyqxmd.com/read/29047178/the-effect-of-montelukast-on-early-life-wheezing-a-randomized-double-blinded-placebo-controlled-study
#13
Ozlem Keskin, Ebru Arik Yilmaz, Christine Motzkus, Cansin Sackesen, Craig M Lilly, Omer Kalayci
BACKGROUND: Cysteinyl-leukotrienes are increased in the airways of infants with virus-associated wheezing. We aimed to determine the effects of a cysteinyl-leukotriene-1 receptor antagonist on symptoms during an early-life wheezing illness and to investigate the factors that affect the response to this drug. METHOD: This placebo-controlled double-blinded randomized controlled trial recruited children aged 3-36 months with wheezing illness and randomized to active drug or placebo for 56 days...
October 19, 2017: Pediatric Allergy and Immunology
https://www.readbyqxmd.com/read/29045341/effect-of-antihypertensive-treatment-on-24-h-blood-pressure-variability-pooled-individual-data-analysis-of-ambulatory-blood-pressure-monitoring-studies-based-on-olmesartan-mono-or-combination-treatment
#14
Stefano Omboni, Kazuomi Kario, George Bakris, Gianfranco Parati
OBJECTIVE: To evaluate the impact of olmesartan alone or combined with one to three antihypertensive drugs on 24-h blood pressure variability (BPV) and on distribution of BP reduction in a pooled individual data analysis of 10 double-blind, randomized, ambulatory BP monitoring (ABPM) studies. METHODS: ABPMs were performed before and after 6-12 weeks of treatment with placebo (n = 119), active control monotherapy [n = 1195, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), dihydropyridine calcium channel blockers (DCCBs)], or DCCBs), olmesartan monotherapy (n = 1410), active control dual combination [n = 79, DCCB + thiazide diuretic (TD)], olmesartan dual combination (n = 637, DCCB or TD), and triple combination therapy (n = 102, DCCB+TD)...
October 16, 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/29045255/listening-to-relaxing-music-improves-physiological-responses-in-premature-infants-a-randomized-controlled-trial
#15
Rafael A Caparros-Gonzalez, Alejandro de la Torre-Luque, Carolina Diaz-Piedra, Francisco J Vico, Gualberto Buela-Casal
BACKGROUND: Premature infants are exposed to high levels of noise in the neonatal intensive care unit (NICU). PURPOSE: This study evaluated the effect of a relaxing music therapy intervention composed by artificial intelligence on respiratory rate, systolic and diastolic blood pressure, and heart rate. METHODS: A double-blind, randomized, controlled trial was conducted in the NICUs of 2 general public hospitals in Andalusia, Spain. Participants were 17 healthy premature infants, randomly allocated to the intervention group or the control group (silence) at a 1:1 ratio...
October 17, 2017: Advances in Neonatal Care: Official Journal of the National Association of Neonatal Nurses
https://www.readbyqxmd.com/read/29044707/the-effect-of-vitamin-d-supplementation-on-bone-metabolic-markers-in-chronic-kidney-disease
#16
Ashok Kumar Yadav, Vivek Kumar, Vinod Kumar, Debasish Banerjee, Krishan Lal Gupta, Vivekanand Jha
Use of active forms of vitamin D is advocated in CKD patients for treatment of mineral bone disease because of the presumption that native forms of vitamin D would not undergo significant activation to calcitriol, the most active biological form of vitamin D. We present secondary analysis looking at bone turnover in subjects who completed the randomized, double blind, placebo controlled trial investigating the effect of cholecalciferol supplementation on vascular function in non-diabetic CKD stage G3-4 and vitamin D ≤20ng/ml [CTRI/2013/05/003648]...
October 17, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/29043927/a-comparative-pharmacokinetic-assessment-of-a-novel-highly-bioavailable-curcumin-formulation-with-95-curcumin-a-randomized-double-blind-crossover-study
#17
Sidney J Stohs, Jin Ji, Luke R Bucci, Harry G Preuss
OBJECTIVE: Curcumin exhibits many beneficial health-promoting characteristics. However, its poor oral absorption precludes its general use. This study assessed the bioavailability of a novel curcumin formulation compared to 95% curcumin and published results for various other curcumin formulations. METHODS: A randomized, crossover, double-blind, comparator-controlled pharmacokinetic study was performed in 12 healthy adult subjects to determine the appearance of free curcumin and its metabolites curcumin sulfate and curcumin glucuronide in plasma after a single dose of a novel proprietary curcumin liquid droplet micromicellar formulation (CLDM) and unformulated 95% curcumin powder in capsule form...
October 18, 2017: Journal of the American College of Nutrition
https://www.readbyqxmd.com/read/29043702/n-acetylcysteine-compared-to-metformin-improves-the-expression-profile-of-growth-differentiation-factor-9-and-receptor-tyrosine-kinase-c-kit-in-the-oocytes-of-patients-with-polycystic-ovarian-syndrome
#18
Ebrahim Cheraghi, Malek Soleimani Mehranjani, Seyed Mohammad Ali Shariatzadeh, Mohammad Hossein Nasr Esfahani, Behrang Alani
Background: Paracrine disruption of growth factors in women with polycystic ovarian syndrome (PCOS) results in production of low quality oocyte, especially following ovulation induction. The aim of this study was to investigate the effects of metformin (MET), N-acetylcysteine (NAC) and their combination on the hormonal levels and expression profile of GDF-9, BMP-15 and c-kit, as hallmarks of oocyte quality, in PCOS patients. MATERIALS AND METHODS: This prospective randomized, double-blind, placebo controlled trial aims to study the effects of MET, NAC and their combination (MET+NAC) on expression of GDF-9, BMP-15 and c-kit mRNA in oocytes [10 at the germinal vesicle (GV) stage, 10 at the MI stage, and 10 at the MII stage from per group] derived following ovulation induction in PCOS...
January 2018: International Journal of Fertility & Sterility
https://www.readbyqxmd.com/read/29043600/effects-of-ultrasound-guided-stellate-ganglion-block-on-sleep-and-regional-cerebral-oxygen-saturation-in-patients-undergoing-breast-cancer-surgery-a-randomized-controlled-double-blinded-trial
#19
Feng Jin, Xiao-Qian Li, Wen-Fei Tan, Hong Ma, Bo Fang, A-Yong Tian, Huang-Wei Lu
Numerous factors could contribute to sleep disturbances in women with breast cancer. We hypothesized that stellate ganglion block (SGB) during surgery would preserve sleep after surgery and increase intraoperative regional cerebral oxygen saturation (rSO2) on the blocked side in patients undergoing breast cancer surgery. A randomized, double-blinded, controlled trial was conducted at the First Hospital of China Medical University from January 2016 to September 2016. Ninety-six patients who underwent radical breast cancer surgery requiring general anaesthesia were randomly assigned to one of two study groups: a control group that received a saline SGB and a block group that received a 0...
October 17, 2017: Journal of Clinical Monitoring and Computing
https://www.readbyqxmd.com/read/29043014/an-open-label-study-to-evaluate-the-long-term-safety-and-efficacy-of-lanadelumab-for-prevention-of-attacks-in-hereditary-angioedema-design-of-the-help-study-extension
#20
Marc A Riedl, Jonathan A Bernstein, Timothy Craig, Aleena Banerji, Markus Magerl, Marco Cicardi, Hilary J Longhurst, Mustafa M Shennak, William H Yang, Jennifer Schranz, Jovanna Baptista, Paula J Busse
BACKGROUND: Hereditary angioedema (HAE) is characterized by recurrent attacks of subcutaneous or submucosal edema. Attacks are unpredictable, debilitating, and have a significant impact on quality of life. Patients may be prescribed prophylactic therapy to prevent angioedema attacks. Current prophylactic treatments may be difficult to administer (i.e., intravenously), require frequent administrations or are not well tolerated, and breakthrough attacks may still occur frequently. Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks...
2017: Clinical and Translational Allergy
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