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Gilvandro Lins de Oliveira, Fernando Cesar Serralheiro, Fernando Luiz Affonso Fonseca, Onésimo Duarte Ribeiro, Fernando Adami, Denise Maria Christofolini, Bianca Bianco, Caio Parente Barbosa
Objective: To compare the anesthetic techniques using propofol and fentanyl versus midazolam and remifentanil associated with a paracervical block with lidocaine in performing ultrasound-guided transvaginal oocyte aspiration. Methods: A randomized double-blind clinical trial (#RBR-8kqqxh) performed in 61 women submitted to assisted reproductive treatment. The patients were divided into two groups: anesthetic induction with 1mcg/kg of fentanyl associated with 1.5mg/kg of propofol (FP Group, n=32), in comparison with anesthetic induction using 0...
July 2016: Einstein
Márcio Alexandre Terra Passos, Pedro Eder Portari-Filho
Background: Elective laparoscopic cholecystectomy has very low risk for infectious complications, ranging the infection rate from 0.4% to 1.1%. Many surgeons still use routine antibiotic prophylaxis. Aim: Evaluate the real impact of antibiotic prophylaxis in elective laparoscopic cholecystectomies in low risk patients. Method: Prospective, randomized and double-blind study. Were evaluated 100 patients that underwent elective laparoscopic cholecystectomy divided in two groups: group A (n=50), patients that received prophylaxis using intravenous Cephazolin (2 g) during anesthetic induction and group B (n=50), patients that didn't receive any antibiotic prophylaxis...
July 2016: Arquivos Brasileiros de Cirurgia Digestiva: ABCD, Brazilian Archives of Digestive Surgery
Yi Cheng, Mu Jin, Xiuhua Dong, Lizhong Sun, Jing Liu, Rong Wang, Yanwei Yang, Peirong Lin, Siyu Hou, Yuehua Ma, Yuefeng Wang, Xudong Pan, Jiakai Lu, Weiping Cheng
BACKGROUND: Stanford type-A acute aortic dissection (AAD) is a severe cardiovascular disease demonstrating the characteristics of acute onset and rapid development, with high morbidity and mortality. The available evidence shows that preoperative acute lung injury (ALI) induced by Stanford type-A AAD is a frequent and important cause for a number of untoward consequences. However, there is no study assessing the incidence of preoperative ALI and its independent determinants before Standford type-A AAD surgery in Chinese adult patients...
October 2016: Medicine (Baltimore)
Ana Rosa Cunha, Jenifer D'El-Rei, Fernanda Medeiros, Bianca Umbelino, Wille Oigman, Rhian M Touyz, Mario F Neves
BACKGROUND: Epidemiological studies demonstrate an inverse association between serum magnesium and incidence of cardiovascular disease. Diuretics commonly cause hypomagneseamia. METHOD: We evaluated effects of magnesium supplementation on blood pressure (BP) and vascular function in thiazide-treated hypertensive women in a randomized, double-blind, clinical trial. Hypertensive women (40-65 years) on hydrochlorothiazide and mean 24-h BP at least 130/80 mmHg were divided into placebo and supplementation (magnesium chelate 600 mg/day) groups...
October 18, 2016: Journal of Hypertension
Kristian Reich, Craig Leonardi, Mark Lebwohl, Francisco Kerdel, Yukari Okubo, Ricardo Romiti, Orin Goldblum, Ellen B Dennehy, Lisa Kerr, Howard Sofen
BACKGROUND: Scalp is a frequently affected and difficult-to-treat area in psoriasis patients. OBJECTIVES: We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI). METHODS: In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12...
October 19, 2016: Journal of Dermatological Treatment
V E Radzinskii, I V Kuznetsova, Y B Uspenskaya, N B Repina, Y K Gusak, O M Zubova, D I Burchakov, A A Osmakova
Peri- and postmenopausal women commonly suffer from climacteric symptoms. We evaluated the effectiveness and safety of dietary supplement Amberen to relieve vasomotor and psychosomatic symptoms during the course of a 3-month, randomized, double-blind, placebo-controlled study. General clinical assessment, evaluation using the Greene climacteric test and Spielberger-Hanin test, determination of plasma levels of gonadotropins, estradiol, leptin and apolipoproteins were used to evaluate 42-60-year-old women with vasomotor and psychosomatic menopausal symptoms...
October 2016: Gynecological Endocrinology
Bernt Johan von Scholten, Frederik Persson, Signe Rosenlund, Peter Hovind, Jens Faber, Tine Willum Hansen, Peter Rossing
AIMS: Patients with type 2 diabetes and albuminuria have high cardiorenal morbidity and mortality despite multifactorial treatment. Short-term reduction in albuminuria is considered suggestive of long-term renoprotective effects. We evaluated the renal effects of the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide on top of multifactorial care, including renin-angiotensin-system (RAS)-inhibition. MATERIALS AND METHODS: Randomised, double-blind, placebo-controlled, cross-over trial including patients with type 2 diabetes and persistent albuminuria (urinary albumin-to-creatinine ratio > 30 mg/g) and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1...
October 17, 2016: Diabetes, Obesity & Metabolism
Hiromitsu Kumada, Hiroshi Miyakawa, Taro Muramatsu, Naoki Ando, Takanori Oh, Kenji Takamori, Hidetomo Nakamoto
AIMS: Patients with chronic liver disease sometimes develop cholestasis, which induces severe whole-body pruritus that may disrupt daily activities and sleep. To determine the efficacy of nalfurafine hydrochloride (5 µg), which is a selective κ-opioid receptor agonist, in improving pruritus, we conducted a double-blind placebo-controlled study in patients with chronic liver disease with refractory pruritus. Nalfurafine hydrochloride at 2.5 µg was also used to evaluate the dose-response relationship...
October 18, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Carmen Folguera-Álvarez, Sofia Garrido-Elustondo, José Verdú-Soriano, Diana García-García-Alcalá, Mónica Sánchez-Hernández, Oscar German Torres-de Castro, Maria Luisa Barceló-Fidalgo, Olga Martínez-González, Lidia Ardiaca-Burgués, Carmen Solano-Villarrubia, Pilar Raquel Lebracón-Cortés, Carmen Molins-Santos, Mar Fresno-Flores, Maria Carmen Cánovas-Lago, Luisa Fernanda Benito-Herranz, Maria Teresa García-Sánchez, Olga Castillo-Pla, María Sol Morcillo-San Juan, Maria Begoña Ayuso-de la Torre, Pilar Burgos-Quintana, Ana López-Torres-Escudero, Gema Ballesteros-García, Piedad García-Cabeza, Maria Ángeles de Francisco-Casado, Milagros Rico-Blázquez
BACKGROUND: Chronic venous insufficiency, in its final stage can cause venous ulcers. Venous ulcers have a prevalence of 0.5 % to 0.8 % in the general population, and increases starting at 60 years of age. This condition often causes increased dependency in affected individuals, as well as a perceived reduced quality of life and family overload. Local Treating chronic venous ulcers has 2 components: topically healing the ulcer and controlling the venous insufficiency. There is evidence that compressive therapy favours the healing process of venous ulcers...
2016: BMC Nursing
L X Quan, H X An, D X Wang
OBJECTIVE: To observe the effects of 0.4 μg/(kg×h) dose of dexmedetomidine on intra-operative wake-up test in children patients undergoing scoliosis surgery. METHODS: Sixty patients for posterior scoliosis correction (ASA I-II, aged 5-16 years) from March 2013 to April 2015 were enrolled in this prospective, double-blinded, randomized, placebo-controlled study, The patients were randomly classified into two groups to receive dexmedetomidine (group RD, n=30) or saline solution (group R, n=30)...
October 18, 2016: Beijing da Xue Xue Bao. Yi Xue Ban, Journal of Peking University. Health Sciences
R E Frye, J Slattery, L Delhey, B Furgerson, T Strickland, M Tippett, A Sailey, R Wynne, S Rose, S Melnyk, S Jill James, J M Sequeira, E V Quadros
We sought to determine whether high-dose folinic acid improves verbal communication in children with non-syndromic autism spectrum disorder (ASD) and language impairment in a double-blind placebo control setting. Forty-eight children (mean age 7 years 4  months; 82% male) with ASD and language impairment were randomized to receive 12 weeks of high-dose folinic acid (2 mg kg(-1) per day, maximum 50 mg per day; n=23) or placebo (n=25). Children were subtyped by glutathione and folate receptor-α autoantibody (FRAA) status...
October 18, 2016: Molecular Psychiatry
Olivier Mir, Thomas Brodowicz, Antoine Italiano, Jennifer Wallet, Jean-Yves Blay, François Bertucci, Christine Chevreau, Sophie Piperno-Neumann, Emmanuelle Bompas, Sébastien Salas, Christophe Perrin, Corinne Delcambre, Bernadette Liegl-Atzwanger, Maud Toulmonde, Sarah Dumont, Isabelle Ray-Coquard, Stéphanie Clisant, Sophie Taieb, Cécile Guillemet, Maria Rios, Olivier Collard, Laurence Bozec, Didier Cupissol, Esma Saada-Bouzid, Christine Lemaignan, Wolfgang Eisterer, Nicolas Isambert, Loïc Chaigneau, Axel Le Cesne, Nicolas Penel
BACKGROUND: Regorafenib is a multikinase inhibitor with proven activity in refractory gastrointestinal stromal tumours and chemotherapy-refractory advanced colorectal cancers. We assessed this agent's efficacy and safety in patients with metastatic soft tissue sarcomas previously treated with anthracycline. METHODS: In this randomised, double-blind, phase 2 trial undertaken in France and Austria, we enrolled patients aged 18 years and older with advanced soft tissue sarcomas who had received previous doxorubicin or other anthracycline treatment...
October 14, 2016: Lancet Oncology
Canan Ziylan, Annemien Haveman-Nies, Stefanie Kremer, Lisette C P G M de Groot
OBJECTIVES: Sufficient protein intake can decrease undernutrition risk among community-dwelling older adults. This study aimed to increase community-dwelling older adults' daily protein intake with acceptable and applicable protein-enriched bread and readymade meals at home. DESIGN: Double-blind randomized controlled trial of 2 weeks. SETTING: Senior residential center in the Netherlands. PARTICIPANTS: Forty-two community-dwelling elderly residents (≥65 years) participated, with a mean age of 74...
October 14, 2016: Journal of the American Medical Directors Association
Jesús F San-Miguel, Vania T M Hungria, Sung-Soo Yoon, Meral Beksac, Meletios A Dimopoulos, Ashraf Elghandour, Wieslaw W Jedrzejczak, Andreas Günther, Thanyaphong N Nakorn, Noppadol Siritanaratkul, Robert L Schlossman, Jian Hou, Philippe Moreau, Sagar Lonial, Jae H Lee, Hermann Einsele, Monika Sopala, Bourras-Rezki Bengoudifa, Florence Binlich, Paul G Richardson
BACKGROUND: Panobinostat plus bortezomib and dexamethasone significantly increased median progression-free survival compared with placebo plus bortezomib and dexamethasone in the phase 3 PANORAMA 1 trial. Here, we present the final overall survival analysis for this trial. METHODS: PANORAMA 1 is a randomised, placebo-controlled, double-blind, phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma with one to three previous treatments...
October 14, 2016: Lancet Haematology
Stella Capriglione, Francesco Plotti, Roberto Montera, Daniela Luvero, Salvatore Lopez, Giuseppe Scaletta, Alessia Aloisi, Giovan Battista Serra, Roberto Angioli
OBJECTIVES: To examine the effects of paroxetine supplementation on hot flashes and sleep in gynecological cancer survivors. METHODS: In a randomized, double-blind, placebo-controlled study, postmenopausal women with a prior history of stage 0-III gynecological cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 7.5mg oral paroxetine or placebo daily for 16weeks. Sleep and hot flashes were assessed at baseline, week 4 and week 16...
October 14, 2016: Gynecologic Oncology
Priccila Zuchinali, Gabriela C Souza, Maurício Pimentel, Diego Chemello, André Zimerman, Vanessa Giaretta, Joyce Salamoni, Bianca Fracasso, Leandro I Zimerman, Luis E Rohde
Importance: The presumed proarrhythmic action of caffeine is controversial. Few studies have assessed the effect of high doses of caffeine in patients with heart failure due to left ventricular systolic dysfunction at high risk for ventricular arrhythmias. Objective: To compare the effect of high-dose caffeine or placebo on the frequency of supraventricular and ventricular arrhythmias, both at rest and during a symptom-limited exercise test. Design, Setting, and Participants: Double-blinded randomized clinical trial with a crossover design conducted at the heart failure and cardiac transplant clinic of a tertiary-care university hospital...
October 17, 2016: JAMA Internal Medicine
Robert Flisiak, Mitchell Shiffman, Juan Arenas, Hugo Cheinquer, Igor Nikitin, Yuping Dong, Khurram Rana, Subasree Srinivasan
BACKGROUND: A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. METHODS: Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks...
2016: PloS One
Paul R Lambert, John Carey, Anthony A Mikulec, Carl LeBel
OBJECTIVE: To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease. STUDY DESIGN: Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months. SETTING: Fifty-two academic and community otolaryngology centers. PATIENTS: One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive. INTERVENTION: Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo...
September 30, 2016: Otology & Neurotology
Aris Oates, Kelly A Benedict, Karen Sun, Paul R Brakeman, Jessica Lim, Cynthia Kim
Evaluate laser acupuncture as an adjuvant therapy in pain management during percutaneous kidney biopsy procedure in children and adolescents. This prospective, double-blinded, randomized controlled trial enrolled patients aged 7-26 years admitted to a children's hospital for percutaneous kidney biopsy. Patients received laser acupuncture to treatment points (acupuncture group) or sham points (control group) prior to the procedure. Laser delivered a dose of 42 J/cm over 10 acupoints. Patients and parents rated the pain during and after the biopsy, and change in pain scores were calculated for each patient...
September 29, 2016: Pain
Adele Bahar, Zahra Kashi, Ezzatossadat Daneshpour, Ozra Akha, Shahram Ala
BACKGROUND: Cabergoline is a long-acting agonist of dopamine, which has a high affinity to dopamine receptors (type 2). Treatment using a dopaminergic agonist reduces hypothalamic stimulation that increases during liver gluconeogenesis, lipids synthesis, and insulin resistance. Our aim was to evaluate the effects of cabergoline on blood glucose levels in patients with type 2 diabetes mellitus (DM). METHODS: This study was a double-blind, controlled clinical trial in patients with type 2 DM...
October 2016: Medicine (Baltimore)
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