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double blind controlled trial

Ricardo Becerro de Bengoa Vallejo, David Sevillano Fernandez, Luis Alou Cervera, Laura Martín Aragón, Marta Elena Losa Iglesias, Luis Rodolfo Collado Yurrita, Daniel Lopez Lopez
BACKGROUND: Chlorhexidine and parachlorometaxylenol (PCMX) are antiseptics recommended for surgical hand antisepsis. To our knowledge, PCMX has not been evaluated for bactericidal efficacy "in vivo. METHODS: We conducted a randomized, double-blind, controlled crossover trial to compare the bacterial loads on fingertips and fingernails under laboratory conditions after use of antiseptic test products, including chlorhexidine digluconate 4%, PCMX 3%, and a reference solution of propan-1-ol 60% (P-1)...
October 2018: Medicine (Baltimore)
Jane C Davies, Samuel M Moskowitz, Cynthia Brown, Alexander Horsley, Marcus A Mall, Edward F McKone, Barry J Plant, Dario Prais, Bonnie W Ramsey, Jennifer L Taylor-Cousar, Elizabeth Tullis, Ahmet Uluer, Charlotte M McKee, Sarah Robertson, Rebecca A Shilling, Christopher Simard, Fredrick Van Goor, David Waltz, Fengjuan Xuan, Tim Young, Steven M Rowe
BACKGROUND: The next-generation cystic fibrosis transmembrane conductance regulator (CFTR) corrector VX-659, in triple combination with tezacaftor and ivacaftor (VX-659-tezacaftor-ivacaftor), was developed to restore the function of Phe508del CFTR protein in patients with cystic fibrosis. METHODS: We evaluated the effects of VX-659-tezacaftor-ivacaftor on the processing, trafficking, and function of Phe508del CFTR protein using human bronchial epithelial cells. A range of oral VX-659-tezacaftor-ivacaftor doses in triple combination were then evaluated in randomized, controlled, double-blind, multicenter trials involving patients with cystic fibrosis who were heterozygous for the Phe508del CFTR mutation and a minimal-function CFTR mutation (Phe508del-MF genotypes) or homozygous for the Phe508del CFTR mutation (Phe508del-Phe508del genotype)...
October 18, 2018: New England Journal of Medicine
Dominic Keating, Gautham Marigowda, Lucy Burr, Cori Daines, Marcus A Mall, Edward F McKone, Bonnie W Ramsey, Steven M Rowe, Laura A Sass, Elizabeth Tullis, Charlotte M McKee, Samuel M Moskowitz, Sarah Robertson, Jessica Savage, Christopher Simard, Fredrick Van Goor, David Waltz, Fengjuan Xuan, Tim Young, Jennifer L Taylor-Cousar
BACKGROUND: VX-445 is a next-generation cystic fibrosis transmembrane conductance regulator (CFTR) corrector designed to restore Phe508del CFTR protein function in patients with cystic fibrosis when administered with tezacaftor and ivacaftor (VX-445-tezacaftor-ivacaftor). METHODS: We evaluated the effects of VX-445-tezacaftor-ivacaftor on Phe508del CFTR protein processing, trafficking, and chloride transport in human bronchial epithelial cells. On the basis of in vitro activity, a randomized, placebo-controlled, double-blind, dose-ranging, phase 2 trial was conducted to evaluate oral VX-445-tezacaftor-ivacaftor in patients heterozygous for the Phe508del CFTR mutation and a minimal-function mutation (Phe508del-MF) and in patients homozygous for the Phe508del CFTR mutation (Phe508del-Phe508del) after tezacaftor-ivacaftor run-in...
October 18, 2018: New England Journal of Medicine
Stanley G Rockson, Wen Tian, Xinguo Jiang, Tatiana Kuznetsova, Francois Haddad, Jamie Zampell, Babak Mehrara, Joshua P Sampson, Leslie Roche, Jinah Kim, Mark R Nicolls
BACKGROUND: Lymphedema is a common condition affecting millions around the world that still lacks approved medical therapy. Because ketoprofen, an NSAID, has been therapeutic in experimental lymphedema, we evaluated its efficacy in humans. METHODS: We first performed an exploratory open-label trial. Patients with either primary or secondary lymphedema received ketoprofen 75 mg by mouth 3 times daily for 4 months. Subjects were evaluated for changes in histopathology, with skin thickness, limb volume, and tissue bioimpedance changes serving as secondary endpoints...
October 18, 2018: JCI Insight
Aulia Rizka, Siti Setiati, Kuntjoro Harimurti, M Sadikin, Indra G Mansur
BACKGROUND: Alphacalcidol, a vitamin D analog, shows immune regulatory potency as it works on the macrophage and T cell to control inflammation and T cell dysregulation in elderly. None has been known about its effect on elderly with various states of frailty syndrome, which have different level of chronic low grade inflammation. This study aimed to determine the effect of alphacalcidol on inflammatory cytokines (IL-6, IL-10, g-IFN ) and T cell subsets (CD4/CD8 ratio and CD8+ CD28-) of elderly with various stages of frailty syndrome...
July 2018: Acta Medica Indonesiana
Harrina Erlianti Rahardjo, Firtantyo Adi Syahputra, Putri Iradita Islianti, Faisal Abdi Matondang
BACKGROUND: urinary tract infection (UTI) is often treated in daily practice as overactive bladder (OAB) by giving anticholinergic, the recommended treatment options of OAB. However, anticholinergic application for UTI symptoms relief has never been investigated. To our knowledge, this study was the first randomized trial which investigate anticholinergic use for UTI treatment. This study aimed to evaluate whether additional anticholinergic is beneficial alongside an empiric antibiotic therapy in reducing symptoms and tolerable for females with uncomplicated UTI...
July 2018: Acta Medica Indonesiana
Jürgen Palm, Katharina Fuchs, Holger Stammer, Anne Schumacher-Stimpfl, Jens Milde
OBJECTIVE: The aim of this multi-centre, randomised, double-blind, placebo-controlled trial was to compare the efficacy and safety of the fixed combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine (study drug marketed as Dorithricin® ) in repeat dosing for 3 days to match placebo lozenges in the treatment of acute pharyngitis in adults. METHODS: Patients (pts, aged ≥18 years) with acute pharyngitis, ie, non-streptococcal sore throat and moderate-to-severe pain (intensity NRS ≥ 7; VAS ≥ 50) were assigned to study drug (n = 160) or matching placebo (n = 161)...
October 17, 2018: International Journal of Clinical Practice
Patrícia Santos, Ana P Herrmann, Elaine Elisabetsky, Angelo Piato
OBJECTIVE: Anxiety disorders are highly prevalent and the efficacy of the available anxiolytic drugs is less than desired. Adverse effects also compromise patient quality of life and adherence to treatment. Accumulating evidence shows that the pathophysiology of anxiety and related disorders is multifactorial, involving oxidative stress, neuroinflammation, and glutamatergic dysfunction. The aim of this review was to evaluate data from animal studies and clinical trials showing the anxiolytic effects of agents whose mechanisms of action target these multiple domains...
October 11, 2018: Revista Brasileira de Psiquiatria
Susana Seca, Miguel Patrício, Sebastian Kirch, Giovanna Franconi, António S Cabrita, Henry J Greten
BACKGROUND: Rheumatoid arthritis (RA) is characterized by pain, functional disability, poor quality of life (QoL), high socioeconomic impact, and annual costs of over $56 billion in the United States. Acupuncture (AC) is widely in use; however, studies show severe methodological shortcomings, did not consider the functional diagnosis for the allocation of acupoints and their results showed no differences between verum and control groups. OBJECTIVE: The authors aimed to objectively assess the safety and efficacy of AC treatments for RA...
October 16, 2018: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
Shuai Mao, Dan-Ping Xu, Xiao-Jing Dang, Winny Li, Huan-Lin Wu
BACKGROUND: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic (ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events (MACE) in stable anginal patients...
October 17, 2018: Chinese Journal of Integrative Medicine
Hadise Aslfalah, Mehri Jamilian, Fatemeh Rafiei, Ali Khosrowbeygi
AIM: Alpha-lipoic acid (ALA) is a short chain fatty acid which has a key role in energy production. ALA is also known as a universal antioxidant. The aim of the present study was to explore the effects of ALA supplementation in women with gestational diabetes mellitus. METHODS: A randomized double-blind placebo-controlled clinical trial study was designed. Women with gestational diabetes mellitus (n = 60) during 24-28 weeks of gestation were selected and divided randomly into drug (n = 30) and placebo (n = 30) groups...
October 16, 2018: Journal of Obstetrics and Gynaecology Research
R G Langley, A W Armstrong, M G Lebwohl, A Blauvelt, S Hsu, S Tyring, S Rastogi, R Pillai, R Israel
BACKGROUND: Brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, has demonstrated superior efficacy and safety versus ustekinumab as induction therapy for moderate-to-severe psoriasis. OBJECTIVE: To evaluate the efficacy and safety of brodalumab through week 52 in patients who had inadequate responses to ustekinumab. METHODS: A subgroup analysis of the phase 3 AMAGINE-2/-3 double-blind randomized controlled trials was performed...
October 17, 2018: British Journal of Dermatology
Hadi Bazyar, Hassan Gholinezhad, Leila Moradi, Parvin Salehi, Faezeh Abadi, Maryam Ravanbakhsh, Ahmad Zare Javid
BACKGROUND: Diabetes mellitus (DM) and periodontitis are two common chronic diseases with bidirectional relationship. Oxidative stress plays a key role in the pathogenesis of these two diseases. The aim of this study was to investigate the effects of melatonin supplementation in adjunct with non-surgical periodontal therapy on periodontal status, serum melatonin and inflammatory markers in type 2 DM patients with chronic periodontitis (CP). MATERIALS AND METHODS: In this double-blind clinical trial study, 50 type 2 DM patients with CP were randomly allocated to the intervention and control groups...
October 16, 2018: Inflammopharmacology
Maxime Sondag, Frank Verhoeven, Xavier Guillot, Clément Prati, Daniel Wendling
Dactylitis is a frequent disabling feature of psoriatic arthritis (PsA). Therapeutic strategy on dactylitis is not really codified. We performed a complementary literature review (since a previous one in 2014) of efficacy of new treatments recently used in PsA on this specific clinical manifestation. Eleven publications were retained (4697 patients). In the randomized double-blind placebo-controlled trials analyzed, authors declared ustekinumab, ixekizumab, adalimumab, and apremilast efficient. Secukinumab, clazakizumab, abatacept, and tofacitinib were promising...
October 16, 2018: Clinical Rheumatology
Darpan Bhargava, Rajkumar Ahirwal, Ganesh Koneru, Balaji R Srikanth, Sivakumar Beena
PURPOSE: To determine the quantity of dexamethasone plasma concentration achieved following intrapterygomandibular space injection of dexamethasone when co-administered with inferior alveolar nerve block correlating with the clinical effects in the postoperative phase. OBJECTIVE: A preliminary prospective study to evaluate the dexamethasone plasma concentration achieved following intrapterygomandibular space injection of dexamethasone with 2% lignocaine inferior alveolar nerve block to achieve hemi-mandibular anesthesia for minor oral surgical procedures and derive clinical correlations...
October 16, 2018: Oral and Maxillofacial Surgery
Katri Korpela, Anne Salonen, Outi Vepsäläinen, Marjo Suomalainen, Carolin Kolmeder, Markku Varjosalo, Sini Miettinen, Kaarina Kukkonen, Erkki Savilahti, Mikael Kuitunen, Willem M de Vos
BACKGROUND: Infants born by caesarean section or receiving antibiotics are at increased risk of developing metabolic, inflammatory and immunological diseases, potentially due to disruption of normal gut microbiota at a critical developmental time window. We investigated whether probiotic supplementation could ameliorate the effects of antibiotic use or caesarean birth on infant microbiota in a double blind, placebo-controlled randomized clinical trial. Mothers were given a multispecies probiotic, consisting of Bifidobacterium breve Bb99 (Bp99 2 × 108 cfu) Propionibacterium freundenreichii subsp...
October 16, 2018: Microbiome
T Kocher, B Holtfreter, A Petersmann, P Eickholz, T Hoffmann, D Kaner, T S Kim, J Meyle, U Schlagenhauf, S Doering, M Gravemeier, K Prior, W Rathmann, I Harks, B Ehmke, R Koch
Evidence is limited regarding whether periodontal treatment improves hemoglobin A1c (HbA1c) among people with prediabetes and periodontal disease, and it is unknown whether improvement of metabolic status persists >3 mo. In an exploratory post hoc analysis of the multicenter randomized controlled trial "Antibiotika und Parodontitis" (Antibiotics and Periodontitis)-a prospective, stratified, double-blind study-we assessed whether nonsurgical periodontal treatment with or without an adjunctive systemic antibiotic treatment affects HbA1c and high-sensitivity C-reactive protein (hsCRP) levels among periodontitis patients with normal HbA1c (≤5...
October 16, 2018: Journal of Dental Research
Rahul Bhattacharyya, Kapil Sugand, Bilal Al-Obaidi, Ian Sinha, Rajarshi Bhattacharya, Chinmay M Gupte
Background and purpose - Cognitive task analysis (CTA) has been used extensively to train pilots and in other surgical specialties. However, the use of CTA within orthopedics is in its infancy. We evaluated the effectiveness of a novel CTA tool to improve understanding of the procedural steps in antegrade femoral intramedullary nailing. Material and methods - Design: A modified Delphi technique was used to generate a CTA from 3 expert orthopedic trauma surgeons for antegrade femoral intramedullary nailing. The written and audiovisual information was combined to describe the technical steps, decision points, and errors for each phase of this procedure Validation: A randomized double-blind controlled trial was undertaken with 22 medical students (novices) randomized into 2 equal groups...
October 17, 2018: Acta Orthopaedica
Eduardo T Moro, Miller F Lambert, Ana Luiza Pereira, Thaís Artioli, Giuliana Graicer, Juliana Bevilacqua, Joshua Bloomstone
STUDY OBJECTIVES: The aim of the present study was to assess the quality of recovery from anesthesia in patients undergoing laparoscopic cholecystectomy (LC) under total intravenous anesthesia, who received either methadone or morphine for post-surgical analgesia by means of questionnaire Quality of Recovery-40 (QoR-40). DESIGN: Prospective Randomized Clinical Trial. SETTING: The setting was at an operating room, postoperative recovery area and hospital ward...
October 13, 2018: Journal of Clinical Anesthesia
Graham Devereux, Seonaidh Cotton, Shona Fielding, Nicola McMeekin, Peter J Barnes, Andrew Briggs, Graham Burns, Rekha Chaudhuri, Henry Chrystyn, Lisa Davies, Anthony De Soyza, Simon Gompertz, John Haughney, Karen Innes, Joanna Kaniewska, Amanda Lee, Alyn Morice, John Norrie, Anita Sullivan, Andrew Wilson, David Price
Importance: Chronic obstructive pulmonary disease (COPD) is a major global health issue and theophylline is used extensively. Preclinical investigations have demonstrated that low plasma concentrations (1-5 mg/L) of theophylline enhance antiinflammatory effects of corticosteroids in COPD. Objective: To investigate the effectiveness of adding low-dose theophylline to inhaled corticosteroids in COPD. Design, Setting, and Participants: The TWICS (theophylline with inhaled corticosteroids) trial was a pragmatic, double-blind, placebo-controlled, randomized clinical trial that enrolled patients with COPD between February 6, 2014, and August 31, 2016...
October 16, 2018: JAMA: the Journal of the American Medical Association
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