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Randomized controlled trials

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https://www.readbyqxmd.com/read/28087725/neurodevelopmental-outcomes-of-extremely-low-birthweight-infants-randomised-to-different-pco2-targets-the-phelbi-follow-up-study
#1
Ulrich H Thome, Orsolya Genzel-Boroviczeny, Bettina Bohnhorst, Manuel Schmid, Hans Fuchs, Oliver Rohde, Stefan Avenarius, Hans-Georg Topf, Andrea Zimmermann, Dirk Faas, Katharina Timme, Barbara Kleinlein, Horst Buxmann, Wilfried Schenk, Hugo Segerer, Norbert Teig, Annett Bläser, Roland Hentschel, Matthias Heckmann, Rolf Schlösser, Jochen Peters, Rainer Rossi, Wolfgang Rascher, Ralf Böttger, Jürgen Seidenberg, Gesine Hansen, Maria Zernickel, Harald Bode, Jens Dreyhaupt, Rainer Muche, Helmut D Hummler
BACKGROUND: Tolerating higher partial pressures of carbon dioxide (PCO2) in mechanically ventilated extremely low birthweight infants to reduce ventilator-induced lung injury may have long-term neurodevelopmental side effects. This study analyses the results of neurodevelopmental follow-up of infants enrolled in a randomised multicentre trial. METHODS: Infants (n=359) between 400 and 1000 g birth weight and 23 0/7-28 6/7 weeks gestational age who required endotracheal intubation and mechanical ventilation within 24 hours of birth were randomly assigned to high PCO2 or to a control group with mildly elevated PCO2 targets...
January 13, 2017: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/28087688/thirty-years-of-evidence-on-the-efficacy-of-drug-treatments-for-chronic-heart-failure-with-reduced-ejection-fraction-a-network-meta-analysis
#2
Heather Burnett, Amy Earley, Adriaan A Voors, Michele Senni, John J V McMurray, Celine Deschaseaux, Shannon Cope
BACKGROUND: Treatments that reduce mortality and morbidity in patients with heart failure with reduced ejection fraction, including angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), β-blockers (BB), mineralocorticoid receptor antagonists (MRA), and angiotensin receptor-neprilysin inhibitors (ARNI), have not been studied in a head-to-head fashion. This network meta-analysis aimed to compare the efficacy of these drugs and their combinations regarding all-cause mortality in patients with heart failure with reduced ejection fraction...
January 2017: Circulation. Heart Failure
https://www.readbyqxmd.com/read/28087683/percutaneous-patent-ductus-arteriosus-pda-closure-during-infancy-a-meta-analysis
#3
REVIEW
Carl H Backes, Brian K Rivera, Jeffrey A Bridge, Aimee K Armstrong, Brian A Boe, Darren P Berman, Tyler Fick, Ralf J Holzer, Ziyad M Hijazi, Sylvia Abadir, Henri Justino, Lisa Bergersen, Charles V Smith, Haresh Kirpalani
CONTEXT: Patent ductus arteriosus (PDA) is a precursor to morbidity and mortality. Percutaneous (catheter-based) closure is the procedure of choice for adults and older children with a PDA, but use during infancy (<1 year) is not well characterized. OBJECTIVE: Investigate the technical success and safety of percutaneous PDA closure during infancy. DATA SOURCES: Scopus, Web of Science, Embase, PubMed, and Ovid (Medline) were searched through December 2015 with no language restrictions...
January 13, 2017: Pediatrics
https://www.readbyqxmd.com/read/28087644/u-s-fda-approval-summary-nivolumab-for-treatment-of-unresectable-or-metastatic-melanoma-following-progression-on-ipilimumab
#4
Maitreyee Hazarika, Meredith K Chuk, Marc R Theoret, Sirisha Mushti, Kun He, Shawna L Weis, Alexander H Putman, Whitney S Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
On December 22, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (OPDIVO®, Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received nivolumab 3 mg/kg intravenously every 2 weeks with at least 6 months follow-up in an ongoing, randomized, open-label, active-controlled clinical trial...
January 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28087591/clinical-trials-in-antineutrophil-cytoplasmic-antibody-associated-vasculitis-what-we-have-learnt-so-far-and-what-we-still-have-to-learn
#5
Divi Cornec, Emilie Cornec-Le Gall, Ulrich Specks
The prognosis of the antineutrophil cytoplasmic antibody associated vasculitides (AAV), microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA) and eosinophilic GPA (EGPA), has been fundamentally improved over the last five decades by the use of glucocorticoids and immunosuppressants, turning them from consistently fatal diseases into chronic conditions. The long-term course is now largely determined by the frequency of disease flares and by accruing damage caused by disease activity and treatment-related comorbidities...
January 12, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28087569/exercise-as-treatment-for-alcohol-use-disorders-systematic-review-and-meta-analysis
#6
Mats Hallgren, Davy Vancampfort, Esther S Giesen, Andreas Lundin, Brendon Stubbs
OBJECTIVES: To conduct a systematic review and meta-analysis investigating effects of exercise for people with alcohol use disorders (AUDs) across multiple health outcomes. We also investigated the prevalence and predictors of dropout from exercise studies in AUDs. DESIGN: Systematic review and random effects meta-analysis with meta-regression analyses. DATA SOURCES: 3 major electronic databases were searched from inception until April 2016 for exercise intervention studies in adults with AUDs...
January 13, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28087567/interventions-to-increase-adherence-to-therapeutic-exercise-in-older-adults-with-low-back-pain-and-or-hip-knee-osteoarthritis-a-systematic-review-and-meta-analysis
#7
Philippa J A Nicolson, Kim L Bennell, Fiona L Dobson, Ans Van Ginckel, Melanie A Holden, Rana S Hinman
OBJECTIVE: To evaluate whether interventions aimed at increasing adherence to therapeutic exercise increase adherence greater than a contextually equivalent control among older adults with chronic low back pain and/or hip/knee osteoarthritis. DESIGN: A systematic review and meta-analysis. DATA SOURCES: Five databases (MEDLINE (PubMed), CINAHL, SportDISCUS (EBSCO), Embase (Ovid) and Cochrane Library) were searched until 1 August 2016. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials that isolated the effects of interventions aiming to improve adherence to therapeutic exercise among adults ≥45 years of age with chronic low back pain and/or hip/knee osteoarthritis were included...
January 13, 2017: British Journal of Sports Medicine
https://www.readbyqxmd.com/read/28087382/efficacy-and-safety-of-high-dose-rush-oral-immunotherapy-in-persistent-egg-allergic-children-a-randomized-clinical-trial
#8
Inmaculada Pérez-Rangel, Pablo Rodríguez Del Río, Carmelo Escudero, Silvia Sánchez-García, José Javier Sánchez-Hernández, María Dolores Ibáñez
BACKGROUND: Egg oral immunotherapy is effective but time consuming. OBJECTIVE: To assess the efficacy and safety of egg rush oral immunotherapy (ROIT) with a targeted dose equivalent to a raw egg white. METHODS: Thirty-three persistent egg allergic children confirmed by double-blind, placebo-controlled food challenge (DBPCFC) were randomized to receive egg ROIT immediately after randomization (ROIT1 group), or to continue an egg avoidance diet for 5 months after randomization (control group [CG])...
January 10, 2017: Annals of Allergy, Asthma & Immunology
https://www.readbyqxmd.com/read/28087370/laparoscopic-versus-open-surgery-for-rectal-cancer-a-meta-analysis-of-classic-randomized-controlled-trials-and-high-quality-nonrandomized-studies-in-the-last-5-years
#9
REVIEW
Ke Chen, Guodong Cao, Bo Chen, Mingqing Wang, Xingyu Xu, Wenwen Cai, Yicheng Xu, Maoming Xiong
OBJECTIVE: To present a meta-analysis of high-quality published reports comparing laparoscopic rectal resection (LRR) and open rectal resection (ORR) for rectal cancer. METHODS: Studies that compared LRR and ORR and were published within the last 5 years were identified. All eligible randomized controlled trials (RCTs) and non-randomized comparative trials (NRCTs) were evaluated based on the Jadad score, the Cochrane risk of bias assessment tool and modified Methodological Indices for Nonrandomized Studies (MINORS)...
January 10, 2017: International Journal of Surgery
https://www.readbyqxmd.com/read/28087178/acupuncture-for-serum-uric-acid-in-patients-with-asymptomatic-hyperuricemia-a-randomized-double-blind-placebo-controlled-trial
#10
Yingjuan Huang, Jun Meng, Baoguo Sun, Ting Xiang, Xin Zhou, Biyu Xu, Yingzi Wu, Zexiong Chen, Shijun Zhang
BACKGROUND: Hyperuricemia (HUA) is the most common disease associated with cardiovascular disease, metabolic syndrome, hypertension, and kidney disease. The objective of the current study was to evaluate the preliminary efficacy, mechanism, and safety of acupuncture on serum uric acid in patients with asymptomatic HUA. METHODS: A randomized, placebo-controlled trial among 123 patients with asymptomatic HUA was conducted. The acupoints used in the acupuncture group were bilateral Five Shu in Spleen Meridian...
January 6, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28087163/clinical-studies-of-ex-vivo-expansion-to-accelerate-engraftment-after-umbilical-cord-blood-transplantation-a-systematic-review
#11
REVIEW
Jeffrey Kiernan, Pauline Damien, Madeline Monaghan, Risa Shorr, Lauralyn McIntyre, Dean Fergusson, Alan Tinmouth, David Allan
Cell dose limits greater use of umbilical cord blood (UCB) in hematopoietic cell transplantation. The clinical benefits of ex vivo expansion need clarity to understand its potential impact. A systematic search of studies addressing UCB ex vivo expansion was conducted. Fifteen clinical studies (349 transplanted patients) and 13 registered trials were identified. The co-infusion of an expanded unit and a second unmanipulated unit (8 studies), the fractional expansion of 12% to 60% of a single unit (5 studies), and the infusion of a single expanded unit (2 studies) were reported...
December 23, 2016: Transfusion Medicine Reviews
https://www.readbyqxmd.com/read/28087133/secukinumab-sustains-early-patient-reported-outcome-benefits-through-1%C3%A2-year-results-from-2-phase-iii-randomized-placebo-controlled-clinical-trials-comparing-secukinumab-with-etanercept
#12
Bruce Strober, Alice B Gottlieb, Bintu Sherif, Patrick Mollon, Isabelle Gilloteau, Lori McLeod, Todd Fox, Margaret Mordin, Ari Gnanasakthy, Charis Papavassilis, Mark G Lebwohl
BACKGROUND: Psoriasis is a chronic condition with negative impact on patients' quality of life that most often requires lifelong effective and safe treatment. OBJECTIVE: This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis. METHODS: The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept...
January 10, 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28087128/intranasal-oxytocin-to-prevent-posttraumatic-stress-disorder-symptoms-a-randomized-controlled-trial-in-emergency-department-patients
#13
Mirjam van Zuiden, Jessie L Frijling, Laura Nawijn, Saskia B J Koch, J Carel Goslings, Jan S Luitse, Tessa H Biesheuvel, Adriaan Honig, Dick J Veltman, Miranda Olff
BACKGROUND: There are currently few preventive interventions available for posttraumatic stress disorder (PTSD). Intranasal oxytocin administration early after trauma may prevent PTSD, because oxytocin administration was previously found to beneficially impact PTSD vulnerability factors, including neural fear responsiveness, peripheral stress reactivity, and socioemotional functioning. Therefore, we investigated the effects of intranasal oxytocin administration early after trauma on subsequent clinician-rated PTSD symptoms...
December 8, 2016: Biological Psychiatry
https://www.readbyqxmd.com/read/28087110/systematic-review-and-meta-analysis-of-randomized-controlled-trials-assessing-safety-and-efficacy-of-posterior-pericardial-drainage-in-patients-undergoing-heart-surgery
#14
Mirosław Gozdek, Wojciech Pawliszak, Wojciech Hagner, Paweł Zalewski, Janusz Kowalewski, Domenico Paparella, Thierry Carrel, Lech Anisimowicz, Mariusz Kowalewski
OBJECTIVES: To investigate the potential beneficial effects of posterior pericardial drainage in patients undergoing heart surgery. METHODS: Multiple online databases and relevant congress proceedings were screened for randomized controlled trials assessing the efficacy and safety of posterior pericardial drainage, defined as posterior pericardiotomy incision, chest tube to posterior pericardium, or both. Primary endpoint was in-hospital/30 days' cardiac tamponade...
December 19, 2016: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28087069/safety-tolerability-and-antiviral-effect-of-rg-101-in-patients-with-chronic-hepatitis-c-a-phase-1b-double-blind-randomised-controlled-trial
#15
Meike H van der Ree, J Marleen de Vree, Femke Stelma, Sophie Willemse, Marc van der Valk, Svend Rietdijk, Richard Molenkamp, Janke Schinkel, Ad C van Nuenen, Ulrich Beuers, Salah Hadi, Marten Harbers, Eva van der Veer, Kai Liu, John Grundy, Amy K Patick, Adam Pavlicek, Jacqueline Blem, Michael Huang, Paul Grint, Steven Neben, Neil W Gibson, Neeltje A Kootstra, Hendrik W Reesink
BACKGROUND: miR-122 is an important host factor for hepatitis C virus (HCV) replication. The aim of this study was to assess the safety and tolerability, pharmacokinetics, and antiviral effect of a single dose of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated oligonucleotide that antagonises miR-122, in patients with chronic HCV infection with various genotypes. METHODS: In this randomised, double-blind, placebo-controlled, multicentre, phase 1B study, patients were randomly assigned to RG-101 or placebo (7:1)...
January 10, 2017: Lancet
https://www.readbyqxmd.com/read/28087066/use-of-water-soluble-contrast-medium-gastrografin-does-not-decrease-the-need-for-operative-intervention-nor-the-duration-of-hospital-stay-in-uncomplicated-acute-adhesive-small-bowel-obstruction-a-multicenter-randomized-clinical-trial-adhesive-small-bowel-obstruction
#16
Michel Scotté, Francois Mauvais, Michael Bubenheim, Cyril Cossé, Leslie Suaud, Celine Savoye-Collet, Isabelle Plenier, Aurelien Péquignot, Thierry Yzet, Jean Marc Regimbeau
BACKGROUND: This study evaluated the association between oral gastrografin administration and the need for operative intervention in patients with presumed adhesive small bowel obstruction. METHODS: Between October 2006 and August 2009, 242 patients with uncomplicated acute adhesive small bowel obstruction were included in a randomized, controlled trial (the Adhesive Small Bowel Obstruction Study, NCT00389116) and allocated to a gastrografin arm or a saline solution arm...
January 10, 2017: Surgery
https://www.readbyqxmd.com/read/28087049/-the-benefits-of-digital-chest-drainage-in-pleural-decortication-in-thoracic-empyema-prospective-randomized-control-trial
#17
José M Mier, Gildardo Cortés-Julián, Juan Berrios-Mejía, Zotés Víctor-Valdivia
BACKGROUND: Prolonged air leak after pleural decortication is one of the most frequent complications. OBJECTIVE: The aim of this study is to compare the effects of prolonged air leak between the digital chest drainage (DCD) system and the classic drainage system in patients with empyema class IIB or III (American Thoracic Society classification) in pleural decortication patients. MATERIAL AND METHODS: A total of 37 patients were enrolled in a prospective randomized control trial over one year, consisting of 2blinded groups, comparing prolonged air leak as a main outcome, the number of days until removal of chest drain, length of hospital stay and complications as secondary outcomes...
January 10, 2017: Cirugia y Cirujanos
https://www.readbyqxmd.com/read/28086992/therapies-for-bruxism-a-systematic-review-and-network-meta-analysis-protocol
#18
Mauro Elias Mesko, Brian Hutton, Jovito Adiel Skupien, Rafael Sarkis-Onofre, David Moher, Tatiana Pereira-Cenci
BACKGROUND: Bruxism is a sleep disorder characterized by grinding and clenching of the teeth that may be related to irreversible tooth injuries. It is a prevalent condition occurring in up to 31% of adults. However, there is no definitive answer as to which of the many currently available treatments (including drug therapy, intramuscular injections, physiotherapy, biofeedback, kinesiotherapy, use of intraoral devices, or psychological therapy) is the best for the clinical management of the different manifestations of bruxism...
January 13, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28086991/does-waterfall-aerosol-influence-mucosal-immunity-and-chronic-stress-a-randomized-controlled-clinical-trial
#19
Carina Grafetstätter, Martin Gaisberger, Johanna Prossegger, Markus Ritter, Predrag Kolarž, Christina Pichler, Josef Thalhamer, Arnulf Hartl
BACKGROUND: The specific microclimate of alpine waterfalls with high levels of ionized water aerosols has been suggested to trigger beneficial immunological and psychological effects. In the present three-armed randomized controlled clinical study, we focused on effects on (i) immunological reagibility, on (ii) physiological stress responses, and on (iii) stress-related psychological parameters. METHODS: People with moderate to high stress levels (n = 65) spent an active sojourn with daily hiking tours in the National Park Hohe Tauern (Großkirchheim, Austria)...
January 13, 2017: Journal of Physiological Anthropology
https://www.readbyqxmd.com/read/28086983/mailed-hpv-self-sampling-for-cervical-cancer-screening-among-underserved-minority-women-study-protocol-for-a-randomized-controlled-trial
#20
Erin Kobetz, Julia Seay, Anthony Amofah, Larry Pierre, Jordan Baeker Bispo, Dinah Trevil, Martha Gonzalez, Martine Poitevien, Tulay Koru-Sengul, Olveen Carrasquillo
BACKGROUND: Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening...
January 13, 2017: Trials
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