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https://www.readbyqxmd.com/read/28523482/an-rct-investigating-patient-driven-versus-physician-driven-titration-of-biasp-30-in-patients-with-type-2-diabetes-uncontrolled-using-nph-insulin
#1
Abdelmjid Chraibi, Shoorook Al-Herz, Bich Dao Nguyen, Djoko W Soeatmadji, Anil Shinde, Balasubramanian Lakshmivenkataraman, Samir H Assaad-Khalil
INTRODUCTION: The aim of this study was to confirm the efficacy of patient-driven titration of BIAsp 30 in terms of glycemic control, by comparing it to physician-driven titration of BIAsp 30, in patients with type 2 diabetes in North Africa, the Middle East, and Asia. METHODS: A 20-week, open-label, randomized, two-armed, parallel-group, multicenter study in Egypt, Indonesia, Morocco, Saudi Arabia, and Vietnam. Patients (n = 155) with type 2 diabetes inadequately controlled using neutral protamine Hagedorn (NPH) insulin were randomized to either patient-driven or physician-driven BIAsp 30 titration...
May 18, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28520610/candidates-for-inclusion-in-a-universal-antiretroviral-regimen-dolutegravir
#2
Pedro Cahn
PURPOSE OF REVIEW: The review addresses the role of dolutegravir (DTG) in first-line therapy. In the era of test and treat, where United Nations AIDS Program and WHO have set the ambitious targets of 90/90/90, new efficacious, well tolerated, and simple therapeutic options are needed. RECENT FINDINGS: DTG has been tested in large clinical trials in treatment-naïve patients, showing noninferiority to raltegravir and superiority compared with efavirenz and ritonavir-boosted darunavir, respectively...
May 16, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28511195/safety-aspects-of-postanesthesia-care-unit-discharge-without-motor-function-assessment-after-spinal-anesthesia-a-randomized-multicenter-semiblinded-noninferiority-controlled-trial
#3
Eske Kvanner Aasvang, Christoffer Calov Jørgensen, Mogens Berg Laursen, Jacob Madsen, Søren Solgaard, Mogens Krøigaard, Per Kjærsgaard-Andersen, Hans Mandøe, Torben Bæk Hansen, Jørgen Ulrich Nielsen, Niels Krarup, Annette Elisabeth Skøtt, Henrik Kehlet
BACKGROUND: Postanesthesia care unit (PACU) discharge without observation of lower limb motor function after spinal anesthesia has been suggested to significantly reduce PACU stay and enhance resource optimization and early rehabilitation but without enough data to allow clinical recommendations. METHODS: A multicenter, semiblinded, noninferiority randomized controlled trial of discharge from the PACU with or without assessment of lower limb motor function after elective total hip or knee arthroplasty under spinal anesthesia was undertaken...
June 2017: Anesthesiology
https://www.readbyqxmd.com/read/28510491/short-term-growth-during-treatment-with-inhaled-fluticasone-propionate-formoterol-fluticasone-and-beclomethasone-treatment
#4
Ole D Wolthers, Ainslee Moore, Sabine Mersmann, Sanjeeva Dissanayake
BACKGROUND: Fluticasone propionate/formoterol (FP/FORM) is a pressurized metered-dose inhaler (pMDI; Flutiform(®)) approved for use in adolescents and adults and under development for pediatric use. OBJECTIVE: To compare short-term growth in asthmatic children treated with FP/FORM, FP pMDI with valved holding chamber, and beclomethasone dipropionate (BDP) in a breath-actuated device. METHODS: Children with persistent asthma (n = 48; 5 to <12 years) participated in an assessor-blinded, randomized, three-way crossover trial with run in, wash out, and active treatment periods, each of 2 weeks duration...
May 16, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/28509761/dabigatran-in-nonvalvular-atrial-fibrillation-from-clinical-trials-to-real-life-experience
#5
Nicola Mumoli, Daniela Mastroiacovo, Eleonora Tamborini-Permunian, Josè Vitale, Matteo Giorgi-Pierfranceschi, Marco Cei, Francesco Dentali
: Atrial fibrillation is the most common arrhythmia in over-midlife patients. In addition to systolic heart failure, cerebral thromboembolism represents the most dramatic complication of this rhythm disorder, contributing to morbidity and mortality. Traditionally, anticoagulation has been considered the main strategy in preventing stroke and systemic embolism in atrial fibrillation patients and vitamin K-dependent antagonists have been widely used in clinical practice. Recently, the development of direct oral anticoagulants has certainly improved the management of this disease, providing, for the first time, the opportunity to go beyond vitamin K-dependent antagonists limits...
July 2017: Journal of Cardiovascular Medicine
https://www.readbyqxmd.com/read/28505909/re-impact-of-hair-removal-on-surgical-site-infection-rates-a-prospective-randomized-noninferiority-trial
#6
David F Penson
No abstract text is available yet for this article.
June 2017: Journal of Urology
https://www.readbyqxmd.com/read/28502278/a-new-health-technology-assessment-system-for-devices-the-first-five-years
#7
Bruce Campbell, Lee Dobson, Joanne Higgins, Bernice Dillon, Mirella Marlow, Chris Pomfrett
OBJECTIVES: The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system. METHODS: All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures...
May 15, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28498154/pediatric-to-adult-transition-and-medication-adherence-in-patients-with-inflammatory-bowel-disease
#8
Jayson Jeganathan, Cheng Hiang Lee, Antony Rahme, Darren K Tiao, Celine Weston, Shoma Dutt, Annabel Magoffin, Vu Kwan, Aladdin Alswaifi, Peter H Katelaris, Kevin J Gaskin, Edward V OʼLoughlin, Rupert W Leong
BACKGROUND: Medication nonadherence is common in inflammatory bowel disease and is associated with poor outcomes. There has been no study on pediatric-to-adult transition as a risk factor for nonadherence in inflammatory bowel disease, which has been demonstrated in other diseases. We aimed to assess whether transitioned (TR) patients have higher nonadherence rates than young adults (YAs) diagnosed in adulthood. METHODS: Consecutive ambulatory subjects were prospectively recruited and completed the validated Medication Adherence Reporting Scale (MARS), with the primary outcome being adherence differences between group age-matched TR and YA groups...
May 11, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28493172/tenofovir-alafenamide-a-review-in-chronic-hepatitis-b
#9
Lesley J Scott, Henry L Y Chan
Tenofovir alafenamide (AF) [Vemlidy(®)], an oral prodrug of tenofovir, was developed to optimize the antiviral potency and clinical safety of the active moiety tenofovir diphosphate (selective reverse transcriptase nucleotide inhibitor). In two identically designed, ongoing, multinational trials in treatment-naive and -experienced adult patients with hepatitis B e antigen (HBeAg)-positive or -negative chronic hepatitis B virus (HBV) infection, once-daily tenofovir AF 25 mg provided effective and sustained viral suppression (120-week analysis), and was generally well tolerated...
June 2017: Drugs
https://www.readbyqxmd.com/read/28492910/effect-of-bevacizumab-vs-aflibercept-on-visual-acuity-among-patients-with-macular-edema-due-to-central-retinal-vein-occlusion-the-score2-randomized-clinical-trial
#10
Ingrid U Scott, Paul C VanVeldhuisen, Michael S Ip, Barbara A Blodi, Neal L Oden, Carl C Awh, Derek Y Kunimoto, Dennis M Marcus, John J Wroblewski, Jacqueline King
Importance: Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data. Objective: To investigate whether bevacizumab is noninferior to aflibercept for the treatment of macular edema secondary to central retinal or hemiretinal vein occlusion. Design, Setting, and Participants: The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab...
May 9, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28489508/tai-chi-chih-compared-with-cognitive-behavioral-therapy-for-the-treatment-of-insomnia-in-survivors-of-breast-cancer-a-randomized-partially-blinded-noninferiority-trial
#11
Michael R Irwin, Richard Olmstead, Carmen Carrillo, Nina Sadeghi, Perry Nicassio, Patricia A Ganz, Julienne E Bower
Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up)...
May 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28486723/prospective-evaluation-of-outcomes-in-patients-undergoing-treatment-for-myopia-using-the-wavelight-refractive-suite
#12
Arthur Cummings, Daniel Durrie, Michael Gordon, Ravaughn Williams, James A Gow, Matthias Maus
PURPOSE: To evaluate outcomes in patients with myopia up to -12.00 diopters (D), with or without astigmatism up to 6.00 D, who underwent LASIK with the WaveLight Refractive Suite (Alcon Laboratories, Inc., Fort Worth, TX). METHODS: This multicenter, prospective, single-arm study evaluated patients at baseline, on the day of surgery, and 1 day and 1, 3, and 6 months postoperatively. The primary outcome was comparison of 1-month postoperative binocular uncorrected distance visual acuity (UDVA) with preoperative binocular corrected distance visual acuity (CDVA)...
May 1, 2017: Journal of Refractive Surgery
https://www.readbyqxmd.com/read/28486265/effect-of-family-presence-on-advanced-trauma-life-support-task-performance-during-pediatric-trauma-team-evaluation
#13
Karen J OʼConnell, Elizabeth A Carter, Jennifer L Fritzeen, Lauren J Waterhouse, Randall S Burd
IMPORTANCE: In many hospitals, family members are separated from their children during the early phases of trauma care. Including family members during this phase of trauma care varies by institution and is limited by concerns for adverse effects on clinical care. OBJECTIVE: The aim of this study is to evaluate the effect of family presence (FP) on advanced trauma life support primary and secondary survey task performance by pediatric trauma teams. We hypothesized that trauma care with FP would be noninferior to care when families were absent...
May 8, 2017: Pediatric Emergency Care
https://www.readbyqxmd.com/read/28483786/faster-aspart-versus-insulin-aspart-as-part-of-a-basal-bolus-regimen-in-inadequately-controlled-type-2-diabetes-the-onset-2-trial
#14
Keith Bowering, Christopher Case, John Harvey, Michael Reeves, Michael Sampson, Robert Strzinek, Ditte-Marie Bretler, Rikke Beck Bang, Bruce W Bode
OBJECTIVE: This multicenter, double-blind, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp) in adults with type 2 diabetes receiving basal insulin and oral antidiabetic agents. RESEARCH DESIGN AND METHODS: The primary end point was HbA1c change from baseline after 26 weeks' treatment. After an 8-week run-in to optimize basal insulin, subjects were randomized (1:1) to mealtime faster aspart (n = 345) or IAsp (n = 344), titrated using a simple daily patient-driven algorithm, plus insulin glargine U100 and metformin...
May 8, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28480267/primary-outcomes-from-a-phase-3-randomized-double-blind-active-controlled-trial-of-surotomycin-in-subjects-with-clostridium-difficile-infection
#15
Vicente Boix, Richard N Fedorak, Kathleen M Mullane, Yves Pesant, Uschi Stoutenburgh, Mandy Jin, Adedayo Adedoyin, Laurent Chesnel, Dalya Guris, Kajal B Larson, Yoshihiko Murata
BACKGROUND: Although the incidence of Clostridium difficile infection (CDI) is increasing, available CDI treatment options are limited in terms of sustained response after treatment. This phase 3 trial assessed the efficacy and safety of surotomycin, a novel bactericidal cyclic lipopeptide, versus oral vancomycin in subjects with CDI. METHODS: In this randomized, double-blind, active-controlled, multicenter, international trial, subjects with CDI confirmed by a positive toxin result were randomized to receive surotomycin (250 mg twice daily) or vancomycin (125 mg 4 times daily) orally for 10 days...
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/28479175/immunogenicity-and-safety-of-13-valent-pneumococcal-conjugate-vaccine-pcv13-formulated-with-2-phenoxyethanol-in-multidose-vials-given-with-routine-vaccination-in-healthy-infants-an-open-label-randomized-controlled-trial
#16
Olubukola T Idoko, Robert B Mboizi, Michael Okoye, France Laudat, Bubacarr Ceesay, John Z Liang, Natacha Le Dren-Narayanin, Kathrin U Jansen, Alejandra Gurtman, Kimberly J Center, Daniel A Scott, Beate Kampmann, Anna Roca
BACKGROUND: This open-label randomized controlled trial in infants compared safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated with the preservative 2-phenoxyethanol (2-PE) in a multidose vial (MDV) to the current PCV13 without 2-PE in a single-dose syringe (SDS). METHODS: Gambian infants were randomized 1:1 to receive PCV13 as either MDV or SDS at ages 2, 3, and 4months. Serotype-specific antipneumococcal antibody responses and opsonophagocytic activity ([OPA]; subset) were measured at age 5months...
May 31, 2017: Vaccine
https://www.readbyqxmd.com/read/28463615/a-new-tool-for-touch-free-patient-registration-for-robot-assisted-intracranial-surgery-application-accuracy-from-a-phantom-study-and-a-retrospective-surgical-series
#17
Francesco Cardinale, Michele Rizzi, Piergiorgio d'Orio, Giuseppe Casaceli, Gabriele Arnulfo, Massimo Narizzano, Davide Scorza, Elena De Momi, Michele Nichelatti, Daniela Redaelli, Maurizio Sberna, Alessio Moscato, Laura Castana
OBJECTIVE The purpose of this study was to compare the accuracy of Neurolocate frameless registration system and frame-based registration for robotic stereoelectroencephalography (SEEG). METHODS The authors performed a 40-trajectory phantom laboratory study and a 127-trajectory retrospective analysis of a surgical series. The laboratory study was aimed at testing the noninferiority of the Neurolocate system. The analysis of the surgical series compared Neurolocate-based SEEG implantations with a frame-based historical control group...
May 2017: Neurosurgical Focus
https://www.readbyqxmd.com/read/28461284/simple-wound-irrigation-in-the-postoperative-treatment-for-surgically-drained-spontaneous-soft-tissue-abscesses-study-protocol-for-a-prospective-single-blinded-randomized-controlled-trial
#18
Annika Rühle, Florian Oehme, Katja Börnert, Lana Fourie, Reto Babst, Björn-Christian Link, Jürg Metzger, Frank Jp Beeres
BACKGROUND: Skin abscesses are a frequent encountered health care problem and lead to a significant source of morbidity. They consequently have an essential impact on the quality of life and work. To date, the type of aftercare for surgically drained abscesses remains under debate. This leads to undesirable practice variations. Many clinical standard protocols include sterile wound dressings twice a day by a home-care service to reduce the chance of a recurrent wound infection. It is unknown, however, whether reinfection rates are comparable to adequate wound irrigation with a nonsterile solution performed by the patient...
May 1, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28459710/cost-minimization-analysis-of-the-management-of-acute-achilles-tendon-rupture
#19
Jeremy N Truntzer, Brian Triana, Alex H S Harris, Laurence Baker, Loretta Chou, Robin N Kamal
BACKGROUND: Outcomes of nonsurgical management of acute Achilles tendon rupture have been demonstrated to be noninferior to those of surgical management. We performed a cost-minimization analysis of surgical and nonsurgical management of acute Achilles tendon rupture. METHODS: We used a claims database to identify patients who underwent surgical (n = 1,979) and nonsurgical (n = 3,065) management of acute Achilles tendon rupture and compared overall costs of treatment (surgical procedure, follow-up care, physical therapy, and management of complications)...
June 2017: Journal of the American Academy of Orthopaedic Surgeons
https://www.readbyqxmd.com/read/28455277/evidence-of-benefit-of-telerehabitation-after-orthopedic-surgery-a-systematic-review
#20
Jose Manuel Pastora-Bernal, Rocio Martín-Valero, Francisco Javier Barón-López, María José Estebanez-Pérez
BACKGROUND: In addition to traditional physiotherapy, studies based on telerehabilitation programs have published the results of effectiveness, validity, noninferiority, and important advantages in some neurological, cognitive, and musculoskeletal disorders, providing an opportunity to define new social policies and interventions. OBJECTIVES: The aim of this systematic review is to investigate the effects of telerehabilitation after surgical procedures on orthopedic conditions as well as to describe how interventions are designed and to determine whether telerehabilitation is comparable with conventional methods of delivery...
April 28, 2017: Journal of Medical Internet Research
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