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https://www.readbyqxmd.com/read/28729311/a-review-of-rate-control-in-atrial-fibrillation-and-the-rationale-and-protocol-for-the-rate-af-trial
#1
Dipak Kotecha, Melanie Calvert, Jonathan J Deeks, Michael Griffith, Paulus Kirchhof, Gregory Yh Lip, Samir Mehta, Gemma Slinn, Mary Stanbury, Richard P Steeds, Jonathan N Townend
BACKGROUND AND OBJECTIVE: Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article , we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity...
July 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28724365/leflunomide-is-equally-efficacious-and-safe-compared-to-low-dose-rituximab-in-refractory-rheumatoid-arthritis-given-in-combination-with-methotrexate-results-from-a-randomized-double-blind-controlled-clinical-trial
#2
Harindu Wijesinghe, Priyadharshini Galappatthy, Rajiva de Silva, Suranjith L Seneviratne, Ushagowry Saravanamuttu, Preethi Udagama, Melanie Hart, Peter Kelleher, Upul Senerath, Rohini Fernandopulle, Lilani P Weerasekera, Lalith S Wijayaratne
BACKGROUND: The standard dose of rituximab used in rheumatoid arthritis (RA) is 1000 mg but recent studies have shown that low dose (500 mg) is also effective. Efficacy of low dose rituximab in rheumatoid arthritis (RA) refractory to first-line non-biologic Disease Modifying Anti Rheumatic Drugs (DMARDs), compared to leflunomide is unknown. In a tertiary care referral setting, we conducted a randomized, double blind controlled clinical trial comparing the efficacy and safety of low-dose rituximab-methotrexate combination with leflunomide-methotrexate combination...
July 19, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28721082/effectiveness-evaluation-of-two-volumizing-hyaluronic-acid-dermal-fillers-in-a-controlled-randomized-double-blind-split-face-clinical-study
#3
Martina Kerscher, Karla Agsten, Maria Kravtsov, Welf Prager
BACKGROUND: Enhancement of the midface can be achieved with volumizing hyaluronic acid (HA) fillers. OBJECTIVE: The objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix(®) 26 mg/mL HA gel (CPM-26) and Vycross(®) 20 mg/ml HA gel (VYC-20) in a controlled, randomized, evaluator-blind, split-face clinical study. PATIENTS AND METHODS: Subjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS) received CPM-26 on one side and VYC-20 on the contralateral side of the face...
2017: Clinical, Cosmetic and Investigational Dermatology
https://www.readbyqxmd.com/read/28720617/protocol-for-an-online-randomised-controlled-trial-to-evaluate-the-clinical-and-cost-effectiveness-of-a-peer-supported-self-management-intervention-for-relatives-of-people-with-psychosis-or-bipolar-disorder-relatives-education-and-coping-toolkit-react
#4
Fiona Lobban, Heather Robinson, Duncan Appelbe, Johanna Barraclough, Emma Bedson, Lizzie Collinge, Susanna Dodd, Sue Flowers, Mahsa Honary, Sonia Johnson, Ceu Mateus, Barbara Mezes, Valerie Minns, Elizabeth Murray, Andrew Walker, Paula Williamson, Catherine Wintermeyer, Steven Jones
INTRODUCTION: Despite clinical guidelines recommendations, many relatives of people with psychosis or bipolar disorder do not currently receive the support they need. Online information and support may offer a solution. METHODS AND ANALYSIS: This single-blind, parallel, online randomised controlled trial will determine clinical and cost-effectiveness of the Relatives Education And Coping Toolkit (REACT) (including an online resource directory (RD)), compared with RD only, for relatives of people with psychosis or bipolar disorder...
July 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28720615/assessment-of-the-effectiveness-and-safety-of-ethosuximide-in-the-treatment-of-abdominal-pain-related-to-irritable-bowel-syndrome-ibset-protocol-of-a-randomised-parallel-controlled-double-blind-and-multicentre-trial
#5
Nicolas Kerckhove, Julien Scanzi, Bruno Pereira, Denis Ardid, Michel Dapoigny
INTRODUCTION: Irritable bowel syndrome (IBS) is characterised by the association of abdominal chronic pain with bowel habit disorders in the absence of identifiable organic disease. This is the first reason for consultation in gastroenterology, with an estimated prevalence of 10%-15% in industrialised countries. Although this is a benign gastrointestinal disease, its chronicity profoundly impacts the patient's quality of life and causes considerable health spending. Actual medical treatments are poorly efficient on IBS-related abdominal pain, making it a major public health concern...
July 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28716168/a-randomized-double-blind-placebo-controlled-trial-of-sublingual-immunotherapy-with-house-dust-mite-extract-for-allergic-rhinitis
#6
Yu Guo, Yanqing Li, Dehui Wang, Quan Liu, Zhuofu Liu, Li Hu
OBJECTIVE: This study was designed to evaluate the efficacy and safety of sublingual immunotherapy (SLIT) with house-dust mite (HDM) extract in Chinese patients with HDM-induced allergic rhinitis (AR). METHODS: A randomized, double-blind, placebo controlled trial was conducted with the outpatients of the Eye, Ear, Nose, and Throat Hospital, Fudan University. Forty-eight patients were eligible for randomization to SLIT with a mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae extract or placebo for 1 year...
July 1, 2017: American Journal of Rhinology & Allergy
https://www.readbyqxmd.com/read/28715577/device-safety-implications-of-the-clinical-data-leading-to-us-food-and-drug-administration-approval-of-soft-tissue-fillers-a-systematic-review
#7
Mary E Lohman, Comeron W Ghobadi, Shuai Xu
Importance: The US Food and Drug Administration (FDA) recently issued a safety warning regarding soft-tissue fillers (STFs) based on the risk of blindness and facial necrosis. Objective: To examine the quality of evidence leading to FDA approval of STFs. Evidence Review: All original approvals for STFs were mined using the publicly available FDA database. The Cochrane Collaboration's risk of bias assessment tool was applied to all randomized clinical trials (RCTs)...
July 13, 2017: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/28715540/predictors-of-hand-foot-syndrome-and-pyridoxine-for-prevention-of-capecitabine-induced-hand-foot-syndrome-a-randomized-clinical-trial
#8
Yoon-Sim Yap, Li-Lian Kwok, Nicholas Syn, Wen Yee Chay, John Whay Kuang Chia, Chee Kian Tham, Nan Soon Wong, Soo Kien Lo, Rebecca Alexandra Dent, Sili Tan, Zuan Yu Mok, King Xin Koh, Han Chong Toh, Wen Hsin Koo, Marie Loh, Raymond Chee Hui Ng, Su Pin Choo, Richie Chuan Teck Soong
Importance: Hand-foot syndrome (HFS) is a common adverse effect of capecitabine treatment. Objective: To compare the incidence and time to onset of grade 2 or greater HFS in patients receiving pyridoxine vs placebo and to identify biomarkers predictive of HFS. Design, Setting, and Participants: This single-center, randomized double-blind, placebo-controlled phase 3 trial conducted at National Cancer Centre Singapore assessed whether oral pyridoxine could prevent the onset of grade 2 or higher HFS in 210 patients scheduled to receive single-agent capecitabine chemotherapy for breast, colorectal, and other cancers...
July 13, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28710850/efficacy-and-safety-of-beclomethasone-dipropionate-breath-actuated-or-metered-dose-inhaler-in-pediatric-patients-with-asthma
#9
M Vandewalker, L Hickey, C J Small
BACKGROUND: Breath-actuated inhalers (BAI) eliminate the need for hand-breath coordination and, therefore, simplify thedelivery of inhaled medication. OBJECTIVE: To evaluate the efficacy and safety of beclomethasone dipropionate BAI and metered-dose inhaler (MDI) versus placebo in pediatric patients ages 4-11 years with persistent asthma. METHODS: In this double-blind, double-dummy, phase III study, 628 children with persistent asthma were randomly assigned(1:1:1:1:1) to twice-daily beclomethasone dipropionate (BAI 80 micrograms/day, BAI 160 micrograms/day, MDI 80 micrograms/day, or MDI 160 micrograms/day) or to placebo...
July 14, 2017: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/28709650/anticoagulation-control-in-warfarin-treated-patients-undergoing-cardioversion-of-atrial-fibrillation-from-the-edoxaban-versus-enoxaparin-warfarin-in-patients-undergoing-cardioversion-of-atrial-fibrillation-trial
#10
Gregory Y H Lip, Naab Al-Saady, James Jin, Ming Sun, Michael Melino, Shannon M Winters, Dmitry Zamoryakhin, Andreas Goette
In the Edoxaban Versus Enoxaparin-Warfarin in Patients Undergoing Cardioversion of Atrial Fibrillation (ENSURE-AF) study (NCT 02072434), edoxaban was compared with enoxaparin-warfarin in 2,199 patients undergoing electrical cardioversion of nonvalvular atrial fibrillation (AF). In this multicenter prospective randomized open blinded end-point trial, we analyzed patients randomized to enoxaparin-warfarin. We determined time to achieve therapeutic range (TtTR); time in therapeutic range (TiTR); their clinical determinants; relation to sex, age, medical history, treatment, tobacco use, race risk (SAMe-TT2R2) score; and impact on primary end points (composite of stroke, systemic embolic event[SEE], myocardial infarction [MI], and cardiovascular death [CVD] and composite of major + clinically relevant nonmajor bleeding)...
June 15, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28708736/mifepristone-plasma-level-and-glucocorticoid-receptor-antagonism-associated-with-response-in-patients-with-psychotic-depression
#11
Thaddeus Block, Georgios Petrides, Harvey Kushner, Ned Kalin, Joseph Belanoff, Alan Schatzberg
BACKGROUND: Psychotic depression has no Food and Drug Administration-approved treatment. Patients demonstrate significant dysregulation of the hypothalamic-pituitary-adrenal axis providing a biologically targeted treatment opportunity. The purpose of this study was to explore the clinical and biological effects of short-duration (7-day) glucocorticoid receptor antagonism with mifepristone and the role of mifepristone plasma levels in patients with psychotic depression. METHODS: This double-blind, randomized study took place at 34 US clinical research centers and included patients with a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, major depressive disorder, severe, with psychotic features...
July 13, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28706321/cryptaphelenchus-varicaudatus-n-sp-rhabditida-ektaphelenchinae-from-tehran-province-iran
#12
Majid Pedram
Cryptaphelenchus varicaudatus n. sp. is described and illustrated. It was isolated from bark samples of dead or dying pine (Pinus spp.) trees with bark beetle frass and galleries, in Tehran province. The new species has 275- to 367-µm-long females (a medium-sized species) with distinctly annulated cuticle having three bands in lateral fields, lip region continuous with body contour, delicate knobbed stylet, monodelphic-prodelphic reproductive system with distinct spermatheca, short postvulval uterine sac (PUS), transverse vulval slit with raised posterior lip and body narrowing behind it, sclerotized vagina, simple intestine ending in a blind sac, having no rectum but vestigial anus in some specimens, and distal body end tip (tail tip) with variation in morphology (shape), from sharply or slightly pointed to bluntly rounded...
June 2017: Journal of Nematology
https://www.readbyqxmd.com/read/28701493/the-crest-e-study-of-creatine-for-huntington-disease-a-randomized-controlled-trial
#13
Steven M Hersch, Giovanni Schifitto, David Oakes, Amy-Lee Bredlau, Catherine M Meyers, Richard Nahin, Herminia Diana Rosas
OBJECTIVE: To investigate whether creatine administration could slow progressive functional decline in adults with early symptoms of Huntington disease. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled study of up to 40 g daily of creatine monohydrate in participants with stage I and II HD treated for up to 48 months. The primary outcome measure was the rate of change in total functional capacity (TFC) between baseline and end of follow-up...
July 12, 2017: Neurology
https://www.readbyqxmd.com/read/28700781/efficacy-and-safety-of-spironolactone-in-acute-heart-failure-the-athena-hf-randomized-clinical-trial
#14
Javed Butler, Kevin J Anstrom, G Michael Felker, Michael M Givertz, Andreas P Kalogeropoulos, Marvin A Konstam, Douglas L Mann, Kenneth B Margulies, Steven E McNulty, Robert J Mentz, Margaret M Redfield, W H Wilson Tang, David J Whellan, Monica Shah, Patrice Desvigne-Nickens, Adrian F Hernandez, Eugene Braunwald
Importance: Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists administered at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. Objective: To assess the effect of high-dose spironolactone and usual care on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels compared with usual care alone. Design, Setting, and Participants: This double-blind and placebo (or low-dose)-controlled randomized clinical trial was conducted in 22 US acute care hospitals among patients with AHF who were previously receiving no or low-dose (12...
July 12, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28692723/safety-of-converting-from-tetrabenazine-to-deutetrabenazine-for-the-treatment-of-chorea
#15
Samuel Frank, David Stamler, Elise Kayson, Daniel O Claassen, Amy Colcher, Charles Davis, Andrew Duker, Shirley Eberly, Lawrence Elmer, Erin Furr-Stimming, Mark Gudesblatt, Christine Hunter, Joseph Jankovic, Sandra K Kostyk, Rajeev Kumar, Clement Loy, William Mallonee, David Oakes, Burton L Scott, Victor Sung, Jody Goldstein, Christina Vaughan, Claudia M Testa
Importance: Tetrabenazine is efficacious for chorea control; however, tolerability concerns exist. Deutetrabenazine, a novel molecule that reduces chorea, was well tolerated in a double-blind, placebo-controlled study. Objectives: To evaluate the safety and explore the efficacy of conversion from tetrabenazine to deutetrabenazine in patients with chorea associated with Huntington disease (HD). Design, Setting, and Participants: In this ongoing, open-label, single-arm study that started on December 21, 2013, 37 patients at 13 Huntington Study Group sites in the United States and Australia who were taking stable doses of tetrabenazine that provided a therapeutic benefit were switched overnight to deutetrabenazine therapy...
July 10, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/28690011/lume-meso-design-and-rationale-of-the-phase-iii-part-of-a-placebo-controlled-study-of-nintedanib-and-pemetrexed-cisplatin-followed-by-maintenance-nintedanib-in-patients-with-unresectable-malignant-pleural-mesothelioma
#16
Giorgio V Scagliotti, Rabab Gaafar, Anna K Nowak, Martin Reck, Anne S Tsao, Jan van Meerbeeck, Nicholas J Vogelzang, Takashi Nakano, Ute von Wangenheim, Derek Velema, Nassim Morsli, Sanjay Popat
Malignant pleural mesothelioma (MPM) is a rare but aggressive disease: median survival is 6 to 9 months if untreated. Standard first-line treatment for patients with unresectable MPM is cisplatin/pemetrexed, with a median overall survival (OS) of approximately 1 year. Improvements in first-line treatment options are needed. With the benefit of combining bevacizumab with standard therapy shown in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS), vascular endothelial growth factor (VEGF) pathway inhibition has gained renewed interest as a treatment approach...
March 22, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28685558/bioimpedance-analysis-metabolic-effects-and-safety-of-the-association-berberis-aristata-bilybum-marianum-a-52-week-double-blind-placebo-controlled-study-in-obese-patients-with-type-2-diabetes
#17
G Guarino, F Strollo, L Carbone, T Della Corte, M Letizia, G Marino, S Gentile
Berberine, a quaternary isoquinoline alkaloid present in Berberis aristata, is well known in terms of cholesterol-lowering, hypoglycemic, and insulin sensitizing effects. Because of its low oral bioavailability, to improve intestinal absorption it has been recently combined with silymarin (Silybum marianum). The aim of our placebo controlled study was to evaluate the effects of its association with silymarin on abdominal fat in overweight/obese patients with type 2 diabetes mellitus (T2DM). To do so, 136 obese subjects with T2DM and metabolic syndrome were analyzed for fasting blood glucose and insulin, Insulin Resistance index according to the Homeostatic Model Assessment (HOMA-R), total, HDL and LDL cholesterol, triglycerides, uric acid, BMI, waist circumference, waist to hip ratio and underwent bioelectrical impedance to assess % of abdominal fat...
April 2017: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/28681394/amenamevir-a-novel-helicase-primase-inhibitor-for-treatment-of-herpes-zoster-a-randomized-double-blind-valaciclovir-controlled-phase-3-study
#18
Makoto Kawashima, Osamu Nemoto, Mariko Honda, Daisuke Watanabe, Juichiro Nakayama, Shinichi Imafuku, Toshiyuki Kato, Tsuneo Katsuramaki
Amenamevir is a potent helicase-primase inhibitor and a novel class of antiviral agent other than nucleoside compounds, such as aciclovir, valaciclovir and famciclovir. This study is the first randomized, double-blind, valaciclovir-controlled phase 3 study to evaluate the efficacy and safety of amenamevir in Japanese patients with herpes zoster when treated within 72 h after onset of rash. A total of 751 patients were randomly assigned to receive either amenamevir 400 mg or 200 mg p.o. once daily or valaciclovir 1000 mg three times daily (daily dose, 3000 mg) for 7 days...
July 5, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28678558/efficacy-of-cysteamine-cream-in-the-treatment-of-epidermal-melasma-evaluating-by-dermacatch-as-a-new-measurement-method-a-randomized-double-blind-placebo-controlled-study
#19
Susan Farshi, Parvin Mansouri, Behrooz Kasraee
BACKGROUND: Melasma is a difficult-to-treat hyperpigmentary disorder. Very few studies have been performed regarding the efficacy of cysteamine in the treatment of melasma. OBJECTIVE: To determine the efficacy of cysteamine cream in the treatment of patients with epidermal melasma using Dermacatch(®) as a more accurate skin colorimetric measurement tool. METHODS: Participating patients (n = 40) received either placebo (n = 20) or cysteamine cream (n = 20) in a double-blind placebo controlled study...
July 5, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28675566/effects-of-two-different-glutamine-containing-enteral-supplements-on-stool-frequency-and-density-in-elderly-patients-recovering-from-acute-critical-illness
#20
Nobutoshi Fushimi, Munenori Yamada, Hiroki Hachiya, Shun Ito, Takashi Shibuya, Noritsugu Ohashi, Akihiro Mori
AIM: Glutamine has various beneficial functions in the gastrointestinal tract. The present study was designed to investigate the effect of two different glutamine supplements on bowel movement at the start of enteral feeding in elderly inpatients. METHODS: This was a double-blind, prospective, randomized comparison study. A total of 25 patients aged >75 years recovering from a critical illness in a non-intensive care unit and scheduled for tube feeding were recruited...
July 4, 2017: Geriatrics & Gerontology International
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