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double blind controlled trial

Eileen R Chasens, Charles W Atwood, Lora E Burke, Mary Korytkowski, Robert Stansbury, Patrick J Strollo, Susan M Sereika
The Diabetes Sleep Treatment Trial (DSTT) is a multi-site, double-blinded, randomized, sham-controlled trial. The study objective is to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) treatment results in improved glycemic control and diabetes self-management behavior compared to participants on a sham-CPAP (sub-therapeutic) device in participants with type 2 diabetes mellitus (T2DM) and co-morbid OSA. The purpose of this paper is to describe the premise for the DSTT, the study design, and the methodology used in this on-going trial...
December 2, 2018: Contemporary Clinical Trials
Susan M Goobie, David Zurakowski, Michael P Glotzbecker, Mary E McCann, Daniel Hedequist, Robert M Brustowicz, Navil F Sethna, Lawerence I Karlin, John B Emans, M Timothy Hresko
BACKGROUND: Tranexamic acid (TXA) is an antifibrinolytic drug that reduces surgical blood loss. Evidence supporting its efficacy in surgery for adolescent idiopathic scoliosis is not robust. This trial was designed to validate the clinical efficacy of TXA in surgery for adolescent idiopathic scoliosis. METHODS: This institutional review board-approved prospective double-blinded trial involved 111 patients with adolescent idiopathic scoliosis who were randomized to receive either a placebo or TXA (50-mg/kg loading dose and 10-mg/kg/h infusion)...
December 5, 2018: Journal of Bone and Joint Surgery. American Volume
Judy W M Cheng, Vincent J Colucci, James S Kalus, Sarah A Spinler
OBJECTIVE: While improving glycemic control with antihyperglycemics has been demonstrated to reduce microvascular complications, the benefits of reduction in cardiovascular diseases (CVDs) have not been demonstrated with older agents. This article reviews current evidence of the CV outcomes of newer antihyperglycemics approved since 2008. DATA SOURCES: Peer-reviewed articles were identified from MEDLINE (1966 to October 31, 2018) using search terms exenatide, liraglutide, lixisenatide, dulaglutide, semaglutide, alogliptin, linagliptin, saxagliptin, sitagliptin, canagliflozin, dapagliflozin, empagliflozin, mortality, myocardial infarction (MI), heart failure (HF), and stroke...
December 5, 2018: Annals of Pharmacotherapy
Magnus O Wijkman, Mary Dena, Sofia Dahlqvist, Sheyda Sofizadeh, Irl Hirsch, Jaakko Tuomilehto, Johan Mårtensson, Ole Torffvit, Henrik Imberg, Aso Saeed, Marcus Lind
Liraglutide is associated with blood pressure reduction in patients with type 2 diabetes. However, it is not known whether this blood pressure reduction can be predicted prior to treatment initiation, and to what extent it correlates with weight loss and with improved glycemic control during follow-up. We analyzed data from a double-blind, placebo-controlled trial, in which 124 insulin-treated patients with type 2 diabetes were randomized to liraglutide or placebo. We evaluated various baseline variables as potential predictors of systolic blood pressure (SBP) reduction, and evaluated whether changes in SBP correlated with weight loss and with improved glycemic control...
December 5, 2018: Journal of Clinical Hypertension
Maren Cecilie Strand, Vigdis Vindenes, Hallvard Gjerde, Jørg Gustav Mørland, Johannes G Ramaekers
AIMS: The present study assessed the acute effects of methadone and buprenorphine on actual on-road driving performance and neurocognitive function. METHODS: Methadone (5 and 10 mg per oral) and buprenorphine (0.2 and 0.4 mg sublingual) were administered to 22 healthy volunteers in a five-way, double-blind, randomized, placebo-controlled, double-dummy, cross-over study. Driving performance was assessed with an on-road driving test. The primary outcome measure was standard deviation of lateral position (SDLP), a measure of road tracking control...
December 4, 2018: British Journal of Clinical Pharmacology
Mauro Merli, Marco Moscatelli, Giorgia Mariotti, Umberto Pagliaro, Eugenia Raffaelli, Michele Nieri
PURPOSE: The objective of this 3-year post-loading parallel randomised controlled trial is to compare two bone substitutes and resorbable membranes in a one-stage procedure for horizontal bone augmentation: anorganic bovine bone and porcine collagen membranes (BB group) versus synthetic resorbable bone graft substitute made of pure β-tricalcium phosphate and porcine pericardium collagen membranes (CJ group). MATERIALS AND METHODS: Patients in need of implant treatment having at least one site with horizontal osseous defect at a private clinic in Rimini, Italy, were included in this study...
2018: European Journal of Oral Implantology
Marloes van Splunter, Olaf Perdijk, Henriëtte Fick-Brinkhof, Anouk L Feitsma, Esther G Floris-Vollenbroek, Ben Meijer, Sylvia Brugman, Huub F J Savelkoul, Els van Hoffen, R J Joost van Neerven
During aging the immune system is dysregulated. Especially plasmacytoid dendritic cells (pDCs) and myeloid DCs (mDCs) have reduced Toll like receptor (TLR)-mediated responses resulting in increased susceptibility to infections. Consumption of bovine lactoferrin (bLF) has been shown to reduce infections with viruses. Galacto-oligosacharides (GOS) and vitamin D are associated with reduced pro-inflammatory cytokine levels in serum, and increased TLR7/8 responses, respectively. A double-blind placebo-controlled nutritional intervention study in elderly women was performed, to investigate the potential of bLF, GOS, and vitamin D to restore TLR responsiveness of pDCs and mDCs and to reduce inflammatory markers in serum...
2018: Frontiers in Immunology
Jason C Yam, Yuning Jiang, Shu Min Tang, Antony K P Law, Joyce J Chan, Emily Wong, Simon T Ko, Alvin L Young, Clement C Tham, Li Jia Chen, Chi Pui Pang
PURPOSE: Low-concentration atropine is an emerging therapy for myopia progression, but its efficacy and optimal concentration remain uncertain. Our study aimed to evaluate the efficacy and safety of low-concentration atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period. DESIGN: Randomized, placebo-controlled, double-masked trial. PARTICIPANTS: A total of 438 children aged 4 to 12 years with myopia of at least -1...
July 6, 2018: Ophthalmology
Angelos G Kolias, Ellie Edlmann, Eric P Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Carol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J Marcus, Aswin Chari, Paul Brennan, Antonio Belli, Simon Bond, Carole Turner, Lynne Whitehead, Ian Wilkinson, Peter J Hutchinson
BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months...
December 4, 2018: Trials
Marilena Petrera, Laura Paleari, Matteo Clavarezza, Matteo Puntoni, Silvia Caviglia, Irene Maria Briata, Massimo Oppezzi, Eva Mihajlovic Mislej, Borut Stabuc, Michael Gnant, Thomas Bachleitner-Hofmann, Wilfried Roth, Dominique Scherer, Walter-E Haefeli, Cornelia M Ulrich, Andrea DeCensi
BACKGROUND: Epidemiological studies and cardiovascular prevention trials have shown that low-dose aspirin can reduce colorectal cancer (CRC) incidence and mortality, including inhibition of distant metastases. Metformin has also been associated with decreased colon adenoma recurrence in clinical trials and lower CRC incidence and mortality in epidemiological studies in diabetics. While both drugs have been tested as single agents, their combination has not been tested in cancer prevention trials...
December 4, 2018: BMC Cancer
Aline Boveto Santamarina, Giovana Jamar, Laís Vales Mennitti, Helena de Cássia César, Verdiana Vera de Rosso, José Ronnie Vasconcelos, Lila Missae Oyama, Luciana Pellegrini Pisani
Nutrigenomics is an emerging field in obesity since epigenetic markers can be modified by environmental factors including diet. Considering juçara composition-rich in anthocyanins, monounsaturated fatty acids (MUFAs) and fibers-it has the potential for epigenetic modulation. We evaluated the juçara supplementation modulating the serum fatty acids profile and epigenetic markers in monocytes of adult obese humans. It was a randomized double-blind, controlled trial with 27 obese (Body mass index between 30.0 and 39...
December 3, 2018: Nutrients
Naoki Ito, Shinobu Seki, Fumitaka Ueda
Aging-associated changes of skin conditions are a major concern for maintaining quality of life. Therefore, the improvement of skin conditions by dietary supplementation is a topic of public interest. In this study, we hypothesized that a composite supplement containing fish derived-collagen peptide and ornithine (CPO) could improve skin conditions by increasing plasma growth hormone and/or insulin-like growth factor-1 (IGF-1) levels. Twenty-two healthy Japanese participants were enrolled in an 8-week double-blind placebo-controlled pilot study...
December 3, 2018: Marine Drugs
Maria Calasso, Ruggiero Francavilla, Fernanda Cristofori, Maria De Angelis, Marco Gobbetti
It has been suggested that sourdough fermented products have beneficial health effects. Fungal proteases and selected sourdough lactic acid bacteria were used to produce wheat bread and pasta with a reduced-gluten content (<50% of traditional products). Fermentable oligo-, di- and mono- saccharides and polyols and amylase/trypsin inhibitors were also evaluated. The sensorial features of new products were similar to traditional ones. The efficacy of these new products in reducing the severity of symptoms in Irritable Bowel Syndrome (IBS) patients were compared to traditional bread and pasta using a randomized, crossover-controlled trial...
December 2, 2018: Nutrients
Talitha C Ford, Luke A Downey, Tamara Simpson, Grace McPhee, Chris Oliver, Con Stough
A diet rich in B-group vitamins is essential for optimal body and brain function, and insufficient amounts of such vitamins have been associated with higher levels of neural inflammation and oxidative stress, as marked by increased blood plasma homocysteine. Neural biomarkers of oxidative stress quantified through proton magnetic spectroscopy (1H-MRS) are not well understood, and the relationship between such neural and blood biomarkers is seldom studied. The current study addresses this gap by investigating the direct effect of 6-month high-dose B-group vitamin supplementation on neural and blood biomarkers of metabolism...
December 1, 2018: Nutrients
Tala Al-Rousan, Jeffrey A Sparks, Mary Pettinger, Rowan Chlebowski, JoAnn E Manson, Andrew M Kauntiz, Robert Wallace
IMPORTANCE: Carpal tunnel syndrome (CTS) is a common and debilitating condition that commonly affects postmenopausal women. OBJECTIVE: To determine the effect of menopausal hormone therapy (HT) in healthy postmenopausal women on CTS risk. DESIGN: We conducted a secondary analysis of the Women's Health Initiative's (WHI) HT trials linked to Medicare claims data. Separate intention-to-treat analyses were performed for the two trials; the conjugated equine estrogens alone (CEE alone) and the trial of CEE plus medroxyprogesterone acetate (MPA) trial...
2018: PloS One
Rinaldi Fabio, Marzani Barbara, Pinto Daniela, Sorbellini Elisabetta
Background Alopecia areata (AA) is a non-scarring auto-immune hair disorder. Recent researches explained the role of growth factors (GFs) in hair follicle cycling. The main reservoir of GFs are alpha-granules of platelets and novel procedures have been implemented aimed at collecting platelet-rich plasma (PRP). PRP has been safely implemented in many medical application and has also been successfully used as alternative cell-based therapies for the treatment of hair growth disorder, among which also AA. Objectives By mean of a randomized double-blinded, placebo and active-controlled, parallel group study we have studied the efficacy of a cosmetic product (named TR-M-PRP plus) comprising biomimetic peptides specific for hair growth mimicking PRP composition for the treatment of AA...
December 4, 2018: Journal of Dermatological Treatment
Michael E Mullins, Charles J Gerardo, Sean P Bush, S Rutherfoord Rose, Spencer Greene, Eugenia B Quackenbush, Brandon Lewis, Victoria E Anderson, Kurt C Kleinschmidt, Richard B Schwarz, Nathan P Charlton, Eric A Toschlog, Kapil Sharma, David A Denning, Eric J Lavonas
OBJECTIVE: To compare the incidence of hypersensitivity reactions following copperhead envenomation treated with Fab antivenom (FabAV) or placebo. METHODS: Patients with copperhead snakebites received treatment and follow-up in a prospective, randomized, double-blind, placebo-controlled trial of FabAV or placebo. The treatment allocation ratio was 2:1 (FabAV:placebo). All of the included patients received at least one dose of study treatment. We reviewed all treatment-emergent adverse events (AEs) using a previously published scale to classify likely hypersensitivity reactions as mild, moderate, or severe...
December 2018: Southern Medical Journal
Farhad Azimi, Kathy Flitcroft, Erin Mathieu, Rebecca Karantonis, Kylie Snook, Andrew J Spillane
BACKGROUND: Breast reconstruction with implants can be complicated by symptomatic capsular contracture, especially after radiotherapy. A phase I, nonrandomized clinical trial demonstrated improvement in capsular contracture and avoidance of revision surgery with low-level laser therapy. This phase II, double-blind, randomized controlled trial assessed the efficacy of low-level laser for treating capsular contracture in women with breast reconstruction following mastectomy for breast cancer...
November 2018: Plastic and Reconstructive Surgery
Marc Carrier, Karim Abou-Nassar, Ranjeeta Mallick, Vicky Tagalakis, Sudeep Shivakumar, Ariah Schattner, Philip Kuruvilla, Danny Hill, Silvana Spadafora, Katerine Marquis, Mateya Trinkaus, Anna Tomiak, Agnes Y Y Lee, Peter L Gross, Alejandro Lazo-Langner, Robert El-Maraghi, Glenwood Goss, Gregoire Le Gal, David Stewart, Timothy Ramsay, Marc Rodger, Debra Witham, Philip S Wells
BACKGROUND: Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban (2...
December 4, 2018: New England Journal of Medicine
Bo Yang, Lin Shi, Ai M Wang, Mei Q Shi, Zi H Li, Feng Zhao, Xiao J Guo, Duo Li
Whether n-3 fatty acid (FA) has hypotensive actions among Chinese adults remains inconclusive. Hypertensive patients from Inner Mongolia, China (n=126) were recruited to a double-blind, randomized controlled trial. We investigated the effects of n-3 FA supplements on blood pressure (BP, mm Hg), plasma concentrations of angiotensin II (Ang II, pg/mL) and nitric oxygen (NO, µmol/L), using fish oil (n=41, 4 capsules/day, equivalent to 2 grams of eicosapentaenoic acid plus docosahexaenoic acid) and flaxseed oil (n=42, 4 capsules/day, equivalent to 2...
December 4, 2018: Journal of Agricultural and Food Chemistry
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