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https://www.readbyqxmd.com/read/28228942/effects-of-renal-denervation-on-vascular-remodelling-in-patients-with-heart-failure-and-preserved-ejection-fraction-a-randomised-control-trial
#1
Hitesh C Patel, Carl Hayward, Jennifer Keegan, Peter D Gatehouse, Ronak Rajani, Rajdeep S Khattar, Raad H Mohiaddin, Stuart D Rosen, Alexander R Lyon, Carlo di Mario
OBJECTIVE: To assess the effect of renal denervation (RDT) on micro- and macro-vascular function in patients with heart failure with preserved ejection fraction (HFpEF). DESIGN: A prospective, randomised, open-controlled trial with blinded end-point analysis. SETTING: A single-centre London teaching hospital. PARTICIPANTS: Twenty-five patients with HFpEF who were recruited into the RDT-PEF trial. MAIN OUTCOME MEASURES: Macro-vascular: 24-h ambulatory pulse pressure, aorta distensibilty (from cardiac magnetic resonance imaging (CMR), aorta pulse wave velocity (CMR), augmentation index (peripheral tonometry) and renal artery blood flow indices (renal MR)...
January 2017: JRSM Cardiovascular Disease
https://www.readbyqxmd.com/read/28228578/proof-of-concept-randomized-trial-of-the-monoclonal-antibody-gsk249320-versus-placebo-in-stroke-patients
#2
Steven C Cramer, Lori A Enney, Colleen K Russell, Monica Simeoni, Thomas R Thompson
BACKGROUND AND PURPOSE: One class of poststroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein. The purpose of the current study was to extend preclinical and clinical findings of GSK249320, a humanized monoclonal antibody to myelin-associated glycoprotein with disabled Fc region, to explore effects on motor outcomes post-stroke. METHODS: In this phase IIb double-blind, randomized, placebo-controlled study, patients at 30 centers with ischemic stroke 24 to 72 hours prior and gait deficits were randomized to 2 IV infusions of GSK249320 or placebo...
February 22, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28225185/preventive-effects-of-topical-washing-with-miconazole-nitrate-containing-soap-to-diaper-candidiasis-in-hospitalized-elderly-patients-a-prospective-double-blind-placebo-controlled-study
#3
Hidenori Takahashi, Noritaka Oyama, Izumi Tanaka, Michiko Hasegawa, Kaori Hirano, Chieko Shimada, Minoru Hasegawa
The objective of the present randomized, double-blind trial was to evaluate the efficacy and safety of daily washing with miconazole nitrate-containing soap for candidiasis at diaper-covered sites in elderly subjects under long-term inpatient care. To confirm the onset and disappearance of candidiasis, we microscopically evaluated the existence of the pseudohyphae and/or blastoconidia of Candida spp. We enrolled 75 elderly patients who wore diapers all day in the hospital or nursing home. Patients were randomly assigned to receive treatment with either miconazole soap or miconazole-free placebo soap, and 28 patients in the miconazole group and 27 patients in the placebo group were followed for 4 weeks...
February 22, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28219920/impact-of-coronary-artery-disease-severity-assessed-with-the-syntax-score-on-outcomes-following-transcatheter-aortic-valve-replacement
#4
Jean-Michel Paradis, Jonathon M White, Philippe Généreux, Marina Urena, Darshan Doshi, Tamim Nazif, Rebecca Hahn, Isaac George, Omar Khalique, Kishore Harjai, Laura Lasalle, Benoit M Labbé, Robert DeLarochellière, Daniel Doyle, Éric Dumont, Siamak Mohammadi, Martin B Leon, Josep Rodés-Cabau, Susheel Kodali
BACKGROUND: The influence of coronary artery disease (CAD) on clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) is still controversial. We sought to evaluate the impact of CAD severity as measured by the SYNTAX score (SS) on patients undergoing TAVR. METHODS AND RESULTS: A total of 377 patients who underwent TAVR in 2 high-volume centers in North America were included in our retrospective analysis. A blinded angiographic core laboratory calculated the SS on all available coronary angiograms with the use of quantitative coronary analysis...
February 20, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28219917/isosorbide-dinitrate-with-or-without-hydralazine-does-not-reduce-wave-reflections-left-ventricular-hypertrophy-or-myocardial-fibrosis-in-patients-with-heart-failure-with-preserved-ejection-fraction
#5
Payman Zamani, Scott Akers, Haideliza Soto-Calderon, Melissa Beraun, Maheswara R Koppula, Swapna Varakantam, Deepa Rawat, Prithvi Shiva-Kumar, Philip G Haines, Jesse Chittams, Raymond R Townsend, Walter R Witschey, Patrick Segers, Julio A Chirinos
BACKGROUND: Wave reflections, which are increased in patients with heart failure with preserved ejection fraction, impair diastolic function and promote pathologic myocardial remodeling. Organic nitrates reduce wave reflections acutely, but whether this is sustained chronically or affected by hydralazine coadministration is unknown. METHODS AND RESULTS: We randomized 44 patients with heart failure with preserved ejection fraction in a double-blinded fashion to isosorbide dinitrate (ISDN; n=13), ISDN+hydralazine (ISDN+hydral; n=15), or placebo (n=16) for 6 months...
February 20, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28215815/influence-of-tramadol-on-acute-thermal-and-mechanical-cutaneous-nociception-in-dogs
#6
Alexandra F Schütter, Julia Tünsmeyer, Sabine B R Kästner
OBJECTIVE: The aim of the study was to evaluate the influence of tramadol on acute nociception in dogs. STUDY DESIGN: Experimental, blinded, randomized, crossover study. ANIMALS: Six healthy laboratory Beagle dogs. METHODS: Dogs received three treatments intravenously (IV): isotonic saline placebo (P), tramadol 1 mg kg(-1) (T1) and tramadol 4 mg kg(-1) (T4). Thermal thresholds were determined by ramped contact heat stimulation (0...
January 7, 2017: Veterinary Anaesthesia and Analgesia
https://www.readbyqxmd.com/read/28215471/dopamine-serotonin-stabilizer-rp5063-a-randomized-double-blind-placebo-controlled-multicenter-trial-of-safety-and-efficacy-in-exacerbation-of-schizophrenia-or-schizoaffective-disorder
#7
Marc Cantillon, Arul Prakash, Ajay Alexander, Robert Ings, Dennis Sweitzer, Laxminarayan Bhat
The study objectives were to evaluate the efficacy, safety, tolerability, and pharmacokinetics of RP5063 versus placebo. The study was conducted in adults with acute exacerbation of schizophrenia or schizoaffective disorder. This 28-day, multicenter, placebo-controlled, double-blind study randomized 234 subjects to RP5063 15, 30, or 50mg; aripiprazole; or placebo (3:3:3:1:2) once daily. The aripiprazole arm was included solely to show assay sensitivity and was not powered to show efficacy. The primary endpoint was change from baseline to Day 28/EOT (End-of-Treatment) in Positive and Negative Syndrome Scale (PANSS) total score; secondary endpoints included PANSS subscales, improvement ≥1 point on the Clinical Global Impressions-Severity (CGI-S), depression and cognition scales...
February 16, 2017: Schizophrenia Research
https://www.readbyqxmd.com/read/28214091/multidonor-intensive-faecal-microbiota-transplantation-for-active-ulcerative-colitis-a-randomised-placebo-controlled-trial
#8
Sudarshan Paramsothy, Michael A Kamm, Nadeem O Kaakoush, Alissa J Walsh, Johan van den Bogaerde, Douglas Samuel, Rupert W L Leong, Susan Connor, Watson Ng, Ramesh Paramsothy, Wei Xuan, Enmoore Lin, Hazel M Mitchell, Thomas J Borody
BACKGROUND: The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis. METHODS: We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia...
February 14, 2017: Lancet
https://www.readbyqxmd.com/read/28213593/randomised-double-blind-parallel-group-placebo-controlled-study-to-evaluate-the-analgesic-efficacy-and-safety-of-vvz-149-injections-for-postoperative-pain-following-laparoscopic-colorectal-surgery
#9
Srdjan S Nedeljkovic, Darin J Correll, Xiaodong Bao, Natacha Zamor, Jose L Zeballos, Yi Zhang, Mark J Young, Johanna Ledley, Jessica Sorace, Kristen Eng, Carlyle P Hamsher, Rajivan Maniam, Jonathan W Chin, Becky Tsui, Sunyoung Cho, Doo H Lee
INTRODUCTION: In spite of advances in understanding and technology, postoperative pain remains poorly treated for a significant number of patients. In colorectal surgery, the need for developing novel analgesics is especially important. Patients after bowel surgery are assessed for rapid return of bowel function and opioids worsen ileus, nausea and constipation. We describe a prospective, double-blind, parallel group, placebo-controlled randomised controlled trial testing the hypothesis that a novel analgesic drug, VVZ -149, is safe and effective in improving pain compared with providing opioid analgesia alone among adults undergoing laparoscopic colorectal surgery...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28203561/comparative-prospective-case-control-study-of-open-versus-laparoscopic-pyeloplasty-in-children-with-ureteropelvic-junction-obstruction-long-term-results
#10
Lisandro A Piaggio, Juan P Corbetta, Santiago Weller, Ricardo Augusto Dingevan, Víctor Duran, Javier Ruiz, Juan C Lopez
INTRODUCTION: We compare open pyeloplasty (OP) versus laparoscopic pyeloplasty (LP) in children in a multicenter, prospective, case-control study. MATERIALS AND METHODS: From May 2007 to March 2009, a program was established at Hospital Garrahan, the reference center, to perform LP with a mentoring surgeon that would attend the institution once a month. Every new case of ureteropelvic junction obstruction (UPJO) diagnosed in the reference institution was offered to participate in the study...
2017: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/28202358/a-prospective-multicenter-double-blind-randomized-trial-of-bladder-instillation-of-liposome-formulation-onabotulinumtoxina-for-interstitial-cystitis-bladder-pain-syndrome
#11
Yao-Chi Chuang, Hann-Chorng Kuo
BACKGROUND: Intravesical instillation of liposomal-formulated botulinum toxin A (lipotoxin) has shown therapeutic effects on treatment of refractory overactive bladder without needle injections. We hereby assessed lipotoxin for the treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: This two-center, double-blind, randomized, placebo-controlled physician-initiated study enrolled patients with refractory IC/BPS. The patients were assigned to intravesical instillation of lipotoxin (onabotulinumtoxinA 200 U with 80mg sphingomyelin) (n=31), onabotulinumtoxinA 200 U in normal saline (n=28), or normal saline alone (n=31)...
February 12, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28199814/baricitinib-versus-placebo-or-adalimumab-in-rheumatoid-arthritis
#12
RANDOMIZED CONTROLLED TRIAL
Peter C Taylor, Edward C Keystone, Désirée van der Heijde, Michael E Weinblatt, Liliana Del Carmen Morales, Jaime Reyes Gonzaga, Sergey Yakushin, Taeko Ishii, Kahaku Emoto, Scott Beattie, Vipin Arora, Carol Gaich, Terence Rooney, Douglas Schlichting, William L Macias, Stephanie de Bono, Yoshiya Tanaka
Background Baricitinib is an oral, reversible inhibitor of the Janus kinases JAK1 and JAK2 that may have therapeutic value in patients with rheumatoid arthritis. Methods We conducted a 52-week, phase 3, double-blind, placebo- and active-controlled trial in which 1307 patients with active rheumatoid arthritis who were receiving background therapy with methotrexate were randomly assigned to one of three regimens in a 3:3:2 ratio: placebo (switched to baricitinib after 24 weeks), 4 mg of baricitinib once daily, or 40 mg of adalimumab (an anti-tumor necrosis factor α monoclonal antibody) every other week...
16, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28198590/effect-of-therapeutic-and-supratherapeutic-doses-of-vonoprazan-on-the-qt-qtc-interval-in-a-phase-i-randomized-study-in-healthy-subjects
#13
B Astruc, H Jenkins, R Jenkins
This phase I, randomized, 4-period, 4-sequence, double-blind, active- and placebo-controlled, crossover study assessed the effects of vonoprazan on the QT/QTc interval in healthy subjects. Subjects received single oral doses of vonoprazan 40 mg, vonoprazan 120 mg, moxifloxacin 400 mg (positive control/open label), and placebo. The primary end point was time-matched, placebo-corrected, baseline-adjusted mean Fridericia-corrected QT interval (ddQTcF). Of 64 subjects (mean age, 37.8 years; 50% male), 63 received all four regimens...
February 15, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28197000/impact-of-an-educational-module-in-antidepressant-naive-patients-prescribed-antidepressants-for-depression-pilot-proof-of-concept-randomized-controlled-trial
#14
Annie P John, Nagendra Madan Singh, Nagarajaiah, Chittaranjan Andrade
BACKGROUND: Patients are educated about their illness and its treatment at the time of diagnosis. However, little is known about how much of this education is retained and how it influences knowledge about, attitudes toward, and experiences with medication in antidepressant-naive patients with depression. METHODS: Antidepressant-naive outpatients with International Classification of Diseases-10 dysthymia or mild to moderate depression, who were advised antidepressant monotherapy, were randomized to control (n = 22) or intervention (n = 17) groups...
October 2016: Indian Journal of Psychiatry
https://www.readbyqxmd.com/read/28190468/curcuma-aeruginosa-roxb-essential-oil-slows-hair-growth-and-lightens-skin-in-axillae-a-randomised-double-blinded-trial
#15
Jukkarin Srivilai, Preeyawass Phimnuan, Jiraporn Jaisabai, Nantakarn Luangtoomma, Neti Waranuch, Nantaka Khorana, Wudtichai Wisuitiprot, C Norman Scholfield, Katechan Champachaisri, Kornkanok Ingkaninan
BACKGROUND: Androgenic hair-growth contributes to secondary gender characteristics but can be troublesome in women. Inhibiting axillary hair-growth via 5-α-reductases using the Thai medicinal plant, Curcuma aeruginosa Roxb. is an attractive treatment strategy. HYPOTHESIS/PURPOSE: C. aeruginosa essential oil (CA-oil) formulated as a lotion is an efficacious and safe inhibitor of axillary hair growth. STUDY DESIGN: This trial was a single center, randomized, double-blind, placebo controlled 10 weeks, intervention in 60 women (18-23 years) and 2 weeks washout with axillary hair length was the primary end-point...
February 15, 2017: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
https://www.readbyqxmd.com/read/28188240/lixisenatide-therapy-in-older-patients-with-type-2-diabetes-inadequately-controlled-on-their-current-antidiabetic-treatment-the-getgoal-o-randomized-trial
#16
Graydon S Meneilly, Christine Roy-Duval, Hasan Alawi, George Dailey, Diego Bellido, Carlos Trescoli, Helard Manrique Hurtado, Hailing Guo, Valerie Pilorget, Riccardo Perfetti, Hamish Simpson
OBJECTIVE: To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODS: In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks...
February 10, 2017: Diabetes Care
https://www.readbyqxmd.com/read/28185672/cariprazine-versus-risperidone-monotherapy-for-treatment-of-predominant-negative-symptoms-in-patients-with-schizophrenia-a-randomised-double-blind-controlled-trial
#17
György Németh, István Laszlovszky, Pál Czobor, Erzsébet Szalai, Balázs Szatmári, Judit Harsányi, Ágota Barabássy, Marc Debelle, Suresh Durgam, István Bitter, Stephen Marder, W Wolfgang Fleischhacker
BACKGROUND: Although predominant negative symptoms of schizophrenia can be severe enough to cause persistent impairment, effective treatment options are lacking. We aimed to assess the new generation antipsychotic cariprazine in adult patients with predominant negative symptoms. METHODS: In this randomised, double-blind, phase 3b trial, we enrolled adults aged 18-65 years with long-term (>2 year), stable schizophrenia and predominant negative symptoms (>6 months) at 66 study centres (mainly hospitals and university clinics, with a small number of private practices) in 11 European countries...
February 6, 2017: Lancet
https://www.readbyqxmd.com/read/28185643/oral-triiodothyronine-for-infants-and-children-undergoing-cardiopulmonary-bypass
#18
Eva M Marwali, Cindy E Boom, Novik Budiwardhana, Dicky Fakhri, Poppy S Roebiono, Anwar Santoso, Sudigdo Sastroasmoro, April Slee, Michael A Portman
BACKGROUND: This study evaluated the efficacy and safety of oral triiodothyronine (T3; Tetronine, Dalim BioTech, Korea) for infants and children undergoing cardiopulmonary bypass in an Indonesian population. METHODS: We performed a single-center, randomized, double-blind, and placebo-controlled trial in children aged 3 years and younger undergoing congenital heart disease operations with cardiopulmonary bypass. We administered oral T3 (1 μg/kg per body weight/dose) or placebo (saccharum lactis) by nasogastric tube every 6 hours for 60 hours after induction of anesthesia...
February 6, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/28161119/monthly-oral-ibandronate-reduces-bone-loss-in-korean-women-with-rheumatoid-arthritis-and-osteopenia-receiving-long-term-glucocorticoids-a-48-week-double-blinded-randomized-placebo-controlled-investigator-initiated-trial
#19
Kichul Shin, Sung-Hwan Park, Won Park, Han Joo Baek, Yun Jong Lee, Seong Wook Kang, Jung-Yoon Choe, Wan-Hee Yoo, Yong-Beom Park, Jung-Soo Song, Seung-Geun Lee, Bin Yoo, Dae-Hyun Yoo, Yeong Wook Song
PURPOSE: Our aim was to investigate the efficacy of monthly oral ibandronate in Korean women with rheumatoid arthritis and reduced bone mineral density (BMD) receiving long-term glucocorticoids. METHODS: Patients (n = 167 women) were randomly assigned (1:1) to receive ibandronate 150 mg or placebo every 4 weeks. Patients had taken glucocorticoid (equivalent of daily prednisolone ≥5 mg) for 3 or more consecutive months before enrollment, and had a lumbar spine 1 to 4 (L1-L4) T-score of < -1...
February 1, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28161079/effect-of-single-treatment-surface-cooled-radiofrequency-therapy-on-vaginal-laxity-and-female-sexual-function-the-viveve-i-randomized-controlled-trial
#20
Michael Krychman, Christopher G Rowan, Bruce B Allan, Leonard DeRogatis, Scott Durbin, Ashley Yacoubian, Deborah Wilkerson
INTRODUCTION: Vaginal laxity is a highly prevalent and undertreated medical condition. AIM: To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial. METHODS: The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained...
February 2017: Journal of Sexual Medicine
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