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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/29045341/effect-of-antihypertensive-treatment-on-24-h-blood-pressure-variability-pooled-individual-data-analysis-of-ambulatory-blood-pressure-monitoring-studies-based-on-olmesartan-mono-or-combination-treatment
#1
Stefano Omboni, Kazuomi Kario, George Bakris, Gianfranco Parati
OBJECTIVE: To evaluate the impact of olmesartan alone or combined with one to three antihypertensive drugs on 24-h blood pressure variability (BPV) and on distribution of BP reduction in a pooled individual data analysis of 10 double-blind, randomized, ambulatory BP monitoring (ABPM) studies. METHODS: ABPMs were performed before and after 6-12 weeks of treatment with placebo (n = 119), active control monotherapy [n = 1195, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), dihydropyridine calcium channel blockers (DCCBs)], or DCCBs), olmesartan monotherapy (n = 1410), active control dual combination [n = 79, DCCB + thiazide diuretic (TD)], olmesartan dual combination (n = 637, DCCB or TD), and triple combination therapy (n = 102, DCCB+TD)...
October 16, 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/29045212/tofacitinib-or-adalimumab-versus-placebo-for-psoriatic-arthritis
#2
Philip Mease, Stephen Hall, Oliver FitzGerald, Désirée van der Heijde, Joseph F Merola, Francisco Avila-Zapata, Dorota Cieślak, Daniela Graham, Cunshan Wang, Sujatha Menon, Thijs Hendrikx, Keith S Kanik
BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who previously had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs). METHODS: In this 12-month, double-blind, active-controlled and placebo-controlled, phase 3 trial, we randomly assigned patients in a 2:2:2:1:1 ratio to receive one of the following regimens: tofacitinib at a 5-mg dose taken orally twice daily (107 patients), tofacitinib at a 10-mg dose taken orally twice daily (104), adalimumab at a 40-mg dose administered subcutaneously once every 2 weeks (106), placebo with a blinded switch to the 5-mg tofacitinib dose at 3 months (52), or placebo with a blinded switch to the 10-mg tofacitinib dose at 3 months (53)...
October 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29045207/tofacitinib-for-psoriatic-arthritis-in-patients-with-an-inadequate-response-to-tnf-inhibitors
#3
Dafna Gladman, William Rigby, Valderilio F Azevedo, Frank Behrens, Ricardo Blanco, Andrzej Kaszuba, Elizabeth Kudlacz, Cunshan Wang, Sujatha Menon, Thijs Hendrikx, Keith S Kanik
BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who had previously had an inadequate response to tumor necrosis factor (TNF) inhibitors. METHODS: In this 6-month randomized, placebo-controlled, double-blind, phase 3 trial, we randomly assigned 395 patients, in a 2:2:1:1 ratio, to four regimens: 5 mg of tofacitinib administered orally twice daily (132 patients); 10 mg of tofacitinib twice daily (132 patients); placebo, with a switch to 5 mg of tofacitinib twice daily at 3 months (66 patients); or placebo, with a switch to 10 mg of tofacitinib twice daily at 3 months (65 patients)...
October 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/29044707/the-effect-of-vitamin-d-supplementation-on-bone-metabolic-markers-in-chronic-kidney-disease
#4
Ashok Kumar Yadav, Vivek Kumar, Vinod Kumar, Debasish Banerjee, Krishan Lal Gupta, Vivekanand Jha
Use of active forms of vitamin D is advocated in CKD patients for treatment of mineral bone disease because of the presumption that native forms of vitamin D would not undergo significant activation to calcitriol, the most active biological form of vitamin D. We present secondary analysis looking at bone turnover in subjects who completed the randomized, double blind, placebo controlled trial investigating the effect of cholecalciferol supplementation on vascular function in non-diabetic CKD stage G3-4 and vitamin D ≤20ng/ml [CTRI/2013/05/003648]...
October 17, 2017: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/29043702/n-acetylcysteine-compared-to-metformin-improves-the-expression-profile-of-growth-differentiation-factor-9-and-receptor-tyrosine-kinase-c-kit-in-the-oocytes-of-patients-with-polycystic-ovarian-syndrome
#5
Ebrahim Cheraghi, Malek Soleimani Mehranjani, Seyed Mohammad Ali Shariatzadeh, Mohammad Hossein Nasr Esfahani, Behrang Alani
Background: Paracrine disruption of growth factors in women with polycystic ovarian syndrome (PCOS) results in production of low quality oocyte, especially following ovulation induction. The aim of this study was to investigate the effects of metformin (MET), N-acetylcysteine (NAC) and their combination on the hormonal levels and expression profile of GDF-9, BMP-15 and c-kit, as hallmarks of oocyte quality, in PCOS patients. MATERIALS AND METHODS: This prospective randomized, double-blind, placebo controlled trial aims to study the effects of MET, NAC and their combination (MET+NAC) on expression of GDF-9, BMP-15 and c-kit mRNA in oocytes [10 at the germinal vesicle (GV) stage, 10 at the MI stage, and 10 at the MII stage from per group] derived following ovulation induction in PCOS...
January 2018: International Journal of Fertility & Sterility
https://www.readbyqxmd.com/read/29043014/an-open-label-study-to-evaluate-the-long-term-safety-and-efficacy-of-lanadelumab-for-prevention-of-attacks-in-hereditary-angioedema-design-of-the-help-study-extension
#6
Marc A Riedl, Jonathan A Bernstein, Timothy Craig, Aleena Banerji, Markus Magerl, Marco Cicardi, Hilary J Longhurst, Mustafa M Shennak, William H Yang, Jennifer Schranz, Jovanna Baptista, Paula J Busse
BACKGROUND: Hereditary angioedema (HAE) is characterized by recurrent attacks of subcutaneous or submucosal edema. Attacks are unpredictable, debilitating, and have a significant impact on quality of life. Patients may be prescribed prophylactic therapy to prevent angioedema attacks. Current prophylactic treatments may be difficult to administer (i.e., intravenously), require frequent administrations or are not well tolerated, and breakthrough attacks may still occur frequently. Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks...
2017: Clinical and Translational Allergy
https://www.readbyqxmd.com/read/29042835/double-blind-randomized-placebo-controlled-trial-of-single-dose-intravenous-acetaminophen-for-pain-associated-with-adenotonsillectomy-in-pediatric-patients-with-sleep-disordered-breathing
#7
Arlyne K Thung, Charles A Elmaraghy, N'Diris Barry, Dmitry Tumin, Kris R Jatana, Julie Rice, Vidya Raman, Tarun Bhalla, David P Martin, Marco Corridore, Joseph D Tobias
OBJECTIVES: Adequate pain control is an important component in the postoperative outcome for pediatric adenotonsillectomy patients with sleep-disordered breathing (SDB). Intravenous acetaminophen appears to be a favorable analgesic adjunct owing to its predictable pharmacokinetics and opioid-sparing effects; however, its role in pediatric adenotonsillectomy pain management remains unclear. METHODS: In this prospective, randomized, double-blinded, controlled study, subjects with the diagnosis of SDB, aged 2 to 8 years, who required extended postoperative admission, received intravenous acetaminophen (15 mg/kg) or saline placebo intraoperatively in addition to morphine (0...
September 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/29042806/feeding-filaggrin-effects-of-l-histidine-supplementation-in-atopic-dermatitis
#8
Siao Pei Tan, Simon B Brown, Christopher Em Griffiths, Richard B Weller, Neil K Gibbs
Atopic dermatitis (AD), also known as eczema, is one of the most common chronic skin conditions worldwide, affecting up to 16% of children and 10% of adults. It is incurable and has significant psychosocial and economic impacts on the affected individuals. AD etiology has been linked to deficiencies in the skin barrier protein, filaggrin. In mammalian skin, l-histidine is rapidly incorporated into filaggrin. Subsequent filaggrin proteolysis releases l-histidine as an important natural moisturizing factor (NMF)...
2017: Clinical, Cosmetic and Investigational Dermatology
https://www.readbyqxmd.com/read/29042788/decreased-frequency-of-adenoidectomy-by-a-12-week-nasal-budesonide-treatment
#9
Haiyu Hong, Fenghong Chen, Xiaobin Zheng, Wei Liao, Zhenpeng Liao, Yujie Cao, Haixin He, Zhe Zhu, Yunping Fan
OBJECTIVE: There is little evidence on the role of topical budesonide in reducing the frequency of adenoidectomy, although it was reported that topical budesonide can effectively ameliorate the symptoms of adenoid hypertrophy (AH). This study was aimed to investigate the possibility and safety of alternatives to adenoidectomy with a 12-week treatment with nasal budesonide. MATERIALS AND METHODS: One hundred patients with AH were randomized to receive either a double-blind budesonide (1 mg once daily) or placebo treatment for 2 weeks by transnasal nebulization...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/29042645/effects-of-intranasal-insulin-application-on-the-hypothalamic-bold-response-to-glucose-ingestion
#10
Anna M van Opstal, Abimbola A Akintola, Marjan van der Elst, Rudi G Westendorp, Hanno Pijl, Diana van Heemst, Jeroen van der Grond
The hypothalamus is a crucial structure in the brain that responds to metabolic cues and regulates energy homeostasis. Patients with type 2 diabetes demonstrate a lack of hypothalamic neuronal response after glucose ingestion, which is suggested to be an underlying cause of the disease. In this study, we assessed whether intranasal insulin can be used to enhance neuronal hypothalamic responses to glucose ingestion. In a randomized, double-blinded, placebo-controlled 4-double cross-over experiment, hypothalamic activation was measured in young non- diabetic subjects by determining blood-oxygen-level dependent MRI signals over 30 minutes before and after ingestion of 75 g glucose dissolved in 300 ml water, under intranasal insulin or placebo condition...
October 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29041942/patient-reported-health-related-quality-of-life-work-productivity-and-activity-impairment-during-treatment-with-alo-02-extended-release-oxycodone-and-sequestered-naltrexone-for-moderate-to-severe-chronic-low-back-pain
#11
Arnold J Weil, Elizabeth T Masters, Alexandra I Barsdorf, Almasa Bass, Glenn Pixton, Jacquelyn G Wilson, Gernot Wolfram
BACKGROUND: The efficacy of ALO-02, an abuse-deterrent formulation containing extended-release oxycodone and sequestered naltrexone, in the treatment of chronic low back pain (CLBP) was studied in a 12-week randomized controlled trial. Primary efficacy endpoint results have been published previously (Rauck et al., 2015). The current paper focuses on patient-reported outcomes for health-related quality of life (HRQL), work productivity, and activity impairment that were assessed during this study...
October 17, 2017: Health and Quality of Life Outcomes
https://www.readbyqxmd.com/read/29040598/effect-of-metformin-on-vascular-function-in-children-with-type-1-diabetes-a-12-month-randomized-controlled-trial
#12
Jemma J A Anderson, Jennifer J Couper, Lynne C Giles, Catherine E Leggett, Roger Gent, Brian Coppin, Alexia S Peña
Context: Children with type 1 diabetes have vascular dysfunction preceding atherosclerosis. Early interventions are needed to reduce cardiovascular disease. Objective: To evaluate the effect of metformin on vascular function in type 1 diabetes children. Design: 12 month double blind, randomized, placebo-controlled trial. Setting: Tertiary pediatric diabetes clinic. Participants: 90 type 1 diabetes children(8-18 years), above 50th percentile body mass index (BMI)...
October 9, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29040525/beta-blockers-for-heart-failure-with-reduced-mid-range-and-preserved-ejection-fraction-an-individual-patient-level-analysis-of-double-blind-randomized-trials
#13
John G F Cleland, Karina V Bunting, Marcus D Flather, Douglas G Altman, Jane Holmes, Andrew J S Coats, Luis Manzano, John J V McMurray, Frank Ruschitzka, Dirk J van Veldhuisen, Thomas G von Lueder, Michael Böhm, Bert Andersson, John Kjekshus, Milton Packer, Alan S Rigby, Giuseppe Rosano, Hans Wedel, Åke Hjalmarson, John Wikstrand, Dipak Kotecha
Aims: Recent guidelines recommend that patients with heart failure and left ventricular ejection fraction (LVEF) 40-49% should be managed similar to LVEF ≥ 50%. We investigated the effect of beta-blockers according to LVEF in double-blind, randomized, placebo-controlled trials. Methods and results: Individual patient data meta-analysis of 11 trials, stratified by baseline LVEF and heart rhythm (Clinicaltrials.gov: NCT0083244; PROSPERO: CRD42014010012). Primary outcomes were all-cause mortality and cardiovascular death over 1...
October 10, 2017: European Heart Journal
https://www.readbyqxmd.com/read/29038901/pre-peritoneal-local-anaesthetic-does-not-reduce-post-operative-pain-in-laparoscopic-total-extra-peritoneal-inguinal-hernia-repair-double-blinded-randomized-controlled-trial
#14
S Kulasegaran, M Rohan, L Pearless, M Hulme-Moir
PURPOSE: Laparoscopic total extra-peritoneal hernia repair (TEP) is associated with less post-operative pain and earlier return to normal activity compared to open hernia repair (OHP). Despite this, post-operative pain remains a major issue. The aim of this double-blinded randomized controlled trial was to identify whether the instillation of local anaesthetic in the pre-peritoneal space improves pain scores following TEP. METHODS: One hundred patients undergoing laparoscopic total pre-peritoneal hernia repair (TEP) between the years of 2009-2014 were included...
October 16, 2017: Hernia: the Journal of Hernias and Abdominal Wall Surgery
https://www.readbyqxmd.com/read/29038286/allogeneic-mesenchymal-stem-cells-for-treatment-of-aki-after-cardiac-surgery
#15
Madhav Swaminathan, Mark Stafford-Smith, Glenn M Chertow, David G Warnock, Viken Paragamian, Robert M Brenner, François Lellouche, Alison Fox-Robichaud, Mohamed G Atta, Spencer Melby, Ravindra L Mehta, Ron Wald, Subodh Verma, C David Mazer
AKI after cardiac surgery remains strongly associated with mortality and lacks effective treatment or prevention. Preclinical studies suggest that cell-based interventions may influence functional recovery. We conducted a phase 2, randomized, double-blind, placebo-controlled trial in 27 centers across North America to determine the safety and efficacy of allogeneic human mesenchymal stem cells (MSCs) in reducing the time to recovery from AKI after cardiac surgery. We randomized 156 adult subjects undergoing cardiac surgery with evidence of early AKI to receive intra-aortic MSCs (AC607; n=67) or placebo (n=68)...
October 16, 2017: Journal of the American Society of Nephrology: JASN
https://www.readbyqxmd.com/read/29038236/efficacy-of-prophylactic-treatment-for-oxycodone-induced-nausea-and-vomiting-among-patients-with-cancer-pain-point-a-randomized-placebo-controlled-double-blind-trial
#16
Hiroaki Tsukuura, Masayuki Miyazaki, Tatsuya Morita, Mihoko Sugishita, Hiroshi Kato, Yuka Murasaki, Bishal Gyawali, Yoko Kubo, Masahiko Ando, Masashi Kondo, Kiyofumi Yamada, Yoshinori Hasegawa, Yuichi Ando
BACKGROUND: Although opioid-induced nausea and vomiting (OINV) often result in analgesic undertreatment in patients with cancer, no randomized controlled trials have evaluated the efficacy of prophylactic antiemetics for preventing OINV. We conducted this randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of prophylactic treatment with prochlorperazine for preventing OINV. MATERIALS AND METHODS: Cancer patients who started to receive oral oxycodone were randomly assigned in a 1:1 ratio to receive either prochlorperazine 5 mg or placebo prophylactically, given three times daily for 5 days...
October 16, 2017: Oncologist
https://www.readbyqxmd.com/read/29038234/patient-reported-symptom-control-of-diarrhea-and-flushing-in-patients-with-neuroendocrine-tumors-treated-with-lanreotide-depot-autogel-results-from-a-randomized-placebo-controlled-double-blind-and-32-week-open-label-study
#17
George A Fisher, Edward M Wolin, Nilani Liyanage, Susan Pitman Lowenthal, Beloo Mirakhur, Rodney F Pommier, Montaser Shaheen, Aaron Vinik
BACKGROUND: In the double-blind (DB) ELECT study, lanreotide depot/autogel significantly reduced versus placebo the need for short-acting octreotide for symptomatic carcinoid syndrome (CS) control in neuroendocrine tumor (NET) patients. Here we present patient-reported symptom data during DB and initial open-label (IOL) treatment. MATERIALS AND METHODS: Adults with NETs and CS history, with/without prior somatostatin analog use, were randomized to 16 weeks' DB lanreotide 120 mg subcutaneous or placebo every 4 weeks, followed by 32 weeks' IOL lanreotide...
October 16, 2017: Oncologist
https://www.readbyqxmd.com/read/29037773/use-of-n-acetylcysteine-plus-simethicone-to-improve-the-mucosal-visibility-during-upper-gi-endoscopy-a-double-blind-randomized-controlled-trial
#18
Hugo Monrroy, Jose Ignacio Vargas, Esteban Glasinovic, Roberto Candia, Emilio Azúa, Camila Gálvez, Camila Rojas, Natalia Cabrera, Josefa Vidaurre, Natalia Álvarez, Jessica González, Alberto Espino, Robinson González, Adolfo Parra-Blanco
BACKGROUND AND AIM: Upper GI endoscopy (UGE) is essential for diagnosis of gastrointestinal diseases. Mucus and bubbles may decrease mucosal visibility. The use of mucolytics could improve visualization. Our aim was to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine is effective improving visibility during UGE. METHODS: This was a randomized, double-blinded, placebo-controlled trial with 2 control groups: no intervention (NI) and water 100 mL (W); and 3 intervention groups: simethicone 200 mg (S); S+NAC 500 mg (S+NAC500); and S+NAC 1000 mg (S+NAC1000)...
October 13, 2017: Gastrointestinal Endoscopy
https://www.readbyqxmd.com/read/29037645/postural-insoles-on-gait-in-children-with-cerebral-palsy-randomized-controlled-double-blind-clinical-trial
#19
Hugo Pasin Neto, Luanda André Collange Grecco, Luis Alfredo Braun Ferreira, Natália Almeida Carvalho Duarte, Manuela Galli, Claudia Santos Oliveira
The aim of the present study was to assess the effect of postural insoles on gait performance in children with Cerebral Palsy (CP). Twenty four children between four and 12 years of age were randomly allocated either the control group (n = 12) or experimental group (n = 12). The control group used placebo insoles and the experimental group used postural insoles. Three-dimensional gait analysis was performed under three conditions: barefoot, in shoes and in shoes with insoles. Three evaluations were carried out: 1)immediately following placement of the insoles; 2)after three months of insole use; and 3)one month after suspending insole use...
October 2017: Journal of Bodywork and Movement Therapies
https://www.readbyqxmd.com/read/29037578/a-phase-i-safety-and-immunogenicity-dose-escalation-trial-of-plague-vaccine-flagellin-f1-v-in-healthy-adult-volunteers-dmid-08-0066
#20
Sharon E Frey, Kathleen Lottenbach, Irene Graham, Edwin Anderson, Kanwaldeep Bajwa, Ryan C May, Steven B Mizel, Aaron Graff, Robert B Belshe
INTRODUCTION: Intentional aerosolization of Yersinia pestis may result in pneumonic plague which is highly fatal if not treated early. METHODS: We conducted a phase 1 randomized, double blind (within each group), placebo controlled, dose escalation trial to evaluate a plague vaccine, Flagellin/F1/V, in healthy adults aged 8 through 45years. Vaccine was administered intramuscularly on Days 0 and 28 at a dose of 1, 3, 6 or 10mcg. Subjects were observed for 4h after vaccination for cytokine release syndrome...
October 13, 2017: Vaccine
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