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Randomized placebo controlled double blind

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https://www.readbyqxmd.com/read/29684661/effects-of-vitamin-d-supplementation-on-adherence-to-and-persistence-with-long-term-statin-therapy-secondary-analysis-from-the-randomized-double-blind-placebo-controlled-vida-study
#1
Zhenqiang Wu, Carlos A Camargo, Kay-Tee Khaw, Debbie Waayer, Carlene M M Lawes, Les Toop, Robert Scragg
BACKGROUND AND AIMS: Long-term statin use increases survival. However, the adherence to and persistence with statin use are challenging and this influences the success of statin treatment. Our aim was to explore if monthly vitamin D supplementation (100,000-IU) improves the adherence to and persistence with long-term statin use in older adults. METHODS: We conducted a secondary analysis of a trial comparing data on dispensed statin prescriptions, between participants allocated to vitamin D supplementation or placebo, for those taking statin therapy...
April 7, 2018: Atherosclerosis
https://www.readbyqxmd.com/read/29684633/efficacy-of-a-carrageenan-gel-against-transmission-of-cervical-hpv-catch-interim-analysis-of-a-randomized-double-blind-placebo-controlled-phase-2b-trial
#2
Sindy Magnan, Joseph E Tota, Mariam El-Zein, Ann N Burchell, John T Schiller, Alex Ferenczy, Pierre-Paul Tellier, François Coutlée, Eduardo L Franco
OBJECTIVE: We evaluated the efficacy of a carrageenan-based lubricant gel in reducing the risk of genital human papillomavirus (HPV) infections in women. METHODS: We conducted a planned interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial. Women aged 18 years and older were randomly assigned (1:1) to a carrageenan-based or a placebo gel to be self-applied every other day for the first month and prior to and following each intercourse during follow-up...
April 20, 2018: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29683755/n-acetylcysteine-decreases-urinary-level-of-neutrophil-gelatinase-associated-lipocalin-in-deceased-donor-renal-transplant-recipients-a-randomized-clinical-trial
#3
Atieh Modarresi, Mohsen Nafar, Zahra Sahraei, Jamshid Salamzadeh, Samira Chaibakhsh, Shadi Ziaie, Mahmoud Parvin, Yunes Panahi, Behzad Einollahi
CONTEXT: Acute kidney injury (AKI) is a common complication after kidney transplantation (KT), especially in recipients from deceased donors. Urinary neutrophil gelatinase-associated lipocalin (u-NGAL) is an early and sensitive marker of AKI after transplantation. OBJECTIVES: We assessed the renoprotective effect of N-acetylcysteine (NAC) on u-NGAL levels as an early prognostic marker of graft function immediately after transplantation. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled trial was conducted on 70 deceased-donor KT recipients ( www...
April 23, 2018: Biomarkers: Biochemical Indicators of Exposure, Response, and Susceptibility to Chemicals
https://www.readbyqxmd.com/read/29682995/efficacy-and-safety-of-the-combination-of-isosorbide-dinitrate-spray-and-chitosan-gel-for-the-treatment-of-diabetic-foot-ulcers-a-double-blind-randomized-clinical-trial
#4
Sylvia Elena Totsuka Sutto, Yunuen Itzet Rodríguez Roldan, Ernesto German Cardona Muñoz, Teresa Arcelia Garcia Cobian, Sara Pascoe Gonzalez, Abril Martínez Rizo, Miriam Mendez Del Villar, Leonel García Benavides
AIM: To evaluate whether a combination of isosorbide dinitrate spray and chitosan gel (10%) topically applied can have additive benefits for management of diabetic foot ulcers. METHODS: In a randomized, placebo-controlled, double-blinded clinical trial, 68 patients were divided into four groups: Group 1: treated with chitosan gel; Group 2: isosorbide dinitrate spray; Group 3: combination of isosorbide dinitrate spray and chitosan gel; Group 4: placebo. RESULTS: Histological analyses showed a significant regeneration in all groups ( p < 0...
April 1, 2018: Diabetes & Vascular Disease Research
https://www.readbyqxmd.com/read/29682796/phase-2a-randomized-double-blind-placebo-controlled-multicenter-parallel-group-study-of-an-h-4-r-antagonist-jnj-39758979-in-adults-with-uncontrolled-asthma
#5
Alexa P Kollmeier, Andrew Greenspan, Xie L Xu, Philip E Silkoff, Elliot Barnathan, Matthew J Loza, Jingzhi Jiang, Bei Zhou, Bin Chen, Robin L Thurmond
BACKGROUND: The effects of H4 R antagonists in preclinical asthma models support the study of antagonists of the H4 R in the treatment of asthma in humans. JNJ-39758979 is a potent and highly-selective oral H4 R antagonist. OBJECTIVE: We sought to evaluate the safety and efficacy of the H4 R-antagonist JNJ-39758979 in adult patients with uncontrolled asthma. METHODS: One hundred and fifteen eligible patients were randomly assigned to JNJ-39758979 300 mg or placebo once daily for 12 weeks in this phase 2a, double-blind, multicenter, placebo-controlled study...
April 23, 2018: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29682020/morphometric-analysis-of-dose-dependent-effect-of-progesterone-on-experimental-vasospasm-induced-rat-femoral-arteries
#6
Metin Kasap, Huseyin Canaz, Gokhan Canaz, Mehmet Tokmak, Alper Bingul, Ibrahim Alatas
Objective: Our aim of this study was to determine effective doses of progesterone which has a vasodilatory effect during the early stage of vasospasm. Cerebral vasospasm (CV) is a predominant cause of morbidity and mortality which develops following subarachnoidal hemorrhage (SAH). Etiopathogenesis of CV is multifactorial. Despite many previously performed studies on this issue, the mechanism by which blood and blood products in the subarachnoidal space induce CV has not been clarified yet...
April 2018: Asian Journal of Neurosurgery
https://www.readbyqxmd.com/read/29681977/effects-of-4-week-intervention-with-ulmus-macrocarpa-hance-extract-on-immune-function-biomarkers-in-healthy-adults-a-randomized-controlled-trial
#7
A Ra Cho, Sang Yeoup Lee, Young Hye Cho, Cheol Min Kim, Sung Goo Kim
Ulmus macrocarpa extract has been shown to have immune-related effects in animals, but no studies have yet been performed in humans. This randomized, double-blind, placebo-controlled trial was conducted to determine the effect of short-term administration of Ulmus macrocarpa Hance extract (UME) on immune function biomarkers and its safety in human subjects. Fifty-eight subjects were randomly assigned to a UME group or a placebo group. Subjects in the UME group were given 500 mg per day of UME orally for 4 weeks...
2018: Evidence-based Complementary and Alternative Medicine: ECAM
https://www.readbyqxmd.com/read/29681333/can-knowledge-of-placebo-and-nocebo-mechanisms-help-improve-randomized-clinical-trials
#8
Elisa Carlino, Lene Vase
Over the last decade, there has been a substantial increase in negative results from randomized controlled trials (RCTs), which may be due to an increasing placebo response among other factors. Currently, identification and exclusion of placebo responders from trials are attempted to overcome this problem, but so far the success of these approaches has been limited. At the same time, the placebo-mechanism literature has highlighted how contextual factors, such as patients' expectations, interfere with the effect of drug administration, leading to a certain degree of uncertainty in RCTs...
2018: International Review of Neurobiology
https://www.readbyqxmd.com/read/29681047/the-effect-of-local-anesthetic-agent-infiltration-around-nephrostomy-tract-on-postoperative-pain-control-after-percutaneous-nephrolithotomy-a-single-centre-randomised-double-blind-placebocontrolled-clinical-trial
#9
Gokce Dundar, Kaan Gokcen, Gokhan Gokce, Emin Yener Gultekin
PURPOSE: Insufficient alleviation of pain after percutaneous nephrolithotomy causes patient dissatisfaction and generates additional morbidity factors by preventing early mobilization. This study investigated the effects of bupivacaine infiltration with two different doses around the nephrostomy tract after percutaneous nephrolithotomy. MATERIALS AND METHODS: Patients who underwent subcostal single entrance percutaneous nephrolithotomy were randomly divided into 3 groups of 20 patients...
April 22, 2018: Urology Journal
https://www.readbyqxmd.com/read/29680809/impact-of-dexmedetomidine-infusion-during-general-anaesthesia-on-incidence-of-postoperative-delirium-in-elderly-patients-after-major-non-cardiac-surgery-study-protocol-of-a-randomised-double-blinded-and-placebo-controlled-trial
#10
Bo-Jie Wang, Chun-Jing Li, Jian Hu, Huai-Jin Li, Chao Guo, Zhen-Han Wang, Qiao-Chu Zhang, Dong-Liang Mu, Dong-Xin Wang
INTRODUCTION: Delirium is a common complication in the elderly after surgery and is associated with worse outcomes. Multiple risk factors are related with postoperative delirium, such as exposure to general anaesthetics, pain and postoperative inflammatory response. Preclinical and clinical studies have shown that dexmedetomidine attenuated neurotoxicity induced by general anaesthetics, improved postoperative analgesia and inhibited inflammatory response after surgery. Several studies found that intraoperative use of dexmedetomidine can prevent postoperative delirium, but data were inconsistent...
April 21, 2018: BMJ Open
https://www.readbyqxmd.com/read/29680317/a-double-blind-placebo-controlled-phase-ii-randomised-cross-over-trial-investigating-the-use-of-duloxetine-for-the-treatment-of-chemotherapy-induced-peripheral-neuropathy
#11
Eva Battaglini, Susanna B Park, Elizabeth H Barnes, David Goldstein
BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant side effect of cancer treatment, potentially leading to early cessation of chemotherapy, enduring symptoms and long-lasting disability. Evidence from preclinical and clinical studies suggests that duloxetine, a serotonin-noradrenaline reuptake inhibitor, may be effective in the symptomatic treatment of CIPN. This double blind, placebo controlled, phase II randomised cross-over trial aims to determine whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment...
April 19, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29680222/effectiveness-of-voice-therapy-associated-with-electromyographic-biofeedback-in-women-with-behavioral-dysphonia-randomized-placebo-controlled-double-blind-clinical-trial
#12
Vanessa Veis Ribeiro, Amanda Gabriela de Oliveira, Jhonatan da Silva Vitor, Ana Carolina Ramos, Alcione Ghedini Brasolotto, Kelly Cristina Alves Silverio
OBJECTIVE: To analyze the effectiveness of vocal therapy associated with electromyographic biofeedback in women with behavioral dysphonia. MATERIALS AND METHODS: This is a randomized placebo-controlled double-blind clinical trial. Twenty-two adult women with behavioral dysphonia were randomly divided into two groups: Experimental Group-11 women participated in vocal therapy associated with the application of electromyographic biofeedback; Placebo Group-11 women participated in vocal therapy associated with the application of placebo electromyographic biofeedback...
April 18, 2018: Journal of Voice: Official Journal of the Voice Foundation
https://www.readbyqxmd.com/read/29678772/minocycline-adjunctive-treatment-to-risperidone-for-negative-symptoms-in-schizophrenia-association-with-pro-inflammatory-cytokine-levels
#13
Lulu Zhang, Hongbo Zheng, Rengrong Wu, Furong Zhu, Thomas R Kosten, Xiang-Yang Zhang, Jingping Zhao
BACKGROUND: We attempted to replicate the efficacy of minocycline, a second-generation tetracycline, as adjunctive therapy for the negative symptoms of schizophrenia, and to investigate its association with pro-inflammatory cytokine levels. METHODS: Seventy-five schizophrenia patients with negative symptoms entered a 3-month, double blind, randomized, placebo-controlled clinical trial. Subjects were assigned low dose (100 mg per day) or high dose minocycline (200 mg per day) or placebo combined with risperidone...
April 17, 2018: Progress in Neuro-psychopharmacology & Biological Psychiatry
https://www.readbyqxmd.com/read/29678471/hematologic-toxicity-from-radium-223-therapy-for-bone-metastases-in-castration-resistant-prostate-cancer-risk-factors-and-practical-considerations
#14
REVIEW
Heather Jacene, Leonard Gomella, Evan Y Yu, Eric M Rohren
Radium-223 dichloride is an α-emitting radiopharmaceutical that localizes to bone matrix and is approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. The cumulative impact of Ra-223 and other therapeutic agents for metastatic CRPC on myelosuppression in bone marrow is unknown. The phase 3 randomized, double-blind, placebo-controlled ALSYMPCA trial of Ra-223 in patients with CRPC and symptomatic bone metastases demonstrated a significant improvement in overall survival...
March 23, 2018: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/29676824/the-safety-effectiveness-and-cost-effectiveness-of-cytisine-in-achieving-six-month-continuous-smoking-abstinence-in-tuberculosis-patients-protocol-for-a-double-blind-placebo-controlled-randomised-trial
#15
Omara Dogar, Deepa Barua, Melanie Boeckmann, Helen Elsey, Razia Fatima, Rhian Gabe, Rumana Huque, Ada Keding, Amina Khan, Daniel Kotz, Eva Kralikova, James N Newell, Iveta Nohavova, Steve Parrott, Anne Readshaw, Lottie Renwick, Aziz Sheikh, Kamran Siddiqi
BACKGROUND AND AIMS: Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost-effectiveness of cytisine - a low-cost plant-derived nicotine substitute - for smoking cessation in TB patients compared with placebo, over and above brief behavioural support...
April 20, 2018: Addiction
https://www.readbyqxmd.com/read/29676689/intravenous-acetaminophen-for-postoperative-supratentorial-craniotomy-pain-a-prospective-randomized-double-blinded-placebo-controlled-trial
#16
Walavan Sivakumar, Michael Jensen, Julie Martinez, Michael Tanana, Nancy Duncan, Robert Hoesch, Jay K Riva-Cambrin, Craig Kilburg, Safdar Ansari, Paul A House
OBJECTIVE Acute pain control after cranial surgery is challenging. Prior research has shown that patients experience inadequate pain control post-craniotomy. The use of oral medications is sometimes delayed because of postoperative nausea, and the use of narcotics can impair the evaluation of brain function and thus are used judiciously. Few nonnarcotic intravenous (IV) analgesics exist. The authors present the results of the first prospective study evaluating the use of IV acetaminophen in patients after elective craniotomy...
April 20, 2018: Journal of Neurosurgery
https://www.readbyqxmd.com/read/29676640/a-pilot-study-assessing-the-ability-of-5-aminosalicylic-acid-to-modulate-the-immune-response-in-chronic-beryllium-disease
#17
Brian J Day, Jie Huang, Briana Q Barkes, May Gillespie, Li Li, Lisa A Maier
Chronic beryllium disease is a granulomatous lung disease, characterized by the accumulation of macrophages and beryllium-specific CD4+ T-cells that proliferate and produce T-helper cell type 1 cytokines. Previous studies indicate that beryllium-mediated oxidative stress enhances cytokine response in chronic beryllium disease CD4+ T-cells. 5-Aminosalicylic acid (5-ASA) is currently used to treat inflammatory bowel disease and has both antioxidant and antiinflammatory actions. We hypothesized that 5-ASA therapy may be a beneficial therapy in chronic beryllium disease...
April 2018: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29676139/-effect-of-xinling-wan-in-treatment-of-stable-angina-pectoris-a-randomized-double-blinded-placebo-parallel-controlled-multicenter-trial
#18
Jian-Wei Gao, Xue-Min Gao, Ting Zou, Tian-Meng Zhao, Dong-Hua Wang, Zong-Gui Wu, Chang-Jie Ren, Xing Wang, Nai-Zhi Geng, Ming-Jun Zhao, Qiu-Ming Liang, Xing Feng, Bai-Song Yang, Jun-Ling Shi, Qi Hua
To evaluate the effectiveness and safety of Xinling Wan on patients with stable angina pectoris, a randomized, double-blinded, placebo parallel-controlled, multicenter clinical trial was conducted. A total of 232 subjects were enrolled and randomly divided into experiment group and placebo group. The experiment group was treated with Xinling Wan (two pills each time, three times daily) for 4 weeks, and the placebo group was treated with placebo. The effectiveness evaluation showed that Xinling Wan could significantly increase the total duration of treadmill exercise among patients with stable angina pectoris...
March 2018: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29674967/no-acute-effects-of-cannabidiol-on-the-sleep-wake-cycle-of-healthy-subjects-a-randomized-double-blind-placebo-controlled-crossover-study
#19
Ila M P Linares, Francisco S Guimaraes, Alan Eckeli, Ana C S Crippa, Antonio W Zuardi, Jose D S Souza, Jaime E Hallak, José A S Crippa
Cannabidiol (CBD) is a component of Cannabis sativa that has a broad spectrum of potential therapeutic effects in neuropsychiatric and other disorders. However, few studies have investigated the possible interference of CBD on the sleep-wake cycle. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD (300 mg) or placebo in the first night in a double-blind randomized design (one volunteer withdrew from the study)...
2018: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29674270/response-inhibition-and-emotional-cognition-improved-by-atomoxetine-in-children-and-adolescents-with-adhd-the-action-randomized-controlled-trial
#20
Kristi R Griffiths, John E Leikauf, Tracey W Tsang, Simon Clarke, Daniel F Hermens, Daryl Efron, Leanne M Williams, Michael R Kohn
Although the non-stimulant medication atomoxetine is effective for attention-deficit hyperactivity disorder (ADHD) in children and adolescents, there are still significant gaps in our knowledge about whether atomoxetine improves anxiety symptoms or cognition in children. Furthermore, while cognition has been proposed as an intermediate phenotype for ADHD dysfunction, the relationships between clinical and cognitive outcomes are not yet understood. We addressed these knowledge gaps in a controlled trial using objective assessments of both general and emotional cognitive functions implicated in ADHD and in anxiety, which commonly co-occurs with ADHD...
March 27, 2018: Journal of Psychiatric Research
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