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double blind controlled trial

Roberto Ferrari, Ian Ford, Kim Fox, Mario Marzilli, Michal Tendera, Petr Widimský, Jean-Pascal Challeton, Nicolas Danchin
BACKGROUND: About 30% of angina patients have persisting symptoms despite successful revascularization and antianginal therapy. Moreover, in stable patients, percutaneous coronary intervention (PCI) does not improve survival as compared with medical therapy alone. Trimetazidine, an antianginal agent devoid of hemodynamic effect, may help reducing symptoms and improving outcomes after PCI. The ATPCI study is investigating the efficacy and safety of adding trimetazidine to standard-of-care in angina patients who had a recent PCI...
January 15, 2019: American Heart Journal
Joel L Ramirez, Warren J Gasper, Sukaynah A Khetani, Greg J Zahner, Nancy K Hills, Pete T Mitchell, Brian E Sansbury, Michael S Conte, Matthew Spite, S Marlene Grenon
BACKGROUND: N-3 polyunsaturated fatty acid (PUFA) supplementation has been associated with reduced mortality and inflammation in patients with cardiovascular disease. There are limited data on the effects of n-3 PUFA supplementation in patients with peripheral artery disease (PAD). MATERIALS AND METHODS: The OMEGA-PAD II trial was a double-blinded, randomized, placebo-controlled trial to assess the effect of 3 mo of high-dose oral n-3 PUFA supplementation on inflammation, endothelial function, and walking ability in patients with PAD...
February 13, 2019: Journal of Surgical Research
Daniel J Wallace, Ellen M Ginzler, Joan T Merrill, Richard A Furie, William Stohl, W Winn Chatham, Arthur Weinstein, James D McKay, W Joseph McCune, Michelle Petri, James Fettiplace, David A Roth, Beulah Ji, Amy Heath
OBJECTIVE: Investigate long-term safety and efficacy of intravenous (IV) belimumab plus standard systemic lupus erythematosus (SLE) therapy (SoC) in active, autoantibody-positive SLE. METHODS: This was a multicenter, open-label, continuation study of IV belimumab given every four weeks with SoC in patients with SLE who completed a Phase II, double-blind study. Adverse events (AEs) and laboratory data were monitored from the first belimumab dose (in either study) until 24 weeks after the final dose...
February 16, 2019: Arthritis & Rheumatology
Samira T Miyamoto, Valéria Valim, Benjamin A Fisher
Health-related quality of life (HRQoL) has an increasing role in medical decision-making. This review of the literature aims to provide an overview on HRQoL, costs, and work disability in SS, a disease characterized by focal lymphocytic infiltration of exocrine glands with no therapeutics of proven immunomodulatory potential. HRQoL is markedly reduced in SS in multiple studies across many countries when compared with HRQoL in healthy controls. The reduction in HRQoL is similar to that observed in other chronic diseases such as RA, SLE, FM and, interestingly, non-SS sicca syndrome...
February 15, 2019: Rheumatology
Arthur Kavanaugh, M Elaine Husni, Diane D Harrison, Lilianne Kim, Kim Hung Lo, Lenore Noonan, Elizabeth C Hsia
OBJECTIVE: Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA). METHODS: This phase III, randomized, double-blind, placebo-controlled trial (GO-VIBRANT) randomized patients with active PsA to receive IV placebo (n = 239) or IV GOL 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Radiographic progression (controlled secondary endpoint) was evaluated as change from baseline at Week 24 in PsA-modified total Sharp/van der Heijde scores (SvdH)...
February 15, 2019: Journal of Rheumatology
Sonja Rutten, Chris Vriend, Jan H Smit, Henk W Berendse, Eus J W van Someren, Adriaan W Hoogendoorn, Jos W R Twisk, Ysbrand D van der Werf, Odile A van den Heuvel
OBJECTIVE: To assess the efficacy of bright light therapy (BLT) in reducing depressive symptoms in patients with Parkinson disease (PD) and major depressive disorder (MDD) compared to a control light. METHODS: In this double-blind controlled trial, we randomized patients with PD and MDD to treatment with BLT (±10,000 lux) or a control light (±200 lux). Participants were treated for 3 months, followed by a 6-month naturalistic follow-up. The primary outcome of the study was the Hamilton Depression Rating Scale (HDRS) score...
February 15, 2019: Neurology
Bertrand Tombal, Fred Saad, David Penson, Maha Hussain, Cora N Sternberg, Robert Morlock, Krishnan Ramaswamy, Cristina Ivanescu, Gerhardt Attard
BACKGROUND: In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study. METHODS: In the randomised, double-blind, placebo-controlled, phase 3 PROSPER trial, done at 254 study sites worldwide, patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months were randomly assigned (2:1) via an interactive voice web recognition system to receive oral enzalutamide (160 mg per day) or placebo...
February 12, 2019: Lancet Oncology
Kassiani Theodoraki, Panagiota Papacharalampous, Athanasia Tsaroucha, Antonios Vezakis, Eriphilli Argyra
BACKGROUND: This prospective double-blind randomized study aimed at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided tranversus abdominis plane (TAP) block in inguinal hernia repair under general anesthesia. METHODS: Sixty patients undergoing inguinal hernia repair were allocated to TAP block with either ropivacaine 0.75% 20 mL or placebo 20 mL. Postoperatively, they had access to a patient-controlled analgesia (PCA) device administering 1 mg doses of morphine as rescue analgesia...
February 12, 2019: International Journal of Surgery
Hatice Kumru, Markus Kofler, Josep Valls-Sole, Joan Vidal
BACKGROUND: The excitability of brainstem interneuronal circuits is partly under control from descending inputs. Since high frequency repetitive transcranial magnetic stimulation (rTMS) modulates cortical output, we hypothesized that it will also modulate brainstem functions. Such modulation may be different in healthy subjects than in subjects with spinal cord injury (SCI), submitted to an altered integration of body afferent inputs. METHODS: In this randomized, double-blind, sham-controlled trial, we recruited 22 subjects with SCI assigned to either real (n = 11) or sham (n = 11) rTMS and nine healthy subjects, who served as control group, receiving both real (at 20 Hz, with double cone coil over vertex) and sham rTMS separated by at least one week...
February 12, 2019: Brain Research Bulletin
James J McGough, Alexandra Sturm, Jennifer Cowen, Kelly Tung, Giulia C Salgari, Andrew F Leuchter, Ian A Cook, Catherine A Sugar, Sandra K Loo
OBJECTIVE: Trigeminal nerve stimulation (TNS), a minimal risk, non-invasive neuromodulation method, has showed potential benefits for attention-deficit/hyperactivity disorder (ADHD) in an unblinded open study. This blinded sham-controlled trial was conducted to assess efficacy and safety of TNS for ADHD, as well as potential changes in brain spectral power using resting-state quantitative electroencephalography (qEEG). METHOD: 62 children aged 8-12 years, with full-scale IQ ≥ 85 and KSADS-diagnosed ADHD, were randomized to four weeks nightly treatment with active or sham TNS, followed by one-week without intervention...
January 28, 2019: Journal of the American Academy of Child and Adolescent Psychiatry
Zahra Darabi, Mina Darand, Zahra Yari, Mehdi Hedayati, Amirhosein Faghihi, Shahram Agah, Azita Hekmatdoost
OBJECTIVES: The aim of this study was to investigate the effects of citrulline (Cit) supplementation on inflammatory markers and liver histopathology in patients with non-alcoholic fatty liver disease (NAFLD). In this clinical trial, fifty NAFLD patients were assigned to receive 2 g/day Cit or placebo for 3 months. RESULTS: At the end of study, serum high sensitive C-reactive protein (hs-CRP) and activity of nuclear factor kappa B (NF-κB) were reduced in Cit group significantly more than placebo group (P-value = 0...
February 15, 2019: BMC Research Notes
Jamie Corroon, Ryan Bradley
OBJECTIVE: There is a medical need to evaluate new treatments that may improve wound healing. This study aimed to determine if Original Healing Salve (OHS, Puremedy, Inc.) a topical, botanically-enriched salve (BES), changes distal leg tissue oxygenation in people with type 2 diabetes. METHOD: A randomised, controlled, crossover, double-blinded clinical trial comparing changes in cutaneous oxygen delivery (mean TcPO2 ) on multiple sites of the lower extremity following application of a botanically-enriched topical salve, as compared with application of the salve's base in patients with type 2 diabetes...
February 1, 2019: Journal of Wound Care
Jing Wang, Yizhuo Zhao, Qiming Wang, Li Zhang, Jianhua Shi, Zhehai Wang, Ying Cheng, Jianxing He, Yuankai Shi, Hao Yu, Yang Zhao, Weiqiang Chen, Yi Luo, Xiuwen Wang, Kejun Nan, Faguang Jin, Jian Dong, Baolan Li, Zhujun Liu, Baohui Han, Kai Li
Objective: Anlotinib hydrochloride is a multitarget tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor, fibroblast growth factor receptor, platelet-derived growth factor receptor, c-Kit, and c-MET; therefore, it exhibits both antitumor and anti-angiogenetic activities. A phase III trial has shown that anlotinib improved progression-free survival (PFS) and overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC), who presented with progressive disease or intolerance after standard chemotherapy...
November 2018: Cancer Biology & Medicine
Rie Wakamiya, Hiroyuki Seki, Satoshi Ideno, Naho Ihara, Rie Minoshima, Kota Watanabe, Yasunori Sato, Hiroshi Morisaki
Dexamethasone is widely used for postoperative nausea and vomiting (PONV) prophylaxis, but its effect on PONV prevention in paediatric patients is validated only in short minor surgical procedures. In this study, we aimed to determine whether a single dose of dexamethasone reduces PONV in highly invasive surgeries that require opioid-based postoperative analgesia. One hundred adolescents undergoing scoliosis correction surgery were randomized to receive intravenous dexamethasone 0.15 mg/kg (dexamethasone group) or saline (control group) at induction of anaesthesia...
February 14, 2019: Scientific Reports
Yuxin Zheng, Xuezong Wang, Zong-Kang Zhang, Baosheng Guo, Lei Dang, Bing He, Chi Zhang, Jiwei Zhou, Wanzhong Shi, Yongfang Zhao, Hongsheng Zhan, Yu Xu, Chao Liang, Jin Liu, Daogang Guan, Luyao Wang, Xiaohao Wu, Jie Li, Zhenjian Zhuo, Zhixiu Lin, Hong Qiu, Lidan Zhong, Zhaoxiang Bian, Yinyu Shi, Bao-Ting Zhang, Ge Zhang, Aiping Lu
Falls in late postmenopausal women with osteopenia usually cause fractures with severe consequences. This 36-month randomized, double-blind and placebo-controlled trial with a 10-year observational follow-up study aimed to investigate the long-term effect of herbal formula Bushen Yijing Fang (BSYJF) on fall risk in the late postmenopausal women with osteopenia. 140 late postmenopausal women (Femoral neck T-score, -2.5~-2 SD) were recruited and randomized to orally receive calcium carbonate 300 mg daily with either BSYJF or placebo for 36 months...
February 14, 2019: Scientific Reports
Mehmet Resul Kadı, Simin Hepgüler, Funda Calıs Atamaz, Emine Dede, Semih Aydoğdu, Kemal Aktuglu, Nadir Ozkayın, Cihat Ozturk
OBJECTIVE: To investigate the effectiveness of interferential current implementation following total knee arthroplasty surgery. DESIGN: Double-blind randomized controlled study. SETTING: Orthopedics and traumatology in-patient clinic. PARTICIPANTS: From an initial enrollment of 132 patients, 113 who met the study inclusion criteria were randomly separated into two groups: the interferential current group ( n = 57) and the sham current group ( n = 56)...
February 14, 2019: Clinical Rehabilitation
Riccardo Gomes Gobbi, Adriana Lúcia Pastore E Silva, Marco Kawamura Demange, José Ricardo Pécora, João Espregueira-Mendes, Gilberto Luis Camanho
This study was designed to evaluate the effect of pulsed signal therapy (PST) on patellofemoral pain syndrome associated with patellar chondropathy. A prospective randomized double-blind placebo controlled trial included 25 patients (41 knees) between 20 and 50 years with pain due to isolated patellofemoral syndrome with chondropathy. PST group received nine 60-min daily sessions of PST treatment. Control group received the same protocol of blinded placebo treatment. The main outcome was change from baseline Kujala score at 3 months...
February 14, 2019: Bioelectromagnetics
Steven K Malin, Emily L Kullman, Amanda R Scelsi, Jean-Philippe Godin, Alastair B Ross, John P Kirwan
INTRODUCTION: Few data exist examining the effects of whole grain (WG) versus refined grain (RG) diets on glucose-stimulated insulin secretion (GSIS) and β-cell function. METHODS: In a double-blind crossover randomized controlled trial, 13 sedentary prediabetic adults (37.2±1.8 y, BMI: 33.6±1.4 kg/m2 , 2h glucose: 146.9±11.6 mg/dl) were provided isocaloric-matched WG and RG diets for 8-weeks each, with an 8-10 week washout between diets. Glucose, insulin and C-peptide metabolism was studied over 240 min following a 75g OGTT...
February 14, 2019: Molecular Nutrition & Food Research
Karim Fizazi, Neal Shore, Teuvo L Tammela, Albertas Ulys, Egils Vjaters, Sergey Polyakov, Mindaugas Jievaltas, Murilo Luz, Boris Alekseev, Iris Kuss, Christian Kappeler, Amir Snapir, Toni Sarapohja, Matthew R Smith
BACKGROUND: Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. We evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less...
February 14, 2019: New England Journal of Medicine
Muhammad I Husain, Imran B Chaudhry, Ameer B Khoso, Mohammad Omair Husain, Raza R Rahman, Munir M Hamirani, John Hodsoll, Andre F Carvalho, Nusrat Husain, Allan H Young
BACKGROUND: A third of patients diagnosed with major depressive disorder (MDD) experience treatment-resistant depression (TRD). Relatively few pharmacological agents have established efficacy for TRD. Therefore, the evaluation of novel treatments for TRD is a pressing priority. Statins are pleiotropic agents and preclinical studies as well as preliminary clinical trials have suggested that these drugs may have antidepressant properties.AimsTo report on a protocol for a 12-week, randomised, double-blind, placebo-controlled trial of add-on treatment with simvastatin for patients meeting DSM-5 criteria for MDD who have failed to respond to at least two adequate trials with approved antidepressants...
January 2019: BJPsych Open
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