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randomized, double-blind, trial

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https://www.readbyqxmd.com/read/28806208/systemic-hypotension-following-intravenous-administration-of-nonionic-contrast-medium-during-computed-tomography-iopromide-versus-iodixanol
#1
Gerlig Widmann, Reto Bale, Hanno Ulmer, Daniel Putzer, Peter Schullian, Franz-Josef Wiedermann, Wolfgang Lederer
BACKGROUND: In light of the increasing number of radiologic interventions performed under general anesthesia, the effects of contrast media (CM) on circulation and organ perfusion are of paramount importance. The objectives of this study were to systematically quantify effects on blood pressure, heart rate, and kidney function following intravenous administration of nonionic CM with normal and low osmolality. METHODS: In this controlled, double-blinded phase IV clinical trial, 40 consecutive patients were randomly assigned to receive repeated measures of either low-osmolar iopromide or iso-osmolar iodixanol...
August 10, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28805670/appetite-and-gut-hormones-response-to-a-putative-%C3%AE-glucosidase-inhibitor-salacia-chinensis-in-overweight-obese-adults-a-double-blind-randomized-controlled-trial
#2
Lihong Hao, Yvette Schlussel, Krista Fieselmann, Stephen H Schneider, Sue A Shapses
Animal studies indicate Salacia reduces body weight, possibly due to its α-glucosidase inhibitor (α-GI) properties, but this has not been examined previously. In this study, a randomized, placebo-controlled, three-way cross-over design was used to evaluate whether Salacia Chinensis (SC) reduces appetite in healthy overweight/obese individuals (body mass index 28.8 ±3.6 kg/m²; 32 ± 12 years). Forty-eight participants were fasted overnight and consumed a dose of SC (300 or 500 mg) or placebo with a fixed breakfast meal at each visit...
August 12, 2017: Nutrients
https://www.readbyqxmd.com/read/28805667/the-effect-of-a-standardized-ginger-extract-on-chemotherapy-induced-nausea-related-quality-of-life-in-patients-undergoing-moderately-or-highly-emetogenic-chemotherapy-a-double-blind-randomized-placebo-controlled-trial
#3
Wolfgang Marx, Alexandra L McCarthy, Karin Ried, Dan McKavanagh, Luis Vitetta, Avni Sali, Anna Lohning, Elisabeth Isenring
Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea (CIN). The aim of this clinical trial was to address significant methodological limitations in previous trials. Patients (N = 51) were randomly allocated to receive either 1.2 g of standardised ginger extract or placebo per day, in addition to standard anti-emetic therapy, during the first three cycles of chemotherapy. The primary outcome was CIN-related quality of life (QoL) measured with the Functional Living Index- Emesis (FLIE) questionnaire...
August 12, 2017: Nutrients
https://www.readbyqxmd.com/read/28805147/a-comparison-of-transdermal-over-the-counter-lidocaine-3-6-menthol-1-25-rx-lidocaine-5-and-placebo-for-back-pain-and-arthritis
#4
Eric Castro, David Dent
AIM: Transdermal lidocaine therapy has become a gold standard as part of a treatment regimen for patients who suffer from localized pain. We compared transdermal patches: over-the-counter (OTC) lidocaine 3.6% combined with menthol 1.25%, prescription lidocaine 5% (Rx) and placebo. METHODS: In a double-blind, placebo-controlled trial, 87 patients were randomized to: OTC, Rx or placebo. RESULTS: OTC met primary end points of noninferiority compared with Rx for efficacy, side effects and quality of life...
August 14, 2017: Pain Management
https://www.readbyqxmd.com/read/28805045/safety-and-efficacy-of-intravenous-golimumab-in-patients-with-active-psoriatic-arthritis-results-through-week-24-of-the-go-vibrant-study
#5
Arthur Kavanaugh, M Elaine Husni, Diane D Harrison, Lilianne Kim, Kim Hung Lo, Jocelyn H Leu, Elizabeth C Hsia
OBJECTIVE: Evaluate the safety and efficacy of intravenous golimumab in psoriatic arthritis (PsA). METHODS: In this Phase 3, randomized, double-blind, placebo-controlled trial, patients were randomized to intravenous placebo (n=239) or golimumab 2 mg/kg (n=241) at weeks 0, 4, 12, and 20. The primary endpoint was the proportion of patients with ≥20% improvement in ACR criteria (ACR20) at week14. Controlled secondary endpoints included change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI), proportions of patients with ACR50, ACR70, and ≥75% improvement in Psoriasis Area and Severity Index (PASI75) at week14, and change from baseline in total PsA-modified van der Heijde-Sharp (vdH-S) score at week24...
August 13, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28805022/hesperidin-supplementation-alleviates-oxidative-dna-damage-and-lipid-peroxidation-in-type-2-diabetes-a-randomized-double-blind-placebo-controlled-clinical-trial
#6
Fatemeh Homayouni, Fatemeh Haidari, Mehdi Hedayati, Mehrnoosh Zakerkish, Kambiz Ahmadi
This study aimed to examine the effects of hesperidin supplement on the glycemic parameters, oxidative DNA damage, and lipid peroxidation in patients with type 2 diabetes. Sixty-four patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on glycemic parameters, total antioxidant capacity (TAC), 8-hydroxydeoxyguanosine (8-OHDG), and malondialdehyde (MDA) were collected at the baseline and at the end of the study. In hesperidin group, TAC increased (0.74 ± 0...
August 14, 2017: Phytotherapy Research: PTR
https://www.readbyqxmd.com/read/28804889/a-randomised-trial-comparing-real-time-double-lumen-endobronchial-tube-placement-with-the-disposcope-%C3%A2-with-conventional-blind-placement
#7
P T Chen, C K Ting, M Y Lee, H W Cheng, K H Chan, W K Chang
Double-lumen endobronchial tube placement is challenging. This study compared double-lumen tube placement with the Disposcope(®) , a wireless videostylet allowing real-time visualisation, with conventional blind placement. Patients undergoing elective thoracic surgery with normal airways requiring one-lung ventilation were randomly allocated into two groups (27 patients in each group). The Disposcope was used to assist left-sided double-lumen tube placement in one group, and conventional blind placement was performed in the control group...
September 2017: Anaesthesia
https://www.readbyqxmd.com/read/28804807/plasma-cortisol-response-cannot-be-classically-conditioned-in-a-taste-endocrine-paradigm-in-humans
#8
Liubov Petrakova, Karoline Boy, Marisa Kügler, Sven Benson, Harald Engler, Lars Möller, Manfred Schedlowski
RATIONALE: Peripheral immune responses can be modified by associative learning procedures. Less is known, however, whether and to what extent neuroendocrine parameters can be classically conditioned. OBJECTIVES: In this randomized double-blind study, we modified an established paradigm to behaviorally condition endocrine responses in humans. METHODS: Thirty-one healthy male participants received a distinctively flavored green drink as the conditioned stimulus (CS) and intravenous injections of corticotropin-releasing hormone (CRH) (CRH group, N = 17) or NaCl (placebo group, N = 14) as the unconditioned stimulus (US) during two subsequent acquisition trials...
August 13, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/28803655/usefulness-of-pa32540-in-protecting-the-gastric-layer-while-providing-secondary-prevention-for-coronary-artery-disease
#9
REVIEW
Deepthi Kagolanu, Najia Sayedy, Syed Haseeb, Shivani Shah, Paul Lam, Swapna Munnangi, Prakash Viswanathan, Kent Stephenson
Aspirin has been the mainstay for secondary prevention of coronary artery disease to decrease early recurrence and severity of recurrent cardiovascular events. However, an increase in gastrointestinal bleeding due to aspirin is preventing many patients from adhering to this daily regimen. PA32540, a combination pill with aspirin and omeprazole, is a newly emerging intervention that has the potential to reinforce patient compliance with the aspirin regimen due to fewer gastrointestinal adverse effects. This systematic review assessed three recent phase 3 clinical trials investigating the safety and efficacy of PA32540...
July 14, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28803601/ultrasound-guided-transversus-abdominis-plane-block-improves-postoperative-analgesia-and-early-recovery-in-patients-undergoing-retroperitoneoscopic-urologic-surgeries-a-randomized-controlled-double-blinded-trial
#10
Ge Qu, Xu-Lei Cui, Hong-Ju Liu, Zhi-Gang Ji, Yu-Guang Huang
Objective To evaluate the effects of ultrasound-guided transversus abdominis plane (TAP) block on postoperative analgesia and early recovery in patients undergoing retroperitoneoscopic urologic surgeries. Methods This was a randomized, controlled, double-blinded trial. Eligible patients scheduled for retroperitoneoscopic urologic surgeries were randomly assigned to two groups. Group TAP received ultrasound-guided TAP block with 0.5% ropivacaine 20 ml at 30 minutes before surgery, and Group C received TAP sham block with normal saline...
September 20, 2016: Chinese Medical Sciences Journal, Chung-kuo i Hsüeh K'o Hsüeh Tsa Chih
https://www.readbyqxmd.com/read/28803502/immunogenicity-antibody-persistence-and-safety-of-the-60-%C3%AE-g-hepatitis-b-vaccine-in-hemodialysis-patients-a-multicenter-randomized-double-blind-parallel-controlled-trial
#11
Yongliang Feng, Xiaohong Shi, Jing Shi, Linying Gao, Guangming Liu, Yanpeng Cheng, Minghu Pan, Chunxia Li, Jun Wang, Xuxia Guo, Yawei Zhang, Xiaofeng Liang, Suping Wang
OBJECTIVES: To evaluate the immunogenicity, antibody persistence, and safety of the 60µg hepatitis B vaccine in hemodialysis patients in China. METHODS: We conducted a multicenter, randomized, double-blind, parallel-controlled trial including 352 hemodialysis patients who were centrally randomized in a ratio of 1:1 to receive a 20 µg (IM20 group) or 60 µg (IM60 group) recombinant hepatitis B vaccine at months 0, 1, and 6. RESULTS: The vaccine-elicited antibody responses peaked at month 7, and declined at month 12...
August 14, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28803087/effect-of-prophylactic-fentanyl-buccal-tablet-on-episodic-exertional-dyspnea-a-pilot-double-blind-randomized-controlled-trial
#12
David Hui, Kelly Kilgore, Susan Frisbee-Hume, Minjeong Park, Diane Liu, Diwakar D Balachandran, Eduardo Bruera
CONTEXT: Episodic dyspnea is one of the most common, debilitating and difficult-to-treat symptoms. OBJECTIVE: We conducted a pilot study to examine the effect of prophylactic FBT on exercise-induced dyspnea. METHODS: In this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients were asked to complete a 6 minute walk test (6MWT) at baseline, then a second 6MWT 30 minutes after a single dose of FBT (equivalent to 20-50% of their total opioid dose) or matching placebo...
August 9, 2017: Journal of Pain and Symptom Management
https://www.readbyqxmd.com/read/28802883/neoadjuvant-therapy-for-localized-and-locally-advanced-renal-cell-carcinoma
#13
REVIEW
Ahmet Bindayi, Zachary A Hamilton, Michelle L McDonald, Kendrick Yim, Frederick Millard, Rana R McKay, Steven C Campbell, Brian I Rini, Ithaar H Derweesh
Neoadjuvant Targeted Molecular Therapy in the setting of localized and locally advanced renal cell carcinoma has emerged as a strategy to render primary renal tumors amenable to planned surgical resection in settings where radical resection or nephron-sparing surgery was not thought to be safe or feasible. Presurgical tumor reduction has been demonstrated in a number of studies including a recently published randomized double-blind placebo-controlled study, and an expanding body of literature suggests benefit in select patients...
August 9, 2017: Urologic Oncology
https://www.readbyqxmd.com/read/28802598/effect-of-parecoxib-sodium-pretreatment-combined-with-dexmedetomidine-on-early-postoperative-cognitive-dysfunction-in-elderly-patients-after-shoulder-arthroscopy-a-randomized-double-blinded-controlled-trial
#14
Jian Lu, Gang Chen, Hongmei Zhou, Qinghe Zhou, Zhipeng Zhu, Cheng Wu
STUDY OBJECTIVE: To evaluate effect of parecoxib sodium pretreatment combined with dexmedetomidine on early postoperative cognitive dysfunction in elderly patients after shoulder arthroscopy. DESIGN: Randomized, double-blind study. SETTING: University-affiliated teaching hospital. PATIENTS: One hundred and fifty-two elderly patients scheduled for shoulder arthroscopy. INTERVENTIONS: At 15min before the induction of anesthesia, 152 patients received intravenously parecoxib sodium 40mg and dexmedetomidine at a dose of 0...
September 2017: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/28802565/the-safety-and-efficacy-of-an-alcohol-free-pancreatic-cyst-ablation-protocol
#15
Matthew T Moyer, Setareh Sharzehi, Abraham Mathew, John M Levenick, Brandy D Headlee, Jonathan T Blandford, Heather D Heisey, James H Birkholz, Brooke B Ancrile, Jennifer L Maranki, Niraj J Gusani, Thomas J McGarrity, Charles E Dye
BACKGROUND & AIMS: Endoscopic ultrasound (EUS)-guided chemoablation with ethanol lavage followed by infusion of paclitaxel, is effective for the treatment of mucinous pancreatic cysts. However, complications arise in 3%-10% of patients, presumably linked to the inflammatory effects of ethanol. We aimed to determine whether alcohol is required for effective pancreatic cyst ablation, if removing alcohol from the ablation process would improve complication rates, and whether a multi-agent chemotherapeutic cocktail could increase the rate of complete cyst resolution compared to the findings reported from previous trials using alcohol followed by paclitaxel alone...
August 9, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28801420/protocol-study-for-a-randomised-controlled-double-blind-clinical-trial-involving-virtual-reality-and-anodal-transcranial-direct-current-stimulation-for-the-improvement-of-upper-limb-motor-function-in-children-with-down-syndrome
#16
Jamile Benite Palma Lopes, Luanda André Collange Grecco, Renata Calhes Franco de Moura, Roberta Delasta Lazzari, Natalia de Almeida Carvalho Duarte, Isabela Miziara, Gileno Edu Lameira de Melo, Arislander Jonathan Lopes Dumont, Manuela Galli, Claudia Santos Oliveira
INTRODUCTION: Down syndrome results in neuromotor impairment that affects selective motor control, compromising the acquisition of motor skills and functional independence. The aim of the proposed study is to evaluate and compare the effects of multiple-monopolar anodal transcranial direct current stimulation and sham stimulation over the primary motor cortex during upper limb motor training involving virtual reality on motor control, muscle activity, cerebral activity and functional independence...
August 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28800861/ipatasertib-plus-paclitaxel-versus-placebo-plus-paclitaxel-as-first-line-therapy-for-metastatic-triple-negative-breast-cancer-lotus-a-multicentre-randomised-double-blind-placebo-controlled-phase-2-trial
#17
Sung-Bae Kim, Rebecca Dent, Seock-Ah Im, Marc Espié, Sibel Blau, Antoinette R Tan, Steven J Isakoff, Mafalda Oliveira, Cristina Saura, Matthew J Wongchenko, Amy V Kapp, Wai Y Chan, Stina M Singel, Daniel J Maslyar, José Baselga
BACKGROUND: The oral AKT inhibitor ipatasertib is being investigated in cancers with a high prevalence of PI3K/AKT pathway activation, including triple-negative breast cancer. The LOTUS trial investigated the addition of ipatasertib to paclitaxel as first-line therapy for triple-negative breast cancer. METHODS: In this randomised, placebo-controlled, double-blind, phase 2 trial, women aged 18 years or older with measurable, inoperable, locally advanced or metastatic triple-negative breast cancer previously untreated with systemic therapy were recruited from 44 hospitals in South Korea, the USA, France, Spain, Taiwan, Singapore, Italy, and Belgium...
August 8, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28800342/use-of-melatonin-versus-valproic-acid-in-prophylaxis-of-migraine-patients-a-double-blind-randomized-clinical-trial
#18
Mohsen Ebrahimi-Monfared, Mojtaba Sharafkhah, Ali Abdolrazaghnejad, Abolfazl Mohammadbeigi, Fardin Faraji
BACKGROUND: Melatonin is known to be effective in curing migraine. OBJECTIVE: This study aimed to investigate the therapeutic effect of melatonin versus sodium valproate in the prophylaxis of chronic migraine. METHODS: This randomized, double-blind, placebo-controlled clinical trial included patients with chronic migraine who were divided into three equal sized groups, and baseline therapy with nortriptyline (10-25 mg) and propranolol (20-40 mg) was used...
2017: Restorative Neurology and Neuroscience
https://www.readbyqxmd.com/read/28800341/robotic-assisted-gait-training-combined-with-transcranial-direct-current-stimulation-in-chronic-stroke-patients-a-pilot-double-blind-randomized-controlled-trial
#19
Han Gil Seo, Woo Hyung Lee, Seung Hak Lee, Youbin Yi, Kwang Dong Kim, Byung-Mo Oh
BACKGROUND: Although robotic-assisted gait training (RAGT) is becoming a standard method in stroke rehabilitation, its effect on chronic stroke patients is uncertain. OBJECTIVE: This study aimed to investigate whether anodal tDCS (transcranial direct current stimulation) enhances the effect of RAGT on functional ambulation in chronic stroke patients. METHODS: Chronic hemiplegic stroke patients with a Functional Ambulatory Category (FAC) score≤4 were randomly assigned to either the RAGT with anodal tDCS (Anodal) group or the sham tDCS (Sham) group...
August 11, 2017: Restorative Neurology and Neuroscience
https://www.readbyqxmd.com/read/28799984/lidocaine-spray-as-a-local-analgesic-for-intravenous-cannulation-a-randomized-clinical-trial
#20
Joris Datema, Jeroen Veldhuis, Jolita Bekhof
OBJECTIVES: Lidocaine spray is an effective analgesic of mucous membranes. Lidocaine spray is also used during intravenous (i.v.) cannulation, especially in children. However, the analgesic effect of lidocaine spray during i.v. cannulation has not been studied. We aimed to assess the analgesic effectiveness of lidocaine spray during i.v. cannulation. METHODS: We conducted a randomized, double-blinded, placebo-controlled trial in seventeen healthy adults who received an i...
August 10, 2017: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
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