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https://www.readbyqxmd.com/read/29775246/tramadol-hydrochloride-at-steady-state-lacks-clinically-relevant-qtc-interval-increases-in-healthy-adults
#1
Joseph Massarella, Jay Ariyawansa, Jaya Natarajan, Stephan Francke, Thomas Murtaugh, Byron DeLemos, Subusola Vaughan, Sergio Fonseca
We evaluated the effects of therapeutic and supratherapeutic doses of tramadol hydrochloride on the corrected QT (QTc) interval in healthy adults (aged 18-55 years) in a randomized, phase I, double-blind, placebo- and positive-controlled, multiple-dose, 4-way crossover study. Participants were randomized to receive 1 of 4 treatments (A-D), 1 each in 4 treatment periods (1-4), separated by a washout period (7-15 days). Treatment A comprised tramadol 400 mg (therapeutic dose) on days 1 through 3, tramadol 100 mg and moxifloxacin-matched placebo on day 4, and placebo on all 4 days...
May 18, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29773572/hemostatic-efficacy-of-pathogen-inactivated-versus-untreated-platelets-a-randomized-controlled-trial
#2
Pieter F van der Meer, Paula F Ypma, Nan van Geloven, Joost A van Hilten, Rinie J van Wordragen-Vlaswinkel, Okke Eissen, Jaap J Zwaginga, MIchael Trus, Erik A M Beckers, Peter Te Boekhorst, Alan Tinmouth, Yulia Lin, Cyrus Hsia, David Lee, Philip J Norris, Raymond P Goodrich, Anneke Brand, Tor Hervig, Nancy M Heddle, Johanna G van der Bom, Jean-Louis H Kerkhoffs
Pathogen inactivation of platelet concentrates reduces the risk of blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen inactivated platelets using riboflavin and ultraviolet B illumination technology (intervention) compared to standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion treatment periods in which the patient had grade 2 or higher bleeding as defined by World Health Organization (WHO) criteria...
May 17, 2018: Blood
https://www.readbyqxmd.com/read/29770454/streamlining-a-blood-center-and-hospital-transfusion-service-supply-chain-with-an-informatics-vendor-managed-inventory-solution-development-implementation-and-3-month-follow-up
#3
Hamilton C Tsang, Adam Garcia, Robert Scott, David Lancaster, Dianne Geary, Anh-Thu Nguyen, Raina Shankar, Leslie Buchanan, Tho D Pham
BACKGROUND: The ordering process at Stanford Health Care involved twice-daily shipments predicated upon current stock levels from the blood center to the hospital transfusion service. Manual census determination is time consuming and error prone. We aimed to enhance inventory management by developing an informatics platform to streamline the ordering process and reallocate staff productivity. STUDY DESIGN AND METHODS: The general inventory accounts for more than 50 product categories based on characteristics including component, blood type, irradiation status, and cytomegalovirus serology status...
May 16, 2018: Transfusion
https://www.readbyqxmd.com/read/29768328/efficacy-and-safety-of-etomidate-midazolam-for-screening-colonoscopy-in-the-elderly-a-prospective-double-blinded-randomized-controlled-study
#4
Jung Min Lee, Geeho Min, Jae Min Lee, Seung Han Kim, Hyuk Soon Choi, Eun Sun Kim, Bora Keum, Yoon Tae Jeen, Hoon Jai Chun, Hong Sik Lee, Chang Duck Kim, Jong-Jae Park, Beom Jae Lee, Seong Ji Choi, Woojung Kim
BACKGROUND AND AIMS: Recent studies have shown that etomidate is associated with fewer serious adverse events than propofol and has a noninferior sedative effect. We investigated whether etomidate-midazolam is associated with fewer cardiopulmonary adverse events and has noninferior efficacy compared to propofol-midazolam for screening colonoscopy in the elderly. METHODS: A prospective, single-center, double-blinded, randomized controlled trial was performed. Patients aged over 65 years who were scheduled to undergo screening colonoscopy were randomized to receive either etomidate or propofol based on midazolam...
May 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29768147/as-needed-budesonide-formoterol-versus-maintenance-budesonide-in-mild-asthma
#5
Eric D Bateman, Helen K Reddel, Paul M O'Byrne, Peter J Barnes, Nanshan Zhong, Christina Keen, Carin Jorup, Rosa Lamarca, Agnieszka Siwek-Posluszna, J Mark FitzGerald
BACKGROUND: Patients with mild asthma often rely on inhaled short-acting β2 -agonists for symptom relief and have poor adherence to maintenance therapy. Another approach might be for patients to receive a fast-acting reliever plus an inhaled glucocorticoid component on an as-needed basis to address symptoms and exacerbation risk. METHODS: We conducted a 52-week, double-blind, multicenter trial involving patients 12 years of age or older who had mild asthma and were eligible for treatment with regular inhaled glucocorticoids...
May 17, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29761382/latanoprostene-bunod-ophthalmic-solution-0-024-a-review-in-open-angle-glaucoma-and-ocular-hypertension
#6
Sheridan M Hoy
Latanoprostene bunod ophthalmic solution 0.024% (hereafter referred to as latanoprostene bunod 0.024%) [Vyzulta™] is a nitric oxide (NO)-donating prostaglandin F2α analogue approved in the USA for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension. It is thought to lower IOP by increasing aqueous humour outflow through the uveoscleral pathway (mediated by latanoprost acid) and increasing the facility of aqueous humour outflow through the trabecular meshwork pathway (mediated by NO)...
May 14, 2018: Drugs
https://www.readbyqxmd.com/read/29760204/model-based-meta-analysis-to-evaluate-optimal-doses-of-direct-oral-factor-xa-inhibitors-in-atrial-fibrillation-patients
#7
Hideki Yoshioka, Hiromi Sato, Hiroto Hatakeyama, Akihiro Hisaka
The noninferiority of direct oral factor Xa (FXa) inhibitors (rivaroxaban, apixaban, and edoxaban) in treatment of atrial fibrillation were demonstrated compared with warfarin by several large clinical trials; however, subsequent meta-analyses reported a higher risk of major bleeding with rivaroxaban than with the other FXa inhibitors. In the present study, we first estimated the changes of prothrombin time (PT) in 5 randomized trials based on reported population pharmacokinetic and pharmacodynamic models and then carried out a model-based meta-analysis to obtain models describing the relationship between PT changes and the event rates of ischemic stroke/systemic embolism (SE) and of major bleeding...
May 22, 2018: Blood Advances
https://www.readbyqxmd.com/read/29759832/safety-and-efficacy-of-multipoint-pacing-in-cardiac-resynchronization-therapy-the-multipoint-pacing-trial
#8
Imran Niazi, James Baker, Raffaele Corbisiero, Charles Love, David Martin, Robert Sheppard, Seth J Worley, Niraj Varma, Kwangdeok Lee, Gery Tomassoni
OBJECTIVES: The MultiPoint Pacing (MPP) trial assessed the safety and efficacy of pacing 2 left ventricular sites with a quadripolar lead in patients with heart failure indicated for a CRT-D device. BACKGROUND: Cardiac resynchronization therapy nonresponse is a complex problem where stimulation of multiple left ventricular sites may be a solution. METHODS: Enrolled patients were indicated for a CRT-D system. Bi-ventricular (Bi-V) pacing was activated at implant...
December 26, 2017: JACC. Clinical Electrophysiology
https://www.readbyqxmd.com/read/29759785/manual-versus-robotic-catheter-ablation-for-the-treatment-of-atrial-fibrillation-the-man-and-machine-trial
#9
Andreas Rillig, Boris Schmidt, Luigi Di Biase, Tina Lin, Leonie Scholz, Christian H Heeger, Andreas Metzner, Daniel Steven, Peter Wohlmuth, Stephan Willems, Chintan Trivedi, Joseph G Galllinghouse, Andrea Natale, Feifan Ouyang, Karl-Heinz Kuck, Roland Richard Tilz
OBJECTIVES: Circumferential pulmonary vein isolation (CPVI) using irrigated radiofrequency is the most frequently used ablation technique for the treatment of atrial fibrillation worldwide. BACKGROUND: To date, no large randomized multicenter trials have evaluated the efficacy and safety of CPVI using robotic navigation (RN) systems compared with the current gold standard of manual ablation (MN). METHODS: In this prospective, international multicenter noninferiority trial, 258 patients with paroxysmal or persistent atrial fibrillation were randomized for CPVI using either RN (RN group, n = 131) or manual ablation (MN group, n = 127)...
August 2017: JACC. Clinical Electrophysiology
https://www.readbyqxmd.com/read/29754669/comparison-of-fractional-flow-reserve-and-intravascular-ultrasound-guided-intervention-strategy-for-clinical-outcomes-in-patients-with-intermediate-stenosis-flavour-rationale-and-design-of-a-randomized-clinical-trial
#10
Jeehoon Kang, Bon-Kwon Koo, Xinyang Hu, Joo Myung Lee, Joo-Yong Hahn, Hyoung-Mo Yang, Eun-Seok Shin, Chang-Wook Nam, Joon-Hyung Doh, Bong-Ki Lee, Chul Ahn, JianAn Wang, Seung-Jae Tahk
BACKGROUND: Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis...
May 2018: American Heart Journal
https://www.readbyqxmd.com/read/29752413/everolimus-with-reduced-calcineurin-inhibitor-exposure-in-renal-transplantation
#11
Julio Pascual, Stefan P Berger, Oliver Witzke, Helio Tedesco, Shamkant Mulgaonkar, Yasir Qazi, Steven Chadban, Federico Oppenheimer, Claudia Sommerer, Rainer Oberbauer, Yoshihiko Watarai, Christophe Legendre, Franco Citterio, Mitchell Henry, Titte R Srinivas, Wen-Lin Luo, AnaMaria Marti, Peter Bernhardt, Flavio Vincenti
Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR<50 ml/min per 1...
May 11, 2018: Journal of the American Society of Nephrology: JASN
https://www.readbyqxmd.com/read/29749260/effectiveness-safety-and-economic-comparison-of-inhaled-flolan-and-veletri-in-cardiothoracic-surgery-patients
#12
Jaclyn M Hawn, Matthew Wanek, Seth R Bauer, Mahmoud A Ammar, Steven Insler, Ahmad Adi, Heather Torbic
BACKGROUND: No previous studies exist examining inhaled Flolan compared with inhaled Veletri in a homogeneous cardiothoracic surgery patient population. OBJECTIVE: To compare the impact of inhaled Flolan and inhaled Veletri on the effectiveness, safety, or cost in cardiothoracic surgery patients. MATERIALS AND METHODS: This was a retrospective, noninferiority study comparing inhaled Flolan and inhaled Veletri in cardiothoracic surgery patients...
May 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29748368/cardiovascular-effects-of-new-oral-glucose-lowering-agents-dpp-4-and-sglt-2-inhibitors
#13
REVIEW
André J Scheen
Cardiovascular disease (CVD) is a major challenge in the management of type 2 diabetes mellitus. Glucose-lowering agents that reduce the risk of major cardiovascular events would be considered a major advance, as recently reported with liraglutide and semaglutide, 2 glucagon-like peptide-1 receptor agonists, and with empagliflozin and canagliflozin, 2 SGLT-2 (sodium-glucose cotransporter type 2) inhibitors, but not with DPP-4 (dipeptidyl peptidase-4) inhibitors. The present review is devoted to CV effects of new oral glucose-lowering agents...
May 11, 2018: Circulation Research
https://www.readbyqxmd.com/read/29746337/bowel-obstruction-and-ventral-hernia-after-laparoscopic-versus-open-surgery-for-rectal-cancer-in-a-randomized-trial-color-ii
#14
Josefin Petersson, Thomas W Koedam, H Jaap Bonjer, John Andersson, Eva Angenete, David Bock, Miguel A Cuesta, Charlotte L Deijen, Alois Fürst, Antonio M Lacy, Jacob Rosenberg, Eva Haglind
OBJECTIVE: The aim of this study was to evaluate the risk of bowel obstruction, incisional, and parastomal hernia following laparoscopic versus open surgery for rectal cancer. SUMMARY BACKGROUND DATA: Laparoscopic surgery for rectal cancer has been adopted worldwide, after trials reported similar oncological outcomes compared with open surgery. Little is known about long-term morbidity, including bowel obstruction, incisional, and parastomal hernia following surgery...
May 9, 2018: Annals of Surgery
https://www.readbyqxmd.com/read/29742926/iclaprim-a-dihydrofolate-reductase-inhibitor-antibiotic-in-phase-iii-of-clinical-development-a-review-of-its-pharmacology-microbiology-and-clinical-efficacy-and-safety
#15
David B Huang, Matthew Dryden
Iclaprim is under clinical development for treating acute bacterial skin and skin structure infections (ABSSSI) and nosocomial pneumonia most often due to Gram-positive bacteria, including infections due to drug-resistant bacteria. In two recent Phase III studies of patients with acute bacterial skin and skin structure infections, intravenous iclaprim 80 mg every 12 h was noninferior to dose-adjusted vancomycin. Additional studies are planned for patients with nosocomial pneumonia. Iclaprim represents an alternative for the treatment of severe skin and pulmonary infections due to Gram-positive bacteria...
May 10, 2018: Future Microbiology
https://www.readbyqxmd.com/read/29740737/comparison-of-the-analgesic-effects-of-modified-continuous-intercostal-block-and-paravertebral-block-under-surgeon-s-direct-vision-after-video-assisted-thoracic-surgery-a-randomized-clinical-trial
#16
Yuka Kadomatsu, Shoichi Mori, Harushi Ueno, Mika Uchiyama, Kenji Wakai
OBJECTIVE: Clinical evidence comparing paravertebral (PVB) and continuous intercostal nerve (ICB) blocks for pain management post video-assisted thoracic surgery (VATS) is limited. This study confirms the analgesic effect of ICB using two catheters is not inferior to that of PVB under direct vision. METHODS: Fifty patients who underwent VATS lobectomy from July 2015 to March 2016 were prospectively recruited and randomly assigned to PVB and ICB groups. Postoperative pain was assessed using the visual analog scale (VAS)...
May 8, 2018: General Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29739969/detection-of-cervical-lymph-node-metastasis-from-oral-cavity-cancer-using-a-non-radiating-noninvasive-digital-infrared-thermal-imaging-system
#17
Fan Dong, Chuansibo Tao, Ji Wu, Ying Su, Yuguang Wang, Yong Wang, Chuanbin Guo, Peijun Lyu
This study aimed to evaluate the diagnostic performance of a non-radiating, noninvasive infrared (IR) thermal imaging system in the detection of cervical lymph node metastasis from oral cavity cancer. In this prospective clinical trial, a total of 90 oral cavity cancer patients suspected of having cervical lymph node metastasis underwent IR imaging of the neck prior to neck dissection. Analysis of the IR images was performed by two methods: manual qualitative analysis and automatic analysis by an entropy-gradient support vector machine (EGSVM)...
May 8, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29739430/relax-restricted-versus-liberal-positive-end-expiratory-pressure-in-patients-without-ards-protocol-for-a-randomized-controlled-trial
#18
Anna Geke Algera, Luigi Pisani, Dennis C J Bergmans, Sylvia den Boer, Corianne A J de Borgie, Frank H Bosch, Karina Bruin, Thomas G Cherpanath, Rogier M Determann, Arjen M Dondorp, Dave A Dongelmans, Henrik Endeman, Jasper J Haringman, Janneke Horn, Nicole P Juffermans, David M van Meenen, Nardo J van der Meer, Maruschka P Merkus, Hazra S Moeniralam, Ilse Purmer, Pieter Roel Tuinman, Mathilde Slabbekoorn, Peter E Spronk, Alexander P J Vlaar, Marcelo Gama de Abreu, Paolo Pelosi, Ary Serpa Neto, Marcus J Schultz, Frederique Paulus
BACKGROUND: Evidence for benefit of high positive end-expiratory pressure (PEEP) is largely lacking for invasively ventilated, critically ill patients with uninjured lungs. We hypothesize that ventilation with low PEEP is noninferior to ventilation with high PEEP with regard to the number of ventilator-free days and being alive at day 28 in this population.  METHODS/DESIGN: The "REstricted versus Liberal positive end-expiratory pressure in patients without ARDS" trial (RELAx) is a national, multicenter, randomized controlled, noninferiority trial in adult intensive care unit (ICU) patients with uninjured lungs who are expected not to be extubated within 24 h...
May 9, 2018: Trials
https://www.readbyqxmd.com/read/29737955/comparison-of-two-neutral-oral-contrast-agents-in-pediatric-patients-a-prospective-randomized-study
#19
Jonathan R Dillman, Alexander J Towbin, Rebecca Imbus, Julie Young, Erica Gates, Andrew T Trout
Purpose To prospectively compare small bowel distention provided by, as well as patient acceptance of, two different neutral (negative) oral contrast materials used for cross-sectional enterography in a pediatric population. Materials and Methods In this noninferiority study, 66 pediatric patients undergoing clinical computed tomographic (CT) or magnetic resonance (MR) enterography were randomized to receive either a flavored beverage for neutral abdominal and pelvic imaging (Breeza; Beekley Medical, Bristol, Conn) or a low-density barium sulfate suspension...
May 8, 2018: Radiology
https://www.readbyqxmd.com/read/29736155/noninferiority-of-99m-tc-ethylenedicysteine-glucosamine-as-an-alternative-analogue-to-18-f-fluorodeoxyglucose-in-the-detection-and-staging-of-non-small-cell-lung-cancer
#20
Dong Dai, F David Rollo, Jerry Bryant, E Edmund Kim
Objective. 99m Tc-ethylenedicysteine-glucosamine (99m Tc-EC-G) was developed as a potential alternative to 18 F-FDG for cancer imaging. A Phase 2 study was conducted to compare 18 F-FDG PET/CT and 99m Tc-EC-G SPECT/CT in the detection and staging of patients with non-small cell lung cancer (NSCLC). This study was aimed to demonstrate that 99m Tc-EC-G SPECT/CT was not inferior to 18 F-FDG PET/CT in patients with confirmed NSCLC. Methods. Seventeen patients with biopsy proven NSCLC were imaged with 99m Tc-EC-G and 18 F-FDG to detect and stage their cancers...
2018: Contrast Media & Molecular Imaging
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