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https://www.readbyqxmd.com/read/28438400/arteriotomy-closure-devices-in-evar-tevar-and-tavr-a-systematic-review-and-meta-analysis-of-randomised-clinical-trials-and-cohort-studies
#1
REVIEW
B P Vierhout, R A Pol, M El Moumni, C J Zeebregts
OBJECTIVES: Cardiac and vascular surgery benefit from percutaneous interventions. Arteriotomy closure devices (ACDs) enable minimally invasive access to the common femoral artery (CFA). The objective of this review was to assess the differences between ACDs and surgical cut down (SCD) of the CFA regarding the number of complications, duration of surgery (DOS), and hospital length of stay (HLOS). DESIGN: A systematic literature search with predefined search terms was performed using MEDLINE, Embase, and the Cochrane Library (2000-2016)...
April 21, 2017: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/28438185/comparison-of-the-efficacy-between-conventional-moxibustion-and-smoke-free-moxibustion-on-knee-osteoarthritis-study-protocol-of-a-randomized-controlled-trial
#2
Lin-Lin Zhu, Jian-Ying Zhou, Ling Luo, Xiang Wang, Jia-Xi Peng, Sha-Sha Chen, Hai-Yan Yin, Qiao-Feng Wu, Cheng-Shun Zhang, Peng Lv, Yong Tang, Shu-Guang Yu
BACKGROUND: Conventional moxibustion is a representative non-drug intervention in traditional Chinese medicine, and it has been reported to produce encouraging results and benefits in relieving symptoms and improving the quality of life for patients with knee osteoarthritis (KOA) in previous clinical trials and systematic reviews. Given that increasing concerns on the safety of generated smoke from conventional moxibustion have received much attention, smoke-free moxibustion is regarded as a potential alternative...
April 24, 2017: Trials
https://www.readbyqxmd.com/read/28437197/pressure-irrigation-of-surgical-incisions-and-traumatic-wounds
#3
Donald E Fry
BACKGROUND: Pressure irrigation of surgical incisions and traumatic wounds is commonly used to prevent infections. Commercial pressure irrigation devices have proliferated rapidly, but scientific validation of clinical benefit or appropriate use remains uncertain. METHODS: The published experimental and clinical investigations of pressure irrigation have been reviewed since the introduction of the Waterpik device in 1967 to identify the evidence for use to prevent soft tissue infections associated with injury wounds or surgical incisions...
March 1, 2017: Surgical Infections
https://www.readbyqxmd.com/read/28435219/clinical-effectiveness-of-currently-available-low-vision-devices-in-glaucoma-patients-with-moderate-to-severe-vision-loss
#4
Yogesh Patodia, Elizabeth Golesic, Alex Mao, Cindy Ml Hutnik
PURPOSE: The aim of this trial is to study the effectiveness of currently available low-vision devices in glaucoma patients with moderate-to-severe vision loss. DESIGN: This is a randomized pilot clinical trial. PARTICIPANTS: Sixteen low-vision glaucoma patients participated in this study. METHODS: Patients with a best-corrected visual acuity between 20/70 and 20/400 in the better eye and a diagnosis of stable primary or secondary open-angle glaucoma were randomized to a low-vision treatment group or a nonintervention control group...
2017: Clinical Ophthalmology
https://www.readbyqxmd.com/read/28433454/a-randomized-comparison-of-three-chest-compression-techniques-and-associated-hemodynamic-effect-during-infant-cpr-a-randomized-manikin-study
#5
Jacek Smereka, Lukasz Szarpak, Antonio Rodríguez-Núñez, Jerzy R Ladny, Steve Leung, Kurt Ruetzler
INTRODUCTION: Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation. High-quality cardio-pulmonary resuscitation (CPR) is essential, but is poorly performed, even by highly skilled healthcare providers. The recently described two-thumb chest compression technique (nTTT) consists of the two thumbs directed at the angle of 90° to the chest while having the fingers fist-clenched. This technique might facilitate adequate chest-compression depth, chest-compression rate and rate of full chest-pressure relief...
April 14, 2017: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/28431226/the-impact-of-automatic-devices-for-capillary-blood-collection-on-efficiency-and-pain-response-in-newborns-a-randomized-controlled-trial
#6
G Sorrentino, M Fumagalli, S Milani, I Cortinovis, A Zorz, G Cavallaro, F Mosca, L Plevani
BACKGROUND: The heel stick is the method of choice in most neonatal units for capillary blood sampling, and it represents the most common event among all painful procedures performed on newborns. The type and design of heel stick device and the clinical procedure to collect a blood sample may have an impact on newborn pain response as well. OBJECTIVE: To compare the pain response and efficiency of different automated devices for capillary blood collection in newborns...
April 11, 2017: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/28431058/additional-electrodes-on-the-quartet%C3%A2-lv-lead-provide-more-programmable-pacing-options-than-bipolar-and-tripolar-equivalents
#7
David O'Donnell, Johannes Sperzel, Bernard Thibault, Christopher A Rinaldi, Carlo Pappone, Klaus-Jürgen Gutleben, Christopher Leclercq, Hedi Razavi, Kyungmoo Ryu, Luke C Mcspadden, Avi Fischer, Gery Tomassoni
Aims: The aim of this study was to evaluate any benefits to the number of viable pacing vectors and maximal spatial coverage with quadripolar left ventricular (LV) leads when compared with tripolar and bipolar equivalents in patients receiving cardiac resynchronization therapy (CRT). Methods and Results: A meta-analysis of five previously published clinical trials involving the Quartet™ LV lead (St Jude Medical, St Paul, MN, USA) was performed to evaluate the number of viable pacing vectors defined as capture thresholds ≤2...
April 1, 2017: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/28430909/clinical-trial-principles-and-endpoint-definitions-for-paravalvular-leaks-in-surgical-prosthesis-an-expert-statement
#8
Carlos E Ruiz, Rebecca T Hahn, Alain Berrebi, Jeffrey S Borer, Donald E Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T O'Gara, Philippe Pibarot, Stephen R Ramee, Charanjit S Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A Swain, Zoltan G Turi, E Murat Tuzcu, Neil J Weissman, Jose L Zamorano, Patrick W Serruys, Martin B Leon
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices...
April 18, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28430908/late-thrombotic-events-after-bioresorbable-scaffold-implantation-a-systematic-review-and-meta-analysis-of-randomized-clinical-trials
#9
Carlos Collet, Taku Asano, Yosuke Miyazaki, Erhan Tenekecioglu, Yuki Katagiri, Yohei Sotomi, Rafael Cavalcante, Robbert J de Winter, Takeshi Kimura, Runlin Gao, Serban Puricel, Stéphane Cook, Davide Capodanno, Yoshinobu Onuma, Patrick W Serruys
Aims: To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and Results: A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI)...
April 18, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28430319/evaluation-of-a-device-for-standardized-measurements-of-reading-performance-in-a-prepresbyopic-population
#10
Tschingis Arad, Martin Baumeister, Jens Bühren, Thomas Kohnen
PURPOSE: Automated measurements of reading performance are required for clinical trials involving presbyopia-correcting surgery options. Repeatability of a testing device for reading (Salzburg Reading Desk) was evaluated in a prepresbyopic population. METHODS: Subjective reading performance of 50 subjects divided into 2 age groups (23-30 years and 38-49 years) with distance-corrected eyes was investigated with different log-scaled reading charts. At study entry, refractive parameters were measured and distance visual acuity assessed...
April 20, 2017: European Journal of Ophthalmology
https://www.readbyqxmd.com/read/28429542/study-of-the-wearable-cardioverter-defibrillator-in-advanced-heart-failure-patients-swift
#11
Alon Barsheshet, Valentina Kutyifa, Theodora Vamvouris, Arthur J Moss, Yitschak Biton, Leway Chen, Eugene Storozynsky, Chingping Wan, Steven J Szymkiewicz, Ilan Goldenberg
INTRODUCTION: The wearable cardioverter defibrillator (WCD) may allow stabilization until reassessment for an implantable cardioverter defibrillator (ICD) among high-risk HF patients. However, there are limited data on the WCD benefit in the acute decompensated HF setting. METHODS AND RESULTS: The Study of the Wearable Cardioverter Defibrillator in Advanced Heart-Failure Patients (SWIFT) was a prospective clinical trial carried out at two medical centers. Patients hospitalized with advanced HF symptoms and reduced left ventricular ejection function (LVEF) were enrolled and prescribed a WCD prior to discharge for a total of 3 months...
April 21, 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28429185/high-content-assessment-of-cardiac-function-using-heart-on-a-chip-devices-as-drug-screening-model
#12
Genevieve Conant, Benjamin Fook Lun Lai, Rick Xing Ze Lu, Anastasia Korolj, Erika Yan Wang, Milica Radisic
Drug discovery and development continues to be a challenge to the pharmaceutical industry despite great advances in cell and molecular biology that allow for the design of better targeted therapeutics. Many potential drug compounds fail during the clinical trial due to inefficacy and toxicity that were not predicted during preclinical stages. The fundamental problem lies with the use of traditional drug screening models that still largely rely on the use of cell lines or animal cell monolayers, which leads to lack of predictive power of human tissue and organ response to the drug candidates...
April 20, 2017: Stem Cell Reviews
https://www.readbyqxmd.com/read/28428666/linear-short-term-heart-rate-variability-parameters-of-subjects-tobacco-cigarette-smokers-and-subjects-nonsmokers-in-preoperative-period
#13
Meldijana Omerbegovic
BACKGROUND: Variations of heart cycles reflect complex dynamic cardiocirculatory regulatory systems in humans. Exposure to tobacco from cigarettes has been shown to elicit specific alterations of heart rate variability parameters leading to predominance of sympathetic and decreasing parameters of parasympathetic measures of cardiac autonomic nervous system tone. AIM: The aim of the trial was assessing differences of linear parameters of heart rate variability in subjects with habit of consuming of cigarettes tobacco in regard to subjects who are not consumers of tobacco...
February 2017: Medical Archives
https://www.readbyqxmd.com/read/28428283/regulatory-aspects-of-optical-methods-and-exogenous-targets-for-cancer-detection
#14
Willemieke S Tummers, Jason M Warram, Kiranya E Tipirneni, John Fengler, Paula Jacobs, Lalitha Shankar, Lori Henderson, Betsy Ballard, Brian W Pogue, Jamey P Weichert, Michael Bouvet, Jonathan Sorger, Christopher H Contag, John V Frangioni, Michael F Tweedle, James P Basilion, Sanjiv S Gambhir, Eben L Rosenthal
Considerable advances in cancer-specific optical imaging have improved the precision of tumor resection. In comparison to traditional imaging modalities, this technology is unique in its ability to provide real-time feedback to the operating surgeon. Given the significant clinical implications of optical imaging, there is an urgent need to standardize surgical navigation tools and contrast agents to facilitate swift regulatory approval. Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process...
April 20, 2017: Cancer Research
https://www.readbyqxmd.com/read/28427582/clinical-trial-principles-and-endpoint-definitions-for-paravalvular-leaks-in-surgical-prosthesis-an-expert-statement
#15
REVIEW
Carlos E Ruiz, Rebecca T Hahn, Alain Berrebi, Jeffrey S Borer, Donald E Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T O'Gara, Philippe Pibarot, Stephen R Ramee, Charanjit S Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A Swain, Zoltan G Turi, E Murat Tuzcu, Neil J Weissman, Jose L Zamorano, Patrick W Serruys, Martin B Leon
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices...
April 25, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28427321/in-silico-assessment-of-biomedical-products-the-conundrum-of-rare-but-not-so-rare-events-in-two-case-studies
#16
Marco Viceconti, Claudio Cobelli, Tarek Haddad, Adam Himes, Boris Kovatchev, Mark Palmer
In silico clinical trials, defined as "The use of individualized computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention," have been proposed as a possible strategy to reduce the regulatory costs of innovation and the time to market for biomedical products. We review some of the the literature on this topic, focusing in particular on those applications where the current practice is recognized as inadequate, as for example, the detection of unexpected severe adverse events too rare to be detected in a clinical trial, but still likely enough to be of concern...
May 2017: Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine
https://www.readbyqxmd.com/read/28427054/preceding-intravenous-thrombolysis-in-patients-receiving-endovascular-therapy
#17
Hong-Kyun Park, Jong-Won Chung, Jeong-Ho Hong, Min Uk Jang, Hyun-Du Noh, Jong-Moo Park, Kyusik Kang, Soo Joo Lee, Youngchai Ko, Jae Guk Kim, Jae-Kwan Cha, Dae-Hyun Kim, Hyun-Wook Nah, Moon-Ku Han, Beom Joon Kim, Tai Hwan Park, Sang-Soon Park, Kyung Bok Lee, Jun Lee, Keun-Sik Hong, Yong-Jin Cho, Byung-Chul Lee, Kyung-Ho Yu, Mi-Sun Oh, Ki-Hyun Cho, Joon-Tae Kim, Dong-Eog Kim, Wi-Sun Ryu, Jay Chol Choi, Wook-Joo Kim, Dong-Ick Shin, Min-Ju Yeo, Sung Il Sohn, Ji Sung Lee, Juneyoung Lee, Byung-Woo Yoon, Hee-Joon Bae
BACKGROUND: The beneficial effects of endovascular therapy (EVT) in acute ischemic stroke have been demonstrated in recent clinical trials using new-generation thrombectomy devices. However, the comparative effectiveness and safety of preceding intravenous thrombolysis (IVT) in this population has rarely been evaluated. METHODS: From a prospective multicenter stroke registry database in Korea, we identified patients with acute ischemic stroke who were treated with EVT within 8 h of onset and admitted to 14 participating centers during 2008-2013...
April 21, 2017: Cerebrovascular Diseases
https://www.readbyqxmd.com/read/28424922/assistive-technology-for-ultrasound-guided-central-venous-catheter-placement
#18
REVIEW
Mohammad Ikhsan, Kok Kiong Tan, Andi Sudjana Putra
This study evaluated the existing technology used to improve the safety and ease of ultrasound-guided central venous catheterization. Electronic database searches were conducted in Scopus, IEEE, Google Patents, and relevant conference databases (SPIE, MICCAI, and IEEE conferences) for related articles on assistive technology for ultrasound-guided central venous catheterization. A total of 89 articles were examined and pointed to several fields that are currently the focus of improvements to ultrasound-guided procedures...
April 19, 2017: Journal of Medical Ultrasonics
https://www.readbyqxmd.com/read/28424889/quality-of-life-with-biweekly-docetaxel-and-capecitabine-in-advanced-gastro-oesophageal-cancer
#19
E A Korkeila, T Salminen, R Kallio, M Mikkola, P Auvinen, S Pyrhönen, R Ristamäki
PURPOSE: This study aimed to evaluate the feasibility and tolerability of biweekly docetaxel with capecitabine as first-line treatment in advanced gastro-oesophageal cancer. METHODS: Fifty-three patients at median age of 61 years with advanced gastric cancer were included in this prospective, non-randomized, multicentre phase II trial to receive intravenous docetaxel 50 mg/m(2) on days 1 and 15, and oral capecitabine 1250 mg/m(2) every 12 h, on days 1-7 and 15-21 of each 28-day cycle...
April 20, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28424223/low-dose-paclitaxel-coated-versus-uncoated-percutaneous-transluminal-balloon-angioplasty-for-femoropopliteal-peripheral-artery-disease-1-year-results-of-the-illumenate-european-randomized-clinical-trial
#20
Henrik Schroeder, Martin Werner, Dirk-Roelfs Meyer, Peter Reimer, Karsten Krüger, Michael R Jaff, Marianne Brodmann
Background -Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease (PAD) of the superficial femoral and popliteal arteries. However, the treatment effect compared to an uncoated balloon has differed greatly amongst the randomized trials with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low dose (2 µg/mm(2) surface dose of paclitaxel) DCB...
April 19, 2017: Circulation
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