keyword
MENU ▼
Read by QxMD icon Read
search

Device clinical trial

keyword
https://www.readbyqxmd.com/read/28819983/an-evaluation-of-the-effectiveness-of-a-risk-based-monitoring-approach-implemented-with-clinical-trials-involving-implantable-cardiac-medical-devices
#1
Christopher A Diani, Angie Rock, Phil Moll
Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28818225/patient-centered-outcomes-of-a-dual-action-pneumatic-compression-device-in-comparison-to-compression-stockings-for-patients-with-chronic-venous-disease
#2
Fedor Lurie, Marc Schwartz
OBJECTIVE: The ACTitouch (AT) device (Tactile Medical, Minneapolis, Minn) represents a new generation of pneumatic compression devices by combining sustained compression with intermittent pneumatic compression. The sustained compression mode provides automatic pressure adjustment every 30 minutes, ensuring pressure consistency regardless of leg volume changes and environmental influences. Designed for mobile patients, this device has not been studied in comparison to standard compression stockings (CS)...
September 2017: Journal of Vascular Surgery. Venous and Lymphatic Disorders
https://www.readbyqxmd.com/read/28814016/applying-a-soft-robotic-glove-as-assistive-device-and-training-tool-with-games-to-support-hand-function-after-stroke-preliminary-results-on-feasibility-and-potential-clinical-impact
#3
Gerdienke B Prange-Lasonder, Bob Radder, Anke I R Kottink, Alejandro Melendez-Calderon, Jaap H Buurke, Johan S Rietman
Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored...
July 2017: IEEE ... International Conference on Rehabilitation Robotics: [proceedings]
https://www.readbyqxmd.com/read/28812129/-device-based-remote-monitoring-current-evidence
#4
REVIEW
David Duncker, Roman Michalski, Johanna Müller-Leisse, Christos Zormpas, Thorben König, Christian Veltmann
Telemedicine is increasingly used in clinical cardiology. It offers early detection of arrhythmias, technical device follow-up and support of heart failure management. Regarding technical device follow-up, remote monitoring significantly reduces usage of the health care system. Furthermore, remote monitoring is associated with a significantly reduced time from device malfunction to physician's perception of the event. Using remote monitoring, inappropriate ICD (implantable cardioverter defibrillator) shocks can be significantly reduced compared to routine in-office follow-up...
August 15, 2017: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/28810022/characteristics-of-clinical-studies-used-for-us-food-and-drug-administration-approval-of-high-risk-medical-device-supplements
#5
Sarah Y Zheng, Sanket S Dhruva, Rita F Redberg
Importance: High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. Objective: To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data)...
August 15, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28809670/cardio-pulmonary-stethoscope-clinical-validation-with-heart-failure-and-hemodialysis-patients
#6
Magdy F Iskander, Todd B Seto, Ruthsenne Rg Perron, Eunjung Lim, Farhan Qazi
OBJECTIVE: The purpose of this study is to evaluate the accuracy of a noninvasive radiofrequency-based device, the Cardio-Pulmonary Stethoscope (CPS), to monitor heart and respiration rates and detect changes in lung water content in human experiments and clinical trials. METHODS: Three human populations (healthy subjects (n=4), heart failure (n=12) and hemodialysis (n=13) patients) were enrolled in this study. The study was conducted at the University of Hawaii and The Queen's Medical Center in Honolulu, HI...
August 14, 2017: IEEE Transactions on Bio-medical Engineering
https://www.readbyqxmd.com/read/28809602/fertility-preservation-and-sexual-health-after-cancer-therapy
#7
Nigel Pereira, Glenn L Schattman
Recent developments in cancer diagnostics and treatments have considerably improved long-term survival rates. Despite improvements in chemotherapy regimens, more focused radiotherapy and diverse surgical options, cancer treatments often have gonadotoxic side-effects that can manifest as loss of fertility or sexual dysfunction, particularly in young cancer survivors. In this review, we focus on two pertinent quality-of-life issues in female cancer survivors of reproductive age-fertility preservation and sexual function...
August 15, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28806199/does-late-hip-dysplasia-occur-after-normal-ultrasound-screening-in-breech-babies
#8
Andrew R Morris, Joanna M C Thomas, Isabel C Reading, Nicholas M P Clarke
BACKGROUND: Recent literature has raised concern regarding the occurrence of late dysplasia after normal screening in breech babies. One paper states a late dysplasia incidence of 29%. This finding is in contrast with other published work, which suggests breech presentation is predictive of spontaneous stabilization of the unstable neonatal hip. We decided to identify the rate of late dysplasia after normal screening in our patient cohort and also to investigate the use of a prophylactic abduction diaper...
August 11, 2017: Journal of Pediatric Orthopedics
https://www.readbyqxmd.com/read/28805066/active-controlled-motion-in-early-rehabilitation-improves-outcome-after-ankle-fractures-a-randomized-controlled-trial
#9
Hendrik Jansen, Martin Jordan, Sönke Frey, Stefanie Hölscher-Doht, Rainer Meffert, Timo Heintel
OBJECTIVE: To evaluate the use of active controlled motion (ACM) after unstable ankle fractures needing initial partial weight-bearing. DESIGN: Prospective randomized controlled trial. SETTING: Inpatient and outpatient clinic. SUBJECTS: A total of 50 patients with unstable ankle fractures and the need for partial weight-bearing for six weeks. INTERVENTIONS: Randomization in two groups: physiotherapy alone or physiotherapy with an additional ACM device...
August 1, 2017: Clinical Rehabilitation
https://www.readbyqxmd.com/read/28802925/objective-measurement-and-monitoring-of-nonmotor-symptoms-in-parkinson-s-disease
#10
Lisa Klingelhoefer, Onanong Jitkritsadakul, Roongroj Bhidayasiri
The comprehensive evaluation of nonmotor symptoms (NMS) in Parkinson's disease (PD) starts with the awareness of physicians, patients, and caregivers on their nature, clinical presentation, and effect on patient's daily activities and quality of life. This awareness can be better achieved if the symptoms can be visualized, measured, and monitored. As NMS are largely subjective in nature, a majority of them cannot be visualized (unlike tremor, which is easily seen), making their identification and quantification difficult...
2017: International Review of Neurobiology
https://www.readbyqxmd.com/read/28801304/how-accurate-is-your-activity-tracker-a-comparative-study-of-step-counts-in-low-intensity-physical-activities
#11
Parastoo Alinia, Chris Cain, Ramin Fallahzadeh, Armin Shahrokni, Diane Cook, Hassan Ghasemzadeh
BACKGROUND: As commercially available activity trackers are being utilized in clinical trials, the research community remains uncertain about reliability of the trackers, particularly in studies that involve walking aids and low-intensity activities. While these trackers have been tested for reliability during walking and running activities, there has been limited research on validating them during low-intensity activities and walking with assistive tools. OBJECTIVE: The aim of this study was to (1) determine the accuracy of 3 Fitbit devices (ie, Zip, One, and Flex) at different wearing positions (ie, pants pocket, chest, and wrist) during walking at 3 different speeds, 2...
August 11, 2017: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/28800725/a-novel-thermal-compression-device-for-perioperative-warming-a-randomized-trial-for-feasibility-and-efficacy
#12
Peter Luke Santa Maria, Chloe Santa Maria, Andreas Eisenried, Nathalia Velasquez, Brian Thomas Kannard, Abhinav Ramani, David Mark Kahn, Amanda Jane Wheeler, John Gerhard Brock-Utne
BACKGROUND: Inadvertent perioperative hypothermia (IPH) leads to surgical complications and increases length of stay. IPH rates are high with the current standard of care, forced air warming (FAW). Our hypothesis is that a prototype thermal compression device that heats the popliteal fossa and soles of the feet, with lower leg compression, increases perioperative temperatures and reduces IPH compared to the current standard of care. METHODS: Thirty six female breast surgery patients, at a tertiary academic hospital, were randomized to the device or intraoperative FAW (stage I) with a further 18 patients randomized to the device with a single heating area only (stage II, popliteal fossa or sole of the feet)...
August 11, 2017: BMC Anesthesiology
https://www.readbyqxmd.com/read/28800313/clinical-validation-of-the-ce-ivd-marked-therascreen-mgmt-kit-in-a-cohort-of-glioblastoma-patients
#13
Véronique Quillien, Audrey Lavenu, François Ducray, David Meyronet, Olivier Chinot, Frédéric Fina, Marc Sanson, Catherine Carpentier, Lucie Karayan-Tapon, Pierre Rivet, Natacha Entz-Werle, Michèle Legrain, Emmanuèle Lechapt Zalcman, Guenaelle Levallet, Fabienne Escande, Carole Ramirez, Dan Chiforeanu, Elodie Vauleon, Dominique Figarella-Branger
BACKGROUND: Pyrosequencing is recognized as a strong technique to analyze the MGMT status of glioblastoma patients. The most commonly used assay, quantifies the methylation levels of CpGs 74 to 78. A more recent CE-marked In Vitro Diagnostic Medical Device (CE-IVD) assay, Therascreen, analyzes CpGs 76-79. METHODS: We performed a comparison of these two assays to evaluate the potential impact of this shift in analyzed CpGs. Therascreen analysis was centrally performed for 102 glioblastoma patients, who were part of a prospective multicenter trial...
July 31, 2017: Cancer Biomarkers: Section A of Disease Markers
https://www.readbyqxmd.com/read/28798898/dark-adapted-chromatic-perimetry-for-measuring-rod-visual-fields-in-patients-with-retinitis-pigmentosa
#14
Lea D Bennett, Martin Klein, Kirsten G Locke, Kelly Kiser, David G Birch
PURPOSE: Although rod photoreceptors are initially affected in retinitis pigmentosa (RP), the full-field of rod vision is not routinely characterized due to the unavailability of commercial devices detecting rod sensitivity. The purpose of this study was to quantify rod-mediated vision in the peripheral field from patients with RP using a new commercially available perimeter. METHODS: Participants had one eye dilated and dark-adapted for 45 minutes. A dark-adapted chromatic (DAC) perimeter tested 80 loci 144° horizontally and 72° vertically with cyan stimuli...
July 2017: Translational Vision Science & Technology
https://www.readbyqxmd.com/read/28795890/point-of-care-fluorescence-imaging-predicts-the-presence-of-pathogenic-bacteria-in-wounds-a-clinical-study
#15
M Y Rennie, L Lindvere-Teene, K Tapang, R Linden
OBJECTIVE: Bacteria in chronic wounds are invisible to the naked eye and can lead to delayed wound healing. Point-of-care bacterial fluorescence imaging illuminates a wound with 405nm light, triggering bacteria to produce red fluorescence and enabling real-time bacterial localisation. Prospective, single-blind clinical trials (clinicaltrials.gov #NCT02682069, #NCT03091361) were conducted to determine the positive predictive value (PPV) of this red fluorescence for detecting bacteria in chronic wounds...
August 2, 2017: Journal of Wound Care
https://www.readbyqxmd.com/read/28795688/interventional-and-surgical-occlusion-of-the-left-atrial-appendage
#16
REVIEW
Etem Caliskan, James L Cox, David R Holmes, Bernhard Meier, Dhanunjaya R Lakkireddy, Volkmar Falk, Sacha P Salzberg, Maximilian Y Emmert
With a steadily increasing prevalence, atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and an independent risk factor for stroke caused by thromboembolic events. The left atrial appendage (LAA) is the primary source of thromboemboli in patients with nonvalvular AF who have a stroke. Novel strategies (such as mechanical and nonpharmacological intervention) targeting the LAA in patients with AF for stroke prevention have become a major focus during the past decade. Some devices for percutaneous LAA occlusion are supported by robust clinical data obtained from randomized trials or large registries, and are a valid alternative to pharmacological stroke prevention...
August 10, 2017: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/28794001/randomized-comparison-of-ridaforolimus-eluting-and-zotarolimus-eluting-coronary-stents-in-patients-with-coronary-artery-disease-primary-results-from-the-bionics-trial
#17
David E Kandzari, Pieter C Smits, Michael P Love, Ori Ben-Yehuda, Shmuel Banai, Simon D Robinson, Michael Jonas, Ran Kornowski, Rodrigo Bagur, Andres Iniguez, Haim D Danenberg, Robert L Feldman, Rajiv Jauhar, Harish Chandna, Manish A Parikh, Gidon Y Perlman, Mercedes Balcells, Peter M Markham, Melek Ozgu Ozan, Philippe Genereux, Elazer Edelman, Martin B Leon, Gregg W Stone
Background -The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. Methods -A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RES) and slow-release zotarolimus-eluting stents (ZES) among 1,919 patients at 76 centers undergoing percutaneous coronary intervention...
August 9, 2017: Circulation
https://www.readbyqxmd.com/read/28790042/multicentre-randomised-controlled-trial-to-investigate-the-usefulness-of-continuous-pneumatic-regulation-of-tracheal-cuff-pressure-for-reducing-ventilator-associated-pneumonia-in-mechanically-ventilated-severe-trauma-patients-the-agate-study-protocol
#18
Nicolas Marjanovic, Denis Frasca, Karim Asehnoune, Catherine Paugam, Sigismond Lasocki, Carole Ichai, Jean-Yves Lefrant, Marc Leone, Claire Dahyot-Fizelier, Julien Pottecher, Dominique Falcon, Benoit Veber, Jean-Michel Constantin, Sabrina Seguin, Jérémy Guénézan, Olivier Mimoz
INTRODUCTION: Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP...
August 7, 2017: BMJ Open
https://www.readbyqxmd.com/read/28781248/long-term-data-of-brs-presented-at-europcr-2017-friday-19-may
#19
Patrick W Serruys, Athanasios Katsikis, Yoshinobu Onuma
Bioresorbable scaffolds (BRS) were designed more than 30 years ago to overcome the disadvantages related to the permanent implantation of a metallic stent and, at present, a number of these devices have obtained a CE mark on the basis of midterm follow-up studies. However, although BRS have already been introduced into clinical practice, intensive research is ongoing worldwide to clarify their long-term safety and effectiveness. This type of research has captivated the interest of the cardiovascular community after the recent publication of long-term follow-up data from randomised trials demonstrating increased late scaffold thrombosis in the Absorb™ BRS (Abbott Vascular, Santa Clara, CA, USA)...
August 4, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28780900/results-from-a-clinical-trial-evaluating-the-efficacy-of-real-time-body-surface-visual-feedback-in-reducing-patient-motion-during-lung-cancer-radiotherapy
#20
Gareth J Price, Corinne Faivre-Finn, Julia Stratford, Sheena Chauhan, Michelle Bewley, Laura Clarke, Corinne N Johnson, Christopher J Moore
INTRODUCTION: Optical surface measurement devices are a maturing technology in radiotherapy. The challenge for such devices is to demonstrate how they can improve clinical care. We present results from a phase 1 clinical trial designed to test the hypothesis that if presented with live data from a novel optical measurement device, showing their deviation from an ideal radiotherapy treatment position, patients will be able to better control their motion and increase their geometrical conformance...
August 7, 2017: Acta Oncologica
keyword
keyword
17894
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"