keyword
MENU ▼
Read by QxMD icon Read
search

Device clinical trial

keyword
https://www.readbyqxmd.com/read/28732252/update-on-medical-treatment-of-uterine-fibroids
#1
REVIEW
Fátima Faustino, Margarida Martinho, José Reis, Fernanda Águas
OBJECTIVES: In this review paper, the pros and cons of the available pharmacological options for the treatment of uterine fibroids are explored, including oral progestogens, levonorgestrel intra-uterine device, gonadotropin-releasing hormone analogs and progesterone receptor modulators with an emphasis on ulipristal acetate. STUDY DESIGN: The choice of the appropriate therapeutic approach for uterine fibroids depends on several factors, including women's age, parity, childbearing aspirations and wish to preserve fertility, extent and severity of symptoms, size, number and location of myomas, risk of malignancy and proximity to menopause...
July 8, 2017: European Journal of Obstetrics, Gynecology, and Reproductive Biology
https://www.readbyqxmd.com/read/28731889/stent-thrombosis-with-bioabsorbable-polymer-drug-eluting-stents-insights-from-the-food-and-drug-administration-database
#2
Abdur R Khan, Avnish Tripathi, Talha A Farid, Bilal Abaid, Deepak L Bhatt, Jon R Resar, Michael P Flaherty
BACKGROUND: SYNERGY, a bioabsorbable polymer-based, everolimus-eluting stent (BP-DES), recently received regulatory approval in the USA for use in percutaneous coronary interventions. Yet, information on the safety of BP-DES in routine clinical practice is limited. Our aim was to compare the safety of the recently approved BP-DES with current durable polymer drug-eluting stents (DP-DES) by analyzing adverse events, namely, stent thrombosis (ST), reported to the Manufacturer and User Facility Device Experience (MAUDE) database...
July 20, 2017: Coronary Artery Disease
https://www.readbyqxmd.com/read/28730949/eric-acute-stroke-recanalization-a-study-using-predictive-analytics-to-assess-a-new-device-for-mechanical-thrombectomy
#3
Susanne Siemonsen, Nils D Forkert, Martina Bernhardt, Götz Thomalla, Martin Bendszus, Jens Fiehler
Aim and hypothesis Using a new study design, we investigate whether next-generation mechanical thrombectomy devices improve clinical outcomes in ischemic stroke patients. We hypothesize that this new methodology is superior to intravenous tissue plasminogen activator therapy alone. Methods and design ERic Acute StrokE Recanalization is an investigator-initiated prospective single-arm, multicenter, controlled, open label study to compare the safety and effectiveness of a new recanalization device and distal access catheter in acute ischemic stroke patients with symptoms attributable to acute ischemic stroke and vessel occlusion of the internal cerebral artery or middle cerebral artery...
August 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28730536/effectiveness-and-feasibility-of-robotic-gastric-neurostimulator-placement-in-patients-with-refractory-gastroparesis
#4
Mia Mowzoon, Francisco Igor B Macedo, Jaskiran Kaur, Ramachandra Kolachalam
Gastric neurostimulation (GNS) with Enterra(®) therapy device (Medtronic, Minneapolis, MN) appears as the last resort for patients with refractory gastroparesis. Currently, the device has Humanitarian Use status by Food and Drug Administration, thereby requiring further investigation. We aim to describe its feasibility and clinical outcomes using robotic technique. From June 2014 to September 2016, 15 consecutive patients underwent robotic insertion of Enterra(®) device. Patient demographics, comorbidities, and clinical outcomes including mortality, length of stay, readmission rates, reoperation and complications were retrospectively collected...
July 20, 2017: Journal of Robotic Surgery
https://www.readbyqxmd.com/read/28729806/evidence-provided-for-the-use-of-oscillating-instruments-in-restorative-dentistry-a-systematic-review
#5
REVIEW
Panagiotis Ntovas, Spyridon Doukoudakis, John Tzoutzas, Panagiotis Lagouvardos
Oscillating diamond instruments are considered gentle sources for the removal of demineralized tooth hard tissues and the preparation of cavity angles and margins needed in minimally invasive dentistry. However, there is a question if literature provides enough evidence for their efficacy in restorative dentistry procedures. A literature search until May 2016 was conducted, using PubMed, Scopus, and The Cochrane Central Register of Controlled Trials databases. The quality of the studies was assessed using the recommendation of the Oxford Centre for Evidence-based Medicine...
April 2017: European Journal of Dentistry
https://www.readbyqxmd.com/read/28729382/recommended-clinical-trial-end-points-for-dialysis-catheters
#6
Michael Allon, Deborah J Brouwer-Maier, Kenneth Abreo, Kevin M Baskin, Kay Bregel, Deepa H Chand, Andrea M Easom, Leonard Mermel, Michele H Mokrzycki, Priti R Patel, Prabir Roy-Chaudhury, Surendra Shenoy, Rudolph P Valentini, Haimanot Wasse
Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration...
July 20, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/28729250/stellarex-drug-coated-balloon-for-treatment-of-femoropopliteal-disease-12-month-outcomes-from-the-randomized-illumenate-pivotal-and-pharmacokinetic-studies
#7
Prakash Krishnan, Peter Faries, Khusrow Niazi, Ash Jain, Ravish Sachar, William B Bachinsky, Joseph A Cardenas, Martin Werner, Marianne Brodmann, J A Mustapha, Carlos I Mena-Hurtado, Michael R Jaff, Andrew H Holden, Sean P Lyden
Background -Drug-coated balloons (DCB) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Due to differences in excipients, paclitaxel dose and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of two studies investigating the pharmacokinetic (PK) and clinical outcomes of a new DCB to treat femoropopliteal disease. Methods -In the ILLUMENATE Pivotal Study, 300 symptomatic patients (Rutherford class 2-4), were randomized to DCB (N=200) or standard angioplasty (PTA) (N=100)...
July 20, 2017: Circulation
https://www.readbyqxmd.com/read/28728922/existing-reporting-guidelines-for-clinical-trials-are-not-completely-relevant-for-implantable-medical-devices-a-systematic-review
#8
REVIEW
Anne-France Motte, Stéphanie Diallo, Hélène van den Brink, Constance Châteauvieux, Carole Serrano, Carole Naud, Julie Steelandt, Jean-Marc Alsac, Pierre Aubry, Florence Cour, Olivier Pellerin, Judith Pineau, Patrice Prognon, Isabelle Borget, Brigitte Bonan, Nicolas Martelli
OBJECTIVE: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices and to identify reporting guidelines which include these items. STUDY DESIGN AND SETTING: A panel of experts identified the most relevant items for evaluating implantable medical devices from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting...
July 17, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28728580/lumbar-microdiscectomy-and-post-operative-activity-restrictions-a-protocol-for-a-single-blinded-randomised-controlled-trial
#9
Chris D Daly, Kai Zheong Lim, Jennifer Lewis, Kelly Saber, Mohammed Molla, Naor Bar-Zeev, Tony Goldschlager
BACKGROUND: Lumbar microdiscectomy is the most commonly performed spinal surgery procedure, with over 300,000 cases performed annually in the United States alone. Traditionally, patients were advised to restrict post-operative activity as this was believed to reduce the risk of disc reherniation and progressive instability. However, this practice would often delay patients return to work. In contemporary practice many surgeons do not restrict patient post-operative activity due to the perception this practice is unnecessary...
July 20, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28727896/proseal-versus-classic-laryngeal-mask-airway-lma-for-positive-pressure-ventilation-in-adults-undergoing-elective-surgery
#10
REVIEW
Muhammad Qamarul Hoda, Khalid Samad, Hameed Ullah
BACKGROUND: The development of supraglottic airway devices has revolutionized airway management during general anaesthesia. Two devices are widely used in clinical practice to facilitate positive pressure ventilation: the ProSeal laryngeal mask airway (pLMA) and the Classic laryngeal mask airway (cLMA). It is not clear whether these devices have important clinical differences in terms of efficacy or complications. OBJECTIVES: To compare the effectiveness of the ProSeal laryngeal mask airway (pLMA) and the Classic LMA (cLMA) for positive pressure ventilation in adults undergoing elective surgery...
July 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28727672/cardiac-rehabilitation-in-patients-with-left-ventricular-assist-device-a-systematic-review-and-meta-analysis
#11
Toufik Mahfood Haddad, Alok Saurav, Aiman Smer, Muhammad S Azzouz, Abhilash Akinapelli, Mark A Williams, Venkata M Alla
PURPOSE: Exercise-based cardiac rehabilitation (EBCR) has been demonstrated to improve functional capacity in heart failure (HF). However, there are limited data on the effect of EBCR in patients with advanced HF and left ventricular assist devices (LVADs). This meta-analysis sought to evaluate the effects of EBCR on functional capacity in patients with LVAD. METHODS: PubMed, Web of Science, CINAHL, and Cochrane Library databases were searched for randomized studies assessing the impact of EBCR in patients following LVAD implantation compared with standard therapy (ST)...
July 19, 2017: Journal of Cardiopulmonary Rehabilitation and Prevention
https://www.readbyqxmd.com/read/28727156/safety-and-effectiveness-of-a-6-french-mri-conditional-pacemaker-lead-the-ingevitytm-clinical-investigation-study-results
#12
Jens C Nielsen, Michael Giudici, Jose Maria Tolasana Viu, Engwooi Chew, Elke Sommerijns, Nicholas Wold, Linda Evert, Charles J Love, Kenneth Stein, Hedrich Olaf
BACKGROUND: The design of pacemaker leads has continued to evolve; ease of lead handling, improved electrical performance and MRI conditional aspects have become more important, while safety remains critical. The INGEVITY™ family leads was designed to provide MRI conditional aspects, decreased diameter, and improved performance of pacemaker leads. The INGEVITY study is an investigational device exemption trial evaluating the acute and chronic safety and effectiveness of these leads...
July 20, 2017: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/28726148/first-human-use-of-hybrid-synthetic-biologic-mesh-in-ventral-hernia-repair-a-multicenter-trial
#13
James G Bittner, Kevin El-Hayek, Andrew T Strong, Melissa Phillips LaPinska, Jin S Yoo, Eric M Pauli, Matthew Kroh
BACKGROUND: Mesh options for reinforcement of ventral/incisional hernia (VIH) repair include synthetic or biologic materials. While each material has known advantages and disadvantages, little is understood about outcomes when these materials are used in combination. This multicenter study reports on the first human use of a novel synthetic/biologic hybrid mesh (Zenapro(®) Hybrid Hernia Repair Device) for VIH repair. METHODS: This prospective, multicenter post-market clinical trial enrolled consecutive adults who underwent elective VIH repair with hybrid mesh placed in the intraperitoneal or retromuscular/preperitoneal position...
July 19, 2017: Surgical Endoscopy
https://www.readbyqxmd.com/read/28725597/canine-prostate-models-in-preclinical-studies-of-minimally-invasive-interventions-part-i-canine-prostate-anatomy-and-prostate-cancer-models
#14
REVIEW
Fei Sun, Claudia Báez-Díaz, Francisco Miguel Sánchez-Margallo
The high prevalence of prostate cancer (PCa) in elderly men and technical advances in early detection of localized PCa have led to continued efforts to develop new therapeutic options of minimally invasive nature in current urologic oncology community. Increasing newly emerging therapies are undergoing preclinical tests on the technical feasibility, efficacy and safety in animal experiments. The dog is an ideal large animal because of its similar anatomy to human and the capability allowing the use of the same medical devices applied in future clinical trials...
June 2017: Translational Andrology and Urology
https://www.readbyqxmd.com/read/28724752/the-fluid-mechanics-of-transcatheter-heart-valve-leaflet-thrombosis-in-the-neo-sinus
#15
Prem A Midha, Vrishank Raghav, Rahul Sharma, Jose F Condado, Ikechukwu U Okafor, Tanya Rami, Gautam Kumar, Vinod H Thourani, Hasan Jilaihawi, Vasilis Babaliaros, Raj R Makkar, Ajit P Yoganathan
Background -Transcatheter heart valve (THV) thrombosis has been increasingly reported. In these studies, thrombus quantification has been based on 2D assessment of a 3D phenomenon. Methods -Post-procedural four-dimensional, volume-rendered CT (4DCT) data of CoreValve, Evolut R, and SAPIEN 3 transcatheter aortic valve replacement (TAVR) patients enrolled in the RESOLVE trial were included in this analysis. Patients on anticoagulation were excluded. SAPIEN 3 and CoreValve/Evolut R patients with and without hypo-attenuated leaflet thickening (HALT) were included in order to study differences between groups...
July 19, 2017: Circulation
https://www.readbyqxmd.com/read/28724309/effects-of-long-term-device-guided-slow-breathing-on-sympathetic-nervous-activity-in-hypertensive-patients-a-randomized-open-label-clinical-trial
#16
Silvana de Barros, Giovanio Vieira da Silva, Josiane Lima de Gusmão, Tatiana Goveia de Araújo, Dinoélia Rosa de Souza, Crivaldo Gomes Cardoso, Bruna Oneda, Décio Mion
PURPOSE: Device-guided slow breathing (DGB) is indicated as nonpharmacological treatment for hypertension. The sympathetic nerve activity (SNA) reduction may be one of the mechanisms involved in blood pressure (BP) decrease. The aim of this study is to evaluate the long-term use of DGB in BP and SNA. SUBJECTS AND METHODS: Hypertensive patients were randomized to listen music (Control Group-CG) or DGB (aim to reduce respiratory rate to less than 10 breaths/minute during 15 minutes/day for 8 weeks)...
July 20, 2017: Blood Pressure
https://www.readbyqxmd.com/read/28723718/three-dimensional-head-mounted-gaming-task-procedure-maximizes-effects-of-vestibular-rehabilitation-in-unilateral-vestibular-hypofunction-a-randomized-controlled-pilot-trial
#17
Alessandro Micarelli, Andrea Viziano, Ivan Augimeri, Domenico Micarelli, Marco Alessandrini
Considering the emerging advantages related to virtual reality implementation in clinical rehabilitation, the aim of the present study was to discover possible (i) improvements achievable in unilateral vestibular hypofunction patients using a self-assessed head-mounted device (HMD)-based gaming procedure when combined with a classical vestibular rehabilitation protocol (HMD group) as compared with a group undergoing only vestibular rehabilitation and (ii) HMD procedure-related side effects. Therefore, 24 vestibular rehabilitation and 23-matched HMD unilateral vestibular hypofunction individuals simultaneously underwent a 4-week rehabilitation protocol...
July 18, 2017: International Journal of Rehabilitation Research. Revue Internationale de Recherches de Réadaptation
https://www.readbyqxmd.com/read/28720557/comparing-mobile-health-strategies-to-improve-medication-adherence-for-veterans-with-coronary-heart-disease-mobile4meds-protocol-for-a-mixed-methods-study
#18
Linda G Park, Eileen G Collins, Janet K Shim, Mary A Whooley
BACKGROUND: Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. OBJECTIVE: The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI...
July 18, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28719996/efficacy-of-short-term-robot-assisted-rehabilitation-in-patients-with-hand-paralysis-after-stroke-a-randomized-clinical-trial
#19
Jorge H Villafañe, Giovanni Taveggia, Silvia Galeri, Luciano Bissolotti, Chiara Mullè, Grace Imperio, Kristin Valdes, Alberto Borboni, Stefano Negrini
BACKGROUND: We evaluated the effectiveness of robot-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT) on stroke patients with hand paralysis. METHODS: A randomized controlled trial was conducted. Thirty-two patients, 34.4% female (mean ± SD age: 68.9 ± 11.6 years), with hand paralysis after stroke participated. The experimental group received 30 minutes of passive mobilization of the hand through the robotic device Gloreha (Brescia, Italy), and the control group received an additional 30 minutes of PT and OT for 3 consecutive weeks (3 d/wk) in addition to traditional rehabilitation...
February 1, 2017: Hand: Official Journal of the American Association for Hand Surgery
https://www.readbyqxmd.com/read/28718878/deep-brain-and-cortical-stimulation-for-epilepsy
#20
REVIEW
Mathieu Sprengers, Kristl Vonck, Evelien Carrette, Anthony G Marson, Paul Boon
BACKGROUND: Despite optimal medical treatment, including epilepsy surgery, many epilepsy patients have uncontrolled seizures. Since the 1970s interest has grown in invasive intracranial neurostimulation as a treatment for these patients. Intracranial stimulation includes both deep brain stimulation (DBS) (stimulation through depth electrodes) and cortical stimulation (subdural electrodes). This is an updated version of a previous Cochrane review published in 2014. OBJECTIVES: To assess the efficacy, safety and tolerability of DBS and cortical stimulation for refractory epilepsy based on randomized controlled trials (RCTs)...
July 18, 2017: Cochrane Database of Systematic Reviews
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"