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Device clinical trial

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https://www.readbyqxmd.com/read/29150922/prospective-evaluation-of-a-nonsurgical-device-for-rhinoplasty
#1
M A Deggeller, D Holzmann, M B Soyka
BACKGROUND: Rhinoplasty represents one of the most challenging and frequently performed procedures in plastic surgery and non-surgical rhinoplasty is rarely considered. The aim of this study was to investigate whether the Nasella Nose Former (NNF), a newly developed non-surgical rhinoplasty device, could improve objective and subjective results following surgical rhinoplasty and even correct the shape of the nose without any surgery at all. METHODOLOGY: In this prospective, monocentric, two-armed, non-blinded randomized, controlled clinical trial, a total of 43 participants were included...
November 18, 2017: Rhinology
https://www.readbyqxmd.com/read/29147473/bioresorbable-vascular-scaffold-versus-metallic-stent-in-percutaneous-coronary-intervention-results-of-the-aida-trial
#2
Syed Raza Shah, Mazia Fatima, Amin Muhammad Dharani, Waqas Shahnawaz, Syed Arbab Shah
Drug-eluting stents have significantly improved the long-term outcomes of percutaneous coronary intervention (PCI) by decreasing the excessive growth of neointima. However, conventional stents have some limitations. PCI with a bioresorbable vascular scaffold (BVS) has emerged as an alternative since the presence of the prosthesis in the coronary artery is transient. A US Food and Drug Administration advisory panel of experts recommended approval of BVS based on the analysis of its risks and rewards in July 2016...
2017: Journal of Community Hospital Internal Medicine Perspectives
https://www.readbyqxmd.com/read/29143099/-left-atrial-appendage-clusure-in-nonvalvular-atrial-fibrillation-clinical-evidence-2017
#3
REVIEW
Steffen Gloekler, Bajram Hajredini, Simon Rycerz, Sebastian Jäckle, Werner Jung
Nonvalvular atrial fibrillation (AF) is the most common arrhythmia with a prevalence of 1-2% and affects approximately 15-20% of all octogenarians. Patients are at increased risk of thromboembolic stroke, with an overall risk of 5% per year. Thrombi form almost exclusively in the left atrial appendage (LAA), a blind sac-like heterogeneous structure trabeculated by pectinate muscles. In the past five decades, life-long oral anticoagulation (OAC) with vitamin K antagonists (VKA) has been the state-of-the art treatment to prevent stroke and systemic embolism from thrombi in AF...
November 15, 2017: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/29142012/a-transcatheter-interatrial-shunt-device-for-the-treatment-of-heart-failure-with-preserved-ejection-fraction-reduce-lap-hf-i-a-phase-2-randomized-sham-controlled-trial
#4
Ted Feldman, Laura Mauri, Rami Kahwash, Sheldon Litwin, Mark J Ricciardi, Pim van der Harst, Martin Penicka, Peter S Fail, David M Kaye, Mark C Petrie, Anupam Basuray, Scott L Hummel, Rhondalyn Forde-McLean, Christopher D Nielsen, Scott Lilly, Joseph M Massaro, Daniel Burkhoff, Sanjiv J Shah
Background -In non-randomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), less symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and mid-range or preserved ejection fraction (EF ≥ 40%). We conducted the first randomized, sham-controlled trial to evaluate the IASD in HF with EF ≥ 40%. Methods -REDUCE LAP-HF I was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, EF ≥ 40%, exercise PCWP ≥ 25 mmHg, and PCWP-right atrial pressure gradient ≥ 5 mmHg...
November 15, 2017: Circulation
https://www.readbyqxmd.com/read/29141860/multicenter-evaluation-of-octreotide-as-secondary-prophylaxis-in-patients-with-left-ventricular-assist-devices-and-gastrointestinal-bleeding
#5
Keyur B Shah, Sampath Gunda, Sitaramesh Emani, Manreet K Kanwar, Nir Uriel, Paolo C Colombo, Patricia A Uber, Melissa L Sears, Joyce Chuang, David J Farrar, Donald F Brophy, George B Smallfield
BACKGROUND: Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. METHODS AND RESULTS: This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015...
November 2017: Circulation. Heart Failure
https://www.readbyqxmd.com/read/29140818/drop-instillation-and-glaucoma
#6
Scott A Davis, Betsy Sleath, Delesha M Carpenter, Susan J Blalock, Kelly W Muir, Donald L Budenz
PURPOSE OF REVIEW: To describe the current state of knowledge regarding glaucoma patients' eye drop technique, interventions attempting to improve eye drop technique, and methods for assessing eye drop technique. RECENT FINDINGS: In observational studies, between 18.2 and 80% of patients contaminate their eye drop bottle by touching their eye or face, 11.3-60.6% do not instill exactly one drop, and 6.8-37.3% miss the eye with the drop. Factors significantly associated with poorer technique include older age, lack of instruction on eye drop technique, female sex, arthritis, more severe visual field defect, lack of positive reinforcement to take eye drops, lower educational level, low self-efficacy, and being seen at a clinic rather than a private practice...
November 14, 2017: Current Opinion in Ophthalmology
https://www.readbyqxmd.com/read/29135066/developing-and-sustaining-a-career-as-a-transdisciplinary-nurse-scientist
#7
Kathleen T Hickey
PURPOSE: The purpose of this article is to provide an overview of strategies to build and sustain a career as a nurse scientist. This article examines how to integrate technologies and precision approaches into clinical practice, research, and education of the next generation of nursing scholars. DESIGN: This article presents information for shaping a sustainable transdisciplinary career. Programs of research that utilize self-management to improve quality of life are discussed throughout the article...
November 14, 2017: Journal of Nursing Scholarship
https://www.readbyqxmd.com/read/29134114/a-single-center-analysis-of-factors-influencing-study-start-up-timeline-in-clinical-trials
#8
Brianna M Krafcik, Gheorghe Doros, Marina A Malikova
Aim: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. Materials & methods: The start-up milestones were assessed for 38 studies and analyzed. Results: Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval...
November 2017: Future Science OA
https://www.readbyqxmd.com/read/29132930/a-novel-algorithm-increases-the-delivery-of-effective-cardiac-resynchronization-therapy-during-atrial-fibrillation-the-crtee-randomized-cross-over-trial
#9
Christopher J Plummer, Christopher M Frank, Zsolt Bári, Yahya S Al Hebaishi, Ruth Nicholson Klepfer, Robert W Stadler, Subham Ghosh, Shufeng Liu, Suneet Mittal
BACKGROUND: Cardiac resynchronization therapy (CRT) requires a high % of ventricular pacing (%Vp) to maximize its clinical benefits. Atrial fibrillation (AF) has been shown to reduce %Vp in CRT due to competition with irregular intrinsic atrio-ventricular (AV) conduction. We report the results of a prospective randomized cross-over trial evaluating the amount of effective CRT delivered during AF with a novel algorithm (eCRTAF). OBJECTIVE: To determine whether eCRTAF increases the amount of effective CRT delivered during AF when compared to a currently available rate regularization algorithm...
November 10, 2017: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/29129031/evaluation-and-management-of-staphylococcus-aureus-bacteriuria-an-updated-review
#10
REVIEW
Stamatis Karakonstantis, Dimitra Kalemaki
BACKGROUND AND AIMS: There is little guidance regarding the evaluation and management of patients with Staphylococcus aureus bacteriuria (SABU). Here, we aimed to provide an up-to-date review of the literature. METHODS: We searched PubMed, Scopus, and clinical trial registries for articles evaluating the epidemiology of SABU, risk factors of SABU, the association of SABU with urinary tract infection, bacteremia and invasive S. aureus infections, and the management of patients with SABU...
November 11, 2017: Infection
https://www.readbyqxmd.com/read/29129011/embodiment-and-estrangement-results-from-first-in-human-intelligent-bci-trial
#11
F Gilbert, M Cook, T O'Brien, J Illes
While new generations of implantable brain computer interface (BCI) devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews...
November 11, 2017: Science and Engineering Ethics
https://www.readbyqxmd.com/read/29128525/respiratory-rehabilitation-in-multiple-sclerosis-a-narrative-review-of-rehabilitation-techniques
#12
REVIEW
J Levy, H Prigent, D Bensmail
BACKGROUND: Respiratory disorders in multiple sclerosis (MS) are an important issue. They can occur early during the course of the disease, are associated with the neurological impairment, and can lead to pneumonia and respiratory failure, which are the main causes of death in advanced MS. Prevailing impaired expiratory muscles and cough abilities has been demonstrated in this population and might constitute a specific target for rehabilitation interventions. However, international guidelines lack recommendations regarding respiratory rehabilitation in MS...
November 8, 2017: Annals of Physical and Rehabilitation Medicine
https://www.readbyqxmd.com/read/29127645/remote-monitoring-of-pulmonary-artery-pressures-with-cardiomems-in-patients-with-chronic-heart-failure-and-nyha-class%C3%A2-iii-first-experiences-in-the-netherlands
#13
REVIEW
J J Brugts, O C Manintveld, N van Mieghem
We report the first patient experiences with the CardioMEMS device in the Erasmus MC Thorax Center in the Netherlands. In line with clinical trial evidence, the device is applicable in patients with chronic heart failure in functional New York Heart Association class III with at least 1 admission for heart failure in the past 12 months. CardioMEMS has been shown to be safe and reliable, and effective in reducing the number of hospitalisations for heart failure by guided therapy based on pulmonary artery pressures...
November 10, 2017: Netherlands Heart Journal
https://www.readbyqxmd.com/read/29127196/mechanical-thrombectomy-for-acute-ischemic-stroke-with-occlusion-of-the-m2-segment-of-the-middle-cerebral-artery-a-meta-analysis
#14
Hamidreza Saber, Sandra Narayanan, Mohan Palla, Jeffrey L Saver, Raul G Nogueira, Albert J Yoo, Sunil A Sheth
BACKGROUND: Endovascular thrombectomy has demonstrated benefit for patients with acute ischemic stroke from proximal large vessel occlusion. However, limited evidence is available from recent randomized trials on the role of thrombectomy for M2 segment occlusions of the middle cerebral artery (MCA). METHODS: We conducted a systematic review and meta-analysis to investigate clinical and radiographic outcomes, rates of hemorrhagic complications, and mortality after M2 occlusion thrombectomy using modern devices, and compared these outcomes against patients with M1 occlusions...
November 10, 2017: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/29127195/microcatheter-contrast-injection-in-stent-retriever-neurothrombectomy-is-safe-and-useful-insights-from-swift-prime
#15
Radoslav Raychev, Reza Jahan, Jeffrey L Saver, Raul G Nogueira, Mayank Goyal, Vitor M Pereira, Elad Levy, Dileep R Yavagal, Christophe Cognard, David Liebeskind
Microcatheter contrast injection (MCI) prior to stent retriever deployment for the treatment of acute ischemic stroke may be useful for evaluation of distal anatomy and flow patterns beyond the occlusion. However, prior data from intra-arterialthrombolysis suggested that MCI increases the risk of intracranial hemorrhage (ICH). The safety and utility of MCI has not been investigated in the setting of thrombectomy. METHODS: We analyzed the Solitaire With the Intention For Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME) trial to correlate pre-intervention MCI flow with collateral flow, and to investigate its impact on ICH and clinical outcome after thrombectomy with the Solitaire device...
November 10, 2017: Journal of Neurointerventional Surgery
https://www.readbyqxmd.com/read/29126848/evaluation-of-external-vibratory-stimulation-as-a-treatment-for-chronic-scrotal-pain-in-adult-men-a-single-center-open-label-pilot-study
#16
Yash S Khandwala, Fernando Serrano, Michael L Eisenberg
BACKGROUND AND AIMS: Chronic scrotal pain is a common yet poorly understood urologic disease. Current treatment paradigms are sub-optimal and include anti-inflammatory drugs and opioids as well as invasive surgical management such as microdenervation of the spermatic cord. In this study, the efficacy of external vibratory stimulation (EVS) was evaluated as an alternative treatment option for idiopathic scrotal pain. MATERIALS AND METHODS: Ten consecutive patients presenting to an academic urology clinic between December 2016 and April 2017 with scrotal pain were prospectively enrolled...
November 7, 2017: Scandinavian Journal of Pain
https://www.readbyqxmd.com/read/29125933/can-use-of-rigid-fixation-after-consolidation-benefit-cleft-patients-following-distraction-osteogenesis
#17
Reza Tabrizi, Kemal Tumer, Shervin Shafiei, Ashkan Rashad
PURPOSE: The stability of distraction osteogenesis (DO) is an important issue in maxillary advancement for patients with cleft lip and palate (CLP). The aim of this study was to evaluate postoperative stability in patients with and without internal fixation after removing maxillary distraction devices. MATERIALS AND METHODS: This randomized clinical trial assessed patients with CLP who needed maxillary advancement greater than 6 mm; they were randomly assigned to 1 of 2 groups...
October 16, 2017: Journal of Oral and Maxillofacial Surgery
https://www.readbyqxmd.com/read/29122494/penile-rehabilitation-therapy-following-radical-prostatectomy-a-meta-analysis
#18
REVIEW
Chunhui Liu, David S Lopez, Ming Chen, Run Wang
BACKGROUND: Penile rehabilitation, defined as the use of any drug or device at or after radical prostatectomy to maximize erectile function recovery, is commonly used for post-prostatectomy erectile dysfunction; however, conflicting results based on each study make it difficult to give a recommendation for clinical practice. AIM: To clarify the effect of oral phosphodiesterase type 5 inhibitors (PDE5is), vacuum erection devices, intracorporeal injection therapy, and the combination of these treatments on penile rehabilitation...
November 6, 2017: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/29122253/the-effect-of-nature-sounds-on-physiological-indicators-among-patients-in-the-cardiac-care-unit
#19
Tahereh Najafi Ghezeljeh, Maryam Nasari, Hamid Haghani, Habiballah Rezaei Loieh
BACKGROUND AND OBJECTIVES: Environmental noises may create physiological and psychological disorders in patients hospitalized in the CCU. Therefore, this study was conducted to investigate the effects of nature sounds on physiological indicators among patients in the CCU. MATERIALS & METHODS: This randomized clinical trial was conducted on 93 patients hospitalized in the cardiac care units of three teaching hospitals in 2016. The patients were selected using the convenient method with three randomized blocks...
November 2017: Complementary Therapies in Clinical Practice
https://www.readbyqxmd.com/read/29121815/preclinical-animal-models-for-temporomandibular-joint-tissue-engineering
#20
Alejandro Almarza, Bryan Brown, Boaz Arzi, David Faustino Ângelo, William L Chung, Stephen F Badylak, Michael Scott Detamore
There is a paucity of in vivo studies that investigate the safety and efficacy of temporomandibular joint (TMJ) tissue regeneration approaches, in part due to the lack of established animal models. Review of disease models for study of the TMJ is presented herein with an attempt to identify relevant preclinical animal models for TMJ tissue engineering, with emphasis on the disc and condyle. Although degenerative joint disease models have been mainly performed on mice, rats, and rabbits, pre-clinical regeneration approaches must employ larger animal species...
November 9, 2017: Tissue Engineering. Part B, Reviews
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