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https://www.readbyqxmd.com/read/29782049/use-of-most-bothersome-symptom-as-a-coprimary-endpoint-in-migraine-clinical-trials-a-post-hoc-analysis-of-the-pivotal-zotrip-randomized-controlled-trial
#1
David W Dodick, Stewart J Tepper, Deborah I Friedman, Amy A Gelfand, Donald J Kellerman, Peter C Schmidt
OBJECTIVE: To better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions. BACKGROUND: Adhesive dermally applied microarray (ADAM) is an investigational system for intracutaneous drug administration. The recently completed pivotal Phase 2b/3 study (ZOTRIP), evaluating ADAM zolmitriptan for the treatment of acute moderate to severe migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints per recently issued guidance by the US Food and Drug Administration...
May 21, 2018: Headache
https://www.readbyqxmd.com/read/29778342/one-year-outcomes-associated-with-a-novel-stented-bovine-pericardial-aortic-bioprosthesis
#2
Joseph F Sabik, Vivek Rao, Rüdiger Lange, A Pieter Kappetein, Francois Dagenais, Louis Labrousse, Vinayak Bapat, Michael Moront, Neil J Weissman, Himanshu J Patel, Michael J Reardon, Federico M Asch, Cathy Zeng, Robert J M Klautz
OBJECTIVES: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. METHODS: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval...
April 18, 2018: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/29777373/safety-and-feasibility-of-pulmonary-artery-pressure-guided-heart-failure-therapy-rationale-and-design-of-the-prospective-cardiomems-monitoring-study-for-heart-failure-mems-hf
#3
Christiane E Angermann, Birgit Assmus, Stefan D Anker, Johannes Brachmann, Georg Ertl, Friedrich Köhler, Stephan Rosenkranz, Carsten Tschöpe, Philip B Adamson, Michael Böhm
BACKGROUND: Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. OBJECTIVE: MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland...
May 19, 2018: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/29763812/computation-of-hip-rotation-kinematics-retrospectively-using-functional-knee-calibration-during-gait
#4
Morgan Sangeux
BACKGROUND: Hip rotation kinematics during gait is a key parameter to support clinical decision making, for example in children with lower limb torsional deformities. However, hip rotation kinematics is also one of the least repeatable parameter because it is difficult to locate the position of the medio-lateral axis of the femur. Functional knee calibration provides an alternative to locate the medio-lateral axis of the femur and may be performed retrospectively, using the movement of the knee joint during gait...
May 8, 2018: Gait & Posture
https://www.readbyqxmd.com/read/29759832/safety-and-efficacy-of-multipoint-pacing-in-cardiac-resynchronization-therapy-the-multipoint-pacing-trial
#5
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/29759434/pulmonary-vein-re-isolation-as-a-routine-strategy-regardless-of-symptoms-the-pressure-randomized-controlled-trial
#6
Moloy Das, Gareth J Wynn, Yawer Saeed, Sean Gomes, Maureen Morgan, Christina Ronayne, Laura J Bonnett, Johan E P Waktare, Derick M Todd, Mark C S Hall, Richard L Snowdon, Simon Modi, Dhiraj Gupta
OBJECTIVES: The goal of this study was to determine whether a strategy of early re-isolation of pulmonary vein (PV) reconnection in all patients, regardless of symptoms, would reduce the recurrence of atrial fibrillation (AF) and improve quality of life. BACKGROUND: Lasting pulmonary vein isolation (PVI) remains elusive. PV reconnection is strongly linked to the recurrence of arrhythmia. METHODS: A total of 80 patients with paroxysmal AF were randomized 1:1 after contact force-guided PVI to receive either standard care or undergo a repeat electrophysiology study after 2 months regardless of symptoms (repeat study)...
June 2017: JACC. Clinical Electrophysiology
https://www.readbyqxmd.com/read/29758590/interobserver-variation-in-cd30-immunohistochemistry-interpretation-consequences-for-patient-selection-for-targeted-treatment
#7
Lianne Koens, Peter M van de Ven, Nathalie J Hijmering, Marie José Kersten, Arjan Diepstra, Martine Chamuleau, Daphne de Jong
CD30 immunohistochemistry (IHC) in malignant lymphoma is used for selection of patients in clinical trials using brentuximab vedotin, an antibody drug-conjugate targeting the CD30 molecule. For reliable implementation in daily practice and meaningful selection of patients for clinical trials, information on technical variation and interobserver reproducibility of CD30 IHC staining is required. We conducted a 3-round reproducibility assessment of CD30 scoring for categorized frequency and intensity, including a technical validation, a "live polling" pre- and post-instruction scoring round, and a web-based round including individual scoring with additional IHC information to mimic daily diagnostic practice...
May 14, 2018: Histopathology
https://www.readbyqxmd.com/read/29750261/validation-of-previously-reported-predictors-for-radiation-induced-hypothyroidism-in-nasopharyngeal-cancer-patients-treated-with-intensity-modulated-radiation-therapy-a-post-hoc-analysis-from-a-phase-iii-randomized-trial
#8
Chawalit Lertbutsayanukul, Sarin Kitpanit, Anussara Prayongrat, Danita Kannarunimit, Buntipa Netsawang, Chakkapong Chakkabat
This study aimed to validate previously reported dosimetric parameters, including thyroid volume, mean dose, and percentage thyroid volume, receiving at least 40, 45 and 50 Gy (V40, V45 and V50), absolute thyroid volume spared (VS) from 45, 50 and 60 Gy (VS45, VS50 and VS60), and clinical factors affecting the development of radiation-induced hypothyroidism (RHT). A post hoc analysis was performed in 178 euthyroid nasopharyngeal cancer (NPC) patients from a Phase III study comparing sequential versus simultaneous-integrated boost intensity-modulated radiation therapy...
May 10, 2018: Journal of Radiation Research
https://www.readbyqxmd.com/read/29747241/stiripentol-add-on-therapy-for-focal-refractory-epilepsy
#9
REVIEW
Francesco Brigo, Stanley C Igwe, Nicola Luigi Bragazzi
BACKGROUND: This is an updated version of the Cochrane review last published in 2015 (Issue 10). For nearly 30% of people with epilepsy, seizures are not controlled by current treatments. Stiripentol is a new antiepileptic drug (AED) that was developed in France and was approved by the European Medicines Agency (EMA) in 2007 for the treatment of Dravet syndrome as an adjunctive therapy with valproate and clobazam, with promising effects. OBJECTIVES: To evaluate the efficacy and tolerability of stiripentol as add-on treatment for people with focal refractory epilepsy who are taking AEDs...
May 10, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29743691/challenging-local-realism-with-human-choices
#10
(no author information available yet)
A Bell test is a randomized trial that compares experimental observations against the philosophical worldview of local realism 1 , in which the properties of the physical world are independent of our observation of them and no signal travels faster than light. A Bell test requires spatially distributed entanglement, fast and high-efficiency detection and unpredictable measurement settings2,3 . Although technology can satisfy the first two of these requirements4-7 , the use of physical devices to choose settings in a Bell test involves making assumptions about the physics that one aims to test...
May 2018: Nature
https://www.readbyqxmd.com/read/29743170/clinical-implications-of-ablation-of-drivers-for-atrial-fibrillation-a-systematic-review-and-meta-analysis
#11
Tina Baykaner, Albert J Rogers, Gabriela L Meckler, Junaid Zaman, Rachita Navara, Miguel Rodrigo, Mahmood Alhusseini, Christopher A B Kowalewski, Mohan N Viswanathan, Sanjiv M Narayan, Paul Clopton, Paul J Wang, Paul A Heidenreich
BACKGROUND: The outcomes from pulmonary vein isolation (PVI) for atrial fibrillation (AF) are suboptimal, but the benefits of additional lesion sets remain unproven. Recent studies propose ablation of AF drivers improves outcomes over PVI, yet with conflicting reports in the literature. We undertook a systematic literature review and meta-analysis to determine outcomes from ablation of AF drivers in addition to PVI or as a stand-alone procedure. METHODS: Database search was done using the terms atrial fibrillation and ablation or catheter ablation and driver or rotor or focal impulse or FIRM (Focal Impulse and Rotor Modulation)...
May 2018: Circulation. Arrhythmia and Electrophysiology
https://www.readbyqxmd.com/read/29733002/temporary-crate-opening-procedure-affects-immediate-post-opening-piglet-mortality-and-sow-behaviour
#12
R L King, E M Baxter, S M Matheson, S A Edwards
Producers are interested in utilising farrowing systems with reduced confinement to improve sow welfare. However, concerns of increased mortality may limit commercial uptake. Temporary confinement systems utilise a standard crate which is opened 3 to 7 days postpartum, providing protection for neonatal piglets at their most vulnerable age and later increased freedom of movement for sows. However, there is anecdotal evidence that piglet mortality increases immediately after the temporary crate is opened. The current study aims were to determine if piglet mortality increases post-opening, to trial different opening techniques to reduce post-opening piglet mortality and to identify how the different opening techniques influence sow behaviour...
May 7, 2018: Animal: An International Journal of Animal Bioscience
https://www.readbyqxmd.com/read/29730497/perceived-freedom-of-choice-is-associated-with-neural-encoding-of-option-availability
#13
Natalie Rens, Stefan Bode, Ross Cunnington
Freedom of choice has been defined as the opportunity to choose alternative plans of action. In this fMRI study, we investigated how the perceived freedom of choice and the underlying neural correlates are influenced by the availability of options. Participants made an initial free choice between left or right doors before beginning a virtual walk along a corridor. At the mid-point of the corridor, lock cues appeared to reveal whether one or both doors remained available, requiring participants either to select a particular door or allowing them to freely choose to stay or switch their choice...
May 3, 2018: NeuroImage
https://www.readbyqxmd.com/read/29730377/adventitial-drug-delivery-of-dexamethasone-to-improve-primary-patency-in-the-treatment-of-superficial-femoral-and-popliteal-artery-disease-12-month-results-from-the-dance-clinical-trial
#14
Mahmood K Razavi, Dennis Donohoe, Ralph B D'Agostino, Michael R Jaff, George Adams
OBJECTIVES: This study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease. BACKGROUND: Drug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy...
April 27, 2018: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29722796/a-randomized-multicentre-trial-to-compare-revascularization-with-optimal-medical-therapy-for-the-treatment-of-chronic-total-coronary-occlusions
#15
Gerald S Werner, Victoria Martin-Yuste, David Hildick-Smith, Nicolas Boudou, Georgios Sianos, Valery Gelev, Jose Ramon Rumoroso, Andrejs Erglis, Evald Høj Christiansen, Javier Escaned, Carlo di Mario, Thomas Hovasse, Luis Teruel, Alexander Bufe, Bernward Lauer, Kris Bogaerts, Javier Goicolea, James C Spratt, Anthony H Gershlick, Alfredo R Galassi, Yves Louvard
Aims: The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Method and results: Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio...
May 2, 2018: European Heart Journal
https://www.readbyqxmd.com/read/29720874/living-with-cystic-fibrosis-a-qualitative-study-of-a-life-coaching-intervention
#16
Karin Bæk Knudsen, Kirsten Arntz Boisen, Terese Lea Katzenstein, Laust Hvas Mortensen, Tacjana Pressler, Marianne Skov, Mary Jarden
Background: Cystic fibrosis (CF) is a chronic, life-shortening disease with a significant treatment burden. To support young adults with CF in their everyday life, we previously conducted a life coaching feasibility trial (published elsewhere). The aim of the current study was to explore how life coaching was experienced by study participants within the context of their lives with CF. Methods: A qualitative study using individual interviews. Respondents (n=14) were recruited from the intervention group after participation in life coaching...
2018: Patient Preference and Adherence
https://www.readbyqxmd.com/read/29716885/an-assistive-technology-system-that-provides-personalized-dressing-support-for-people-living-with-dementia-capability-study
#17
Winslow Burleson, Cecil Lozano, Vijay Ravishankar, Jisoo Lee, Diane Mahoney
BACKGROUND: Individuals living with advancing stages of dementia (persons with dementia, PWDs) or other cognitive disorders do not have the luxury of remembering how to perform basic day-to-day activities, which in turn makes them increasingly dependent on the assistance of caregivers. Dressing is one of the most common and stressful activities provided by caregivers because of its complexity and privacy challenges posed during the process. OBJECTIVE: In preparation for in-home trials with PWDs, the aim of this study was to develop and evaluate a prototype intelligent system, the DRESS prototype, to assess its ability to provide automated assistance with dressing that can afford independence and privacy to individual PWDs and potentially provide additional freedom to their caregivers (family members and professionals)...
May 1, 2018: JMIR Medical Informatics
https://www.readbyqxmd.com/read/29701555/stereotactic-radiosurgery-for-trigeminal-neuralgia-a-systematic-review
#18
Constantin Tuleasca, Jean Régis, Arjun Sahgal, Antonio De Salles, Motohiro Hayashi, Lijun Ma, Roberto Martínez-Álvarez, Ian Paddick, Samuel Ryu, Ben J Slotman, Marc Levivier
OBJECTIVES The aims of this systematic review are to provide an objective summary of the published literature specific to the treatment of classical trigeminal neuralgia with stereotactic radiosurgery (RS) and to develop consensus guideline recommendations for the use of RS, as endorsed by the International Society of Stereotactic Radiosurgery (ISRS). METHODS The authors performed a systematic review of the English-language literature from 1951 up to December 2015 using the Embase, PubMed, and MEDLINE databases...
April 27, 2018: Journal of Neurosurgery
https://www.readbyqxmd.com/read/29701311/crystallization-of-a-novel-germanosilicate-ecnu-16-provides-insights-into-the-space-filling-effect-on-zeolite-crystal-symmetry
#19
Le Xu, Lin Zhang, Jian Li, Koki Muraoka, Fei Peng, Hao Xu, Cong Lin, Zihao Gao, Jin-Gang Jiang, Watcharop Chaikittisilp, Junliang Sun, Tatsuya Okubo, Peng Wu
Synthesis of new zeolites involving organic molecules heavily relies on the trial-and-error approach because it is difficult to interpret the determining effects of organics on zeolite crystal symmetry. Here, the intrinsic relationships among the space-filling of organics, included volume of channels and zeolite crystal symmetry are systematically demonstrated by experimental and computational means. Under controlled conditions, the "dimer" and "monomer" organics of 1-ethyl-3-methylimidazolium selectively direct different but related germanosilicates, the ECNU-16 with a new topology and the existing IM-16 with the UOS topology, respectively...
April 27, 2018: Chemistry: a European Journal
https://www.readbyqxmd.com/read/29696097/mechanical-validation-of-an-mri-compatible-stereotactic-neurosurgery-robot-in-preparation-for-pre-clinical-trials
#20
Christopher J Nycz, Radian Gondokaryono, Paulo Carvalho, Nirav Patel, Marek Wartenberg, Julie G Pilitsis, Gregory S Fischer
The use of magnetic resonance imaging (MRI) for guiding robotic surgical devices has shown great potential for performing precisely targeted and controlled interventions. To fully realize these benefits, devices must work safely within the tight confines of the MRI bore without negatively impacting image quality. Here we expand on previous work exploring MRI guided robots for neural interventions by presenting the mechanical design and assessment of a device for positioning, orienting, and inserting an interstitial ultrasound-based ablation probe...
September 2017: Proceedings of the ... IEEE/RSJ International Conference on Intelligent Robots and Systems
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