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Device clinical trial

Fabio Sonvico, Adryana Clementino, Francesca Buttini, Gaia Colombo, Silvia Pescina, Silvia Stanisçuaski Guterres, Adriana Raffin Pohlmann, Sara Nicoli
In the field of nasal drug delivery, nose-to-brain delivery is among the most fascinating applications, directly targeting the central nervous system, bypassing the blood brain barrier. Its benefits include dose lowering and direct brain distribution of potent drugs, ultimately reducing systemic side effects. Recently, nasal administration of insulin showed promising results in clinical trials for the treatment of Alzheimer's disease. Nanomedicines could further contribute to making nose-to-brain delivery a reality...
March 15, 2018: Pharmaceutics
Aslam Alkadhimi, Ebrahim A Al-Awadhi
INTRODUCTION: In recent years, extensive research has introduced novel ways of reinforcing orthodontic anchorage using a variety of devices temporarily anchored in bone (miniscrews). Currently, there are numerous manufacturers with different miniscrew designs on the market. AIMS: The aim of this paper is to discuss the key design features of different miniscrew systems on the market. Furthermore, to present clinical selection criteria of miniscrews in different settings taking into account the determinant factors...
March 15, 2018: Journal of Orthodontics
Verònica Gálvez, Adrienne Li, Christina Huggins, Paul Glue, Donel Martin, Andrew A Somogyi, Angelo Alonzo, Anthony Rodgers, Philip B Mitchell, Colleen K Loo
BACKGROUND: Ketamine research in depression has mostly used intravenous, weight-based approaches, which are difficult to translate clinically. Intranasal (IN) ketamine is a promising alternative but no controlled data has been published on the feasibility, safety and potential efficacy of repeated IN ketamine treatments. METHODS: This randomised, double-blind, placebo-controlled pilot study compared a 4-week course of eight treatments of 100 mg ketamine or 4.5 mg midazolam...
March 1, 2018: Journal of Psychopharmacology
Mosarrat J Qureshi, Manoj Kumar
BACKGROUND: Providing effective positive pressure ventilation is considered to be the single most important component of successful neonatal resuscitation. Ventilation is frequently initiated manually with bag and face mask (BMV) followed by endotracheal intubation if respiratory depression continues. These techniques may be difficult to perform successfully resulting in prolonged resuscitation or neonatal asphyxia. The laryngeal mask airway (LMA) may achieve initial ventilation and successful resuscitation faster than a bag-mask device or endotracheal intubation...
March 15, 2018: Cochrane Database of Systematic Reviews
Mardjono Tjahjadi, Joseph Serrone, Juha Hernesniemi
Background: Basilar apex aneurysms constitute 5-8% of all intracranial aneurysms, and their treatment remains challenging for both microsurgical and endovascular approaches. The perceived drawback of the microsurgical approach is its invasiveness leading to increased surgical morbidity. However, many high-volume centers have shown excellent clinical results with better occlusion rates compared to endovascular treatment. With endovascular therapy taking a larger role in the management of cerebral aneurysms, the future role of microsurgery for basilar apex aneurysm treatment is unclear...
2018: Surgical Neurology International
Mark N Belkin, Cesar E Soria, Albert L Waldo, C Jan Willem Borleffs, David L Hayes, Roderick Tung, Jagmeet P Singh, Gaurav A Upadhyay
BACKGROUND: Despite the clear association between atrial fibrillation and risk for thromboembolic events (TEs), the clinical significance of new-onset device-detected atrial tachyarrhythmia (DDAT) and TE remains disputed. We aimed to determine the risk of TE in patients with new-onset DDAT. METHODS AND RESULTS: The OVID Medline, Cochrane, and Scopus databases (inception to November 2016) were searched. Randomized controlled trials, prospective, or retrospective studies of pacemaker or defibrillator patients reporting incidence of DDAT were selected...
March 2018: Circulation. Arrhythmia and Electrophysiology
Aoife Healy, Sybil Farmer, Anand Pandyan, Nachiappan Chockalingam
BACKGROUND: Assistive products are items which allow older people and people with disabilities to be able to live a healthy, productive and dignified life. It has been estimated that approximately 1.5% of the world's population need a prosthesis or orthosis. OBJECTIVE: The objective of this study was to systematically identify and review the evidence from randomized controlled trials assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions...
2018: PloS One
Adisa Kursumovic, Jenny C Kienzler, Gerrit J Bouma, Richard Bostelmann, Michael Heggeness, Claudius Thome, Larry E Miller, Martin Barth
STUDY DESIGN: Post hoc analysis of a randomized controlled trial. OBJECTIVE: To characterize the morphology and clinical relevance of vertebral endplate changes (VEPC) following limited lumbar discectomy with or without implantation of a bone-anchored annular closure device (ACD). SUMMARY OF BACKGROUND DATA: Implantation of an ACD following limited lumbar discectomy has shown promise in reducing the risk of recurrent herniation in patients with large annular defects...
March 13, 2018: Spine
Heidi J Reich, Lawrence S C Czer, Danny Ramzy, Francisco Arabia, Jaime Moriguchi, Deborah D Ascheim, Timothy D Henry
The use of stem cell therapy in combination with a left ventricular assist device (LVAD) for patients with advanced heart failure (HF) is an attractive concept with the potential to alter the natural history of HF. Cell therapy trials for HF have demonstrated excellent safety and encouraging results, but current rates of myocardial recovery after LVAD implantation are limited. Early trials combining these 2 therapies to increase the likelihood of recovery and to potentially obviate the need for subsequent transplantation appear promising...
March 13, 2018: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
Mehdi Shajari, Emanuel Wanner, Vladimir Rusev, Shervin Mir Mohi Sefat, Wolfgang J Mayer, Thomas Kohnen, Siegfried Priglinger, Daniel Kook
PURPOSE: To compare corneal densitometry values after Femtosecond Laser-Assisted In Situ Keratomileusis (Fs-LASIK) and Small Incision Lenticule Extraction (SMILE) using Scheimpflug Imaging. METHODS: Our retrospective clinical trial included a total of 146 eyes where 57 eyes underwent Fs-LASIK and 89 eyes underwent SMILE. Examinations with a Pentacam Scheimpflug device (Oculus, Wetzlar, Germany) were performed before surgery, 1 week, 1 month, 3 months, 6 months, and 1 year after surgery...
March 14, 2018: Current Eye Research
Nevin Witman, Makoto Sahara
Major cardiovascular events including myocardial infarction (MI) continue to dominate morbidity rates in the developed world. Although multiple device therapies and various pharmacological agents have been shown to improve patient care and reduce mortality rates, clinicians and researchers alike still lack a true panacea to regenerate damaged cardiac tissue. Over the previous two to three decades, cardiovascular stem cell therapies have held great promise. Several stem cell-based approaches have now been shown to improve ventricular function and are documented in preclinical animal models as well as phase I and phase II clinical trials...
2018: Stem Cells International
Enya Daynes, Neil J Greening, Theresa C Harvey-Dunstan, Sally J Singh
BACKGROUND: COPD is characterized by expiratory flow limitation, which results in symptomatic dyspnea and reduced exercise capacity. Changes in breathing mechanics mean the respiratory muscles are unable to respond to the ventilatory demands, increasing the sensation of dyspnea. A high-frequency oscillating device has been developed to improve dyspnea in patients with COPD. We conducted a feasibility trial to gain insight into the potential for recruitment, retention, and study design for a future randomized controlled trial...
March 13, 2018: Respiratory Care
Thomas Hanser, Romain Doliveux
PURPOSE: The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. MATERIALS AND METHODS: Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible...
March 2018: International Journal of Oral & Maxillofacial Implants
Andrea O Rossetti, Kaspar Schindler, Vincent Alvarez, Raoul Sutter, Jan Novy, Mauro Oddo, Loane Warpelin-Decrausaz, Stephan Rüegg
Continuous video-EEG is recommended for patients with altered consciousness; as compared to routine EEG (lasting <30 minutes), it improves seizure detection, but is time- and resource-consuming. Although North American centers increasingly implement continuous video-EEG, most other (including European) hospitals have insufficient resources. Only one study suggested that continuous video-EEG could improve outcome in adults, and a recent assessments challenge this view. This article reviews current evidence on the added value for continuous video-EEG in clinical terms and describes a design for a prospective study...
March 8, 2018: Journal of Clinical Neurophysiology: Official Publication of the American Electroencephalographic Society
David J Cottrell, Alex Wright-Hughes, Michelle Collinson, Paula Boston, Ivan Eisler, Sarah Fortune, Elizabeth H Graham, Jonathan Green, Allan O House, Michael Kerfoot, David W Owens, Eirini-Christina Saloniki, Mima Simic, Sandy Tubeuf, Amanda J Farrin
BACKGROUND: Self-harm in adolescents is common and repetition rates high. There is limited evidence of the effectiveness of interventions to reduce self-harm. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of family therapy (FT) compared with treatment as usual (TAU). DESIGN: A pragmatic, multicentre, individually randomised controlled trial of FT compared with TAU. Participants and therapists were aware of treatment allocation; researchers were blind to allocation...
March 2018: Health Technology Assessment: HTA
Alessandro Proclemer, Massimo Zecchin, Antonio D'Onofrio, Giuseppe Boriani, Domenico Facchin, Luca Rebellato, Marco Ghidina, Giulia Bianco, Emanuela Bernardelli, Elsa Pucher, Dario Gregori
BACKGROUND: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2016 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. METHODS: The registry collects prospectively national PM and ICD implantation activity on the basis of European cards...
February 2018: Giornale Italiano di Cardiologia
Federico M Asch, Mani A Vannan, Siddharth Singh, Bijoy Khandheria, Stephen H Little, Dominic J Allocco, Ian T Meredith, Ted E Feldman, Michael J Reardon, Neil J Weissman
BACKGROUND : Comparative echocardiographic data on transcatheter aortic valve replacement systems from randomized trials are limited. The REPRISE III trial (Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Randomized Clinical Evaluation) is a multicenter, randomized comparison of a mechanically expanded (Lotus) versus self-expanding (CoreValve) transcatheter aortic valve replacement device. This analysis rigorously assesses Doppler-derived valve hemodynamics and the impact on outcomes at 1 year in patients with extreme/high surgical risk treated with Lotus and CoreValve from REPRISE III...
March 12, 2018: Circulation
Anthony Pease, Clement Lo, Arul Earnest, Danny Liew, Sophia Zoungas
BACKGROUND: Technology has been implemented since the 1970s with the hope of improving glycaemic control and reducing the burden of complications for those living with type 1 diabetes. A clinical and cost-effectiveness comparison of all available technologies including continuous subcutaneous insulin infusion (CSII), continuous glucose monitors (CGMs), sensor-augmented pump therapy (including either low-glucose suspend or predictive low-glucose suspend), hybrid closed-loop systems, closed-loop (single-hormone or dual-hormone) systems, flash glucose monitoring (FGM), insulin bolus calculators, and 'smart-device' applications is currently lacking...
March 12, 2018: Systematic Reviews
Diren Arsoy, Nicholas J Giori, Steven T Woolson
BACKGROUND: The use of chemoprophylaxis to prevent thromboembolic disease after primary THA and TKA can be associated with postoperative bleeding complications. Mechanical prophylaxis has been studied as an alternative to chemoprophylaxis with greater safety in patients undergoing THA, but no data have been published comparing the safety of chemoprophylaxis versus mechanical methods for patients undergoing TKA. The risk of readmission resulting from bleeding and venous thromboembolism (VTE) has also not been determined for patients undergoing THA or TKA when treated with low-molecular-weight heparin (LMWH) alone compared with mechanical prophylaxis plus aspirin (ASA)...
February 2018: Clinical Orthopaedics and related Research
Megan Kruse, Jame Abraham
Chemotherapy-induced alopecia is a common and distressing adverse effect of many types of chemotherapy. Scalp cooling has been used since the 1970s for prevention of chemotherapy-induced alopecia; however, most data regarding this treatment modality are retrospective in nature, and use in the United States has been limited by safety concerns, specifically the potential for scalp metastases. Two prospective studies of scalp-cooling systems performed in the United States were published within the last year and add evidence supporting the efficacy and safety of scalp cooling in preventing chemotherapy-induced alopecia in patients receiving chemotherapy for solid tumor malignancies...
March 2018: Journal of Oncology Practice
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