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Device clinical trial

Kateki Vinod, Steven J Gedde
PURPOSE OF REVIEW: This article reviews recent studies evaluating the efficacy and complication profiles of novel glaucoma procedures promoting aqueous outflow. RECENT FINDINGS: Literature from the 2015 to 2016 review period includes abundant data regarding new and emerging glaucoma procedures. Notable findings from recent randomized clinical trials include titratability of intraocular pressure with multiple trabecular microbypass stents (iStent; Glaukos, Laguna Hills, California, USA) and greater reduction in intraocular pressure and medication usage following intracanalicular scaffolding (Hydrus Microstent; Ivantis Inc...
October 19, 2016: Current Opinion in Ophthalmology
David Sanders, Dianne Bryant, Christina Tieszer, Abdel Lawendy, Mark MacLeod, Steven Papp, Liew Allan, Viskontas Darius, Coles Chad, Gurr Kevin, Carey Tim, Gofton Wade, Bailey Chris, Bartley Debra, Andrew Trenholm, Stone Trevor, Leighton Ross, Julia Foxall, Mauri Zomar, Kelly Trask
OBJECTIVES: To compare outcomes in elderly patients with intertrochanteric hip fractures treated with either the sliding hip screw (SHS) or InterTAN intramedullary device (IT). DESIGN: Prospective, randomized, multi-centre clinical trial SETTING:: Five level 1 trauma centresPatients/Participants: 249 patients aged 55 years or older with AO/OTA 31A1 (43) and OA/OTA 31A2 (206) fractures were prospectively enrolled and followed for 12 months. INTERVENTION: Computer generated randomization to either IT (n=123) or SHS (n=126)...
September 30, 2016: Journal of Orthopaedic Trauma
M C O'Hara, L Hynes, M O'Donnell, N Nery, M Byrne, S R Heller, S F Dinneen
BACKGROUND: Many young adults with Type 1 diabetes experience poor outcomes. The aim of this systematic review was to synthesize the evidence regarding the effectiveness of interventions aimed at improving clinical, behavioural or psychosocial outcomes for young adults with Type 1 diabetes. METHODS: Electronic databases were searched. Any intervention studies related to education, support, behaviour change or health service organizational change for young adults aged between 15-30 years with Type 1 diabetes were included...
October 20, 2016: Diabetic Medicine: a Journal of the British Diabetic Association
Massimo Del Fabbro, Stefano Corbella, Patrick Sequeira-Byron, Igor Tsesis, Eyal Rosen, Alessandra Lolato, Silvio Taschieri
BACKGROUND: When primary root canal therapy fails, periapical lesions can be retreated with or without surgery. Root canal retreatment is a non-surgical procedure that involves removal of root canal filling materials from the tooth, followed by cleaning, shaping and obturating of the canals. Root-end resection is a surgical procedure that involves exposure of the periapical lesion through an osteotomy, surgical removal of the lesion, removal of part of the root-end tip, disinfection and, commonly, retrograde sealing or filling of the apical portion of the remaining root canal...
October 19, 2016: Cochrane Database of Systematic Reviews
Homero Rivas, Ignacio Robles, Francisco Riquelme, Marcelo Vivanco, Julio Jiménez, Boris Marinkovic, Mario Uribe
OBJECTIVE: To evaluate a new magnetic surgical system during reduced-port laparoscopic cholecystectomy in a prospective, multicenter clinical trial. BACKGROUND: Laparoscopic instrumentation coupled by magnetic fields may enhance surgeon performance by allowing for shaft-less retraction and mobilization. The movements can be performed under direct visualization, generating different angles of traction and reducing the number of trocars to perform the procedure. This may reduce well-known associated complications of trocars, including incisional pain, scarring, infection, bowel, and vascular injuries, among others...
October 17, 2016: Annals of Surgery
Wolfgang G Kunz, M G Myriam Hunink, Wieland H Sommer, Sebastian E Beyer, Felix G Meinel, Franziska Dorn, Stefan Wirth, Maximilian F Reiser, Birgit Ertl-Wagner, Kolja M Thierfelder
BACKGROUND AND PURPOSE: Endovascular therapy in addition to standard care (EVT+SC) has been demonstrated to be more effective than SC in acute ischemic large vessel occlusion stroke. Our aim was to determine the cost-effectiveness of EVT+SC depending on patients' initial National Institutes of Health Stroke Scale (NIHSS) score, time from symptom onset, Alberta Stroke Program Early CT Score (ASPECTS), and occlusion location. METHODS: A decision model based on Markov simulations estimated lifetime costs and quality-adjusted life years (QALYs) associated with both strategies applied in a US setting...
October 6, 2016: Stroke; a Journal of Cerebral Circulation
Jodi A Antonelli, Heather Beardsley, Stephen Faddegon, Monica Sc Morgan, Jeffrey C Gahan, Margaret S Pearle, Jeffrey A Cadeddu
PURPOSE: We developed a polyethylene sack (the PercSac) that fits over the shaft of a rigid nephroscope and is deployed into the collecting system to capture a stone and contain fragments during PCNL. We previously reported results using the PercSac in a percutaneous cystolithopaxy model. Herein we compare the efficiency of stone fragmentation with and without the PercSac in an anatomically correct in vitro PCNL model. MATERIALS AND METHODS: The PCNL model consisted of a human collecting system model created on a 3-D printer...
October 19, 2016: Journal of Endourology
Keith W Muir, Gary A Ford, Claudia-Martina Messow, Ian Ford, Alicia Murray, Andrew Clifton, Martin M Brown, Jeremy Madigan, Rob Lenthall, Fergus Robertson, Anand Dixit, Geoffrey C Cloud, Joanna Wardlaw, Janet Freeman, Philip White
OBJECTIVE: The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). DESIGN: Eligible patients had IVT started within 4.5 hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90 min...
October 18, 2016: Journal of Neurology, Neurosurgery, and Psychiatry
Shashank S Sinha, Devraj Sukul, John J Lazarus, Vivek Polavarapu, Paul S Chan, Robert W Neumar, Brahmajee K Nallamothu
BACKGROUND: Cardiac arrest is a major public health concern worldwide. The extent and types of randomized controlled trials (RCT)-our most reliable source of clinical evidence-conducted in these high-risk patients over recent years are largely unknown. METHODS AND RESULTS: We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on the acute treatment of nontraumatic cardiac arrest in adults...
October 18, 2016: Circulation. Cardiovascular Quality and Outcomes
Angelo Alonzo, Scott Aaronson, Marom Bikson, Mustafa Husain, Sarah Lisanby, Donel Martin, Shawn M McClintock, William M McDonald, John O'Reardon, Zeinab Esmailpoor, Colleen Loo
Transcranial Direct Current Stimulation (tDCS) is a new, non-invasive neuromodulation approach for treating depression that has shown promising efficacy. The aim of this trial was to conduct the first international, multicentre randomised controlled trial of tDCS as a treatment for unipolar and bipolar depression. The study recruited 120 participants across 6 sites in the USA and Australia. Participants received active or sham tDCS (2.5mA, 20 sessions of 30min duration over 4weeks), followed by a 4-week open label active treatment phase and a 4-week taper phase...
October 15, 2016: Contemporary Clinical Trials
Cindy X Guo, Raiju J Babu, Joanna M Black, William R Bobier, Carly S Y Lam, Shuan Dai, Tina Y Gao, Robert F Hess, Michelle Jenkins, Yannan Jiang, Lionel Kowal, Varsha Parag, Jayshree South, Sandra Elfride Staffieri, Natalie Walker, Angela Wadham, Benjamin Thompson
BACKGROUND: Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults...
October 18, 2016: Trials
Joël L'Hermite, Elisabeth Dubout, Sophie Bouvet, Laure-Hélène Bracoud, Philippe Cuvillon, Jean-Emmanuel de La Coussaye, Jacques Ripart
BACKGROUND: Sore throat is a common complaint after surgery. It affects patient satisfaction and can affect activity after discharge. The supraglottic airway device (SAD) offers an alternative to traditional tracheal intubation with potential benefit in preventing sore throat. OBJECTIVE: The aim of this study was to compare the incidence of sore throat following three different SADs, the laryngeal mask airway Unique (LMA-U) and the more recent LMA Supreme (LMA-S) and the I-gel...
October 15, 2016: European Journal of Anaesthesiology
Sven Reek
PURPOSE OF REVIEW: The wearable cardioverter-defibrillator has been available for over a decade. In recent years, the device has been prescribed increasingly for a wide range of indications. The purpose of this review is to describe the technical and clinical aspects of the wearable cardioverter-defibrillator. The available literature on safety, efficacy and cost-effectiveness is reviewed, and indications for use will be discussed. RECENT FINDINGS: The wearable cardioverter-defibrillator has been used successfully in more than 100 000 patients for a variety of indications...
October 15, 2016: Current Opinion in Cardiology
Jinho Shin
Arterial pulsation which had long been studied for estimation of blood pressure or mean blood pressure was replaced by the measurement of systolic and diastolic blood pressure using Korotkoff sound detected by stethoscope in the beginning of the previous century. In the meantime, vast of modern knowledge of human hypertension from epidemiology to randomized clinical trial had been built on the Korotkoff sound and stethoscope methodology. Hypertension is very special clinical entity in terms of the diagnosis is solely dependent on the manual blood pressure measurement by a physician or nurse...
September 2016: Journal of Hypertension
Yutaka Imai
It has been confirmed that clinical significance of home blood pressure measurements (HBPM) is higher than clinic BP measurements and ambulatory BP monitoring. However, several drawbacks of HBPM have also been mentioned, e.g. selection and reporting biases, difficulties of calculation of multiple measurements, difficulties of onsite judgement of numerous recordings, etc. Recent devices for HBPM incorporate memory function. This function can overcome such drawbacks of HBPM. These memorized data can transmit, storage, retrieve, be arithmetic and control, be judged based on algorithm and be got feedback...
September 2016: Journal of Hypertension
Jing Zhang, Lei Sun, Yu Liu, Hongyi Wang, Ningling Sun, Jia Yu, Yao He, Sijin Yan, Puhong Zhang
OBJECTIVE: To evaluate the feasibility and acceptability of a mobile device based electronical data capture (mEDC) system applied in one randomized clinical trial (RCT). DESIGN AND METHOD: The mEDC, an android smartphone-based application, was developed to support real-time data capture, project management and quality control in a multicenter randomized double-blinded parallel controlled pharmaceutical trial. Four user interfaces are shown in Figure 1. The RCT is to evaluate the efficacy of telmisartan (40mg) and hydrochlorothiazide (25mg) monotherapy in high sodium intake patients with mild to moderate hypertension in 14 hospitals, including one baseline survey and three follow-ups...
September 2016: Journal of Hypertension
Michael Weber
: Age is the most powerful cardiovascular risk factor. Based on a meta-analysis of a million control patients in hypertension trials, the Clinical Trialists Collaboration has estimated that doubling of major cardiac and stroke events occurs with age increments of < 10 years (1). Data from the ACCOMPLISH trial, which will be presented at this ISH meeting for the first time, show that patients aged > 70 (mean: 75.2), compared with those < 70 (mean: 63.7), had a 2.82-fold greater event rate for cardiovascular death and a 2...
September 2016: Journal of Hypertension
Iwao Kuwajima
Since a concept of Evidence-based Medicine appeared in medical field in 1991, modern medical treatment have been remarkably changed.However, delusive belief of EBM without criticism has brought negative aspect, such as utilization of EBM by companies as a tool of promotion of drug or medical device.Although most of clinical trials were financially supported by drug companies. result of clinical trial does not always ended in favor of test drug or device. When negative results appeared, various way were taken by industry such as usage of SPIN, emphasizing secondary endpoint...
September 2016: Journal of Hypertension
Susanne Hafner, Sabine Haubensak, Tanusree Paul, Oliver Zolk
Background | Differences (polymorphisms) in genes encoding drug targets, drug transport proteins, or drug metabolizing enzymes may be responsible, among other factors, for the observed variation in patients' responses to medications. The field of pharmacogenetics aims to identify patients at higher genetically-determined risk of adverse effects or poor response to medication. This information would allow for modification of dosage or substitution with alternative therapy. However, there is a lack of awareness of pharmacogenetic clinical practise guidelines...
October 2016: Deutsche Medizinische Wochenschrift
Priccila Zuchinali, Gabriela C Souza, Maurício Pimentel, Diego Chemello, André Zimerman, Vanessa Giaretta, Joyce Salamoni, Bianca Fracasso, Leandro I Zimerman, Luis E Rohde
Importance: The presumed proarrhythmic action of caffeine is controversial. Few studies have assessed the effect of high doses of caffeine in patients with heart failure due to left ventricular systolic dysfunction at high risk for ventricular arrhythmias. Objective: To compare the effect of high-dose caffeine or placebo on the frequency of supraventricular and ventricular arrhythmias, both at rest and during a symptom-limited exercise test. Design, Setting, and Participants: Double-blinded randomized clinical trial with a crossover design conducted at the heart failure and cardiac transplant clinic of a tertiary-care university hospital...
October 17, 2016: JAMA Internal Medicine
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