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https://www.readbyqxmd.com/read/28549309/switching-between-intravenous-and-subcutaneous-trastuzumab-safety-results-from-the-prefher-trial
#1
Joseph Gligorov, Giuseppe Curigliano, Volkmar Müller, Ann Knoop, Valerie Jenkins, Sunil Verma, Stuart Osborne, Sabine Lauer, Zuzana Machackova, Lesley Fallowfield, Xavier Pivot
AIM: To assess the safety and tolerability of switching between subcutaneous (SC) and intravenous (IV) trastuzumab in the PrefHer study (NCT01401166). PATIENTS AND METHODS: Patients with HER2-positive early breast cancer completed (neo)adjuvant chemotherapy and were randomised to receive four cycles of SC trastuzumab, via single-use injection device (SID; Cohort 1) or hand-held syringe (Cohort 2), followed by four cycles of IV, or vice versa (the crossover period presented here) as part of their 18 standard cycles of adjuvant trastuzumab treatment...
May 23, 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28548196/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-%C3%A2-on-clinical-trials-of-pharmaceutical-products-and-medical-devices%C3%A2-and-of-the-bylaw-that-will-regulate-its-application
#2
Gloria López S, Gloria Valdés S, Emilio Roessler B, Vicente Valdivieso D
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3...
March 2017: Revista Médica de Chile
https://www.readbyqxmd.com/read/28546755/pediatric-ventricular-assist-devices-current-challenges-and-future-prospects
#3
REVIEW
Sarah Burki, Iki Adachi
The field of mechanical circulatory support has made great strides in the preceding 2 decades. Although pediatric mechanical circulatory support has lagged behind that of adults, the gap between them is expected to close soon. The only device currently approved by the US Food and Drug Administration for use in children is the Berlin Heart EXCOR ventricular assist device (VAD). The prospective Berlin Heart Investigational Device Exemption Trial demonstrated good outcomes, such as bridge to transplantation or recovery, in ~90% of children supported with this device...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28545525/rotational-alignment-of-femoral-component-with-different-methods-in-total-knee-arthroplasty-a-randomized-controlled-trial
#4
Joon Kyu Lee, Sahnghoon Lee, Sae Hyung Chun, Ki Tae Kim, Myung Chul Lee
BACKGROUND: Femoral component rotation (FCR) is one of the most important factors in total knee arthroplasty. In this prospective study, we used three different techniques for FCR and analyzed their accuracy with postoperative axial computed tomography (CT) images. We also evaluated effect of FCR to clinical outcome. METHODS: One hundred sixty-five patients were randomly allocated into three groups. In the measured resection group, FCR was set by externally rotating the axis 3° off the posterior femoral condylar axis...
May 25, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28544460/portable-oxygen-concentrators-versus-oxygen-cylinder-during-walking-in-interstitial-lung-disease-a-randomized-crossover-trial
#5
Yet H Khor, Christine F McDonald, Anita Hazard, Karen Symons, Glen Westall, Ian Glaspole, Nicole S L Goh, Anne E Holland
BACKGROUND AND OBJECTIVE: Ambulatory oxygen therapy is often provided to patients with interstitial lung disease (ILD). Lightweight portable oxygen concentrators (POCs) provide an alternative to traditional portable systems such as compressed oxygen cylinders; however, their efficacy in patients with ILD has not been assessed. This study aimed to evaluate the clinical performance of three ambulatory oxygen systems (two different POCs and a compressed oxygen cylinder) during 6-min walk tests (6MWTs) in patients with ILD and exertional desaturation...
May 23, 2017: Respirology: Official Journal of the Asian Pacific Society of Respirology
https://www.readbyqxmd.com/read/28544397/efficacy-and-acceptance-of-a-high-velocity-microdroplet-device-for-interdental-cleaning-in-gingivitis-patients-a-monitored-randomized-controlled-trial
#6
I Stauff, Shm Derman, A G Barbe, K C Hoefer, M Bizhang, S Zimmer, M J Noack
OBJECTIVES: To compare in a randomized clinical trial the efficacy of a high-velocity microdroplet device for interdental cleaning vs dental floss at reducing plaque and gingivitis. METHODS: Sixty participants with an irregular interdental home cleaning regime were randomly assigned to use either a microdroplet device (n=40, test) or dental floss (n=20, control) for 4 weeks. At baseline and reassessment, the papilla bleeding index, the modified proximal plaque index and the amount of gingival crevicular fluid (GCF) were recorded...
May 24, 2017: International Journal of Dental Hygiene
https://www.readbyqxmd.com/read/28544361/drug-coated-balloons-for-the-treatment-of-in-stent-restenosis-in-diabetic-patients-a-review-of-currently-available-scientific-data
#7
Alberto Minacapelli, Davide Piraino, Dario Buccheri, Bernardo Cortese
After the introduction of drug eluting stent (DES) the rate of in-stent restenosis (ISR) has decreased if compared to the BMS era; however, treatment of patients with ISR remained a major issue for the interventional cardiologist. DES has been largely used with good results also as second layer for the treatment of ISR, but the overall percentage of patients suffering from restenosis still remains high, especially in some subgroups of patients as ones with diabetes mellitus (DM). In this clinical scenario, drug coated balloon (DCB) has been gaining an important role for the treatment of ISR...
May 22, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28543780/intranasal-midazolam-versus-rectal-diazepam-for-the-management-of-canine-status-epilepticus-a-multicenter-randomized-parallel-group-clinical-trial
#8
M Charalambous, S F M Bhatti, L Van Ham, S Platt, N D Jeffery, A Tipold, J Siedenburg, H A Volk, D Hasegawa, A Gallucci, G Gandini, M Musteata, E Ives, A E Vanhaesebrouck
BACKGROUND: Intranasal administration of benzodiazepines has shown superiority over rectal administration for terminating emergency epileptic seizures in human trials. No such clinical trials have been performed in dogs. OBJECTIVE: To evaluate the clinical efficacy of intranasal midazolam (IN-MDZ), via a mucosal atomization device, as a first-line management option for canine status epilepticus and compare it to rectal administration of diazepam (R-DZP) for controlling status epilepticus before intravenous access is available...
May 24, 2017: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/28543777/efficacy-and-safety-of-non-invasive-body-tightening-with-high-intensity-focused-ultrasound-hifu
#9
E J Ko, J Y Hong, T-R Kwon, E J Choi, Y-J Jang, S Y Choi, K H Yoo, S Y Kim, B J Kim
BACKGROUND: Noninvasive skin-tightening devices have become increasingly popular in response to increasing demand for improvements in skin laxity and tightening with minimal risk and recovery time. OBJECTIVE: We evaluated the efficacy and safety of HIFU for skin tightening in the face and body. METHODS: A total of 32 Korean subjects enrolled in this prospective clinical trial. The subjects were treated with HIFU to both cheeks, lower abdomen, and thigh...
May 22, 2017: Skin Research and Technology
https://www.readbyqxmd.com/read/28543062/an-adaptive-vestibular-rehabilitation-technique
#10
Benjamin T Crane, Michael C Schubert
OBJECTIVES/HYPOTHESIS: There is a large variation in vestibular rehabilitation (VR) results depending on type of therapy, adherence, and the appropriateness for the patient's level of function. A novel adaptive vestibular rehabilitation (AVR) program was developed and evaluated. STUDY DESIGN: Technology and procedure development, and prospective multicenter trial. METHODS: Those with complete unilateral vestibular hypofunction and symptomatic at least 3 months with a Dizziness Handicap Inventory (DHI) >30 were eligible...
May 23, 2017: Laryngoscope
https://www.readbyqxmd.com/read/28541602/three-dimensional-printing-in-cardiology-current-applications-and-future-challenges
#11
Hongxing Luo, Jarosław Meyer-Szary, Zhongmin Wang, Robert Sabiniewicz, Yuhao Liu
Three-dimensional (3D) printing has attracted a huge interest in recent years. Broadly speaking, it refers to the technology which converts a predesigned virtual model to a touchable object. In clinical medicine, it usually converts a series of two-dimensional medical images acquired through computed tomography, magnetic resonance imaging or 3D echocardiography into a physical model. Medical 3D printing consists of three main steps: image acquisition, virtual reconstruction and 3D manufacturing. It is a promising tool for preoperative evaluation, medical device design, hemodynamic simulation and medical education, it is also likely to reduce operative risk and increase operative success...
May 25, 2017: Cardiology Journal
https://www.readbyqxmd.com/read/28541131/clinical-use-of-continuous-glucose-monitoring-in-adults-with-type-1-diabetes
#12
David Slattery, Pratik Choudhary
With the emphasis on intensive management of type 1 diabetes, data from studies support frequent monitoring of glucose levels to improve glycemic control and reduce glucose variability, which can be related to an increase in macro and microvascular complications. However, few perform capillary blood glucose that frequently. There are currently two available alternatives that this review will discuss, continuous glucose monitoring (CGM) and flash glucose monitoring. CGM has become an important diagnostic and therapeutic option in optimizing diabetes management...
May 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28540615/clinical-evaluation-of-marketed-orthodontic-products-are-researchers-behind-the-times-a-meta-epidemiological-study
#13
Jadbinder Seehra, Nikolaos Pandis, Padhraig S Fleming
BACKGROUND: The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers' claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies...
December 2017: Progress in Orthodontics
https://www.readbyqxmd.com/read/28539571/do-implantable-cardioverter-defibrillators-reduce-mortality-in-patients-with-chronic-kidney-disease-at-all-stages
#14
Linghua Fu, Qiongqiong Zhou, Wengen Zhu, Huang Lin, Ying Ding, Yang Shen, Jinzhu Hu, Kui Hong
The benefits of implantable cardioverter defibrillator (ICD) implantation in chronic kidney disease (CKD) patients with high sudden cardiac death (SCD) risk are uncertain. To clarify the effects of receiving an ICD in CKD patients, we conducted this meta-analysis to identify the effects of ICDs on patients with CKD, including those on dialysis. We searched the Cochrane library, EMBASE, PubMed, and clinical trials for studies published before July 2016. Eleven studies including 20,196 CKD patients were considered for inclusion...
May 23, 2017: International Heart Journal
https://www.readbyqxmd.com/read/28539541/sleep-disordered-breathing-in-heart-failure%C3%A3-a-therapeutic-dilemma
#15
Nobuhiko Haruki, John S Floras
Sleep-disordered breathing (SDB) occurs in approximately 50% of patients with reduced left ventricular ejection fraction receiving contemporary heart failure (HF) therapies. Obstructive (OSA) and central sleep apneas (CSA) interrupt breathing by different mechanisms but impose qualitatively similar autonomic, chemical, mechanical, and inflammatory burdens on the heart and circulation. Because contemporary evidence-based drug and device HF therapies have little or no mitigating effect on the acute or long-term consequences of such stimuli, there is a sound mechanistic rationale for targeting SDB to reduce cardiovascular event rates and prolong life...
May 23, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/28538071/bone-scrapers-versus-piezoelectric-surgery-in-the-lateral-antrostomy-for-sinus-floor-elevation
#16
Claudio Stacchi, Teresa Lombardi, Paolo Cusimano, Federico Berton, Floriana Lauritano, Gabriele Cervino, Roberto Di Lenarda, Marco Cicciù
The purpose of this investigation is to evaluate 2 different methods for reducing cortical wall thickness in sinus floor augmentation surgery. A manual bone scraper was compared in terms of efficacy, speed, and safety to an ultrasonic insert for osteoplasty, in a randomized controlled clinical trial with a split-mouth design. Twenty-five patients with severe posterior maxillary atrophy were treated with bilateral sinus floor elevation with lateral approach. Antrostomies were randomly performed by eroding the cortical wall with a manual bone scraper (test site) or with an ultrasonic insert (control site) until the membrane was visible under a thin layer of bone, before outlining the window with a piezoelectric device...
May 19, 2017: Journal of Craniofacial Surgery
https://www.readbyqxmd.com/read/28537355/safety-and-cost-effectiveness-in-thyroidectomy-using-the-harmonic-scalpel-compared-to-traditional-hemostasis-a-controlled-clinical-assay
#17
Erich O P Basurto-Kuba, Maybelline Robles-Estrada, Luis Mauricio Hurtado-López, Edgar D Montes E Oca-Duran, Carlos Campos-Castillo, Felipe Rafael Zaldivar-Ramirez, Abraham Pulido-Cejudo
INTRODUCTION: The aim of this clinical control trial is to analyze the cost-effectiveness and to understand the efficacy of the HARMONIC FOCUS®+ (Ethicon Inc., Somerville, New Jersey) scalpel as the only system to cut and coagulate in thyroidectomy. MATERIALS AND METHODS: One hundered patients of the thyroid clinic of the Mexico City General Hospital were included. All patients underwent surgery and were divided into two randomized groups. In Group 1, the HARMONIC scalpel was the only device used for cut and coagulate (50 patients), and in Group 2 clamp, tie, and electrocautery (50 patients) were used...
May 24, 2017: Surgical Technology International
https://www.readbyqxmd.com/read/28537354/the-use-of-transcutaneous-electrical-nerve-stimulation-after-total-knee-arthroplasty-a-prospective-randomized-controlled-trial
#18
Deepak Ramanathan, Anas Saleh, Alison K Klika, Carlos A Higuera, Wael K Barsoum
INTRODUCTION: Multimodal pain management is used after total knee arthroplasty (TKA) to reduce opioid intake. Transcutaneous electrical nerve stimulation (TENS) has generated much interest as a non-pharmacologic, patient-controlled therapy. The aims of this study were to evaluate the efficacy of TENS in reducing opioid intake and improving recovery after TKA. MATERIALS AND METHODS: This was a prospective, parallel-group, double-blinded, randomized trial of patients receiving femoral nerve catheter block with allocation to either active or placebo TENS device groups...
May 24, 2017: Surgical Technology International
https://www.readbyqxmd.com/read/28537000/advances-in-clinical-cardiology-2016-a-summary-of-the-key-clinical-trials
#19
REVIEW
Alastair Gray, Conor McQuillan, Ian B A Menown
INTRODUCTION: The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA)...
May 23, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28535555/paresthesia-independence-an-assessment-of-technical-factors-related-to-10-khz-paresthesia-free-spinal-cord-stimulation
#20
Giuliano De Carolis, Mery Paroli, Lara Tollapi, Matthew W Doust, Abram H Burgher, Cong Yu, Thomas Yang, Donna M Morgan, Kasra Amirdelfan, Leonardo Kapural, B Todd Sitzman, Richard Bundschu, Ricardo Vallejo, Ramsin M Benyamin, Thomas L Yearwood, Bradford E Gliner, Ashley A Powell, Kerry Bradley
BACKGROUND: Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation...
May 2017: Pain Physician
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