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Kotsis Sandra V SV Ann Arbor, Mich. From the Section of Plastic Surgery, Department of Surgery, the University of Michigan Health System; and the Section of Plastic Surgery, University of Michigan Medical - - 2014
Many instructional guides have been published on how to write scientific papers. Likewise, many published articles have focused on the reasons why submitted manuscripts are rejected. However, fewer publications have been presented to guide authors on how to address reviewers' comments in a manuscript revision. Even fewer counsel authors on ...
Mandell Samuel P SP Harborview Medical Center , 325 9th Avenue, Box 359796, Seattle, WA 98104-2499 , USA +1 206 744 3140 ; +1 206 744 2896 ; - - 2014
Introduction: Fibrin sealants (FS) have been approved for use in the United States since 1998. Since approval, they have been used in a wide variety of clinical settings and new products continue to be introduced. Areas covered: This review covers the literature supporting the USA FDA-approved indications for FS products ...
McPheeters Melissa L ML Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Suite 600, 2525 West End Avenue, Nashville, TN 37203-1738, USA; Vanderbilt Evidence-Based Practice Center, Institute for Medicine and Public Health, Vanderbilt University Medical Center, Suite 600, 2525 West End Avenue, Nashville, TN 37203-1738, USA. Electronic address: - - 2013
This report provides an overview of methods used to conduct systematic reviews for the US Food and Drug Administration (FDA) Mini-Sentinel project, which is designed to inform the development of safety monitoring tools for FDA-regulated products including vaccines. The objective of these reviews was to summarize the literature describing algorithms ...
Polito Carmen C CC 11Divison of Pulmonary and Critical Care Medicine, Emory University, Atlanta, GA. 2Division of Trauma, Critical Care and Emergency Surgery, University of Arizona, Tuscon, AZ. 3Departments of Medicine and Surgery, University of Maryland, Baltimore, MD. 4Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, - - 2013
To characterize variation in the institutional review board application process of a multicenter, observational critical care study. Survey analysis of 36 investigators who applied for participation in the United States Critical Illness and Injury Trials Group: Critical Illness and Outcomes Study, an observational study of 69 adult ICUs. None. Analysis ...
Häfner M F - - 2013
Radiodermatitis is a very common side effect in cancer treatment often leading to therapy delays and diminution of the patients' health state and quality of life. Despite a wide range of supportive strategies, radiodermatitis is still a major problem necessitating further improvements in prevention and treatment. Lactokine is a milk-based ...
Yokota M - - 2013
External experts play an important role in shaping regulatory decisions in the new drug review process in the United States, Europe and Japan. No rigorous study has been performed addressing how and to what extent external experts, in contrast to internal reviewers in the agency, influence the regulatory decisions during ...
McDonagh Marian S - - 2013
A key systematic review (SR) methodology is comprehensive searching. The Drug Effectiveness Review Project (DERP) SRs search US Food and Drug Administration (FDA) documents to identify unpublished evidence. This study evaluates the success of those efforts. We examined DERP reports published since 2003 for the use of FDA preapproval and ...
Wallace Daniel J - - 2013
Belimumab has recently been approved, and several other types of biological therapy with different mechanisms of action are currently in phase II and III studies. This review puts these approaches in context, emphasizing mechanistic categories and clinical trial designs. Most of the promising approaches involve B cell depletion or modulation. ...
Achkar Jihad - - 2013
Balloon dilation for subglottic stenosis allows for a controlled radial expansion of the airway and is considered superior to older techniques of airway dilation. We report the case of a 39-year-old woman with idiopathic subglottic stenosis who had entrapment of an inflated balloon in her subglottis due to device failure ...
Murphy Timothy F TF Clinical and Translational Research Center, University at Buffalo, State University of New York, Buffalo, New York 14203, USA. - - 2013
The objective is to perform a comprehensive review of the literature from January 2007 through June 2011 on the virology, bacteriology, and immunology related to otitis media. PubMed database of the National Library of Medicine. Three subpanels with co-chairs comprising experts in the virology, bacteriology, and immunology of otitis media ...
Shah Rashmi R - - 2013
We compared, and determined the reasons for any differences in, the review and approval times of tyrosine kinase inhibitors (TKI) by the FDA and the EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for ...
Tominaga T - - 2013
Regulators must balance societal and medical requirements against the need for certainty about benefit and risk for new medicines. This is described in a case study of the expedited review and approval of peramivir, a novel neuraminidase inhibitor, in Japan in the context of the emergence of new strain of ...
Primus F E FE Department of Surgery, University of California, San Francisco, CA 94143-0104, - - 2013
We used an evidence-based approach to determine whether the promotions and claims of superiority of biologic mesh over synthetic mesh use in ventral hernia repairs (VHRs) under contaminated conditions were sound and valid. We searched the Medline database to specifically identify review articles relating to biologic mesh and VHR and ...
Pope Janet Elizabeth - - 2013
Raynaud's phenomenon is an episodic, reversible vasospasm of the peripheral arteries (usually digital). It causes pallor, followed by cyanosis and/or redness, often with pain and, at times, paraesthesia. On rare occasions, it can lead to ulceration of the fingers and toes (and, in some cases, of the ears or nose). ...
Young Colin - - 2012
A 26-year-old male was presented to a military treatment facility in Afghanistan shortly after taking a weight-lifting supplement called Jack3d with a severe headache and was subsequently found to have suffered a Dejerine-Roussy variant right thalamic hemorrhagic stroke. Jack3d active ingredients include geranamine, schizandrol A, caffeine, beta-alanine, creatine monohydrate, and ...
Shafritz Adam B - - 2012
Reverse total shoulder arthroplasty was officially approved for use in the United States in 2003. The procedure is proving to be one of the most exciting advances in upper extremity surgery in the past quarter-century. The prosthesis is used to salvage the arthritic, unstable, rotator cuff-deficient shoulder and allow patients ...
Shimazawa Rumiko - - 2012
BACKGROUND: Although approved elsewhere, many drug indications remain unapproved in Japan. Many of these unapproved indications are off-label, which, despite strong supporting evidence, are not covered by the Japanese health insurance system. To address this situation, the Ministry of Health, Labour and Welfare of Japan announced in 1999 that, under ...
- - 2012
Due to budget concerns, the NIH has added an extra review to all grant applications from investigators currently receiving $1 million or more in agency funding.
Bowman Seth - - 2012
ABSTRACT:: Dengue virus is one of the most common known causes of arboviral disease. Classic dengue fever (DF) is rarely fatal, but it may be incapacitating and require hospitalization. Atypical forms have been described involving the cardiac system, the central nervous system, and the hepatobiliary system. A 47-year-old white man ...
Scalabre Aurelien - - 2012
The objective of this study is to describe the evolution of 8 cases of congenital malformations of the umbilical-portal-hepatic venous system diagnosed before the first month of life. All cases of congenital malformation of the portal and hepatic venous system diagnosed prenatally or during the first month of life in ...
Sharma Jayendra - - 2012
Libman-Sacks endocarditis is rare in children and adolescents, more so as a first manifestation of systemic lupus erythematosus. Currently, sterile verrucous lesions of Libman-Sacks endocarditis are recognised as a cardiac manifestation of both systemic lupus erythematosus and antiphospholipid syndrome. They are clinically silent in a majority of the cases. The ...
Hoshino Ana Cristina Hiromi - - 2012
Mercury is neurotoxic, and numerous studies have confirmed its ototoxic effect. However, the diagnosis and follow-up of mercury exposure require understanding the pathophysiology of the chemical substance. Based on a systematic literature review, this study aimed to demonstrate whether mercury is ototoxic and to analyze its mechanism of action on ...
Miller B - - 2012
Purpose: It is essential for radiation oncology departments to have comprehensive patient safety and quality programs. Two years ago we undertook a systematic review of our safety/QA program. Existing policies were updated and new policies created where necessary. One crucial component of any safety/QA program is continually updating it based ...
Deisch Jeremy K - - 2012
Juvenile xanthogranulomas (JXG) are uncommon non-Langerhans cell histiocytic proliferations which arise most often in children. While most cases present as solitary cutaneous lesions, occasional cases involve extracutaneous sites. Rare examples of JXGs have been reported involving all levels of the neuroaxis. We present two cases of JXGs involving the nervous ...
Majeed B - - 2012
SUMMARYVisceral leishmaniasis (VL) is an endemic parasitic disease transmitted by the bite of sand flies. To describe trends and demographics of reported VL cases, we reviewed surveillance data from 1990-2009. Reported VL incidence per 100 000 population was 2·6 in 2007, 3·1 in 2008, and 4·8 in 2009, mostly in ...
Poursadegh Fard Maryam - - 2012
Scleroderma or systemic sclerosis is a multisystem disease due to excessive collagen deposition in different organs and autoimmunity by production of autoantibodies.According to previous reports, brain is rarely affected in scleroderma, howeverrecent studies show central nervous system can be affect not only as a complication of systemic involvement (hypertension, renal ...
Egevad Lars - - 2012
Context.-Histologic grading is the clinically most useful tissue-based predictor of prognosis for prostate cancer. Over the years, there has been a gradual shift in how the Gleason grading is applied in practice, with a general trend toward upgrading. A consensus conference was organized in 2005 by the International Society of ...
Kuo Ya-Hui - - 2012
A Web-based reporting system is essential to report incident events anonymously and confidentially. The purpose of this study was to evaluate a Web-based reporting system in Taiwan. User satisfaction and impact of system use were evaluated through a survey answered by 249 nurses. Incident events reported in paper and electronic ...
Bhutada Shraddha - - 2012
Normally, there is no obvious communication between the intracranial and extra cranial venous drainages in the head. In Sinus Pericranii, there is an abnormal communication, either from the extra cranial system to the intracranial venous sinuses or from the intracranial venous system to the extra cranial draining veins. Venous anomaly ...
Aldea A - - 2012
PURPOSE: This study was conducted to evaluate relevant new information about ADRs reported in the Spanish paediatric population over a 6-year period. METHODS: Adverse drug reactions (ADRs) for individuals aged 0-17 years reported to the Spanish Pharmacovigilance System from 2004 to 2009 were analysed with respect to time, age and sex, ...
Da Silva Keith - - 2012
Premature loss of primary teeth associated with a parafunctional habit in 30-month-old child is reported. Report details, clinically and radiographically, these effects in a very young child and reviews diagnostic possibilities. Early detection and scrutiny by the pediatric dentist is important to determine origin and to rule out periodontal disease ...
Güneş Mustafa - - 2012
Henoch-Schönlein purpura (HSP) is the most common systemic vasculitis of childhood. It is usually seen following upper respiratory tract infections. It rarely involves the genital system or causes scrotal edema. With this report, we wanted to bring a different perspective to this clinic of acute scrotum. Herein, we present two ...
Vanderlaan Paul A - - 2012
There is substantial variation in the reported rates of different diagnostic categories in The Bethesda System for Reporting Thyroid Cytopathology (TBS). Specifically, the relationship between the nondiagnostic (ND) and atypia of undetermined significance (AUS) categories has not been closely examined previously. Data from published series in the literature and from ...
Han Jie - - 2012
Although involvement of the reticuloendothelial system in systemic lupus erythematosus (SLE) is a well-recognised concomitant of the disease, spontaneous splenic rupture is an unusual occurrence. We observed a 54-year-old woman with SLE who had spontaneous splenic rupture during the late course of the disease and showed some changes histopathologically. The ...
Srba Jindrich - - 2012
PURPOSE: Spontaneous reporting systems in European countries are crucial for collecting adverse drug reaction (ADR) reports. The aim of this study was to evaluate reporting activity among countries and their strategy to increase the number of reports. We also established the best measure for assessment quantity of reports. METHODS: This ...
Oyama Ian A - - 2012
This study aimed to determine whether the Pelvic Organ Prolapse Quantification (POPQ) system should be simplified based on its use in the peer-reviewed literature. The American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology, and International Urogynecology Journal were used for this study. All articles relating to pelvic organ prolapse ...
Saha Manjari - - 2012
Chyluria is the passage of chyle into urine, and develops as a result of communication between the lymphatic system and the urinary system. It is an unusual manifestation of lymphatic filariasis reported mainly from South Asian countries. We report the case of a 38-year-old man from an endemic area who ...
Mutz Rüdiger - - 2012
One of the most frequently voiced criticisms of the peer review process is gender bias. In this study we evaluated the grant peer review process (external reviewers' ratings, and board of trustees' final decision: approval or no approval for funding) at the Austrian Science Fund with respect to gender. The ...
Girouard Sasha D - - 2012
Hidradenitis suppurativa is a chronic, inflammatory disease of the follicular epithelium that presents as tender, subcutaneous nodules in an intertriginous distribution with sinus tract formation. Most commonly, hidradenitis suppurativa results in local complications, such as scarring and infection. However, systemic complications, such as anemia and arthropathies, have also been described. ...
Kashkouli Mohsen Bahmani - - 2012
Epiphora is a common complaint of patients who present to an Ophthalmology Clinic. In many cases, epiphora is due to an obstruction in the lacrimal drainage system. However, a subgroup of symptomatic patients with epiphora has a patent lacrimal drainage system. Such cases are usually termed 'functional obstruction' and / ...
Abdoul Hendy - - 2012
Peer review of grant applications has been criticized as lacking reliability. Studies showing poor agreement among reviewers supported this possibility but usually focused on reviewers' scores and failed to investigate reasons for disagreement. Here, our goal was to determine how reviewers rate applications, by investigating reviewer practices and grant assessment ...
Eschle-Meniconi Margherita E - - 2011
We present an illustrative case of endogenous ocular Nocardia (EON) infection in a man with Hodgkin disease treated by chemotherapy who underwent aggressive vitreoretinal surgery for diagnosis and treatment of a subretinal abscess. Visual acuity recovered from hand movements to 20/25. We review the 38 reported cases of EON published ...
Mashhadi Mohammad Ali - - 2011
Systemic lupus erythematosus (SLE), is sometimes complicated by the rare fatal syndrome, Thrombotic thrombocytopenic purpura (TTP), but the occurrence of TTP as the initial manifestation of SLE is very rare. Since they have similarities in some features, the differentiation of TTP from SLE may be missed. SLE patients are also ...
Blunden A S - - 2011
This paper describes a case of hypertrophic feline muscular dystrophy (HFMD) in the UK. The cat under investigation died unexpectedly following routine vaccination, and postmortem investigation revealed myopathy, particularly affecting the diaphragm as well as multiple skeletal muscles. The right lung lobes were also partially collapsed and this was considered ...
Keppler-Noreuil Kim M - - 2011
Jeune syndrome, originally described as asphyxiating thoracic dystrophy by Jeune et al. [Jeune et al. (1955); Arch Fr Pediatr 12:886-891], is an autosomal recessive osteochondrodysplasia with characteristic skeletal abnormalities, and variable renal, hepatic, pancreatic, and retinal complications. We present eight patients, including two brothers with Jeune syndrome, and an extensive ...
Suzaki Ai - - 2011
Disseminated gonococcal infection (DGI) is quite a rare condition, especially in the Japanese population; only 10 cases have been reported in case notes and minutes. We describe a man in which Neisseria gonorrhoeae was suspected to have infected the patient through his pharynx. He developed chills, fever, tonsillitis, papules, tenosynovitis ...
Kkhattala Khalid - - 2011
Urethral diverticula are saclike dilations of the urethra and are classified as either congenital or acquired. While urethral diverticula are commonly seen in female patients, they are rarely seen in men. The most common etiologies of male acquired diverticula include urethral trauma, stricture, abscess or post-hypospadias repair. We report a ...
Mohapatra Abinash - - 2010
Odontogenic anomalies can occur as a result of conjoining or twinning defects. This article reports the case of fusion in a 10-year-old boy in relation to the primary maxillary right incisors. Clinicoradiographic examination revealed the presence of triple teeth, ie, fusion between the maxillary right incisors along with a supernumerary ...
Sala-Pérez Sergi - - 2010
The authors present six cases of mandibular condyle malformation. They also conducted a literature review of bifid mandibular condyle (BMC) to analyze the various hypotheses that have been made regarding the etiopathogenesis of this entity. Type of Studies Reviewed. The authors searched the PubMed database for all instances of BMC ...
Oh Se-Lim - - 2010
The biologic width includes both the connective tissue attachment and the junctional epithelium and has a mean dimension of approximately 2 mm. Invading the biologic width with a restoration can result in localized crestal bone loss, gingival recession, localized gingival hyperplasia, or a combination of these three. When restoring teeth ...
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