Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials.

Background: Historically, four divisions of the National Institute of Allergy and Infectious Diseases (NIAID) that manage clinical trials and oversee data and safety monitoring have operated fairly autonomously with respect to their approaches to Data and Safety Monitoring Board (DSMB) operations. We recognized the need for a revised policy on DSMB operations in an effort to encourage greater harmonization of procedures across the four divisions.

Purpose: The purpose of this article is to describe the considerations that motivated the development of the new policy, summarize current DSMB policies and ongoing harmonization efforts across the four divisions, and offer some recommendations for DSMB operations in the hope that other organizations may benefit from our experience.

Functional indications for upper eyelid ptosis and blepharoplasty surgery: a report by the American Academy of Ophthalmology.

Objective: To evaluate the functional indications and outcomes for blepharoplasty and blepharoptosis repair by assessing functional preoperative impairment and surgical results.

Methods: Literature searches of the PubMed and Cochrane Library databases were conducted on July 24, 2008, with no age or date restrictions, and they were limited to articles published in English. These searches retrieved 1147 citations; 87 studies were reviewed in full text, and 13 studies met inclusion criteria and were included in the evidence analysis.

Treatment of ruptured and unruptured cerebral aneurysms in the USA: a paradigm shift.

Background: Integration of data from clinical trials and advancements in technology predict a change in selection for treatment of patients with cerebral aneurysm.

Objective: To describe patterns of use and in-hospital mortality associated with surgical and endovascular treatments of cerebral aneurysms over the past decade.

Materials And Methods: The data are 34 899 hospital discharges with a diagnosis of ruptured or unruptured cerebral aneurysm from 1998 to 2007 identified from the Nationwide Inpatient Sample (NIS).

Reliability of estimating ductions in thyroid eye disease: an International Thyroid Eye Disease Society multicenter study.

Purpose: To determine intraobserver and interobserver reliability of 3 clinical techniques for measuring ocular ductions in patients with thyroid eye disease and to compare these with an established method using a Goldmann perimeter. Our secondary goals were to compare the clinical methods for test duration, ease of learning and performance, and whether these differed between novices and experts.

Design: Multicenter, prospective, comparative trial.

Isolated bilateral abducens nerve palsy without radiographic etiology and unique mechanism of injury.

Isolated bilateral abducens palsy is a rare event, especially in the setting of closed head injury. Cases that lack radiographic or pathologic findings to explain the etiology of the palsy are limited to case reports. Injury mechanisms have been postulated, but a consensus does not exist.

Microwave-based reaction screening: tandem retro-Diels-Alder/Diels-Alder cycloadditions of o-quinol dimers.

We have accomplished a parallel screen of cycloaddition partners for o-quinols utilizing a plate-based microwave system. Microwave irradiation improves the efficiency of retro-Diels-Alder/Diels-Alder cascades of o-quinol dimers which generally proceed in a diastereoselective fashion. Computational studies indicate that asynchronous transition states are favored in Diels-Alder cycloadditions of o-quinols.

Primary vertebral tumors: a review of epidemiologic, histological and imaging findings, part II: locally aggressive and malignant tumors.

This second part of a comprehensive review of primary vertebral tumors focuses on locally aggressive and malignant tumors. As discussed in the earlier part of the review, both benign and malignant types of these tumors affect the adult and the pediatric population, and an understanding of their subtleties may increase their effective resection. In this review, we discuss the epidemiologic, histological, and imaging features of the most common locally aggressive primary vertebral tumors (chordoma and giant-cell tumor) and malignant tumors (chondrosarcoma, Ewing sarcoma, multiple myeloma or plasmacytoma, and osteosarcoma).

Primary vertebral tumors: a review of epidemiologic, histological, and imaging findings, Part I: benign tumors.

Primary vertebral tumors, although less common than metastases to the spine, make up a heterogeneous group of neoplasms that can pose diagnostic and treatment challenges. They affect both the adult and the pediatric population and may be benign, locally aggressive, or malignant. An understanding of typical imaging findings will aid in accurate diagnosis and help neurosurgeons appreciate anatomic subtleties that may increase their effective resection.

Attitudes to cadaveric organ donation in Irish preclinical medical students.

There is a worldwide shortage of organs for transplantation. It has been shown that the attitude of healthcare professionals can improve the rates of organ donation, and that educational programs aimed at improving both attitudes and knowledge base of professionals can have positive outcomes. Although there has been research carried out on this topic, there has been none in Ireland.

Tuberculous dactylitis in the setting of low serum vitamin D: a case report.

We present the case of a previously well patient who presented to the Emergency Department of a Dublin hospital with a tuberculous infection of his dominant index finger and a very low serum vitamin D level--this has been implicated in both primary and reactivation infections with Mycobacterium Tuberculosis. This case highlights and reviews both the importance of considering non-endemic pathologies in the setting of a patient base of diverse ethnicity, and the emerging importance of vitamin D in the immune response to M. tuberculosis infection.

Treatment and survival of patients with nonmalignant intracranial meningioma: results from the Surveillance, Epidemiology, and End Results Program of the National Cancer Institute. Clinical article.

Object: The authors conducted a study to determine population-based estimates of survival following the diagnosis and treatment of nonmalignant intracranial meningioma in the US in the modern era.

Methods: Patients with nonmalignant intracranial meningioma were identified through the Surveillance, Epidemiology, and End Results (SEER) database for the years 2004-2007. Predictors of undergoing resection were identified and odds ratios calculated.

Cannabinoid type 1 receptor antagonists for smoking cessation.

Background: Selective type 1 cannabinoid (CB1) receptor antagonists may assist with smoking cessation by restoring the balance of the endocannabinoid system, which can be disrupted by prolonged use of nicotine. They also seeks to address many smokers' reluctance to persist with a quit attempt because of concerns about weight gain.

Objectives: To determine whether selective CB1 receptor antagonists (currently rimonabant and taranabant) increase the numbers of people stopping smoking To assess their effects on weight change in successful quitters and in those who try to quit but fail.

Nicotine receptor partial agonists for smoking cessation.

Background: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). Varenicline was developed as a nicotine receptor partial agonist from cytisine, a drug widely used in central and eastern Europe for smoking cessation. The first trial reports of varenicline were released in 2006, and further trials have now been published or are currently underway.

Clinical and pathologic eyelid alterations in a patient with Darier disease.

Darier disease (DD) is a rare autosomal dominant dermatosis that has infrequent ocular manifestations, especially those involving the eyelids. The authors describe a patient with long-standing DD who presented with both classic and unique clinical findings. Eyelid biopsy samples studied with electron microscopy demonstrated histopathological changes consistent with DD.

Outcomes for single-level lumbar fusion: the role of bone morphogenetic protein.

Study Design: Retrospective analysis of a population-based insurance claims data set.

Objective: To determine the risk of repeat fusion and total costs associated with bone morphogenetic protein (BMP) use in single-level lumbar fusion for degenerative spinal disease.

Summary Of Background Data: The use of BMP has been proposed to reduce overall costs of spinal fusion through prevention of repeat fusion procedures.

Delayed development of os odontoideum after traumatic cervical injury: support for a vascular etiology.

A previously healthy 2-year-old girl sustained a C1-2 ligamentous injury after a motor vehicle accident and underwent successful halo immobilization, with postimmobilization images showing good cervical alignment. At the time, plain radiography, CT scanning, and MR imaging showed a normal odontoid. Four years later, however, the patient was found to have an os odontoideum, evident on plain radiography and CT imaging.

Phosphodiesterase 6C, cGMP-specific cone alpha'.

Network Map States Transitions Functions Protein Classes Sequence Interactions Pathways Domains & Motifs Protein Structure Orthologs Sequence Interactions Pathways Domains & Motifs Protein Structure Orthologs Blast Data.

Reconstructive options for the medial canthus and eyelids following tumor excision.

General principles provide the framework for eyelid and periorbital reconstruction following tumor excision. Eyelid tumors involving the medial canthus region and/or lacrimal system add to the complexity of reconstructive planning. The nature of the tumor, patient and tissue factors, and surgeon preference guide repair design choices.

Trends in survival after surgery for breast cancer metastatic to the brain and spinal column in medicare patients: a population-based analysis.

Background: Central nervous system (CNS) metastases are a common occurrence in patients with breast cancer and are identified in up to 30% of patients at autopsy.

Objective: To determine population-based estimates of survival times after surgical intervention for Medicare patients with metastatic breast cancer to the brain and spinal column.

Methods: Female breast cancer patients with metastases to the brain and spinal column and undergoing neurosurgical treatment were identified through the Surveillance, Epidemiology, and End Results-Medicare database.

Nicotine receptor partial agonists for smoking cessation.

Background: Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). Varenicline was developed as a nicotine receptor partial agonist from cytisine, a drug widely used in central and eastern Europe for smoking cessation. The first trial reports of varenicline were released in 2006, and further trials have now been published or are currently underway.

Cell-penetrating peptides, electroporation and drug delivery.

Certain short polycations, such as trans-activating transcriptional activator and oligoarginine, rapidly pass through the plasma membranes of mammalian cells by a mechanism called transduction, as well as by endocytosis and macropinocytosis. These cell-penetrating peptides can carry with them cargos of 30 amino acids, more than the nominal limit of 500 Da and enough to be therapeutic. An analysis of the electrostatics of a charge outside the cell membrane and some recent experiments suggest that transduction may proceed by molecular electroporation.