Clinical end points in coronary stent trials: a case for standardized definitions

BACKGROUND: Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. METHODS AND RESULTS: The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. CONCLUSION: Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.

Ear acupuncture points in neonates

OBJECTIVE: The aim of this study was to determine the presence and absence of acupuncture ear points in healthy neonates. DESIGN: This was a prospective observational study performed at a university teaching hospital. Subjects: The subjects were healthy neonates. We compared male and female neonates, right and left lobe, term and preterm deliveries, and cesarean sections versus vaginal deliveries. Examinations took place on the fifth day after delivery and were performed by a neuronal pen (SVESA 1070, SVESA GmbH, Munich, Germany). An integrated optical signal detected the ear points that were assigned to the Chinese ear map. MAIN OUTCOME MEASURES: This study looked at the presence and absence of acupuncture ear points in neonates. RESULTS: There were 27 male neonates and 23 female neonates. In 66% of neonates, no points at all were found. We detected 0-4 points on the right lobe and 0-2 points on the left lobe. The psychovegetative rim was the most common point in 26% of all children. No psychic points were detected. No significant differences were found between right and left ear lobes, male and female neonates, or term and preterm deliveries with respect to numbers of points or access of points. Moreover, there were no differences among modes of delivery. CONCLUSIONS: Some ear points in healthy neonates are detectable and not dependent on side of the ear lobe. Females had significantly more acupuncture points. There was an extremely significant difference in the group with 2 active earpoints between cesarean and vaginally delivered neonates. The most important point was the psychovegetative rim and the absence of psychic points in favor of the organ points. Possibly, ear points in neonates could be used for diagnostic and therapeutic options in neonates in the future.

Decelerator elements for ramp transfer points in fruit packing lines

Two different decelerator elements used to reduce impacts on fruits on ramp transfer points in fruit packing lines were designed and tested. The performance of these elements, a powered decelerator and a multiple curtain, was compared to commercial decelerators (blankets). A ramp of length 60 cm was placed at an angle of 30º in an experimental fruit packing line between a roller transporter and a conveyor. The decelerators were placed on top of the ramp. Different tests were carried out to study the performance of the decelerators using instrumented spheres (IS 100) of various sizes. Results showed that decelerators can reduce the impact intensity down to safe thresholds. The powered decelerator was the most effective because it reduced the speed of fruits and did not cause retention of the fruit, when correctly regulated.

Some points in choosing textiles /

Cover title.

Precious truth : or, Some points in gospel doctrine vindicated in a series of letters addressed to Christians of every denomination : shewing the falsehood of the charges brought against the writings of Mr. Marshal, Mr. Hervey, and others by Mr. Bellamy in his dialogues and letters /

Shoemaker 9842 and 9843.

Mercantile Trust Company vs. the Portland & Ogdensburg Railroad Company et als. : hearing on bill; answers and proofs : abstract and points in behalf of Nathan Webb, Samuel E. Spring and Weston F. Milliken, trustees /

At head of title: Circuit Court of the United States. District of New Hampshire.

The number of lattice points in a k-dimensional hypersphere,

Mode of access: Internet.

High points in the work of the high schools of New York City.

Editors: Jan. 1919- L.A. Wilkins and others.

A Hebrew and English lexicon without points: in which the Hebrew and Chaldee words of the Old Testament are explained in their leading and derived senses, ... . To this work are prefixed, a Hebrew and a Chaldee grammar, without points.

"A brief sketch of the life of the late Rev. John Parkhurst ...": p. [iii]-vi.

A short synopsis of the most essential points in Hawaiian grammar,

Mode of access: Internet.

Leading points in South African history, 1486 to March 30, 1900, arranged chronologically, with date-index,

Mode of access: Internet.

Employee benefit plans in agreement of AFL tobacco workers.

"Reports and Publications of the Bureau of Labor Statistics on Employee Benefits Programs": p. [49].