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21 U.S. Code § 387j - Application for review of certain tobacco products
(a) In general
(1) New tobacco product defined
For purposes of this section the term "new tobacco product" means—
(A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.
(2) Premarket review required
(A) New products
An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless—
(i) the manufacturer has submitted a report under section 387e (j) of this title; and the Secretary has issued an order that the tobacco product—
(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and
(B) Application to certain post-February 15, 2007, products
Subparagraph (A) shall not apply to a tobacco product—
(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and
(ii) for which a report was submitted under section 387e (j) of this title within such 21-month period,
except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not substantially equivalent.
(3) Substantially equivalent defined
(A) In general
In this section and section 387e (j) of this title, the term "substantially equivalent" or "substantial equivalence" means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product—
(ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.
(B) Characteristics
In subparagraph (A), the term "characteristics" means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.
(4) Health information
(A) Summary
As part of a submission under section 387e (j) of this title respecting a tobacco product, the person required to file a premarket notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such information will be made available upon request by any person.
(B) Required information
Any summary under subparagraph (A) respecting a tobacco product shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such tobacco product is substantially equivalent to another tobacco product.
(b) Application
(1) Contents
An application under this section shall contain—
(A) full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;
(B) a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product;
(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;
(D) an identifying reference to any tobacco product standard under section 387g of this title which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
(E) such samples of such tobacco product and of components thereof as the Secretary may reasonably require;
(2) Referral to Tobacco Products Scientific Advisory Committee
Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—
refer such application to the Tobacco Products Scientific Advisory Committee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting the application, together with all underlying data and the reasons or basis for the recommendation.
(c) Action on application
(1) Deadline
(A) In general
As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall—
(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or
(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.
(B) Restrictions on sale and distribution
(2) Denial of application
The Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that—
(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;
(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f (e) of this title;
(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or
(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.
(3) Denial information
Any denial of an application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form (which measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary).
(4) Basis for finding
For purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(5) Basis for action
(A) Investigations
For purposes of paragraph (2)(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well-controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product.
(B) Other evidence
If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A)) which is sufficient to evaluate the tobacco product, the Secretary may authorize that the determination for purposes of paragraph (2)(A) be made on the basis of such evidence.
(d) Withdrawal and temporary suspension
(1) In general
The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from the Tobacco Products Scientific Advisory Committee, and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued under subsection (c)(1)(A)(i), issue an order withdrawing the order if the Secretary finds—
(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health;
(C) that the applicant—
(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 387i of this title;
(ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title; or
(iii) has not complied with the requirements of section 387e of this title;
(D) on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was reviewed, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 387f (e) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;
(E) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was reviewed, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or
(F) on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such order was issued, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 387g of this title, compliance with which was a condition to the issuance of an order relating to the application, and that there is a lack of adequate information to justify the deviation from such standard.
(2) Appeal
The holder of an application subject to an order issued under paragraph (1) withdrawing an order issued pursuant to subsection (c)(1)(A)(i) may, by petition filed on or before the 30th day after the date upon which such holder receives notice of such withdrawal, obtain review thereof in accordance with section 387l of this title.
(3) Temporary suspension
If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a tobacco product under an order would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market, the Secretary shall by order temporarily suspend the authority of the manufacturer to market the product. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.
(e) Service of order
An order issued by the Secretary under this section shall be served—
(f) Records
(1) Additional information
In the case of any tobacco product for which an order issued pursuant to subsection (c)(1)(A)(i) for an application filed under subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, as the Secretary may by regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such order.
(2) Access to records
Each person required under this section to maintain records, and each person in charge of custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.
Source(June 25, 1938, ch. 675, § 910, as added Pub. L. 111–31, div. A, title I, § 101(b)(3),June 22, 2009, 123 Stat. 1807.)
Prior Provisions
A prior section 910 of act June 25, 1938, was renumbered section 1010 and is classified to section 399a of this title.
LII has no control over and does not endorse any external Internet site that contains links to or references LII.


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By KEVIN SCANNELLSun Advocate sports reporter
In the end, good things can happen to those who wait.
For the Price American Legion Baseball team, the wait had gone on for long enough.
After enduring tough losses all season long, the Price team finally had everything go their way on the diamond as they came away with an 8-2 win over Moab on Friday afternoon.
Despite playing Moab in two other games this week, including a 7-0 loss in the second game of a double header on Friday and 20-6 loss on July 23, the win was sweet vindication to a team that took a number of tough losses this season.
"It was a great way for the kids to finish the season off," said head coach Willie Ellington.
The team was able to put together a successful game at the plate scoring seven runs which helped give starting pitcher John Grasso plenty of room to work with as he pitched a complete game for the win.
Ellington said the team dealt with plenty of adversity over the season. Through all of the losses the team continued to play the games with respect and dignity, he said.
"They were really excited about getting that first win," Ellington said. "As a coach it was great to see them put everything together. The kids never gave up and it made the long wait for a win worth it."

subset: commoncrawl


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I was doing something similar. Grab a flavor of vnc for each unit and intall the server on each box that wont ahve a keyborad & mouse attatched. On the one with the keyboard and mouse, install the client.
Then you just run the vnc program and you get a window for each remote system. X11 based GUIs generally will give you a new Xsession. I dont know about OS X. But winders will give you control of the unit as if you were in front of it.
As long as there is a LAN connection, you really arent limited to how many connections (excpet bandwidth). I highly reccomend that you close out any sessions that are not going to be used -- sending 3 1024x768x32 screens every refresh cycle can be quite exhaustive


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Welcome to the website of Mayor Tom Bates at the City of Berkeley, CA.
Berkeley - We're an innovative city with economic vitality, healthy and safe neighborhoods, a clean and green environment, a diverse population and a unique cultural experience. We are nationally recognized as an environmental, solar, and green city with the number one public university in the country. To green our economy and reduce greenhouse gas emissions in and around our community, I co-founded the East Bay Green Corridor Partnership with the Mayors of Oakland, Emeryville, and Richmond, the Chancellor of the University of California, Berkeley, and the Director of the Lawrence Berkeley National Laboratory. We work closely with community partners, public agencies, the business community, neighboring cities, and through my representation on planning bodies such as Metropolitan Transportation Commission (MTC), Bay Conservation Development Commission (BCDC), and the Bay Area Air Quality Management District (BAAQMD) to meet our goals. We are a city dedicated to serving the interests and preserving the well-being of its people.
News from Mayor Tom Bates - This page contains press releases from the Mayor's Office. You can see news from our office also in The Bates Update newsletters. [more...]


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Purchase Trans Globe Lighting and you get:
Need Help with what You are Looking for? We're happy to offer Lighting Design Assistance to help you find just the right product for your space. Please Call us toll free at 1.888.308.4353 Click here to view our contact information.


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Edited by rmjapan on 06/19/2015 12:09:57 MDT.
Ian said: "I'm probably making a distinction in my mind between windshirts and windbreakers which doesn't need to be there. So far I've been using my hardshell for double duty and haven't purchased a windshirt yet. I was considering a softshell but now I'm more inclined to buy a windshirt. I keep hearing that they breathe much better so it's time for me to find out. "A windshirt is just a lightweight windbreaker. The concept is the same: prevent heat loss from wind and get some protection from light precip. Breathability is key. Get a Houdini and don't look back :)Softshell jackets are heavy and cold. A 100w fleece and a windshirt are warmer than the Patagonia Super Guide jacket that I **had**. I tried a Millet too. Like I said, they are like a polyester Levi jacket to me. What I can't logically reconcile is that I really like soft shell pants. Maybe there are differences in the fabrics, but they work for me on cold rainy days.
I use my R1 for summer and winter.I use it with a windshirt for snowshoeing and its perfect.I just bought a big puffer for cold weather, when on breaks or cool summer evenings.I get cold pretty easy and my downsweater didnt work for me in the sierra.Just sold my softshell cause i realized it was a lot of bulk but couldnt figure a specific use-sort of a redundant piece.Have to figure out the use of my R2.
Spending summers in Denali (think days of 40s-50s, constant rain and wind, and helpin' spoonfuls of soak-you-to-the-bone bushwhacking) and winters in Western Oregon (think the same minus the schwhacking) taught me to love fleece. In those conditions, you're going to be and stay wet. If you generate enough body heat to stay warm when soaked and have the stamina to never stop moving in order to continue generating that heat, more power to you. I found that I didn't. I also found that synthetic insulation worked well when damp but sucked when soaked. So, I started packing ye olde fleece. Low and behold, it actually kept me warm when wet. And wringing it out and throwing it back on removed a significant amount of water, at least for awhile.So, yeah, if you recreate in conditions that allow you to stay warm and dry enough that you don't need insulation while moving, pack the puffy. But for wet, cool/cold conditions, fleece is awesome. The minor increase in weight and packed volume is so very worth being able to actually enjoy trips in continuously wet weather.
If you don't need it in your bag/quilt at night it does make a great pillow. Another positive for the lack of compressibility.
I have a lightweight fleece vest that I wear in cold weather under my windshirt or my rain jacket, depending on whether or not it's precipitating at the time.IMHO, the folks above who say fleece is best for insulation while moving while the puffy is best for insulation when sitting still, are correct!
Edited by rmjapan on 06/19/2015 12:04:03 MDT.
where the softshell shines is in durability ... i get pinholes very fast in windshirts climbing ... if your softshell doesnt breath decently well and takes forever to dry, you got the wrong type of softshell ... buy the unlined, non-membrane ones ... they also tend to be the cheapestthe other part of synthetic puffies is that they are "additive" ... that is you put them OVER your softshell/windshirt at belays ... if you are ever at a hanging/semi-hanging belay with the wind howling and need to take off your windshirt, put on your fleece, put back on your windshirt, you know what i mean ... with puffies you simply put on the needed layer without taking anything off ...that said im always a fan of fleece for a mid layer .. my current MEC r1 copy has enough holes to prove it ...a fleece is a great piece for newer people who dont need the fancy $$$$$ gear when they start out ... buy it cheap and on sale ...as for fun in the wet ... plenty of people in the PNW go out in wet conditions ... i tend to ONLY "hike" in marginal to poor weather ... if its not raining and dry enough, im climbing ;)
Edited by bearbreeder on 04/09/2013 01:35:52 MDT.
Fleece is good. One caveate that I may have missed is that these are usually recycled PET or similar. As such they do NOT take permethrin very well. It usually washes out. I don't even try. In the NE, with all the Blackfly's that show up in spring, I have to be carefull about which shirts I bring, though I far prefer the fleece as a sweater. Like good wool, they can maintain a certain amount of insulating value even if they are soaking wet. My puffy is reserved for after I get my tarp up at night, cooking supper, sleeping and in the morning getting breakfast and packing.
Rick M: "Being out in cold continuously wet weather for days on end does not sound like recreational Type 1 hiking fun to me! Sounds more like work or an endurance journey where circumstances force total disregard for conditions or short term forecasts. Learning when not venture out into the wilderness should be part of the basic UL skill set too."Fair enough.I've started a new thread about this issue.
I agree Paul, both fleece AND wool (i also read and enjoyed your wool pants article) have their place depending on conditions. Re: wool pants, i also like these for colder temps, but i tend to use wool-poly blends--the poly for added durability and speeding up the drying time a bit, and the wool for odor control, moisture absorption, and naturally better breathability. I try to find pants with about a 60% wool to 40% poly blend + or - 10% in either fabric or direction. Then i soak the bottom half in nikwax.We are going to Alaska in mid June to very beginning of July, and we will definitely be bringing some fleece.
For example, MEC's Watchtower pants, thick snug leggings of fuzzy unfaced fleece (not at all like sweatpants). They've been ideal as a seasonal midlayer, in cold rain, in camp and as sleepwear, for under 9 oz and under $40 (some $19, fyi). Now all my other bottom layers are four-season gear.
Thanks for the Mec tip B&B. I have experimented a bit with using the cheap micro fleece pajama/sleeping bottoms. Most of the ones i have weighed, weighed in from around 8 to 10 oz range. I just bought a pair the other day for 4 dollars. I'm just guessing, but maybe the Mec pants will be a bit more durable long term? Do you know if the MEC watchtower pants use micro fleece or regular? I like micro fleece because it's warmer per weight and more comfortable.
Hi Justin: the MEC pants are not a grid fleece. It's stretch-woven 100% polyester, 'furry' both sides, at least 1/4" thick. No membrane, highly breathable on its own (300 CFM). 245g/8.5 oz in medium.http://www.mec.ca/AST/ShopMEC/MensClothing/PantsTights/PRD~5017-968/mec-watchtower-pants-mens.jsp
Thank you Bogs, i got that part earlier, was just wondering if the stretch woven polyester fibers are more the microfiber size or more the classic fleece size. One easy way to tell is by the softness. Microfiber fuzzy fleece will feel noticeably softer than regular fuzzy fleece. Microfiber (anything) will trap more air and thus be warmer, and depending on density/tightness of weave, usually for a lower weight. Can repel water better too depending on density/tightness of weave.
I don't think its an either or. I use fleece insulation to be warm enough when moving and puffys to go over top for breaks.So for summer in the rockies I don't bring a fleece as a long sleeve base layer plus a rain shell while moving is good to zero degrees for me.In winter, spring and fall the MEC R1 clone or the MEC T2(lighet than a Cap4) or both get added depending on temperature. These will generally be worn almost all of the day. For stops though I love the ex-lite in the summer and fall and my big down coat of the winter.My philosophy in general is just keep adding fleece layers until you are thermal neutral while moving and then add puffy layers until you are thermal neutral at rest.
>>I don't think its an either or. I use fleece insulation to be warm enough when moving and puffys to go over top for breaks.That's what I do, too. Wear my fleece and wool when moving, but throw on my down parka (GoLite Bitteroot) in camp and sometimes at break.Nothing is either/or. I like to mix, match, use, discard and replace as conditions and trips warrant. :)
Justin: I'm sorry, yes, hence the weight/thickness ratio, some water beading without DWR, some stretch without lycra, also softness and half-decent compressibility. Compared to my Polartec 200 buff, these (which are not Polartec) might be 300 weight? I'm guessing?
I total agree when applying it to myself but some people are always pushing their envelope and like everything else much of this is relative to an individuals strengths, skills and tolerance to severe conditions. Safety should be paramount but that too is relative. I guess the most important skill is recognizing ones limitations. (to paraphase 'Dirty Harry').
I've had the same issue as Dale regarding softshells. My jacket has been relegated to city use or climbing only. It's just not light or warm enough for overnight trips.Pants on the other hand seem best as softshell. For core insulation softshell just isn't warm enough, but it does breathe decently but is better at wind blocking and has great abrasion. For legs you don't need as much insulation but you do need wind protection (hence so many people love their UL wind pants as primary leg wear) and the added abrasion resistance of softshell is welcome. One light/medium softshell also can be worn in a 60F degree range (20-80F) fairly well, and the 30F range the most people recreate in rather comfortably.
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This is an activity about Earth's magnetic field. Learners will construct a soda bottle magnetometer, collect data, and analyze the results to detect magnetic storm events. Ideally, learners should collect data for at least a month. If several... (View More) months are available for data collection, this is ideal. This is the first activity as part of the iMAGiNETICspace: Where Imagination, Magnetism, and Space Collide educator's guide. Instructions for downloading the iBook educator's guide and the associated Transmedia book student guide are available at the resource link. (View Less)
In this activity, community members of all ages are invited to contribute photographs — taken with cell phones, film cameras, or more sophisticated equipment — of the Moon. The images are collected over the course of a month or more and posted... (View More) in chronological order. The collection forms a display featuring the Moon's changing appearance in your local sky over the course of a month or more. This community engagement activity is part of Explore! Marvel Moon. (View Less)
Materials Cost: Free
This is a 15-day unit of inquiry-based lessons about the surface features of the Moon and the Earth and how these two worlds formed and continue to evolve. Students participate in real science as they help lunar scientists map the surface of the... (View More) Moon with MoonMappers, an online citizen science project that lets the public analyze real data from NASA's Lunar Reconnaissance Orbiter. The lessons in this unit follow the 5E instructional model. Includes an overview of citizen science, glossary of lunar feature vocabulary, alignment to NGSS and NSES, and featured links. (View Less)
Materials Cost: $10 - $20 per group of students
This is an activity about sunlight as an energy source. Learners will create a plant box and observe that a plant will grow toward the Sun, its primary source of energy. This hands-on activity is an additional lesson as part of the book, The Day... (View More) Joshua Jumped Too Much. (View Less)
Materials Cost: $1 - $5 per group of students
In this problem-based learning activity, learners explore the significance of sunspots on the Earth's climate. Sunspots are temporary phenomena on the photosphere of the Sun that appear visibly as dark spots compared to surrounding regions. During... (View More) periods of low sunspot activity, the sun's irradiance decreases. Although this decrease is small, it appears that various feedback mechanisms can amplify the impact. Instructions to access NASA data are provided along with additional resources and activities. This module was developed to be used in the Earth System Science Education Alliance (ESSEA) courses for middle and high school teachers and is also available to teachers to adapt for general classroom use. (View Less)
Materials Cost: Free per group of students
This is an activity about lunar and terrestrial stratigraphy. Learners will design a development on the Moon that is suitable, feasible, and beneficial and present proposals for developments on the Moon in a competition for approval from a... (View More) student-staffed Lunar Council. This activity is in Unit 3 of the "Exploring the Moon" teachers guide, which is designed for use especially, but not exclusively, with the Lunar Sample Disk program. (View Less)
Materials Cost: 1 cent - $1 per group of students
This is an activity about observation. Learners will first observe a first quarter Moon and as a group, predict which phase the Moon will be in during the next observation. After this, learners will continue to chart the progress of the lunar cycle... (View More) of phases throughout the following weeks to better understand the sequence. This is Activity A-2 of Universe at Your Fingertips 2.0: A Collection of Activities and Resources for Teaching Astronomy DVD-ROM, which is available for purchase. (View Less)
Learners will first observe a first quarter Moon and as a group, predict which phase the Moon will be in during the next observation. They then continue to chart the progress of the lunar cycle of phases throughout the following weeks to better... (View More) understand the sequence. This is Actividad 1.2 as part of El Universo a Sus Pies, a Spanish-language curriculum, available for purchase. (View Less)


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Yes there are quests. Check the guide for controls.
Player amount online can range from 0 - 10.
not that bad but it doesnt look like zelda in my eyes .Just the normal rpg maker xp sets combined with some sprites
we've recently added several new features, new areas, many updates!
newest client release is 1.6.3, get it here:
if you need the register.bat or the library files they can be found here:
the client hasn't been updated on the site there, so that's still 1.6.2, don't get that.
and we've had a solid 10-25 people online for awhile since we started pushing updates out every week or so and adding so much new.
and to the ones who say it doesn't look like zelda...
come check us out anyways, our community is solid, we have amazing people, AND...there could be a new project in the works from us that involves LttP tiles or similar tiles...could be *wink*
but we're giving our players more and more while we have them and drumming up new players where we can
Last edited by baltes; 11-23-2008 at 04:10 PM.
this game is pretty good
Don't mind if I speread this game around some ppl
looks sick, we should star an onrpg guild/alliance/association.
IGN= typhoon
Ok think this one princess zelda, one gannon, 100+ links.....ya know.....brutal man just imagine -.-
What? You expect something?
haha, yeah guys, spread it around.
i won't lie, things may seem a bit disorderly in the game currently because a staff member went psycho on us...but it's nothing we can't deal with, although it's causing a little bit of aggravation.
What are you going to do in this day and age? No one knows how to control their temper and not hack. Once the security is back up maybe we can all play and have fun without a worry.
P.S. Great game
Is this game even legal? Did you get permision from nintendo?


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Mildred Irene Tate Duckworth, 84, of Borger, passed away, Tuesday, April 12, 2011.
Mildred (Wickerd) Duckworth was born Tuesday, June 29, 1926 in Eagle Rock, CA to Oliver Henry and Ina Pearl Wickerd. She was a beautician.
She is preceded in death by her parents; her first husband, Marion Lawrence Tate; her second husband, David R. Duckworth; and her son, Kirk Raymond Tate.
Survivors include one son, Brian Tate and wife Timmie Sue of Days Creek, OR; four daughters, Virginia Tate of Reno, NV, Brenda Walker and husband Chuck of Sacramento, CA, Valarie Tate of Fernley, NV and Audrey Brown of Winston, OR; one sister, Evelyn Hanks of Borger, TX; seven grandchildren and eight great grandchildren.
No services are scheduled.
Cremation was entrusted to Brown Funeral Directors.
Send personal condolences to www.brownfuneraldirectors.net.


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Update (Nov. 15, 11 a.m. PT): Due to popular demand, this offer is no longer available on: Nov. 23; Dec. 15.
Escape to a AAA 4-Diamond hotel in the California coastal town of Monterey for $134 per night. Save 40% on the complete package, which includes daily breakfast buffet for two with unlimited mimosas.
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By JOHN SERFUSTINISun Advocate associate editor
Section by gigantic section, pieces of the nation's Space Shuttle program were laid to rest last week at the ECDC Environmental landfill in East Carbon.
When assembled, the cylinders once made up a full-scale, full-weight mock-up of the shuttle's reusable solid rocket motor. In all, the RSRM was about 126 feet high and 12 feet in diameter, weighing in at about 1.3 million pounds. These were the motors that were attached to either side of the main body, providing a combined thrust of about 5.3 million pounds for the first two minutes of the launch..
Aerospace manufacturer ATK built the model more than 30 years ago so that assembly and transport machines at NASA could be designed to exact tolerances for handling the real things.
Instead of being filled with real solid fuel, though, these parts are filled with an inert compound that weighs the same. The landfill has no problem accepting what has now become non-hazardous waste, said ECDC manager Jeff Green.
It took two heavy-lifting Wagstaff Crane Co. cranes to move each cylinder from the rail car to a truck bed that hauled them up to the working face at the landfill.
At the face, they were rolled into a trench and covered with dirt.


text: Money starting to flow in for tsunami cleanup efforts Share this story email Share this story «Previous 4 of 5 Photos Next » Read the story « » Tsunami Dock Removal In this photo provided by Oregon Parks and Recreation Department, the Japanese dock that was torn away by last year's tsunami is prepared for removal at Agate Beach in Newport, Ore., Tuesday, July 31, 2012. Salvage workers will start cutting up the dock today and hauling the pieces away on flat-bed trucks. But a chunk will be preserved as a memorial to victims of the Japanese tsunami.(AP Photo/Oregon Parks and Recreation Department)


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- Northern New York Newspapers
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It was a special night for OFA football.
And special teams play sparked the Blue Devils a flying start to a 48-0 victory over Canton in the final varsity game played on the Alton W. Elliott Athletic Complex Field.
The victory also vaulted the Blue Devils into Fridays Section 10 Class C Championship game at 8-0 Potsdam which broke away to a 46-18 win over St. Lawrence Central.
We have unfinished business. We need 110 percent all week from everyone, said OFA Co-Captain Kevin Goolden about the opportunity to avenge their only
loss of the season and move on to the New York State Tournament.
The Devils (7-1) capitalized on short fields created by three-and-outs, two blocked punts and the sacking of the punter after a high center snap to open a 27-0 first quarter lead against the Bears (1-7).
Spencer Mayette deflected the first punt of the game and quarterback Josh Liebstein bolted 20 cards to cap a 47-yard drive. On the Bears second possession Mayette and Nick Sweeney blocked a punt and Ryan Denny recovered it on the 10 yardline.
Two plays later Jordan McCormick ran untouched four yards to the corner of the endzone. The lead became 21-0 on John Taylers third straight PAT after Liebstein scored on a five-yard keeper set up when Mitchel Barber sacked the punter after a bad snap.
Jon Rogers closed out the first quarter burst with a 25-yard run on a night when he would run for two scores and catch three passes for 83 yards.
The Devils would add single touchdowns and PAT kicks by Tayler in the last three quarters. Liebstein, who rushed for 71 yards and went 8-for-8 in the air for 120 yards, pitched a four-yard TD pass to Tayler in the second quarter.
McCormick bulled from two-yards out for his second TD of the night in the third quarter and Rogers slammed across the goalline from two-yards out in the fourth quarter for his second TD.
The guys played well and capped their legacy on this field very well tonight, said OFA Coach Matt Tessmer.
Our specials had a good night with the two blocked punts and converting six of seven PAT kicks.
Sparked by connections between quarterback Hunter Yerdon (6x18-2-70) and tight end Cole Zeller (3-49) and flanker Louden Porter (3-21), Bears mounted a scoring threat in the final stages of both halves. Both were snuffed by interceptions in the endzone.
Taylor Bouchard made a leaping interception with just seconds remaining in the half and Cody Rolfe stepped in front of an a receiver on the goal line with 1:46 left in the game.
Two Minute Drill: Canton played without its leading rusher and tackler in Peyton VanBibber (arm injury)...Barber, Taylor Richardson and Jake King were in on sacks for OFA and Lenny Walwrath and Zeller combined on a Canton sack..Joe Loffler led OFA with six tackles and Mayette had four tackles on kick coverage in the first half. Andy Knight led Canton with seven stops...Cantons Zach Martel produced the only fumble recovery of the game...Tackles behind the line were noted by OFAs Joe Loffler (3), Taylor Bouchard, Quinton Denner and Cody Rolfe and Cantons Markel...OFAs backup QB Joe Dalton ran for 27 yards and passed for 39 yards.
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|Print Page
Using a big shovel to break up the fight
The other day I was cleaning my dog kennels and I had some of the dogs out in the dog yard running around while I did it.
Guest Column
The end of the Farm Bill?
Letters to the Editor
A few weeks ago I had the chance to exchange words on politics with a good friend of mine who sits on the County Democratic Central Committee. As conversations that start about politics usually end up we ended up talking about marriage and governmen...
Letters to the Editor
This letter is in regards to the article in the Sun Advocate on January 22 which references the letter sent to the White House concerning our second amendment rights to keep and bear arms....
Letters to the Editor
Open letter to the President
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CANTON Canton native Tom Ryan, a former All-American and professional player, is joining the St. Lawrence University mens lacrosse team as an assistant coach, the school announced.
Ryan will join head coach Mike Mahoney and assistant Kyle Benton on the staff.
Ryan played and coached collegiately and professionally. He led Team USAs indoor team from 2006-11. He last coached for NCAA Division II Belmont Abbey College.
Ryan helped Canton to a Section 10 title and later broke records for Division III Bowdoin College. As a professional in the National Lacrosse League, he drew a cult following with his dreadlocks and intensity on the field. Concussions forced him off the field in 2003.
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MALONE - Though not advertised as a rally against the New York Secure Ammunitions and Firearms Enforcement (SAFE) Act, all of the comments at Thursdays Franklin County-sponsored forum on the new gun legislation were very much against it.
Approximately 80 people showed up to at forum held in the Malone Middle School auditorium.
Following several presentations from county officials and others, many in attendance voiced their opinions against the act.
Boycott your fishing and hunting licenses, said one attendee.
Wheres the DA (district attorney)? asked another. I want him here tonight.
Another attendee said that the counties in New York City are the only ones not opposed to the act and that area should become its own state.
That will get rid of 90 percent of the problem, he said.
Another urged everyone to join the National Rifle Association (NRA).
Others had concerns about the law and a variety of questions, many of which law enforcement and county officials were unable to answer.
The evening started out with county Sheriff Kevin Mulverhill using a slide show presentation to explain the main provisions of the SAFE Act, which was passed on Jan. 15.
This is meant to be an educational presentation, he said.
Mr. Mulverhill described how the SAFE Act reclassifies what is considered an assault weapon, which for many weapons means having one military-like feature. He added that any existing assault weapons must be registered.
Other provisions of the law Mr. Mulverhill mentioned include a requirement that pistol permits and assault weapon registrations must be renewed every five years, gun holders can apply for a freedom of information law (FOIL) exemption to keep their identities private, and that magazines can only have a capacity of seven rounds, not 10 as in the past.
Mr. Mulverhill noted that the New York Sheriffs Association met shortly after the SAFE Act passed.
There wasnt a sheriff in the room that didnt oppose the SAFE Act or at least parts of it, he said.
Mr. Mulverhill added that the act was passed in response to the tragic shooting at Sandy Hook Elementary School in Newtown, Conn.
If we believed the act could prevent an incident from happening in New York, we would not be here, he said.
Franklin County Board of Legislators Chairman Billy Jones, D-Chateaugay, provided the county legislatures view on the law.
From the county perspective, weve come out and opposed it, he said, adding that many county residents contacted the legislature about the act.
We did pass a very good resolution last Thursday, Mr. Jones said of the resolution the legislators passed against the act. At the end of the day, we decided to oppose the whole thing.
According to the countys resolution, the legislators are against any portions of the act that infringe upon the right of the people to keep and bear arms, as enumerated in the Second Amendment of the U.S. Constitution.
Another presentation was given by Deputy Franklin County Clerk Kip Cassavaw, who described how the work load for his office has increased substantially since the act was passed due to people changing their pistol permits or applying for FOIL exemptions.
Suzanne Goolden, director of the countys community services/mental health department, also spoke about the provision of the law that requires mental health professionals to report any individuals who could be in danger of harming themselves or others to their director of community services, who would then evaluate the individual and report it to the New York state Division of Criminal Justice Services. She said this could be a detriment.
We are concerned that this will prevent people from seeking the help they need, she said.
Despite the comments and concerns of the crowd at the end of the forum, Mr. Mulverhill said he believed that the act will correct itself.
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Product Test: Frozen Concoction Maker
You can buy the Frozen Concoctino Maker at www.walmart.com for $170. You just add the ice and ingredients according to directions. What makes this different is the fact that it shaves the ice and then mixes it with the ingredients. Our testers thought it worked well and was a great idea.
It makes up to 36 ounces at once. It is fast, easy and the clean up is not bad at all. This was given two thumbs up.


text:
Product 6/50
Pattern delivered as an electronic download.
Make your very own Frog Prince by following the setp-by-step directions and illustrations included in this PDF pattern.
- The pattern features 15 detailed drawings of how to stitch and assemble this handsome fellow.
- Finished Frog measures approximately 8" tall by 3.5" wide
- If you are looking for a taller prince, simply photocopy and scale him up to size!
You'll hop for joy when completing this toy.
He is a prince for the taking if you do the making!
Stitch him up nice,
With love and some spice.
Put a crown on his head,
Put your worries to bed,
He is yours for the keeping,
He won't do much peeping,
Just a quiet companion,
For your desk or divan,
Get out your needle,
Break out your thread!
Stitch and be happy…
Frogs are fun!
Name him Fred!
Format: PDF File - Available for Instant Download
Pages: 7
Downloadable Pattern FAQs


text:
Over at Baseball Prospectus, Russell Carleton does a nice investigative piece about when players more or less stop developing.
His conclusion:
It looks like a critical period for player development ends around 26. So, if your favorite player hasn't figured it out by then, chances are that he won't.
This is not really news, but adds a layer of complexity to peak age discussions about whether players peak at 27 (many) or 30 (others).
Put another way, the jump between players' age 25 and 26 seasons is the last good (common) chance to improve.With that conclusion in mind, lets take a look at the 2013 Opening Day ages for Mets position players.
Mike Nickeas – 30
Josh Thole – 26
Kelly Shoppach – 32
Josh Thole came into this year a career .276/.350/.356 hitter in 204 big league games. He's plummeted to .237/.299/.294 entering his age 26 season. There's no question concussions marred Thole's 2012. Where he goes from here, moving from 25-26, at an age when players regularly still develop, will be crucial. So, for fans eager to cut bait on Thole, be patient, he should get one more year.
Ike Davis – 26
Zach Lutz – 26
Daniel Murphy – 28
Ruben Tejada – 23
Justin Turner – 28
David Wright – 30
Is there a reasonable chance that Ike Davis improves on his 2012? Sure.
On the other hand, Daniel Murphy is Daniel Murphy at this point.
Mike Baxter – 28
Jason Bay – 34
Lucas Duda – 27
Scott Hairston – 32
Kirk Nieuwenhuis – 25
Andres Torres – 34
Jordany Valdespin – 25
Put simply, Lucas Duda is at an age where players do not generally continue developing dramatically.
At .239/.329/.392, that's bad news for the Mets. Kirk Nieuwenhuis, on the other hand, for all of his troubles, and his 32% strikeout rate in 2012 still is at an age where players do get better.
Age always matters. It matters for prospects and it matters for big leaguers.


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18 U.S. Code § 3557 - Review of a sentence
Source(Added Pub. L. 98–473, title II, § 212(a)(2),Oct. 12, 1984, 98 Stat. 1991.)
Effective Date
Section effective Nov. 1, 1987, and applicable only to offenses committed after the taking effect of this section, see section 235(a)(1) ofPub. L. 98–473, set out as a note under section 3551 of this title.
LII has no control over and does not endorse any external Internet site that contains links to or references LII.


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Ellen Crimi-Trent
Alphabet Print
$24 Gilt
- Color:
- multi
- Size :
- 11x14
Qty: 1
- 1
- 2
Please select an available size.
Please select a size.
Description: Alphabet Print
- Printed on Epson Presentation Paper
- Backed with hard board or foam core for protection
- Each print is signed by the artist on the back
Measurements: 11" L x 14" W
Care: Wipe with a dry cloth
Material: Paper
Care: Wipe with a dry cloth
Brand: Ellen Crimi-Trent
Origin: United States


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AMHERST, N.Y. - Carin Stahlka was on vacation with her family when she had a stroke.
"I didn't know the signs, because when you're 36 it's not something you research," said Stahlka.
Anthony Gabamonte was driving on the skyway when he had his.
"I had no idea what was going on, all I knew is that I felt very tired, very weak," said Gabamonte.
When Debra Ulhman had hers, she was told she might never walk again.
"I couldn't even stand, after I had my stroke, I needed two people to help me," said Ulhman.
They are three very different experiences, and each is a valuable part of the "Sharegivers" program run through the American Heart Association/ American Stroke Association.
The program pairs people like Carin, Anthony and Debra with people who've just experienced the pain and uncertainty of a stroke.
"It gives them the encouragement to go on, because then can see how far I've come from when I had my stroke," said Ulhman, "So they think, oh, maybe I can do that too."
Gabamonte is doing it because he remembers a visit from a Sharegiver while he was at the hospital as a unique perspective that gave him something essential to healing: hope.
"He came in at a good time, because I was feeling very lost," said Gabamonte of his Sharegiver. "It was just nice having somebody to relate to who went through what I was going through."
There aren't many programs like this around the country, in part because in addition to volunteers, it takes a dedicated person to coordinate the Sharegivers.
Roseanne Hennitt fills that role here in Western New York. As Director of Quality Improvement, Hennitt oversees day to day operations, including weeks of training volunteers must go through in order to start giving back. Hennitt has never had a stroke herself, but she cared for her mother after she had one, and Hennitt's grandson had two, just hours after he was born.
"In my estimation, when I look at some of our stroke survivors, they are probably the bravest of the brave, because they have the fortitude to keep moving forward and determination that is like something I've never seen before," said Hennitt.
Determination that grows during the time spent as a "Sharegiver."
"Sometimes I'll see somebody laying in a bed and I'll think, that's how I was, and now look at me, how far I've come, and so it makes me realize something by visiting them," said Ulhman.
Experts say signs of stroke include:
* Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
* Sudden confusion, trouble speaking or understanding
* Sudden trouble seeing in one or both eyes
* Sudden trouble walking, dizziness, loss of balance or coordination
* Sudden severe headache with no known cause
If you experience any of these signs, call 911. Experts say you should also check the time, so you'll known when the first symptoms appeared. Drugs administered within the first three hours of symptoms can reduce long-term disability for the most common type of stroke, according to the American Heart Association.
For more information on the Sharegivers program, contact Roseanne Hennitt at 716-614-1986 or firstname.lastname@example.com.


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Do y'all love candy corn as much as I do? Those waxy little wedges make my mouth happy, and taste *amazing* when paired with slightly salted peanuts. Seriously, if you haven't tried the ol' candy corn/peanut combo, you need to hit up Wally World right now and getcha some. But only if you're on the West Coast and it's only 9pm instead of midnight like it is here. I need to go to bed.
Spurred on by my love of candy corn and the fact that making predictions is an excellent skill for improving comprehension and enhancing imagination, I made a little seasonal activity that incorporates both.
Meet: The Candy Corn Bandit.
"He's climbin' in yo' windows. Snatchin' your candy up. Tryin' to hide it. So you better, hide yo' Kit Kats, hide yo' Whoppers. Hide yo' Kit Kats, hide yo' Whoppers. And hide your Snickers 'cause he's takin' everthing up in here!" So sorry. I couldn't resist. And, at midnight, this is ENORMOUSLY funny. Google "Bed Intruder Song" if you have no idea what I'm talking about!
And we're back!
Okay, so this activity is a fun way to incorporate making predictions with a little scavenger-hunt-like lesson that leads your class throughout the school building in search of clues that will lead them to a missing treat. {I was careful to say "treat" for those of you who aren't allowed to hand out sweets in school.} It doesn't necessarily have to be candy corn, though that's what I'm using.
The clues are all found in common places in school buildings, including your classroom, the gym, the lunchroom, the playground, and the library. Each clue is little poem {my very talented little sis helped me write them!}, and provides hints about where they Candy Corn Bandit may have taken the treat.
The activity comes complete with a detailed lesson plan, as well as extension activities – the craftivity pictured above, writing prompts, and sequencing (pictured below).
Also, let's do a *GiVeAwAy*!!!! Check out the picture below, specifically the candy dish. Can you *PREDICT* how many pieces of candy corn it is holding?! I'll give away 3 copies of this activity to the closest {or spot-on} guesses! Guessing ends at 11:59pm tonight, October 15th.
Happy, happy weekend to you and yours!


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10/25/05-Chockoloskee, Florida, south of Everglades City, appeared to have suffered the most damage from Hurricane Wilma. People could be seen milling about the island, cleaning up the remains of structures on Tuesday. Michel Fortier/Staff
10/25/05-Marco Island Firefighters battle a blaze on Goodland, Florida Tuesday, the day after Hurricane Wilma impacted Southwest Florida.
10/25/05-Pool cages and boats seemed to show the brunt of the damage, despite Marco Island being in Hurricane Wilma's bullseye. A majority of the buildings showed little structural damage from the air. Michel Fortier/Staff
10/25/05-Even with storm shutters in place, wind damage from Hurricane Wilma is evident in this North Gordon Drive condominium building in Naples Tuesday, the day after Hurricane Wilma slammed into Southwest Florida. Michel Fortier/Staff
10/25/05-A line of cars more than a mile long in each direction force their way into Barron Collier High School in Naples, Florida, waiting for FEMA aid in the form of ice and water Tuesday. Michel Fortier/Staff
Ferol Page, left, hands out disaster relief items to residents of Bonita Springs Tuesday. Red Cross sent two trucks near the intersection of Old 41 and Rosemary, supplying residents with food and supplies in relief of Hurricane Wilma. Cary Edmondson/Naples Daily News
Hurricane Wilma took it's toll on the few remaining structures on Cape Romano, completely removing a house on stilts and further damaging "igloo" structures on the desolate point.
Hurricane Wilma took it's toll on the few remaining structures on Cape Romano, completely removing a house on stilts and further damaging "igloo" structures on the desolate point. Michel Fortier/Staff
Hurricane Wilma did extensive damage to Pelican Bend Marina including leveling the chickee bar, right, that overlooked the bay. Jason Easterly/Staff .je
Larry Schrock, front right, and Monroe Herschberger, front left, talk about how to fix the roof, while Kenny Herschberger, back right, and John Gingerich, back left, remove blue tarps, on a roof on Tim Gallegos' home in Immokalee on Wednesday January 31, 2007. The four, from Illinois, were volunteering for IHOPE (Immokalee Helping Our People in Emergencies), which was founded after Hurricane Wilma. There are still about 180 homeowners in Immokalee that are currently hoping to get assistance from IHOPE. Tracy Boulian/Staff
Aaron Newsome, 5, plays with his siblings and friends behind their home on Immokalee Drive on Thursday evening, Jan. 4. Newsome's mother, Benita Uvalle, is waiting for one of 30 FEMA full-size trailers for families affected by Hurricane Wilma. David Ahntholz/Staff
Anthony Newsome, 9, plays on the remnants a car frame with his sister Alisha, 8, behind their home on Immokalee Drive on Thursday, Jan. 4. The children's mother, Benita Uvalle, is waiting for one of 30 FEMA full-size trailers for families affected by Hurricane Wilma. David Ahntholz/Staff
A blue tarp covers the roof the the Naples Preserve at U.S. 41 and Fleischmann Boulevard, a reminder of the damage caused by Hurricane Wilma. The building, designed by a student of Frank Lloyd Wright, has an angular roof which would be altered if it were to be replaced with a metal one. Anthony Souffle/Staff
Fernando Pinto from John Bruce Construction installs drywall, left, as Denecia Blanca cleans the second floor of Everglades City Hall on Tuesday, Oct. 24. Restoration work is ahead of schedule on the historic landmark, one year after it was severely damaged by Hurricane Wilma. Everglades City mayor Sammy Hamilton says City Hall should be re-open by December. David Ahntholz/Staff
Morgan Daffin, 10, left plays with her friend Kristin Grimm, 11, in the flooded water along Camellia St. near the Everglades City Post Office after Tropical Storm Ernesto made landfall in South Florida Wednesday morning August 30, 2006. The girls remarked that the water was cold and was not nearly as high as last year. They were comparing this storm to Hurricane Wilma, a Category 3 storm which came through late October 2005 and put the whole city under water. Garrett Hubbard/staff
"Business is real slow," says Jose Granados, owner of a small produce stand just across the road from the Hoover Dike. The remenants of a packing plant's foundation, destroyed during Hurricane Wilma, sits just across the street as a reminder of how precarious his situation is. "If a hurricane comes and takes everything, ok, I'll move on." Granados had several feet of water surrounding his business after Hurricane Wilma and plans to evacuate to Georgia in the event of another. Michel Fortier/Staff
This satellite image provided by NOAA and taken at 3:15 p.m. EDT Thursday Oct. 20, 2005 shows Hurricane Wilma as it approaches the Mexican Yucatan peninsula. Wilma, a Category 4 storm with winds of 150 mph, churned toward the Yucatan peninsula and south Florida after its outer bands hit Haiti and Jamaica, where it killed at least 13 people. (AP Photo/NOAA)
Everglades City mayor Sammy Hamilton leaves city hall following a tour Tuesday afternoon, May 2, to show renovation work to rebuild the historic building which was damaged by Hurricane Wilma. David Ahntholz/Staff
Everglades City mayor Sammy Hamilton talks about the renovation work in the old city council chambers of the Everglades City Hall during a tour Tuesday afternoon, May 2. The city hall is undergoing more than $3 million in repairs after it was damaged by Hurricane Wilma. After the renovation is complete, the mayor's office and city council chambers will be located on the top floor. David Ahntholz/Staff
Everglades City mayor Sammy Hamilton, right, and Collier County Commissioner Jim Coletta head into the Everglades City Hall to see the renovation work on the building Tuesday afternoon, May 2. Hamilton said the city has received $3 million from FEMA and additional grant money to fix the historic building after it was damaged by Hurricane Wilma. David Ahntholz/Staff
Oakridge Middle School Students Adam Farina, 12, left, and Alexis Schlaupitz, 13, center, carry donated Christmas presents with their teacher Vicki Peterson to cars that will take the gifts to The Learning Center in Immokalee. Peterson organized the "Kids to Kids" multi-state gift donation project after learning that many students attending The Learning Center wouldn't be getting Christmas presents due to financial stresses caused by Hurricane Wilma. Photo taken on December 20, 2005 in North Naples. Garrett Hubbard/Staff
Catherine Cartwright was working hard boarding windows outside the Westgate Center in Bonita Springs not too long ago. At first glance, she seemed to be pretty good at what she was doing. In fact, she looked like a pro. Little did I know I was right. She was in fact a professional. Just not in the same fashion I had expected to hear. "Do you know who she is", said the man next to her. "She's a professional golfer," he stated emphatically. "She's on the LPGA!" For a split second I could only wonder. Why in the world was a professional golfer out boarding windows during the heat of day? Shouldn't she be out practicing at the golf club? But before I could put my thoughts into words, the answer was quickly given to me. "She's my daughter," said the man, who now turned out to in fact be her father. The man's name was Paul Cartwright, and he had brought his family out to help him board windows in preparation of Hurricane Wilma. This day stands out in my mind because not yet had everyone prepared for what lied ahead. The storm, which seemed to slowly crawl across the Gulf of Mexico, was stalling many people from proceeding with their normal hurricane preparations. But not the Cartwrights. When they heard there was a chance that a hurricane could cross over parts of Southern Florida, the family took no chances by waiting to see if the storm would stay on it's predicted course. They started boarding windows around town at the first hint of a threat, but according to the family, they started early because they had no time to wait. "It's going to take all day just to board these offices," indicated Paul, "There is no time to wait." Though it was an all-day project, Catherine did not seem to mind working with her family in the least bit. "I look at this as my morning workout," said Catherine, who was missing a day of golf to help her family out. "It's good exercise." Now that three weeks have passed since the hurricane struck, Catherine's exercise seems to have paid off. Mu
About 350 people wait in line to fill out food stamp applications Monday morning in the parking lot of the Wal-Mart Supercenter on Collier Blvd. Department of Children & Families, in partnership with the U.S. Department of Agriculture, is implementing the "Food for Florida" Disaster Food Stamp program for people adversely affected by Hurricane Wilma. To qualify for the "Food for Florida" benefits program, applicants must have lived in Collier County 24, 2005, and not be receiving food stamps through the regular program. Lexey Swall/Staff
Daniel Samet, co-owner of TCB Farms in Immokalee, had 20 acres of greenhouses filled with peppers destroyed by Hurricane Wilma. While he had insurance, he could not get insurance covering hurricane damage. Tracy Boulian/Staff
A pile of debris sits in front from Dale Blodgett's home on Clyburn Street. The damage to was done after Hurricane Wilma caused water damage to the interior, as well as causing frame damage all of her windows. Blodgett turned to FEMA for help, but was not successful. Jason Easterly/Staff .je
A helicopter crew from Haverfield International in Orlando sprays electrical insulators along SR 951 with fresh water for Lee County Electrical Cooperative rinsing salt residue from them left by Hurricane Wilma. LCEC is washing all their electric facilities in the coastal regions to prevent the possibility of power outages caused by the salt. Jason Easterly/Staff .je
Jann Gierman, 57, moves old Christmas decorations and other personal items around in the storage shed next to her mobile so she can drive her golf cart out of it Monday morning. Gierman came back to her mobile home from Michigan on Saturday to find that the shed had been destroyed during Hurricane Wilma. "I'm just thankful to still have a home," Gierman said. Lexey Swall/Staff
Chris Young, a groundskeeper at the Citrus Park mobile home complex, loads piles of tree brances into his truck Monday. The complex, which was one of the hardest hit in Bonita Springs, is slowly recovering from damage done by Hurricane Wilma. Cary Edmondson/Staff
Fred Elkins, right, carries a piece from a mobile home unit to the side while Al Vollmer, left, disassembles portions of the roof Monday inside the Imperial Harbor mobile home complex. Vollmer, owner of "Green Side Up", expects to work on homes at the complex for another month because of damage caused by Hurricane Wilma. Cary Edmondson/Staff
Al Vollmer, owner of "Green Side Up" salvages sections of a roof inside the Imperial Harbor mobile home complex in Bonita Springs Monday. Because of the damage done to homes after Hurricane Wilma, Vollmer plans on working in the mobile home complex for the next 3-4 weeks. Cary Edmondson/Staff
Hurricane Wilma Goodland
Alvino Serrano, right and Carlos Solis of Bill's Tree Service, far right, load up tree debris at the Meadow Brook development in Estero Monday. Although hurricanes provide a financial windfall says the owner's son Billy Cobb, the job can be tough because of client's personal losses. Cobb feels it'll be months before the cleanup is done. Michel Fortier/Staff
Donny Wood cries during worship at Church of God's first worship service since Hurricane Wilma on Sunday October 30, 2005 in Chokoloskee, Fla. Wood lost everything he owned except the belongings in his car after his home was completely destroyed by the Category 3 hurricane. Garrett Hubbard/Naples Daily News
RVers 3: It's not all bad news for mobile home enthusiasts like Christine Douglas, who fled Wilma with her husband Johnny in their 1992 Ford Jamboree E-350. The Douglases drove to LaBelle Woods RV Resort in LaBelle, Fla., with dogs Dixie and Wendy. They pack up the motor home and leave any time a hurricane threatens. .?Photos by Matt Herrick?
A traffice light at the corner of Davis Blvd. and County Barn Road hangs precariously from a wire Monday morning as cars drive around it and downed power lines after Hurricane Wilma blew them over. Lexey Swall/Staff
____ Davis assesses the damage while walking through his neighborhood at Naples Estates mobile home community in East Naples on Rattlesnake Hammock on Monday while winds from Hurricane Wilma continue to blow through the area. Lexey Swall/Staff
The roof of a stilt home lies on the beach, near the pilings that held it before Hurricane Wilma tore it apart at Cape Romano, the site where officials believe the eye of the storm came ashore. Darron R. Silva/Staff
A small piece of land and shredded mangrove trees remain after the eye Hurricane Wilma came ashore at Cape Romano. Darron R. Silva/Staff
Jerry Hubbart, Senior Market Manager at Immokalee State Farmers Market stands in one of their damaged Vegetable Packing Houses that lost part of its roof when Hurricane Wilma came through on Monday. Photo taken on Friday October 28, 2005 in Immokalee, Fla. The Farmers Maket sustained heavy damages to all of its packing plants. Garrett Hubbard/Naples Daily News
Steven Sematus,9, right, looks up at a bag of groceries that is being handed to Immokalee residents outside the "Our Lady of Guadalupe" church Friday morning. "Catholic Charities" organized the event, which provided lunches, water and bags of groceries to residents affected by Hurricane Wilma. Cary Edmondson/Naples Daily News
Ray Shands from the First Baptist Church in Orlando patches part of the roof at the East Naples Baptist Church on Davis Blvd. on Friday morning. Shands and a disaster response team from Highlands Baptist Church in Panama City, Fla. traveled to Naples, Fla. to help people clean up their property and repair roofs. The team of responders has helped with Hurricanes Dennis, Katrina, Rita and now Wilma. Lexey Swall/Naples Daily News
RVers 1: At the Gladehaven Mobile Village on East Terry Street, this preconstructed trailer home was demolished by Hurricane Wilma on Monday morning, suffering the worst fate in the small community. The home's owner evacuated to Orlando, said maintenance man David Fine. ? ? < .?Photos by Matt Herrick?
MasTec trucks line SR 951 as they work at restoring power to Isles of Capri on Thursday afternoon. Isles of Capri has been without power since early Monday morning due to Hurricane Wilma. Jason Easterly/Staff .je
The Everglades City Hall suffered roof damage and was surrounded by water after Hurricane Wilma passed through Southwest Florida on Monday. Michel Fortier/Staff
Debry lines the front parking lot of The Chalet condominium complex on S. Collier Blvd. after Hurricane Wilma on Oct. 24. Jason Easterly/Staff .je
Hurricane Wilma Chuck Curry/Staff
Twisted metal and sunken empty docks litter the muddy brown waterways around Everglades City, remenants of the disaster caused by Hurricane Wilma on Monday. Michel Fortier/Staff
Jesse Galonte cuts apart a mobile home roof from his front yard in Riviera Golf Estates in East Naples, Thursday afternoon, October 27. The roof was blown from his neighbor's mobile home two doors down when Hurricane Wilma moved through the area Monday. David Ahntholz/Staff
Janet Kuers, left, helps neighbor Betty Heverin clean up her damaged mobile home in Riviera Golf Estates in East Naples Thursday afternoon, October 27. Heverin, who is recovering from a bad heart, and her husband Carol, who is battling cancer, stayed in their home during Hurricane Wilma, which peeled the roof from their mobile home when it moved through the area Monday morning. David Ahntholz/Staff
Jay Mullins finishes removing a large piece of mobile home roof wrapped in a tree behind the home of Charlie Bush, right, in Riviera Golf Estates in East Naples Monday afternoon, October 27. The metal roof became entangled in the black olive tree after it was peeled off the home of Charlie and Harriet Bush during Hurricane Wilma Monday. Riviera Golf Estates was one of the worst hit areas of Naples by the Category 3 hurricane. David Ahntholz/Staff
Faye Lennon carefully covers up a shell painting that one of her daughters loves at whats left at her home in Imperial Harbor. Lennon flew down ffrom Kalamazoo Michigan to see what was left by Hurricane Wilma. Lennon's home was condemed by the city and is staying at her grandaughters in Tampa and driving down each day to collect what remains. Erik Kellar/Staff
Denny Wright slowly has gathered up loose debris from one of his neigbors mobile homes in Imperial Harbor Thursday. C;eanup continued in many mobile home communities as people tried to pick up the piecesw of their lives torn apart bny Hurricane Wilma. Erik Kellar/Staff
A boat that sank after the stearn came off the davits during Hurricane Wilma behind a home in Royal Harbor of Naples Bay. Jason Easterly/Staff .je
Thousands of flowers and plants lie in disorder underneath torn nets at a plant nursery in North Naples after Hurricane Wilma swept through Southwest Florida on Monday. Michel Fortier/Staff
Residents of Farmworkers Village line up for food Wednesday after water receded from the area that was underwater from Hurricane Wilma until Tuesday night into Wednesday morning. Various organizations, such as Taking it to the Streets Ministries from St. Petersburg and Christian Fellowship from Louisiana, came to Immokalee to distribute food to people in need. Lexey Swall/Staff
Ronda Venable sits in a friends truck at the Army National Guard command station in Immokalee, Fla. wiping tears from her eyes after receiving ice and water Wednesday afternoon for the first time since Hurricane Wilma hit the area on Monday. "I'm dumb to everything here. I don't know what to do or who to call," Venable said adding that she doesn't have a car and has run out of food at her home that she shares with her two daughters and two grandchildren. Lexey Swall/Staff
Jacob Daffin, 9, right, chases friend Mitchell Blankenship, 13, out the door of neighbor Frank Wellman's living room in Plantation Island, just south of Everglades City in Collier County on Wednesday October 26, 2005. The roof over Wellmans porch and living room was stripped off as Hurricane Wilma passed through Southwest Florida. Garrett Hubbard/Naples Daily News
Weak from lack of water after Hurricane Wilma, 11-month-old Dakota George waits for his father Tom George, left, to pour donated water into a drinking container Tuesday while his mother, Misty George holds and comforts him with the aid of Fiolomena Poole, right. Michel Fortier/Staf
With ragged patches of trees as a backdrop, an American Flag flies ouside of an 8th Ave. South home in Old Naples Wedesday, two days after Hurricane Wilma made landfall in Southwest Florida. Michel Fortier/Staff
Valentin Bernabe of A Personal Touch Lawn Service hauls plant debris scattered around Cambier Park Wednesday by Hurricane Wilma two days prior. Most of the trees in the park received significant damage from the storm. Michel Fortier/Staff
Youth advocate Katie Nolan stacks damaged insulation and drywall outside the Children's Advocacy Center on Sixth Avenue North Wednesday, October 26. The nonprofit organization had just finished a major renovation to their building, which suffered severe damage when it lost its roof in Hurricane Wilma. David Ahntholz/Staff
Bob Malloy, left, of Windstorm Inspections, and Enel Lemorin unfurl a tarp to cover the roof of Fun Time Daycare Wednesday, October 26. The child care center was flooded and lost its roof when Hurricane Wilma moved through the area Monday. David Ahntholz/Staff
Cpt. Jim Gentile of SeaTow Ft. Myers examines a Hunter 310 after hauling it from the waters of The Tarpon Club Marina on Isles of Capri on Wednesday afternoon. Approximately 12 boats sunk on Isles of Capri due to damage sustained during Hurricane Wilma. Jason Easterly/Staff .je
Vern Bolen, a resident at Imperial Bonita Estates Mobile Home and RV Park in Bonita Springs, helps some neighbors remove the aluminum pieces of a car port and sun room that was ripped off of the opposite side of their home during Hurricane Wilma. Tracy Boulian/Staff
Fran Laurendeau looks out of a window as her husband Milt Heywood attaches a tarp to the roof of their home, which was damaged due to Hurricane Wilma. The couple lives at Imperial Harbor in Bonita Springs, and hopes to move out of Florida to avoid future hurricanes. Tracy Boulian/Staff
Mike Pottorf, a year-round resident at Imperial Harbor in Bonita Springs, waves to a neighbor while helping another neighbor move pieces of an aluminum roof from his home. The roof was blown off of a nearby mobile home and onto the back of another home due to Hurricane Wilma. Residents were left trying to move the left over debris themselves. Tracy Boulian/Staff
Samuel Garcia carries off some plywood for storage hopefully for next years hurricane season while working on returning Doc's Beach House back to working order on Bonita Beach Wednesday. Doc's filled around 3,000 sandbags and boarded up all off its windows in an effort to minimize the effects of Hurricane Wilma. Erik Kellar/Staff
Gene Wilber of Naples checks out the bottom of a Banyan tree along Crayton Road in Naples Wednesday afternoon that was ripped out of the ground by Hurricane Wilma in Naples. Darron R. Silva/Naples Daily News
Hurricane Wilma Bonita Submitted by From: THOMAS CARRIE STEELE [mailto:firstname.lastname@example.com]
Bimini's on Marco Island after Hurricane Wilma.
Alejandro Milkes of Naples looks over the destruction left by Hurricane Wilma at a dock in Isle of Capri, Florida, Monday afternoon, October 24, 2005. Several yachts were damaged or destroyed at the dock by the hurricane. Darron R. Silva/Naples Daily News
Marie Thompson (verify last name with story), Chokoloskee Post Office clerk fills a bucket with water to clean the muddy floors of the building with a mop and broom on Wednesday, October 25, 2005 in Chokoloskee, Fla. Chokoloskee did not have power or running water and residents were forced to use muddy water left behind by Hurricane Wilma for to clean up. Garrett Hubbard/Naples Daily News
Five months pregnant, Maria Dolores Barra, center is consolded by friends Sara Blanco, left, after coming home to Glades Haven RV Park in Bonita Springs Monday and finding her home destroyed by Hurricane Wilma. Michel Fortier/Staff
The remnants of a ceiling fan and a structure without walls still stands on a cracked and sunken foundation is all that remains at the Chokoloskee Marina devastated by Hurricane Wilma in Chokoloskee, Fla on Monday October 24, 2005. Garrett Hubbard/Naples Daily News
The Hess gas station at the corner of Golden Gate Parkway and Goodlette-Frank Road suffered severe damage to the roof of the service island when Hurricane Wilma moved through the area Monday, October 24. Workers had the damage removed and pumps working by Wednesday. David Ahntholz/Staff
Dennis Poling, right, gets help from his nephew Jordan, 6, moving a street sign from the corner of Forrest Lakes Blvd. and Unica Court to the front yard of his father-in-law's home Tuesday. "My father-in-law owns the sign company that makes these street signs, so I'll just put it in the yard until we figure out what to do with them," Poling said adding that the sign was knocked down during Hurricane Wilma on Monday morning. Lexey Swall/Naples Daily News
10/25/05-Marco Island Firefighters battle a blaze on Goodland, Florida Tuesday, the day after Hurricane Wilma impacted Southwest Florida. According to fire officials, the house was a total loss. Michel Fortier/Staff
10/25/05-The National Guard saved the day for hurricane victims Tuesday in an East Naples parkinglot after a false television report indicated ice and water would be handed out at noon. Several hours later, Sgt. Ryan Atkinson and others from the National Guard handed out cases of water to those in need. Michel Fortier/Staff
10/25/05-Tom George, 22, left, pours water for his sick son, Dakota George, 11 months, being comforted by his mother Misty George, 22, and good samaritan Filomena Poole, right. Falsely informed by television media there would be relief efforts at noon, the George family and hundreds of others endured a three hour wait for water, provided by the National Guard, to show up in the East Naples parkinglot. Michel Fortier/Staff
The remains of a dock float next to a sinking yacht at Isles of Capri, Florida, Tuesday afternoon, October 25, 2005. Hurricane Wilma sunk many boats at Isles of Capri. Darron R. Silva/Naples Daily News
JoAnne Lundquist and her daughters Jenna, 10, center, and Lexie, 8, sweep up the remains of sliding glass doors at their condo on Marco Island, Florida, Tuesday afternoon, October 25, 2005. Hurricane Wilma blew out most of the windows in the condo complex, the Essex. The Lundquist do not live in the condo, they live on Marco Island and rent out the condo. Darron R. Silva/Naples Daily News
Petie Peterson, 55, looks over the destruction done to the RV of his frient, Edward Schaput, 56, in Goodland, Florida, Tuesday morning, October 25, 2005. Hurricane Wilma blew out most of the windows in the RV. Darron R. Silva/Naples Daily News
Vern Zodiak picks up debris from the remains of her lanai at Holiday Manor Co-Op Senior Community in East Naples, Florida, Tuesday afternoon, October 25, 2005. Hurricane Wilma tore apart the trailer's roof, lanai, and car port. "I don't know where to start," said Zodiak. Zodiak winters with her husband, Sam Zodiak, at the trailer, but the couple evacuated for the storm. Darron R. Silva/Naples Daily News
Miguel Jimenez removes the metal roof from Candy Rodriguez Tire Shop in Immokalee Tuesday afternoon, October 25 which collapsed as Hurricane Wilma moved through the area the day before. David Ahntholz/Staff
Immokalee residents wait in line to get food from Guadalupe Social Services Tuesday afternoon, October 25. The center, which normally provides assistance to Immokalee residents, has been inundated by people looking for food and water in the aftermath of Hurricane Wilma. David Ahntholz/Staff
Jerrett Oakes, 15, left, navigates his way down washed up stairs as his cousin Kevin Sylvest, also 15, pulls a kayak from the debris laden water channel in Chokoloskee, Fla October 25, 2005. Oakes and Sylvest were helping a neighbor salvage the remnants of his his home that was completely destroyed by Hurricane Wilma. Garrett Hubbard/Naples Daily News
Macky Collins, 4, lays down on the porch of his mothers restaurant, the Havana Cafe, after helping a family friend rescue belongings from the remains of their their home that was completely destroyed by Hurricane Wilma in Chokoloskee, Fla October 25, 2005. Collins salvaged a picture frame and a small photograph that he would hold in his hands and stare at as others searched for valuables to rescue. Garrett Hubbard/Naples Daily News
10/25/05-Two boats try to occupy the same space the day after Hurricane Wilma slammed into Isle of Capri and other Southwest Florida cities. Michel Fortier/Staff
10/25/05-A lone worker attacks the damaged roof of a condominium structure in Everglades City Tuesday, the day after Hurricane Wilma slammed into Southwest Florida. Michel Fortier/Staff
Neighbors at Spring Creek Village in Bonita Springs work together to clean up debris left in the water next to their homes as a result of Hurricane Wilma on Tuesday October 25, 2005. Tracy Boulian/Staff
Spring Creek Village resident Jean Shelley looks around her sun room which lost its roof due to Hurricane Wilma on October 25, 2005. "I guess it could have been worse," she said. Tracy Boulian/Staff
Larry Chesebro carries pieces of aluminum roofing from a home in Spring Creek Village in Bonita Springs on Tuesday October 25, 2005. Chesebro and numerous others from the mobile home park got together to help their neighbors clean up the debris left from Hurricane Wilma. Tracy Boulian/Staff


text:
Infliximab to Treat Children With Juvenile Rheumatoid Arthritis
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This study will determine whether a stepwise increase of the drug infliximab (Remicade® (Registered Trademark)) controls juvenile rheumatoid arthritis more effectively than a fixed dose. It will look at the safety and effectiveness of increasing the dose to a maximum of 15mg/kg body weight per dose, examining the drug's effect on bone and cartilage, and whether it can improve abnormal growth, metabolism and hormones. Infliximab is approved for treating adults with rheumatoid arthritis and Crohn's disease.
Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not respond adequately to standard therapy may be eligible for this study.
Participants will receive nine infusions of infliximab during this 62-week study. The drug is given intravenously (IV, into a vein) over 2 hours. The first three infusions will be at a dose of 5 mg/kg of body weight. Children who improve on this regimen will receive another 6 infusions at the same dose. Children who do not significantly improve on 5 mg/kg at the end of 6 weeks (the third infusion) may continue with phase 2 of the study, in which they will be randomly assigned to receive either: 1) 6 additional doses of the drug at 5 mg/kg per dose, or 2) a gradually increased dose to a maximum of 15 mg/kg. In addition, all children will continue to take methotrexate at the same dose as when they entered the study.
Participants will visit the NIH Clinical Center 12 times (about every 8 weeks) during the study for the following tests and procedures:
- History and physical examination, including a complete joint exam
- Puberty assessment - breast development in girls, testicle size in boys, and pubic hair
- Height and weight measurements
Children will have imaging studies (x-rays, MRI and Dexa scan) at the beginning and end of the study and will collect a 24-hour urine sample before each infliximab infusion.
Patients may elect to have an endocrine evaluation. This involves Clinical Center hospitalizations for 1-1/2 days on visits 1, 4 and 12. Small amounts of blood will be drawn every 20 minutes (through an indwelling catheter to avoid multiple needle sticks) for 8 hours while the child sleeps. The blood will be examined for the normal rhythm of growth hormone and other substances in the body and how they are affected by arthritis.
Participants will complete a questionnaire once a year for 2 years to provide information on their health status and any problems that might be related to the study drug.
Juvenile Rheumatoid Arthritis
Drug: Infliximab
Phase 2
|Study Type:
|Study Design:
|Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Official Title:
|A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis
|Estimated Enrollment:
|Study Start Date:
|January 2002
|Study Completion Date:
|October 2005
Infliximab, a murine chimeric monoclonal antibody targeted against TNF-alpha has recently been licensed for the treatment of adult patients with established rheumatoid arthritis (RA). A double blind placebo controlled trial in children with juvenile rheumatoid arthritis (JRA) using a single dose fixed infusion regimen is currently ongoing. This dose finding study is designed to determine whether a clinically guided intravenous (iv) infusion regimen allowing for intra-patient dose escalation is superior in achieving a 70% clinical response to fixed dose administration of infliximab in children with a polyarticular course of JRA. We will model the pharmacokinetic profile in both phases of the study. We plan to enroll a maximum of 48 patients to allow for 36 patients to be randomized into the two treatment arms. In the first phase of the study all patients will receive a fixed dose of 5mg/kg/dose for a total of 3 infusions over 6 weeks (weeks 0, 2, 6). In the second phase at week 14, patients who have not achieved a 70% improvement will be randomized at a 2:1 ratio to either receive intra-patient dose escalation capped at 15mg/kg/dose every 8 weeks or continue to receive 5mg/kg/dose every 8 weeks in a blinded fashion. After 6 additional IV doses, patients will again be evaluated clinically, radiographically and serologically for clinical response. Patients who achieved a 70% response by week 14 will be kept on 5mg/kg/dose every 8 weeks for the trial duration of 62 weeks, but will not be included in the primary endpoint analysis. We also plan to evaluate patients endocrinologically and metabolically to determine the effect of TNF blockade on these systems.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Age: Patients must be less than 18 years of age and greater than or equal to 4 years of age.
Diagnosis of pauciarticular, polyarticular or systemic onset JRA according to the 'Criteria for the diagnosis of Juvenile Rheumatoid Arthritis' with evidence of active disease including all of the features within each category:
Pauciarticular JRA (if patients continue to develop a polyarticular course):
- active synovitis involving at least 4 swollen joints
- tenderness or pain on movement of greater than 4 involved joints
Polyarticular JRA:
- active synovitis involving at least 4 swollen joints
- tenderness or pain on movement of greater than 4 swollen joints
- elevated acute phase reactants (ESR greater than 20mm/hr or CRP greater than 0.8mg/dl)
Systemic onset JRA (if patients develop a polyarticular course):
- active synovitis involving at least 4 swollen joints
- tenderness or pain on movement of greater than 4 swollen joints
- elevated acute phase reactants (ESR greater than 20mm/hr or CRP greater than 0.8mg/dl)
Disease onset at age less than16 years.
Informed Consent: All parent(s) or their legal guardian(s) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility). Pediatric patients will be included in all discussions in order to obtain verbal or written assent.
All patients enrolled must have an incomplete response to methotrexate at a dosage of at least 0.75 mg/kg/week or a maximum of 25 mg/week orally or subcutaneously for a minimum of 12 weeks.
No other disease modifying anti-rheumatic drugs will be allowed while on study. Patients on combination DMARD therapy will have all DMARDs (except methotrexate) withdrawn at least 2 weeks prior to trial initiation. Patients must be off etanercept for 4 weeks prior to enrolling in this study.
Stable doses of non-steroidal anti-inflammatory drugs including selective Cox-2 inhibitors. Patients enrolling should be on stable NSIAD doses for at least 2 weeks. If currently not on NSAIDs, patients must not have been using them for 2 weeks.
Stable dose of prednisone (or equivalent amount of any other corticosteroid) equal or less than 0.4 mg/kg/day for at least four weeks. If currently not on corticosteroids, patients must not have been using them for 4 weeks.
Subject has negative PPD.
If anergy control skin tests and PPD are negative, Infectious Disease (ID) will be consulted and if cleared by the ID the patient will be included into the study.
Pregnant women and nursing mothers, sexually active men or women of childbearing potential not practicing birth control. (Sexually active subjects of childbearing or child-fathering potential must be willing to use an acceptable form of birth control, which includes oral contraceptives, barrier methods with spermicides, intrauterine devices (IUD's), medroxyprogesterone acetate (Depo-Provera), progestin implants or intrauterine system or surgical sterilization. All post-menarche females or females greater than or equal to 12 years must test negative on a urine pregnancy test. Sexually active males and females will be instructed to use condoms).
Patients with other rheumatic diseases that may confound the analysis including but not limited to Lyme disease, post streptococcal reactive arthritis, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus, other infectious or reactive arthritis, or Reiter's syndrome.
Previous treatment with iv infliximab at doses greater than 3mg/kg/dose every 8 weeks.
Poor venous access.
Treatment with any monoclonal antibody in the past other than infliximab.
Allergy to murine-derived products.
Previous history or ongoing infection with tuberculosis or pneumocystis and patients with acute or chronic infections requiring anti-microbial therapy, serious viral infections (e.g. hepatitis, herpes zoster, CMV or HIV) or fungal infections or history of recurrent serious bacterial infections.
History of live vaccinations within the past 3 months.
Confounding medical illness that in the judgment of the investigators would pose added risk for study participants (e.g. chronic hepatic, hematologic, neurologic, renal, or pulmonary disease).
Past medical history or be currently diagnosed with any solid organ or hematologic malignancies including lymphoproliferative diseases and leukemias.
History of substance abuse within the past 5 years.
History of psychiatric illnesses that in the opinion of psychiatric consultants would pose added risk for study participants.
Pre-existing or recent onset of demyelinating disorders or type I diabetes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029042
|United States, Maryland
|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|Bethesda, Maryland, United States, 20892
No publications provided
|ClinicalTrials.gov Identifier:
|NCT00029042 History of Changes
|Other Study ID Numbers:
|Study First Received:
|January 4, 2002
|Last Updated:
|August 26, 2008
|Health Authority:
|United States: Federal Government
Keywords provided by National Institutes of Health Clinical Center (CC):
Juvenile Rheumatoid Arthritis
Joint Disability
Biologic Therapy
Rheumatoid Arthritis
Joint Inflammation
Additional relevant MeSH terms:
Arthritis, Juvenile
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
ClinicalTrials.gov processed this record on October 09, 2015


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It takes lush rains, intense sun, volcanic soils and a lot of aloha to create the distinctive characteristics of Kona coffee. Grown at 2,000 feet above the Kona Coast, Kona coffees are prized world wide for their rich aromas, mild, delicate taste, and thick body. Because Kona coffees are so highly valued, each lot is graded and registered by the State of Hawaii to prevent adulteration.
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Very Good Coffee
By Almost an empty nester
from Deming, WA
Comments about The Coffee Bean 100% Kona Coffee:
I really enjoy Kona coffee and this is some of the best. I have a cup of this wonderful coffee very Saturday morning as that is the only morning that I can just sit and enjoy every drop.
Bottom Line Yes, I would recommend this to a friend
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White Wedding
Comedy, Romance
It's modern day South Africa, and in Cape Town, the beautiful Ayanda is just days away from achieving her lifelong dream: the perfect white wedding. The only problem is that her husband-to-be, the loyal, committed Elvis is 1800 kilometres away in Johannesburg. He sets off on Tuesday night by bus to Durban intending to connect with his childhood friend and best-man Tumi. But the plans start to go awry when Tumi doesn't show up at the bus station. Not an auspicious beginning, but this is just the first in many comic and illuminating misadventures they meet along the way. In the end, the two lovers learn that celebrating their union is more about the journey than getting to the church on time.
Cast: Jodie Whittaker, Rapulana Seiphemo, Kenneth Nkosi, Zandile Msutwana, Mbulelo Grootboom
Produced by:
Directed by: Jann Turner
Written by:
Running time: 1hr 33min
Opens: Sep 03, 2010 NY/LA
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