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Masthead & Contact Info
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Planet Ice Gosport
Now a Planet Ice Arena, previously known as Gosport Ice Rink, this is a large indoor facility, which boasts one of the souths only all year round Ice Rinks.
If you've had fun on your family day out to Planet Ice Gosport, tell us about it your visit, so other people will know it's a great place to go as well.
It may be worth checking out Planet Ice Gosport's website to see if there are any special events or seasonal fun things to do that may be going on during the day.
Holbrook Rec Centre Fareham Road
Off Forest Way
Telephone: 02392 511217
Click below for some other things to do with kids near to Planet Ice Gosport
Prices vary from £8 including skate hire. Opening Times: 2014 Opening Details:
The only days we are closed throughout the year are Christmas Day, Boxing Day and
New Year's Day.
Bank Holidays we are open but close early.
Ring for details of skating session times.
Click DAYoutWITHtheKIDS logo at the top of this page, to take you back to the homepage for thousands of
family days out all over the country, or click this link to find Hampshire kids days out.
Finally. if you fancy a day out in the capital, click this link to find great things to do in london
Also you can find all your local things to do in Gosport for kids
Ice Skating Rinks and Rollerskating in Hampshire | Ice Skating Rinks and Rollerskating near Gosport
Nearest Counties
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subset: commoncrawl


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New York City, New York
Financial Services, Finance, Investment banking
Citibank, a major international bank, is the consumer banking arm of financial services giant Citigroup. Citibank was founded in 1812 as the City Bank of New York, later First National City Bank of New York. As of March 2010, Citigroup is the third largest bank holding company in the United…
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50th album. Ektachrome 64T Expired 2010. Brilliant contrast, love it.
This photo was shot on film. Taken by aldaer with a Lomo LC-A+ (available in our Online Shop) loaded with Kodak Ektachrome 64T (35mm) film in London, United Kingdom. These tags describe this photo: blue, london, 2010, expired, and tungsten. Date: 2013. Time: Afternoon. This photo can also be found in the album A Storm is coming..Please login to get more out of this site
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Wow! nice colors!
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As much as we love our pets, the one thing that most of us could do without is their constant shedding. Although cleaning up pet hair is part of owning a pet, you now can help reduce the amount of shedding while promoting healthy skin and shiny coat with PSCPets Skin and Coat Soft Chews for Dogs. This formula is specially designed with ingredients that promote healthy skin and coat in dogs of all breeds and sizes, including non-shedding breeds.
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text: HomeARCHIVESWorld Dance Movement a Castellana Grotte From 6 to the 27 July 2014, back to Puglia's largest international dance workshops taking place in Italy, SIXTH EDITION "WORLD DANCE MOVEMENT a Castellana Grotte (BA). EVERY WEEKEND SHOWS OPEN TO THE PUBLIC IN THE SQUARES OF THE CITY 'OF THE VALLEY ITRIA It 'great expectations for the new major event that thousands of dancers from all over the world are waiting, il World Dance Movement, the largest international dance workshops to be held in Italy ! Born with the aim of creating an opportunity of contact for the dancers on the planet, WDM has been characterized from the outset by the individual attention given to each student and for its international, thanks to the students and teachers from over 20 different countries. Among the many prominent personalities, WDM can count the big dance professionals as Michèle Assaf (artistic director), Desmond Richardson (defined by the NY Times as "one of the greatest modern dancers these days"), Giuliano Peparini (Artistic Director / Choreographer of the famous talent show Amici di Maria De Filippi and as a director of the beautiful modern opera Romeo and Juliet), Bruno Collinet, Igal Perry, Stefano Di Martino, just to name a few. Il World Dance Movement, thanks to the impeccable organization of the on-site Artinscena Annalisa Bellini, at the center of the Itria Valley with its sea, nature and excellent gastronomy, This year will be enriched by the addition of the prestigious International Ballet Competition. The WDM year is supported by the strategic program I.C.E. (Innovation, Culture and Creativity for a new Economy) Grecia Italia 2007-13, lead partner the tourism service of the Puglia Region, with eight partners from Italian and Greek, including the Teatro Pubblico Pugliese and the Apulia Film Commission. During the course of the internship and the Competition will be assigned 140.000 EUR in scholarships for prestigious dance schools including the International Broadway Dance Center, PeridanceCapezio Center e Steps on Broadway di New York, Studio Harmonic in Paris, l'AMDA College and Conservatory of PerformingArts and many other towns in the world of professional dance. The lessons will suit all tastes: Classical, Jazz, Lyric, Hip Hop, Contemporary, Complexions Contemporary Technique, William Forsythe Technique e Repertoire, Modern Jazz, GagaMovement Language, OhadNaharin Repertoire, Choreographic Workshops, Active-Isolated Flexibility, Aerial Dance, Acrobatic Dance. The words of MichèleAssaf: "World Dance Movement is an idea that I and Desmond Richardson began to develop while swimming in the Mediterranean. Now after six years, thanks to the collaboration with Artinscena in people Annalisa Bellini and Domenico Daoli and co-artistic director Bruno Collinet, it's really amazing to see how this event touches the lives of thousands of dancers worldwide. The World Dance Movement that saw its birth in Puglia, in Castellana Grotte, is now an event that takes place on the 4 European nations. I am grateful for the opportunity that every year we have to create, educate, do show and share our art with prestigious dancers and teachers from around the world. Come dance with us as we discover the beautiful Puglia Region. The WDM will change your life ". For Desmond Richardson "The experience of the WDM is simply unique! From the brilliant staff at incredible group of international students, There is an atmosphere of love and creativity that is palpable and invigorating in the beautiful surroundings of the town of Castellana Grotte". OTHER IMPORTANT NEWS ' From the synergy between Teatro Pubblico Pugliese, QuaLiBò - visions of (p)Art and Artinscena, Puglia and WDM are enriched more and more dance. In addition to workshops and training are provided for the following events: 11/19/27 July: Show "Choreographic creations – the performance of the WDM" with leading international choreographers and guest companies. In Largo Porta Grande in Castellana Grotte – free admission 18/26 July: World Dance Movement Street Percussion, the old town of Castellana will be invaded by the dancers of the WDM accompanied by a group of drummers (residence theatrical Ruvo di Puglia – Theatres inhabited). In the same evening is expected to attend the major dance companies in Puglia. The historic centers of international dance and theater will become the excellence of Puglia, a real "invasion choreographic" !!! 12 July: WDM Competition, the concurrence of the WDM. Dancers from all over the world for cash prizes and scholarships in major international dance companies and centers. The festival will be accompanied by other initiatives such as: conferences, photographic exhibition, meetings between the industry. Also planned conferences in which they are presented a few important dance companies, meeting, tastings of typical products, educational tour. Also, in order to strengthen the network with the dance of Puglia, first, WDM provides the components of the professional dance companies OPEN CARD for free access to any workshop edition 2014. Another important initiative, is the project Flick. From the collaboration between two of the dance of Apulia, World Dance Movement Italia (by the School Artinscena / Tezoro Productions) and Visions of (p)Art – International Festival of Contemporary Dance, QuaLiBò of and in coordination with the Teatro Pubblico Pugliese (strategic program I.C.E. – Innovation, Culture and Creativity for a new Economy) nasce Flick, a project aimed at professionalising 8 Young dancers in Puglia. Two distinguished choreographers of contemporary dance, invited by the WDM respectively - Eva Sanchez Martz – and from QuaLiBò - Barbara Toma – will lead the dancers in the creation of two production projects. Both works will debut on the 11th and 12 October, in First National, in the International Festival of Contemporary Dance, Visions of (p)Art 2014, and will perform within the review of the WDM 2015. Selected from among the participants of the workshop WDM ITALY 2014 (6/19 July) the 8 dancers face the first session of production in the third week of the same (20/27 July). The second session of the production will take place in Bari at the opening of the International Festival of Contemporary Dance Visions (p)Art (3/12 October). The project provides Flick, also, at the discretion of the Teatro Pubblico Pugliese, a possible circuitry of the two shows in the theaters of the area. The production route also provides free entry to the theoretical and practical laboratories organized by the International Festival of Contemporary Dance Visions (p)Art. To 8 Dancers will be provided with an attendance. The dancers interested in participating in the selection must be requested at the time of registration for the workshop (advanced / pro): Saturday 5 July for the first week and Sunday 13 July for the second, starting at 15.00, at Semiramide Palace Hotel in Castellana Grotte. A gadget identifier numbered allow you to make an initial selection during class. All selected during the two weeks will participate in a selection / interview the final afternoon of the 20 July at the Studio One WDM Italy. THE TIMES: 6-12 July first selection – WDM ITALIA (Castellana Grotte) 20 July selection / final interview – WDM ITALIA(Castellana Grotte) 21 – 26 July First session of production – WDM ITALIA (Castellana Grotte) 4-5 October theoretical and practical laboratories - Visions of (p) Art (Bari) 6-12 October Second Session of production - Visions of (p)Art (Bari) 11 and 12 October Presentation at First National 2 spectacular productions – Visions of (p) Art (Bari) July 2015 Presentation of 2 spectacular productions – WDM ITALIA 2015 FOR MORE INFORMATION: WDM ITALY firstname.lastname@example.com – firstname.lastname@example.com – such: 360.829733 – www.WDMItaly.com – www.WDMCompetition.com – Infotel 080 4962634 Visions of (p)Art firstname.lastname@example.com – email@example.com – such: 335.7107603


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This Thursday, Christopher Meloni returns to television as the titular character in the half-hour Fox comedy "Surviving Jack." And we couldn't be happier. Why? Residual checks. But also, Thursday marks the culmination of a marathon that may not have gone past the starting line without Chris Meloni leading the pack.
He was everyone's first choice for the role, hands down: an actor with a rare combination of likeability—the holy grail of casting—and shit-inducing scariness. The billboards read, in bold red block letters: "Putting the 'F' back in Fatherhood." One need only recall a couple of shows in Chris's past body of work to know he could put the "F" in just about anything. The guy thrived for several years of maximum-security lockup as sociopathic inmate Chris Keller on HBO's prison drama "OZ," and spent 12 seasons on NBC's "Law & Order: SVU"(12 seasons!) cleaning scum off the streets of New York as Detective Elliot Stabler.
With a resume like that, an actor will surely garner a group of fans. But Meloni comes with a special army of devotees—self-proclaimed "Melonians"—whose appreciation for the star goes far beyond his acting chops.
We're of course talking about his man parts. Keep reading »


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El-Salvador -
War we are in
Okay mandrakes you can stop with the " horrifying " comments about the protocols.
What is horrifying about them, that they are false, or that they are true ?
Or actually, simply that people read them for themselves, and make up their own mind ???
I probably should read them, just because you keep obsessing about them...
Go ahead, be hysterical as you wish, but a better substitute would be thinking.
It is time to stop being scared, about words.
If the protocols are wrong, then expose them, provide the documentation, refute them point by point, and show how they are wrong.
Here is a novel idea: some things, some patterns, some conduct, some examples might be true, even if they are in the protocols.
But the issue are just a bit larger than those found in THAT one book.
The movie is interesting, and as to the point about Communism, Marxist- Leninists murdered millions and millions of people in the old Soviet Union, for the high crime of disagreement. And that is not counting all the other millions who were sentenced to the Siberian prisons of the Gulag , for either praying [religion was a crime] or exercising freedom of speech.
mandrakes -
playing loose with language
Once again we see people confusing economic terms: capitalism vs. socialism with political terms: democracy vs communism.
Democracy and capitalism are not hand-in-hand of course.
And it's horrifying, though not surprising when you look at his comment history, to see Ron Raygun referring to the 'protocols of the elders of zion' as anything but an anti-Semitic forgery.
Ron Raygun -
History Repeats Itself
Bill Clinton should have gone to Harding College instead of Oxford. In 1962, only two years after Comrade Khrushchev pounded his shoe on the podium at the U.N. screaming, "We Will Bury You", the film is a patriotic speech and warning of the menace. The Soviet Union lasted about only 70 years, but the world threat of Communism continues. About 100 years before Karl Marx, it was the "The Protocols of the Elders of Zion", which was a foundation for Communism. Today, that threat still exists.
donwert -
That Was Then...
This is part of a speech made in 1962 by George Benson, president of Harding College, a small
fundamentalist school in Arkansas. By the hyper-ventilated standards of today's right-wingers
(Limbaugh, Beck, etc.) this is a fairly calm, straight-forward review of the Communist threat
of that era. One of the earlier posters noted that everything Benson said would happen did happen. OK, but nonetheless, we won and they lost. It took a long period of sacrifice, patience and determination on our part, but finally, the USSR collapsed in upon itself from its absurdity. Cuba and North Korea are the only two communist nations left in the world. The Castro regime would collapse in a few years if we lifted the embargo and exposed the people there to our people and commerce. From Castro's point of view, the embargo is a gift that keeps on giving, providing a ready-made excuse for why
Cuba is desperately poor. I wouldn't be surprised, however, if the current students at Searcy College are taught that President Obama is a Kenyan socialist determined to ban guns, set up death panels, blah, blah, blah...such is the debased rhetoric of the modern right-wing. They ought to study this film for lessons in logical, fact-based debate.
verschlagenfuchs -
This guy is on something
An effective way to get someone to believe something is to plant a lie inside an accepted fact. This film is classic propaganda. Had this guy been Speaking German, hmmm. Also, change communism to Muslim fundamentalists or terrorists and it sounds much like recent speeches
skunkbait -
Exceptional Courage
Dr. Benson was a charismatic, energetic speaker. Although I did not agree with all of his stances throughout the years, I could not help but be moved by his passion for the things he believed. If anyone questions his motivation for opposing communism so vehemently, they must look to his years in China as a missionary at the time that communism was taking over. The animalistic brutality that he saw ravage the young Christian churches would lend a sense of urgency to his rhetoric, that most of us in this post-Cold War era can not understand. May God Bless those who would follow in Dr. Benson's footsteps rather than bowing to public opinion and prostituting themselves to anti-christian culture as later leaders have. (Later leaders: You know who you are and you should be ashamed.) As an impressionable young man, I attended Dr. Benson's funeral 14 years ago. U.S. Presidents (from both sides), senators, and Governor Clinton sent their condolences. His extraordinary courage will not soon be forgotten.
Historically interesting
Many things that Dr. Benson said about the Communists were true, but it worked two ways. Our government, unfortuantely, made some big blunders in those years. Also using J Edgar Hoover as a reference is now questionable. HIstorically, I found the speech very interesting and Dr. Benson well meaning.
Spuzz -
Benson Burner!
Another Harding College anti-communist rant, but in a pleasant turn of events, the presenters are reversed. In the previous films presented, usually George Benson introduces Clifton Ganus Jr. Well, in this film, Ganus, who for some odd reason looks rather old and tired, introduces Benson, who uh, is quite animated in this otherwise boring speech about how them commies are trying to infiltrate U.S. society! For the whole speech I was glued to this manÃÂÃÂÃÂÃÂs hands I donÃÂÃÂÃÂÃÂt know, it seems Mr. Benson has been reading the book on ÃÂÃÂÃÂÃÂHand Gestures for Better EmphasisÃÂÃÂÃÂÃÂ because heÃÂÃÂÃÂÃÂs always pointing, finger waving, hand waving, etc. HeÃÂÃÂÃÂÃÂs doing this way too much, and itÃÂÃÂÃÂÃÂs almost like heÃÂÃÂÃÂÃÂs doing the gestures deliberately, rather forced.
preachr -
God Bless George S. Benson, a Great American
I knew George S. Benson. I was born in Searcy, AR and educated at Harding University. And, while he was certainly an eccentric, he was also a courageous man and, in a sense, a prophet.
It only takes a surface reading of history to discover that much of what Dr. Benson was warning America back in 1962 was attempted in the following years.
The Cold War did accelerate.
Herculean efforts were made to weaken America's resolve.
Churchmen were recruited to lead "peace fronts" and put pressure on America to unilaterally disarm.
The USSR did accelerate its atomic development.
The US was blamed for all the world's ills (and continues to be blamed for them)
Anticommunist groups were smeared.
Etc. Etc. Etc.
Most, if not all, of the developments about which Dr. Benson warned, did happen to one degree or another.
And maybe it's because I grew up "down there" and heard Dr. Benson speak often, but his style, while admittedly eccentric, didn't seem to me to be "psychotic" (perhaps a little "smearing" is going on at this site?).
George S. Benson was a great American. He was a missionary, a college president and one of the few voices in academia who told the truth about communism.
quartknee -
Funny and sad, at the same time
I totally disagree with user:AmericanGothchick because even though she seems to see how psychotic this speaker is, she does not realize that such conservative and uninformed opinions about what communism is is one of the tragedies exposed by this "educuational" film. Just as we fight "terrorists" now, we fought "communists" then, which still means that, like Chavez in Venezuela, that they are unwilling to bend to Washington's quest for world domination, which is precisely what this man said communism was doing. This is a fantastic cultural artifact that can help us learn from our mistakes. Though, it's not very outdated because people still think anyone who doesn't believe in "free" market capitalism and its right to supercede civil and human rights is un-American. Hopefully some people who see this will pick up on this and its importance to public opinion and widespread neurosis and paranoia and not to "education" or history.
Steve Nordby -
The war we want
Peek into insanity passing for normality. An old white guy in a near state of hysteria.
AmericanGothchick -
Pertinant to our time
By today's standards Dr. Benson is hardly an enrapturing public speaker. It would be easy to snicker at the man who seems to preach empty fear. Unfortunately for us he was not entirely incorrect. History has shown that the Communists have done just as Dr. Benson predicted. Even today, Young Socialist type groups work on college campuses trying to recruit new members, and program them to work against their own country. See it for yourself and see if it didn't come true!
Christopher -
A man whose ideas live on?
This film's worth seeing just for Benson's peculiar, half-Scottish accent and his barely-controlled, near-fanatic enthusiasm. He's a trip. Bill Frist, the current Senate Majority Leader, quotes Benson prominently on his Web site.
Benson's organization also gave us the films "Brink of Disaster" and "Tragedy or Hope", available here at archive.org. Yipes!
dwarvenenergies -
This guy is completely psychotic!


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09 December 2009
In the next few weeks, a Christmas present with a difference will arrive in the Gambia as part of a UK-wide appeal to support the development of the country's higher education system.
This week, a new shipment of 40 high-grade desktop computers will be on its way to the University of the Gambia which will significantly change the learning experience of thousands of students in the Gambia.
The Gambia is the smallest and one of the poorest countries in Africa, and until 2001 had no university of its own. Today, it is home to a growing institution, with 2,500 students and run by highly qualified Gambian professors who have returned home to set up the University.And thanks to the generosity of staff across Cardiff University, staff and students at University of the Gambia are enjoying a growing academic library and soon-to-be better equipped computer facilities.In 2008, staff at Cardiff undertook a major effort to provide the Gambian students with access to books and equipment in support of the Gambia University Appeal, a charitable organisation set up by the British Study Partnership. For the last 12 months the International Office and Information Services have been coordinating the appeal across the University. The initial book appeal saw more than 1,000 textbooks from three of the University's libraries sent to University of the Gambia – forming the largest part of a shipment sent out to the Gambia in January 2009. Rhys Evans, a senior international officer in the International Office at Cardiff University, said: "We are in a fortunate position to be able to help University of the Gambia. Our computer donation should be arriving in late January, and should make a huge difference to the 2,500 students who are currently sharing a single computer laboratory in the University buildings."Mr Lamin Touray, Registrar of University of the Gambia, said: "Our University expands in student numbers every year to meet growing needs of our country, and yet our computer equipment does not increase to match these higher numbers. The gift from Cardiff University will enable us to furnish a new computer suite, which will allow more students to access computers and the internet."
Lowri JonesPublic RelationsT: 02920 870 995E; email@example.com
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The Great!
I've personally experienced the results of this organization in...
That I received six handwritten letters from our troops stating they received the packages.
Ways to make it better...
If I had to make changes to this organization, I would...
Everything went very well, I wouldn't change a thing.
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What specific problem, purpose, priority, or project prompted your gift?
I am a Wildland FireFighter, I too got stuck out in the middle of nowhere sometimes for up to a month. I know what it is like to be without. I started thinking about our troops stuck out there for years! I felt it was the least I could do to help a few soldiers. I respect their efforts and sacrifices. Unless you have had a job where you have no access to showers, water, hot food or a bed for days and weeks on end, you just don't understand.
Why did you make your donation at this time?
I started at Christmas time, the season for giving. I contacted a fellow FireFighter who had returned from Iraq and asked about charities that he felt really made a difference on his tour.
What would you tell others about this organization?
It is a worthwhile organization. They do not require you make a donation to them in order to send a package to your chosen Soldier. I did not make a donation the first time I shipped but I certainly do now. Once I received the thank you letters from the soldiers I was assured this was a trustworthy way to help our troops.


text:
This Gulf access luxury estate home has everything you could possibly ask for. This 2400 plus square foot home features every upgrade imaginable including an infinity edge pool and spa, 2 boat docks, amazing curb appeal, gourmet kitchen with granite counters, wood cabinets, stainless steel appliances, crown moulding, multi-tray ceilings and fanimation ceiling fans. Villa Leila also has state of the art electronics, including a 3D HD DVR, surround sound and flat screen TVs. This home does not disappoint! Pictures cannot do this home justice!
The world-renown romantic Sanibel Island, Estero Beach and Captiva Island as well as Fort Myers Beach with its beautiful sand and many more islands are within a short time's reach both by boat and by car. Cape Coral and Fort Myers offer a big variety of Shopping Malls and Entertainment. There is a Casino Boat Cruise that leaves daily from Ft. Meyers Beach and if you like there is a daily cruise to Key West. The options are limitless. Spring training Baseball, The Henry Ford & Thomas Edison Estates and Everglades all within reach. Sports Fans will love this area. There are plenty of Golf Courses, Fishing and Water sports opportunities available.
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Rates shown above are for 1 - 2 guests. Low Season each additional guest $100/week.
High Season each additional guest $150/week. No charge for kids under the age of 10. Rate includes electricity up to US $50.00 per week (additional use US $0.12/KWH). Minimum stay: 7 days, Christmas and Easter: min. stay 7 days plus 15%.


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There is a revolution brewing in the office—a revolution, which, as a totally unintended side effect, may well sound the death knell for the design profession as we know it today. The revolution doesn't have anything to do with sophisticated computer-based local area networks, state-of-the-art systems furniture, or even "new approaches" to office layout. Rather, its seeds are sown in a much more fundamental question: do we even need offices at all?
This may sound like a rhetorical (or even silly) question. After all, if we didn't have offices, where would we put millions of American office workers? What would we do with billions of square feet of existing office space? What would happen to the thousands upon thousands of people whose livelihood depends on the continuing existence of the office—from custodians to leasing agents? What would magazines like Contract find to write about? Perhaps most important, what would office designers design?
As important as these questions might be to each of us as individuals, they ignore a basic point: the "modern office" is a relatively recent phenomenon. Its foundations were laid down only a little more than 100 years ago, during the period of dramatic social, economic, and technological upheaval historian Arnold Toynbee characterized as the "industrial revolution." As a result, the modern office is a product of a "mechanized" way of thinking about the relationships between labor, management, and machines. Perhaps even more significant, the form and function of the modern office is a product of a set of technological constraints—in particular, in the areas of communication and transportation—that existed in the 1800s and early 1900s but that no longer holds true today.
Whether we are simply experiencing the rolling after-shocks of Toynbee's revolution…or whether we are, indeed, in the midst of yet another and perhaps even more profound revolution…there is no question that we are experiencing an era of unprecedented social, economic and technological change. Thus, should we really expect that the white-collar workplace that will eventually emerge from what we might characterize (for lack of a better term) as the officing revolution will bear even a passing resemblance to its industrial predecessor?...Of course, the logical follow-up question is a bit more difficult:
If the office of tomorrow won't look like the office of today, what will it look like?
Technomania as the 'magic bean'
In recent years, corporate America's strategies to improve office productivity have been largely driven by management's knowledge about the nature of the office and of office work—specifically, that the office is some kind of "information factory." The result has been that management has come to view massive infusions of technology as the "magic bean" that will once and for all turn the nation's white-collar productivity cow into a goose that lays golden eggs.
What makes all of this even more interesting, of course, is the fact that, in spite of a decade or more of investment in new technology of all kinds, office productivity may well be getting worse rather than better. Robert Solow, serving as vice chairman of an MIT blue ribbon panel on American productivity, summed up the situation this way: "If someone landed from Mars or, more to the point, from Tokyo, he'd conclude that the computer has had essentially no impact on our white-collar productivity [Fortune, September 28, 1987, p. 62]." Anecdotal evidence garnered from survey research conducted by BOSTI, Steelcase, and others notwithstanding, the same can certainly be said for systems furniture and "new" approaches to office design.
This doesn't mean, of course, that people shouldn't expect to work in safe, supportive environments,
or that they won't be more satisfied—and perhaps even work a bit harder—if they have non-glare task lighting…, a pleasant view, an operable window, a closeable door, individualized control over air flow and temperature, more space to spread out, and an ergonomically designed chair.
However, this again misses the essential point. This is one of those all too frequent instances where corporate America and its designers, with all good intentions, are trying to solve the wrong problem.
The knowledge machine
Just as the sun looks as if it revolves around the earth, the office often looks like a factory. In fact, parts of some offices…even function like the "paper mills" that they really are. However, when it comes to what most of us think of as "office work"… we need something that will help us gain enough perspective to see the office for what it really is—how it really works.
We are all familiar with the concept of analogy—a form of logical inference in which it is assumed that if two things are alike in some respects, then they must be alike in other respects. Used properly, analogy can be a powerful problem solving tool. For example, the story is told that Henry Ford got the idea for the automobile assembly line by watching beef carcasses being pushed along an overhead rail in a meat packing plant while individual butchers performed specialized operations as each carcass passed by their work stations—just as "Model Ts" were later pushed from station to station along overhead rails in Ford's first assembly plants. Whether this story is apocryphal or not, it clearly illustrates the intellectual power of analogy.
Imperfectly drawn, however, analogies can be problematic and, when it comes to an issue as important as maintaining a sustainable competitive advantage in a rapidly changing world, even downright dangerous. For example, with the development of robotics and concepts like computer-integrated manufacturing (CIM), a traditional assembly line is probably the least cost-effective way to produce cars today. Nevertheless, breaking out of traditional ways of thinking about the process of building cars…continues to be on of the biggest competitive stumbling blocks facing American automobile manufacturers.
When it comes to addressing the "problem" of office productivity, exactly the same thing is happening today in the office….The office-as-information factory analogy has led management to adopt a mechanistic way of thinking about the office, both as a physical entity and as a process. Many companies even have gone so far as to try to measure "office productivity" in the same way it has historically been measured on the farm and in the factory—in terms of the efficiency with which inputs are converted into outputs—leading to such absurdities as multibillion dollar corporations worrying about counting the keystrokes of individual word processing operators.
It is true that offices, like factories, have floors, walls, and ceilings. But here the similarity ends. While we can talk about the "flow" of office work and the "productivity" of office workers, the office is not an "information factory." In fact, the office is not a factory of any sort. This helps to explain why productivity improvement strategies that have worked so amazingly well in the fields and on the shop floor have largely failed to live up to management's expectations when transferred into the office.
Clearly, we have lost sight of the purpose of the office….. The office wasn't invented to fulfill some deeply felt social need…. The purpose of the office is not to produce what we normally think of as "information"—the memos, letters, management reports, etc., that pile up on our desks. Rather, it is to create knowledge, which allows us to get along in a hostile and (more often than not) contradictory world. This is the purpose of the human mind. As an extension of the human mind, it is also the purpose of the office.
The distinction between information and knowledge is not a trivial one—something that Francis Bacon knew very well when he observed, in Meditationes Sacrae (1957), that "knowledge is power." Information, rather than being something tangible that can be "managed," is simply what chemists would call an "intermediate product" in the intellectual process we call information processing. It is an intellectual experience, based on the interpretation of sensory data (sights, sounds, smells, etc.), which answers some immediate question about the world we live in.
Our day-to-day survival as a species depends on how efficiently we process data from the environment. Likewise, it is in the management of the process of information processing—both at the individual level and, equally important, at the organizational level—that companies will find the key to increased competitiveness, not in the management of artifacts of the process.
Nevertheless, it is in the management of artifacts that most companies are spending the bulk of their technology dollars today. However, in a world in which intellectual agility counts for much more than physical prowess, companies must learn to manage what is essentially an intellectual rather than a production process.
This will be a difficult challenge to meet. Not only will it require a totally different set of management skills than that which exists in today's executive ranks…but it will very likely mean the demise of the office as we have come to know and love it. Why? Because, as companies are inextricably drawn into the vortex of what Harvard sociology professor David Bell has dubbed the "postindustrial" society, competitive pressures will force management to ask—and answer—what is perhaps the most difficult question of all: If we didn't have offices as we know them today, what (if anything) would we invent? Perhaps needless to say, as the office goes, so goes office design.
The birth of the virtual office
For the first time in history, officing—undertaking the intellectual work that is necessary to meet a commonly agreed upon set of organizational goals and objectives—can take place with total independence of time and space, something that was impossible before the development of modern telecommunication and transportation technology.
This doesn't necessarily mean, of course, that future generations of middle managers will find themselves working out of "electronic cottages" rather than traditional office buildings—although that possibility certainly exists. What it does mean, however, is that management can, if it chooses, begin to free itself from traditional concerns like constructing corporate headquarters buildings and focus, instead, on two much more critical issues:
• Managing organizational knowledge.
• Managing variables that impact the efficiency of organization-level information processing.
This, in turn, will require management to pay much more attention than it does today to the question of how and where people work best.
If our goal is to take fullest advantage of our intellectual resources…we can no longer afford to adopt a monolithic approach to the office. We can no longer afford to constrain our most valuable asset—the human mind—by force fitting it into what amounts to an anachronistic straightjacket called "the office," no matter how pleasant and well-planned that office may be, and no matter how many design awards it may have won. We have to find ways to exploit the fact that not only do we often do our best intellectual work at strange times and in strange places (and sometimes even in strange company), but that the mind "works" 24 hours a day, 365 days a year, for as long as we live. And herein lies both the risk—and the opportunity—for the design profession: management has no one else to turn to help them meet this challenge.
For years, the behavioral sciences have been viewed with skepticism (if not outright derision) by top management. Perhaps this skepticism is deserved, perhaps it is not. Nevertheless, the office—whatever form it eventually takes—has been and will forever remain a behavioral rather than a technical phenomenon. Thus, management will need designers who understand how to create and manage the creation of knowledge systems—information processing megasystems that are, themselves, comprised of individual information processing systems we call people. This will require:
• An in-depth understanding of the process of human information processing
and, of equal importance, an in-depth understanding of the role that technology
can and should play in this regard, whether we are talking about computers or
buildings—an expertise that doesn't exist in most organizations today.
• An amalgam of what are now viewed as distinct disciplines—architecture
(and, in particular, interior architecture), the cognitive sciences, sociology,
information systems, and probably a number of others.
• The ability to design seamless infrastructures of technology (including, of
course, facilities) that support officing whenever, wherever, and in whatever
form it requires to be effective—at home, in the car, on an airplane, in a hotel,
or even in a "traditional" office setting.
Obviously, this is not something that today's designers are well-prepared to do, even if they wanted to. However, it is an issue that will confront the design profession head-on in the not too distant future. Why? Because this is not only an American problem. The issue of increased office productivity—of intellectual competitiveness—is on the minds of management in virtually all industrialized countries (and even in some countries like China that although not full industrialized, are keeping a weather eye to the future).
As for the future of office design, the scenario cast here holds both risk and opportunity. The opportunity is evident. The risk, on the other hand, is that a totally new profession will emerge that will subsume much of what has traditionally been viewed as the purview of design.
This is not as far-fetched as it might sound. Throughout history, lots of professions have come and gone, more often than not as a direct result of technological shifts like the one the world is now experiencing. And consider this: Japan has recently taken a keen interest in what they call "FM"—facility management. Only some Japanese companies have a rather interesting perspective on what this term encompasses—everything from the design of a corporate logo to the management of a corporate culture. How does that old saying go? "Forewarned is forearmed."
Duncan Sutherland is chairman of the Sutherland Group, Inc., Socio + Technical Systems Consultants, Reston, Va. He consults with corporations and governments in the United States and abroad on issues related to technology strategy and the development of innovative, technologically enabled approaches to improved office productivity. Prior to that, he was a vice president and director of officing for Houston-based CRS Sirrine Inc., where he continues as officing consultant. He is the author of a Japanese book on the future of the office, Officing: Bringing Amenities and Intelligence to Knowledge Work.


text:
I once left an entire bag of goodies on an airplane en route from Heathrow to Seattle via Reykjavik. I realized I felt much lighter than I had at Heathrow and just likened it to not being in a shithole. After a few more minutes I realized I had left the bag back on the plane and ran across the (little) airport to the gate.
Nobody was at the gate. Nobody was on the plane. I ran on and walked right up to the seat where the bag was in plain view.
Yeah, nobody checks that shit.


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Title: An Open-Label, Randomized, Multi-center, Controlled Study of PROCRIT (Epoetin alfa) for the Treatment of Anemia or Chronic Kidney Disease in the Long Term Care Setting. (EPOCKD2002) Purpose: To demonstrate that PROCRIT in extended dosing intervals (every 2 weeks followed by every 4 weeks dosing) is safe and effective for the treatment of anemia in subjects with chronic kidney disease who reside in long term care facilities. Principal Investigator: Levy, Susan Phase: III Approved Enrollment Number: 20 Current Enrollment: 0
Title: A Single Center, Randomized, Open Label, Parallel Group Pharmacodynamic Study of a Novel Combination Form of Aspirin and Phytosterol versus Aspirin in Healthy Adult Subjects. (Bayer 13144) Purpose: To determine if administration of the phytosterols 400 mg twice a day when taken as a combination tablet with aspirin effects the antiplatelet effects of aspirin vs. aspirin alone, as measured by serum thromboxane levels. To compare the effects of administration of phytosterols 400 mg twice a day in a combination tablet with aspirin and aspirin alone on platelet aggregation in response to arachidonic acid and collagen using LTA. Principal Investigator: Gurbel, Paul A. Phase: I Approved Enrollment Number: 32 Current Enrollment: 30
Title: A Phase II Study of Doxorubicin/Taxotere (DT) Followed by Gemcitabine/Cisplatin (GS) in Patients with Locally Advanced/Metastatic Cancer of the Bladder/Urothelium. (GCC 0318) Purpose: To determine whether an investigational combination of chemotherapy drugs is capable of having an effect on the growth of bladder/urothelium cancer. Principal Investigator: Hussain, Arif Phase: II Approved Enrollment Number: 12 Current Enrollment: 0
Title: Reamer Irrigation Aspirator (RIA) Effluent Evaluation. Purpose: To see if growth factors can be captured (specifically BMP-2) from RIA effluent using a Synthes proprietary technology. Principal Investigator: Conway, Janet D. Phase: I Approved Enrollment Number: 10 Current Enrollment: 9
Title :A Phase 3 Study of SU011248 in Combination with Paclitaxel Versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer. (A6181094) Purpose: To compare the progression-free survival (PFS) for patients having locally recurrent or metastatic breast cancer who receives SU011248 plus Paclitaxel versus bevacizumab plus Paclitaxel. To compare the safety of SU011248 plus Paclitaxel versus bevacizumab plus Paclitaxel in this patient population. To compare measures of duration of tumor control and overall survival. To assess patient reported outcomes. To explore the relationship between specific biomarkers and cancer- and treatment-related outcomes. Principal Investigator: Truica, Cristina Phase: III Approved Enrollment Number: 10 Current Enrollment: 2
Title: IXTEND: A Randomized Phase 2 Study to Evaluate the Combinations of Ixabepilone plus Capecitabine or Capecitabine plus Docetaxel in the Treatment of Metastatic Breast Cancer. (CA163131) Purpose: To assess the response rate of subjects with metastatic breast cancer to treatment with ixabepilone plus capecitabine, and to investigate the response rate of subjects with metastatic breast cancer to treatment with docetaxel plus capecitabine. To investigate the response rates in triple-negative (TN) subjects and non-triple (NTN) subjects treated with ixabepilone plus capecitabine or docetaxel plus capecitabine. To evaluate the safety and toxicity profiles of the treatment regimens (ixabepilone plus capecitabine or docetaxel plus capecitabine). To evaluate the efficacy profiles, including time to progression, duration of response, and disease control rate. Principal Investigator: Truica, Cristina Phase: II Approved Enrollment Number: 6 Current Enrollment: 1
Title: A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive or High Risk Node-Negative Breast Cancer. (EPP E1199/SWOG E1199)
Purpose: To compare different chemotherapy drugs in terms of side effects, survival, and disease-free survival and to determine whether weekly administration of taxane chemotherapy drugs improves disease-free survival and overall survival when compared to the conventional schedule.
Principal Investigator: Noga, Stephen
Phase: III
Approved Enrollment Number:
Current Enrollment:1
Title: Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients with Metastatic Breast Cancer. (SO430)
Purpose: To evaluate the response rate benefit (complete or partial response) progression-free and overall survival in women with metastatic breast cancer treated with simple oral combination therapy with cyclophosphamide and capecitabine. To assess the adverse events associated with this regimen.
Principal Investigator: Truica, Cristina
Phase: II
Approved Enrollment Number: 5
Current Enrollment: 1
Title: A Phase 2, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer. (SNX-1012-CLN2-006)
Purpose: To decide the most effective dose of SNX-1012 that would shorten the length of time that subjects have oral mucositis. Also to evaluate how safe and how well-tolerated SNX-1012 is in subjects who have oral mucositis.
Current Enrollment: 0
Title: Prospective Randomized Clinical Trial on the Effect of Abound on Wound Healing in Surgical Patients.
Purpose: To study whether the post-operative administration of Abound (Abbott Nutrition) to patients undergoing colonic resection with primary anastomosis increases wound healing.
Principal Investigator: Barbul, Adrian
Phase: I
Approved Enrollment Number: 60
Title: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab with and without Panitumumab in the First-Line Treatment of Subjects with Metastatic Colorectal Cancer. (Amgen 20040249)
Purpose: To assess whether treatment with panitumumab given concomitantly with every 2 (Q2) week oxaliplatin-based chemotherapy and bevacizumab improves progression-free survival (PFS) compared to treatment with Q2-week oxaliplatin-based chemotherapy and bevacizumab alone.
Approved Enrollment Number: 10
Current Enrollment: 4
Title: Demonstration of the Pharmacodynamic Antiplatelet Effect of PRT060128 in Patients with High Platelet Reactivity During Clopidogrel and Aspirin Maintenance Therapy.
Purpose: This study is being carried out to see how well an investigational drug, PRT061028, given in addition to Clopidogrel and aspirin, works on preventing blood clots in patients who do not respond adequately to Clopidogrel or those patients who have a higher rate of clot formation.
Principal Investigator: Gurbel, Paul A.
Approved Enrollment Number: 45
Current Enrollment: 20
Title: A Randomized Double-Blind, Double-Dummy, Parallel Group Study of the Onset and Offset of the Antiplatelet Effects of AZD6140 Compared with Clopidogrel and Placebo with Aspirin as Background Therapy in Patients with Stable Coronary Artery Disease and Additional Detailed Assessment of Cardiopulmonary Function. (D5130C00048)
Purpose: The primary objective of this study is to compare an experimental drug call AZD 6140 to Clopidogrel for treatment in the prevention of clot formation in people who have had acute coronary syndrome (ACS) and/or subjects who receive cardiac stents. Currently, the only available medication for those two indications is Clopidogrel (Plavix). However, it has been observed that not all subjects respond to treatment with Clopidogrel (Plavix) and some people still may form a clot while taking it. If approved, AZD 6140 will be an alternative drug in place of Clopidogrel (Plavix).
Approved Enrollment Number: 75
Current Enrollment: 43
Title: A Randomized, Double-Blind, Outpatient, Crossover Study of the Anti-platelet Effects of AZD6140 Compared with Clopidogrel in Patients with Stable Coronary Artery Disease Previously Identified as Clopidogrel Non-responders or Responders. [RESPOND]
Purpose: The primary objective of this study is to compare an experimental drug called AZD 6140 to Clopidogrel for treatment in the prevention of clot formation in people who have had acute coronary syndrome (ACS) and/or subjects who receive cardiac stents. Currently, the only available medication for those two indications is Clopidogrel (Plavix®). However, it has been observed that not all subjects respond to treatment with Clopidogrel (Plavix®) and some people still may form a clot while taking it. Patients, who are known to have very little effect on their platelets by clopidogrel (Plavix®) (non-responder), will be studied as well as patients who seem to have a typical response to clopidogrel (Plavix®) (responder). If approved, AZD 6140 will be an alternative drug in place of Clopidogrel (Plavix®). AZD6140 has been administered to 11,000 patients in clinical studies and is only available to patients enrolled in such clinical studies.
Approved Enrollment Number: 80
Current Enrollment: 42
Title: A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12-Receptor Inhibitor, vs. Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent Percutaneous Coronary Interventions (INNOVATE-PCI)
Purpose: To help find out if a new investigational drug called PRT060128 is safe and effective for use in patients having a non-urgent PCI. A PCI is a procedure that is done to clear blockages in the blood vessels of your heart.
Approved Enrollment Number: 50
Current Enrollment: 27
Title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS ElementTM) for the Treatment of Up to Two De Novo Coronary Artery Lesions
Purpose: To compare the safety and effectiveness of two drug-eluting stents (a stent is an expandable metal tube that helps to hold the artery open so that blood can continue to flow through the artery) in the treatment of coronary artery disease: the PROMUS Element Everolimus-Eluting Coronary Stent System and the PROMUSTM Everolimus Eluting Coronary Stent System. The PROMUS Element and PROMUS stents are both coated with the same drug, everolimus. However, the two stents are made of different metals and are designed differently.
Approved Enrollment Number: 30
Current Enrollment:0
Title: A Phase I Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients with Degenerative Joint Disease Prior to Total Knee Arthroplasty. (TGC-03-01)
Purpose: To investigate the safety and bioavailability of TissueGene-C administered intra-articularly (IA) to patients with Degenerative Joint Disease, once over a four (4) week period prior to their scheduled total knee arthroplasty.
Principal Investigator: Mont, Michael A.
Approved Enrollment Number: 12
Current Enrollment: 6
Title: An 8-Week, Randomized, Double-Blind, Parallel-Group, Multi-Center, Active-Controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to Amlodipine (10 mg) in Patients with Stage 2 Systolic Hypertension and Diabetes Mellitus.
Purpose: To demonstrate the BP lowering effect of aliskiren HCTZ (300/25 mg) combination versus amlodipine (10 mg) on mean sitting systolic blood pressure (msSBP) in patients with both stage 2 systolic hypertension and diabetes mellitus by non-inferiority testing, followed by superiority testing after 8 weeks of treatment.
Principal Investigator: Ravi, Chaitanya Kumar
Phase: IV
Current Enrollment: 3
Title: A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers. (KC-002)
Purpose: To determine the safety and effectiveness of the device, KC-002 interactive wound dressing, in the promotion of healing diabetic foot ulcers compared with conventional wound therapy regime for subjects with Type 1 or Type II diabetes mellitus.
Title: A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Diabetic Foot Ulcers. (VGF3554g)
Purpose: To evaluate the efficacy of daily treatment with topical telbermin (three different concentrations) versus placebo in healing diabetic foot ulcers. To evaluate the safety and tolerability of telbermin daily treatment for 12 weeks. To evaluate the pharmacokinetic properties of topical telbermin as measured by systemic concentration levels of vascular endothelial growth factor (VEGF) in subjects at various timepoints.
Title: A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy. (Biogen 206OC202)
Purpose: To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
Principal Investigator: Abbas, Fouad M.
Phase: I/II
Approved Enrollment Number: 3
Current Enrollment: 2
Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia (The HARMONY Study).
Purpose: To find out if lixivaptan, an investigational medication, can be used to decrease the amount of extra water in the body and to obtain additional information about the safety and effectiveness of lixivapatan.
Principal Investigator: Rajani, Sunil
Approved Enrollment Number: 4
Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects with Euvolemic Hyponatremia (The HARMONY Study).
Principal Investigator: Krug, Esther
Title: COG AEWS0521: A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND#7921) combined with Vincristine, Topotecan and Cyclophosphamide in Patients with Recurrent Ewing Sarcoma.
Purpose: To determine the feasibility of administering bevacizumab in combination with vincristine, topotecan, and cyclophosphamide (VTC) to patients with first recurrent Ewing Sarcoma (EWS). To estimate the progression free survival with vincristine, topotecan, cyclophosphamide with bevacizumab (VTC/bevacizumab in patients with first recurrent Ewing Sarcoma. To estimate the response rate to 2 cycles of VTC compared to 2 cycles of VTC/bevacizumab. To evaluate biological markers as related to prognosis and specifically related to angiogenesis by encouraging concurrent enrollment on the Ewing Sarcoma banking studies (AEWS02B@ and/or AEWS07B1), and ancillary correlative endothelial cell, surrogate marker and angiogenic gene studies.
Principal Investigator: Wiley, Joseph M.
Title: COG AEWS0621: Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults with Recurrent or Refractory Ewing Sarcoma.
Purpose: To estimate the response rate to cytarabine in children and young adults with relapsed or refractory Ewing sarcoma. To evaluate, in a preliminary fashion, the use of Ewing specific transcripts detected in peripheral blood as a surrogate marker for disease response. To evaluate, in a preliminary fashion, whether gene expression profiles of Ewing sarcoma tissue samples at diagnosis predict response to cytarabine.
Title: CO5011: A Phase 2 Study of VELCADE (bortezomib) in Combination with Bendamustine and Rituximab in Subjects with Relapsed or Refractory Follicular Lymphoma.
Purpose: To determine the maximum tolerated dose (MTD) of bendamustine in combination with bendamustine and rituximab provides benefit to subjects with relapsed or refractory follicular lymphoma as assessed by complete response (CR) per the revised International Working Group (IWG) criteria. To determine the maximum tolerated dose (MTD) of bendamustine in combination with VELCADE and rituximab, up to a maximum bendamustine dose of 90mg/m2. To evaluate the safety and tolerability of VELCADE in combination with bendamustine and rituximab. To determine the overall response rate (ORR: CR + partial response [PR]). To determine progression free survival (PFS). To determine duration of response (DOR).
Approved Enrollment Number: 6
Title: A Phase III, Randomized, Double-Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma. (114-NH-301)
Purpose: To compare the clinical benefit of galiximab and rituximab versus rituximab alone in patients with relapsed or refractory non-hodgkin's lymphoma. To determine the safety of galiximab when given in combination with rituximab. This will include looking at what side effects occur and how often they occur. Determine how galiximab and rituximab are broken down and eliminated by the body. Principal Investigator: Noga, Stephen
Title: A Randomized, Open-Label, Multicenter Study of Velcade with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory Rituximab Naïve or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma. (26866138-LYM-3001)
Purpose: To learn whether VELCADE when given with rituximab as a combination treatment is better than rituximab alone in treating patients with lymphoma. The primary comparison is to find out the difference of whether the condition responds to the study medication and if it does, how long the condition remains stable or continues to respond to the study medication.
Title: An Open-Label, Intravenous to Oral Switch, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Immunocompromised Children Aged 2 to <12 Years Who Are At High Risk For Systemic Fungal Infection. (A1501088)
Purpose: To find out how the body uses the anti-fungal medicine called voriconazole when it is given intravenously and then switched to be given by mouth in children aged 2 to 12 years who are at high risk for systemic fungal infection. To find out what are the effects, good and/or bad, or giving voriconazole intravenously and then switching to oral (by mouth). To find out if there are any factors such as age, body weight, and genetic factors that affect the way the body uses voriconazole.
Title: Phase III Trial of High Dose Interferon Alpha-2b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma. (SWOG 0008)
Purpose: To compare overall survival and disease-free survival between patients with high-risk melanoma who receive high-dose interferon alpha-2B versus cisplatin, vinblastine, DTIC plus IL-2 and interferon. Also, to evaluate the toxicities of these two regimens in this patient population.
Principal Investigator: Didolkar, Mukund S.
Title: A Phase III Study for the Treatment of Children and Adolescents with Newly Diagnosed Low Risk Hodgkin Disease. (COG AHOD0431)
Purpose: To investigate the paradigm of response-based therapy for low risk Hodgkin disease by eliminating involved-field radiation therapy (IFRT) for subjects who achieve a CR with initial chemotherapy. To investigate whether three cycles of AV-PC for the treatment of low risk Hodgkin disease is sufficient to induce CR in at least 80% of subjects. To investigate whether subjects who experience a low risk relapse after initial treatment with chemotherapy alone can be successfully treated with a salvage regimen consisting of IV/DECA and IFRT. To maintain the overall survival (OS) for subjects with low risk Hodgkin disease at or above 97%. To determine the prognostic significance of very early response as measured by FDG-PET or gallium after the first course of chemotherapy. To evaluate the prognostic significance of elevation of ESR and CRP at the time of diagnosis in low risk Hodgkin disease on CR rate and relapse rate after chemotherapy alone. To determine the frequency and severity of late effects of therapy including thyroid dysfunction, infertility, cardiotoxicity and second malignant neoplasms.
Title: Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Low Tumor Burden Patients with Indolent Non-Hodgkin's Lymphoma. (CTSU/E4402)
Purpose: To establish whether single doses of rituximab given at 12-week intervals can prolong disease control compared to giving rituximab once a week for four consecutive weeks at time of disease progression.
Title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease. (R331333-PAI-3002)
Purpose: To determine the efficacy of CG5503 immediate-release (IR) using the sum of pain intensity difference (SPID) over 5 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR in subjects who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis.
Title: A Multi-center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax (L-BLP25 or BLP25 liposome vaccine) in Non-Small Cell Lung Cancer (NSCLC) Subjects with Unresectable Stage III Disease. (EMR 63325-001)
Purpose: Primary objective is to compare survival duration of all randomized subjects by treatment arm. Secondary objectives of this trial are to compare all randomized subjects by treatment arm for time to symptom progression (TTSP) as measured by the Lund Cancer Symptom Scale (LCSS); time to progression (TTP) as determined by the investigator; one, two and three year survival; and safety.
Principal Investigator: Erlich, Rodrigo
Title: A Phase III, Open-Label, Prospective, Two-armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment with the Zevalin (ibritumomab tiuxetan) Study Regimen Versus Observation in Patients with Diffuse Large B-cell Lymphoma Who are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy. (307940/106-20)
Purpose: Evaluation of efficacy and safety of Zevalin, as well as assessment of quality of life.
Title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid) in Combination with Dexamethasone in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (CC-5013-NHL-005)
Purpose: To determine the efficacy of lenalidomide in combination with dexamethasone in relapsed or refractory diffuse large B-cell lymphoma. To evaluate the safety of lenalidomide in combination with dexamethasone as treatment for subjects with relapsed or refractory diffuse large B-cell lymphoma.
Title: An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects with Lymphoma. (Amgen 20050144)
Purpose: To identify a safety dose and schedule of AMG 531 that is appropriate for treatment of chemotherapy induced thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy. To evaluate the overall efficacy of AMG 531 in subjects with severe thrombocytopenia due to multi-cycle chemotherapy.
Title: A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine with Placebo. (CA 184024)
Purpose: To examine the safety and effectiveness of two different treatments for patients with melanoma.
Title: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma. (ECOG E2603)
Purpose: To compare the overall survival, progression-free survival, response rate, and safety of patients with stages 3 or 4 melanoma by randomizing them into two groups.
Title: A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With 'No Evidence of Disease' after Complete Surgical Resection of 'Locally Advanced' and/or Stage IV Melanoma. (SWOG E4697)
Purpose: To compare overall survival, two-year survival, and time to progression of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with GM-CSF vs. no GM-CSF, or other high risk patients listed in the eligibility section.
Approved Enrollment Number: 2
Title: A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination with Bortezomib in Patients with Relapsed or Refractory Multiple Myeloma. (AVF4064g)
Purpose: To make a preliminary assessment of the efficacy of combining bevacizumab with bortezomib relative to bortezomib with placebo in patients with relapsed or refractory multiple myeloma, as measured by progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria, as assessed by the investigator. To evaluate the safety and tolerability of combining bevacizumab with bortezomib relative to bortezomib with placebo in patients with relapsed or refractory multiple myeloma. To make a preliminary assessment of the efficacy of combining bevacizumab with bortezomib relative to bortezomib with placebo, as measured by overall response, duration of response, and overall survival in patients with relapsed or refractory multiple myeloma. Overall response and duration of overall response will be based on investigator assessment using the IMWG Uniform Response Criteria.
Title: NKV110721, A Study of Single Dose Intravenous Casopitant in Combination with Ondansetron and Dexamethasone for the Prevention of Oxaliplatin-Induced Nausea and Vomiting
Purpose: To demonstrate the superiority of triple therapy, single-dose 90 mg IV casopitant in combination with ondansetron and dexamethasone, over dual therapy ondansetron and dexamethasone for the prevent of emesis over the first 0-120 hours(overall phase) following initiation of the first cycle of oxaliplatin-based MEC. To determine whether the addition of single-dose 90 mg IV casopitant provides incremental improvement in the prevention of emesis over the acute (0-24 hours) and delayed (24-120 hours) phases following initiation of the first cycle of oxaliplatin-based MEC. To determine whether the addition of single-dose 90 mg IV casopitant provides incremental improvement in the prevention of emesis over the overall (0-120 hours) phase following the second cycle of oxaliplatin-based MEC. To determine whether the addition of single-dose 90 mg IV casopitant provides incremental improvement in the control of nausea over the overall, acute and delayed phases following initiation of the first cycle of oxaliplatin-based MEC. Quantify the impact of the prophylactic anti-emetic regimens on daily life activities, as assessed by the FLIE questionnaire during the first cycle of oxaliplatin-based MEC. Evaluate the PK of single-dose 90mg IV casopitant and metabolites in a sub-set of subjects when administered in combination with ondansetron hydrochloride and dexamethasone during the first cycle of oxaliplatin-based MEC. Determine the safety and tolerability of single-dose 90 mg IV casopitant when administered as part of the antiemetic regimen outlined in this protocol.
Title: A Phase II Study of Irinotecan + Temozolomide in Children with Recurrent Neuroblastoma. (COG ANBL0421)
Purpose :To find out whether neuroblastoma in children who have recurrent or refractory disease responds to treatment when the children are given the chemotherapy drugs irinotecan and temozolomide.
Title: A Phase II Study of hu14.18-IL2*(BB-IND-9798) in Children with Recurrent or Refractory Neuroblastoma. (COG ANBL0322)
Purpose: To determine the response rate, adverse events, and immunologic activation induced by hu14.18-IL2* in children with recurrent/refractory neuroblastoma.
Title: A Randomized Phase 2 Trial of Erlotinib With or Without PF-3512676 for the Treatment of Patients with Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy Regimen. (A8501006)
Purpose: To assess Progression Free Survival (PFS) in patients randomized to PF-3512676 in combination with erlotinib (Investigational Treatment Arm) and PFS in patients randomized to erlotinib alone (Control Treatment Arm). To assess secondary measurements of efficacy for PF-3512676 in combination with erlotinib. To assess the safety and tolerability of PF-3512676 in combination with erlotinib. To assess the effect of PF-3512676 on the steady-state plasma trough concentration of erlotinib. To assess the effect of PF-3512676 in combination with erlotinib on selected biomarkers of immune activation. To evaluate EGFR expression gene amplification and genotype in NSCLC tumor tissue. To determine germline TLR-9 and EGFR genotypes, and to explore the association between genotype and measures of efficacy, safety and immune activation.
Title: A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination with Paclitaxel and Carboplatin for Advanced Non-squamous Non-Small Cell Lung Cancer. (Amgen 20060136)
Purpose: To estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arms A and B) and the paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC. To estimate the duration of response, progression-free survival, and overall survival in each of the 3 treatment arms. To evaluate the safety and tolerability in the 3 treatment arms. To evaluate the pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B.
Principal Investigator: ;Erlich, Rodrigo
Title: PR104-2003: A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer.
Purpose: To determine if Doxetaxel is more effective when given alone or when Doxetaxel is given with PR104.
Approved Enrollment Number: 8
Title: MAGRIT 109493: A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of reMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients with Resectable MAGE-3-Positive Non-Small Cell Lung Cancer.
Purpose: To demonstrate the clinical efficacy of reMAGE-A3 + AS15 versus placebo in NSCLC after complete surgical resection. Two co-primary objectives are efficacy in the overall population and efficacy in the population of patients who did not receive adjuvant chemotherapy (no-CT population).
Title: Multi-center Clinical Trial of the Application of Tissue Repair Cell (TRC) Therapy of Osteonecrosis of the Femoral Head. (Protocol ABI-55-0705-1 Rev 01)
Purpose: To evaluate the use of tissue repair cells to prevent the progression of osteonecrosis of the hip. Tissue repair cells are the patient's own bone marrow cells, removed from the patient's pelvic bone, grown and processed in a nutrient-rich solution, and mixed with bone proteins and blood proteins.
Current Enrollment: 7
Title: A Phase II Study of Aerosolized GM-CSF (NSC #613795, IND# 11042) in Patients with First Pulmonary Recurrence of Osteosarcoma (COG AOST0221).
Purpose: To find out the effects, good and bad, of inhaling GM-CSF, and find out whether inhaling GM-CSF will stimulate the body's natural line of defence (the immune system, specifically in this study the macrophages, dendritic cells, and membrane receptors) to destroy the osteosaroma lung tumors.
Title: Phase 3, Multicenter, Multi-National, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects with Occluded Central Venous Access Devices. (HA008) Purpose: To evaluate the safety of Alfimeprase as assessed by monitoring of adverse events. To evaluate the efficacy of Alfimeprase as measured by the restoration of the catheter flow at various time points: 15 and 30 minutes after initial drug administration, and 30 minutes after the administration of one or two doses of the study drug. Principal Investigator: Noga, Stephen Phase: III Approved Enrollment Number: 10 Current Enrollment: 0
Title :A Phase II Single Arm Study of Carboplatin and DOXIL Plus Bevacizumab in Subjects with Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers. (DOXILOVC2007)
Purpose: To establish which dose of DOXIL plus Carboplatin and Bevacizumab (AVASTIN) can be given safely to patients and obtain the desired result in order to determine the effectiveness of the combination in treating ovarian, fallopian tube, or peritoneal cancer that has reoccurred.
Title: Phase II Evaluation of Weekly Hycamtin in Recurrent Platinum-Sensitive and Platinum-Resistant/Refractory Ovarian Cancer.
Purpose: To evaluate a 30-minute infusion of Hycamtin given on a weekly basis for 6 weeks in a row, followed by 2 weeks off.
Title: Phase 3 Randomized Study of TLK286 Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer. (TLK286.3017)
Purpose: To learn whether TLK286 is better than standard therapy in prolonging the life of patients with recurrent ovarian cancer. Also, to compare the effects on tumor growth and the safety of the different study treatments.
Title: An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study of Repeat-Doses of DIC075V (Intravenous Diclofenac Sodium) in Patients with Acute Post-Operative Pain. (DFC-010)
Purpose: To evaluate the safety of DIC075V (Diclofenac Sodium) an injectable non-steroidal drug (NSAID) under investigation as a 37.5mg/ml injection to alleviate post operative pain following multiple doses (minimum of 8 doses) over multiple days (maximum of 5 days).
Title: A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients with Metastatic Breast and Colorectal Cancer. (CCC-03-26)
Purpose: To determine the efficacy of celecoxib in reducing the incidence and severity of Hand/Foot syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal cancer.
Title: A Randomized, Open-Label, Cross-Over, Study to Evaluate the Inhibitory Effect of Clopidogrel Plus EC Aspirin (325 mg) and Clopidogrel Plus PA32540 on Platelet Aggregation in Healthy Volunteers.
Purpose: This study will examine the effects of aspirin, clopidogrel, and omeprazole on platelet functions.
Current Enrollment: 30
Title: Envision Surface Evaluation for Patients with Stage II, III or Stage IV Pressure Ulcers.
Purpose: To gather early clinical information for a new hospital mattress.
Principal Investigator: Papantonio, Cathie
Approved Enrollment Number: 40
Current Enrollment: 17
Title: Phase I/II Study of Weekly Doxorubicin and Taxotere, Followed by Total Androgen Suppression (TAS) in Patients Who Experience Biochemical Failure after Prostatectomy and/or Radiation for Localized/Locally Advanced Prostate Cancer. (GCC 0162)
Purpose: To determine whether an investigational combination of chemotherapy drugs followed by hormone therapy can stop or slow down prostate cancer from growing.
Principal Investigator: Hussain, Arif
Title: Phase I/II Study of Weekly doxorubicin and Taxotere for the Treatment of Patients with Hormone Refractory Prostate Cancer. (GCC 9983)
Purpose: To determine efficacy and safety of a weekly regimen of doxorubicin and taxotere in which the doxorubicin dose remains fixed, while that of taxotere is modified in patients with HRPC with respect to toxicity and tolerability, PSA response, overall response with the above treamtent combiantion, and overall survival.
Title: A Randomized Double-Blind Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone with and without Bevacizumab (IND #7921, NSC #704865) in Men with Hormone Refractory Prostate Cancer. (CALGB 90401)
Purpose: To compare the effects of the standard combination of the drugs docetaxel and prednisone with the combination of docetaxel, prednisone, and the experimental drug bevacizumab on subjects with prostate cancer.
Principal Investigator: VanderVelde, Nancy
Title: An International, Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Study of 3-Month or 6-Month Treatment with SSR126517E (3.0 mg s.c. once weekly) Versus Oral INR-Adjusted Warfarin in the Treatment of Patients with Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Venous Thrombosis. (EFC6034)
Purpose: To compare the safety and effectiveness of biotinylated idraparinux with the standard treatment of pulmonary embolism. It will also assess the safety and effectiveness of avidin, which will act as an antidote for biotinylated idraparinux in case of major bleeding.
Title: Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior To and Following Combined Prolonged Venous Infusion Plus Pelvis XRT vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior To and Following Combined Pelvic XRT in Patients with Rectal Cancer, Phase III, Intergroup. (SWOG 9304)
Purpose: To investigate which of three methods of 5-FU administration (prior to and following radiation and chemotherapy), and whether the administration of other drugs (leucovorin and levamisole) plus 5-FU, produces the best cure rates. In addition, the side effects of 5-FU with or without leucovorin or levamisole along with radiation and chemotherapy will be evaluated.
Title: COG ADVL0525: A Phase II Study of Pemetrexed in Children with Recurrent Malignancies.
Purpose: To estimate the response rate to pemetrexed administered intravenously every 21 days in children with relapsed or refractory osteosarcoma, Ewing sarcoma/peripheral PNET, rabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/surpratentorial PNET or non-brainstem high grade glioma. To further define and describe the toxicities of pemetrexed.
Title: Phase II Trial of Ixabepilone (BMS-247550), An Epothilone B Analog, in Children and Young Adults with Refractory Solid Tumors. (COG ADVL0524)
Purpose: To Determine the response rate to Ixabepilone in various strata of recurrent solid malignant tumors of childhood and young adults. The target tumors are embryonal or alveolar rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/Peripheral neuroectodermal tumor (PNET), synovial sarcoma or malignant peripheral nerve sheath tumor (MPNST), Wilm's tumor, and neuroblastoma. To determine the time to progression for each tuor strata. To prospectively evaluate the feasibility and utility of automated volumeteric tumor measurement in patients with measurable pulmonary metastases, and escriptively compare volumetric measurements to 1D (RECIST criteria) and 2D (WHO criteria) measurements. To further define and describe the toxicities of Ixabepilone. Principal Investigator: Wiley, Joseph M.
Title: A Phase II Study of Bortezomib (Velcade, PS-341, IND #58443) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Refractory/Recurrent Hodgkin Disease. (COG AHOD0521)
Purpose: To determine the efficacy and safety of bortezomib as a chemo-sensitizing agent in primary refractory HD or HD in first relapse. Response rate to bortezomib with ifosfamide/vinorelbine (IVB) will be compared to the historical response rate using ifosfamide/vinorelbine (IV) alone. Primary response rate will be determined by complete response (CR) rate following two cycles of chemotherapy. The secondary objectives are to determine the overall response rate (CP+PR) after 2 and 4 cycles of therapy, induction success rate after 2 or 4 cycles of therapy, and the reinduction rate (CR) after 4 cycles of therapy and to determine the proportion of patients able to mobilize sufficient hematopoietic stem cells (CD34+) after 2 cycles of IVB.
Title: A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/day Monotherapy in Subjects with Partial-onset Seizures. (SP902)
Purpose: To demonstrate the efficacy and safety of conversion to lacosamide 400 mg/day monotherapy for partial-onset seizures (with or without secondary generalization) in subjects 16 to 70 years of age who are withdrawn from 1 to 2 marketed antiepileptic drugs.
Principal Investigator: Sinha, Saurabh
Title: A Multicenter, Open-Label Extension Trial to Assess the Long-Term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures. (SP904)
Purpose: To obtain information about the percentage of subjects who remain on lacosamide monotherapy, and the duration of lacosamide monotherapy treatment. To obtain information about the long-term safety of lacosamide when used as monotherapy or adjunctive therapy in subjects with partial-onset seizures.
Title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock. (Protocol F1K-MC-EVDP)
Purpose: To determine if drotrecogin alfa (activated) treatment provides significant mortality reduction and organ function improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. Will assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock.
Title: The IMPROVE Trial: Improving Pain Management and Outcomes with Various Strategies of Patient-Controlled Analgesia (PCA)
Purpose: To find out which two different treatment plans of Patient-Controlled Analgesia is more effective when used to treat people with Sickle Cell disease who is admitted to the hospital for a pain crisis.
Principal Investigator: Fixler, Jason M.
Title: A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients with Extensive Small Cell Lung cancer Sensitive to First-Line Chemotherapy. (CNF3140-SCLC-05004)
Purpose: To evaluate the effect of amrubicin compared to topotecan on lung cancer.
Title: COG ADVL0221: A Phase II Study of Trabectedin (ET-743, Yondelis) in Children with Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomysarcomatous Soft Tissue Sarcomas.
Purpose: To estimate the response rate to trabectedin administered as 24 hour continuous infusion every 3 weeks in patients with recurrent or refractory rhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma and Ewing sarcoma family of tumors. To further assess the tolerability and toxicity of trabectedin in children with recurrent cancer. To further delineate the pharmacokinetics of trabectedin in children with recurrent cancer.
Title: Deep Vein Thrombosis Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy versus Low Molecular Weight Heparin. (R-QAP-04-01-01-001)
Purpose: To evaluate the safety and effectiveness of ActiveCare Continuous Enhanced Circulation Therapy (CECT) device with or without baby aspirin (81 mg aspirin daily) for lowering the potential risk of Deep Vein Thrombosis (blood clots) during and after Total Hip Arthroplasty (THA) in comparison with Low Molecular Weight Heparin (LMWH).
Approved Enrollment Number: 100
Current Enrollment: 51
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty. (114-03P)
Purpose: To evaluate the postoperative analgesic effectiveness, safety and tolerability of a single intra-operative dose of the study drug 4975 in patients undergoing primary unilateral total hip replacement. The pharmacokinetic profile of 4975 will be studies as well.
Approved Enrollment Number: 20
Title: A Randomized, Double-Blind, Active and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension. (R331333-PAI-3001)
Purpose: To evaluate if CG5503 is safe and effective in treating pain.
Current Enrollment: 5
Title: A Randomized Controlled Study to Evaluate the Healing Rate of Stage III and Stage IV Ulcers Comparing the New Envision Surface with Flexicair Eclipse Mattress Surfaces. (Eclipse Mattress)
Purpose: To measure the rate of wound healing in pressure ulcers for a new hospital mattress called Envision and compare those rates to a surface called Flexicair Eclipse, that has been used widely to treat pressure sores.
Approved Enrollment Number: 15
Title: Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension Study
Purpose: This study is an extension of the Einstein VTE treatment study. This is being done to show that the incidence of recurrence of pulmonary embolism or deep vein thrombosis during an additional 6 or 12 months of treatment with rivaroxaban (BAY 59-7939) is lower when compared to 6 or 12 months of placebo and that the likely advantage of an extended effect is not offset by an increase of bleeding complications.
Principal Investigator: DiMarsico, Ledys
Title: EFC6521: A Multinational, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and who are Undergoing Chemotherapy.
Purpose: To compare the efficacy of once daily (q.d..) subcutaneous (s.c.) injections of 20 mg AVE5026 with placebo in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy.
Approved Enrollment Number: 9