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A couple of weeks ago I bought two beautiful Craftsman tool chests for my back lanai area. These are really nice ones, on wheels, and I had been looking at them for months. Finally they went on sale and I bought them.
Anyway, I suddenly had more space for my scattered tool collection and set about to organize them. I found an old toolbox full of wrenches I had inherited and started to put them in one of the drawers of the tool chest. I gradually realized that I had no idea about what many of the wrenches were used for. I am not very mechanically inclined, and I think that some of the wrenches were for auto work.
So I had tools but did not know what they were used for.
Sound familiar?
In Karate, our movements, whether in kata, kumite drills, or otherwise, are tools. They are the tools of Karate. If you had the opportunity to organize your Karate "tool" collection, would you know what each of them mean or can be used for?
I have to admit that I don't know what everything means. I do understand some things and often ask my senior friends what they think certain movements mean. Karate is a constant learning process.
When the movements are scattered in our general curriculum, we do not have to really think about each one. But when we sit down and try to organize all of them, some questions might arise.
Since Karate has evolved over at least a few hundred years, we also have to deal with the fact that some movements might have made more sense at the time and in the cultural context in which they were developed. For example, today we do not wear kimono (or similar clothes) and do not wear metal spikes (jiffa) in our hair. Movements based on the use (or restrictions on use) presented by such items might not make much sense today. And three hundred years ago, people did not have cell phones or cars.
I feel tempted to throw away some of the wrenches I might never use. But who knows, maybe I will learn their proper meaning and use them one day... like some of the movements in Karate I might not quite understand yet.
Charles C. Goodin
My Craftsman Tool Chests
A couple of weeks ago I bought two beautiful Craftsman tool chests for my back lanai area. These are really nice ones, on wheels, and I had been looking at them for months. Finally they went on sale and I bought them.
Posted by Charles C. Goodin on Wednesday, August 29, 2007


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Thanks so much for joining in!! I'll be trying to run these monthly, and you never know when I might toss in another FLASH CONTEST with extra prizes!!!
Our winning group should all have their badges, and this time included:
Spoiler Alert! Click to show or hide
This time the quote was from
Imitating the various beauties of nature is refined and all, but imitating humans is perhaps the most fun. Doing that, and enjoying ourselves at their events alongside them is strangely amusing. "It's a manifestation of our idiot blood!"
It was a longer quote, so more of my friends on the staff helped me out
Spoiler Alert! Click to show or hide
Bjaker - Imitating the various beauties of - IMITATING THE VARIOUS BEAUTIES OF, Crunchyroll is a full time job. T T
beardfist - nature is refined and all - NATURE IS REFINED AND ALL, but I love the strange things of science more.
lorreen - I thought I'd do better than crunchybot BUT IMITATING HUMANS is hard.
thenicooole - is perhaps the most fun - "Over everything else, being with my friends IS PERHAPS THE MOST FUN!"
Kippu - My sweet Caroline. DOING THAT, AND ENJOYING OURSELVES is the only way to live.
MakotoKamui - at their events, alongside them - Training w/the heroes of legend; AT THEIR EVENTS, ALONGSIDE THEM, in battle
AHTL - is strangely amusing - "I love cyberpunk, it IS STRANGELY AMUSING. There isn't enough cyberpunk in the world."
Serenity_07 - It's a manifestation of - "IT'S A MANIFESTATION OF visual art works"
Karkarov - our idiot blood - OUR IDIOT BLOOD fell into todays pudding mix! Gross!!!!
I sure hope everyone will get a chance to try our next contest, too~~!!!
- Contest-Hime
Spoiler Alert! Click to show or hide
The FLASH CONTEST may be over, but we are still throwing this badge contest until the beginning of next month! So be sure to check back later... we'll be giving away more stuff!!!
Hey everyone!!! Are you ready for another Scavenger Hunt??!? This time it's a Hot Pot Scavenger Hunt, based on another great show, The Eccentric Family!!!
Here's how it works:
Some of the Community Staff have added part of a quote from an episode of Eccentric Family to their Headline. Find all of these parts of the quote and arrange it properly. To win, just PM me with each staff member's name and what part of the phrase they had in the correct order!!
Good luck, everyone!!! If you can find the right staff on or before October 4th, you'll get this cool badge!!!
Would you like a hint??
Spoiler Alert! Click to show or hide
Last time our quote was from Attack on Titan:
Once I'm dead, I won't even be able to remember you. So I'll win, no matter what. I'll live, no matter what!
Here's how a few of the staff used their parts!
Remember, different staff take part each time, so be sure to check them all!
And, as always, any participation counts... I can't wait to show you what I've got planned... ehehehehe...
Taking a Break!
That was kind of fun. Missed the AoT contest, but I think that one would have been much more of a challenge for me.
t/ @ishikusui || PSN: ishikusui / XBL: TakenIdiot
I enjoyed my first scavenger hunt, thanks for the fun. It was an even greater pleasure as I thoroughly enjoy The Eccentric Family, I had a good time re-watching episodes.
"No matter where you are, people find a way to entertain themselves."
I love uchouten kazoku! Def. taking part~
Fee Fi Foe Fum
eyeofpain wrote:
That was kind of fun. Missed the AoT contest, but I think that one would have been much more of a challenge for me.
Yes! It's okay, we'll try and do shows from the ones that are here on CR! So everyone can have a chance at them!
Trahma wrote:
I enjoyed my first scavenger hunt, thanks for the fun. It was an even greater pleasure as I thoroughly enjoy The Eccentric Family, I had a good time re-watching episodes.
Please look forward to more contests!!!!
kawaiicelia wrote:
:) I love uchouten kazoku! Def. taking part~
Yay~! Badges for everyone!!!
Taking a Break!
Awesome I was just wondering when there would be another contest recently and I really enjoyed the AoT one. The Eccentric Family is an awesome anime too.
Okay...my profile skin didn't work like it was supposed to :(
WoOT! I got it! Only took me like a hundred tries! Well, actually 3. xD
This one was a lot more fun for me (than the 1st AoT hunt), since I wasn't familiar with the show and really had to use some logic in fitting each of the phrases together so they made sense and flowed coherently.
I agree, I found this one a lot more fun because it was a lot longer and I didn't know the show as well
This has actually inspired me to go watch The Eccentric Family when my internet starts working properly again
Thanks, Contest-Hime!
Ehehehehe.. don't worry, these will be getting harder and harder... I've been talking plans with my friends over here.....
But keep in mind, you can enter these scavenger hunts as often as you like!!! Just because you didn't get it on your first try, don't let that discourage you! Look at suikojay, they've got the right idea
Taking a Break!
I'm normally caught up on my anime...but this is one of those shows that I watch with my husband so we're a few episodes behind. I guess my guess wasn't guessy enough - off to catch up on my series so I can get this right!
Hey Mister, I am Mad Scientist! It's so cool!
I can't believe how time flies!! Today is the last chance to enter!
And don't forget - the season finale aired, so why not do a marathon of Eccentric Family? I know I will!!!
Taking a Break!
I didn't see this till last saturday, but was totally too busy to participate I'll keep an eye out for the next one
Some day you'll be able to walk past a fez without picking it up...
daraksharnah wrote:
I didn't see this till last saturday, but was totally too busy to participate I'll keep an eye out for the next one :D
Don't worry!!! I'll be running many more contests Lots of chances to take part!!!
Taking a Break!

subset: commoncrawl


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SARATOGA SPRINGS, N.Y. - Thinking of his wife and seven children, Jose Santos decided to play it safe for a change.
Six months after breaking his back in a spill at Aqueduct, the jockey who rode Funny Cide to victory in the 2003 Kentucky Derby and Preakness called it a career.
"I am going to retire because my back is in real bad shape right now," Santos said Monday at a news conference at Saratoga Race Course. "With time, definitely it's going to get better. But my doctor advised me it's not a good idea to come back. If I have another spill, I'll probably not be able to walk again.
Santos, who walks gingerly these days, has said he's lucky he wasn't more seriously injured in the three-horse spill Feb. 1, and doesn't want to risk another injury.
"I think it's going to be the best for my interest and my kids," he said.
Santos' retirement comes a week before the popular 46-year-old rider is inducted into racing's Hall of Fame, along with former trainer John Veitch, Derby and Preakness winner Silver Charm and other racing greats.
"This has been very hard for me, because I really wanted go out on my own terms," Santos said. "That didn't happen. I decided that I wanted to make this announcement today because I didn't want to take anything away from the Hall of Fame ceremonies."
The decision also comes 17 days after 7-year-old Funny Cide was retired. The gelding is a stable pony for his trainer, Barclay Tagg.
"It's only right that we go out together," Santos said. "I just hope I find a job as good as his."
Santos, from Concepcion, Chile, was among the nation's leading jockeys in the 1980s, and leaves the sport with more than 4,000 victories. But he will be remembered for his run at the Triple Crown with Funny Cide.
The New York-bred Funny Cide was the surprise winner in the Derby, then demolished the field in the Preakness by 9 lengths. On a rainy day at Belmont Park, nearly 102,000 fans showed up for the Triple Crown attempt, but Funny Cide finished third.
Santos was dogged by controversy after the Derby, when a published photograph prompted Churchill Downs officials to investigate whether the jockey carried something other than a whip in his right hand during the race. After being cleared of wrongdoing, Santos said: "I am thankful this nightmare is over. A week ago, I was in the happiest moment of my life. And then this photograph came in and destroyed my career, actually."
Santos also won the 1999 Belmont aboard Lemon Drop Kid. He was the nation's leading rider four years running during the 1980s and won an Eclipse Award in 1988.
Through the end of 2006, Santos had 4,076 victories in North America with purse earnings of $186.9 million and 331 graded stakes wins.
"I am extremely grateful for the career I've had, for the owners and trainers that had faith in me, to my fellow jockeys who helped bring out the best in me and to the fans for their support," Santos said. "Most of all, I am grateful to my family. They have always supported me, and it is tough because every time you ride a horse, you are in danger. They don't have to worry anymore, and that is a relief."
Santos' injuries were serious. His spine was fractured in five places and he broke several ribs.
"Three of them were compression fractures of the (thoracic) vertebrae," he said. "The other two the T-7 and T-8 - were more serious fractures. My doctor said that the way they were pressing against the spinal cord, there would be an 80-percent chance that I could wind up in a wheelchair."
Santos rode his first race at Hipico Racecourse in Chile, following in the footsteps of his father and three of his seven brothers. In 1984, he began riding at South Florida racetracks and moved to New York a year later.
In 1992, Santos had his first serious injury, fracturing his right arm and collarbone and cracking his hip in a spill at Belmont Park. He had 14 screws and two pins inserted to repair the arm.
Santos decides to hang up the saddle
SARATOGA SPRINGS, N.Y. - Thinking of his wife and seven children, Jose Santos decided to play it safe for a change.


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With the impending Thanksgiving Holiday on Thursday, and the biggest shopping day of the year ahead of us, the concert calendar is a little slim this week – but that doesn't mean you shouldn't get out there and enjoy a show. Things start off pretty heavy on Tuesday with Kyuss Lives!, The Sword, and BlackRead more…
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No, New Orleans is still pretty bad. I was so naive and had no idea that it was so bad when I started school there. Talk about culture shock but I am glad I went there b/c I def. learned some much needed street smarts. Anyway, I would suggest applying to a few more schools, just in case. Cold Schmold...have you ever felt Louisiana in August? I have poker straight hair...it actually curled in the humidity. Plus, it rains and the whole place floods including Tulane (not so much the law school) and some rooms stink like mold. I am happy to stay in the midwest for law school. Have you thought about Madison?
I wish I knew more about law schools that offer sports law but I almost failed gym in high school and really had no idea my undergrad had sports teams!
Here is my list so far for schools:1) Marquette2) Tulane3) Michigan State4) University of GAAny opinions?
U can add GW to the list and have been talking to people- when i take the lsat I am going to aim for 167 and work on GPA to at least a 3.5- I have the time, at the moment I live in FL and taking classes at a local community college to transfer back to my university in Pittsburgh (a long story of why I am in FL) anyway will return to Pittsburgh in fall of 2005 to finish BSBA in May 2006.
kaest4, if you are interested is sports law, check out this website/blog: http://sports-law.blogspot.com/ It is written by a law student at Harvard. I love it.


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You can check our events calendar to find out what will be happening during your stay with us in Ischia.
Our guests can make use of the beautiful La Rotonda sul Mare residence facilities with seafront platform, bar, pedal boat and kayas, compliments of Colella Family Hospitality.
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Learn to make real Napolitan style pizza and impress your friends and family. Lorenzo will take you through step by step so you can take with you a true Ischian souvenier.
La Rotonda sul Mare Beach ResortRing Backpackers Hostel
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Choose Showtime to Buy Tickets
Burque Beer Walk
Sample the best brews in Albuquerque!
Burque Beer Walk at Hyatt Regency
330 Tijeras Ave NW
Ste. Q
Albuquerque NM 87102
View Website |
Other Events at Burque Beer Walk At Hyatt Regency
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New for 2017! This 2.5-hour walking tour includes stops at 3 local craft breweries/taprooms in Downtown Albuquerque. Your knowledgeable Beer Guide will lead you through the streets of Downtown with a backdrop of Route 66's neon-drenched streets, beautiful public art, and 300 years of rich history while you enjoy some of the best suds in the Southwest!
The Burque Beer Walk begins Downtown at the Albuquerque Tourism & Sightseeing Factory at 219 Central Ave NW (Central between 2nd & 3rd St). The tour starts with rooftop views from the historic Banque Building before hitting the streets! Tour guests enjoy a guided experience, tastes at each location, $5 voucher to use toward a purchase (beverage, merchandise, food) at any brewery/taproom on tour, a complimentary bottle of water, and exclusive discounts on beer/food: $1 off each pint at all locations and a special $3 rate for a 10oz. pour. A behind-the-scenes tour of a brewery will be based on availability. All participants must be 21+ with a valid ID.
If this is your first visit to Albuquerque (nicknamed 'Burque' by locals), you will enjoy how walkable and vibrant downtown Albuquerque is. The breweries and taprooms on our tour are less than a 10 minute walk from one another along city sidewalks.
Comfortable shoes are recommended. Don't forget your valid ID and cash to tip your servers and guide!
Albuquerque Beer Rankings:
Albuquerque is rapidly becoming a top craft beer destination. See some of the city's recent accolades below:
- Travel + Leisure ranked Albuquerque one of America's 20 Best Cities for Beer Lovers.
- Livability.com ranked Albuquerque one of the 10 Best Beer Cities for 2014.
- Singletracks.com ranked Albuquerque one of 10 Beer Town with a Mountain Biking Problem.
- Albuquerque was ranked as one of the Top 10 Beer Cities by Livability.com.
- Amog.com ranked Albuquerque as one of the Top 10 American Cities that Brew the Best Beer
- Albuquerque fills the #1 top spot on Livability.com's Top 10 Beer Cities list
The breweries/taprooms on the Burque Beer Walk:
The 2.5 hour tour includes 3 of the above breweries/taprooms (rotating week to week). Participants must be 21+ with a valid ID.


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Get the Flash Playerto see this player.
|Euro Babes Fever
Short review: Everything is nicely listed from Euro Babes Fever, so there'll be no guessing as to what the videos hold, it's either solo, lesbian, backstage or hardcore. From the extra video section of this site, it all seems to be hardcore for each of the 6 sets of episodes. The images were beautifully done, and presented with nothing short of a totally professional look.
Content Amount: With this site I'm left relying on the updates and how often they bring them. With just 161 galleries and less than 40 video episodes, that won't keep you busy for weeks on end, but it may just keep you drawn in long enough for new material to be added.


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Thursday, April 20, 2006
Heart of Darkness
And I got some interesting responses.
Kate said: "I don't see why female crime writers would feel they had anything to prove... Historically in the UK crime fiction has been dominated by women."
Tania stated: "I probably read slightly more male authors because lately I've been dipping my reading toes into the darker end of the pool, and there are more male authors writing those kinds of books. It has to do with availability rather than any conscious effort to seek out male authors."
Of course, the one person who stated that they liked male writers better commented via email and I don't have consent to quote, so you have to take my word for it…
But that isn't the point today. Besides, those of you who've been hanging around for a while were likely thinking (if you didn't email me to point it out) that my tendency to get on better with guys might have something to do with problems with my mother. But I'm going to save the psychoanalysis for another day.**
I was reading Karin Slaughter's introduction to her story in Tart Noir. She said, "I've always thought of noir as a male-dominated genre, not because women can't do noir, but because the moral of these stories generally seems to be that men are basically solid, upstanding citizens until they meet the Wrong Woman. It's a classic retelling of Adam and Eve, only with more liquor and sex… The women of classic noir were defined by the men in their lives: they were dames and broads, singled out as real lookers for their gams that wouldn't quit. To get away from one man they would latch onto another."
And the men are all saying bring back classic noir, right?
When I read this comment, I was surprised. I'd never thought of this as the moral of these stories. I'd never thought of noir as being about men and women.
In fact, recently I participated in a discussion about noir. Nobody even went near this idea.
It was the combination of that comment, and the fact that "who writes better crime" will be debated at Harrogate Crime Festival that got me wondering about it all. Until then, I assumed it was just me being an oddity, that for the first long while I had a hard time finding women writers I really connected with.
That's long past. Laura Lippman is cozying up to my Rankin collection. Cornelia Read is snuggling with Stuart MacBride, and Simon Kernick rubs shoulders with Val McDermid. I just got the latest Natasha Cooper, so Steve Mosby is sandwiched between her and Denise Mina. I really want to reiterate I'm not anti-women! Even my musing about whether or not women felt they had something to prove was not intended to infer that they do have something to prove, but rather that some of them believe they have something to prove. One thing's for sure – this will be a hell of a start of Friday morning at Harrogate!
I really do believe that noir is about stripping the hope and faith out of a person's life, until there's nothing left but darkness. There might even be hope there, but they can't see it. They can't find their way to it. They're lost.
I don't think it has anything to do with men or women. Cornelia Read's debut book is being called WASP Noir. And even it isn't completely bleak.***
Next week, you'll be able to decide for yourself if I can do noir. One of my short stories will be wondering how the hell it managed to crash the swanky party that features such ladies of taste and talent as Sarah Weinman, Jen Jordan,
Kim Harrington, Aliya Whiteley, Patricia Abbott,
and JT Ellison.
In the mean time, I just love the challenge of fleshing out real characters of all kinds and trying to make the story come alive. Keep hoping to improve, keep setting new goals and working towards them. Sometimes I aim to write first person. Sometimes I try to write tough chick. Sometimes, the goal is to elicit one single emotion. When I write short stories in particular, this is how I do it. I have to think narrow framework, or else they start turning into novellas.
You writers – have you set any goals for yourself lately? Tried to stretch yourself in any way?
Maybe I should make a real leap and try to do romance… Speaking of which, any men that write good romance? Oh, come on, I bet we're all thinking this is something women definitely do better!
Because I'm obsessing over the genders lately…
You may not know that many non-living things have a gender:.
For example:
1) Ziploc Bags- They are Male, because they hold everything in, but you can see right through them.
2) Copiers- They are Female, because once turned off, it takes a while to warm them up again. It's an effective reproductive device if the right buttons are pushed, but can wreak havoc if the wrong buttons are pushed.
3) Tires- Male, because they go bald and are often over-inflated.
4) Hot Air Balloon- Male, because, to get it to go anywhere, you have to light a fire under it, and of course, there's the hot air part.
5) Sponges- Female, because they're soft, squeezable and retain water.
6) Web Page- Female, because it's always getting hit on.
7) Subway- Male, because it uses the same old lines to pick people up.
8) Hourglass- Female, because over time, the weight shifts to the bottom.
9) Hammer- Male, because it hasn't changed much over the last 5,000 years, but it's handy to have around.
10) Remote Control- Female...... Ha! You thought it'd be male. But consider this - it gives a man pleasure, he'd be lost without it, and while he doesn't always know the right buttons to push, he keeps trying.
** I know some of you are wondering and I've been mum on the subject since I talked about what happened. I have begun to rebuild a bridge with my mother. It's pretty surreal after 8 years, but there you have it. I'm fine, things are fine, it's a fair start.
*** Trying to avoid spoilers of any kind…
23 comments:
I think pushing yourself to do other genres and viewpoints, at least in short fiction, is a good way to built depth. I'd be afraid I was stagnating if I wrote one kind of story.
- 9:02 a.m.
- Lisa Hunter said...
"Even my musing about whether or not women felt they had something to prove was not intended to infer that they do have something to prove, but rather that some of them believe they have something to prove."
Actually, women writers DO have something to prove. Unless you are entirely alone in your view that men are better writers, that attitude is a major obstacle to overcome. It makes it harder for women writers -- including you -- to get published, get blurbs, sell books, and be taken seriously. Is that really the way you want the public to view your own work?
- 9:05 a.m.
- Boy Kim said...
Hey, what happened to *?
- 9:49 a.m.
"I just got the latest Natasha Cooper, so Steve Mosby is sandwiched between her and Denise Mina. I really want to reiterate I'm not anti-women!"
Are you implying Natasha and Denise might see that as some form of punishment? ;-)
- 9:59 a.m.
- JamesO said...
At the risk of starting something:
'Cornelia Read is snuggling with Stuart MacBride'
Does She Who Must... know?
I missed out on yesterday's discussion due to technical problems, but as a reader, it's never occurred to me to consider the gender of authors. I either enjoy the book and will read more, or I don't and won't. As writers, I guess there are genres where women have to work twice as hard just to be taken seriously - it's the same in many walks of life and it will take many years of de-conditioning to change.
When it comes to ability, talent, skill or whatever, there are far more differences between individual people than there are between men and women.
- 10:19 a.m.
- Sandra Ruttan said...
Here here Jason!
Lisa, we should take a survey! And at the same time, how many men are publishing romances? Erotica? Any? Is there a dominance between the genders in any other genre?
I've never wondered this before.
I don't know that I think men are better writers. I've continued to think about this since I wrote that post. I think men are perhaps better writers of some things, just like women are better writers of other things. Val McDermid does noir that gives me the creeps and freaks me out.
I guess, maybe I should've been thinking about it not from a technical aspect but from a content aspect. Men tend to write about things I'm more interested in. Women, I think, write about a much broader range of things, some of which I'm not interested in.
Boy Kim, I ate it.
Steve, I'm sure they wouldn't see that as some form of punishment. But it was darned hard to type that with my fingers crossed...
James, I'm not sure She Who Must Knows. I mean, they live in the sticks and he has one of those ankle monitoring devices for a reason.
- 10:35 a.m.
- E. Ann Bardawill said...
I just read 'Memoirs of a Geisha', an incredibly romantic book.
By Arthur Golden.
The only other romances I liked were by Jennifer Wilde.
Another guy.
I'm detecting a trend here.
E. Ann
Solid member and founder of of BEDS-ME*
* Ask Sandra.
- 11:17 a.m.
- M. G. Tarquini said...
I never notice the sex of the author.
Is that a bad thing?
- 11:36 a.m.
- Sandra Ruttan said...
MG, I guess it all depends... I'm sure you've noticed the sexiness of some authors.
BARDAWILL! I'm very glad you brought up Memoirs of a Geisha, because that is a great book, one I really enjoyed.
See how I think in stereotypes?
And you'd best ask BARDAWILL about BEDS-ME. She's a card-carrying member...
- 11:54 a.m.
Whatever women do they must do twice as well as men to be thought half as good. Luckily, this is not difficult. ~Charlotte Whitton
I don't take much notice of a writer's sex either (except my own), but I don't think there are many female writers amongst my favourites. Or even that I like all that much. Diana Wynne-Jones, Mo Hayder, Val McDermid - that's about it, and one of them's not even a crime writer. It's quite weird, now I actually come to think about it, but like I said, I'd not even really considered it much before.
- 12:03 p.m.
- Sandra Ruttan said...
Steve, do you think there's any merit to my idea that women do cover a broader range of style, which may make it harder to find the ones you like if you have a narrow range of preference?
I mean, I don't really like romantic books, or erotica. And I was born without a sense of humour - I mean, some people do it well, but I tend to think there isn't much funny about crime, and the minute a cat is intricately involved in the solution, I'm long gone - that's fine if other people like it. It isn't my thing. I mean, I know there will be people who don't like my books too because they aren't for them. It isn't that the writing is bad, it just doesn't tickle my fancy.
Lately, I seem to be discovering more and more brilliant female writers. And a lot of them seem to be American. Again, just an oddity I've noticed, and I occasionally wonder why the trends in my reading habits. Maybe I'm just really really weird.
See, I didn't even just reduce that to you liking men better...
- 12:10 p.m.
- Trace said...
Karin Slaughter rocks. I can't wait to read your short story.
- 12:32 p.m.
- This comment has been removed by a blog administrator.
- 5:43 p.m.
Since you were going to discuss what Karin Slaughter said, I think when you quoted me you should have left in the middle part of what I said. It was, "but maybe it's different in the US."
I thought you might be going to quote Karin Slaughter on women writers and violence. Another day, maybe?
I think of writers as individuals whose work I might like or dislike, not male writers or female writers. I do read more books by female writers but it's not a huge majority.
I read about a UK survey that found that although women read books by men and women, men often only read books by men. This starts with children's books. Girls will read books written for boys. Boys wouldn't be seen dead with a girly book. At school teachers look for books that will appeal to boys because they can rely on the girls to read them anyway.
Crime fiction might be the most equal genre. More men are prepared to be seen reading crime novels by women.
- 6:05 p.m.
- Sandra Ruttan said...
I was more intrigued by the idea that noir was about the genders, something I'd never ever considered. And I don't think I agree on it. But that's interesting about the men reading books by men, although some of the guys seem to have no issue with it.
I took out that bit about the US, probably erroneously, because I didn't want to make it a US-UK issue, for one thing. I mean, the oddity for me seems to be that I read mainly American women and British men! Why my reading habits have evolved this way, I don't know.
But I'm making a concentrated effort to push myself out of boxes and explore new terrain. I have heard people locally talk about choosing to 'read Canadian' or to 'not read American' and those are trends I don't like. I never deliberately set out to create my reading patterns years back - but now that I've assessed them and I see where I'm at, I wonder how it happened, and I'm trying to move in different directions. Read translated work (not easy to come by here) and read Australian, Canadian and Irish authors as well.
Male and female doesn't seem to be much of an issue anymore.
But I never thought of noir as being about gender. Anybody see it differently?
- 6:14 p.m.
- Gabriele C. said...
Are you very fond of the new colours? Because they hurt my poor eyes.
I usually don't care about the gender of a writer. Except when I want to read something heavy on battles and heroism - in that case I go for male writers. I haven't yet found a female Bernard Cornwell or David Gemmell. So, if I buy a Hist fic or Fantasy book by a woman, I have different expectations about the ratio of battles/relationships and the way both are written.
As writer, I try for a more male-oriented way of writing, closer to Cornwell than Penman. :)
- 8:21 p.m.
- Sandra Ruttan said...
As you can see Gabriele, I'm not married to anything!
- 9:12 p.m.
I haven't read enough classic noir to comment on it. I have even less idea what noir is now.
- 9:19 p.m.
Sandra - I'm not sure. If you mean women write across a broader range of genres, then I don't think that's true. Certainly all the genres I read - crime, thriller, sci-fi, horror - tend to be dominated by men. In terms of crime, I'm not sure women write a broader range of styles either. Do you reckon?
Within crime (and I'm kind of just talking blind here), maybe it's something to do with the traditions of the genres and the worlds they reflect. The police force, the underworld, private investigators, hitmen, spies, soldiers, investigative journalists, lawyers - they're predominantly male environments. I'm generalising wildly and I know it, before anyone shouts at me, but you tend to start off writing what you know, which at its most basic means probably having a protagonist who's the same sex as you. And of course, you do get female cops, PIs (etc), but when you think of a PI you probably think of Humphrey Bogart rather than VI Warshawski. It's a basic thing - I write men better than I write women, so I would have trouble writing a sex and shopping novel, because the main characters tend to be women.
So maybe the fact there are few female crime writers I like is just down to statistics: I don't like that many authors anyway, and the pool I'm drawing from is mostly men. But my gut tells me it's also about voice. I like first-person stuff, I like male protagonists, and so on. I like John Connolly's voice and Michael Marshall Smith's voice, which are very distinctive and very male. I don't think any writing is objectively better than any other, and I would never say women can't write crime as well as men - that's bullshit. But I don't seem to find many with the kind of voice that appeals to me.
- 4:23 a.m.
- Sandra Ruttan said...
Hmmm. Good points Steve. Maybe it's that the particular niches women tend to go into (and I am speaking in generalities) are the ones that don't interest me as much.
I get the impression that Zoe Sharp's books might really appeal to me. At least, she's given me a pretty darned good sales job.
Huh- you like first-person. That's interesting. I've always had a preference for third. But I also prefer a male protagonist.
One thing's for sure - with us both going to Harrogate, it will be interesting to see what we think AFTER the debate. This could be the subject of a whole blog post to analyse what gets said! Frankly, I think the discussion will be risky, no matter what. I'm sure there are some that could be a bit sensitive about it. I'm just really curious to see where these guys will take the discussion, and how poor Natasha Cooper's going to maintain the peace.
Hope she's getting paid well.
- 7:41 a.m.
- Gabriele C. said...
Sandra, that's a lot easier to read. Thanks.
Did you get tired of the old layout? Hehe, some women need new shoes (me, for example) others redecorate their blog. :-)
- 7:22 p.m.
- Sandra Ruttan said...
Yeah, sometimes, I just need to shake things up! But I like the format better too.
- 7:58 p.m.
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- 11:13 p.m.


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The association annually stages the "Kick-Off" event, an all-day celebration built around the start of the prep football season. It is the single-largest fundraiser of the year for the Pointer Association, with a goal of $12,000.
All funds raised go directly back to the school in various forms, last year totaling nearly $300,000 to offset some budgetary cuts and help PLHS students.
As part of school tradition, 2012 Pointer football teams will all make their debuts, with the freshman team playing at 10 a.m. and the junior varsity at
12:30 p.m. before the 3 p.m. varsity main event. All games are against Mar Vista High from Imperial Beach.
Athletes will also christen a new playing surface on Bennie Edens Field, adding to this year's festivities in Pete Ross Stadium.
PLHS parent and Pointer Association board member Maria Gibson is putting the community celebration together. Among the day's highlights will be:
• grilled hamburgers and hot dogs
• ice-cold sodas, water and sports drinks
• the first performance by the 2012 PLHS Vanguard band
• special halftime performances during all three games
• recognition of athletes in all fall sports at PLHS
• a "silent auction" for fabulous items and packages
School board member Scott Barnett will be on hand to help dedicate the school's new weight-room facility, which has already drawn raves from visitors. The ceremony after the varsity game will include public tours of the building.
All equipment came from a $90,000 "Champions Grant" from the Jimmie Johnson Foundation award two years ago after then-PLHS parents Lisa Tumbiolo and Ron Gemmill wrote the application. Senior class president Josh Morse made a video showing how a new weight room would benefit all students.
Guests are reminded the Voltaire Street entrance to Pete Ross Stadium will be closed.


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Page Title: ManageDirect® > Payroll Zero-Percent C of I Redemption Confirmation
What you can do on this page:
Your redemption request is complete. View your remaining Payroll Zero-Percent C of I security balance at the bottom of the page. Use the ManageDirect tab if you would like to redeem another security. You should print this page for your records.
HELPFUL HINT: You'll be given a confirmation number for each Payroll Zero-Percent C of I redemption. The first character will be "W" for Payroll Zero-Percent C of I Redemption. Each confirmation number will be sequentially designated and never repeated for each account number. Increments build from letters AAAA to numbers 9999 for each confirmation number.


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Guard Royal Ivey has returned to the Sixers, coach Doug Collins told reporters today.
The 6-4 Ivey played in 71 games with the Sixers in 2008-09, averaging 3 points per game in 12.1 minutes as a reserve. Ivey appeared in 26 games the following season before he was traded to Milwaukee in the deal that brought Jodie Meeks.
He spent the last two seasons with Oklahoma City, playing in 25 games two years ago and 34 games last season. He also appeared in five playoff games as the Thunder reached the NBA Finals this past season.
In eight seasons out of the University of Texas, Ivey, 31, has averaged 3.4 points, 1.1 rebounds and 1.1 assists.
Collins also announced that Kwame Brown passed his physical. The 30-year-old center will be joining his seventh NBA team since being selected with the No. 1 overall pick out of high school in 2001.


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YourKit is a technology leader, creator of the most innovative and intelligent tools for profiling Java & .NET applications. The YourKit Java Profiler has been already recognized by the IT professionals and analysts as the best profiling tool.
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Yolo CountyHome Sitemap Contact
Calendar of County Events
Winters - Walk N' Talk Book Club
Literary Trails
- Date: 01/03/2018 2:00 PM - 3:00 PM
- Location: Winters Community Library
708 Railroad Avenue
Winters, California 95694
Teens are welcome to join this program that combines critical thinking and social skills with physical exercise. Participants will discuss what books they are currently reading and the book of the month while walking around town for an hour.
No reservation is required and this event is free. The Winters Community Library is accessible for persons with disabilities. Program is sponsored by the Yolo County Library and the Winters Friends of the Library.
For more information, please call the Winters Community Library at: 530-795-4955, visit the Yolo County Library at www.yolocountylibrary.org or connect with us on Facebook at: www.facebook.com/yolocountylibrary.org.
We hope to see you there!


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Panagia Pantanassa
Panagia Pantanassa (Gr. 'The Most Holy Queen of All') is one of the many surnames given to the Virgin Mother and is the name of an icon and monastery.
Location of original
- Vatopaidi Monastery, Mount Athos
List of Pantanassa monasteries
- Monastery of Pantanassa (Mangrove Mountain, New South Wales), (Australia)
- Historical Mystras (Sparta/Laconia, Greece)
- Kranidi, 76km from Nafplio (Ermionida, Greece)
List of Pantanassa churches
- (Athens, Greece)
- (Patras, Greece), consecrated in 1859.
- Chora, Folegandros island (Cyclades, Greece)
- Seafront, Naxos island (Greece)
Categories > Arts
Categories > Church Life > Theotokonymia
Categories > Church Life > Theotokonymia > Icons of the Theotokos
Categories > Images > Icons
Categories > Liturgics > About Icons
Categories > Liturgics > Feasts
Categories > Places > Monasteries
Categories > Spirituality > Asceticism


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SOUND OFF: Nov. 8
There are more than 56,000 American GIs stationed in Germany and they are there for no good reason. Germany is completely capable of defending itself. So why are they there? They are there wasting money and giving it to the defense industry. If the government wants to make them useful, they should be brought home and placed along the Mexican border.
-- Berkley
My partner and I were in Georgia's Coney Island on Oct. 24 and, when we got ready to pay our bill, we were told that three young gentlemen who were in the back booth paid our bill. We did not get a chance to thank them, but we want to acknowledge them in the newspaper. We have no idea who they are or what their names are, but it was very thoughtful and nice of them to pay up our bill. We are senior citizens and we really appreciate it.
-- Rochester Hills
I had tickets to the Bill Maher concert at the Fox Theater on Sept. 27. Curtain time was 8 p.m. I got to the theater 45 minutes early. I found myself locked in baseball game frenzy, confusion and stupidity, and was misdirected to a $40 parking space. Like my friend said, it was truly a traffic cluster nightmare. After circling the blocks for at least 20 minutes looking for a parking space and realizing there was none, I returned home. Here is what I would like to know: How many empty seats were there at the Fox for the Bill Maher concert, and is he going to reschedule? And, lastly, I would like the address of the Tiger organization so I can bill them for the two $50 tickets I was unable to use because of baseball madness.
-- Auburn Hills


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Adding to the news is the fact that LogicMark is bringing aboard former Honeywell execs Ben Cornett, who will be the new CEO, and Kevin O'Connor, who will serve as president. Both formerly worked at Honeywell Security Group, as president and vice president of global sales, respectively. Most recently they have been involved with EZ Watch, another company in Chicago-based Gen3's portfolio. Cornett is still serving as CEO, while O'Connor has moved on full time to LogicMark.
"The PERS market is growing rapidly in both the durable medical equipment and security channels," O'Connor said. "We are excited to be involved with LogicMark and have the opportunity to work with some new customers in the DME market, as well as working with some old friends in the security market."
What are Cornett's views on the PERS world? I'll learn more in an interview with him this week, with a story to follow.
CSAA webinar: For anyone with a hole in his (or her) dance card Jan. 18, the CSAA has announced that it will be the new date for a webinar on "Social Media Marketing and Search Engine Optimization (SEO)." The online session will feature panelists Yvonne Grahovac of Alarm.com, and Richard Hahn of Bold Technologies. Register at https://www2.gotomeeting.com/register/164912682.
© 2018 United Publications Inc. ALL RIGHTS RESERVED.


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Relationship Details
Celebrity Biographies
Karrine Steffans hooked up with Eminem in 2003. Karrine Steffans is currently available.
Arts - Author
Why Famous: Confessions of a Video Vixen, memoir
Age: 55 (b. 8/24/1963)
Music - Rapper
Why Famous: The Marshall Mathers LP, album
Age: 46 (b. 10/17/1972)
Check out our New "Top 10 Worst Celebrity Husbands"
Relationship Timeline
|Start Date
|Hook Up
Children of this Relationship
No known children for this relationship. Add a child for this couple.
No known Affairs for this Relationship. Add an Affair
Check out our New "Top 10 Greatest Celebrity Studs"
Relationship Information, Quotes, and Trivia
Where and/or how did Karrine Steffans and Eminem meet?
Why did Karrine Steffans and Eminem break up?
Other Relationship Information about Karrine Steffans and Eminem:
Add other Relationship Information
Classic Quotes by Karrine Steffans and Eminem about their relationship:
Go To Karrine Steffans' Profile Go To Eminem's Profile


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People who cannot win arguments soon discover that a good tactic is to avoid debate by bullying potential opponents into silence. From imposing campus speech codes to protesting commencement speakers to passing laws that make it harder for others to speak out, this tactic has been deployed with great effectiveness in recent years.
Now, U.S. Senate Majority Leader Harry Reid, with the backing of Sen. Jeanne Shaheen, is taking it to its ultimate end point. He is pushing an amendment to the U.S. Constitution that would amend the First Amendment to allow the government to curtail citizens' speech.
The amendment, proposed by Sen. Mark Udall and co-sponsored by Shaheen, is almost five times as long as the First Amendment, which it would cripple.
It would give both Congress and the states the "power to regulate the raising and spending of money and in-kind equivalents" and "the amount of contributions to candidates" and "the amount of funds that may be spent by, in support of, or in opposition to such candidates" under the broad justification that such restrictions are to "advance the fundamental principle of political equality for all, and to protect the integrity of the legislative and electoral processes."
Orwell could not have written it better himself. In the name of protecting the people, the government would assume for itself the power to control the people's political participation.
The First Amendment states that "Congress shall make no law… abridging the freedom of speech, or of the press…." Udall's amendment states: "Nothing in this article shall be construed to grant Congress the power to abridge the freedom of the press." Notice the exclusion of the words "freedom of speech." That was not by accident.
Shaheen has signed on to a constitutional amendment designed to give government the power to regulate political speech by regulating the amount of money that can be raised and spent on it. If you think Congress would judiciously use this power only in public-spirited and high-minded ways, and only against the super-wealthy, you have not paid much attention to Congress.
The Foundation for Individual Rights in Education has documented 145 instances since 1987 of college commencement speakers who have been uninvited or protested or who have withdrawn their names from consideration under pressure, The Washington Post reported this week. Nearly 100 of those came in the last five years.
Last week the state Legislature passed a bill (SB 120) that would dramatically expand state power to regulate the activity of people who organize to participate in political campaigns. The impulse to silence other Americans is increasing.
This amendment is the ultimate realization of that impulse. It is the desired end result of everyone who would rather force an opponent to shut up than engage in an open debate.
It is, in a word, unAmerican. Shaheen should be ashamed for supporting it.


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New York: People with moderately elevated levels of arsenic in their urine may have an increased risk of kidney cancer -- particularly if they have high blood pressure and kidney disease, a new study suggests.
The findings, reported in the Journal of Urology, do not prove that arsenic contributes to kidney cancer, however. One possibility, the researchers say, is that kidney cancer, by impairing the kidneys` ability to filter waste from the body, leads to increased arsenic levels in the urine.
Arsenic is an element found in rock, soil, water and air. It is also released into the environment through industrial activities, and can be found in products like paints, dyes and fertilizers.
High arsenic exposure can lead to cancer. And some studies -- but not all -- have linked even moderately elevated levels of arsenic in the body to high blood pressure and type 2 diabetes.
But in general, the potential health effects of chronic, low-level arsenic exposure remain unclear.
In the new study, researchers in Taiwan looked at the relationship between urinary arsenic levels and the risk of kidney cancer among people living in an area with low arsenic concentrations in the drinking water.
Most lived in Taipei City, where arsenic in tap water ranges from undetectable to 4 micrograms per liter.
In the U.S., the Environmental Protection Agency (EPA) has set an allowable limit of 10 micrograms per liter, and most U.S. drinking-water supplies have levels well below that.
The study researchers recruited 132 patients with kidney cancer and compared them with 260 cancer-free adults the same age.
Overall, there was an association between higher urinary arsenic levels and higher odds of kidney cancer, according to Dr. Yu-Mei Hsueh of Taipei Medical University and colleagues.
But the connection appeared strongest for people who had high blood pressure or impaired kidney function -- both established risk factors for kidney cancer.
If study participants had both of those conditions plus relatively high arsenic levels, their odds of kidney cancer were six times higher than those of people with none of the three risk factors.
Those with any two of those risk factors, meanwhile, had a four-fold increase in risk for kidney cancer.
In all, 17 kidney cancer patients and 17 cancer-free participants had all three risk factors.
It`s possible, according to Hsueh`s team, that arsenic exposure led to high blood pressure or kidney disease in some people, which then contributed to their kidney cancer.
That is a possibility, agreed Dr. Anthony Smith, chief of urology at the University of Mexico in Albuquerque, who was not involved in the study.
On the other hand, impaired kidney function might allow for greater concentrations of arsenic to build up in the urine.
"I don`t think they really can tell from this study," Smith said in an interview.
He called the findings interesting, however, and said additional, larger studies to confirm or refute the results would be helpful.
"Arsenic exposure has been linked to a number of cancers -- bladder cancer, lung cancer, liver cancer," Smith noted. But it`s unclear whether the low drinking-water exposures of people in the current study -- and most Americans -- present a cancer risk.
"Right now, they think this level is safe," Smith said, referring to the EPA threshold. "But no one knows for sure. It`s still up in the air."
It is estimated that 13 million Americans live in areas where the public water supply exceeds the limit of 10 micrograms per liter. And unregulated private wells might also contain too much arsenic -- particularly in certain areas of the West, Midwest and New England where the groundwater contains high concentrations of the toxic chemical.
Experts suggest that people have private well water tested for arsenic. If the level exceeds 10 micrograms per liter, it can be treated with special filtration systems.
Worldwide, potentially dangerous arsenic levels in drinking water are major problem.
Researchers have estimated that about 140 million people around the world drink water with arsenic levels above 10 micrograms per liter. Bangladesh has been hardest hit, with millions being exposed to high levels of naturally occurring arsenic in well water.
Bureau Report


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New Mexicans are urgently calling for policy reforms. A robust education system, a stronger economy, health care that works, sensible water management, substance abuse prevention and long-term energy planning are among the priorities developed earlier this year at New Mexico First's Centennial Town Hall.
Many of those worries are echoed nationally. Our state dropped to 49th this year in the Casey Foundation's Kids Count Data Book — which tracks child well-being in economics, education, health and community.
On the business front, the Forbes 2012 list of the best states for business reported, "New Mexico took the biggest tumble, down 11 spots to number 43 as its current economic climate and growth prospects declined relative to the rest of the country."
The upcoming legislative session is an opportune time for the Legislature and executive branch to make bold changes that will improve the lives of New Mexicans. Drawing on consensus recommendations developed by 200 people at the March 2012 Centennial Town Hall, New Mexico First offers a platform of reforms.
WATER: 98 percent of town hall participants urged policymakers to advance a comprehensive, long-range strategy for surface and ground water. As an initial step, New Mexico First supports the Office of the State Engineer's funding request to update regional water plans.
WORKFORCE: 94 percent of town hall attendees urged increased collaboration between state agencies on workforce development and higher education, as well as training to qualify people for specific industries. One legislative strategy is the Job Training Incentive Program that offers job creators financial support to hire and train new employees.
SUBSTANCE ABUSE: 93 percent of participants called for more peer-to-peer substance abuse programs. New Mexico First urges the Departments of Health and Human Services to examine existing drug prevention programs, and, where possible, incorporate peer-to-peer programs. We also support the reinstatement of funding for peer education programming conducted by the Center on Alcoholism, Substance Abuse and Addiction.
ECONOMIC DEVELOPMENT: 92 percent of town hall attendees supported a statewide economic policy that is competitive with surrounding states for existing economic base industries (such as ag, tourism, energy, arts and technology). To advance these goals, New Mexico First supports increased tourism funding for advertising and marketing, corporate income tax reform and investment in the MainStreet program, which spurs rural business growth.
EARLY CHILDHOOD EDUCATION: 87 percent of participants supported the alignment and funding of a comprehensive, high quality, early childhood education system. As a result, New Mexico First supports continuation of home visiting services, Pre-K and the K-3 plus program that offers an additional 25 instructional days of school.
ELEMENTARY EDUCATION: 81 percent of town hall attendees supported the identification of practices in other states that have brought 4th grade reading levels up to national standards. We recommend continued research into why other states were able to improve their 4th grade reading proficiency when New Mexico did not.
HEALTH CARE: 81 percent of participants wanted health care equity and access without regard to income, race or ethnicity, geographic location, or health status. Given that New Mexico is among the lowest in the nation for percentage of citizens with health insurance, we recommend that New Mexico accept federal dollars to expand Medicaid under the Affordable Care Act.
It is clear that New Mexicans want policymakers to work together to get things done. Let us all set partisanship aside to improve the lives of New Mexicans.
New Mexico First is a nonpartisan organization that engages citizens in public policy. The 2012 Centennial Town Hall implementation process is led by Toney Anaya, former democratic governor; Edward Lujan, former chair of the Republican Party of New Mexico; and Heather Balas, president of New Mexico First.


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Your tween daughter is begging to take a weekly yoga class with her friends. Should you steer her toward a sport instead?
Parent advice
(from our panel of staff contributors)
Once you've checked it out, I'd say let her go for it. As the parent of a girl this age, I think they can benefit from learning anything that increases their focus and ability to calm themselves, which I've found to be one of the great, lasting benefits of yoga. And while team sports are great, I think it's important to promote physical activities that kids can still be doing at age 80. Like yoga.
I would think the benefits of yoga would outweigh those of most other activities. Even if your daughter is interested only because her friends are and she's just following the pack, something might click, and she'll become involved in a body/mind practice that she can benefit from long after she'll have lost the ability to kick a soccer ball.
Teaching children about the mind/body connection, breathing and stretching can have lifelong benefits. Plus there's a fitness component, and it's a great stress reliever. Also, the noncompetitive nature of it can improve self-esteem in kids more than a team sport. And what tween couldn't use a bit of self-esteem?
Expert advice
Adolescence is actually a prime time for yoga, says Paula Walker, yoga instructor at Miami-based Green Monkey yoga studios, which partners with schools to offer children's yoga classes.
"Self-confidence, self-esteem and self-respect are the three most important things for preteen girls to develop as their bodies are changing," Walker says. "Yoga teaches them to become very in touch with their bodies from the inside out."
The breathing techniques, spiritual teachings and mindfulness meditations that accompany the stretches and other physically taxing parts of yoga classes can give tweens the tools they need to navigate any number of stressful situations.
"It teaches you to calm down your nervous system," Walker says. "You learn to calm down your anxiety and panic modes so when you're 13 and you're facing a big test or pressure from the outside world, you can control your breathing and think more clearly."
A few other benefits for tweens, Walker says:
Nutrition awareness: "Yoga becomes a lifestyle that permeates the rest of your life. So when you leave yoga, you're not going to want to go eat at McDonald's. You start to choose all kinds of healthier ways to live."
Connectedness: "It builds a sense of belonging and community with the other people in your class. And preteens can take adult classes, so it's something that moms and daughters and sisters can all do together."
Crossover: "Yoga makes you more flexible and strengthens your core. So if you do ballet or gymnastics, it's a great add-on. If you swim, if you do any other sport, it's going to elevate your skill set."
Posture: "It makes you sit up straighter and roll your shoulder blades back and just be more mindful of your posture." Just in time for prom photos.
Have a solution? Your spouse wants to break up every fight between your kids. You want them to work out their own differences. Who's right? Email us at email@example.com. Find "The Parent 'Hood" page on Facebook, where you can post your parenting questions and offer tips and solutions for others to try.


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Kelcy Quarles, D.J. Swearinger look to give Gamecocks their fourth straight victory against Clemson on Saturday.
South Carolina defensive tackle Kelcy Quarles kept peace in the family residence and avoided any annual house-divided discourse this time of year by choosing to attend his father's alma mater.
Quarles, a 6-foot-4, 286-pound sophomore from Greenwood, received his first recruiting offer from nearby Clemson, but after one season at Fork Union Military Academy decided to follow in dad Buddy's footsteps. Buddy played at USC under Joe Morrison from 1984-87.
"When the recruiting process started my dad always told me he didn't really care what school I went to, but I knew in the back of my mind if I did go to Clemson it would be a big thing in my family and a big thing in the media and everything," Quarles said during USC's weekly press conference.
"I knew in my heart and knew in his heart what he really wanted me to do so I just went with my gut and where I wanted to be. If I'd gone to Clemson my dad and everybody would've been proud of me, but it would be a real big thing in my family."
His father went 2-1-1 against the Tigers in his four seasons and doesn't say much to his son regarding the rivalry. Then again, he really doesn't have to.
"He just tells me every day to go get it done and bring back the win," Quarles said. "Clemson isn't far from Greenwood and they offered me (a scholarship) and this has been a big game in my family for a long time. It's very, very important and vital that we get this one done."
The former Shrine Bowler is tied for ninth on the team with 36 tackles and tied for third with seven for loss despite missing two games. He's been fired up for Saturday's rivalry since arriving early Monday to watch additional film of Clemson's last victory over North Carolina State.
"Every day I wake up I think about this game," Quarles said. "I've never played (in Death Valley) after they moved the (high school) state championship game from there. Just to step out there for the first time I know I'm going to be out of my mind going crazy and have to just try and control myself."
One player who has plenty of experience with the madness of the rivalry and has won in Death Valley is another Greenwood product in senior safety D.J. Swearinger. A win would give this USC senior class a record-tying fourth consecutive against the Tigers, something that was done once from 1951-54. Only four times in history has USC won three straight in the rivalry with the last coming from 1968-70.
"The word is indescribable," Swearinger said. "To beat these guys four years in-a-row would be a tremendous honor and 20 years from now we could look back on that and we're ready to make history.
"It's a game people have been waiting for all year so there's going to be a lot of trash talk. It makes it more exciting because you want to make plays and you want to make the other team look bad."
Swearinger, who is second on the team behind Shaq Wilson with 65 tackles, including a team-best 50 solo stops, is arguably the team's best NFL draft prospect but right now the focus is on the rivalry and revenge. The former Shrine Bowler was also offered by Clemson albeit very late in the recruiting process. It would also be a long offseason at home even suffering one career loss to the Tigers.
He estimates the fans in his hometown to be "75 percent to 25, Clemson" adding "there are Clemson flags and orange paws everywhere in Greenwood, but there are a lot of South Carolina fans also.
"This game is very motivating. (Clemson) didn't offer me until about three weeks before signing day so this is a personal game for me being from 30 minutes down the road. I take it as motivation every year and little more this year being a senior."


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The new Lisbeth goes to Stockholm
It's Rooney Mara, the girl who beat everyone to become The Girl With The Dragon Tattoo. In Stockholm yesterday preparing for the role. She's supposed to speak with a Swedish accent. So I guess she's starting to practise.
I can see it a little, I guess, in her face – that wounded animal expression about her, a reticence in her eyes, the look of a forever child. But Lisbeth's vulnerability was well hidden, not only by her physical embellishments – the tats, the piercings, the dark makeup – but also in her attitude: this Lisbeth has yet to grow into the kind of fierce aggression that can only come from years and years of scar tissue reopened over and over again.
I saw faces like these every day working at Covenant House Vancouver. Most people think street kids are just lazy and don't want to do chores. Most street kids are running from abuse – when they come at you with their squeegees on the street corner looking smug and punky, it's not because they're genuinely smug and punky, it's because that's the kind of armour they need to stay alive.
This is part of the reason Lisbeth's story resonates on so many levels with so many people. It's a compelling narrative, sure, but she's really just a street kid who like so many other street kids got f-cked over by the people who were supposed to protect her.
Noomi Rapace played this very convincingly. Can Rooney Mara?
Also attached – Noomi in Venice for the premiere of Raavanan.
Click here to catch up on the Covenant House Vancouver blog for real life stories from our youth. Right now, we are in need of jeans as the weather is turning and our kids are inadequately dressed for the wet and the chill.
Photos from Wenn.com and Splashnewsonline.com


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Style # 222732
AVAILABILITY: Unavailable for immediate shipment.
Open Neck Blouse is rated out of 5 by 6.
Rated 5 out of 5 by BebeDiva from Super top! Love this top, fits well in the front and back with not too much extra fabric in the back (which I hate!) Very sweet looking on and can wear with anything. I got the L and it fits perfect. Great with leggings that have design at the waist or any fancy jeans where the glitz can show!. Sleeves are also a good length.
Date published: 2014-10-20
Rated 5 out of 5 by Licho99 from Top Elegant ,and Perfect material for summer lve it how fit
Date published: 2014-04-13
Rated 5 out of 5 by brina from so very pretty it a beautiful shirt, I got In black to match the crackle pants I got too. looks amazing on. I usually wear a medium but had to get it Large just because it don't strech and it was tight around my upper arms. the large fit perfect.
Date published: 2013-10-16
Rated 5 out of 5 by SpirytSista from So Elegant I ordered this in Black, and i just love it. It is stylish, yet very forgiving (for those days when you just need to hide the belly, lol) It is such an elegant piece.
Date published: 2013-10-04
Rated 5 out of 5 by Nicky18 from Loved it!` I love this top! Is so trendy but classic. I received so many compliments on it.
Date published: 2013-10-03
Rated 5 out of 5 by BebeBeauty03 from Beautiful Top! Just received this top in the mail and I am in love with it! I ordered the bleached aqua and its a very lovely color :) I do recommend this top so get it while it lasts!
Date published: 2013-09-16


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Gulf fishing group are treated to rare Whale Shark sighting
A group fishing in the Gulf of Mexico has been treated to a rare sighting of the world's largest fish species.
The crew fishing off the coast of Tampa, Fla., managed to catch the serene, spotted beauty – a whale shark -- on video as it swam by their boat about 40 miles from Anna Maria island.
Tracey Gardner whipped out her iPhone to record the giant. Whale sharks have been known to reach more than 40 feet in length and almost 50,000 pounds in weight.
The three couples on the boat are heard exclaiming, "Wow," on the video, amazed by the size of the mammoth creature.
"We could have touched it," Beverly Higgins told the Sarasota Herald-Tribune, adding that the whale shark seemed longer than their 26-foot boat.
Whale shark sightings are highly unusual. Many scuba divers spend their whole careers hoping for one.
Whale sharks are known as gentle filter fish and are generally found in tropical and warm oceans, sometimes living to age 70.
As well as being the world's largest fish species, whale sharks are by far the largest living non-mammalian vertebrate, rivaling many of the largest dinosaurs in weight.


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"I feel like if I go through this life and don't make a difference, it is a life wasted," Sedig said last week during a stopover in Moab.
He dropped out of college and spent a year figuring out what to do with his life. Then, he remembered a story about a man who had traveled to the 48 continental U.S. states in 48 weeks to volunteer his time in whatever way was needed. Sedig decided to do the same.
"I already knew the head of Child Reach, and I contacted the man from the story to find out more about what he had done," Sedig said. "I want to start my own non-profit in the future, and this seemed like a good start to see what is out there already and get a name out there for the type of work I want to do."
At 21, Sedig packed his bags and headed out to volunteer his time for a week at a time in each of the 48 contiguous U.S. states. Along the way, he is also raising money for Child Reach USA.
He started in Wisconsin and headed north, looping through the Pacific Northwest, down the western coastline, and back through the West before stopping in his hometown of Morrison, Ill., for a brief break on his way to the East Coast.
"I thought I had a basic plan, but as I go, things are working out differently. The fundraising efforts have been great," Sedig said. "I had a big fundraising event in my hometown before I left, and along the way, people have just basically been donating money to me."
Utah is the 15th state on Sedig's journey. Throughout the first 14 states he has volunteered weeding or landscaping, picking up trash, teaching English to refugees, working with Habitat for Humanity, herding cattle in Montana, and serving as a shuttle to the Grand Canyon for international visitors. In preparation for Moab, he called the National Park Service to see what sort of work he could do in this region.
"They didn't have much set up that I could do because of the timeframe and paperwork involved, but they did give me recommendations on who to contact in the community," he said.
Sedig was given Sara Melnicoff's name and joined her to help out with Moab Solutions, a local organization that provides green job training for the homeless in the community and works to keep Mill Creek Parkway clean of recycling and trash.
"I think what he is doing is pretty cool," Melnicoff said. "I am amazed at how young he is, and doing what he is doing. He is an impressive young man."
Sedig also had the opportunity to work with the Moab-based Community Rebuilds for two days. He helped the group work on a current home rebuild on 200 East and the group provided him with a place to stay while in Moab. He also did trail work in Negro Bill Canyon along state Route 128.
His family has mixed feelings about what he is doing, Sedig said. But they are proud of him for doing something worthwhile with his life.
"I'm looking forward to seeing a familiar face. It isn't as easy being on the road as I thought," Sedig said. "I'm trying to keep my expenses low, so I've been sleeping in my car a lot. But people have been very friendly and have offered assistance when they could."
To donate to Sedig's cause, offer assistance or a volunteer opportunity, or to find out more about Childreach USA, visit www.childreachusa.org/48states.


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FDA Clinical Trials and the Regulatory Process
A look at how initiatives being implemented by the FDA affect clinical investigation of contact lenses.
|Dr. Lippman is vice president of Ophthalmic Product Regulatory Affairs for R.P. Chiacchierini & Associates, LLC, Statistical & Regulatory Consulting, Rockville, Md. He is former director, Division of Ophthalmic Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration from 1984 to 1993. He has been consulting in regulatory affairs and clinical trials to the ophthalmic device industry for the past 19 years. He is also a consultant or advisor to Bausch + Lomb, Vistakon, CooperVision, and SynergEyes. You can reach him at email@example.com.
By Richard E. Lippman, OD, FAAO
The regulation of medical devices in the United States is codified by law and interpreted and implemented by the Code of Federal Regulations. The Medical Device Amendments were promulgated in 1976 when Congress split off devices from drugs and created a separate Center for Medical Devices. Implementation of the device regulations was further defined by specific product guidelines written to address the scientific needs and requirements for each product group. These guidelines were developed in the United States Food and Drug Administration (FDA) ophthalmic division and were further enhanced by input from industry groups and the Ophthalmic Devices Panel experts who met periodically to review applications submitted to the FDA for approval. The guidelines are intended to outline the scope of preclinical and clinical tests needed to determine device safety and efficacy.
Recently, the agency has published new Guidance relating to its initiative to improve the quality of clinical trials used to support both Premarket Approvals (PMAs) and 510(k) clearances.
While this Guidance restates much of what has transpired in regulatory clinical study design in recent memory, it provides a comprehensive review of the nature of clinical investigations and the impact that good clinical design and statistical planning have on medical device approvals. These initiatives come on the heels of changes brought about by Congress regarding the medical device program as well as the introduction of drug study design models brought over from the Center for Drug Evaluation at the FDA.
This article describes many of the initiatives being implemented by the FDA regarding clinical investigation of medical devices and, more specifically, how these initiatives relate to clinical studies of contact lenses.
Medical Device Classification
Medical devices are classified into three specific classes: Class I—general controls, Class II—special controls and substantial equivalence to a predicate device on the market since May 1976, and Class III—premarket approval. All devices are initially assigned a Class II designation until further classified by classification panels. All contact lenses were initially placed into Class III under that paradigm. In 1994, daily wear contact lenses were down-classified to Class II, but extended wear continued to be regulated as premarket approval in Class III. The classification of a given device usually determines what type of clinical investigations are required to support an application. Clinical trial requirements for extended wear contact lens indications far exceed those for a daily wear approval.
Regulatory Clinical Trials
For each regulatory classification, clinical studies take different approaches. Product-specific Guidance provides the means to determine what kind of clinical study is necessary to support a given submission. For daily wear contact lenses, most studies are required to support a 60- patient completion profile of three-months duration for a new daily wear product to demonstrate substantial equivalence to a predicate contact lens already cleared for marketing. This sample size is approximate, and is to be divided into test and control arms, usually in a 2:1 ratio, test lens to a known control lens. To complete a full cohort of 60 subjects, it is often necessary to enroll an additional 15 percent of the proposed sample to cover eventual dropouts and discontinuations over the course of the clinical trial.
Extended wear clinical trials are subject to a greater regulatory demand that includes a required minimum of one year (or more) of follow up with a sample population of at least 400 completed subjects, also divided into test and control arms. Safety concerns for prolonged overnight use defines the rationale for a more closely watched investigational period. Whether the material is polyHEMA or silicone hydrogel (SiHy), the indication for use governs the nature and length of the trial necessary to establish safe and effective determination.
Because new lens materials (SiHy) have been developed over the past 10 years, general clinical guidance rules, while still applicable, have demanded larger cohorts to establish more comprehensive reporting and understanding of the unique characteristics of these materials. Material characteristics of SiHy lenses that are unfamiliar to the agency—and not yet identified into lens groupings—have created an environment in which clinical study requirements are greater in terms of size and duration. Additional specialized testing may include endothelial cell studies, contrast sensitivity analysis, near-point visual analysis, topographic studies, etc., and have been employed in certain circumstances. While daily wear studies remain limited in scope at a 90-day follow-up period, extended wear cohorts of a one-year follow-up period are often saddled with longer-term postapproval follow up of three years on new and novel materials. The FDA has imposed post-market study requirements for this broader group of SiHy materials in the extended wear indication.
Studies are being designed with increased attention to statistical design to better define the study objectives and their outcomes. The early SiHy lens studies included much higher populations compared to that stated in the Guidance Document for Extended Wear Contact Lenses. These early studies included some 800 to 1,100 subjects in their respective protocols. Outcome measures were modeled to demonstrate target outcomes. In general, for targets that are not achieved, additional steps must be taken to demonstrate a safe and effective product. This is still true for new material studies today. Target outcomes have more of a drug model design compared to what has been used traditionally for medical device studies.
One reason for the increase in study size as indicated above has been the challenge of defining the lens groups under which SiHy lenses fall due to unique material properties. There is currently no consensus for identifying SiHy group characteristics, leaving the industry to identify individual material characteristics and to test and validate their specific material profile. This has given rise to a level of regulatory discomfort regarding potential safety and effectiveness with these products. Until now, each new material has been defined as its own group, unlike traditional polyHEMA lenses, which are defined into one of four group categories based on water content and ionic/non-ionic surface characteristics (Tables 1 and 2). The effort to define lens groups for SiHy lenses continues to evolve and will be better defined once the FDA and consultants reach consensus regarding the more generalized material characteristics and predictability as to material behavior.
Classic FDA Soft Hydrophilic Contact Lens Groupings
|Group 1
|Group 2
|Group 3
|Group 4
|Low Water (<50% H2O) Non Ionic
|High Water (≥50% H2O) Non-Ionic
|Low Water (<50% H2O) Ionic
|High Water (≥50% H2O) Ionic
|Hefilcon C
|Ocufilcon B
|Omafilcon A
|Deltafilcon A
|Ocufilcon C
|Hioxyfilcon A
|Bufilcon A
|Ocufilcon D
|Tetrafilcon A
|Hilfilcon B
|Bufilcon A
|Hefilcon A
|Alphafilcon A
|Phemfilcon A
|Hefilcon B
|Lidofilcon A
|Methafilcon A
|Hioxyfilcon A
|Hilafilcon A
|Methafilcon B
|Vasurfilcon A
|Vilfilcon A
|Surfilcon A
|Etafilcon A
|Lidofilcon B
|Ocufilcon F
|Ocufilcon E
|Perfilcon A
Clinical Study Categories/Valid Scientific Evidence
The FDA divides clinical investigations into two categories: significant risk and non-significant risk. Significant risk includes investigations of medical devices for which serious safety concerns, such as the potential for life threatening and/or sight threatening conditions, may be present. The corollary is nonsignificant risk device investigation, in which major concerns for catastrophic events are diminished. For example, daily wear contact lenses are defined under the non-significant risk category whereas extended wear is considered as significant risk.
The regulatory determinations associated with significant versus non-significant risk are defined in the Code of Federal Regulations (21CFR 812) regarding investigational device exemptions for conducted clinical trials. For daily wear studies, the non-significant risk designation allows the conduct of studies under the abbreviated rules, while extended wear requires the submission of an Investigational Device Exemption (IDE) application directly to the agency. While Institutional Review Board approval is required for either daily wear or extended wear studies, the abbreviated IDE does not require submission to the agency for prior approval before starting a clinical investigation, whereas an IDE approval is necessary to commence an extended wear study. These distinctions often govern the approach that an industry sponsor will take to introduce a new product in the effort to gain market clearance sooner than would otherwise occur (i.e., daily versus extended wear). Nevertheless, sponsors are encouraged to approach the agency prior to the start of any study for early collaboration and input with the intention of avoiding potential problems in study design.
Premarket Approval and Valid Scientific Evidence
For PMAs, the statutory definition of evidence provided in the Food, Drug, and Cosmetic Act is: reasonable assurance of safety and effectiveness. Interpreted, that means that safety and effectiveness of a device are to be determined:
• With respect to the persons for whose use the device is represented or intended,
• With respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and
• Weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.
Further, by regulation, "…the valid scientific evidence used to determine the safety of a device shall adequately demonstrate the absence of unreasonable risk of illness or injury associated with the use of the device for its intended uses and conditions of use."
For 510(k) type studies, clinical performance and determination of substantial equivalence to a known predicate device determines a successful outcome for regulatory purposes.
Regardless of the class to which a study is assigned, the regulation applied to valid scientific evidence (21CFR860.7(c)(2)) states that it is gained from well-controlled clinical investigations, partially controlled studies, studies without matched controls, or well-documented case histories by qualified experts among other ancillary activities. It is not very often that the FDA has accepted historical controls as valid scientific evidence because of the propensity for anecdotal evidence and because the potential bias of data as reported in published literature does not match well with regulatory study designs. The FDA has thwarted the use of meta-analyses from peer-reviewed literature in support of 510(k)/PMA applications for those very reasons.
A claim is an assertion of truth about a product. Claims associated with a given device often dictate the clinical endpoints or measurements that indicate device success or failure. In contact lens studies, claims are more often ignored in favor of defining a safe and effective product. After initial studies and approvals are obtained, sponsors may come back and conduct further studies to support specific claims such as increased comfort, better water retention, superior oxygenation, and more.
Studies should define the principal study variables that demonstrate the performance of the device. These are defined as the primary and secondary clinical endpoints. They are further defined as the definition of the study objective. These endpoints should be pre-specified in the final clinical protocol and are further divided into safety and effectiveness endpoints.
Study designs should do the following:
• Characterize the clinical effects of the device (both safety and effectiveness) for the intended use.
• Describe what endpoints or outcomes are being measured, when they are being measured, and how they will be analyzed statistically.
• Be clinically relevant to the stated study objectives.
• Specify who will evaluate and analyze the study data. An independent team of analysts who have no proprietary interest in the study at hand is recommended.
• Be evaluated for specific claims such as lens deposit resistance (which should be evaluated by independent reading centers and be pre-defined in the study protocol).
• Provide patient surveys for use when the outcome of interest is measured from the subject's perspective (e.g., lens comfort).
• Provide scientific rationale when more than one primary or safety endpoint is desired by explaining the role and importance of each endpoint.
Safety Endpoints Primary safety endpoints in contact lens studies are identified by permanent loss of two or more lines of Snellen visual acuity. A percentage of subjects such as 1 percent or more who have lost two or more lines of Snellen acuity is often cause for concern and may impact the study outcome. An additional primary safety outcome would be associated with serious adverse reactions related to visual acuity loss as well as accompanying slit lamp findings and other associated observations.
Secondary safety endpoints are characterized through slit lamp findings by which in a standard clinical grading scale of 0 to 4, grades 3 to 4 are considered serious endpoint concerns for safety. Symptoms, problems, and complaints as well as additional safety-related observations including keratometric changes and adverse reactions that are deemed as serious or complicated all play a part in the safety analysis of a contact lens investigation.
Effectiveness Endpoints A primary effectiveness endpoint is defined as the percentage of subjects with best-corrected contact lens visual acuity of 20/25 and 20/20 or better. Wearing time can also be defined in this category. Additional secondary effectiveness endpoints can include lens comfort over time, symptoms of dryness with the lens for the recommended wearing time, etc.
A new area of interest in contact lens usage is myopia control in children. Recent journal articles and public discourse have expressed the desire to use contact lenses in specific lens designs, including aspheric and reverse geometry as well as other unique peripheral defocus curves, as a means to demonstrate a reduction in the progression of myopia. The effectiveness measure in these clinical outcome studies is the rate of change as compared to a control group in a parallel study format that does not wear the same lens design profile. These studies are currently being defined, and their time durations for follow-up periods are hotly debated.
Bias in Clinical Studies
Studies are designed to minimize the effect of bias— or the introduction of systematic errors. Bias may be reduced in the following ways:
• Careful inclusion and exclusion criteria.
• Use of diverse populations including age, gender, race, and ethnicity.
• Masking investigators, patients, and monitors as to the intervention.
• Coding of test and control lenses.
• Employing randomization.
Sample Size Determination
For regulatory clinical contact lens studies, sample size has been pre-determined by prior Guidance and is addressed above. All studies are comparative to a known control lens. Larger studies lend themselves to better statistical grounding while shorter studies provide for a clinical impression through summary statistics.
Sample size is more often determined by study purpose and material uniqueness—to demonstrate substantial equivalence to a known predicate device, or to demonstrate safety and effectiveness as in extended wear. Newer-generation silicone hydrogel lenses with no defined predicates often need larger sample cohorts to better illustrate their unique clinical characteristics.
Soft Silicone Hydrogel Lens Listings
|Scientific Name
|Water Content
|Balafilcon A
|Comfilcon A
|Enfilcon A
|Efrofilcon A
|Galyfilcon A
|Lotrafilcon A
|Lotrafilcon B
|Narafilcon A
|Narafilcon B
|Senofilcon A
|• Lenses are not associated with any consolidated lens groups.
• Lenses are listed by lens Dk and water content.
• Dk and water content do not relate directly as compared to HEMA-based hydrogel lens groups.
• Additional factors that complicate classification of silicone hydrogel lenses into lens groups include but are not limited to surface characteristics, modulus, and other HEMA-derivative combinations such as additives and cross-linkers.
• Chemistry composition for each material's principal monomers is unique to that material, presently precluding a viable lens grouping system consolidation, which is the main reason why the FDA has required clinical trial investigations for each new silicone hydrogel contact lens.
Clinical Outcome Studies—Types of Study Designs
Most contact lens studies are designed as clinical outcome studies. Subjects are assigned to either the test lens or to a control lens and at scheduled follow-up visits are examined for various objective and subjective observations including best-corrected visual acuity, slit lamp analysis, subjective symptoms, problems and complaints, keratometry or topographic analysis, corneal thickness (pachymetry) evaluation, and wearing time. Safety analysis includes monitoring for adverse events, both serious (corneal ulcers/bacterial keratitis, iritis, central infiltrates, permanent loss of Snellen visual acuity of two or more lines) and significant (peripheral infiltrates, superficial punctate keratitis, abrasions, hyperemia, conjunctivitis, etc.). Special clinical protocols such as for orthokeratology, for example, include analysis of refractive change over time, stability of change, and regression of visual acuity during the course of the study in addition to the customary clinical study parameters discussed above. Recent open discussion of myopia control is a relatively new area of interest that will be closely evaluated in the coming years.
All study observations are cross-referenced to associated clinical findings and how they relate to a specific finding so as not to miss anything that may be associated with a particular clinical observation.
For example, how adverse events may be related to slit lamp findings, visual acuity loss, symptoms, etc., are evaluated in the analysis process. These kinds of analyses often provide information relating to a contact lens fitting characteristic, lens design issue, lens material compatibility, and other clinical or manufacturing concerns.
Each of these analyses is compared to an active control that is reported in a parallel fashion, upon which the data is compared for outcomes in all subsections of the study.
Types of Comparative Study Designs
There are three types of comparative study designs:
Parallel Group Design Each subject is assigned to only one intervention, and comparisons are made between subjects in each study group. Randomization assures an equal footing between subgroups. These designs are most common in standard contact lens regulatory study plans.
Paired Design Each subject receives both the test and control interventions. For example, one eye receives the test device, the opposing fellow eye receives the control device. Randomization and investigator masking help to reduce inadvertent bias being introduced into the study.
This design assures that every subject is exposed to each device (lens) whereas in parallel designs, variability may exist between subjects that confound observations among the enrollees.
Cross-Over Design A design in which all subjects receive two interventions at different times. One group of patients receives the test lens and the second group receives the control lens. At some point in time, these are reversed. A wash-out period between the change-over is provided to minimize residual effects from the initial lens usage. There is a stronger statistical basis for designs of this nature, which is useful when subtle differences are suspected between the test and control lens.
Controls Used in Contact Lens Studies
Controls used in clinical studies and how they relate to studies of contact lenses include:
Active Concurrent Control The most common type of control used in contact lens studies is the active control—a lens of relatively comparative features and indication for use. Ideally the lenses are similar in material design and indication, although that is not always possible.
Historical Control This type of control involves comparisons of test devices to known predicate devices for which the data has been derived from published peer-reviewed literature or another form of validated study. The FDA has difficulty in accepting this form of control lens because much if not all of published literature bears little resemblance to that of a standardized clinical format for regulatory purposes. Meta analyses from these kinds of studies provide only loose associations to real-time clinical study designs and are therefore prone to poolability challenges for purposes of regulatory trials. Historical controls most often do not meet the agency's definition of valid scientific evidence as defined under 21CFR 860.7.
Placebo Controls This type of control design has no place in contact lens studies. It is more appropriately used in accessory lens product studies such as in comfort drop solution studies.
No Control This design has been useful in situations such as corneal overnight swelling studies in which one of the test arms is no intervention. This provides the opportunity for a baseline comparison when compared to a test lens of unknown characteristics and a control lens with known swelling profiles.
The design has little use in prospective studies of new contact lens materials in which the only viable test would be against a known entity such as comparative contact lens.
Regulatory clinical studies are specifically defined, limited to clearly identified objectives and well described endpoints, and are highly accountable. These studies are made to support safety and efficacy for market clearances or approvals licensed by the FDA. Most studies follow well established Guidance published by the agency and follow good clinical practice regulations and international clinical harmonization guidelines.
Daily and extended wear contact lens regulatory studies have evolved over many years, but are constantly being scrutinized for best clinical practices in an ever-changing clinical environment. This has been evident with the development of more sophisticated contact lens materials and will be subject to further modifications as even newer materials come into the marketplace.
For silicone hydrogel lenses for which no group class has been defined, it is anticipated that each new material being advanced will be considered as unique, making the demands for clinical trials of these materials more burdensome to sponsors. CLS
To obtain references for this article, please visit http://www.clspectrum.com/references.asp and click on document #202.