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Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions
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|Drug: Clarithromycin 250mg/5mL
|Study Type:
|Study Design:
|Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|Official Title:
|An Open Label, Balanced, Randomised, Two-Treatment, Four-Period, Two- Sequence, Single-Dose, Crossover Fully Replicated, Bioavailability Study on Clarithromycin Formulations Comparing Clarithromycin 250 mg/5 mL Powder for Oral Suspension of Ranbaxy Laboratories With Biaxin® Granules 250 mg/5 mL Oral Suspension in Healthy, Adult,Human, Male Subjects Under Fed Conditions.
- Bioequivalence
|Estimated Enrollment:
|Study Start Date:
|September 2005
|Study Completion Date:
|December 2005
|Primary Completion Date:
|October 2005 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: 1
clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories
|Drug: Clarithromycin 250mg/5mL
Active Comparator: 2
Biaxin® granules 250 mg/5 mL oral suspension
|Drug: Clarithromycin 250mg/5mL
Detailed Description:
The study was conducted as an open label, balanced, randomised, two-treatment, four-period, two-sequence, single-dose, crossover fully replicated, bioavailability study on clarithromycin formulations comparing clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension in healthy, adult, human, male subjects under fed conditions
A single oral dose of clarithromycin 250 mg/5 mL was administered during each period under supervision of a trained Medical Officer.
During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology & biochemical parameters) were performed again at the end of the study.
|Ages Eligible for Study:
|18 Years to 45 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- Be in the age range of 18-45 years.
- Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Have voluntarily given written informed consent to participate in this study.
- Be of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
Exclusion Criteria:
- History of allergy to clarithromycin, erythromycin and related macrolides.
- History of severe diarrhoea within 2 weeks preceding Day 1 of this study.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
- Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- QTc interval beyond normal limits
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
- History of any psychiatric illness which may impair the ability to provide written informed consent.
- Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
- Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- A haemoglobin concentration of less than 7 % of lower limit of reference range e.g. 13 gm % for reference range of 14-18 gm at screening.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775372
|Ranbaxy Research Laboratories
|Gurgaon, Haryana, India
Additional Information:
|Responsible Party:
|Tausif Monif, Ranbaxy Research Laboratories
|ClinicalTrials.gov Identifier:
|NCT00775372 History of Changes
|Other Study ID Numbers:
|Study First Received:
|October 16, 2008
|Last Updated:
|October 17, 2008
Keywords provided by Ranbaxy Inc.:
Bioequivalence study of clarithromycin 250mg/5mL powdder
Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
ClinicalTrials.gov processed this record on September 19, 2017


text:
When play was finally halted due to darkness at 8.30 pm, the rain was pouring down again and only 25 of the 48 groups had completed their first rounds. The best clubhouse score was 77 and only four players managed to break 80.
On the course, three players shared the lead on one under par, but Hindhead's Leslie Bruckner, Royal Jersey's Trevor Gray and American Matthew Sughrue had all just made it through three holes.
Fortunately, the forecast is better for day two and play will resume at 7:00 am. The hope is to complete the 36 holes and the cut will reduce the field to the top 60 and ties for the final round on Friday.
Brady Exber, the defending champion from Las Vegas, completed nine holes in seven-over-par before play was stopped for the night.
"It was horrendous," said the 59-year-old winner at Ganton 12 months ago. "It was really a little too difficult for us oldies. I honestly had no idea what I shot out there."
He started reasonably with three straight pars but bogeyed the fifth and had double-bogeys at the fourth, eighth and ninth.
When the klaxon sounded, the leader in the clubhouse on six-over-par 77 was Irishman Tom Cleary. Holder of the Munster, Cork and Connaught Senior titles, the Cork golfer highlighted his round with an eagle at the long 12th and a birdie at the tenth.
"It was a tough old day out there," he admitted. "But I've played the course quite a few times, including at the Seniors Home Internationals a couple of years ago."
A shot behind was American John McClure, who finished tied for third last year. Playing alongside Cleary, he had a chance to share the lead, but dropped a shot at the 18th.
American Tom Schultz, who was first off the tee at 7:00 am, finally completed a 79 eight hours later. He had endured two stoppages – one for two and a half hours and another for 35 minutes – but he did manage a couple of birdies.
He would have been closer to par but ran up a double-bogey seven at the final hole, the par five 18th.
Schultz was almost relieved when the marathon was over. "I think there about five holes when conditions were reasonable and 13 when it was awful," he said. "The double-bogey wasn't a good way to finish.
"But at least it wasn't too cold. I come from Trinidad in Colorado and sometimes we play when it is really freezing."
Don Dubois, who is more accustomed to playing in the sunshine in his native California, was the fourth man to break 80.
American Paul Simson, a three-time former winner, was going along quite nicely in the terrible conditions, but hit the buffers at the end and signed for an 80, the same score as two-time former champion, Chip Lutz.
"I finished really poorly," Simson lamented after he had signed for an 80. "I lost a ball at the 16th and had a triple-bogey seven and also had a seven at the last."
The British Amateur, called the "Seniors
Amateur Championship" in the United Kingdom,
was launched by The R&A in 1969 to help select
a Great Britain & Ireland side to play in the
World Senior Amateur Team Championship.
Though the British Amateur, played for the first
time at Formby, was an instant success, the
team event did not survive beyond 1969. Charlie
Green has been the most successful player in
the history of the event, winning six times in
seven years beginning in 1988. Like the U.S.
Senior Amateur, players must be over the age of
55 to play. Notable courses played over the
years include Royal County Down, Royal
Portrush, Royal Aberdeen, and Walton Heath.
View Complete Tournament Information
View full results for British Senior Amateur Golf Championship
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subset: commoncrawl


text:
Movies & TV / Columns
A Bloody Good Time 04.19.12: The Top Ten Godzilla Monsters (That Aren't Godzilla)
Opening Logo courtesy of Benjamin J. Colón (Soul Exodus)
Welcome to A Bloody Good Time.
Last week I presented my choices for the best horror films in the public domain. There were some asking about some other films, and for those that missed it, They Live, The Invisible Man, Psycho and The Birds are all owned by Universal and Phantasm is still owned by MGM. If you see these on public domain sites, you should probably alert them that they are, in fact, not public domain, if you want that site to stick around. They Live in particular, a point of contention with one of you, just had a home video release from Universal in 2009 and they are working on a blu-ray.
I also asked about this week's topic, but if you're reading it you already know what we're getting to. Let's see the rest of the feedback first.
Bill Fn Murray wrote: You missed Francis Ford Coppola's Dementia 13 which went into public domain. Night of the Living Dead gave us the modern zombie. Coppola gave us the modern ax murderer. Dark, weird, and violent.
I didn't miss it, I just didn't care for it all that much. I can certainly see why others do, it just fell flat for me. Personal preference and all that. Love the direction and score, but the acting and pacing don't work for me.
AndrewCrow replied: I prefer the version of Nosferatu with the Type O Negative soundtrack, personally. There's just something about Peter Steele's (RIP) depressingly sardonic and menacingly beautiful croon that fits perfectly with the theme of the picture.
I don't think I've watched that one. There have been several different versions so I think I'll have to look this up this weekend.
Norvic said: Good list. Nosferatu is a brilliant piece of film making, and even today it is still really creepy – especially on the stairs and getting off the ship. The lighting and acting was just fantastic. And, as a (very) unofficial adaption of quite a complicated book it was actually one of the better ones that have been done over the years, including talkies.
Pretty much, yeah. It still holds up almost 100 years later, a lot more than some films five years ago do. There's a reason classic movies are classic movies.
AG Awesome: Wow, I was convinced you were going to have FREAKS on here somewhere! Very surprised. Nice list for the most part though.
I'm not 100% on this, but I'm fairly sure that Freaks is still owned by MGM. My only real evidence here is that it doesn't appear with the other PD movies of that era on the multi-film sets so I could be completely wrong.
Before I get going with this week, I would like to say that if you're a fan of horror and you haven't seen Cabin in the Woods, do so. Without even getting into the fact it's a really smart and funny film, every horror fan should be able to appreciate the insanity of that second half. Personally, I loved the Hellraiser references. Right now it's my favorite film of the year in any genre.
Now, let's talk about Godzilla. Actually, let's not talk about Godzilla. This week's list isn't about the Big G himself, because it would make things incredibly obvious and this list itself would be pointless just for a conclusion like that. If I made a top ten Godzilla monsters list that included Godzilla, of course he'd be #1! I'm pretty sure I'd be lynched by a mob of Toho enthusiasts if I said otherwise. So to make the list a little more unpredictable (I hope), this will be a top ten list of Godzilla's friends and enemies that have appeared in the series.
I will say that my picks tend to skew towards the Heisei series of films, so yours may vary if that's not your favorite line of Godzilla movies.
#10: Jet Jaguar
And there goes all of the fans, leaving in droves. Wait, come back! Jet Jaguar is considered a joke by some, but as a kid, I thought he was the coolest guy ever. Which is why he still makes this list at #10. He was made during the really kid-friendly era of the Godzilla films and he was supposed to make kids want to buy toys of him. It worked, because who the hell wouldn't want a man-sized robot that can grow gigantic and fight monsters. Unlike the T-Rex, you wouldn't have to worry about Jet Jaguar eating you!
It's sad that Jet Jaguar only appeared in Godzilla vs Megalon and nothing else. He was a cool robot and maybe could have helped Godzilla again. At the very least he could have showed up in Final Wars as a nod to the fans. He didn't even get his own series to star in, even though Godzilla vs Megalon was originally intended to be Jet Jaguar vs Megalon. To all those who hate him, I present the best possible defense for this guy. His music:
#9: Rodan
Rodan's one of the oldest of Toho's monsters, appearing just two years after Godzilla did, in his own film no less. He's fought Godzilla, and he's fought with Godzilla. Rodan first appears to fight Godzilla, but is convinced by Mothra to work with him against Ghidorah. This caused both monsters to turn good, as before this Godzilla had been the bad guy. But considering how evil and destructive Ghidorah is, someone would have to turn good to save the world.
He's a mutated pteradon and has all sorts of neat abilities. He's got spikes on his chest, he can fly at supersonic speeds and can let out sonic booms or hurricane winds. He may just look like a flying nuisance to the untrained eye, but Rodan would not have lasted this long if he couldn't hold his own. Fire Rodan's even cooler, as he's stronger and can fire a heat beam from his mouth, among other things.
#8: SpaceGodzilla
At first glance, SpaceGodzilla is just regular Godzilla, but from space. But that makes sense, because he likely came from Godzilla's cells, either through Mothra or Biollante going into space. Not only does this crystal-shouldered behemoth have most of Godzilla's own abilities, but he can fly and control gravity. He can also create crystals that come out of the grown to charge his powers and can be used as projectile weapons.
This is where my Heisei bias starts to come into focus because to most fans, there's no real reason why SpaceGodzilla should rank. He only appears in one film and is soundly defeated by Godzilla. But he did provide Godzilla with a tough opponent while he was alive, and is one of the monsters that is pure evil. He only exists to kill Godzilla. He even kidnaps his offspring at one point! He's a worthy adversary that will hopefully make appearances in the future.
#7: Mothra
There is no other monster on this list that can make the claim of being the Guardian of Earth, but Mothra can. Mothra has never been portrayed as evil, at least from what I've seen, and the only reason she ever attacks Tokyo is because of some evil businessman decided to keep her twin messengers. She was just trying to get what was hers back. From then on she's been portrayed as a force for good and usually either teams with Godzilla or fights him, depending on which side he's on at the time.
Since Mothra is a giant moth, she also has a larvae stage with two twin caterpillars. The insects are babies, but still able to fight on their own and have actually defeated Godzilla before. The larvae have a better success rate against Godzilla than Mothra does, because she's actually been killed by him twice. Mothra is also the monster to turn Godzilla good for the first time, as pointed out above. She makes this list not because she's good, but because she wins so much. She has one of the highest win rates of any of the Toho monsters!
#6: Biollante
Here's another monster from the Heisei series that for some reason never made another appearance. I find this odd considering Biollante not only defeated Godzilla, but took off afterwards and left the character available for more appearances. It's not often that Godzilla is defeated and doesn't at least get a rematch against the foe to prove himself. But that happened with Biollante.
Like SpaceGodzilla, this creature was made with tissue samples from Godzilla after he destroyed Tokyo. He used his daughter's DNA, combined with plants and Godzilla's DNA to unknowingly create this bizarre monstrosity. Godzilla actually defeated the early rose form of Biollante, only for the more evil-looking version to spring forth and smack him around for daring to rise against her. It's not every day you get a monster that can actually eat Godzilla, as the poster for this film showed the creature attempting to do.
#5: King Kong
This is for Toho's version of Kong, because otherwise he'd probably be much higher. Kong is another monster to defeat Godzilla and then go his own way, but at least he would return in his own Toho films, even if he never crossed paths with Godzilla again. King Kong in the Toho films is able to conduct electricity (and is also immune to it) and he stands much much taller than any American version of the beast.
He also has the attributes that an ape would, such as the strength and ability to grab and throw things. This helps when he's launching giant boulders at his opponent. Godzilla's not even the only monster that Kong faces, as before that colossal fight he makes a giant octopus run away. Kong, like Godzilla would become later, is a force of nature with no real allegiance one way or another. He's just an animal. So the Japanese government decides that instead of letting him destroy Tokyo, they'll put him in the path of the (at the time) evil Godzilla and let them finish each other off.
#4: Destoroyah
Just look at this thing. If we were ranking this list on looks alone, Destoroyah would be #1. Thie creature just looks like it could seriously mess any of these other monsters up, and it does almost kill Godzilla in what was to be the final film of the Heisei series and Godzilla's final film for four years, when the Millennium series began. Destoroyah is one of the strongest villains Godzilla's ever faced, and that's why he's ranked as high as he was. Really, if it wasn't for the Japan Self-Defense Forces and The Super X-III, Destoroyah may have ended up killing Godzilla, who was already suffering from a meltdown.
Destoroyah has several different forms over the course of his movie. He has his crab form, which when exposed to the same Oxygen Destroyer that killed the original Godzilla, turn him into a series of grotesque monsters. The Juvenile form is man sized, and there were several of them, killing many humans in the streets. They threw themselves together and created a new form, before turning into a flying form and then finally the power plant irradiated version you see above. There's no doubt that this monster had what it took to take down Godzilla if he didn't have help.
#3: Gigan
Gigan has all the tools necessary to defeat any monster, because he was built that way. The creature is not only a cyborg, but an alien cyborg and comes equipped with a buzzsaw chest and giant hooks for hands, as well as eye beams and the ability to fly. Gigan can also teleport (in the games), fire grappling cables and razor discs. And that's before he gets chainsaw arms in Final Wars. There's not many of Godzilla's foes that are as dangerous as Gigan. Unlike Destoroyah, he also has the advantage of making several appearances in the film series.
Gigan made his first appearance in Godzilla vs Gigan, where he teamed with King Ghidorah against Godzilla and Anguirus. I'm still not sure how Anguirus was able to help defeat the pair, because Anguirus generally sucks. But when he was teamed with Megalon in the next movie, only another robot in Jet Jaguar could stop him. Yeah, Jet Jaguar defeated Gigan. Don't ever question him being on this list. Final Wars is when the monster was at his most powerful, which is probably why he's at #3. If it were just his earlier appearances, his defeats even when teamed with powerful allies may have knocked him off.
#2: Mechagodzilla
If we're talking about mechanized beings that fight Godzilla, you can't go wrong with Godzilla's robotic counterpart. When this creation first appeared, it was actually wearing a disguise to make everyone believe Godzilla had become evil again. Of course Anguirus tried to stop him, but then Anguirus got his jaw broken and had to run away. Only Godzilla himself could stop this threat, and even then he needed…King Caesar. Okay let's just strike that from the record, it makes everyone look bad.
Mechagodzilla appeared in five Godzilla films, and he wasn't always a force for evil. In the Millennium series, he was called Kiyru and was a force for good against an evil Godzilla, harboring a skeleton of the original Godzilla inside. He was also designed by the government in the Heisei series to destroy monsters as well. These versions tend to be more popular with some fans. I could list all of Mechagodzilla's powers, but it would take a long, long time. He's had various tools and gadgets over the course of the series. Missiles, laser beams, shock cables, plasma grenades, this thing has it all.
#1: King Ghidorah
Three heads, gold skin, the strongest and most prevalent of all of Godzilla's enemies. Ghidorah is a monster so powerful that in Destroy All Monsters it took ten monsters to defeat him, including Big G. No other monster on this list can claim that. Sure, some of the monsters happened to be Anguirus, and minor threats like Kumonga, but it counts! Ghidorah comes from space, like Gigan, but he's way more powerful. He's appeared in six Godzilla films, not including Keizer Ghidorah in Final Wars.
Why is this monster so awesome? Could it be the fact that he's a three-headed golden dragon? Could it be the fact he shoots lightning from his mouths? The answer is yes. Ghidorah is the ultimate Godzilla villain and it usually takes more than one monster to defeat him. If you do manage to defeat him, good luck because he'll probably come back stronger or with an ally. My favorite version is the Heisei version, because then we get Mecha-Ghidorah. Two dragon heads, one robot head, lots of destruction.
That's it for me. Which monster is your favorite? Leave some comments here on or my Twitter. Next week sees the actual release of The Raven, so I'm finally doing the Poe column. See you then.
Closing Logo courtesy of Kyle Morton (get your own custom artwork and commissions at his Etsy account)
A Bloody Good Time: The Store is now officially open! Like this design? You can now find it on most of my merchandise! Click here to find shirts, posters and more!


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The big three auto CEOs Bob "Big Bob" Nardelli, Alan "Leavin' On A Jet Plane" Mulally, and our personal favorite Rick "The Station" Wagoner are apparently going to drive to Washington to beg for your money. Previously, they all flew on private jets.
Auto CEOs Promise To Ditch The Private Jets And Drive To Washington
By December 3, 2008


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Who knew I'd be making home goods? I sure didn't. It dawned on me when I was making a wholesale catalog that I had enough products for that new category (Mason Jar Sleeves already in production and releasing soon). Granted, I didn't really plan for any of this to actually happen, but now I've got a bunch of products in the store and even more in works in the shop. It's been really exciting.
In the spirit of making things I need in my own life, I decided to create some W&F coasters and a trivet. Great for saving furniture from drips and scorches, and also look nice too. I agonized over what design to stamp on them, and after trying out lots of objects and looks, I settled on a simple pattern of tiny crosses.
Coasters come in packs of four and the trivets are sold singularly. They're made with the same English bridle leather that I've been using on the Camp Stools – a beautiful example that is tanned here in the US. Cut, stamped and burnished in our Portland shop.


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The Obama administration has unveiled new fuel economy and emissions rules for light duty vehicles. The Environmental Protection Agency and National Highway Traffic Safety Administration guidelines cover model years 2017-2025 and begin the formal rule-making process of the agreement in principle announced in July. The standard will be open for additional public comment for 60 days.
"Americans can breathe easier. The win-win car and light truck standards proposed by the Administration today mean cleaner air and better protection for wildlife and America's natural resource heritage, while taking major steps forward for America's energy and economic security," said Joe Mendelson, director of global warming policy for the National Wildlife Federation. "These deep oil savings give us the freedom to choose the foreign and domestic energy projects that best protect America's economy, security, land and wildlife for our children's future, while clean innovative auto manufacturing is building US jobs and cutting pollution."
The proposed standards will nearly double fuel economy and deeply cut carbon pollution for America's cars and light trucks through 2025. Taking the recently enacted 2012 and 2014 car and heavy truck standards together with the 2017-2025 proposal, new, clean and advanced cars and trucks will cut US oil consumption by 3.4 million barrels a day. That's more oil than we get from all of the Persian Gulf and Venezuela and more than three times the capacity of the controversial Keystone XL Pipeline project delayed last week.
Improved fuel economy means car and truck owners will individually save thousands over the life of their vehicles, and America as a whole will save tens of billions of dollars per year. The proposal for the next phase of the Light Duty National Program follows a framework released in July that garnered the support of industry, labor, and consumer groups.
"This is a win-win-win scenario. We look forward to strong final enactment of the standard in 2012 to secure these gains for all Americans," said Mendelson. "The proposal, which would meet both fuel economy and carbon pollution requirements under the Clean Air Act, shows that America can still come together around innovation, prosperity, security and natural resource protection."
Learn more about how fuel efficiency rules can benefit consumers in NWF's recent Trucks That Work report.
Oil and Gas Methane Pollution Report


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Queensland Coalition
- Ian Macdonald and Barry O'Sullivan: are these Coalition senators the rudest men in Australia?Sydney Morning Herald
- QSenator adopts Sky Muster watching briefqueenslandcountrylife.com.au
- Stuart Robert's latest disgrace adds to case for corruption law reformtheage.com.auChina , Dubai , Middle East , Australia , Queensland
- Land-clearing laws' failure jeopardises climate change targets, says ministerThe Guardian
- CMoore / Safe in the certainty of political fearcitynews.com.auTownsville , Syria , Nice , Normandy , France
- Analysis: Scott Morrison just wants you to like himSydney Morning Herald
- LNP asks for a fiver to 'fight unions'brisbanetimes.com.au
- Liberal leadership: Malcolm Turnbull 'could save' some Queensland MPsSydney Morning Herald
- Coalition to decide on same-sex marriage vote within fortnight, says Tony AbbottSydney Morning Herald
- Malcolm Turnbull and Christopher Pyne only government frontbenchers to turn up for same-sex marriage billSydney Morning Herald
- SMarriage equality bill introduced to Parliament as Prime Minister prevaricates on "people's vote"starobserver.com.auAustralia , The Prime , Australia , Sydney , Queensland
- SQueensland Coalition MP responds to criticisms of marriage equality electorate pollstarobserver.com.au
- Liberal MP's bizarre indiscretionnews.com.au
- Numbers inside Liberal Party swing in favour of marriage equality as email campaign hots upSydney Morning Herald
- Same-sex marriage debate to reignite in Federal ParliamentSydney Morning Herald
- Meet the new Whip, Scott BuchholzSydney Morning Herald
- View from the Street: Hockey prepares for our zombie healthcare apocalypseSydney Morning Herald
- Medical marijuana legalisation 'closer'brisbanetimes.com.au
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|RAIN AND WET ROCK The sandstone in Red Rocks is fragile and is very easily damaged when it is wet. MORE INFO >>>
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|These routes are actually pretty good. Nice place to get out of the wind. Sort of slabby, but with good rock. The anchor atop the two routes on the right is a bit funky (perhaps more than a bit)---it's kind of like rapping off a coral reef.


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Is the guy's ankle broken? He hasn't even had a limited practice designation since after the Dolphins game in week 2.
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Is the guy's ankle broken? He hasn't even had a limited practice designation since after the Dolphins game in week 2.
Could be a high ankle sprain. Those usually take a couple of months to heal.
Treatment Options
The goals of treatment are to have the tibia and fibula located in the correct position with respect to each other and to heal in that position. It is very important to note that these injuries can take a lot longer than typical ankle sprains to heal. In the absence of a broken bone, the treatment immediately following the injury is to rest the leg, ice for 20 minutes every two to three hours, provide gentle compression in the form of an Ace wrap, and elevate the leg with the toes above the nose. The patient will commonly have enough tenderness that they need a CAM Walker boot (removable walking boot). Aggressive therapy when weight bearing is possible is very important. This includes strengthening those tendons on the outside of the ankle called the peroneals and doing proprioception (teaching a patient to feel how the ankle is positioned and moves).
It usually takes six weeks or more to return to play, but can sometimes take even longer. One good indication that a person is ready to go back to sports is if they can hop on the foot 15 times. This type of treatment is acceptable if there is no obvious widening between the tibia and the fibula on the x-rays. If there is widening, which is called "diastasis," or if there is an ankle fracture (broken bone) in the same setting, surgery is often needed. There is debate as to how to properly fix these injuries, but the idea is to put the fibula and tibia back together and hold them with either screws or new devices that contain a suture, which is the same type of material used to close wounds.
As mentioned above, the recovery for high ankle sprains can take considerably longer than typical ankle sprains. In fact, it can take six to seven weeks before athletes return to play. In those cases in which a separation of the tibia and fibula or fracture has occurred and surgery is necessary, patients will likely need to be nonweightbearing in a cast followed by a walking boot for about 12 weeks. It is important to do early range of motion passively, meaning with the help of a therapist that moves the ankle, so as to avoid stiffness. The screws are commonly taken out in a second, small surgery before full weightbearing is allowed so they will not break.
Just because you're offended, doesn't mean you're right. ― Ricky Gervais.
Jamaal Tinsley version 2.0
Loved watching him play when he was not injured......which sadly wasnt often
As I said on the other thread
Wells tweeted earlier today that it is a high ankle sprain.
Just because you're offended, doesn't mean you're right. ― Ricky Gervais.
...and he should be back for the game @ San Diego according to Chuck.
and he's not playing against San Diego. This is getting old.
It's a high ankle sprain, it takes time to heal
Don't ask Marvin Harrison what he did during the bye week. "Batman never told where the Bat Cave is," he explained.
I don't think you can compare a legitimate injury to Tinsely's Pacer issues (regardless of what it was called on paper).
Nuntius was right for a while. I was wrong for a while. But ultimately I was right and Frank Vogel has been let go.
"A player who makes a team great is more valuable than a great player. Losing yourself in the group, for the good of the group, thats teamwork."
-John Wooden
regardlesa, my point was i loved Landry when he was healthy. Which was not often.
it was the same thing in Washington. Get used to it Colts fans
08 and Beyond
If its a high ankle sprains then it doesn't shock me at all that his out, he should no doubt be ready vs Denver though, or else I will be worried about how serious it is
Honestly I already wrote him off as out for the season you think I'm exaggerating but I really don't trust teams being honest with injuries.
We've had bad luck with the health of our 2013 free agent signings:
- Donald Thomas out for season
- Ahmad Bradshaw out for season
- LaRon Landry has only played two games so far
- Ricky Jean Francois has only played three games so far
I'm assuming you have never dealt with a high ankle sprain before? This isn't out of the ordinary for this type of injury at all, he will be back for the Denver game, if not, then be worried
We are. His name is Bob Sanders
Don't ask Marvin Harrison what he did during the bye week. "Batman never told where the Bat Cave is," he explained.
No I haven't but that's not really what I was referring to its really Laron Landry in general he is a steroid user(one that we know of anyways) so him not being durable is no surprise I mean the Redskins have made a lot of stupid decisions but dumping him wasn't one of them.
I just won't be surprised when it turns out he's not coming back for the season. The Colts have done well in his absence that I don't miss him .
Will it last? Who knows.
now, I will agree that LaRon is absolutely jacked when it comes to muscle, but to say he is a definite steroid user is not true, could he be using them? Definitely, but we don't know for sure, and obviously it hasn't showed up on the steroid test yet. You can get that big naturally without the use of steroids, some people just have the genetics to be big, which obviously LaRon has. A high ankle sprain is an injury that can usually take 3-4 weeks to heal, and this will be his fourth straight game that he missed, so nothing out of the ordinary here, now like I said, if he misses next week too, then I would be worried
I was referring to his stint on the Redskins it came out he used PEDs
you sure? by no means would it surprise me, I think Sanders was on roids too, but he's never been suspended.
I dont remember it ever coming out that he used PED's, but I could be wrong
I just remember hearing about it but maybe the Redskins fans will be able to clarify and I wouldn't be surprised about Bob would explain why he also could never stay healthy
Course I might be thinking of Santana Moss here
Last edited by Basketball Fan; 10-14-2013 at 12:27 AM.
Have not read every post in here, but since I saw the roid question. It was often rumored, but never confirmed (there were "leaks" that we found legit, but never verification from the NFL)
These were pictures that came out when Laron really blew up:
Just to confirm, the NFL never confirmed he failed a PED test. Now I am not sure what the process is (do they announce the first failed test?) but to the best of my knoweldlge he never failed a test as a Redskins publicly.
EDIT: you are thinking of Santana Moss and HGH. Though I do not think (but I could be wrong) that he was ever suspended
holy ****. no, thats not natural.


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Report: Cowboys fear Bryant's injury could be serious
Marcas Grant | Tags: Three and out, Aaron Rodgers, Atlanta Falcons, Dallas Cowboys, Dez Bryant, Green Bay Packers, Matt Flynn, Roddy White, Seneca Wallace
Bryant could have herniated disc: Dallas Cowboys star wideout Dez Bryant missed Wednesday's practice with a back injury. While Bryant returned in limited fashion for Thursday's workouts, there are reports that the team fears the issue could be serious. For his part, the receiver says emphatically that he'll play on Sunday against the Saints. If he's in the lineup for the Cowboys, he should be in fantasy lineups — unless more serious information is revealed. However, it's worth keeping an eye on Bryant to see if this in any way hinders his effectiveness this week.
White says he'll play: According to Roddy White, he'll be back on the field for the Atlanta Falcons this week against the Seattle Seahawks. White has struggled with injuries for most of the season, missing the first three games of his career. His absences, coupled with the loss of Julio Jones have had a distinct impact on quarterback Matt Ryan, despite the emergence of Harry Douglas. Even if White is back this week, his matchup isn't a good one against the Seahawks, who excel at slowing down some of the league's bigger receivers.
Flynn to work out for Packers: The whispers were there from the moment Aaron Rodgers left Monday night's game with an injury — could Matt Flynn return to Green Bay? While the Packers passed on a chance to claim Flynn off waivers, there are reports that the journeyman will work out for his former team. Flynn, famously, threw six touchdown passes in a late season game for the Pack in 2011 and signed a large contract with the Seahawks the next year. Since then, he's been passed over for starting jobs in favor of Russell Wilson and Terrelle Pryor. In the short term, it will be Seneca Wallace starting under center for Green Bay, but Packers quarterbacks have a favorable fantasy playoff schedule. But Flynn, who has played for more teams (3) than he has thrown TD passes (1) in the past two seasons, seems the ideal choice to take you to a fantasy championship.
— Follow Marcas on Twitter @MarcasG


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The all-stars game was one of the first events held during North Creek and the Town of Johnsburg's Independence Day Celebration.
The Town of Johnsburg held Fourth of July festivities that ended with a fireworks display at Ski Bowl Park on Saturday, July 7.
Beginning at 12:30 p.m., there was an all-star baseball game between yellow and blue teams that were made up from a mix of five Warrensburg teams, as well as the Gore and North Creek teams. The blue team won with a score of 17-10.
A number of vendors provided food and refreshments.
The Pack 36 Cub Scouts served hamburgers, sausage and peppers, hotdogs and other fare.
Phil Wilson, the co-owner of Pete's Ahh — the pizza place located on Main Street in North Creek — had a booth and enjoyed a busy day. He said that this was one of their busiest days and the only event they do outside of the restaurant. His wife, Gail, said they were busier earlier in the day than they were last year, and based on the past year's demand they had brought more pizza and added a variety of finger foods to their offerings.
Marc and Cheryl Kenyon, owners of Adirondack Maple Farm, operated a cotton candy stand. Marc explained that they use maple sugar from their farm to create the unique cotton candy they were selling. The Kenyons said they had been busy all day. Their niece, Jordan, who had been helping out, sighed and added, "Busy isn't the word!"
The dunking booth was one of the most popular entertainments at the park.
"Kids have been at it all day," said Kyle Mulligan of the Johnsburg Volunteer Fire Company.
The nearby air-filled bounce houses and slides also drew a steady crowd. Mulligan added that apart from 20 minutes of light rain, the weather had been great throughout the day despite worries about thunderstorms. In fact, due to the heat, the town decided to use one of Gore Mountain's snow making tower guns to provide a jet of cold water and mist for people to cool down in and children to play through.
The bands Decadence, Fingerdiddle, The Willy Play More Band, and Avalanche provided live music throughout the day.
"It's been awesome, couldn't be better, and it's great for the town," said Brett Darrow, lead vocalist for Avalanche.
Mike Sutfin, Avalanche's bass player agreed.
"The food's great, and everyone has been helpful and nice," Sutfin said.
At about 9:15 p.m., the fireworks show sponsored by Braley & Noxon began. It featured a variety of fireworks and lasted around 40 minutes. One young boy said, "It was amazing! I kept thinking the show was over because I didn't think they could top what they just did!"
The Independence Day celebration was sponsored by the town of Johnsburg.
Raffle winners
A number of items were raffled for the event. Braley & Noxon raffled a girls and boys Huffy bicycle, which were won by Nicole Clark and Martin Dunn, respectively. Several items were raffled by Adirondack Tri-County Nursing and Rehabilitation Center. The winners and items for their raffle were:
•Christy Rosick won the 21" MTD Self-Propelled Lawn Mower.
•Greg Fish won the 18" STIHL MS250 Chain Saw.
•Tina Schmidt won the 10 Ft. Perception Kayak
•Tiney Perry won the CHAR-BROIL 4 Burner Grill with Side Burner.
•Taylor Lawler won the 2012-2013 Rafting Trip for Two by North Creek Rafting and Co.
•Starla Utley won the picnic table made by Windy Baker
•Pete Haslestad won the STIHL F545 25 cc. 2 Cycle Curved Shaft Gas Trimmer.


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Using Prospects, search:Leisure, sport and tourism
Alternatively, search careers information via:BASES - British Association of Sport and Exercise Sciences
www.bases.org.uk/- British Association of Sport and Exercise Scienceswww.cimspa.co.uk/ - Chartered Institute for the management of sport & physical activity.
http://sportwales.org.uk/ - Sport Wales.www.uksport.gov.uk/ - UK Sport.
www.bluedome.co.uk/ -
Information on sport qualifications and jobs.Cardiff Met Sport - Children's sport, facilitated by Cardiff School of Sport.www.kingswoodjobs.co.uk/ -Activity holiday centre in England and
North Wales.www.lakesideymca.co.uk/ - Lakeside, the YMCA national
outdoor centre.www.outdoorjac.co.uk/ - Adventure industry jobs and training
courses.www.outdoorstaff.co.uk/ - Opportunities for
Instructors in the
outdoor adventure industry. www.pgl.co.uk/ - School trip, adventure holidays and group
residential courses.www.robinwood.co.uk/jobs/ - Adventure and problem-solving
activities for young people.www.seasonal-jobs.com/ - Jobs in health, leisure and sport.www.seasonworkers.com/ - The working and travel website UK and abroad.www.supercamps.co.uk/ - Variety of outdoor activity opportunities.
See also: Working Abroad


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Star and Staret jewelry was originally produced by the Star Novelty Company, Inc of Chicago. The company began making costume pieces marked "Star" in 1925 -1940. The company changed its name to "Staret" in the 1940's. Known for exuberant design and exceptional use of enameling and high quality rhinestones. The company ceased operations in 1947.
This fantastic creation, circa 1940's, is gold plating over pot metal. Oval in shape, it measures 3 1/2" in length and 2" in width. Set with a multitude of baguette, marquise and chaton rhinestones of various sizes in beautiful pastel shades of pink, blue, lavender, green and clear. The condition is excellent vintage with no missing rhinestones and very little metal wear. Lots and lots of sparkle; you will be the center of attention.
A varied selection of ANTIQUE & VINTAGE ITEMS for all tastes and budgets.
It's never too early to think CHRISTMAS. Shop early from a great selection for those SPECIAL PEOPLE on your list.


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Russian Town So Cold Boiling Water Instantly Turns To Snow! [Video]
Ya'll…YA'LL! There's cold, and there's holy snikees it's too cold to even function outside! Check out this video taken in a Russian town where it's -41 degrees. This guy boils a pot of water and tosses it outside his window. It's so cold, it's immediately turn to snow!
Subscribe to 97.3 The Dawg on


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First, a word about wattage:
Confused about how to pick a heater best suited for your room? You can figure it out following these easy steps: The first step is calculating the British Thermal Units (BTU's) the heater generates. You'll need to know the wattage of the heater (all heaters on our site specify wattage) and multiply the wattage by 3.41. This will give you the number of BTU's. Incidentally, almost all heaters have a maximum wattage of 1500, usually resulting in 5120 BTU's. The next step is determining the number of BTU's you will need to actually do the job you want. This can be done by multiplying the square footage of the room by the difference in the beginning and desired temperatures. This will give you the BTU's needed to heat the room to your desired temperature.
BTU=(Desired Temp - Starting Temp) x Square Footage of Room
If this number is lower than the BTU rating of the heater, then the heater will do the job just fine. But if the number you calculate is higher than the rating of the heater then you may need an additional heater. It is also important to keep in mind that this is based on a perfect environment, and does not take variables into consideration like insulation, outside temp, windows, drafts, ceiling height, etc.
Heater Features:
There are many different models of space heaters from which to choose, with varying features for your needs. See the following list of features to better help you choose the space heater best suited for your needs:
Safety Features:
When considering a heater, safety concerns are paramount. Space heaters, while extremely practical and useful, can be dangerous when not used properly. Some heaters contain a tip-over switch, which automatically shuts the heater off when tipped over, either forwards or backwards. Another common safety feature is overheat protection, which prevents the unit from overheating and doing damage to itself or the surrounding environment. A "cool to the touch" option is also a fairly common and useful safety feature which ensures that the outer casing of the heater remains cool even when the unit is running.
Convection vs. Radiant:
There are two main types of space heaters: Convection and Radiant. Radiant heaters provide quick and focused heating. A radiant heater is more of a personal heater than a convection heater because it heats you directly, as opposed to indirectly heating the air around you. Because of this, radiant heaters are much more energy efficient, running at a lower wattage than traditional heaters.
Most space heaters on the market today use convection heat. Convection heaters function by pulling air over a heated surface. The heat that convection heaters generate is non-directional, which makes them a good choice for whole-room heating, or for rooms with multiple people. Convection heaters are ideal for quickly warming and maintaining warmth within a room or area. The heating coils running through the heater draw cool air into the unit through natural convection. Most models have two heat settings (low/high), and some models also have small built-in fans which aid in the circulation of the warm air. Convection heaters come in many different styles, including ceramic, fan-forced, and oil-filled radiators:
Now you're ready to start shopping for a Portable Space Heater!


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Monterey Peninsula business leaders are calling for a "slowdown" in spending on a proposed recycled water project until completion of source-water agreements and a firm cost.
Coalition of Peninsula Businesses co-chairman John Narigi said questions about whether source water is available, and about the eventual cost of the groundwater replenishment project, should be answered before more public money is spent on the proposal.
Narigi said the coalition is dissatisfied with answers it has received from the Monterey Regional Water Pollution Control Agency and believes the public should be given more information before the bill climbs too high.
"At the end of the day, this is all being paid by the ratepayers," he said.
Narigi, who serves on the advisory committee to the Peninsula mayors' water authority, said the coalition is opposed to a request by the agency for an additional $1.3 million for expanded environmental review work.
The request to the Monterey Peninsula Water Management District was on the board's agenda last week but was postponed until Feb. 13.
The water district and the pollution control agency have already spent about $4 million on the project, with the district providing about 75 percent of the money.
Agency general manager Keith Israel said more money is needed to address project issues raised by an independent review panel and the public.
The project would treat Peninsula and Salinas Valley wastewater and stormwater and convert them to potable water at a new treatment plant. The water would then be injected into the Seaside water basin for later use.
If completed on time, the project would provide added water as part of California American Water's planned Peninsula water supply project and allow a smaller desalination plant to be built.
Agreements 'the key'
Narigi said the coalition is concerned about a lack of progress on critical project elements, arguing the agency has had "plenty of time" to negotiate source-water agreements.
Narigi acknowledged the coalition prefers relying on a larger desal plant rather than recycled water. He said there's still much uncertainty about the latter proposal, and argued Cal Am should be allowed to go ahead with a larger plant and add recycled water later, if feasible.
Israel said the groundwater replenishment project offers many benefits, including lower environmental impact and energy demand, and it should be given a full chance to succeed.
He said there is still no source-water agreement, but he remains optimistic a deal can be reached with the county Water Resources Agency before the end of March — a deadline of sorts for an agreement that would avoid a potentially lengthy and expensive arbitration process.
The agencies have held confidential talks over the source water since last summer. The main sticking point appears to be disagreement over the rights of some Salinas Valley agricultural interests to treated Peninsula wastewater for irrigation from the pollution control agency's existing treatment plant.
The agency is required to have source-water agreements in place by the end of June, well in advance of December's hearings before the state Public Utilities Commission.
Israel said the agreements are "kind of the key" to the project's overall success. Reaching a deal would likely serve as a critical precursor for a range of recycled water opportunities in the drought-stricken area, he said.
"The drought has reminded us how vulnerable we are to Mother Nature," he said. "We're basically at a crisis point and we can't blink. (An agreement) may not be the perfect solution, but if we don't pull the trigger we won't get anything done. I think we're getting there."
David Chardavoyne, general manager of the water resources agency, declined to characterize any progress made in the private sessions, but agreed the goal is to avoid arbitration.
Chardavoyne said a meeting is being scheduled later this month between the two agencies' negotiators and representatives from the city of Salinas, the Peninsula water management district, the Marina Coast Water District and Salinas Valley growers.
Israel said he remains hopeful the project can stay on track for completion by the end of 2016, which coincides with the full implementation of a state-ordered cutback in pumping from the Carmel River. He said finishing the project by then would help the Peninsula's argument that it deserves a relaxation of the cutback order. Local officials agree they will need that because Cal Am's desal plant won't be online until mid-2018 at the earliest.
"It's going to be extremely tight to meet (the project) deadlines, but we're going to keep going full-speed ahead," he said. "I believe the state water board wants to see actual projects."
Israel has estimated the project's water would cost about $2,500 an acre-foot, but more accurate cost figures would be available after reaching source-water agreements and testing at a pilot plant.


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**HONEST REVIEW** Each individual is going to experience different levels of pain depending on both how sensitive their teeth are, and what kind of preparation they do. I got Zoom Teeth Whitening done by my dentist, who carefully explained the procedure to me beforehand, and about these "zingers". In order to prepare my teeth, she gave me a prescription for Duraphat 5000ppm Sodium Fluoride toothpaste which I was to use for about a week beforehand to help de-sensitise my teeth (not that they were sensitive before). I was also given a painkiller directly before we started. The actual procedure itself wasn't that bad a all. Like many of you I read all of these comments and went into the Dental Surgery almost dreading it as I did not want to be in as much pain as I had read everyone else was in. The first 15minutes were fine, no pain, no discomfort. The second 15minutes were ok too, got one or two very minor zingers which weren't really anything to write about. Ok so I was really not looking forward to the final 15minutes as this seemed to be the most painful. It was absolutely fine! In fact the little zingers in the 2nd 15minute stage were worse. So I completed the 3 sessions and the Dentist took out all of the stuff in my mouth and then showed me the results. My teeth were much whiter. I'm 24 years old and don't drink coffee or red wine so my teeth were quite white to begin with but after the treatment they still were noticably whiter, which I was really pleased about. When I left the Dental Surgery and went home, I did start to have zingers, however my Dentist had given me soothing gel to rub on my teeth, which helped. I just took another 2 painkillers and went to sleep, which I think is the best thing to do because when I woke up there was no pain and there were no zingers. Although I do want to state that when I was having zingers they were not the "ungodly, excruciating" pain that people are scaring you with on here. Bottom line is, it's not that bad, and certainly bearable. The results are good, and if you prepare your teeth beforehand by using the correct toothpaste (which your Dentist should be giving you prior to the treatment anyway) then you'll be fine and pleased with the results. I am now continuing to do the home treatment to keep them white. If you have any questions, please feel free to contact me
Very Pleased - Scotland, UK
**HONEST REVIEW** Each individual is going to...
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Archive for the 'Host Blogs' Category
12/29/13 Toccata Rundown
6:00 PM Franz Liszt Soirees Musicales (Rossini transcription Naxos 553961
WBJC Choral Hour 12-29-13
8:00 AM Joseph Haydn — Te Deum Key: C Conductor: Trevor Pinnock Ensemble: The English Concert and Chorus DG/Archiv, 423097 8:09 AM Sir Edward Elgar — The Music Makers Opus: 69 Conductor: Jaap van Zweden Ensemble: Netherlands Radio Philharmonic and Chorus Jane Irwin, mezzo-soprano Nederland, 200901 8:50 AM Edvard Grieg — Two Religious Choruses Conductor: […]
12/28/13 Vocalise Rundown
8:00 PM Johann Strauss II Emperor Waltz Op 437 Kaiserwalzer Philips 420246 COND Franz Bauer-Theussl ORCH Vienna State Opera Orchestra SOLO and Chorus SOLO Eva Lind, soprano 8:09 PM Johannes Brahms Neue Liebeslieder Walzer Op 65 Telarc 80326 COND Robert Shaw SOLO Robert Shaw Festival Singers SOLO John Wustman, piano SOLO Norman Mackenzie, piano 8:30 […]
1-9-14 Word On Wine Winter 2014!
Winter is here and there is no getting past it! Mary and I talk about what we like to drink In The Deep Mid-Winter! Let us know what you like during these freezing months.
1-2-14 Word On Wine Trends 2014
This week Mary and I discuss what trends might be taking place in the wine world during 2014! Check out the show and let us know what you think might be coming!
1-6-14 Word On Wine Review 2 American Favs!
This week Mary and I review two wines from the good old USA! 1)2010 Wildwood Pinot Noire from from Oregon. $15. Mary had this at Thanksgiving and was very impressed. It's hard to find good pinot at this price point so I say Mazel Tov! 2)2012 Dry Creek Fume Blanc from Sonoma County. This Sauvignon […]
12-30-13 Word On Wine Review 2 From Maryland!
This week Mary and I tasted two wines as part of the Winter Wine at Evergreen event sponsored by the Maryland Wineries Association. Kevin Atticks of the MWA was kind enough to let Mary and me sample a few wines and we are posting a quick review. Hope to see you at the event…see below […]
12-26-13 Word On Wine New Year's Resolutions for 2014!
This week Mary and I discuss our New Year's resolutions…I actually took care of my last year's resolution and finally had a wine rack installed in my Superstorm Sandy rebuilt basement! Nice to have those bottles off the floor. Click below to see what Mary and I are thinking about for this year. If you […]
12/22/13 – Toccata Rundown
6:25 PM Franz Liszt — Christmas Tree Suite Leslie Howard, piano Hyperion, 66388 6:18 PM Johann Sebastian Bach — In Dir ist Freude Marie-Claire Alain, organ Erato, 10703 6:16 PM Johann Sebastian Bach — Das alte Jahr vergangen ist Marie-Claire Alain, organ Erato, 10703 6:14 PM Johann Sebastian Bach — In Dulci […]
WBJC Choral Hour 12-22-13
8:00 AM Johann Sebastian Bach — Christmas Oratorio: Parts 1-3 Conductor: Philippe Herreweghe Ensemble: Collegium Vocale Barbara Schlick, soprano Michael Chance, countertenor Howard Crook, tenor Peter Kooy, bass Virgin, 90781


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A Man for All Seasons is a timeless exploration of politics, religion and power. Robert Bolt's classic drama is based on the fascinating true story of English Chancellor Sir Thomas More and his moral objection to King Henry VIII's plan to leave the Catholic Church. Starring Frank Langella. Directed by Doug Hughes.
Regular Schedule:
Tues at 8pm / Wed at 2pm and 8pm / Thur at 8pm / Fri at 8pm / Sat at 2pm and 8pm / Sun at 2pm
Thanksgiving Schedule:
Tues, Nov 25 at 8:00pm
Wed, Nov 26 at 2:00pm & 8:00pm
Thur, Nov 27 - DARK
Fri, Nov 28 at 8:00pm
Sat, Nov 29 at 2:00pm & 8:00pm
Sun, Nov 30 at 2:00pm


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It's the season of giving, and right now we're all spending a lot of time buying presents and getting dressed up for holiday parties. But there's a group of men and women amongst us who tirelessly put their lives on the line year round to give the rest of us a safe community. They're the San Francisco Guardian Angels, a band of volunteers who patrol city neighborhoods each weekend, looking for crime to stop, working with the police and acting as an extremely motivational tool for people stuck on the streets. We recently talked with Colonel Jerry "JD" Longoria about the work the San Francisco Guardian Angels do:
Who started the SF Chapter, and when?
It started in SF in 1984. It all began in New York in 1979 with founder Curtis Sliwa and then expanded to SF. The city officials initially didn't want us here. They thought we were vigilantes and that it would cost more problems than it was worth. But we just went ahead and did it anyway. In the beginning, we heard stories about Guardian Angels going out starting fights and carrying weapons. It got a bad reputation, but things changed. We got more experience, more training and we're more grown up.
How did you get involved?
I started in October 2002. You start out as just a trainee, just a rookie. The more you listen to the leaders, the better you get. The more you put in, the more you're going get out of it. You have to really know the areas you're going into, plan out your patrols, be organized, have a plan, and try to connect with community leaders, city leaders, and the police department. If you get along with them, they're going accept you into their neighborhoods.
What's the organization's manifesto, if it has one?
Our motto is "We Dare To Care." We do things that other people wouldn't even think of doing. Our goal is to help protect the community, make the community safer and give something back. I was a drug user, an alcoholic and now I'm giving something to help other people get off drugs and alcohol. I go to meetings and I talk to people and say "If I can change, anybody can change!" Being in this organization helps me to do that.
So the same goes for the whole team?
Well yeah, they either came from gangs, were ex-drug users, or were having problems. This organization and this chapter helps you make something positive of your life.
How many crimes have you stopped?
Well, we're not going out busting heads, doing arrests, drug busts or sting operations. We're more of a deterrent to crime. We've made citizens arrests, like if we see someone out in the open selling drugs, we're going to stop it. They can't disrespect us like that, because we're trying to abide by the law. If someone's smoking crack in front of us, in a non-violent way, we'll take the crack, put handcuffs on them, and call the police. We have a direct line to the police departments in the Mission and the Tenderloin.
Do you work with the police at all?
At night before we leave on patrol, we call the police department to check in, we let them know how many Angels are going out, what areas we'll patrol and how late we'll be out. It's not that we need to get their permission, it's just that we want to work together with them.
Do you report all the crime you see to the police?
Not really, because if we did, there'd be too many. If we see a crackhead and bust him on the street, we say "Hey, get into treatment, get off this, you're better than this." If we take a joint away from somebody and tell them to hit the road, that's too little to report to police. But if they've got rocks, that's a felony. It's got to be something major to get the police involved. We use our best judgment, and that comes with experience.
What are some of the craziest things you've seen?
Well, about a month ago, we were patrolling the Tenderloin. We walked up on these three guys who were smoking crack at one of the bus stops and we said "Hey, what you got in your hands?" One of them opened up his hands and he had four or five rocks, and we said "Hey, give us those right now!" But he put them in his mouth and swallowed them. All we could say was "Go to a clinic, go to a hospital, if you don't do something, you will get sick." He was so scared and so nervous he just left. We didn't have the rocks in our hands to call the police.
How do they usually react to you?
They know what we're about. Before, we would go into the Tenderloin but we weren't as organized, and drugs were really rampant. They would smoke right in front of us. It was so much worse before, but now once they see our red berets, they know what we're doing, what we're about, and they'll cool off for a while, and that enables the kids or the families to go to the corner stores, or walk their dogs.
The Mission District's totally different. You've got your organized gangs. The first corner we ever hit in the Mission was the 16th St. BART station. They've gotten really smart about it. Once they see us, they'll go underneath to the 24th St. BART station, and sell their drugs there. They try to outsmart us, but now we circle around, and we don't tell anybody where we'll be patrolling. It helps us be more secretive.
What are you thinking when you're on patrol? Are you ever scared?
Nope, never. I stay focused, and I tell my guys to stay focused. And the more focused you are, the safer you'll be. You're putting your life on the line, and anything can happen. One thing we do have as a safety precaution, which a lot of chapters don't have, is bulletproof vests. We've never been shot at, but it can happen.
Which neighborhood is your favorite to patrol and why?
One of the favorites for my guys, because it's a rush, is the Tenderloin. Everytime you go there, there's gonna be something. Once we walked through an alley and we saw some cocaine dealers, and they got panicked and took off in a car. We were doing some searching around in the alley, and we found a quarter ounce of cocaine. We turned it into the cops, and they said "Where the hell did you find this?" We told them and they said "You don't get paid to do this stuff?" And we told them what we're all about, and he said "Well without you, drugs would be rampant, and you guys are a lot of help."
We don't beat anybody up and say "Give me your crack pipe!" We say "This is not the way to go, this is not the way to live", and they usually just give whatever they have to us, and we bust it in front of them to show that we're not keeping it for ourselves.
Do you guys have a special code or language you communicate with when you're on patrol?
We all have code names. I go by "JD", and my second in command is named "Scorpion." And then my captain, his name is "Cobra." We have hand signals, and we have radios we take out with us. Code 4 means all clear, Code 50 is a dead body. Code 5150, that's somebody who's crazy. Code Red is an emergency.
Out of an international network of 140 chapters around the globe, this group of about 30 volunteers is one of the most decorated, having received "Chapter of the Year" twice. They've got a lot to be proud of. Visit the Guardian Angels on Youtube and on Facebook to learn more.


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Conventional LCDs use a high-intensity blue LED backlight whose glow is converted by a phosphor coating to create a broadband, white light used to make the moving TV images. The new Triluminos tele*visions instead pair an uncoated blue LED with a thin glass tube filled with quantum dots. Two kinds of quantum dots in the tube absorb some of the blue light from the backlight and re-emit it as pure red and green light.
Mark Henninger, Senior Editor at AVS Forum
I talked with a Sony rep about Triluminos at CES, and he didn't say anything about this. He said it was white LEDs whose light was split into RGB by tiny prisms in the diffusion layer. But then again, he was just a product babysitter in Sony's booth, so I wouldn't be all that surprised if he had it wrong. I will definitely look into this. Interestingly, another company at CES, Hisense, was demonstrating something it calls U-LED, which was described to me (in very poor English by a Chinese engineer) as blue LEDs exciting red and green phosphors, which is similar to the description presented here. I intend to find out more about that as well. I did a podcast about quantum-dot technology with Jason Hartlove, CEO of Nanosys, which can be found here: twit.tv/show/home-theater-geeks/99
Scott Wilkinson
Editor, AVS Forum
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H&M have announced that they are set to collaborate with Versace this autumn. Following on from the sell-out success of previous collaborations with the likes of Lanvin, Jimmy Choo and Stella McCartney, Donatella Versace will design an exclusive collection for both the men's and women's ranges, as well as home wear (we want the dinner plate set in every colour).
Donatella herself is excited about her new project too. She said, "I am thrilled to be collaborating with H&M and to have the opportunity of reaching their wide audience. The collection will be quintessential Versace, perfect for H&M and Versace fans everywhere".
The collection will be available in 300 H&M stores from 17 November this year and we've heard there will be plenty of studded leather dresses and killer heels to match. We can't wait. Take a look at the video below to hear more about the news and see the first pictures of the collection!


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" wrote:You can be sure that Kohls reports to the credit bureaus. I forgot about a $15 payment in April; by June the ding showed up on my otherwise flawlwss credit history. I found out when I applied for a small call loan.
ScoreOnTheRise wrote:As far as all CRs are concerned, my Kohl's has a perfect payment history. They did lower my CL from $800 to $600, however.


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A CYCLIST has been taken to hospital after a crash with a van in South Tyneside this morning.
The man in his 30s was taken to South Tyneside District Hospital but his injuries are not believed to be serious.
He collided with a Fiat van at 8.20am in Lord Nelson Street, South Shields.
Police are carrying out inquiries and anyone with information is asked to contact police on 101 ext 69191.
Twitter: @ShieldsGazVicki


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Here's a Thought: Making Sense of Kevin SloweyJuly 15, 2009
Dan Haren, Roy Halladay, Zack Greinke, Javier Vazquez, Kevin Slowey.
The first four pitchers on that list are aces. The fifth is Kevin Slowey.
Those five lead all qualified pitchers in strikeout-to walk ratio.
Looking at that leaderboard, Slowey sticks out. The first four pitchers have FIPs well below 3.00. Slowey's is 4.22.
Everyone's taught that to succeed as a pitcher, you have to throw quality strikes. And no pitcher in baseball understands that better than Slowey. Some (like those first four) may understand it as well as him, but none better than him.
Slowey throws the third-most strikes in baseball, and leads the majors in first-pitch strike percentage (68.5 percent).
Slowey obviously executes the "throw quality strikes" idea to perfection.
But why isn't he up with Haren, Halladay, Greinke, and Vazquez?
The first, and biggest, reason for this is Slowey's propensity to allow the home run ball. Slowey is an extreme flyball guy who works high in the strike zone. He actually has allowed as many homers as walks this year (15). He's given up more homers in his three-year career (53) than walks (50).
Slowey's high homer rate is not a fluke, as his HR/FB luck is about average. It's just that nearly half of balls hit of the Winthrop alum are outfield flies.
So that's Slowey's first problem.
Slowey's next problem is out of his control: his batting average on balls in play. Since he's a flyball guy, Slowey should actually have a BABIP around .280 or .290. However, this season, it's .352. That's why Slowey's 4.87 ERA is higher than his 4.22 FIP.
Slowey posted a pretty bad 4.90 xFIP in his 2007 debut, but improved greatly last year, with a 4.14 mark. It appeared (at least to me) that the righty was a bit of improvment away from being an ace.
This year, he's slipped backward slightly to a 4.39 xFIP, certainly not what I would have expected.
The xFIP increase has occurred, on a statistical level, because Slowey's K/BB ratio has inched down (from 5.13 to 5.00) and his FB% (and consequently, the number of homers you'd expect him to allow) has inched up (from 44.8% to 47.6%).
So those are the numbers.
But what's the real reason for Slowey's lack of improvement?
He doesn't have any good pitches.
Alright, that's a bit unfair. Slowey's fastball isn't bad. Even though it only goes 87-92 mph, averaging 88-90, he's gotten above average results from it over the course of his career, as it's been .53 runs above average per 100 pitches for his career.
However, Slowey has lost a mile per hour off his fastball this year, and he's seen his effectiveness plummet.
Year Velocity Runs Above Average/100 Pitches
2007 89.7 .64
2008 89.9 .81
2009 88.9 -.04
The fastball, Kevin Slowey's best pitch, has dropped from a plus pitch to an average pitch this season.
That's huge, because Slowey's offspeed pitches are terrible.
I've only seen Slowey pitch maybe three times, so I can't speak as well as a Twins fan can about what his offspeed stuff looks like, but he throws a slider, curveball, and changeup, and none have ever been effective in the major leagues.
The slider comes in at 1.32 runs below average per 100 pitches for Slowey's career. The curve is 1.65 below average, and the changeup is 1.85 below average.
None have ever broken out of the red for a full big-league season.
Last year, Slowey actually got OK results from his offspeed stuff, as all three pitches rated between .17 and .4 runs below average.
Given that he throws a lot of fastballs (usually near 70 percent), when Slowey has the fastball working and is coming close to average with his offspeed stuff, he's effective.
This year, however, Slowey's seen his slider slip to a run below average, his changeup slip to 1.21 below average, and his curve slip to (gulp) 3.79 below average.
It seems that Slowey had a plus fastball and functional offspeed pitches last year. This year, he has an average fastball and non-functional offspeed pitches.
Needless to say, that's not a good combination.
Still, Slowey has premium command, and he strikes out his fair share of batters. If he can get his velocity back in the 90-mph range and sharpen his breaking stuff, he could still be a #1 starter.
If he can't, he'll continue to look out of place on the walk-to-strikeout ratio leaderboard, a back-of-the-rotation guy in the company of aces.


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Found a deal today? Here's the place to share it.
Have a question that doesn't fit into any of the other threads? Here's the place to ask it.
I hope you have a fabulously frugal day! As I always say, It's your money, spend it wisely!
Published: 2015-06-26 06:00:00
Updated: 2015-06-26 06:00:00
Found a deal today? Here's the place to share it.
Have a question that doesn't fit into any of the other threads? Here's the place to ask it.
I hope you have a fabulously frugal day! As I always say, It's your money, spend it wisely!
Please sign in with your WRAL.com account to comment on this story. You also will need a Facebook account to comment.
nstutt - I agree. It's a toss up. On the one hand it will be easier. On the other hand, we may miss out on promos. Hopefully, once the option to enter codes manually is gone, they will have other ways to get bonus points. And I hope you had no hail damage.
Thanks Faye, yes that hail fell south of Clayton too. But the KFR changes means that holding on products for weeks or months before submitting the codes so that you can take advantage of a special bonus like the one around Memorial Day is no more. So it is a simpler solution and does avoid the hassle of codes not being accepted which happened to me on numerous occasions resulting in a lot of 4 letter words. But taking advantage of bonus promotions and such is more difficult.
Be careful everyone! Bad weather out there. We just had a hail storm in the 40/42 area in Johnston County!
nstutt - according to an e-mail I got from KFR today since I added my FL MVP card to KFR yesterday, you don't have to enter codes from stores where you have loaded a reward card.
Here is the info:
- Remember to use this loyalty card or membership every time you shop to collect points based on your purchases of KFR-participating products.
- Points from loyalty card or membership purchases are usually added to your account within
2–7 days.
- Regularly check your activity to ensure you received all the points you've collected via your
connected loyalty cards or memberships, uploaded receipts and entered codes.
- Log in to your KFR account at least once every 90 days to keep your points because they can
expire due to inactivity. Please note that using a connected loyalty card or membership does
not count as activity.
Heads up! There is a Swag Code available today from 3 pm - 4 pm for 3 Swag Bucks!
Code: JustSpinIt
Careful with that rebate that says receipt(s) must total $50. I did one of those a while back with multiple receipts and they said that it didn't qualify because it was not all in one purchase.
I registered my HT loyalty card with Kellogg's and bought a box cereal at HT today. Do the points automatically show up in my KFR account or do I still have enter the code?
RAESMOM - I wish I had some to send to RAE but I gave all I had left to the church for bible school party .so sorry .
I HOPE all is well with you and yours and your are still going to see your family soon !
SO GOOD to SEE you !!
I was worried you had melted in this heat . lol
Thanks for the KFR bonus granoftwenty!! I have 3 codes in my purse right now that I need to enter, glad I held out.
HEY PR!!!! Good to see you around again!!
Losltp~i think it was you (and someone else) who posted about the food lion deals on baking stuff. I didn't find any at our local food lion, but it was nice of you to mention Rae :) I have to keep cupcake liners, frosting and sprinkles in the house AT ALL TIMES lol


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How to find newly joined instructables members?
I would love to greet new instructables members and maybe answer their very first question or comment...and so on...so is there a way to find out if anyone has given their first comment or question and if there are any new members that just joined who I can greet!
Please don't.
If you happen to notice a newcomer, and are replying to they anyway, "welcome" is appropriate. But I wouldn't suggest doing it when you don't already have a strong reason for talking to them. I know *I* would find that more disturbing than helpful; I'm not here to meet people, I'm here to share ideas.
But that's just the opinion of one user. De gustibus.
I welcomed 1 user and from now on not really going to welcome any more users!
Thanks for the opinion!
I think that function was disabled a long time ago, so it's a "no".


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2012-10-04 / Top News
The Monterey Garden Club visited the newly restored Head Waters Schoolhouse Oct 2. Above, Peggy Bird and Susan Blanchard inspect a photo album of the restoration as Barbara Hevener looks on.
You must be an online subscriber to view this story.
Full versions of news stories from the current issue and our extensive archives are available to online subscribers only. You can buy single issues from the link below.


text:
LAKELAND, Fla.—Look at Hanley Ramirez's arms these days and you don't think shortstop. Linebacker or bodybuilder, perhaps. But not shortstop.
The Florida Marlins' All-Star shortstop beefed up to 225 pounds two springs ago, and he hasn't stopped gaining. He reported to camp this year at 240, though he has said he wants to drop 15 pounds by opening day.
At any weight, Marlins manager Edwin Rodriguez says no big deal.
"He's going to be fine," Rodriguez says. "We can see him taking better swings every time he's out there. The timing is getting there." And the weight? "We're not worried."
Rodriguez says Ramirez never has been a cat-quick shortstop anyway. "He always relies on positioning and with more experience, he will position himself better," Rodriguez said. "We're not worried about the range."
Ramirez is trying to bounce back from the most disappointing of his six seasons, though he still hit .300 with 21 homers and 92 runs in 2010. In addition, Rodriguez says the 27-year-old is stepping into a leadership void left by second baseman Dan Uggla's trade to the Atlanta Braves.
"I would say he's more vocal in the clubhouse although he's not loud," Rodriguez says. "He's getting more involved. When we do some early work or extra work with the young guys, he's there to help."


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Police in RI prepare for Westboro Baptist Church protest
Several police departments met Friday in anticipation of anti-gay-marriage protests in Rhode Island.
The Westboro Baptist Church of Kansas has demonstrated around the country in opposition to same-sex marriage. It's the same group that has gained notoriety for offensive protests at the funerals of deceased military fighters.
On its website, the church has promised to protest in three cities in Rhode Island on Aug. 1, the first day marriage licenses will be issued to same-sex couples.
State police met Friday with police from two of the cities -- Cranston and Pawtucket.
Maj. Arthur Martins, of the Pawtucket Police Department, was in the meeting and said no violence is expected and that the group has the right to protest.
Providence Public Safety Commissioner Steven Pare said Police Chief Hugh Clements is also making a plan to ensure peaceful protests, which are expected at city hall clerk's offices where the licenses will be issued.


text:
WATCH: Vancouver fans celebrate Germany's World Cup win
VANCOUVER — Commercial Drive was packed as soccer fans hit the local restaurants and bars to watch the World Cup Final. Some went to extremes to make sure they could be there for the final goal, including one man who postponed his honeymoon to watch the match.
© 2014 Shaw Media


text:
Please wait...
EDM Popping Festival Hooks
'EDM Popping Festival Hooks' from Mainroom Warehouse is a must-have pack for you if you are inspired by the sounds of Global Gathering, Ultra Music Festival, Tomorrowland, Tomorrow World and Electric Daisy Carnival. This pack will help you create sounds like the top artists of today, such as Martin Garrix, Hardwell, Tiesto, and many, many more. The download features 50 lead hook MIDI files, alongside 11 kits from the demo track, each including key-labelled kick drum, Sylenth1 patch and corresponding MIDI loop for instant production heaven!Product Contains: • 50 Popping MIDI Hooks • 11 Key-Labelled Kicks (24-Bit WAV) • 11 Sylenth Popping Patches (.fxp) and as 1 .fxb file. • 11 Kits inspired by the Demo (1 Key-Labelled Kick, 1 MIDI & 1 Sylenth Popping Hook Patch). The Sylenth patches are compatible with Version 2.2 & 2.21 Beta.
Royalty-Free: All of the content in this download is 100% royalty-free. Once purchased, you can use these sounds in your own commercial music releases with no restrictions.
Quick Links: Browse By Genre | WAV Sample Packs | MIDI Packs | Construction Kits | REX Loops | Combi Packs | Reason Refills | Apple Loops
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• Each Folder Incl: 1 Key-Labelled Kick,
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• Download Size: 7MB
Works with Cubase, Logic, Ableton Live, Pro Tools, Reason, Reaper, Sonar, FL Studio, Garageband and many more...
PC & Mac Compatible


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- Home
- Papercraft
- Die Cutting & Embossing
- Dies
- Darice® Craft Dies: Square Nesting Die Cuts with Bracket Edge
Darice® Craft Dies: Square Nesting Die Cuts with Bracket Edge
Product ID: 2014-01
These nesting die cuts make it easy to create fancy die cut squares - in graduated sizes! Versatile Darice® die cutting dies allow you to die cut OR emboss shapes, and they can even be used as stencils, too.
Each nested set includes bracket-edged square craft dies in 6 different sizes, with the largest die measuring 4.25 inches square. Use them together or separately to create exactly the look you want. They're great for scrapbooks, handmade cards, home decor, and more.
Note: Darice® nesting die cuts are recommended for use with manual machines like the Cuttlebug™ or Sizzix™. The red lines on the square die cuts image show the cut and emboss lines.
Color: Other
Material: Other
Product Type: Shape Cutting Dies
Shape: Other
Our Price: $8.97
6 nesting die cuts per package.


text:
I decided to have a Lifestyle Lift, and had a positive experience from the onset. The staff was so supportive and the surgery itself was a great success. I consulted with Dr. Robledo, waited another month until my weight loss goals was met, then came in for my procedure with full confidence.
My recovery was smooth because I followed Dr. Robledo's careful instruction to the letter. Now I am 6 months out post procedure. I look 15 years younger, I feel 25 years younger an the attention I receive is priceless. I have a new found confidence that is worth every dime and can never thank Dr. Robledo enough for his skill and compassion.


text:
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
This study has been completed.
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
First received: November 18, 2008
Last updated: December 3, 2013
Last verified: December 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.
|Cystic Fibrosis
|Drug: FTI, AZLI Drug: Placebo, AZLI
|Phase 2
|Study Type:
|Study Design:
|Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:
|A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa
Resource links provided by NLM:
Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Fosfomycin Tobramycin Tobramycin sulfate Pseudomonas aeruginosa Fosfomycin tromethamineU.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Relative change in lung function from baseline at Day 28. [ Time Frame: 28 Days ]
|Estimated Enrollment:
|Study Start Date:
|November 2008
|Study Completion Date:
|March 2010
|Primary Completion Date:
|February 2010 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: FTI 80mg/20mg BID
Fosfomycin/Tobramycin combination 80mg/20 mg inhaled twice daily
Drug: FTI, AZLI
Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation)
Experimental: FTI 160mg/40mg BID
Fosfomycin/Tobramycin combination 160 mg/40 mg inhaled twice daily
Drug: FTI, AZLI
Evaluation of 2 dosage combinations of fosfomycin and tobramycin inhaled twice daily for 28 days following 28 days of inhaled AZLI (Aztreonam Lysine for Inhalation)
Placebo Comparator: Placebo A BID
Placebo A inhaled twice daily
Drug: Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
Placebo Comparator: Placebo B BID
Placebo B inhaled twice daily
Drug: Placebo, AZLI
Volume-matched placebo inhaled twice daily for 28 days following 28 days of AZLI (Aztreonam Lysine for Inhalation).
Detailed Description:
Gilead is developing a broad spectrum combination antibiotic (FTI) consisting of fosfomycin (an antibiotic with activity against gram-positive and gram-negative bacteria) and tobramycin (an aminoglycoside antibiotic with potent gram-negative activity) for treatment of patients with CF. FTI offers a potential option for treatment of CF lung infections. It is important to note that the concentration of tobramycin in FTI is lower than that of the approved dose of inhaled tobramycin alone, thereby demonstrating the potential of FTI to minimize long-term toxicity from repeated exposure to aminoglycosides like tobramycin. This study will evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.
|Ages Eligible for Study:
|18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- Males or females aged 18 years and older
Patients with CF as diagnosed by one of the following:
- Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test, OR
- Documented sweat sodium greater than or equal to 60 mmol/L, OR
- Abnormal nasal potential difference, OR
- Two well-characterized genetic mutations in the CF transmembrane conductance regulator (CFTR) gene, AND
- Accompanying symptoms characteristic of CF
- Documented presence of PA in an expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within 12 months prior to Visit 1; one of the previous PA-positive cultures must be within 3 months prior to Visit 1
- Patients must be able to provide written informed consent prior to any study related procedures
- FEV1 greater than or equal to 25% and less than or equal to 75% predicted at Visit 1
- Ability to perform reproducible pulmonary function tests
- Chest radiograph at Visit 1 without significant acute findings (e.g., infiltrates [lobar or diffuse interstitial], pleural effusion, pneumothorax); or chest radiograph, CT, or MRI obtained within the 90 days prior to Visit 1 without acute findings or significant intercurrent illness; chronic, stable findings (e.g., chronic scarring or atelectasis) are allowed.
Exclusion Criteria:
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day
- History of sputum or throat swab culture yielding B. cepacia in the previous 2 years
- Current requirement for daily continuous oxygen supplementation or requirement for more than 2 L/minute at night
- Administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)
- Known local or systemic hypersensitivity to monobactam antibiotics
- Known allergies/intolerance to tobramycin or other aminoglycosides
- Known allergies/intolerance to fosfomycin
- Inability to tolerate inhalation of a short acting beta2 agonist
- Changes in or initiation of chronic azithromycin treatment within 14 days prior to Visit 1
- Administration of antipseudomonal antibiotics by inhalation, IV, or oral routes within the 14 days prior to Visit 1
- Changes in antimicrobial, bronchodilator (BD), corticosteroid, hypertonic saline, or dornase alfa medications within 7 days prior to Visit 1
- Changes in physiotherapy technique or schedule within 7 days prior to Visit 1
- History of lung transplantation
Abnormal renal or hepatic function or serum chemistry at Visit 1, defined as:
- AST, ALT > 3 times upper limit of normal range (ULN)
- Creatinine > 1.5 times ULN
- Positive pregnancy test at Visit 1; all women of childbearing potential will be tested
- Female patients of childbearing potential who are lactating or are not (in the opinion of the investigator) practicing an acceptable method of birth control; female patients who utilize hormonal contraceptives as a birth control method must have used the same method for at least 3 months before study dosing
- Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794586
Show 36 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794586
Show 36 Study Locations
Sponsors and Collaborators
Gilead Sciences
|Principal Investigator:
|Bruce Trapnell, MD
|Children's Hospital Medical Center, Cincinnati
More Information
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 20, 2017
|Responsible Party:
|Gilead Sciences
|ClinicalTrials.gov Identifier:
|NCT00794586 History of Changes
|Other Study ID Numbers:
|Study First Received:
|November 18, 2008
|Last Updated:
|December 3, 2013
Keywords provided by Gilead Sciences:
cystic fibrosis
inhaled antibiotic
antipseudomonal antibiotic
lung infection
pseudomonal infection
Additional relevant MeSH terms:
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
ClinicalTrials.gov processed this record on September 20, 2017