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Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
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- How to Read a Study Record
This phase II trial is studying how well giving capecitabine with or without vorinostat works in treating patients with recurrent and/or metastatic head and neck cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine together with vorinostat is more effective than capecitabine alone in treating patients with cancer of the head and neck.
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Metastatic Squamous Cell Carcinoma to the Neck With Occult Primary
Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma Metastatic to the Neck With Occult Primary
Stage III Lip and Oral Cavity Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma
Stage IV Laryngeal Squamous Cell Carcinoma
Stage IV Laryngeal Verrucous Carcinoma
Stage IV Lip and Oral Cavity Squamous Cell Carcinoma
Stage IV Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Stage IV Oral Cavity Verrucous Carcinoma
Stage IV Oropharyngeal Squamous Cell Carcinoma
Tongue Carcinoma
Drug: Vorinostat
Drug: Capecitabine
Phase 2
|Study Type:
|Study Design:
|Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:
|A Phase II Study of Vorinostat and Capecitabine in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) and Nasopharyngeal Carcinoma (NPC)
- Objective response rate (complete and partial response) according to RECIST (Cohort A) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]95% confidence intervals will be provided for all interesting results.
- PFS (Cohort B) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method. 95% confidence intervals will be provided for all interesting results.
|Estimated Enrollment:
|Study Start Date:
|December 2010
|Estimated Primary Completion Date:
|June 2015 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: Arm I (capecitabine)
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Capecitabine
Given orally
Other Names:
Experimental: Arm II (vorinostat and capecitabine)
Patients receive oral vorinostat once daily and capecitabine as in arm I on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Vorinostat
Given orally
Other Names:Drug: Capecitabine
Given orally
Other Names:
Detailed Description:
I. To determine the objective response rate (complete and partial) and duration of response of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic SCCHN.
I. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic SCCHN.
II. To determine the rate of progression-free survival (PFS) at 6 months. III. To determine the rate and duration of stable disease (SD). IV. To determine the median PFS, and the rate of PFS at 1 year. V. To determine the median overall survival (OS), and rates of overall survival at 6 months and at 1 year.
OUTLINE: This is a multicenter, open-label study of patients with squamous cell carcinoma of the head and neck followed by a randomized study of patients with nasopharyngeal carcinoma (NPC).
Patients receive oral capecitabine twice daily and oral vorinostat once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with complete response may receive two additional courses. Patients with NPC are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral capecitabine twice daily on days 1-14.
ARM II: Patients receive oral vorinostat once daily and capecitabine as in arm I on days 1-14.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients will be followed up every 6 months for 1 year.
|Ages Eligible for Study:
|18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
Histologically or cytologically confirmed disease meeting 1 of the following criteria:
Squamous cell carcinoma of the head and neck (SCCHN)
- Oral cavity
- Oropharynx
- Larynx
- Hypopharynx
- Paranasal sinus
- SCCHN of unknown origin must be reviewed and approved by principal investigator
- Nasopharyngeal carcinoma (NPC)
- Patients with NPC must have completed one prior chemotherapy regimen for recurrent or metastatic disease at least 4 weeks prior to enrollment; in addition, they may have received prior systemic chemotherapy (ie, induction, concurrent or adjuvant) for NPC as part of the initial multimodality treatment for locally advanced disease if the chemotherapy is completed > 6 months prior to enrolment; patients are eligible if they received 5-FU as part of the initial multimodality treatment; patients are not eligible if they received capecitabine previously
Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- Indicator lesions must not have been previously treated with surgery, radiotherapy, or radio frequency ablation unless there is documented progression after therapy
- No known brain metastases
- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy > 12 weeks
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN (≤ 5 times ULN for patients with documented liver metastases)
- Creatinine ≤ 1.25 times ULN OR creatinine clearance ≥ 50 mL/min
- ECG with normal tracing or non-clinically significant changes that do not require medical intervention
- QTc interval < 470 msec and without history of Torsade de Pointes or other symptomatic QTc abnormality
- Not pregnant or nursing
- Fertile patients must use effective contraception (abstinence or 2 birth control methods) prior to and for the duration of study
- Willing and able to comply with schedule visits, treatment plan, laboratory tests, and other study procedures
More than 5 years since another malignancy except stage 0-IB cervical carcinoma, non-invasive basal cell or squamous cell skin carcinoma, or radically treated prostate cancer (prostatectomy or radiotherapy) with normal PSA and not requiring ongoing anti-androgen hormonal therapy
- More than 10 years since malignant melanoma
- No inability to take oral medications and/or a clinical or radiological diagnosis of bowel obstruction
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in this study
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Active peptic ulcer disease
- Myocardial infarction within the past 6 months
- Congestive heart failure
- Symptomatic congestive heart failure
- Active cardiomyopathy
- Unstable angina pectoris
- Cardiac arrhythmia
- Uncontrolled hypertension
- Psychiatric illness and/or social situations that would limit compliance with study requirements
- Not HIV positive
- No known dihydropyrimidine dehydrogenase (DPD) deficiency
- No concurrent radiotherapy (except for metastatic bone lesions)
At least 4 weeks since prior targeted therapy for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)
- No prior or other concurrent histone deacetylase (HDAC) inhibitors (e.g., valproic acid)
More than 6 months since prior systemic chemotherapy (i.e., induction, concurrent, or adjuvant) as part of the initial multimodality treatment for locally advanced disease
- No prior fluorouracil as part of initial modality treatment for patients with SCCHN
- Prior fluorouracil for patients with nasopharyngeal carcinoma (NPC) allowed
- No prior capecitabine for patients with SCCHN or NPC
- At least 4 weeks since prior surgery or radiotherapy
- Concurrent medication or substances known to affect or with the potential to affect the activity of vorinostat will be reviewed in a case by case by principal investigators
- No other concurrent investigational agents
- No concurrent medications that are generally accepted to have risk of causing Torsades de Pointes
No other concurrent anticancer therapy
- Palliative interventions, such as paracentesis or palliative surgery, allowed
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267240
|United States, California
|Tower Cancer Research Foundation
|Beverly Hills, California, United States, 90211-1850
|City of Hope
|Duarte, California, United States, 91010
|University of Southern California/Norris Cancer Center
|Los Angeles, California, United States, 90033
|Contra Costa Regional Medical Center
|Martinez, California, United States, 94553-3156
|Veterans Administration Hospital - Martinez
|Martinez, California, United States, 94553
|City of Hope Medical Group Inc
|Pasadena, California, United States, 91105
|University of California at Davis Cancer Center
|Sacramento, California, United States, 95817
|United States, Pennsylvania
|Penn State Milton S Hershey Medical Center
|Hershey, Pennsylvania, United States, 17033-0850
|University of Pittsburgh
|Pittsburgh, Pennsylvania, United States, 15232
|Canada, Alberta
|Tom Baker Cancer Centre
|Calgary, Alberta, Canada, T2N 4N2
|Canada, British Columbia
|BCCA-Vancouver Cancer Centre
|Vancouver, British Columbia, Canada, V5Z 4E6
|Canada, Ontario
|Juravinski Cancer Centre at Hamilton Health Sciences
|Hamilton, Ontario, Canada, L8V 5C2
|London Health Sciences Centre-Corporate
|London, Ontario, Canada, N6A 4L6
|London Regional Cancer Program
|London, Ontario, Canada, N6A 4L6
|University Health Network-Princess Margaret Hospital
|Toronto, Ontario, Canada, M5G 2M9
|Principal Investigator:
|Eric Chen
|University Health Network-Princess Margaret Hospital
No publications provided
|Responsible Party:
|National Cancer Institute (NCI)
|ClinicalTrials.gov Identifier:
|NCT01267240 History of Changes
|Other Study ID Numbers:
|Study First Received:
|December 24, 2010
|Last Updated:
|November 21, 2014
|Health Authority:
|United States: Food and Drug Administration
Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Head and Neck Neoplasms
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
ClinicalTrials.gov processed this record on November 27, 2014


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Welcome to Vicki's Website! Just like the Denver Nuggets, this site is a work in progress! It will never be finished. The site will evolve and change as do the Denver Nuggets.
YouTube – Vicki Video – What it's like to be a Nuggets Fan 24 x 7
Known fondly as "The Signlady", Vicki has enjoyed many years following the Denver Nuggets. All years have been special… some years more than others. Like most Fans Vicki started at McNichols Sports Arena however we were not around to enjoy the ABA days at either McNichols or of course the Denver Coliseum, but we've heard the stores!
We started out in the upper level. We had just moved to Denver (New home of Peyton Manning by the way!), Vicki didn't know anyone and was home-sick. I came home with some tickets and she said, "I don't want to go to no damn basketball game". How I remember those words!
It wasn't too long and we had two folding chairs at the point of the wedge on the south side where the players came out. It was the start of more than I could have imagined! The Sonics game. Chopper's big standing ovation though he was in a wheelchair at the time. When he left the court he clasped Vicki's hand for what seemed like a very long time… and then he disappeared into the tunnel. No tears, just a big smile.
Vicki's first favorite player was Bryant Stith. Vicki still visits Bryant and his family on vacations. When Bryant was traded, Vicki was not sure what to make of the "new" #23 Marcus Camby. Marcus however was great. Sadly Marcus has also recently left the team… but that is the business side of the NBA.
The first night Kenyon arrived in Denver, he sent out a pair of autographed shoes to Vicki, after he heard stories of what a Fan she is. Kenyon is a great guy and wonderfully talented player, but he too is now gone.
We've had the same seats since the Pepsi Center opened… Section 130, Row 1 right in the corner where the Nuggets come out of their locker-room. Stop in and say "hello" when you are at a game… we would love to meet you! Who knows? If you are a die-hard Fan you just might get invited to stand in "Vicki's Corner" and high-five some players.
Well, that's it for now. But check back often as I update the site. I'll be adding more stuff as time and life permit!
Be sure and read our updated Terms of Service.
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subset: commoncrawl


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Yes it gives threat, dont think its modified by presence you are in.
I've found a couple conflicting threads via google on whether or not Rune Weapon gives threat to the DK, and if it does, if it's modified by Frost Presence. Could anyone give me a clear answer on this, please? It would be much appreciated .
Yes it gives threat, dont think its modified by presence you are in.
Originally it didn't was modified to give the damage it does as threat no modifiers for presence.
** Remember Warcraft players fail in directions you never thought possible.
^ Thank you both for your answers .
Is it an okay talent to have, though? I feel like a blood tanking spec has a few points you can play around with depending on what you're tanking and how much extra avoidance you need. If I don't need mark of blood, why not put the point in Rune Weapon, right? Or is it hardly any extra threat without the Frost Presence modifier?
Personally i never tried out Rune Weapon. Yes blood has a few floater points but i always found some really nifty things to spend it on before i ever came close to Rune Weapon. But then, i'm a huge fan of Rune Tap which a lot of specs just jump over.
Still if i really had points to spend elsewhere, i'd first go over & grab virulance before thinking about rune weapon. I feel i lose a lot more threat reapplying diseases that i missed than a 12 sec minor boost every 1.5 mins would give but then i havent tested it out either.
i love rune weapon not only because of threat but because it allows u to put 4 diseases on the target spread them around, then use death strike for bigger heals not to mention the extra heals u get from 2 death strikes.


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Yasufumi Nakanoue
Real Name
Osamu Nakagami
Date of Birth
June 14, 1986
Place of Birth
Since the bunny that accompanies Adam Rose has been featured more frequently on television as of late, fans have been speculating that WWE will eventually have him work a match. It looks like that might happen sooner than later. There are talks that Rose and the bunny could be teaming up to battle Heath Slater and Titus ONeil during the kickoff match at Night of Champions 2014.
September 11, 2014
Reports going around state that Rob Van Dam finished up his latest stint with WWE during the kickoff match at Summerslam 2014. His departure from the company had been expected since he only agreed to a short term contract. Some are under the belief that this might be the last stint for RVD since the audience has been a bit lackluster towards him this time around.
August 18, 2014
For those of you that did not watch the Payback 2014 kickoff match, El Torito defeated Hornswoggle with a flying top rope moonsault. Hornswoggle had gotten distracted by thinking that he won after pulling off the mask. Afterwards, Hornswoggle was forced to sit in a barber chair while El Torito shaved his head. Hornswoggle is now bald, and expect WWE to promote that on Monday Night Raw this week.
June 1, 2014
During the Extreme Rules 2014 kickoff match, El Torito defeated Hornswoggle. He picked up the pin fall victory after jumping off the top rope and driving Hornswoggle through the table. Miniature tables and ladders were utilized during the WeeLC match. Diego, Fernando, Heath Slater, Jinder Mahal and Drew McIntyre were all involved in the match.
May 4, 2014
In an action filled Wrestlemania 30 kickoff match, Jimmy Uso and Jey Uso retained the WWE tag team championship by defeating Diego, Fernando, Curtis Axel, Ryback, Jack Swagger and Antonio Cesaro in a fatal four way elimination tag team bout. Afterwards, Cesaro did a face turn after Swagger attempted to attack him for being pinned.
April 6, 2014
Despite being thrown into the kickoff match at Wrestlemania 30, Antonio Cesaro is the choice for Mick Foley when it comes to being the guy that will be given the big spotlight on the next episode of Monday Night Raw. Generally, WWE considers this episode to be the start of the new season, so they try to elevate someone up the ladder that evening.
April 6, 2014
Rumor has it that there are several people backstage in WWE that are disappointed with how Antonio Cesaro is being utilized at Wrestlemania 30. Instead of being given a big singles match on the pay per view, he is working a kickoff match with Jack Swagger. It also features Jimmy Usu, Jey Uso, Fernando, Diego, Ryback and Curtis Axel.
April 4, 2014
Initially, the belief was that the tag team championships were going to be given some spotlight by WWE at their biggest pay per view of the year, but it has now been announced that Ryback, Curtis Axel, Fernando, Diego, Antonio Cesaro, Jack Swagger, Jimmy Uso and Jey Uso are being moved to the Wrestlemania 30 kickoff match spot.
April 1, 2014
Since time constraints might be an issue, there were talks earlier this week of putting the Andre the Giant memorial battle royal as a kickoff match, but management wants to use it as a promotional vehicle, so it is now back on the main Wrestlemania 30 card. Many are expecting the segment to be heavily rushed, though.
March 19, 2014
While a lot of fans bought into the hype of the match since a legendary name was attached to it, WWE is viewing the Andre the Giant memorial battle royal as an afterthought. There is even a strong push to move it off the pay per view and utilized it as a kickoff match, despite several stars such as Ryback, Kofi Kingston, Big E Langston and Dolph Ziggler being rumored for spots.
March 15, 2014
Once you get into that WWE dog house, it's pretty hard to get out. Management has sent more messages to Ryback this month. First, he and Curtis Axel are utilized as a filler tag team during the Elimination Chamber 2014 kickoff match. This week, the two of them are paired up with Jinder Mahal and Drew McIntyre in an eight man tag team match on WWE Superstars.
February 26, 2014
While many were under the impression that Cody Rhodes was being left off of the Elimination Chamber 2014 main card because of his knee injury, apparently, he is healthy enough to work, as WWE has placed him into the kickoff match. He will be teaming with Goldust in a tag team match against Ryback and Curtis Axel.
February 19, 2014
In case you missed the announcement on Monday Night Raw this week, Darren Young and Titus ONeil will be having their grudge match on the main Elimination Chamber 2014 pay per view next Sunday night. Many were under the belief that it was going to be the kickoff match, but management decided to step things up a bit.
February 19, 2014
During the kickoff match for Royal Rumble 2014, Road Dogg and Billy Gunn shocked the wrestling world when they were able to defeat Cody Rhodes and Goldust to become the new WWE tag team champions. Many were under the impression that their return was a temporary one.
January 26, 2014
Cody Rhodes and Goldust will be defending the WWE tag championships against Road Dogg and Billy Gunn before the Royal Rumble 2014 starts. The kickoff match was announced via the website, and there should be a mention of it on television tonight during Monday Night Raw.
January 20, 2014
A video interview of Great Muta, Seiya Sanada and Yasufumi Nakanoue discussing their big victory over Chris Sabin, Frankie Kazarian and Christopher Daniels at TNA Lockdown 2014.
March 13, 2014
In a steel cage match at TNA Lockdown 2014, the Great Muta, Seiya Sanada and Yasufumi Nakanoue defeated Chris Sabin, Christopher Daniels and Frankie Kazarian. All three Japanese wrestlers were representing Wrestle-1.
March 9, 2014
A message on Twitter from Kevin Nash about the death of his former WCW protege Sean OHaire.
September 10, 2014
A message on Twitter from Lance Storm about the death of Sean OHaire.
September 10, 2014
A status update on Twitter from Scotty Riggs, where the former WCW star states that Sean OHaire has passed away.
September 9, 2014
A status update on Twitter from Diamond Dallas Page, where he provides an update on the condition of Jake Roberts.
August 28, 2014
A status update on Twitter from Kizarny, where the former WWE star provides us with an update on Jake Roberts, who passed out on an airplane and has been unconscious at a Las Vegas hospital since then.
August 28, 2014
A post from Twitter, where JBL mocks Shelton Benjamin by taking a picture of Rico Constantino, who is visiting Monday Night Raw today, and stating that Constantino is the best tag team partner that Charlie Haas has ever had in WWE.
August 18, 2014
A post on Twitter from Tommy Dreamer, where he praises MVP for getting involved in the protests in Ferguson, Missouri.
August 16, 2014
A Twitter post from former WWE star Kevin Nash where he jokes about trying to do a Vulcan mind meld with Brock Lesnar to let him know that he is only back on Monday Night Raw for the beers and not looking for a fight.
August 14, 2014
A status update on Twitter from Zack Ryder, informing fans that WWE is no longer selling any of his merchandise. Rumors have been circulating that the company wants to downplay his popularity, and this revelation lends credibility to those speculations. The fact that Ryder actually pointed it out in public is a sign that he could be really frustrated with his situation in WWE.
July 1, 2014
As many of you already know by now, several WWE stars were on the receiving end of a release today, as the company is trying to cut cost a bit. As that is happening, Mark Henry decided to celebrate his 18th year anniversary with the company by posting a message on Twitter, which did not sit well with Curt Hawkins, who was one of the performers released. Hawkins posted this response to Henry.
June 12, 2014
A status update on Twitter from Mick Foley, where he stated that TNA wished him a happy birthday while WWE has yet do so. While the former world heavyweight champion is more than likely just playing around, there appears to be some truth in jest, as rumors have been floating around that there is backstage heat between Foley and some members of management in WWE.
June 8, 2014
A status update on Twitter from Drew McIntyre, where the WWE star mocked Dean Ambrose, Seth Rollins and Roman Reigns for breaking up while he, Jinder Mahal, Hornswoggle and Heath Slater still remain a team.
June 4, 2014
A picture of Ricardo Rodriguez trying to break into the Adam Rose tour bus.
May 27, 2014
A status update from Twitter from Frankie Kazarian, which involves Chris Sabin and potentially taking a jab at TNA for not paying their performers on time.
May 27, 2014
A couple of years back, fans witnessed a real life shoot incident in the ring between JBL and the Blue Meanie. Some blood was involved. Apparently, the two of them have resolved their issues since then, as JBL took to Twitter to wish the Blue Meanie a happy birthday. The former WWE stars appear to be quite cordial with one another now.
May 20, 2014
A status update on Twitter by Hernandez, where the former TNA star posted a funny picture of a guy in an Aquaman outfit.
May 11, 2014
A status update on Twitter from Chris Sabin, where the former world heavyweight champion revealed that he is now a free agent and is no longer under contract to TNA.
May 9, 2014
A status update on Twitter from Prince Devitt, where the departing international star thanked New Japan Pro Wrestling for the last eight wonderful years of his career.
May 9, 2014
A status update on Twitter from Dixie Carter, where the TNA president takes a jab at Jim Ross.
May 9, 2014
A status update on Twitter, where Seiya Sanada, the current TNA X Division Champion, playfully mocks Robbie E for looking like "Uncle Jesse", who was famously portrayed by John Stamos.
May 7, 2014


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Vaccines, Blood & Biologics
Resources for You
SOPP 8506: Management of Shortages of CBER-Regulated Products
- FDA Draft Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (February 2012) (PDF - 226KB)
Food and Drug Administration Safety and Innovation Act (FDASIA) A Review of FDA's Approach to Medical Product Shortages Industry (Biologics) Healthcare Providers (Biologics) Consumers (Biologics)
- Return to the Office of Compliance and Biologics Quality (OCBQ) Page
CBER-Regulated Products: Shortages and Discontinuations
CBER's Office of Compliance and Biologics Quality (OCBQ) directs the CBER-regulated product shortage program, which includes product discontinuations.
The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products. More information on FDASIA is provided on FDA's FDASIA Fact Sheet Page.
Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA. For more information please see FDA Facts: Drug Shortages in the United States.
Additional information regarding possible causes of CBER-regulated product shortages is provided on the CBER-Regulated Products: Possible Causes of Shortages Page.
CBER-Regulated Products: Current Shortages
A tabular listing of current shortages of CBER-regulated products is provided on the page.
CBER-Regulated Products: Resolved Shortages
A tabular listing of resolved shortages of CBER-regulated products is provided on the page.
CBER-Regulated Products: Discontinuations
A tabular listing of discontinued CBER-regulated products is provided on the page.
Report a Shortage or Supply Issue to FDA
Contact information to report a shortage or supply issue to the appropriate Center is provided on the page.
- Federal Register Notice for Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Prosposed Rule
Strategic Plan for Preventing and Mitigating Drug Shortages(PDF - 381KB) A New Plan for Drug Shortages to Build on FDA's Success FDA Acts to Prevent More Drug Shortages FDA takes two important actions on drug shortages
Recalls & Alerts
Approvals & Clearances
Complete List of Licensed Products and Establishments Complete List of Vaccines Licensed for Immunization and Distribution in the US Complete List of Currently Approved NDA and ANDA Application Submissions(PDF - 17KB) Complete List of Currently Approved Premarket Approvals (PMAs)(PDF - 19KB) Complete List of Substantially Equivalent 510(k) Device Applications(PDF - 318KB)
Related Information
Contact FDA
Biological Product Shortages


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You are absolutely right! It takes physical and mental toughness to win at the NHL level. That is why Captain Serious is playing golf with his hot girlfriend down in Florida or where ever along with Sharp, Kieth, Kane, and the rest of the privledged bums with their hot girlfriends. It is obvious that the grit players like Dustin, Campbell, Eager, Niemi, etc. that left were the real unsung heros.
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Apr 28, 2012, 8:51 AM
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You got that right
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Posted: Feb 17, 2014 1:31 AM
Updated: Feb 17, 2014 1:32 AM
BEIRUT (AP) The coalition of Syrian opposition groups in exile has appointed a new army chief, following a year of seeing their influence fade among fighters within Syria.
The Western-backed Syrian National Coalition said Tuesday that it was appointing Brigadier Abd al-Ilah al-Bashir to head the Free Syrian Army.
He replaces Gen. Salim Idris, seen as a secular-leaning moderate.
In a statement, the coalition said they hoped al-Bashir would strengthen the role of the FSA.
The switch comes after a series of so-far failed talks in Switzerland between officials loyal to President Bashar Assad and exiled opposition activists to try to resolve the three-year war.
It also comes after at least a year of the FSA losing influence to other, more hard-line rebel groups, including al-Qaida affiliates and spinoffs.


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Monday, September 9, 2013
The Skyline Golf Course is beautiful, no matter the season. But, in the fall, it can be absolutely breathtaking. The rolling hills, the blazing colors of the hardwoods and the deep green of the pines—all this combines to create a mesmerizing visual display. Grab your clubs and experience the magic of fall golf in Black River Country.


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2013 Annual Report
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MyAnneArundel is an integrated mapping application that was developed to provide the County's citizens, businesses, and visitors with access to useful services and data. Please click on one of the following "Themes" and follow the subsequent instructions to launch that specific area of the application:
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County Executive Leopold Announces Renegotiation of Prescription Drug Plan Contract to Save $2.5 Million
Annapolis (December 3, 2010) — County Executive John R. Leopold today announced that changes to the current prescription drug contract for County employees and retirees will save taxpayers $2.5 million over the next two years.
"This Administration is committed to identifying cost savings and using shrewd negotiating tactics to decrease spending," County Executive Leopold said. "Employee healthcare costs are one of the driving forces in rising costs to government. I am pleased that our team has been able to negotiate better deals with regard to our health plans and our prescription drug plan. This is in addition to the $15 million savings that has been realized over the last 3 years as result of new health care contracts negotiated during my first term."
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Neighborhood girl missing.
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Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
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Music is a very colorful thread woven into the entire fabric of our lives. Soon after birth we hear our first melodies as our mothers hum soothing lullabies to help us sleep. We learn nursery rhymes that are designed to both entertain and educate us in our preschool years, which help build the framework for the social and language skills we need to function in society.
We're taught music in school, and some of us participate in the school marching band, orchestra, or theater. We sing church hymns to help build our spiritual being, and patriotic songs to give us a sense of national identity. In every step of our lives music places another brick on the foundation of who we are.
Music helps each one of us find our unique social niche, bringing us together with other folks that share similar interests. It documents the history of social and cultural changes in society, and is always in a state of perpetual evolution, combining new ideas with older ones to create a sound that's unique to each generation. Familiar songs help us recall special moments in our lives, such as our first love, or maybe our first kiss.
Music of all genres in television, radio, film and the Internet have become an indispensable commodity. With the increasing popularity of websites like MySpace Music, more music is available to us now than ever before. Our appetite for new music is insatiable, and many of us have enormous libraries of music at our fingertips to suit whatever mood we may in in at the time. Digital music players and cell phones store hundreds of our favorite songs to carry wherever we go, and many popular songs are used in video games like "Guitar Hero" or "Rock Band". Music is used to sell everything from beer to burgers.
As a professional musician, composer and songwriter, music is my life. My dream has always been to write songs that will move people and hopefully make a difference in their lives. I can't even imagine a world without music!


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Saturday, February 8th from 6:00 pm to 9:00 pm
Pipes & Drums Dinner & Concert begins at 6 p.m. in the Brandt Student Center, Ferrari Room, and features traditional Scottish entertainment. Tickets are $60. For more information, go to http://winchesterpipesanddrums.org
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Pics Canada
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British Museum
Great Russell Street,
British Museum, Great Russell Street, London, WC1B 3DG
(alternative entrance on Montague Place)
There are bike racks inside the Museum gates on Great Russell
Transport for London: cycling information
The nearest docking station is just outside the Museum gates, on
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About Barclays Cycle Hire Scheme
The Museum is within the Congestion Charge zone.
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When I charge in to the boss I notice that sometimes I charge up to the boss, sometimes I go through the boss but am still facing the direction I was facing, and sometimes i charge and then find myself on the other side of the boss flipped around.
Is this just a random thing (force/distance from boss etc.) or is there something in the way I position myself when charging, or something I can do during the charge travel distance that can influence this.
My impression is that it was random last night, but some pulls did have army of the dead agroing the boss just as I charged, so that may have been the variable.


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Have I created a monster (by cooking so well)?
- Scargod Sep 28, 2008 01:00 PM
My name is Scargod. I am a reformed perfectionist. I cook at home. I have (Walter Middy-like), aspirations of being a great chef...
My SO, her children and our friends like my cooking. OK, that's too self-effacing; they generally love my cooking. She brags when she says, "that was restaurant grade!"
Yet, there are times when I feel unappreciated. There are times when I don't hit the mark, because I was experimenting, didn't have everything I needed, or perhaps I was tired. Yadda-yadda.
"Honey, I don't feel like it tonight, I've got a headache!" Yet, I am expected to perform.
We have differences... She likes fish far less than me. She might sprout feathers any minute from the chicken she eats (mostly in Italian food). She generally likes the resurrection of leftovers as a new dish less than me. Southern cooking are less interesting to her, as well as fried foods and game. This limits my ability to please her (as well as me), and stay out of a rut.
Perhaps what I am saying is, my SO knows I can cook. She is picky, yet usually is quiet and picks at her food if she doesn't like it. I can tell..... Vegetable melanges like ratatouille or stews don't suit her too much. Thus leftovers are harder to deal with. She likes soups and sandwiches, but not so much with soups if she knows it's recycled.
She likes simpler foods and mono-vegetable dishes. I did onions, potatoes, caraway seeds, bacon and savoy cabbage (from the garden), and she did not want it a second time. On the other hand she frequently likes potatoes. She loves my sandwiches with chicken and the kitchen sink!
This may be a whiney rant, but what am I to do? How do I please her on a regular basis, and keep up my level of cooking, when she doesn't appreciate my creativity, diversity and adventurous repitoire?
It's hard to keep up the level of cooking when I don't feel appreciated. If I don't keep up the level then I'm below normal and she notices that, too. Usually she doesn't complain, critique my cooking or tell me what she wants. She wants me to make the decisions and not make her head spin with choices!
We eat out only about one dinner a week. On the other hand, she has lunch out about twice a week. I cook 10-12 meals a week for us.
Heloise, What can I do to feel better about my cooking and please both of us?
You deserve better.
You're good enough, you're smart enough, and darn it people like you...to quote Stuart Smalley. You food sounds terrific! Can't please everyone, and some people make living out of being hard to please.
Have more dinner parties.
Stop deriving your self esteem from the reactions of others.
Talk to her, not us. It seems like she does enjoy your cooking. Make sure that's true.
Calculate your stats, ala baseball, and try to improve them.
Ever heard of the Cookbook of the Month on a site called Chowhound?
I advise you to join in the cook along and change out the rut you seem to be in.
That will be - Oh forget it. It's free. Advise, that is.
re: Scargod
on the home cooking boards
re: Firegoat
And here's a link to the September one, which I think all participants have really enjoyed - we've eaten pretty much only Vietnamese food at home all month:
re: Firegoat
Well, there you go! You know how I hate abbreviations... I did not know that COTM was it. I guess it always is stickied?
re: Scargod
Yes, the thread for the current month, which has all of the 'reporting back thread' links in it, is always stickied for that month. Then, a second one is stickied - we go through a 'suggestions' thread early in the month, then a 'voting' thread, and then the 'announcement' thread.
Here the link to a post with all the months we've done - September is the two year anniversary.
re: Scargod
I hope you will join us this month when we will be cooking from 3 of Mario Batali's books and/or his on-line recipes.
Here's a link to the past COTM (Cookbook of the Month) listing so you can see what you've missed:
And, here's a link to a Batali thread with comments:
re: MMRuth
You're welcome, MM. I edit interminably so I can certainly empathize.
re: Gio
MMRuth and Gio: Thanks, very much!
On first inspection I was thinking of "Being John Malkovich" or turning over a rock and finding a whole sub-culture that I never knew existed! I had no idea this was going on at Chow.
What another great way for me to be distracted and use up my time!
re: Scargod
One thing I would note - there have been months where I've loved the book and could have cooked from it all month, where my husband has tired of the food, and so I've stopped, even though I didn't want to (Dunlop - Chinese). Other months - Well's Vegetable Harvest, and the Greek month, we both tired of the food quite quickly. My husband (almost) literally put his foot down on the former, as a result of a brocolli puree. That said, I got two great recipes out of that book that I make pretty regularly, so it was worth it.
re: Scargod
<"What another great way for me to be distracted and use up my time!">
It's good CHow, for heaven sakes. It's almost better than ... sliced bread.
re: MMRuth
No doubt-for me, too. I was thinking that when I started considering it and saying what I did. I may have to stop with the other BS.
BTW, I bought Batalia's Molto Italiano. I've cooked quite a bit of Italian. It's right up there with Thai, Mexican and "Southern". I was just shopping for a good, second Thai cookbook, but couldn't decide.
Grab the vacuum and say "Darlin' ,you've done all the hard Hooverin' whilst I've done all the easy cookin' here for five years, I apologize, and we'll switch it around for the next five." Use you best Fut Wurth accent, and she will beg for more of the same...;) Trust me just this once.
re: Caroline1
Veggo knows me a little. We fight about Mexican food... :) Caroline1, since you are in Plano and a relic (like us), I have always enjoyed reading your posts.
SO and I are semi-retired. She can cook and does so if I am ill, working on a critical project or too tired (like from yard work); this is rare. I cook circles around her. She does simpler meals well and I've been told that she once baked bread pretty well.
I am the "woman" of the house.... and the man. I do all house upkeep. Hell, I put in a new boiler and water filtration system last fall. I'm installing a new WI-FI router today. In fairness, we have a housekeeper once a week, so I don't use the vacuum much. Mostly the shop-vac in my woodshop. I used to have a male helper once a week but he stopped showing up two weeks ago.
SO brings home the bacon and I help facilitate her doing that in numerous ways. Being the house frau is just one. I used to have a good-sized small business back in Daahl-us but that was almost eight years ago. I don't miss it now. I have enough to keep me busy!
I think the idea of doing more dinner parties is a good suggestion. I do about six or eight a year, if you include larger parties. Problem is, almost no one reciprocates. My male friend (a Texan), who used to come over and cook with me, finished his degree and moved away :( I lost a tennis partner, too. Double loss.
SO really doesn't like competing... I mean working.... with me on meals. If we have a big party she may help and occasionally prepare a dish or two. I move too fast, I'm bossy and she feels she's intruding on my space, so it seldom works out that we cooperate. The way I wave a knife around, gesturing, freaks her out. She keeps asking where stuff is. When I was in BC for two weeks she cleaned out and re-arranged the fridge and really screwed me up!
Mostly, this is whining in good fun. I have a bird nest on the ground. If I get a few good suggestions about how I can find a more satisfying compromise, then fine.
re: Scargod
This sounds like someone who needs a good dose of chicken fried rabbit :D
re: Scargod
If she has a sense of humor, may I suggest one of those inflatable dolls with a remote controlled tape hidden in it's head that says, "Oh my god! This is sooOOOOooOOOoOoooOOOoo delicious! Thank you, thank you, thank you!" Then on nights when she's rather cool about your culinary efforts, I'd just push the praise button and enjoy it! '-)
On the other hand, if she doesn't have a sense of humor, you're on your own!
I was really lucky. My first husband enjoyed every single bite I ever prepared. Including some stuff I wouldn't have a second bite of. My second husband was like that for the two years we lived together, but as soon as the "I do's" were done, so was his enthusiasm for food. Hey, 50% ain't so bad!
The obvious answer is to only cook on the nights she really enjoys it. The problem is how to figure that one out. Know anyone who reads chicken innards? '-)
re: Scargod
Dinner parties...I stopped doing official dinner parties often and started having evenings like "game night", (I also joined a book club), or something less food focused so that people that aren't good cooks feel ok about hosting. As good cooks, I think we all forget how intimidating that can be for the would be host. I definitely get props for all my fabulous snacks when it's at my house, but I find folks more inclined to reciprocate.
re: emmaroseeats
Very good point. I am always happy to accept hospitality in whatever form the host feels most comfortable with...but you are correct in that many people don't feel comfortable about their cooking skills.
In my house the person who cooks decides what the weekly menu is(perhaps listening to some input, and requests). At my house, until someone else steps up and starts cooking they will eat what I prepare.
I do enjoy cooking for others, I cook to enjoy myself, so positive feedback, or pats on the back are not necessary for me to feel good about my cooking.
The days I feel burned out on cooking, are the nigths we order in a pizza, or go out to eat.
re: swsidejim
I don't ask very often what SO wants before I go to the store and when I do It is usually "get some fruit for my cereal... I always get a chicken!
I lived for quite a while with a woman who said that people could eat what she cooked or lump it. She was adamant about not fixing special things for picky eaters. That's pretty much my philosophy, with exceptions for vegetarians and SO. That could be (or has been (?)), a thread of its own!
re: Scargod
I have always beleived picky eaters will fall in line if what is put on the table is the only option. Thankfully I dont cook for any vegetarians, so I do not have to alter menus for their tastes(that would be a struggle for me).
re: swsidejim
I recently had a small birthday dinner for my daughter, who has a few Indian friends with various food restrictions. One will not eat animals (never beef!) or even eggs on Tuesdays so I had to have it on Wednesday. I made a fresh pasta (I made the pasta!) ricotta (no meat!) lasagna, meatballs in sauce on the side. One of my friends said she isn't eating cheese because of asthma so I had to boil up a pot of penne just for her and then she saw the lasagna and ate that, too. I took leftovers to a Muslim friend so that's why no sausage in the lasagna. My head swims trying to keep track of it all; anyway, it was a great dinner. Great salad and I made red velvet cupcakes and coconut cupcakes (recipe from Tastespotting included coconut milk in batter).
re: walker
I tip my White Sox hat to you, it sounds like you pulled it off pretty well. I dont know if I would have the patience.
Awesome post! I'm a good cook so it's always up to me. When I get burned out by too much home cooking I wish I could just clone myself. What I really want I guess is for me to cook at home for me! Maybe a mini-me? I feel sometimes like I've pained myself into a corner, that my skill and passion are sometimes a flaw because it's always my turn. Once when I was living with someone who really appreciated my cooking I went on a diet and we fought a lot more. He didn't even want to make his own sandwich for his bagged lunch for work. I calmly explained that it was too tempting to pop a slice of swiss cheese in my mouth and could he please just make his own sandwich til I got off the diet? He flipped out and threatened to leave me. We had a four hour fight with tears and much drama and he told me that he felt unloved because I wasn't taking care of him. So it's not even just excellent cooks who get backed into a corner with no respite. Later I realized that his mom showed her love by cooking for him so not cooking meant I didn't love him in his view. Have you asked her about her favorite foods from childhood? Or other family members who were around when she was little? A lot of couples get into trouble when they retire or semi-retire. I personally think the key is to get her more involved in the decision making. That way she has more invested in the meals. The biggest perfectionist I ever met refused to make any decisions. That way she could never make a wrong decision. Not saying your SO other is that way but I have little patience with those who are passive, yet critical of those who are active. I blame television for this. Hope some of this helps and please get back to us on how things are going.
Hi Scargod,
I think I understand how you feel. I'm the primary cook in my house, although my SO can cook, although not as well as I can (his genius is leftovers and toasted sandwiches, which is useful!). I cook because I love it, I like to choose what I eat and I work from home (he has a long commute). And while he will eat anything, I have over our seven years together finetuned his palate so that he can critique food as well as I can. A mixed blessing and a curse! Because he will never refuse to eat anything, but like you, I can read his moods and I know when he's just not enjoying something.
One part of me says 'toughen up! If he's not complaining, why should you go looking for criticism?' but the other part of me which knows I cook for him as an expression of my love is always disappointed when he doesn't enjoy my food, to the point that it lessens my enjoyment of the food, too.
Time has taught me we have different tastes, and that's both normal and ok. I love subtle flavours, one-vegetable dishes like your wife enjoys, whereas he reserves his highest praise for strong, spicy, saucy, rich food. So even if I cook an amazing cream of carrot and almond soup - from the get-go, he's just not going to wax lyrical about it, even if it would do Chez Panisse proud. So I try to alternate between foods we both will like, and the occasional meal where it's food he will eat, but I know it's more about my taste than his - and I'm honest with both of us about that. He's entitled to his tastes, and I'm entitled to cook to my tastes, too.
When I get all experimental, I've learned to limit it to one dish or course (the soup, or a side dish) so if it's a flop or he's just not keen, the whole meal won't feel like a failure.
Also, I have instituted one meal a week which he has to cook. He gets to pick whatever he likes, and I will eat it. I think it makes him more aware of how much effort goes into cooking a delicious, healthful meal every night, so the love is acknowledged even if the dish in question isn't to his taste. It also helps him become a better cook, and allows me to reverse roles and learn what it's like to eat stuff I don't like that much, and be gracious about it.
And when I'm craving the rare foods he won't touch (asparagus, anyone?) I invite over a couple friends, make enough variety that he doesn't have to eat it, and enjoy the appreciation of the other diners.
re: Gooseberry
"Also, I have instituted one meal a week which he has to cook. He gets to pick whatever he likes, and I will eat it. "
My husband is a 'by the seat of his pants' cook, and, only after a number of years of nudging (loving nudging) will he produce a meal that is more that one dish - say, a salad with a roast chicken. That said, I have learned to stay out of the kitchen, both literally and figuratively, while he is cooking. No 'helpful' suggestions from the sidelines. Most of the time it turns out well, and these days we even get some vegetables as well.
re: MMRuth
I do most of the cooking in my house. Tonight SO made dinner and I stayed in the living room the whole time, but he kept popping in to ask me questions! I nearly went bonkers. Where does the basil grow? Do we have a ripe lemon? Should I peel the shrimp? It ended up tasting great, but I read maybe two pages of my book while he "took care of everything." I think your idea of staying out of the kitchen is a good one, but it didn't work for me.
re: Glencora
My problem is the opposite - keeping my mouth shut while he's cooking!
re: Gooseberry
Very nice comment and some good ideas I'll consider.
I have brought her along to the point where she is more vocal and critical of my cooking. Partly this has occurred because of my enjoyment of critiquing restaurant meals (for CH). She is more interested and mindful of the food and wine than she used to be and helpful in assessing the pros and cons of a meal. Thus the bar has gone up, all 'round. She used to not know the difference in a Zin and a Merlot and now she is requesting specific wines and clearly verbalizing the wine's qualities! We did have a loose agreement that she would cook once a week but that was when I was working more (you know, work that brings in money or fame).
I think I will pay more attention to what she likes. I know pot roast on Sunday was a family tradition, and she's big on ritual and tradition.
Partly, please realize that I previously had a nine year relationship with a much older woman who wanted a second childhood. We went around Europe and we both cooked and we cooked together and we were quite adventurous.
SO does like asparagus and I planted a huge bed of it for her! This is pic of about two-thirds of the vegetable-rose garden. Asparagus bed is just out of view.
re: Scargod
It's useful to know their favourites. when I know he's had a tough day, there's something very heart-warming when he arrives home and his whole face lights up because it's spaghetti and meatballs for dinner! And it's also prompted him to return the favour, within his cooking ability. So when he cooks, Valentine's romantic dinner is usually my favourite mac 'n cheese, my Tough Day meal is tomato pasta bake, and if I look sad, a suggested outing across town for pork dumplings cheers me up just as much as if he had and could make them himself.
We like making our own traditions too, especially routine traditions. Monday is date night - aka quick-dinner-and-a-movie night - for us, and Friday nights are usually soup, cheese and bread by candlelight.
I think planting your SO an asparagus bed is very romantic, Scargod. And phallic!
We'r renting at the moment, so an asparagus bed is out of the question, but one day I'd like to plant one.
Interestingly, I discovered my SO isn't so keen on sugarsnap peas -only after I planted two whole pots of them. Although I didn't remain disappointed for long, since I've been eating them all myself, straight off the plant! Gardener's privilege.
Thanks for the photo.
Another one for the choir! I love to cook; it's my creativity, my visible love for myself and others, my meditation. But I don't love to HAVE to cook, and I'm feeling like that's where I am right now. I have a full time job and am going to school so I don't have as much time in the evenings or on weekends to myself as I used to. I love big project cooking. And there are days I just don't want to cook. Not because I don't love cooking but I think because I don't want another thing on my plate and there is definitely the expectation that I cook. Maybe there's a piece of that in your feeling too? I think there are times that if it wasn't expected from me I'd be more at peace with eating cheese and bread on those nights I just don't have the capacity... Appreciation really makes cooking more fun.
I am lucky in that my sweetie likes food, appreciates most of it (no spicy), and the experience of eating out.
I like Gooseberry's idea of having one day a week that is his responsibility, but there is only so much pizza, burgers & philly cheese steaks a girl can eat!
re: emmaroseeats
That's how it is with me too. Feeling like you have no choice can take the wind out of your sails. One lady I knew was content with toast and a glass of soda for dinner and seemed puzzled as to why I would go to so much effort. One of these days I tell myself. But not today he he.
re: emmaroseeats
Very insightful posts; particularly about not wanting another thing on my plate and willing to eating cheese and bread. Particularly, when I feel SO is not stressed at all...
I usually don't think about some folks feeling inferior or intimidated. I don't think I've ever said no to an invite and I've been served some awfully simple leftovers from good-hearted people.
re: emmaroseeats
I know, emmarose eats - man-cooked foods seem to involve a whole lot more frying, mayo and cheese! But I figure, it's one night a week, it builds his confidence, and I get to pick the other six nights' meals (and can compensate for a really big fry up accordingly, with lighter foods). Or if it's something really heavy, I tell him there's got to be vegetables or salad on the side - any veg or salad, his choice, but something so I will not get the meat sweats for the rest of the evening!
His standbys: spaghetti carbonara, tomato pasta bake, grilled cheese or chicken salad sandwiches, breakfast for supper, burgers, steak and mashed potatoes, risotto.
re: Gooseberry
Y'all so sexist; generalizing and talking about phallic edibles! My, my.
FYI, I grill or roast chicken, I don't fry it. I hardly ever eat pizza or burgers. Yesterday I did killer chicken sandwiches from my last grilled chicken which was covered in fresh rosemary and Italian seasonings. It had watercress, vidalia onion, avocado, basil and gruyere cheese.
SO loves "beens and greens", an Italian soup, tortilla soup and soup-soup. That and salads often get grated parmigiano-reggiano on it but I rarely melt on or combine cheeses in my dishes! I guess roll-ups or burritos are an exception.
I can't wait to get involved in the COTM and rub up against some of you women in the kitchen. Batali's Molto Italiano should arrive any day..
re: Scargod
ew.... I was gonna play in COTM this month.... no rubbing!
re: Scargod
you're right, it's a total generalisation. However, it's true of most of the men in my life. Very few watch their weight, and all love meat. Which means a caloric free-for-all in the kitchen!
That's not to say I don't join them from time to time....
re: emmaroseeats
I love to cook. I like trying new tastes, and having a bunch of small, precise tasks (peel garlic, chop onions, rinse rice) helps focus my attention. DBF seems to really appreciate a quiet home cooked meal whatever is served, especially when he's stressed from work which lately is all the time.
Example: I'm cleaning out the pantry so last night was waffles. No complaints, and the plates were empty pretty quick.
He claims to be able to cook, but I'm too much a flaming control freak to let anyone into my kitchen. Also embarrassed, it's a bit of a mess.


text:
an unequal marriage
(translated by Toshiya Kamei)
It was starting to get dark by the time we reached Covadonga. A crescent moon was almost in the middle of the sky, and its weak light was mixed with the last hints of twilight, giving a fantastic aspect to all objects, amplifying their proportions with indecisive silhouettes.
For days we had been dreaming of Covadonga. With a feverish impatience to visit that historic place, we revived its traditions and chronicles in our minds and expanded the legends that sprouted from each one of the cantos inspired by those rocks, sacred for the Spaniards. Thus, as we arrived and descended into the ravine at the mysterious hour, our imagination was piqued, and we thought we were hearing the shriek of the Moors and the hoarse cry of the Christians; and we gazed at those soaring crags in wonderment, and Covadonga seemed like an enormous granite shell that had closed its huge valves to shelter a band of heroes like a pearl, and opened them later to disperse the seeds of a people who would grow stronger every day, reconquer their homeland, and wave their flags triumphantly over half the world in the sixteenth century.
We took shelter in an inn, and at eight in the evening, we sat to eat with the few pilgrims who were there.
The after-dinner conversation took on a pleasantly informal tone, because there were only a few of us and we all had come in search of the impression the place produced in us.
Across the table from me sat a young German man, who looked about thirty-five, and at his side a woman of about fifty-five—it was impossible to tell at first sight whether she was his mother or wife.
The two spoke Spanish correctly and were tactful enough not to say anything in German to each other, for fear that we wouldn't understand it, thus proving to us, though indirectly, they were persons of distinction.
Halfway through the meal, we already knew the woman was the wife of the German, whose name was Leopoldo Schloesing; but to our surprise, his wife called him Guillermo, while he was Don Leopoldo to us.
Perhaps Leopoldo came to notice that we were puzzled by this, besides their great age difference and their deep affection for each other, as, turning to me, he said:
"Do you think my wife is older than I am?"
I didn't know how to answer, because saying no was a lie that my eyes would have given away; yet saying yes was a lack of manners toward the woman, who smiled sweetly when she heard her husband's question and looked at him with a deep tenderness.
"Well, no, señor," continued the German. "I'm at least eight years older than she is, and I can assure you of that on my word of honor."
None of us dared say a word. If what he had said was a joke, even though laughing at it would probably have offended the woman, we would give way to laughter; but as he said it, his features assumed a solemn expression, his voice had prophetic vibrations, and he looked beyond us, his eyes lost in infinity.
"It's not a secret, nor do I want to make a mystery out of what I'm going to tell you. Surely you will take me for a madman and feel pity for my poor Margarita, but it's true."
The woman squeezed her husband's arm, laid her head on his shoulder, and we saw her eyes well up in tears.
It seemed as though we were dreaming, and even a servant and two girls who served the table stood thunderstruck with the plates and cutlery, which they washed in a basin at the back of the dining room.
The lamps seemed to have dimmed. The man had begun to move us, even fascinate us.
I was twenty-eight years old; I was honest, hardworking, and intelligent; with all my heart, I loved Margarita, who was then twenty and lived with her kind mother in Hamburg—not rich, but not destitute either. Her father, at his death, had left them income, well invested, enough to cover the needs of the two women, who had no other relative.
"Our love had grown when we were children, and I was waiting to make my fortune to marry Margarita; well, for that, I not only had her mother's approval, but the kind woman also loved me like her own son.
"In those days a brilliant enterprise in America fell into my lap, which would take too long to explain, but after a year's absence from my country, it would quadruple my investment; but I didn't have the capital, and it came to worry me so much that Margarita and her mother noticed something was wrong with me, and they urged me to reveal my secret. How could I have refused? They were my only loved ones on earth! When I told them everything, they tried to comfort me; but I was inconsolable as I felt a fortune slipping through my fingers, and with it, my happiness, because the realization of my marriage depended on it.
"A few days later, on arriving at Margarita's house, the two women flung themselves into my arms, shedding happy tears. They had sold everything they owned and were offering it to me for my enterprise.
"I adamantly refused to accept it, but they begged, cried, and insisted on it, making me understand that we were all part of the same family, that we had to share one another's joys, sorrows, and hopes, and if that money was lost, Margarita and I would marry penniless, and I would support the family with the blessed fruits of my labor. I couldn't possibly refuse the offer. I accepted it: the day for my departure arrived; I said goodbye to Margarita and her mother, and set sail for America."
*note: To read the full story featured in Epiphany Winter/Fall 2011-2012 please subscribe or buy the issue!


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Welcome to our newly designed website. Please bear with us as we continue to populate the site with new products and information to better serve your needs. We appreciate your support and look forward to having the best information possible for you to access via our website. We are constantly adding new linen. If there is something specific you require please call us and one of our consultants will be pleased to inform you of all of our new and soon-to-be linen.
Chair Decor is pleased to welcome Tania Newman to our Vancouver office. Tania will be tasked with further expanding our reach into the West. With her extensive knowledge of the rental industry and her passion for the event industry we look forward to having her continue to grow our presence in Vancouver and the Western provinces.
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Thank you so much for the services you provided for our August 13,2011 wedding. I found that the most stressful part of wedding planning was repeatedly trying to communicate with vendors effectively. Dealing with your company was one of the LEAST stressful and most pleasant of all of our wedding taskes because you were easy to talk to, easy to get in touch with, and you delivered the chairs exactly as discussed. Not only that, but you were incredibly accomodating to us, given that we live in London, and were only able to visit your location on certain days. You truly embody what every event vendor should strive to be! Thank you!Aurelia Valiulis-Cool
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text: Kiri commented: <<< Well, our plans got changed because I have a really nasty cold and sore throat...and, quite frankly, don't feel like fixing anything!! >>> I hope you are feeling better soon. <<< So, instead of going to a friend's house for dinner, my wonderful husband is going to make beef strogonoff for today. >>> If he has a favorite recipe for this, I'd like to see it. <<< Later, probably tomorrow, I'll make the buttermilk-cardamom pie (going to try it with Splenda) >>> Please let us know how this works out and maybe the recipe. I like custard type pies (and pecan), but they do tend to have more sugar than I should consume. Stefan -------- THLord Stefan li Rous Barony of Bryn Gwlad Kingdom of Ansteorra Mark S. Harris Austin, Texas StefanliRous at austin.rr.com **** See Stefan's Florilegium files at: http://www.florilegium.org ****


text:
What's Trending: Elf on the Shelf is popping up everywhere
The holiday season is plump with age-old family customs such as watching an entire hour of the yule log burn or tuning on the Christmas classic, "It's a Wonderful Life."
But now, America's homes have a new tradition. It's "The Elf on the Shelf."
It all started with a book and a keepsake box with a pixie scout elf. Written by a daughter and mother, Carol Aebersold and Chanda Bell, it tells the tale of a little helper who's Santa's eyes and ears.
He helps Jolly old St. Nick know who's naughty or nice. And the loveable super-snitch is popping up everywhere from New York City and the big screen to all around your home.
Legend has it, the elf, which you adopt and name, comes alive with magic and travels every night between the North Pole and your own home. Videos are uploaded again and again capturing the infamous friend.
Thanks to elves on shelves, Santa doesn't have to spend time and money wiring houses with hidden cameras, but it seems the elf can be unruly.
One family found the helper hanging out in the family fridge.
Here in this video, he made a mess.
Whether he's naughty or nice, you better watch out and you better not pout, for Santa's little helper is coming to town.
Has the elf on the shelf made mayhem on your mantel or is he keeping Santa's list legit. Take a picture of him around your house and send it to The List at firstname.lastname@example.com.


text:
The Annual New Orleans and Region Benefit Production of "It's a Wonderful Life" has become etched into the calendar of annual New Orleans "unmissables" for the New Orleans Christmas Holiday season.
Whether you are an established or aspiring performer on-stage, on-screen, on-camera, or behind-the-mic, you will enjoy the fun, professional-yet-informal, and informative workshops atmosphere where you will improve your voice and gain valuable information that will help you to enhance your career. Work with scripts in a group environment, supported and coached by experienced voice-over actor and educator, Stephen James.
Dates subject to change. Please check back regularly and look out for members' bulletins in your email.
Dates subject to change - please check back regularly and register with the web-site (it's FREE) to receive regular bulletins.
There will be no NOLA Voice Talent practical mid-week workshops in June, July, and August
and between Thanksgiving and New Year
Look out for news of this production workshop to be held in spring 2015
Location: New Orleans - to be arranged
In the wake of the huge success of the annual fundraiser "It's a Wonderful Life", and in response to several requests to be involved in a further production, The NOLA Voice Talent Foundation has teamed up with Pink Hat Productions to introduce a new concept in performance workshop, for stage and screen performers as well as voice actors: a one-day performance workshop.
The workshop works like this: following advance pre-arranged auditions, the cast and crew assembles in the morning, rehearse throughout the day, and perform the production as a live radio-play in the evening in front of a live audience. Participants receive a recording of the performance.
There are only NINE roles to be filled for this production, so please ensure you book your participation early to ensure you get to audition. Audition for this production workshop is by advance registration only. Workshop fee is only $50 (or $35 for Full Members of The NOLA Voice Talent Foundation).
Auditions are free and will be held in advance for all who pre-register. Workshop fee will be payable only by those who pass the audition (a limited number of spaces are also available at $25 for those who wish to attend without a role).
You can pre-register by email to firstname.lastname@example.com or by signing-up at our mid-week workshops. In the meantime, don't forget to register as a member of The NOLA Voice Talent Foundation (it's FREE!) to receive bulletins and updates.
Full membership of The NOLA Voice Talent Foundation is only $150 for full 12 months and covers the cost of ALL mid-week workshops in New Orleans, Denham Springs/Baton Rouge, and Biloxi, MS., as well as providing discounts on production and other workshops and participating suppliers.
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Become a FULL MEMBER of not-for-profit The NOLA Voice Talent Foundation now for only $150 annual subscription and save money on workshops and vendors' discounts.
Please first register above, then click here to subscribe via our web-store.
Stephen James founded The NOLA Voice Talent Foundation in 2009, and is Executive Director of the Foundation, which is subsidized by he and his wife Debi. Stephen is a prolific voice actor and coach who possesses a rare versatility which enables him to perform just about any role required. His training has included Standard American English, and the combination of that and his native British accent makes his voice perfect for narration and commercial voice-over.
He has performed in countless commercials, audio-books, computer games, and narrations; while he is also runs the specialist voice-over agency NOVA:The New Orleans Voice Agency and Pink Hat Productions.
A trained and highly-experienced educator and communicator, Stephen has coached voice techniques and the business of voice-over to hundreds of performers, including leading actors and voice-over talent, through his weekly workshops in southern Louisiana and the Mississippi Gulf coast, in seminars in a number of states, and through private coaching.
Stephen is also a director and producer, his most recent success directing the multi-award-winning movie "My Choice is Clear" alongside David Mills; while he is currently Producer of "Boys Will Be Boys - The Movie", currently in development.
Read all about Stephen James Voice Actor and Coach at www.stephenjamesvoice.com


text:
These fantastic stuido apartments to rent at Florida Park, Tenerife are solely for the over 45's. Offering peace and relaxation yet located just 5 minutes in Las Americas.
Florida Park Club is a residential-holiday complex run for the British over 45s. It is the only company offering residential-holiday complexes purely for the British over 45s in Tenerife. The complexes main objective is to provide a safe, secure enviroment maintained to the highest of standards where people can relax and enjoy the climate. Whilst it is strictly for the over 45s, this does not mean there isnt plenty to do! As well as the onsite bar / social area, there is a lovely heated pool, a jacuzzi and organised outings and entertainment. Of course all that Las Americas has to offer is just a 5 minute stroll away.Florida Park is simply a relaxing place for people who love the atmosphere that Las Americas provides but who dont neccesarily want to be caught up in the hustle and bustle that other complexes may have. It is a place where like minded people can socialise but also get away from it all if required.There is a dedictated on-site manager who is available to all guests if required.This studio apartment to rent in Florida Park is particularly spacious and offers high quality accommodation in an immaculately maintained complex.AccommodationKitchenWell equipped with cooker, oven, hob, microwave, kettle. 2 x sofas (one sofa bed), coffee table, ceiling fans, Satellite TV picks (BBC,1 2, ITV, CH4 and many more), 2 English radio channels. Lounge has patio doors leading to the balcony.Twin beds, fitted wardrobes, bedside table, celing fans.BalconyPatio table and chairs with views to the sea.BathroomShower, bath, marble sink unit, WC.The complex Immaculately kept heated pool. Social area / bar, internet point, gym, jacuzzi, launderette, security, onsite manager, organised trips and entertainment, visiting masseuse, hairdresser and beauty therapist.LocationJust 20 minutes from Tenerife South airport. Florida Park is brilliantly located with everything that Las Americas has to offer within walking distance.HousekeepingBed linen and towels included (except for beach use outside the complex). Linen and towels are changed once weekly or more frequently for an extra charge. Extra cleaning can also be arranged. Please contact housekeeping.LocationWell located just 2 minutes from Siam Park in San Eugenio Alto. Nice an quiet yet within waking distance of amenities.
The Apartment is in a very quiet area. It has access to a shared swimming pool, a balcony, sea views. If you are driving there is private parking with the outside areas of the house having external lighting.
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+44 (0) 203 696 2870
Mon – Fri 8:30am – 5:30pm
Famagusta, South
Provence Alpes
Cote d'Azur
Silver Coast
Balearic Islands
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Top destinations
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1/1 Photo of Cajun Country Smoked Ribs
Prep Time:
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If you don't have a smoker you can still grill these ribs with the seasoning blend. From the cookbook, Smoke and Spice.
Units: US | Metric
Serving Size: 1 (97 g)
Servings Per Recipe: 4
The following items or measurements are not included:
celery salt
Every recipe, menu, tip and how-to is right here, at your service.


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Philip Glass to Score Least Magical Disney Musical Ever
Philip Glass has been commissioned by the New York City Opera to compose an opera based upon The Perfect American, a novel by Peter Stephan Jungk about the final months of Walt Disney's life. If Glass's opera stays true to the spirit of his source material, Disney enthusiasts are likely to be, uh, enthused: Jungk's book, which is told from the perspective of a fictional Australian cartoonist working for Disney in the fifties, portrays Disney as a miserable, vindictive man who harbored racist and virulently anti-Communist beliefs. [Variety]


text:
HOT TOPICS: Alcoholism Addiction AA Cocaine Heroin
Morning Roundup: January 14, 2014
By Shawn Dwyer
Jennifer Lawrence 'too drunk' to talk, firefighters battle blaze with beer, Florida proposes medical pot for seizures, and Colorado stoners steal mile marker 420. MORE
Morning Roundup: May 29, 2013
By Victoria Kim
There are now over 280 "legal highs" in Europe, "innocent" Arizona woman held in Mexico on drug smuggling charges, and marijuana gardens linked to owl deaths. MORE
Morning Roundup: April 18, 2013
By Victoria Kim
Most teen-drinking deaths are not driving-related, magnets remove cigarette cravings, and Lindsay Lohan shoots mock ad for whisky-infused gum. MORE
Morning Roundup: April 1, 2013
Painkiller deaths keep rising, UPS pays $40 million over illegal drug shipments, and Madonna's homeless alcoholic brother blames his family. MORE


text:
|Start About The Resort Rates Gallery Guestbook Contact
·Secret Garden Guestbook·Leave us a note.
Brenda Almamlouk [Islamabad, Pakistan]
Hi I would like to book a room for one person for 8 Aug - 14 Aug 2013.
Please e-mail me back to confirm.
12 Jul 2013
JIAO Yun [china,beijing]
hello,I\'d want to reservation a room for my family travel in Chiangmai . We will check in at feb,19,2014,and check out about five days later. Please reply to me with my email .thanks!
10 Jul 2013
Chris Yeung [Taipei, Taiwan]
Hi, my girlfriend and I would like to stay at your hotel 1/29 to 2/4/2014. Would you please confirm availability and rate? Thanks.
04 Jul 2013
Kristine Girard [San Francisco, CA]
I would like to book the Sukhothai House checking in on Feb 27, 2014 and checking out on March 5, 2014. I sent an email inquiry as well. Thanks.
23 Jun 2013
|Secret Garden Chiang Mai - Bungalow Hotel Resort Chiang Mai, Bor Sang Thailand
Our recommendation for Koh Samui:
Bay View Resort Samui


text:
Free Will Astrology
Published: January 2, 2013
ARIES (March 21-April 19) In 2013, I pledge to conspire with you to increase your mastery of the art of friendship. Together we will concentrate on making you an even stronger ally than you already are. We will upgrade your skill at expressing your feelings with open-hearted clarity in ways that don't make people defensive. We will also inspire you to help others communicate effectively in your presence. I hope you understand that doing this work will empower you to accomplish feats that were never before possible for you.
TAURUS (April 20-May 20) Chickens and alligators share a common ancestor. Seventy million years ago, they were both archosaurs. That's why chickens possess a gene that has the ability to grow teeth. A few years ago, a biological researcher at the University of Wisconsin managed to activate this capacity, inducing a few mutant chickens to sprout alligator teeth. I predict there will be a metaphorically comparable event happening for you in 2013. The "chicken" part of you will acquire some of the gravitas of an alligator.
GEMINI (May 21-June 20) "People wish to learn to swim and at the same time to keep one foot on the ground," said French novelist Marcel Proust. An attitude like that is always a barrier to growth, of course, but in 2013 it would be especially ill-advised for you. In order to win full possession of the many blessings that will be offering themselves to you, you will have to give up your solid footing and dive into the depths over and over again. That may sometimes be a bit nerve-racking. But it should also generate the most fun you've had in years.
CANCER (June 21-July 22) Here's the horoscope I hope to be able to write for you a year from now: You escaped the chains that kept you enslaved to your primary source of suffering. You broke the trance it kept you in, and you freed yourself from its demoralizing curse. Now you have forged a resilient new relationship with your primary source of suffering – a relationship that allows you to deal with it only when it's healthy for you to do so and only when you feel strong enough to do it. Very nicely done! Congratulations! Excellent work!
LEO (July 23-Aug. 22) "In this world," said Oscar Wilde, "there are only two tragedies. One is not getting what one wants, and the other is getting it." I'm counting on you to refute the last part of that questionable assertion. According to my analysis of the long-term astrological omens, you will definitely be getting what you want in the next six months. You will receive your prize … you will earn your badge … you will win a big game or claim your birthright or find your treasure. When that happens, I trust you will make sure it is an enduring blessing. There will be no sadness involved!
VIRGO (Aug. 23-Sept. 22) English poet Alfred Tennyson wrote so many memorable lines that he is among the top 10 most frequently cited authors in The Oxford Dictionary of Quotations. One of his most famous passages was "'Tis better to have loved and lost / Than never to have loved at all." When he was on his deathbed at age 83, his enigmatic last words were, "I have opened it." Let's make that declaration your mantra for the coming year. In your case, it will have nothing to do with death, but just the opposite. It will be your way of announcing your entrance into a brighter, lustier, more fertile phase of your life. Try saying it right now: "I have opened it!"
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2001 OPEN FORUM Abstracts
DanielJ Marek BS, Alexander Adams RRT, David Dries MD, John Marini MD,John Hotchkiss MD. Regions Hospital ? HealthPartners, Univ. of Minn., St. Paul,MN.
Background:Patients with ALI or ARDS can require high ventilatory pressures to maintainadequate gas exchange. Such pressures may cause damage to the alveolar epitheliumand lead to ventilator-induced lung injury (VILI). Currently, the relative rolesof inflammation and mechanical stress in the evolution of lung injury are beinginvestigated. The actual damage caused by mechanical stress can be postulatedbut has not been clearly identified. Using scanning electron microscopy (SEM),we obtained images of lung tissue ventilated under low and high mechanical stressconditions.
Methods: In anisolated, perfused rat lung model, rat lungs were extracted, perfused, and ventilatedfor 2 hours at a pressure of either Pset=30/PEEP=3 cmH2O or 20/10cmH2O. The lungs were harvested, CPAP of 20 cmH2O wasapplied and the lungs were fixed with 3% glutaraldehyde. Random samples of lungunderwent SEM preparation using the Murakami and OTO methods followed by criticalpoint drying. Images were captured using a Hitachi S-4700 FESEM scanning electronmicroscope.
Observations:Figure 1 - SEM image of alveolar epithelium from rat lung ventilated at 30/3.NOTE: The obvious rupture in the alveolar epithelium. Figure 2 - SEM image ofalveolar epithelium ventilated at 20/10. NOTE: An alveolar pore of Kohn identifiedin lung ventilated at 20/10. Ruptures were not observed in the 20/10 lung..
Conclusion: Analveolar rupture can be easily identified by SEM. Using SEM, studies that quantifyand locate ruptures may help determine the precise mechanical-stress mechanismsof VILI.
|Figure 2
Support by AHA SDG 9930184N;NIHSCOR 50152


text:
Doctor Who: Matt Smith says his partnership with Jenna Louise Coleman is like "an arranged marriage" but she thinks it's romantic!
Doctor Who fans are of course eagerly awaiting a proper introduction to former Emmerdale star Jenna Louise Coleman in her new role as Clara Oswin, the Doctor's new companion…
And that will happen in the show's Christmas special, The Snowmen, which airs on Christmas Day on BBC1.
However, ahead of it, Matt Smith – who plays the Time Lord – has revealed that his partnership with Jenna is rather like an "arranged marriage."
Speaking to The Sun, he said, "I liken it to an arranged marriage, not that I know what one of those is like.
"It is like, 'You are married, have chemistry'."
Jenna however said she thought their pairing was more like a "blind date". Read more & comment »


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Who were the two fifteen-year-old girls from Little Rock—one black, one white—in one of the most unforgettable photographs of the civil rights era? From what worlds did they come? What happened to them? How did the picture affect their lives?
This groundbreaking book brings to light derogatory stereotypes that shape the experiences of African American women, then assesses the emotional and political costs of the struggle to counteract such negative assumptions.
In this new assessment of Martin Luther King, Jr.s 1963 I have a dream speech, Eric J. Sundquist explores the origins of the speech, its place in the long history of American debates about equality and race, and why it is now hailed as the most powerful American address of the twentieth century.
Black Gotham is a fascinating look at a little-known segment of American history: African-American elites in New York City in the nineteenth century, told through Carla Peterson's intriguing account of her quest to reconstruct the lives of her ancestors.