text:
Last month was the first month of my Eating Al Fresco Linky which will be running throughout the Summer months on this blog. I was a little nervous having never organised my own linky before ( I have guest hosted for others ) and I was ever so slightly worried that nobody else would join in, but I was wrong. Thank you to the 17 other bloggers who linked up to Eating Al Fresco for making the first month a success. A little further along in the post you will find links and images of their recipes as well as finding out who won the first Homesense gift card. Anyone who wants to join in with this months linky will find the details at the end of the post – it’s simple, just write about any of your outdoor dining experiences, link back to this one and you will be included in a full round up at the end of the month as well as have a chance to win a Homesense gift card each month ( chosen via random.org ).
So what have my outdoor dining experiences been like this month? Limited unfortunately as the Welsh weather hasn’t allowed for much Al Fresco fun but when we have the odd glimpses of sunshine I have made sure we have been out in the garden. On a few occasions I have enjoyed my evening meal after work while the girls eat their bedtime cereal on the grass besides me. My meals haven’t necessarily been cooked out there but they still taste better outside right?
The only exception has been this pork belly cooked on a small BBQ we picked up in one of the clearance sales last Summer. Just rubbed with oil, salt and pepper and chargrilled just enough so it was crispy yet succulent. Such a depth of flavour that I didn’t eat anything else alongside it just a brioche roll. Simple food. Cooked properly.
And my Greek Basil plants are seriously flourishing so I have been adding it to all my salads and pasta dishes:
I did intend to buy a Firepit from Homesense this month but my local store sold out before I had the chance – you have to remember in Homesense to buy as soon as you see something you love as they aren’t there for long but it means lots of the items are pretty unique. I have bought lots of their melamine serving dishes though which I will share in my next post.
Without further ado here are the recipes which have been linked up to this months Eating Al Fresco:
Kicking off with Dutch Oven Roast Chicken from The Hedgecombers:
Ice Cream Topped Waffles From Coffee & Vanilla
Baked & Barbecued Thai Chicken Thighs from Fab Food 4 All:
Asparagus Pesto Tarts from Tin & Thyme:
Best Ever Chunky BBQ Relish from Fab Food 4 All:
BBQ Waffle S’mores from Foodie Quine:
Vegan Picnic Pies from Thinly Spread:
Mediterranean Roasted Vegetable Pasties from Jo’s Kitchen:
Three Bean Salad With Asparagus & Coconut Dressing from The Taste Space:
Our Family Favourite Potato Salad from Elizabeth’s Kitchen Diary:
Grilled Sweetcorn, Samphire & Avocado Salad from Roast Chicken & A Country Walk:
Tenderstem & Cucumber Soba Noodle Salad from The Veg Space:
Portobello Mushroom Puff Pastry Tarts from Maison Cupcake:
Marmalade Marinated Chicken from Farmersgirl Kitchen:
Mojito Cupcakes from Caroline Makes…
Strawberry Cream Cakes from Tin & Thyme:
The winner of this months linky is Fab Food 4 All with her Baked BBQ thighs as chosen by Random.Org:
If you want to enter this month please see the ( very loose ) guidelines below:
You can add up to three links each month as long as they either write about your outdoor dining experiences, feature a recipe for the BBQ or similar or simply show images of your food being eaten outdoors. You just need to add your link to the linky at the bottom of the page each month and link back to this post – simple yes? Now for the good part – each month one entrant will be randomly chosen via a number generator to win £30 in Homesense vouchers just for taking part. Tweet your entries to me ( @writingforfun ) using #eatingalfresco and I will retweet.
What a fabulous collection of Al Fresco recipes, lots of great inspiration here;-) Can’t believe I’m your first winner – woo hoo:-)
Wonderful Alfresco recipes! The weather isn’t really helping this week, but hoping to be able to enjoy a lovely barbecue with family some time next week 🙂
Kerry at Kerry Cooks says
Yum – so much inspiration here! I REALLY want to have a bbq now – thank goodness the weather is going to be dryer this week 🙂
Claire @foodiequine says
What a fab roundup! I must remember to add some more this month, didn’t realise I could add three. Thanks for including my BBQ waffles. They have been so popular.
Yay, well done. Nice round-up. So wishing we could do more outside eating, but it’s been pretty miserable here a lot of the time. Still hope springs eternal …!
Sus // roughmeasures.com says
Lovely idea, if only we had some more sunshine!

domain: food


Imagine Washington DC, a few days after the election in 2014. The Democratic Party has lost control of both houses of Congress. Harry Reid, the most senior Democratic congressman, can’t be reached. He has left town for a yoga retreat, no cellphones allowed at the ashram. President Obama won’t answer questions about the election or the future, and will only talk about Michele’s plans for next year’s White House garden.
Of course that didn’t happen. Political leaders don’t have the luxury of taking time off, much as they might like to ignore the results of Tuesday’s vote. When votes are counted, the losing politician has to get up on stage and make a speech. Losers have to stand up and face the music, and talk to their supporters face to face.
But in Great Barrington on Tuesday, after a smashing defeat for the School Committee, and for many other elected officials who’d put themselves in front on the $51-million high-school renovation project, I was reminded of the British comedy Fawlty Towers. I thought of the episode when the Fawltys, who managed a hotel, were preparing for a group of German guests. “Just don’t mention the War!” Basil Fawlty admonished the hotel staff. He talked, instead, nonstop about anything and everything else. “Anything but the War!”
That was the Berkshire Hills School Committee on Thursday night. Anything, but anything, except the defeated building project.
On the Thursday evening after the vote, cold rain was falling, but my spirits were high. At last, we might be able to break through and get the change that Great Barrington needs. Last year, a virtually identical project was defeated, and that’s when I re-engaged with local politics. It was a breathtaking moonlit evening when I went to a School Committee meeting for the first time since 2001. [You can read about that here.] I was hopeful then, too, but in spite of what I heard that night, the School Committee had simply brought the same proposal back to the voters. It had been even more resoundingly defeated.
Everyone had expected the subject of the first School Committee after the vote to be, well, the vote – win or lose. But the most important topic – the War, in Fawly Towers terms – was off the table. Conveniently, the district’s superintendent, Peter Dillon, had left for China immediately after the vote, providing the ostensible reason for not saying a word about the most divisive campaign the town has ever seen, even though the elected leadership of the school district was, to a man and woman, there in the room.
But there was no sign of Dick Coons, who has been at the center of every construction project for the last two decades, and who last year at the same time sat just off to the side of the school committee, at the front of the room with them. There was no sign of Karen Smith, the volunteer leader of the 2014 committee outreach, who got the job because she stood up last year and gave one of what I think of as her “denouncement” speeches. (I was the target of one, once upon a time, and have heard others.) [You can read about that here.]
The meeting began with a committee reorganization that went like a roll call, every vote unanimous starting with Steve Bannon’s re-election as chair. “High school renovation is officially dissolved,” he said, and that was that. “We’ll talk about it on the 22nd, when Peter is back.”
They ran down the list of committees, joking amiably. What a good-humored group they are. “I want to be on that. It should be an interesting year,” said a man in yellow shirt when they got to the Building & Grounds Committee.
A student in suit and tie provided the “good news” that has become a feature of reporting from the district. I see the point of this (so often people just hear about things that go wrong) but wish it didn’t come across as so much like kindergarten notes. On Thursday, I would have liked to hear something substantial from the high school, the center of the current political battle. Instead, the good news was just school sports, leading with golf, a Shakespeare program, and student government contact with another high school. Nothing was said, for example, about college applications (early acceptance letters were due this week) or anything academic.
The committee members were clearly determined not to say a word about the vote – like Harry Reid away at the ashram and Obama refusing to talk about anything but the importance of fresh vegetables. The affable Steve Bannon, whom I think of as Teflon Bannon, sets the tone.
I gave up and went home an hour into a presentation about MCAS results. The presenter repeatedly apologized for “rushing through this,” as he took went through the data in slide after slide after slide, with the committee members’ nodding with solemn fascination. Anything, anything at all, just don’t talk about the War.
But I was glad to have heard what I did. I learned just how poor our district families are, and that instead of being a country version of a top suburban school district we’re on the verge of being eligible for a program that would give every child a free lunch. (Eligibility for the program requires 40% of families, and we’re at 37%.) That’s not well-off suburban but inner-city or poor rural. Most of our MCAS results are lower than the state average, and hitting that average seemed to be our target. I asked about this, saying it seemed a surprisingly low bar. This is not the high-performing district I remembered from the days when I was on the school committee. The speaker answered my question by explaining, sympathetically, that ours is a poor rural school district.
I was shocked by this because it’s not what I’ve heard of late about the district. Here’s a typical example, from a recent post from Karen Smith: “Berkshire Hills’ programming is so rich and its academic standards are so high, we have more students than we can accommodate clamoring to choice into the district.” I now have a better understanding of the challenges our teachers face, and realize that the children and families in our community need a great deal of support to get the kind of start in life that US public education is designed to offer.
Is there a disconnect between parents who want the Great Barrington schools to be the equivalent of Westchester or Bethesda public schools, and therefore want the community to support building projects on that scale? It would be natural. We all want the best for our children, and that means that we want great schools in Great Barrington. But demographic realities suggest that our challenges are not STEM teaching or adding a new AP program, but helping a student population that needs the most basic support.
I’m no expert but I imagine that our students need more of what children in any poor neighborhood need: better nutrition, language coaching, after-school tutoring, mentoring programs, etc. But not big new buildings that would make it even harder for their parents to make ends meet.
By the way, I checked with someone who stuck it out to the end of the Thursday meeting and was assured that the building project was not mentioned again. Not in polite company. Don’t mention the War!


text:
2023 i4Kids Symposium Recordings and Pediatrics Article
The 2023 i4Kids Symposium recording is now available to view! i4Kids was also featured in a Pitt Pediatrics article titled "i4Kids Hosts 2023 Annual Research Symposium." The article provides an overview of the 2023 symposium. Check out the links below for the recording and the Pitt Pediatrics article.

domain: medical


text:
|VAMPBLADE: SEASON THREE No. 1, March 2018|
Admittedly, that doesn’t necessarily mean though that there’s no fun to be had with “Action Lab Comics” ‘rebooted’ risqué story of a mystically-bladed cosplayer fending off “the Glarkian space vampire invasion all over again…” If the more morality-laden readers amongst this tome’s audience can momentarily set aside their Victorian values then the periodical’s opening panels alone do a rather stellar job of both providing the uninitiated with a rather tongue-in-cheek introduction to this warped incarnation of downtown Detroit, as well as providing a few laughs along the way; “The translucent space dicks decided to change up their game and go full on scorched Earth!”
Likewise, Martin isn’t stingy about imbuing his eighteen-page long script with plenty of over-the-top violence either, as the “comic shop owner” literally severs hands, impales chests and guts criminals with her evidently lethal namesake weaponry, whilst all the time wearing next to nothing. Why, even Vampblade’s previously deceased father gets in on the graphically-pencilled action, courtesy of a behind the counter hand-gun and a somewhat callous head-shot which partially blows away the brains of a temporarily distracted, bald-headed robber.
Possibly this book’s biggest attraction however, is in its dynamically-charged, colourful and cartoony illustrations. Featuring the work of “new artist” Marcelo Costa, a Brazilian with a clear talent for turning even the most harmless looking stuffed animals into terrifyingly frenzied killing machines, few observers can surely question the forceful speed with which either version of Carva can wield her razor-sharp throwing swords, or just how blood-flow stoppingly tight the girls’ minimal “getup” is.
‘First published on the "Dawn of Comics" website.'
|The regular cover art of "VAMPBLADE: SEASON THREE" No. 1 by Marcelo Costa|

domain: hobby


Engineers, as practitioners of engineering, are professionals who invent, design, analyze, build, and test machines, systems, structures and materials to fulfill objectives and requirements while considering the limitations imposed by practicality, regulation, safety, and cost. The word engineer (Latin ingeniator) is derived from the Latin word singeniare (“to create, generate, contrive, devise”) and ingenium (“cleverness”).There are many branches of engineering, each of which specializes in specific technologies and products. Typically, engineers will have deep knowledge in one area and basic knowledge in related areas. For example, mechanical engineering curricula typically includes introductory courses in electrical engineering, computer science, materials science, metallurgy, mathematics, and software engineering.
When developing a product, engineers typically work in interdisciplinary teams. For example, when building robots an engineering team will typically have at least three types of engineers. A mechanical engineer would design the body and actuators. An electrical engineer would design the power systems, sensors, electronics, embedded software in electronics, and control circuitry. Finally, a software engineer would develop the software that makes the robot behave properly. True Engineer is one who not only know basic laws & principle but also has ability to apply this knowledge to solve the world’s most critical problems like electricity, environment, transportation, healthcare, food etc. True engineer should always strive for innovation and think out of box to solve problems of today and generation to come.
Done by: Safarov Bakhtiyor, Student first course, “Power engineering” faculty, gr. 430101 A1.


text:
This is evident within the number of Alabama sports fans registered with vital betting websites like Bovada and BetOnline. We would strongly advocate keeping an eye fixed on the betting law modifications in Alabama, as this one could change sooner quite than later. The hottest betting choices are likely to have adverse odds. For example, most sportsbooks supply -110 on both side of a degree spread or a total points line.
Most trendy computers allow websites to use your location, which they usually determine with built-in GPS signals or IP addresses. That’s how certain sportsbooks block citizens of the United States, however not international gamblers. This is why we have collected the top and safest on-line sportsbooks for you. Florida boasts a broad vary of sports followers, with many choosing to play online. There is not any magic quantity that differentiates a “big chalk” from a “small chalk” in any given sport. The more you get involved in sports betting, the quicker you’ll start to kind your individual definition for “big chalk” and “small chalk”.
While it doesn’t seem like state governors are excited about altering the law, we may see this stance change subsequent year. California – Sports betting still isn’t legal within the Golden State, regardless of boasting a number of the country’s most historic and profitable sports activities groups. With a wave of sports betting legalisation sweeping the nation, we will probably see issues modify within the coming years.
Wyoming Sports Betting
DraftKings and FanDuel went reside in WV soon thereafter and have since been joined by different operators. Sports betting was legalized in Virginia in April 2020 and officially launched its first sportsbook in January 2021. According to state law, there might be a minimal of 4 and as many as 12 cellular sportsbook choices obtainable.
Types Of Bets
Implied likelihood is the anticipated likelihood of an end result as determined by bookmakers, and it’s proven using odds. “Casino trade ramps up effort to repeal sports activities betting ban – Las Vegas Sun Newspaper”. Modern analysis has suggested that the claims of betting were unsubstantiated. Such actions instead represent violations of the ICC’s code of conduct. Any occasion in any multisport competitors in which an individual is collaborating. For example, an Olympic baseball or softball participant can’t guess on any Olympic event taking place at that particular Summer Olympics.
Who Sets Sports Activities Betting Lines?
For example, a $100 wager on the Phillies would earn you a $114 profit, while a $100 wager on Stephens would deliver a $142 profit. Forbes Advisor adheres to strict editorial integrity requirements. To the most effective of our knowledge, all content is accurate as of the date posted, although provides contained herein might no longer be out there.
Australia-based PointsBet is called a website that’s geared towards sports activities bettors. The web site features a unique betting possibility often known as PointsBetting, and careful consideration is at all times paid to the chances and contours. PointsBet also has an intriguing ‘name a bet’ characteristic where bettors can submit requests and obtain odds upon approval. These are wagers supplied as options to money line wagers in baseball, hockey, or soccer, respectively.
Sports betting officially debuted in New Hampshire in December 2019 after being approved by the state Legislature earlier in the 12 months. The approval lined both retail and cell, but the state of affairs is exclusive in NH. DraftKings is the unique supplier of on-line and mobile wagering within the state and likewise the operator of the lone retail retailers.
DraftKings, FanDuel, BetMGM, and Caesars had been among the first sportsbook operators to open for enterprise in Arizona. The list of cell sports betting options continues to develop. Here is a list of the top 10 sports betting sites in the US.
Professional sports activities leagues up to date their positions once more on May 14, 2018, when the Supreme Court of the United States overturned the Professional and Amateur Sports Protection Act of 1992 . ufabet Proposition bets are wagers made on a very particular end result of a match not related to the final rating, normally of a statistical nature. To get ready for a great 12 months, we’ve received presents from the highest sportsbooks ready.

domain: law


The Ultima X gas monitor series now is available for duct-mounted monitoring applications. This kit enables gas sampling even when the flow rate within the duct is at a high velocity, says the company. It is sealed to prevent the gas within the duct from escaping, states the manufacturer. Users can calibrate the sensor via a calibration port without disassembling or removing the sensor from the duct, states the company. According to the manufacturer, the disconnect-under-power feature allows sensors in an explosion-proof unit to be changed without the need for hazardous-area declassification.
MSA Instrument Division, Data Sheet 07-2051; P. O. Box 427, Pittsburgh, PA 15230; 800-672-4678; www.msagasdetection.com.


text:
Martina from Confessions of a Sewing Addict continues her search for the perfect bag, this time with her Simply tote. She claims that this is still not the perfect bag, though with a zippered top, two large outside pockets, and an inside zippered pocket, it seems pretty perfect to me. Like her other designs in this series, she shares a tutorial so you can make one. She’s also giving away her example purse to one lucky reader. Giveaway deadline is March 18. Go to her blog for the tutorial and to enter her giveaway.
[photo from Confessions of a Sewing Addict]
[tags]sewing, tutorial, simply, simple, tote, purse, bag, zipper, pocket[/tags]

domain: artistic


text:
The first airfield at Chièvres was established at the end of 1917 by the Germans who flew fighters from the unprepared grass field. In 1939, the Aéronautique Militaire/Militair Vliegwezen planned to turn Chièvres into a diversion airfield for which first work started by the end of that same year. Overtaken by the events in May 1940 construction was left unfinished and in June 1940 the Germans started rebuilding and expanding the airfield, calling it "base 404". On 27 September 1940, the Italian Air Force stationed Fiat BR.20M “Cigogna” bombers (43° Stormo) and Cant Z.1007bis reconnaissance aircraft (172° Squadriglia Ricognizione Strategica Terrestre) at the base. The 43 Stormo participated in several air raids over Britain, bombing the ports of Ramsgate, Harwich and Ipswich. Many of these raids did not end well for the Italians mainly due to the inexperienced pilots in combat situations and difficult weather conditions. At the end of December 1940, the Italian government recalled the Italian Air Corps from Belgium as the military situation was becoming increasingly worse in the Mediterranean area and by 10 January 1941 all Italian troops had left the base. Later on, numerous Luftwaffe bomber-units equipped with aircraft such as the Ju 88, Ju 188, He 111 and Ju 86 were stationed at Chièvres to attack targets in England and the same time the base also served as diversion field for Luftwaffe fighter units. On the 14th of June 1944, approximately thirty German aircraft of Chièvres based K.G. 6 bombed the landing beaches in Normandy. By the first of September 1944 the last Luftwaffe aircraft left Chièvres for Holland and the installations were destroyed. Two days later the Allied troops took over command of the airbase and the Army engineers of the USAAF immediately started rebuilding the infrastructure. By October 1st, the Republic P-47D Thunderbolts of the 361th Fighter Groups arrived at Chièvres (by now designated A-84) to attack the retreating Germans and to bomb positions in the Ardennes during the Battle of the Bulge. To give assistance during the Ardennes offensive (12/1944) the base was also used by the Hawker Typhoons of 123 Wing RAF (including semi-Belgian operated 609 Squadron). By March 1945 it was the sound of the Packard-Merlin engines of n° 352 Fighter Group's P-51D Mustangs who filled the skies over Chièvres. In all, Chièvres airfield was bombed over 30 times during the war. With the end of the hostilities, Chièvres became a transit station for US soldiers retuning home to the States as well as being a German POW camp. By the end of 1945 almost all activity had stopped and the base was turned over to the Belgian authorities. Two years later the Aviation Militaire/Militaire Vliegwezen (the term "Belgian Air Force" was only introduced from 15 January 1949) started an ambitious rebuilding and expansion plan to turn Chièvres in a modern post-war jet-fighter base. On 1 December 1950 the 7th Fighter Wing was officially established at Chièvres through IA/AO n° 32/50 while its first Gloster Meteor jet-fighters arrived by May of the following year in order to equip N°s 7 and 8 Squadrons. On 29 October 1951 the three squadrons of the newly created 10th Fighter Wing (N°s 23, 27 and 31st Squadrons) were stationed at Chièvres to start their operations with Spitfire F(R).14 aircraft awaiting their transfer to Kleine Brogel airbase and reception of the first Republic F-84E/G Thunderjet fighter bombers. By 23 February 1953 all 10th Wing Thunderjets had left Chièvres for Kleine Brogel. In June 1956 the resident 7th Wing Squadrons converted to the very elegant Hawker Hunter Mk. 4 only to replace it by the more advanced Hunter F.6 two years later. N° 7 Wing finally met its end on 28 October 1963 with the disbandment of N° 7 Squadron. This by no means was the end of military flying for Chièvres as the Blind Flying Squadron (VZZ - Vliegen Zonder Zicht/VSV -Vol Sans Visibilté) transferred on 14 November 1963 to the base from Kleine Brogel. On 3 July 1967 even this squadron left the base and on 31 December 1967 the Belgian Authorities officially turned over Chièvres Airbase to the Supreme Headquarters Allied Powers Europe [SHAPE.]. The Americans established on January 1st 1968 the "NATO SHAPE Support Group (U.S.), a U.S. Army unit now known as 80th Area Support Group (NSSG). Chièvres air base was operated by a US Air Force unit to provide logistic support to NATO and SHAPE, and welcome its distinguished visitors. The first U.S. Air Force unit was Det 4, 7104 Air Base Wing which became the 7104 Air Base Squadron, then Det 1, 52nd Tactical Fighter Wing Det 1, 86 Operations Group.
Mike Terlinden Collection
Interesting view of the south-western side of Chièvres airbase taken at 14h30 on 13 October 1953 by a Gloster Meteor FR.9 of N° 2 Squadron
RAF based at Wahn (Germany). Many Gloster Meteor F.8 fighters and a single Airspeed Oxford "base hack" can be seen in front of the main hangars.
Last updated 10/06/12 07:55 Daniel Brackx

domain: history


text:
It is the reliable and standardized clinical data behind a medicinal product that makes the evaluation and approval of a medicine or a medical device possible by the regulatory authorities. This regulatory procedure is a cornerstone to ensure the clinical safety and efficacy of medicinal products ultimately marketed for use by the medical community and by patients. Regulatory approval requirements primarily define which data elements should be collected and how they should be presented and analyzed. Within the context of this paper, the definition of in silico clinical trial is taken from the Avicenna Alliance as “the use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention”.1
Regulatory data requirements for medical device clinical trials
In vivo medical device trials
Medical device clinical trials in European Union (EU) are currently regulated by Regulation 2017/745 (also known as the ‘EU Medical Devices Regulation’ [EU MDR]) and are termed as ‘clinical investigations’ (ie, any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device). In EU MDR, ‘clinical data’ means information concerning safety or performance that is generated from the use of a device. Intracardiac devices are classified as Class III medical devices and their review demands (with certain exceptions) performing clinical investigations.2 EU MDR provides the requirements for medical device clinical investigations under Annex XV Clinical Investigations, which are generally like the ones required by EU regulations for pharmaceutical randomized clinical trials. While EU MDR is the overarching European regulation for medical device clinical trials, regulatory overview of medical devices is managed by accredited notified bodies on a member state level with the scientific opinion sought from the European Medicines Agency (EMA) in case (a) medicines are used in combination with a medical device, (b) medical devices contain an ancillary medicinal substance, (c) a medical device is a companion diagnostic test, (d) medical devices are made of substances that are systemically absorbed, or (e) a medical device is categorized as a high-risk medical device.3
Currently, there is no Europe-wide mandate for any clinical data standard to be applied for the regulatory overview of a pharmaceutical or a medical device. European initiatives, however, exist at EMA and Heads of Medicines Agencies (HMA) levels to promote the use of standards to facilitate interoperability of data and possible adoption of relevant Clinical Data Interchange Standards Consortium (CDISC) standards for collecting raw data in clinical studies.4,5
The medical device data requirements of the United States Food and Drug Administration (FDA) are managed by the Center for Devices and Radiological Health (CDRH). CDRH encourages manufacturers to use data and terminology standards in pre-market submissions and post-market reports for medical devices yet does not require the use of specific clinical data standards. Medical device clinical trial data are accepted by the CDRH in any format, including CDISC standards.6 However, CDRH is expected to adopt an approach in the future for data standardization in medical device clinical trial data submissions and early adoption of clinical data standards by medical device developers could support process optimization, successful data submission, and timely regulatory review.7,8,9,10,11 Of note on this possible change in the FDA policy for medical device clinical trial data submissions, the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) already require pharmaceutical clinical trials data to be presented in CDISC standards, along with controlled terminologies.12
In silico medical device trials
While 75 EU-funded research projects concerning in silico trials are ongoing in Europe, there is not yet a European framework or strategy for implementing in silico medical device trials.13 In fact, a few of these projects are expected to support the European framework for in silico trials.14,15 This paper itself is a similarly targeted assessment of the current and evolving framework.
The FDA has recently published draft guidance for the assessment of the credibility of in silico approach in medical device regulatory submissions.16 While this guidance does not directly address any clinical data standard, it does provide an important framework for credibility assessment of different in silico clinical trial approaches, from defining the question of interest to generating the adequacy assessment and reporting, following the document ‘Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices’, prepared by the American Society of Mechanical Engineers.17 The FDA presents different evidence categories for in silico clinical data generation; two categories are relevant for medical device trials: Category 5 – Evidence generated using in vivo conditions to support the current context of use (for individual-level data and for comparison between model predictions and a clinical dataset) and Category 8 – Population-based evidence (no comparison is made on a patient-level basis). Relevance of each of these clinical evidence categories is considered within the verification and validation needs.16A reporting guidance document by the FDA is also available for reporting modeling studies in medical device submissions.18
As a section summary, data standards are not currently mandated for medical device clinical trial submissions in the EU or the United States yet regulators might be expected to adopt or to broaden the scope of clinical data standards. Inclusion of in silico medical device trials data into regulatory submission files also raises issues of data conformity and verification/validation with the corresponding in vivo medical device trials data. Use of clinical data standards for medical device trials has been presented by medical device developers in recent literature.7,8,9,10,11 Interestingly, the FDA itself is currently partnered with the private sector to produce the first simulated human heart, the ‘Living Heart’. Objectives of this project include in silico testing of new medical devices.19 While other data standards could also be employed for medical device trials, CDISC standards represent the most advanced set availablefrom a regulatory point of view. The next section valuates the potential use of CDISC standards for the management of in vivo and in silico medical device trials data.
CDISC standards and medical device trials
CDISC is a standards development organization that manages data standards and controlled terminology for clinical research data management. These standards make standardized clinical data collection, organization, analysis, and review possible.20 CDISC standards also include a tabulation standard for animal studies (Standard for Exchange of Nonclinical Data, [SEND]), study planning, data exchange, and descriptive dataset metadata (Define-XML). CDISC standards employ different domains for clinical trial data, such as medical history, adverse events, laboratory test results, and medical device properties. Domains are further grouped into classes, with most belonging to the following three: General Observation Classes of Interventions (Concomitant Medication and Exposure), Events (Adverse Events and Medical History) and Findings (Laboratory and Questionnaires). Domains and classes have associated variables, controlled terminologies, and business rules.20 The structured model can support clinical researchers in becoming proficient with the standard. CDISC has implementation guides already in place for the SDTM and ADaM standards, for use in medical device clinical trials. This guidance covers seven medical device-related domains (for device identification, fixed and variable device properties, device tracking, and device-subject exposure), and complements other foundational CDISC standards.21
Since 17 December 2016, the FDA, CDER, and CBER require pharmaceutical submission data and metadata to be structured using CDISC standards, namely Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), SEND, and Define-XML.22 The Japanese Pharmaceuticals and Medical Devices Agency requires CDISC standards for both pharmaceutical and medical devices submissions.23 The Chinese National Medical Products Administration has made a recommendation to report data in CDISC standards.24 While CDISC standards are mostly used by the pharmaceutical industry for regulatory submission purposes and have only been partially implemented in the academic world, CDISC now collaborates with Research Electronic Data Capture (REDCap) and OpenClinica initiatives to promote the adoption and use of CDISC and Clinical Data Acquisition Standards Harmonization (CDASH) standards in academic clinical research as well.25,26 An academic research community has also expressed interest in using CDISC standards for investigator-led clinical research without a regulatory mandate.27
The FDA has published guidance for industry on specifics of standardized study data and controlled terminologies for pharmaceutical submissions.12,28 There are two major needs that are fulfilled by these technical requirements: (1) To facilitate and expedite the regulatory review process of the clinical data (using a study data standardization plan, data standards, and controlled terminologies); and (2) to conduct comparative analyses across studies. An additional benefit of data sharing and reuse is facilitated by applying the same data standards across different research groups.29,30 For simulation and modeling purposes, data sharing is more than an ethical imperative: validation and improvement of the models require patient- and/or population-level clinical data over time from the studies within the therapeutic area, and any shared clinical data should be made interoperable to serve the purpose.1,31 It is reasonable to expect that these regulatory and data sharing benefits would similarly apply to clinical data generated within medical device trials if clinical data standards are adopted for regulatory submission and data sharing procedures.
Limitations of CDISC Standards
While comprehensive, CDISC standards have some general and device-related limitations. As an example, the FDA states that ADaM structures do not support simultaneous analysis of multiple dependent variables or correlation analysis across several response variables. Conversion of legacy study data (data in a non-standardized format) to SDTM and ADaM formats could also raise traceability issues and may require extensive work on the data to conform to regulatory standards, depending on the complexity and available documentation of the source data.22 Prospective application of CDISC standards is therefore a more appropriate procedure. As CDISC standards are not binding for medical device manufacturers, clear implementation of the standards has not been possible so far. Example implementation strategies and associated problems to be considered in advance have been shared in the literature.7,8,9,10,11 Finally, CDISC standards do not address specific data management requirements for in silico trials; these specific aspects are further elaborated below.
Considerations for physics-based or physiological modeling data
CDISC standards have been developed for real-world clinical data, meaning that they help organize biologically or operationally obtained data. In in silico trials, however, data will be generated solely through simulation and modeling. While clinical components of these data could be managed using CDISC standards (assuming that data will be generated as one record per subject per parameter per timepoint), the physics-based or physiological data generated within a medical device simulation model could require a different structure and/or standard. An FDA guidance document provides a general outline for the reporting requirements of computational medical device modeling studies, without naming particular data submission requirements.18 If new medical device standards were to be developed to support the modeling and submission of underlying physics-based or physiological data to regulatory bodies, a cross-functional team including CDISC experts could support on this task. The data could be mapped to CDISC SDTM and ADaM domains and datasets, and have additional metadata described in the Define-XML as needed. This approach could also help to map relatedness and causality links between medical device physics-based or physiological data and clinical events, findings, and interventions datasets.
Implementation issues and scenarios
From a technical perspective, implementing CDISC standards for the clinical data of a medical device trial should take the same approach and involve the same considerations whether the trial is in vivo or in silico. The key decision point is the anticipated purpose of conducting an in silico device trial: If the purpose is to validate the in silico trial model for supporting the regulatory submission of a new device, the reviewers will require a twin set of identical in vivo and in silico trials for validation purposes, depending on the novelty and the associated risks of a the new medical device. This assumption demands an in silico trial generating patient-level data and the same CDISC standards and considerations should apply for the in vivo as well as the in silico trial. The regulators will also require the same data approach from the Case Report Form (CRF) variables and format up to the analysis results and metadata to verify model validation and conduct patient-level comparative analyses. It will be ideal, therefore, to prospectively implement the in silico trial strategy into an actual and in vivo clinical development program of a medical device.
If the purpose of the in silico approach is to supplement the assumptions and findings of an in vivo trial (eg, extrapolation for patient populations with different baseline characteristics), an approach should be taken for generating population-level model and data. An in silico trial with population-level findings would be of limited use for regulatory purposes as the cross-comparison of in silico and in vivo clinical data would be restricted to the level of aggregated data.
In silico trials are expected to be accompanied by additional animal, human and/or cadaver studies within a regulatory submission package of a medical device (whether for model validation purposes or for parameters that could not be addressed by the in silico trial, or both).32 As discussed above, CDISC standards (along with Controlled Terminologies) provide an interoperable and harmonized data framework for all of these study types. The FDA study data technical conformance guide provides a folder structure to organize clinical and non-clinical datasets from multiple studies within the same submission package.28,33 Care should be taken to harmonize any custom term or domain created by the sponsor (if required) across the submission dossier.
Another potential challenge in in silico medical device trials would involve traceability and causality links with the underlying physics model.34 For example, how would an in silico transcatheter aortic valve implantation (TAVI) medical device trial simulate the adverse event of procedural bleeding in a single patient? Would the adverse event have causal (ie, mathematical) connection to the underlying physics data or would it appear solely stochastically through statistical probability analysis? In any case, the in silico trial should clearly define individual elements of engineering and modeling outcomes and their relation to the clinical outcomes. CDISC standards (SDTM, ADaM, and Define-XML) could be employed to identify and map the metadata of these outcomes, just as they are used to identify the clinical ones. The Define-XML specification document provides methodology and examples, including use of supplemental files, for linking computational methods, algorithms, and code to a clinical variable.35
Full technical details of successful implementation of CDISC standards for TAVI medical device trials is beyond the scope of this paper and readers are advised to consult the references of previous publications.7,8,9,10,11 Of special interest for TAVI trials, the Edwards Lifesciences group reported their successful implementation of CDISC standards for their TAVI trials and their involvement with the CDISC authors to work on CDISC implementation and the development of user guides9 The last, but highly crucial, step would include direct and trial-/device-specific discussions with the regulators for the data requirements. The FDA emphasizes this point and advises that the discussions should be initiated at an early development phase.28 EU authorities similarly offer expert panel consultation for all class III devices, and prior to the clinical investigation, the manufacturer may consult an expert panel with the aim of reviewing the manufacturer’s intended clinical development strategy and proposals for clinical investigation.2,3
This paper assessed the feasibility of using CDISC data standards for in vivo and in silico medical device trials from a regulatory requirements and data management perspective. TAVI medical device trials were taken as a use case for practical implications. For regulatory evaluation and approval procedures, clinical data submission requirements should be considered to be the same for in vivo and in silico medical device clinical trials for data validation, traceability, and interoperability purposes. These trials should be expected to be complementary to each other, possibly along with supplemental non-clinical or observational data, within the same submission package. While there are no binding regulatory frameworks in the United States and EU for clinical data submission of medical device clinical trials, the available FDA framework of CDISC standards and controlled terminologies for pharmaceuticals offers a viable and feasible option. CDISC standards and additional controlled terminologies should be considered as the most advanced clinical and non-clinical data tools from a regulatory and clinical development perspective for practical adoption into the data management structure of medical device trials. Use of CDISC standards for medical device clinical development could facilitate and expedite the regulatory review process, cross-study comparative analyses, clinical data sharing and use, and model validation and improvement. While this reasoning for CDISC standards is supported by available guidance documents and successful real-world TAVI medical device approval cases made available in the literature, adoption of CDISC standards for medical device trials is still an active research area and requires prospective consideration and built-in investment in a clinical data management program, ideally starting from the CRF development stage. Plans for providing standardized clinical data should be discussed with regulators at an early stage of a medical device clinical development program.
When compared to in vivo medical device trials, an in silico approach comes with specific opportunities and challenges for implementing CDISC standards. If validation of an in silico trial model is desired with the use of patient-level data along with in vivo clinical studies of a medical device, in vivo and in silico clinical development activities and elements, including data format and standards, should be prospectively harmonized within the same development program before any data collection begins. This approach should avoid traceability and interoperability problems. If the purpose of an in silico trial model is limited to supplementing an in vivo medical device trial, a population-level data generation model could be built. In this case, the statistical analysis plan and structure of datasets generated by the in silico approach require careful consideration to provide reliable supplementary outcomes while conforming with regulatory statistical principles. In both cases, an early discussion with regulators should again help medical device developers to design and implement an optimal in silico model within the clinical development activities of a medical device.
A unique challenge for in silico medical device trials will be the formatting and mapping of physics-based or physiological data generated by a medical device computational model. As medical device modeling studies mature, new data structures and standards could be required to present datasets of computational outputs linked with medical device trials to support regulatory submissions. CDISC metadata standards could be used for mapping model-generated data to CDISC, SDTM, and ADaM domains. Addressing this challenge will require the multidisciplinary work of subject matter experts in computational modeling, clinical research, and data management. CDISC community and research activities are ongoing for mitigation. Specifically, an ongoing European project called ‘In-Silico testing and validation of Cardiovascular IMplantable devices (SIMCor)’ is aiming to establish a computational platform for in silico development, validation, and regulatory approval of cardiovascular implantable devices.36 One of the project’s objectives to mitigate the challenges stated above is to contact medical device manufacturers that are sponsoring TAVI clinical trials for which the possibility of anonymized patient-level data sharing was announced on clinical trial registries, and to request the reuse of trial metadata and anonymized patient-level data. If made available, the trial metadata will be used to build up template CRFs, SDTM, ADaM, and Define-XML files for pilot implementation of mapping between computational model-generated data and clinical outcomes, while anonymized patient-level data will be used to support computational model development, verification, and validation.37 Additionally, the SIMCor project involves scientific and regulatory advisory boards to facilitate the formation of the desired multidisciplinary forum for advancement of in silico medical device trials methodology.
This feasibility assessment concludes that CDISC standards are an ideal foundation to start addressing harmonized clinical data management of in vivo and in silico medical device trials for regulatory approval procedures. This ssessment is limited to the scope of a single-use case of TAVI medical device trials;similar steps should be taken for different types of medical devices for which clinical trials for regulatory approval are required and an in silico clinical trial approach could provide added benefit. For specific disease areas, CDISC Therapeutic Area User Guides can support in silico medical device trials design and evaluation teams with disease-specific examples and guidance for CDISC standards implementation.38 While the learnings from in vivo medical device trials using CDISC standards are relevant for in silico trials, continous regulatory discussion, multidisciplinary teamwork, and reuse of available trial metadata and clinical data are needed to overcome specific challenges and to successfully implement CDISC standards for complementary in vivo and in silico medical device trials.
The authors wish to thank Steve Canham (ECRIN) for his input.
This paper was prepared within the ‘In-Silico testing and validation of Cardiovascular IMplantable devices (SIMCor)’ project activities. This project received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101017578.
BA is currently an employee of Aixial Group on behalf of Sanofi. This paper is not related in any way with BA’s current role or employer. ÉK is an authorized CDISC Instructor and has performed consultancy work for CDISC. CO has no competing interests to declare.
BA provided the first and the updated version of the manuscript. ÉK and CO reviewed the manuscripts and gave feedback to BA. ÉK provided input as CDISC specialist and CO as a previous head of a clinical trial unit. BA, ÉK and CO have been involved in the SIMCor project.
1. Viceconti M, Henney A, Morley-Fletcher E. in silico Clinical Trials: How Computer Simulation Will Transform the Biomedical Industry. January 2016. DOI: http://doi.org/10.18203/2349-3259.ijct20161408
2. European Parliament and European Council. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union 2017, 5.5.2017; L 117/1.
3. European Medicines Agency. Human regulatory – medical devices. Accessed February 21, 2022. https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
4. Heads of Medicines Agencies and European Medicines Agency. HMA-EMA Joint Big Data Taskforce – summary report. February 13, 2019. EMA/105321/2019. Accessed February 22, 2022. https://www.ema.europa.eu/en/documents/minutes/hma/ema-joint-task-force-big-data-summary-report_en.pdf
5. Heads of Medicines Agencies and European Medicines Agency. European Medicines Regulatory Network Data Standardisation Strategy. December 16, 2021. EMA/447502/2021. Accessed February 22, 2022. https://www.ema.europa.eu/en/documents/other/european-medicines-regulatory-network-data-standardisation-strategy_en.pdf
6. Food and Drug Administration. Data Standards and Terminology Standards for Information Submitted to CDRH. Accessed June 3, 2022. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/data-standards-and-terminology-standards-information-submitted-cdrh
7. Smoak C. CDISC Standards for Medical Devices: Historical Perspective and Current Status. PharmaSUG 2020, Paper MD-020. Accessed February 22, 2022. https://www.pharmasug.org/proceedings/2020/MD/PharmaSUG-2020-MD-020.pdf
8. Hall P. Successful US Submission of Medical Device Clinical Trial using CDISC. PharmaSUG 2020, Paper MD-041. Accessed February 22, 2022. https://www.pharmasug.org/proceedings/2020/MD/PharmaSUG-2020-MD-041.pdf
9. Hall P, Karunasundera T, Maharjan S, Vegesna V. Multiple Successful Submissions of Medical Device Clinical Trial in the US and China using CDISC. PharmaSUG 2021, Paper MD-044. Accessed February 22, 2022. https://www.pharmasug.org/proceedings/2021/MD/PharmaSUG-2021-MD-044.pdf
10. Smoak C. A Critique of Implementing the Submission Data Tabulation Model (SDTM) for Drugs and Medical Devices. PharmaSUG 2017, Paper DS25. Accessed February 22, 2022. https://www.pharmasug.org/proceedings/2017/DS/PharmaSUG-2017-DS25.pdf
11. Teli R, Sacco A. Medical Device SDTM: A Real Case. PHUSE EU Connect 2019, Paper PP05. Accessed February 21, 2022. https://phuse.s3.eu-central-1.amazonaws.com/Archive/2019/Connect/EU/Amsterdam/PAP_PP05.pdf
12. Food and Drug Administration. Providing Regulatory Submissions In Electronic Format – Standardized Study Data Guidance for Industry. June 2021, revision 2. Accessed August 22 2023. https://collections.nlm.nih.gov/catalog/nlm:nlmuid-9918350982006676-pdf
13. European Commission. The Community Research and Development Information Service, (CORDIS). Search conducted with the keyword ‘in silico trial’, accessed February 21, 2022. https://cordis.europa.eu/search/en
14. European Commission. The Community Research and Development Information Service (CORDIS). In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials. Accessed February 21, 2022. https://cordis.europa.eu/project/id/101016503
15. European Commission. The Community Research and Development Information Service (CORDIS). A European standardization framework for data integration and data-driven in silico models for personalized medicine. Accessed February 21, 2022. https://cordis.europa.eu/project/id/825843
16. Food and Drug Administration. Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions – Draft Guidance for Industry and Food and Drug Administration Staff. December 2021. Accessed August 22, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions
17. American Society of Mechanical Engineers. Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices. 2018, V&V 40.
18. Food and Drug Administration. Reporting of Computational Modeling Studies in Medical Device Submissions Guidance for Industry and Food and Drug Administration Staff. September 2016.
19. Dassault Systèmes and the FDA Extend Collaboration to Inform Cardiovascular Device Review Process and Accelerate Access to New Treatments. Accessed February 21, 2022. https://www.3ds.com/newsroom/press-releases/dassault-systemes-and-fda-extend-collaboration-inform-cardiovascular-device-review-process-and-accelerate-access-new-treatments
20. Clinical Data Interchange Standards Consortium. CDISC Standards. Accessed August 22, 2023. https://www.cdisc.org/standards
21. Clinical Data Interchange Standards Consortium. Medical Devices. Accessed February 21, 2022. https://www.cdisc.org/standards/foundational/medical-devices
22. Food and Drug Administration. Data Standards Catalog v8.0 (02-15-2022) – Supported and Required Standards. Accessed February 23, 2022. https://www.fda.gov/media/156273/download
23. The Japanese Pharmaceuticals and Medical Devices Agency. Revision of Technical Conformance Guide on Electronic Study Data Submissions. January 2019, Notification No. 0124001. Accessed August 22, 2023. https://www.pmda.go.jp/files/000229468.pdf
24. The Chinese National Medical Products Administration. Guideline on the Submission of Clinical Trial Data. July 2020.
25. Clinical Data Interchange Standards Consortium. CDISC and REDCap Work Together to Foster More Meaningful Clinical Research for Academics. Accessed February 23, 2022. https://www.cdisc.org/news/cdisc-and-redcap-work-together-foster-more-meaningful-clinical-research-academics
26. Clinical Data Interchange Standards Consortium. CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward. Accessed February 23, 2022. https://www.cdisc.org/news/cdisc-and-openclinica-collaborate-drive-academic-clinical-research-forward
27. Takahara S, Saito TI, Imai Y, Kawakami T, Murayama T. A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial. Nagoya J Med Sci. 2022; 84(1): 120–132. DOI: http://doi.org/10.18999/nagjms.84.1.120
28. Food and Drug Administration. Study Data Technical Conformance Guide – Technical Specifications Document. March 2022, Version 4.9. Accessed August 22, 2023. https://www.fda.gov/media/153632/download
29. Kush RD, Warzel D, Kush MA, et al. FAIR data sharing: The roles of common data elements and harmonization. J Biomed Inform. 2020; 107: 103421. DOI: http://doi.org/10.1016/j.jbi.2020.103421
30. Ohmann C, Banzi R, Canham S, et al. Sharing and reuse of individual participant data from clinical trials: principles and recommendations. BMJ Open. 2017; 7(12): e018647. DOI: http://doi.org/10.1136/bmjopen-2017-018647
31. Romero K, Ito K, Rogers JA, et al. The future is now: model-based clinical trial design for Alzheimer’s disease. Clin Pharmacol Ther. 2015; 97(3): 210–214. DOI: http://doi.org/10.1002/cpt.16
32. Faris O, Shuren J. An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials. N Engl J Med. 2017; 376(14): 1350–1357. DOI: http://doi.org/10.1056/NEJMra1512592
33. Food and Drug Administration. Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry. February 2020. Accessed August 22, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications
34. Bodner J, Kaul V. A Framework for In Silico Clinical Trials For Medical Devices Using Concepts From Model Verification, Validation, And Uncertainty Quantification (VVUQ). ASME VVS 2021, VVS2021-65094. DOI: http://doi.org/10.1115/VVS2021-65094
35. Clinical Data Interchange Standards Consortium. Define-XML. Accessed February 23, 2022. https://www.cdisc.org/standards/data-exchange/define-xml
36. European Commission. The Community Research and Development Information Service (CORDIS). In Silico testing and validation of Cardiovascular Implantable devices. Accessed February 21, 2022. https://cordis.europa.eu/project/id/101017578
37. Aydin B, Ohmann C. SIMCOR Deliverable 10.1: In-silico trial impact assessment framework. Zenodo. December, 2021. DOI: http://doi.org/10.5281/zenodo.6353628
38. Clinical Data Interchange Standards Consortium. Therapeutic Areas. Accessed February 23, 2022. https://www.cdisc.org/standards/therapeutic-areas


Rapid Detection and Monitoring of Biomarkers for Traumatic Brain Injury
Small Business Information
RADIATION MONITORING DEVICES, INC.
44 Hunt Street, Watertown, MA, 02472
AbstractDESCRIPTION (provided by applicant): Over 370,000 people in the US are hospitalized for traumatic brain injury (TBI) each year. In the US, the cost associated with the treatment, hospitalization and rehabilitation of TBI are estimated to be $48.3 billion annually. A fast, easy, accurate and effective test for brain injury is required to identify head trauma and monitor the progression of the condition. Once the primary impact associated with TBI occurs, rapid response is critical to limit the impact of the secondary damage due to increased cranial pressure and abnormal changes in ion transport processes. Neuroproteomic changes in injured patients underlie the complex molecular events that are indicative of TBI. The high- speed and high-immediacy assessment of these proteomic changes should permit the specific and sensitive diagnosis of TBI and continued evaluation of the condition. Radiation Monitoring Devices proposes to develop a compact, disposable microfluidic sensor that will rapidly detect a panel of multiple TBI biomarkers from a blood sample. To accomplish this, we will integrate silicon-based CMOS (complementary metal oxide semiconductor) photon counting optical (GPD) detectors directly into a microfluidic chip which will detect target protein components with very high sensitivity using fluorescently label monoclonal antibodies. This high sensitivity is achieved by the placement of the photon detectors very close to the source of the fluorescent signal within the microfluidic channel. In Phase I, we will modify an existing microfluidic sensor to develop a test platform to demonstrate the integration of the photon-counting detector, and measure clinically significant concentrations of TBI biomarkers in model samples. In Phase II, we will optimize the design of the microfluidic system, develop software to run on a "palmtop" computer for data analysis and user interface, and measure TBI biomarkers in cerebral spinal fluid. The resulting device will be a general technology platform for the detection of multiple proteins in a single unit. RMD proposes to develop a compact disposable sensor that will rapidly detect biomarkers for traumatic brain injury. The sensor will simultaneously detect a panel of ten to twenty protein biomarkers that are used to diagnose and monitor brain injury. The sensor is based RMDs proprietary photon counting detector array technology.
* information listed above is at the time of submission.


text:
This weekend Medway Park will host an international trampoline competition, welcoming more than 400 competitors from across the globe.
This year the Jumpers Rebound Centre and The David Ward-Hunt Cup, an Internationally recognised Trampoline, DMT (double mini trampoline) and Synchro competition, will take place in Gillingham and tickets are still available.
This year’s competition will see a number of gymnasts, including Olympic level competitors, from countries including Brazil, Sweden, Switzerland, Great Britain, Belgium and more.
The David Ward Hunt Cup takes place in memory of trampoline legend, David Ward-Hunt, from Great Britain and this will be the first time that the competition has come to Medway.
Enjoy the incredible sport on your doorstep
Cllr Howard Doe, Deputy Leader of Medway Council and Portfolio Holder for Community Services, said: “I’m so pleased that Medway Park will welcome sport competitors from across the globe to showcase their skills. It’s great news that Medway residents will be able to enjoy watching this incredible sport and Olympic level competitors on their doorstep. I would encourage residents to find out more about the competition and grab a ticket while they still can.”
Find out more and to book a ticket (ticket prices start at £18 per person).
The competition takes place on Saturday, 5 and Sunday, 6 November.


text:
This is the 91st consecutive season of Cleveland Play House, the multi-venue resident Equity theatre complex in Ohio.
Bloom will direct the season opener, Rabbit Hole, an audience favorite on Broadway this spring. The play concerns the healing process of two parents struggling with the recent death of their young son. The Play House is among the few regional theatres to produce the critically acclaimed Broadway drama in the coming season.
Tony Award nominee Tina Fabrique will bring her performance as Ella Fitzgerald to the Bolton Stage for The Play House production of Ella.
The Play House will host the first regional performance of Off-Broadway's RFK, the play about Robert F. Kennedy, written by and starring Jack Holmes.
John Strand's new political comedy, Lincolnesque, commissioned by South Coast Rep, will appear next spring. The Play House's successful production of Phil Grecian's adaptation, A Christmas Story, will be remounted.
The season at a glance:
Amanda Dehnert will direct Lerner and Loewe's My Fair Lady in the Bolton Theatre Oct. 6–Nov. 5. The staging is billed as a "special, intimate two-piano version of the production" approved by the authors years ago, but rarely performed.
Larry Moss directs RFK in the Drury Theatre Oct. 27–Nov. 19.
Seth Gordon directs A Christmas Story in the Bolton Nov. 30-Dec. 23, and then helms John Steinbeck's Of Mice and Men in the Drury Jan. 5-28. 2007.
Israel Hicks will stage Cuttin' Up, Charles Randolph Wright's musical portrait of African-American barbershops, in the Bolton Feb. 2-25, 2007.
Davis McCallum directs Sarah Ruhl's The Clean House at the Drury Theatre, March 2–25, 2007.
Ella, by Jeffrey Hatcher, conceived by Rob Ruggiero and Dyke Garrison, with musical direction and arrangements by Danny Holgate, based on an original play by Dyke Garrison, plays the Bolton March 23–April 15, 2007.
Michael Bloom will direct Lincolnesque at the Drury April 27-May 20, 2007. In it, "Leo is a speechwriter for a United States congressman who is behind in the polls. Desperate to save his job, and eager to infuse idealism into a tattered campaign, he turns for advice to his older brother Francis — who just happens to believe he's Abraham Lincoln. Suddenly the words of a great President make Leo and his boss frontrunners. This sassy new political comedy presents a view of behind-the-scenes-Washington, D.C. you won’t find on 'The West Wing.'" *
Founded in 1915, The Cleveland Play House is America's first permanently established professional theatre. Over the past 88 years, more than 11 million people have attended The Cleveland Play House's 1,300 productions — 100 of which were American and/or world premieres. At 300,000 square feet, the Philip Johnson-designed Cleveland Play House complex houses five performance spaces making it the largest regional theatre complex in the country.

domain: entertainment


text:
Hills science diet K/D prescription Dog
I bought this case and used one can out of it, ordered from Chewy a few weeks ago Prescription K/D wet dog food 11 cans Make sure your doctor has prescribed a kidney diet for your dog before feeding
Shipping & Payments
Mercari keeps your payment information secure.
Mercari sellers never receive your credit card information.
Receive your item as described or your money back for eligible orders. Learn more

domain: pet


text:
Hollywood couple Boris Kodjoe and Nicole Ari Parker looked lovely in a new photo posted on social media during their date at the Art Institute of Chicago.
"Soul Food" couple Boris Kodjoe and Nicole Ari Parker had significant romantic content on Instagram as always after Parker posted a photo of the two during their date at the Art Institute of Chicago.
The couple posed outdoors in the snapshot with their facemasks in place. Parker opted for a black facemask with her brown hair fanning both sides of her face.
Boris Kodjoe and Nicole Ari Parker at the 2015 BET Experience in Los Angeles, California on June 27, 2015. | Photo: Getty Images
She rocked a protective outfit with her black leather jacket peeping from a part of the photo. Kodjoe stood on the far end in a grey muffler, his white face masks, and protective clothes.
The duo posed for the camera with some colorful murals acting as a backdrop. Although it was hard to tell their expressions, the couple looked radiant. Parker captioned:
"That time we had a date ❤ to see The @BisaButler Portraits at The ART INSTITUTE of CHICAGO..."
Parker and Kodjoe are one of the finest spotlight couples, and in the many years that they have been together, their marriage has prospered through hitches and little drama.
She noted that she missed Kodjoe being her boyfriend.
Once in an interview, the star actors shared snippets on how they keep it going. Parker said that the first key to staying happy with one's partner was good grooming.
She also explained that it was highly essential to take care of oneself. She relayed that it was not only about the physical aspects but also about one's mental health.
The "Brown Sugar" actress believes that being emotionally sound was part of one's relationship staying on the right track. She explained that this has to do with projecting one's emotions, whether anger, excitement, or sadness, on the significant other.
While the couple might seem to have the ultimate manual to keep a marriage working, they have had some tumultuous times, one of which made it to TV.
During their chat with Chris Spencer, Parker did not shy away from sharing some of her grievances toward where their marriage was headed at the time. She mentioned that Kodjoe was not as romantic.
She noted that she missed Kodjoe being her boyfriend and having that single life where one got random texts, kisses, and spontaneous romantic gestures.
Although Parker's spouse did not react to her words, he sure took note. Last year, they splendidly celebrated their 15th anniversary. Kodjoe took their romance to a new height despite the COVID-19 pandemic.
While many social events were put on hold, Kodjoe found a creative way to celebrate their love. He organized a surprising couple date out on the beach and had a folklorist provide entertainment.


text:
Janette K. KlingnerJanette K. Klingner, PhD, until her death in 2014, was Professor of Bilingual Special Education at the University of Colorado Boulder. Her principal areas of research were reading comprehension strategy instruction in diverse, inclusive secondary science and social studies classes; professional development that enhances teacher quality in diverse, inclusive classrooms; response to intervention for English learners; and the disproportionate representation of students of color in special education. She authored or coauthored more than 130 articles, books, and book chapters. Dr. Klingner was past president of the Division of Learning Disabilities of the Council for Exceptional Children, Vice President of the International Academy for Research on Learning Disabilities, and Associate Editor of the Journal of Learning Disabilities. She was a recipient of the Early Career Award from the American Educational Research Association (AERA) and the Distinguished Researcher Award from the Special Education Research Special Interest Group of AERA.
All titles by Janette K. Klingner:
Teaching Reading Comprehension to Students with Learning Difficulties: Third EditionSharon Vaughn, Alison Boardman, and Janette K. Klingner
Teaching Reading Comprehension to Students with Learning Difficulties: Second EditionJanette K. Klingner, Sharon Vaughn, and Alison Boardman

domain: library


OR :Water Bureau's new computer over budgetand past duegreenspun.com : LUSENET : Grassroots Information Coordination Center (GICC) : One Thread
Water-sewer rate relief on hold The Portland Water Bureau's changeover to a new computer system is running over budget at the expense of customers
Thursday, July 6, 2000
By Scott Learn of The Oregonian staff Glitches in the Portland Water Bureau's new computer billing system, already at least $1.5 million over budget and a year past due, have forced the city to postpone water and sewer rate reforms for a month.
The delay, approved by the City Council on Wednesday, will reduce savings for residential customers, particularly for the low water users that the reforms targeted. It's a black eye for the Water Bureau, which bills 160,000 accounts in Portland.
And it highlights the problems the bureau has had with the new system, purchased from Severn Trent Systems of Houston. A "Fixable" Problem? discuss city computer glitches in the SE PDX forum
Water Bureau workers are having to review each of the 2,000 to 3,000 bills that go out each day for accuracy and are hand-calculating an estimated 100 to 200 bills a week. Long hold times on customer service phone calls are prompting the bureau to open an hour earlier and extend customer service hours until 7 p.m.
Bureau officials originally predicted the system would be in place by December 1998, two years in advance of the year 2000 changeover. Instead, the system didn't "go live" until late February, forcing the city to spend at least $350,000 to reprogram its existing computer system to handle the new millennium.
Meanwhile, the estimated costs of the new system -- for software, training, extra staff and several consultants -- have risen steadily. In 1997, the bureau projected costs as low as $2 million to replace its 15-year-old system. After bids arrived, the budget came in at $6.5 million.
Now bureau consultant Martin C. Wilson pegs the cost at $9.76 million once the new system is operating fully. Bureau officials told Wilson they think they can keep costs down to $8 million, still $1.5 million over budget.
The city is withholding roughly $900,000 in billings on its $3.2 million contract with Severn Trent Systems because of the delays.
Commissioner Erik Sten, who oversees the Water Bureau, defended the computer system, saying it is largely working despite being "the first system of its kind in the country." Large computer changeovers are notorious for unforeseen glitches, he said. And the bureau's computer problems, while "disappointing," are fixable.
Some commissioners alarmed But the problems have clearly alarmed the rest of the council, especially Commissioner Dan Saltzman. Saltzman oversees the Bureau of Environmental Services, the city's sewer agency, which recommended against Severn Trent in 1997 and called its software "vaporware."
Saltzman, whose bureau will have to pick up half the tab for the new system, peppered Water Bureau Director Mike Rosenberger with questions during a Wednesday meeting. Saltzman said Rosenberger assured him months ago that the system would be ready to handle rate reforms, including reduced service charges, by July 1. "I'm very worried that this is a mess that I don't see us getting out of," Saltzman said.
Rosenberger said he's confident the rate reforms can take effect in a month. And he pledged that the bureau will take budget cuts rather than raise water rates to compensate for the cost overruns on the project.
The report from Wilson, the consultant, said the system is the right one for the Water Bureau. The total costs, even at $9.76 million, would still come in less per customer than the average of 17 U.S. utilities that bought new computer systems in the 1990s, the March 16 report says. And the time frame is reasonable compared with the industry.
Utilities' record on implementing new computer systems "has been dismal -- no maybes about it," the report says. Costs have been exorbitant, schedules "seemingly infinite" and the computer-system "vendor world is currently a sea of mediocrity."
Portland's quirks a factor Dan Perrin, Severn Trent's project manager, said in a phone interview that it has been tough to convert Portland from a homegrown system with local quirks to a Windows-based system that largely follows industry standards. But the company considers Portland's system "very successful," he said.
"This is the transition stage," Perrin said. "It's painful. But all of a sudden the clouds clear and things work fine."
The glitch causing the delay stems from Portland's quarterly billing system. The bureau implements new water and sewer rates every fiscal year, beginning July 1.
But many customers' quarterly bills straddle July 1, so the bureau has to figure the bills using old and new rates. At this point, Severn Trent's software can't prorate those bills properly.
Rosenberger said there are other glitches with the system, including some that won't be fixed in a month. Among them are problems with complex sewer bills, trouble billing customers on payment plans and mix-ups with billing addresses.
Service saving predicted In a January memo to Rosenberger, Bureau of Environmental Services Director Dean Marriott noted that the Water Bureau predicted savings in customer service and a 40 percent reduction in manual work as a result of the new system.
"We do not yet see any potential decrease in employees, due to problems in the new system," Marriott wrote.
Rosenberger says the improvements will come; he predicted last July that it would take six to nine months to work the bugs out of the system after it went live.
Rosenberger will report back to the council by July 20 on the fixes to the rate glitch. He said he is negotiating with Severn Trent on damages tied to the delay.
The bureau's contract with the company includes damages of $1,000 a day for a "go-live" date after April 23, 1999. But those potential damages are capped at $250,000.
Sten and Rosenberger said the city has to maintain relations with Severn Trent Systems. Wilson agreed, noting in his consultant's report that "the city will be dependent on STS for a decade -- probably longer -- for maintenance and enhancement support."
-- Martin Thompson (firstname.lastname@example.org), July 06, 2000


The Grow Wire Road Trip Stops In Silicon Valley
By Suzy Strutner, managing editor of Grow Wire
Greetings from Silicon Valley! Today, Grow Wire celebrated the first stop on the Grow Wire launch tour, a multi-city journey to celebrate our official debut. The Grow Wire team hosted a lunchtime party in San Mateo, California to show off the awesomely redesigned Grow Wire site, our first podcast episode and new
galore to help you grow your big ideas and your business.
Peek at tweets and photos from the action below. To join the party, follow us on LinkedIn, Twitter, Instagram and Facebook, and subscribe to the Grow Wire Email Newsletter.
Sun, July 1, 2018


Bought a pair of these for my Ducati ST4 last month, what a difference, best tire ever!
Write your review and you'll automatically be entered in our monthly drawing. Include an image or video to DOUBLE your chances to win!Write Your Review
Purchased these tire for my 2002 zx12r. Excellent grip, comfortable ride
Bought as a combo, got 3k out of rear tire front still looks good.
The good: turns quick, good grip, good milage even with aggressive riding, excellent warm up time.
The bad: very picky with tire pressure seems to work best at 32/32, these tires do not like yellow lines, not much feel rear slides around quite a bit under heavy braking got 3k out of rear but after 2200 tire started to move around alot more.
I was a track day guy and rode on super corse pro's , although for a nice sport bike tire that wears better, and is better in wet and cold, i am very happy with the Diablo Rosso 2 , I have a TL1000S , you might even get away with a trackday on them, depending on how aggressive you are , been running Pirelli and Metzler for over 30 years
Loved the miles I got out of this tire
Great price on a pair of Pirelli tires. Shipping was quick.
So I pretty much have the Rosso family of tires on all my bikes and just love them. The latest set I put on my NSR250r and what a change!! I thought it was on rails b4 the new Rosso tires but I was so wrong. Just got another set for my RGV250. Time to get busy mounting and balancing !
They stick but not for long, esp in the rear. However, if you don’t pile up too many miles but want to carve, it’s hard to go too far with these!
Grip pretty good. Have to warm up the back tire for a really good hook up.
The last digit on the tire size is the SPEED RATING.
| (Y) Above 186 mph Above 300 km/h
ZR -| Y 186 mph 300 km/h
| W 168 mph 270 km/h
V 149 mph 240 km/h
H 130 mph 210 km/h
U 124 mph 200 km/h
T 118 mph 190 km/h
S 112 mph 180 km/h
R 105 mph 170 km/h
Q 99 mph 160 km/h
P 93 mph 150 km/h
N 86 mph 140 km/h
M 80 mph 130 km/h
L 74 mph 120 km/h


text:
A new campaign has been launched in Scotland to warn parents about potentially fatal common errors made in fitting child car seats.
The campaign – developed by Road Safety Scotland, in partnership with the child seat specialist, Good Egg Safety – will see images of incorrectly-fitted child seats released via social media, backed up by nine short videos.
The images and videos are designed to ‘graphically demonstrate’ why the child seats, or the children seated within them, are unsafe.
The new campaign coincides with the launch of an annual programme of free car seat checking events across Scotland, which in summer 2017 will visit 50 locations. Good Egg Safety says that previous checks in Scotland have shown that, on average, 54% of child car seats are incorrectly-fitted or incompatible with the child or the vehicle.
Last week, Good Egg Safety issued a safety alert in relation to incorrect routing of seatbelts through child seats, which it says is being found in about 10% of child seat checks across the UK.
Michael McDonnell, director of Road Safety Scotland, said: “Many parents would be horrified to learn their child car seats are not fitted properly and, therefore, not providing the protection their children need.
“This campaign seeks to highlight that, not only by raising awareness of the issue and providing advice and guidance, but it also has a very practical element in that people can check the website, find the nearest car seat clinic and get the child-seat-car combination checked by an expert. It only takes a few minutes yet could save a child’s life.”
Superintendent Louise Blakelock, Police Scotland, said: “It is absolutely essential that child safety seats are properly fitted, as the consequences of them not being so can be fatal for a young child, even in a relatively slow speed collision.
“We continue to work with partners to highlight the dangers and encourage parents and carers to ensure their precious passengers are properly and safely secured.”
New video highlights ‘fatal’ car seat fitting errors
7 August 2017

domain: news


text:
Asian Americans are two and a half times more likely to be appointed as CEOs when companies are struggling rather than succeeding, reported a recent study co-authored by a Wharton professor.
Jointly conducted by Andrew Carton, a management professor, and University of Amsterdam professors Astrid Homan and Seval Gündemir, the study indicated that Asian Americans were appointed to the leading position two and a half times more frequently in a period of decline than during success.
The researchers also discovered that this hiring trend was likely partially due to the influence of stereotypes. They hypothesized that this tendency could expose the Asian American leaders for more stress or blame in handling the challenge of saving a company.
"It's important to understand that some seemingly positive stereotypes about minorities may appear to be silver linings on the surface, but they often obscure underlying challenges that perpetuate discrimination," Gündemir said in a press release.
The study also revealed that Asian American CEOs served terms that were on average half as long as those of their white counterparts.
The study was published in the Journal of Applied Psychology on Sept. 24.
The co-authors noted that Asian Americans remain "underrepresented at the top of the corporate hierarchy," with less than 1 percent of CEOs being Asian American.
Other studies have also found that Asian Americans face a "bamboo ceiling" in the workplace; despite being highly skilled, research has found that they are often not appointed to executive positions because of the perceived personality traits that they are not assertive or strong leaders.
"A fairer representation of minority groups in positions of power can not only contribute to organizational productivity and innovation but also provide role models to minority employees," Gündemir said in the press release.


text:
Total amount: € 0,00
Official Journal of the Italian Society of Social Psychiatry
Indexed/Abstracted in: EMBASE, e-psyche, PsycINFO, Scopus
Online ISSN 1827-1731
EATING DISORDERS 2010
Department of Psychiatry and Pediatrics, Stanford University School of Medicine, Stanford, CA, USA
Although eating disorders are common psychiatric disorders that usually onset during adolescence, few evidence-based treatments for this age group have been identified. A critical review of treatments used for anorexia nervosa (AN) and bulimia nervosa (BN) and related conditions (EDNOS) is provided that summarizes the rationale for the treatments, evidence of effectiveness available, and outcomes. Critical review of published randomized clinical trials (RCTs). There are only 7 published RCTs of psychotherapy for AN in adolescents with a total of 480 subjects. There are only two published RCTs for outpatient psychotherapy for adolescent BN with a total of 165 subjects. There are no published RCTs examining medications for adolescent AN or BN. For adolescent AN, family-based treatment (FBT) is the treatment with the most evidence supporting its use. Three RCTs suggest that FBT is superior to individual therapy at the end of treatment; however, at follow-up differences between individual and family approaches are generally reduced. For adolescent BN, one study found no differences between cognitive behavioral therapy and FBT at the end of treatment or follow-up, while the other found FBT superior to individual therapy. Although the evidence remains limited, FBT appears to be the first line treatment for adolescent AN. There is little evidence to support a specific treatment for adolescent BN. There is a need for additional studies of treatment of child and adolescent eating disorders. New treatments studies may build on current evidence as well as examine new approaches based on novel findings in the neurosciences about cognitive and emotional processes in eating disorders.


text:
Blake Not That Lively For Pride and Prejudice and Zombies
We sort of saw this one coming, did you? Blake Lively is the latest star to turn down a role in Pride and Prejudice and Zombies.
The Gossip Girl actress was approached with the script after Natalie Portman, Emma Stone and Scarlett Johansson turned it down.
The search is still on for a lead actress with the film due for release in 2013.

domain: celebrity


text:
I've created the following script on testnet:
OP_IF 2 <pubkey1> <pubkey2> <pubkey3> 3 OP_CHECKMULTISIG OP_ELSE 1 OP_CHECKSEQUENCEVERIFY OP_DROP <pubkey1> OP_CHECKSIG OP_ENDIF
I am currently able to unlock the funds when I satisfy the 2 of 3 multisig condition.
However, when I attempt to unlock the funds using the else condition, I get the following error: 64: non-mandatory-script-verify-flag (Locktime requirement not satisfied)
This confuses me, because I thought I was setting the lock time to a block height of 1, which should have already passed.
I have also tried using OP_CHECKLOCKTIMEVERIFY as well.
Any help on this would be greatly appreciated! Thanks so much!

domain: finance


Discover more from Wonkette
Forty-Four Percent Of Americans Continue To Be Fucking Idiots
That seems high.
Donald Trump ended his weekend of petty, shriveled-up raisin heart vindictiveness tweeting his latest approval ratings. His supporters, I'm sure, were waiting with bated breath like Ed McMahon at the end of one of Johnny Carson's Carnak routines. The NBC/WSJ poll covered a period during which totally random individuals with no real connection to Trump, such as his former campaign chairman and his personal attorney, either pleaded guilty or were found guilty of serious felonies. So, what was the damage? Are we close to waking from this "long, national nightmare"?
Between Aug. 18 and Aug. 22 — the day after the news involving former Trump campaign chairman Paul Manafort and former Trump attorney Michael Cohen — the president's approval rating stood at 46 percent approve, 51 percent disapprove.
In a separate NBC/WSJ survey, conducted Aug. 22 through Aug. 25, Trump's approval rating was 44 percent approve and 52 percent disapprove. That's within the poll's margin of error.
Republican pollster Bill McInturff of Public Opinion Strategies, who conducted this survey with Democratic pollster Peter Hart and his team at Hart Research Associates, called Trump's approval rating "remarkably stable" despite the Manafort and Cohen developments, both of which became public on the same afternoon last Tuesday.
Trump's approval is "remarkably stable"! Can you all join me in a collective WTF? He's still in the mid-40s after all this? Even after he gave an interview last week where he not so subtly implied everyone's furniture store would suddenly go up in flames if he were impeached? Yes, keeping Trump in office is for our own "protection." (What a racket!) Maybe a startling number of Americans just plain want a Mafioso as their president. Mobster movies have always been popular here -- far more popular than, say, black people, which reminds me of our previous non "unindicted co-conspirator" president.
Barack Obama's approval sank to 44 percent during the period of November 16 to 22, 2015. What nefariousness had Obama been up to then? Terrorists attacked Paris on November 13, and although Obama was later proven not to be responsible (he wasn't near France or even a croissant at the time), his approval numbers dipped quickly five points from the previous week's 49 percent. Republicans, including then-candidate Trump, hammered Obama about his perceived inability to stamp out ISIS and his refusal to say "radical Islamic terrorism," because those are the special magic words that make terrorism go away.
Obama continued to strike out with the public by not buckling under to irrational bigotry and fear. He resisted calls from Republicans to ban Syrian refugees or only accept Christians. Looking back at all this, it seems like the GOP was better at keeping Obama on the defensive. It of course helped that they controlled Congress, but Democrats, especially the leadership (looking at you, Chuck Schumer), tend to resist any urge to go for the jugular. In hindsight, maybe "unindicted co-conspirator" is too mild, too much fancy law-talking to move the needle. It's time to break out the heavy artillery. Maybe start ragging on his momma or something. Anything!
Meanwhile, Trump is so pleased that the nation stands by him (it doesn't) that he flies his approval ratings at full staff.
Over 90% approval rating for your all time favorite (I hope) President within the Republican Party and 52% overall.… https: //t.co/iDNjDIKyNz
— Donald J. Trump (@Donald J. Trump) 1535330378.0
Besides those numbers being a lie, this is not what we needed to hear from our commander in chief on the same day a deranged individual in Jacksonville, Florida, shot and killed two people and injured almost a dozen others. But the shooter was white and one of the dead was a person of color. That won't help you build walls.
Oh, and he's straight-up lying in your gullible face about his approval ratings, but on the other hand, he's also really stupid. It's entirely possible he misread the NBC/WSJ poll, which clearly stated that his disapproval rating (all the losers who don't like him) was 52 percent not his approval rating. All those numbers are confusing. Just like I'm confused by the continued support for this ass goblin in the White House.
Follow SER on Twitter .
Wonkette is ad-free and supported ONLY by YOU. Please hit the tip jar below, or click this link to make it monthly!


text:
Journal of East-West Nursing Research is the official journal of the East-West Nursing Research Institute. The abbreviated title of this journal is J. East-West Nurs. Res. It was launched in 1997.
The Journal publishes original, peer-reviewed work in all areas of nursing including traditional Korean nursing, complementary nursing, and modern western nursing. The goal of Journal of East-West Nursing Research is to provide a platform for clinician and academicians to promote and share various perspectives of nursing theory, practice, and education.
The journal is published biannually in May and November. Total of the articles in this journal are indexed in KCI (KoreanCitation Index), Google Scholar, and CrossRef. Full text is freely available fromhttp://journal.ewnri.or.kr/past/list.asp
For further information, visit the website of the East-West Nursing Research Institute and refer to the guideline for the online manuscript submission system. Contact the East-West Nursing Research Institute through e-mail (email@example.com) or question in the system.
The application charge of this journal is Korean Won, 50,000.


Start getting excited, because it looks like Tottenham Hotspur’s long transfer drought might soon be over. Numerous journalists, including Dan Kilpatrick at the Evening Standard, are reporting that Spurs are close to the signing of 18-year old Leeds winger Jack Clarke, and that the club expect a transfer fee of about £8.5m.
Contrary to reports in some of the tabloid papers in England, Kilpatrick states that no deal has been reached yet with the Championship club for the transfer of Clarke, and that’s going to probably get the caustic ire up of a lot of people who are reading this. However, the general tenor of all the reports I’ve seen on the Clarke transfer thus far is that all parties expect this to be completed, and probably in the near future. This isn’t a £60m+ transfer, so the horse trading and haggling will most likely shake itself out sooner rather than later.
Clarke is considered one of the best young talents in England at present and had a breakthrough season last year with Leeds, scoring two goals and tallying two assists in just under 900 minutes of action. That’ s not a lot, but remember that he was 17 at the time. Clarke is expected to stay at Spurs after his signing and fight for a first team place instead of returning to Leeds on loan, as some have suggested.
Is Clarke going to be the signing that propels Spurs up a level? Probably not initially. However, Spurs have a long history of signing young talent out of the Championship (or lower) — Gareth Bale, Aaron Lennon, Danny Rose, Kyle Walker, and Dele Alli were all signed out of the lower divisions, and I’m sure I’m missing other players who had a significant impact after being signed to Spurs young. Clarke is exactly the kind of player they should be targeting as they look to the future, and £8.5m is a stupid low fee for a player of his ability. Tanguy Ndombele, whom Kilpatrick says is Spurs’ “top target” this window, is the kind of player Spurs should be targeting as they try and improve the current team.
It’s not a done deal (yes, I hear the derision coming from the comments) but this looks like a signing that will happen, and for a price that looks to be extremely good.


text:
I love to play defense games and RPG's so please keep me updated on the latest and coolest. Feel free to give me info on your fav's as well.
You must be logged in to comment on this post.
newgrounds.com — Your #1 online entertainment & artist community! All your base are belong to us.


text:
In a finding that is not likely to come as a shock to Fuddruckers executives, a recent survey of the eating habits of 14,000 American adults found that, in general, men are more likely to report eating meat and poultry, while women are more likely to report chomping on fruits and vegetables.
Researchers from the Centers for Disease Control and Prevention's Foodborne Diseases Active Surveillance Network found men more frequently consuming duck, veal and ham, as well as certain types of shellfish, such as shrimp and oysters, while strawberries, blueberries, apples, raspberries, carrots and tomatoes more often appeared on women's plates. Women also more regularly chowed down almonds and walnuts, eggs and yogurt.
Asked to account for the differences by the Washington Post, Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine, cited "cultural influences, which suggest that salads and quiche are dainty; hunks of meat manly." In other words, real men don't eat quiche. However, in some cases, the differences noted by the survey were really quite small. For instance, 21 percent of males surveyed had eaten ham in the past week, while 18 percent of females had done so, which hardly amounts to a vast gender divide over sliced pig.
Plus, the survey also uncovered some results that ran counter to the general trend. For instance, men were "significantly" more likely to eat asparagus and Brussels sprouts than were women. While women were more likely to eat hamburgers made from fresh, raw meat -– you know, the juicy kind that drips blood -- men favored burgers fashioned from the less primal frozen patty.


text:
Levy, mill rate up in finalized Ellsworth School District budget
Bill Kirk Pierce County Herald
+1 715-273-4334 customer support http://www.piercecountyherald.com
news The 2010-11 budget was finalized by the Ellsworth School Board early this week.
A total levy of $8,014,111 was certified by the board after members adopted the budget during their special meeting Monday, according to Superintendent Barry Cain. This represents a 4.01 percent increase in the levy over...
Ellsworth Wisconsin 126 S. Chestnut St. 54011
The 2010-11 budget was finalized by the Ellsworth School Board early this week.
Bill Kirk has been editor at the Pierce County Herald in Ellsworth, Wisconsin, since 1988. He holds a bachelors degree in journalism from the University of Wisconsin-Eau Claire. He previously worked in the media distribution department at the University of Minnesota's Minneapolis campus and is past editor of The Tri-County News in Osseo, Wisconsin.