Read the in depth Review of Carvaan Musicbar CBWY121 Audio Video. Know detailed info about Carvaan Musicbar CBWY121 configuration, design and performance quality along with pros & cons, Digit rating, verdict based on user opinions/feedback.

Read the in depth Review of Coocaa 32-inch HD Ready LED TV(32S3U-Pro) TV. Know detailed info about Coocaa 32-inch HD Ready LED TV(32S3U-Pro) configuration, design and performance quality along with pros & cons, Digit rating, verdict based on user opinions/feedback.

The Congress will begin a month-long 'Delhi Nyay Yatra' from Rajghat on Friday to corner the Aam Aadmi Party government on various issues affecting the city.

Rajya Sabha MP Raghav Chadha marked his 36th birthday in Varanasi.

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The Nigeria Civil Aviation Authority has warned flight crew members, especially pilots against working for multiple airlines concurrently with their approved privileges simulators and proficiency checks endorsed on their licence. The authority stated that such action posed a serious threat to safety and would be treated as a serious violation of the NCAA Regulations. This

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Madaxweynaha Ukraine Volodymyr Zelensky ayaa ku dhawaaqay isniintii in ciidamada Ukraine ay isku dhacyo kula jiraan…

The post Zelensky: Ciidamadeenu waxay dagaal kula jiraan 50,000 oo askarta Ruushka ah appeared first on Horseed Media.

Isniintii, 3 diyaaradood oo reer Yurub ah ayaa ku dhawaaqay inay kordhiyeen hakinta duullimaadyada ay ku…

The post Shirkadaha diyaaradaha ee Yurub ayaa kordhiyey hakinta duulimaadyadooda Israel appeared first on Horseed Media.

Xildhibaanada kumetela Puntland Baarlamaanka federaalka ayaa soo saaray warsaxaafadeed ay sheegeen in aysan qeyb ka aheyn…

The post Xildhibaano soo saarey warsaxaafadeed: “Waxaan ka digeynaa duulaanka Xasan Sheekh ee Puntland iyo Jubaland” appeared first on Horseed Media.

Jawiga siyaasadeed ee Soomaaliya ayaa muddo dheer ahaa mid jaahwareersan  oo cakiran. Saddex xilli ayaa la…

The post Ma la gaaray xilligii uu Raysal Wasaare Xamse Barre is casili lahaa? appeared first on Horseed Media.

War-saxaafadeed ka soo baxay wasaaradda arrimaha gudaha ee Dowaldda Federaalka ayaa looga hadley doorashada Madaxweynaha iyo…

The post Dowladda Federaalka oo bogaadisey doorashada Somaliland appeared first on Horseed Media.

Ra’iisul Wasaaraha Xukuumadda Jamhuuriyadda Federaalka Soomaaliya, Mudane Xamsa Cabdi Barre, ayaa gelinkii danbe ee Salaasada ku…

The post Ergadii Dhexdhexaadinta Jubaland iyo Federaalka oo la kulmey Raysalwasaare Xamse appeared first on Horseed Media.

Waxaa saacado kadib Shacabka Somaliland u dareeri doonaan goobaha codbixinta ee  doorashada Madaxweynaha Somaliland iyo ururada…

The post Doorashada Somaliland, Saadaasha Guusha iyo  Khatarta Jirta appeared first on Horseed Media.

PORT-AU-PRINCE, Haiti — The Federal Aviation Administration announced Tuesday that it will prohibit U.S. airlines from flying to Haiti for 30 days after gangs shot a Spirit Airlines flight. The United Nations also said it will suspend flights, "obviously limiting the flow of humanitarian aid and humanitarian personnel into the country."  The bullets hit the plane when it was about to land Monday in the country's capital, Port-au-Prince, injuring a flight attendant. It was part of a wave of violence that erupted in Haiti as the country swore in its new prime minister after a politically tumultuous process.  Life in much of Haiti's capital was frozen after the wave of violence, which came to a head when gangs shot the Spirit Airlines airplane Monday, forcing the airport to shut down. Photos and videos obtained by The Associated Press show bullet holes dotting the interior of a plane. A number of airlines suspended flights to Haiti through Thursday, but it was unclear how long closures could drag on.  Neither the former interim prime minister, Garry Conille, nor the newly inaugurated Alix Didier Fils-Aime commented on the violence.  But Luis Abinader, who as president of the neighboring Dominican Republic has cracked down on Haitian migration, called firing on the airplane terrorism.  "This was a terrorist act; the countries that are following and helping Haiti should declare these armed gangs as terrorist groups," Abinader said in a news conference.  On Tuesday, heavily armed police in armored cars outside the airport checked trucks used for public transportation passing by.  Schools were closed, as were banks and government offices. The streets, where just a day before gangs and police were locked in a fierce firefight, were eerily empty.  The sound of heavy gunfire was heard in the streets in the afternoon — a reminder that despite political maneuvering by Haiti's elites and a strong push by the international community to restore peace, the country's toxic slate of gangs kept its firm hold on much of the Caribbean nation.  The United Nations estimates that gangs control 85% of the capital. A U.N.-backed mission led by Kenyan police to quell gang violence struggles with a lack of funding and personnel, prompting calls for a U.N. peacekeeping mission.

Khalid al-Asaad, an 83-year-old caretaker of antiquities in Syria, was beheaded by ISIS, but did not receive the same attention as a slain lion.

LUCENA CITY — Classes were suspended on Wednesday afternoon, Nov. 13, in Calaca City, Batangas province, due to the harmful presence of volcanic smog or “vog” from Taal Volcano. The Calaca public information office announced the suspension around 11:30 a.m. in a post on its Facebook page. “In accordance with the directive of the DepEd Calaca City Sub-Office and Calaca City DRRMO, the suspension of classes this afternoon is recommended for all public and private schools at all levels in Calaca City due to volcanic smog or “vog” from Taal Volcano,” the post said in Filipino. Local authorities advised the […]...

Keep on reading: Calaca City suspends classes due to 'vog' from Taal Volcano

[Radio Dalsan] A Turkish-made drone armed with missiles reportedly crashed on Tuesday in the Al-Shabaab-controlled village of Farsooley, located in Somalia's Lower Shabelle region, local sources have confirmed.

[Shabelle] Mogadishu, Somalia -- The National Intelligence and Security Agency (NISA) of Somalia announced on Thursday the arrest of two men with ties to the militant group Al-Shabaab in the capital city of Mogadishu.

[Shabelle] Mogadishu, Somalia -- In a decisive move to strengthen national security, Somalia's Cabinet of Ministers has officially endorsed General Odowa Yusuf Raage as the Commander of the Somali National Army, according to a statement released after an emergency meeting held on Sunday night.

[Radio Dalsan] The Somali Council of Ministers has reappointed General Odowa Yusuf Raage as Commander of the Somali Armed Forces, replacing General Ibrahim Muhyiddin, during an emergency meeting held in Mogadishu on Sunday night.

[Shabelle] Mogadishu -- Somalia's National Intelligence and Security Agency (NISA) conducted a targeted operation in the Dharaarweyn area near Galcad city, within the Galgaduud region.

ADB sought to understand what improving transport meant for the community. Prior to project design, consultations were conducted with residents in Ulaanbaatar’s ger areas. Design decisions were tested back to ensure that mobility pain points were addressed.

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Title: Hurricane Isaac Could Stir Up Allergies, Asthma
Category: Health News
Created: 8/29/2012 2:05:00 PM
Last Editorial Review: 8/30/2012 12:00:00 AM

Tencent Games subsidiary LightSpeed Studios has announced Hideaki Itsuno, who recently left Capcom after 30 years working for the company, will be leading a new video game studio called LightSpeed Japan Studio.

LightSpeed Japan Studio will have two locations in Tokyo and Osaka and is focused on developing original AAA games.

"Joining LightSpeed Studios is an exciting new chapter for me," said Hideaki Itsuno. "With LightSpeed’s strong development capability and global network, I look forward to creating original AAA action game titles together with the amazing team and building aesthetic and innovative experiences for the global player community. We welcome all talented and passionate game creators from the world over to join our vision."

LightSpeed Studios president Jerry Chen added, "It is our great honor to have Hideaki Itsuno join LightSpeed Studios. The establishment of LightSpeed Japan Studio is a significant step in LightSpeed Studios’ expansion and demonstrates our commitment to bringing the best possible games to our players."

Itsuno directed entries in the Rival Schools, Power Stone, Capcom VS. SNK, Devil May Cry, and Dragon’s Dogma franchises.

A life-long and avid gamer, William D'Angelo was first introduced to VGChartz in 2007. After years of supporting the site, he was brought on in 2010 as a junior analyst, working his way up to lead analyst in 2012 and taking over the hardware estimates in 2017. He has expanded his involvement in the gaming community by producing content on his own YouTube channel and Twitch channel. You can contact the author on Twitter @TrunksWD.

Full Article - https://www.vgchartz.com/article/463041/hideaki-itsuno-to-lead-new-aaa-developer-lightspeed-japan-studio/

There’s plenty that you could justifiably expect from a Bioware RPG: chats with mates, opportunities to get those mates horribly killed, surviving mates turning to the side then walking offscreen. But I don’t think anyone expected Dragon Age: The Veilguard to be, at least on a purely technical level, one of the smoothest-performing, settings-rich AAA PC releases of the year so far.

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Beloved roguelike traumatic-childhood-em-up The Binding Of Issac: Rebirth turned 10 yesterday, and it’s half off on Steam to celebrate. What’s more, maker Edmund McMillen has announced that the foretold online co-op update is due on the 18th of this month, alongside a “considerable” balance update. Consider me considering the considerability of said considerable update!

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The finale doesn’t look to provide a definitive answer to what drove Aaron’s actions, much to the show’s credit.

Reports indicate that Chauhaan may have died by suicide, a claim supported by a social media post from his former co-star Vibhuti Thakur, who expressed her shock and sorrow over his untimely death

Directed by debutant Sidharth Vishwanath, ‘Sorgavaasal’ also stars Selvaraghavan, Natty, Saniya Iyappan, Sharaf-U-Dheen, Hakkim Shah, Anthonythasan, Ravi Raghavendra, and Samuel Robinson

The buzz surrounding his post even caused a temporary block on his Instagram account due to a surge in user engagement

The show originally aired on Doordarshan in 1997, became one of India’s most beloved superhero shows, running for over 450 episodes

Released in 1993 and directed by the Abbas-Mustan duo, ‘Baazigar’ was a game-changer for Shah Rukh Khan’s career, marking his debut in an anti-hero role that diverged sharply from typical Bollywood protagonists of that era

Aamir Khan recently kicked off the campaign at New York’s Indian restaurant, The Bungalow, where he was joined by Kiran Rao and hosted by chef Vikas Khanna

The ‘Umrao Jaan’ director speaks about reviving his passion project ‘Zooni,’ which was shelved in 1989 due to the insurgency in Kashmir, and his artwork of the Kashmiri muse that evolved out of the sketches he made for the Dimple Kapadia-starrer

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

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In a surprise development, the GOI has told us that it would welcome US participation as an Observer to SAARC.

Several Muslim leaders in the State expressed displeasure at the parleys that a group of Jamaat-e-Islami Hind leaders held with their RSS counterparts in New Delhi in January.

AARP's Travel Ambassador Samantha Brown Unveils the 2016 Top Travel Trends for Baby Boomers

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ESPN College Basketball Analyst and LG Color Commentator Jay Bilas shares his tips on how to do game day right.