Celiac Disease Guidance


Celiac disease:- FDA guidance on drug development

The US Food and Medication Organization (FDA) on Friday gave a draft direction to industry on creating drugs or biologicsto treat celiac illness (CeD) as a supplement to a without gluten diet.


The direction was created by FDA's Division of Gastroenterology in the Middle for Medication Assessment and Exploration (CDER) and the Middle for Biologics Assessment and Exploration (CBER). The record remembers subtleties for qualification standards, preliminary plan, contemplations for adequacy and security, and clinical result appraisals. It doesn't address the improvement of medications planned to supplant a sans gluten diet or for treating asymptomatic patients with insignificant histologic irritation.

FDA characterizes the sickness as an "immune system condition in which dietary gluten sets off little gut aggravation and villous decay, causing malabsorption and gastrointestinal side effects. The main treatment for CeD is a severe, long lasting sans gluten diet." The sickness influences roughly 1% of the US populace.

That's what the organization said "legitimate" biopsy methods are basic to affirm the illness' presence and that "various" histologic scoring frameworks have been made to recognize and order the seriousness of little entrail aggravation.

"The objectives of treatments in patients with CeD incorporate goal of digestive aggravation and related clinical signs and side effects," the direction states. "For some grown-ups, severe adherence to a sans gluten diet will bring about progress in both histologic discoveries and signs and side effects; in any case, a few grown-ups will most likely be unable to accomplish standardization of the mucosa." It further notes that "confusions of CeD incorporate unfortunate development, osteoporosis, tooth polish deformities, neuropathy, and nutrient lacks."

FDA prescribes supports adjust a patient's qualification to partake through utilizing an esophagogastroduodenoscopy with biopsy to guarantee histologic measures are met at season of enlistment. Supports are urged to utilize a "focal peruser" to guarantee the consistency of histologic assessments.

Patients ought to likewise be "adequately suggestive at standard" to notice treatment upgrades and ought to "rigorously" stick to a sans gluten diet through the preliminary's term.

Clinical preliminaries ought to be randomized, twofold visually impaired, and constrained by a fake treatment. The treatment term ought to be something like 52 weeks to portray the medication's security profile and solidness of reaction. Patients ought to record any "unexpected or thought coincidental gluten openness" during the preliminary.

The prescribed essential endpoint for preliminaries is to "evaluate indicative improvement" in view of prespecified center signs and side effects of the sickness. The endpoint ought not be restricted to a solitary sign or side effect. An optional endpoint is to assess the extent of patients with further developed signs and side effects of mucosal irritation.

Supporters ought to utilize "clear cut and dependable" patient-detailed result (Genius) instruments to evaluate clinical results. These instruments ought to be finished by patients simultaneously every day.

To guarantee that preliminary outcomes are measurably substantial, the direction prescribes that examinations be acclimated to reflect patient qualities that might influence effectiveness results, like age, term of sickness, infection seriousness, and the length of adherence to without gluten diet.

How to understand Celiac Disease

What is Celiac Disease and how to understand.

Introduction

Celiac disease is a common but often misunderstood condition that affects how our bodies react to gluten. Gluten is a protein found in many everyday foods, and for people with celiac disease, consuming it can lead to a range of health issues. In this article, we'll break down what celiac disease is, its symptoms, diagnosis, and how to manage it through a gluten-free diet.

  1. What is Celiac Disease?
  2. Signs and Symptoms
  3. Diagnosing Celiac Disease
  4. Living with Celiac Disease
  5. The Importance of a Gluten-Free Diet
  6. Gluten-Free Food Options

What is Celiac Disease?

Celiac disease is a medical condition where the body reacts badly to gluten. Gluten is like a puzzle piece found in wheat, barley, and rye. When people with celiac disease eat gluten, their body's defense system, called the immune system, gets upset. This can harm the tiny finger-like parts in the gut that help us absorb nutrients from food.


       



Signs and Symptoms

Celiac disease can make you feel unwell in many ways. Some people get tummy troubles like belly pain, bloating, and diarrhea. Others might feel tired, have skin problems, or even have trouble growing properly. If you notice these issues a lot, it's a good idea to see a doctor.

Diagnosing Celiac Disease

Doctors can do tests to find out if you have celiac disease. They might take a small piece of your belly's insides (not the painful part!) to look at it closely. Blood tests can also help show if your body is reacting to gluten. If the tests say you have celiac disease, don't worry – there are ways to manage it.

Living with Celiac Disease


If you have celiac disease so  it is important to avoid gluten and user Gluen Free products. But don't worry, there are plenty of yummy foods you can still eat! Fruits, veggies, meats, and some grains like rice are safe. You might need to be careful about things like bread, cookies, and pasta. Checking labels for "gluten-free" helps.

The Importance of a Gluten-Free Diet


Eating gluten-free might sound tricky, but it's super important. When people with celiac disease eat gluten, their gut can get hurt, making it hard to absorb good stuff from food. By saying no to gluten, you're helping your body stay healthy and strong.

Gluten-Free Food Options

You don't have to say goodbye to tasty food! There are gluten-free versions of many things you love, like pizza, cookies, and even bread. You can find them at special stores or even make your own. Plus, lots of natural foods are already gluten-free, so you have plenty of yummy choices.ou feel unwell in many ways. Some people get tummy troubles like belly pain, bloating, and diarrhea. Others might feel tired, have skin problems, or even have trouble growing properly. If you notice these issues a lot, it's a good idea to see a doctor.


LIFE SAVING OPERATION SURVEY

Online support in the operating room is an option for many | 56 percent would undergo surgery remotely assisted by specialists

Whether it's a routine procedure or a life-saving operation: if specialist knowledge of a particular medical discipline is required, patients do not necessarily have to switch to a more specialized hospital. Fully digitized operating rooms make it possible for doctors to be connected via video and give the surgical team on-site instructions on how to carry out the procedure. So far, this method has not been used much in Germany - however, a large proportion of people are open to online support in the operating room: 56 percent say they would have an operation under such circumstances - very few (1 percent) have even done so done once. This is the result of a representative survey among 1,157 people in Germany aged 16 and over.




According to this, the popularity of video support during an operation is high across all age groups: 66 percent of 16 to 29 year olds can imagine this, 52 percent of 30 to 49 year olds and 62 percent of 50 to 64 year olds. The proportion of those over 65 who would have an operation performed remotely using online support is also high at 49 percent.

According to this, the popularity of video support during an operation is high across all age groups: 66 percent of 16 to 29 year olds can imagine this, 52 percent of 30 to 49 year olds and 62 percent of 50 to 64 year olds. The proportion of those over 65 who would have an operation performed remotely using online support is also high at 49 percent. 

“A growing number of clinics in Germany have state-of-the-art, networked operating rooms. New imaging methods, augmented reality and robotics support doctors, especially in highly complicated procedures, and ensure more precision and safety," says Dr. Ariane Schenk, Head of Health & Pharma at Bitkom. "Even if specialists are connected via video, they can pass on valuable experiences or tips directly to the operating room." For many people, this is not science fiction: 65 percent also believe that remote-controlled, robot-assisted operations will be commonplace in the future. "Smart hospitals will significantly improve medical care in Germany in the future," says Schenk. "The widespread availability and usability of 5G will soon give digital operating theaters the next boost: This will allow complicated telemedical operations to be carried out in real time."

Note on the methodology: The information is based on a survey conducted by Bitkom Research on behalf of the Bitkom digital association. In May 2021, 1,157 people in Germany aged 16 and over were surveyed by telephone. The survey is representative.

The question was: "Which of the following digital offers have you already used or can you imagine using in the future?"


The Founder of Pakistan

 



QUAID AZAM FOUNDER OF PAKISTAN

From a very young age, I remember my family being quite poor. As children, we used to go hungry and when people asked us for help we would not give (as I used to be a child when the rest of the household was not working at that time). During our childhood, there were various incidents that affected us when trying to raise our head above water. My father once left home at night without informing me that he was going out in search of food or money due to how his family members were suffering from poverty. We had two sisters who did all they could to keep their mother in abides but they came up with nothing. The situation escalated when my friend started using a credit for his sister so that she could come home. This made it difficult for me to be able to find food. When I went to my paternal grandfather’s house, my aunt informed me that someone had been to my uncle’s house and stole his chicken. It was obvious how much my family members were starving. At first, I stayed at my maternal grandmother’s house but when my father decided to leave home at night to look for money, my mother was forced to take charge of their finances. However, my aunt managed to get my uncle to provide her with rice and meat. She had no other option, and then she started to prepare meals for the whole family (Shelton & Craig, 2005).

I was always a bright student due to my family’s financial status. However, when I moved to school, I went through numerous difficulties and finally graduated among my peers. After graduating, I had little option since I got a job as a babysitter since my family was low financially. By the time I went to college, my only option was to work for my parents because they had no money. However, after graduating, I went back home to start working in the factory but after some months, my boss moved away. Then, my father decided to ask my aunt if she was willing and she said yes. So, my brother was handed over responsibility and after I started working at another one, my mother got into some serious debts. I worked the same job until my brother took over the company where I used to work (Shelton & Craig, 2005).

In later life, I was offered a chance to join the military and I accepted because of my relatives and friends. In my first-service, my country got involved in war and the soldiers had to leave the city. They were given basic food but those who were lucky enough to survive were taken into custody. However, they were very lucky to have enough food. Due to my relatives and friends, I had peace in my mind and this is what motivated me into joining the army (Shelton & Craig, 2005).

As an Army officer, I had to work hard because I wanted to become successful in my career. For my success, I had to make sure that I was strong and ready to face any threat. In some cases, threats were so severe that my enemies managed to break my bones. These times made me feel like a weak person but those times were the best times in my life. Those times are also part of my favorite memories in most cases. Even though I had never experienced death before, I managed to see many dead soldiers in front of my eyes. The most difficult time was when I saw my father looking at me and saying, “Son, you are so proud of yourself” (Bergis, 2005). There were moments that were very hard for us both. During these times, I used to cry sometimes but the people around me helped by promising me a better future ahead of myself. Despite being in such harsh conditions, I got to enjoy every moment I was in the army. Some days, I felt that I was getting too old to go out of here and they would force me to go back home. But on some occasions, they were happy. Just, they gave me freedom to choose. I often think about how others were in such situations as well as their choices.

During the Second World War, a lot of people in Pakistan were killed by bullets. Since I was in England, I was sent out for training after my father died in France. On August 5, 1942, the Germans surprised us by attacking at Jidah, which was known as one of the biggest cities in Europe. A good number of soldiers were killed during the attack and therefore, the British army had to move into Jidhah. My father became worried at that time and he said to me, “Son, you will need to attend my funeral and I will send someone to bring you back early so that you can protect us all from those who want to kill us (Bergis, 2005)’

I had to run for cover during some attacks. Most attacks I faced were from German troops but some attacks were from enemy groups such as the Pathan tribesmen. Such attacks were difficult to deal with even though they were coming from different directions. The biggest challenge was when I was in Pakistan’s capital area. When I arrived at Dacca (South), Karachi, my soldiers thought I must have got shot down on my way from behind. Fortunately, my fellow officers and me stood firm against the attack. Our commander ordered a counter attack and this was a great victory to us (Bergis, 2005).

In January 1945, my father died while in France and by that time, the British army had occupied South. I was sent to teach English in schools near Jidah. During this time, the Germans occupied more parts of Karachi but they eventually broke up into smaller units. The Jews that lived in those areas were murdered by the terrorists. The Germans had already captured my home and therefore, I had to wait till they released me to live there (Bergis, 2005).

I got married in 1946 and I came back to South. Around this time, the Japanese soldiers invaded India and they attacked several places including the capital and my village. I managed to escape after fighting them a long period. Unfortunately, the British army then captured Karachi and by this time, the Germans had taken my property, clothes, and food. That day, I went to meet my husband. He told me they had saved me from this place and we had to spend the night together. Before dawn, I had to flee again but somehow, the Germans were aware of my movements and they followed me. My husband and four men had to watch closely to ensure that nobody was going to hit us. One of our men had a handgun with him and we quickly fled to hide in a cellar. All together, we managed to survive those hours. My wife, children, and my nephew who I had no contact with anymore were also killed during the raid. Luckily, nobody was actually hurt.

After going through numerous hardships, I managed to marry the love of my life and we got married in 1947. I did not go back home since I loved the land of Pakistan. I had to relocate my family to Karachi. Once I returned to my hometown, I worked on my education so that I could earn some money for my marriage. I attended classes and got a certificate. Therefore, I was back in the workforce. I am proud of this; nevertheless, I had to work so that I could support my family (Shelton & Craig, 2005). With my husband, eight children, and two grandchildren, life was full of happiness and even at times, you could be lonely due to the lack of social ties. I thought of having gone through a lot of hardships but then, my eldest son suggested that we get married. That was after a lot of pressure from my children until I agreed to accept him into us and then he agreed that I will be his bridegroom (Bergis, 2005).

After living in London and London, I decided to return to Karachi to do more studies so that I can acquire a master’s degree. Unfortunately, I lost my opportunity to get a Master’s Degree during the 1960s. I studied in Britain but that was not my true love. Instead, I chose to study at the University of Pennsylvania. By 1977, I had received three doctorates but the three fellowships were rejected by American universities since I lacked a research experience. However, the US government supported me by giving me a PhD fellowship in 1980. This experience changed my understanding of science and technology. Now, I believe that I know everything about scientific inventions.

I had to work for thirty years before being offered a teaching position. Until 1987, I worked as a teacher and I became attached to the East Pakistani Institute, a learning institution that provides training and development programs for overseas students. I was also tasked with developing curriculum materials that are appropriate for foreign language learning. Nevertheless, I had to attend my postgraduate program so that I can meet my requirements in order to continue my services as a university professor. At this point, I had a small business running in downtown Karachi. I had to sell t-shirts, jackets, hats, and even glasses once in the morning hours. During these sales, I managed to save up for extra expenses but my savings were completely wiped out. Luckily, I was determined to succeed in the world of academics, and so, during my second year of completing my MSc degree, I was employed on contract as assistant director of NEDC. Having a PhD degree also equipped me economically, although I still suffered the same issues as my brothers did.

After finishing my PhD, I managed to join the faculty of Harvard University and I earned a Bachelor of Arts (BA). Being a Professor of a prestigious university allowed me to have access to resources and knowledge that are necessary to carry out my duties in the field of public health.

NIKE SHOES

 




NIKE SHOES

Background

A brand of athletic footwear, sporting goods and accessories produced by the company Nike. The products are sold in a wide range of sportswear for men and women, including running shoes; basketball shoes and tennis shoes; baseball shoes; football shoes; hockey shoes; ski boots and other accessories. Nike was founded in 1964 in Beaverton, Oregon. As of March 25th, 2018, Nike employed more than 2,550,000 people worldwide who serve its customers with a wide range of high quality sports-related products and services from its subsidiaries around the world. It has operations and sales teams located in 38 countries and sells its merchandise in approximately 190 nations or regions. Nike's headquarters is located at 888 Northfield Square, Chicago, IL 60654, United States, which employs about 5,500 people in various locations around the world. In 2015, Nike reported to be the second-largest public corporation in terms of shareholder returns, according to data compiled by BloombergNEF. However, it also ranked first among non-U.S.-based companies in the same year on profitability and growth based on operating and financial reports, as well as the best performers since last year's report. Nike has been a successful global corporate social responsibility (CSR) initiative in recent years. Its "Unapologetic" campaign, which highlights ethical issues facing athletes around the world, generated more than $11 million (USD), in 2014. Nike has been criticized by many environmentalists and human rights groups for its production of polyester fibers used in some of its clothing. For example, in 2013, its use of dyes and toxic chemicals in making socks resulted in several deaths. This prompted protests against the company and led to temporary shutdowns of plants in several cities around the globe.

History

In 1963, Joe Shaker began working in New York City's garment factory where he became aware of his great love for his work. Inspired by that passion, he opened two shoe stores called Blue Ribbon Sports in 1968 at the start of what would become Nike, Inc. His daughter, Marisa Shaker Murphy, was named President of Nike Corporation in 1998 after her father was killed in an automobile accident in 1997 while returning home from medical leave. When Mark Parker became CEO in 1999, Nike had grown into one of the most recognizable brands around the world, with over 3 million retail stores around the U.S., Canada, and various international markets. While the original sole focus of Nike's marketing efforts was to sell sneakers, their sales eventually expanded into numerous consumer goods categories. Their business model shifted to wholesaling footwear and related products as they increased market penetration. According to Reuters, Nike gained market share in China between 2000 and 2003, but this was mainly due to their partnership with Beijing Jinhua Shoes Co., Ltd. (now part of Anhui Jinhua Group Holdings Limited) a subsidiary of Yili Group, now a major Chinese footwear manufacturer. By 2004, Nike had overtaken Adidas to become the largest seller globally despite losing some significant market shares to Adidas. After losing a large percentage market share to Adidas, the second-largest competitor to Nike became Under Armor in January 2005. Nike acquired the remaining assets of the acquired company, then rebranded them under their own name. During these times, Nike started a new design process by cutting away all of the features that their competitors had. They started redesigning their designs, with very few exceptions, focusing on aesthetic rather than function. Eventually, Nike ended up releasing three main styles; Air Force 1, Tiger Woods, and Kobe Bryant. Since 1990, Nike has dominated the sneaker world, producing and selling millions of pairs of sneakers each year. Each year Nike releases a batch of five million sneakers.

Nike Company Headquarters in Illinois City, Chicago, USA

As of December 2017, Nike was the number two-highest grossing brand in the U.S. The next year, July 2018, their stock was included in Fortune Magazine’s list on how well their stock is doing in the stock market.

On October 10, 2019, Nike was listed in the S&P 500 index. On August 24, 2020, Starbucks and General Motors announced that they could begin trading publicly, joining another big company like Apple. But for investors, even though Starbucks and GM are both privately owned companies, they have different advantages. Also, if Starbucks went public, other coffee shops would no longer need access to their proprietary software to remain competitive and be able to compete against Starbucks, since everyone and anyone can buy their coffee with just a phone.

On January 21, 2021, Nike released its quarterly update for the fourth quarter of 2016. In January 2017, Nike introduced their famous Magicshoes collection; later in April 2017, Nike launched NKE+, the world’s first smartwatch for athletes, allowing them to stream video games on their wrist to improve the flow of sports, play music, enjoy videos, track their heart rate, monitor sleep pattern, send reminders, and take long-distance workouts. From September 2018 to November 2019, Nike hosted the X Games event in Sydney. To celebrate this success, they designed a poster, which showed the theme of infinity where you can look down and see it, feel the atmosphere, and understand everything. On February 6, 2018, Nike unveiled the collaboration with British fashion designer Stella Maxwell "Naked". On May 14, 2019, Nike released the newest edition of their Nike+ product lines called “Nike Revival Series”.

KE FUEL ADJUSTMENT CHARGES

 


FUEL CHARGE ADJUSTMENT RELIEF ANNOUNCED BY THE PRIME MINISTER ON 3RD SEP 2022


Q 1. What is the Fuel Charge Adjustment Relief announced by the Prime Minister on 3rd Sep 2022?

For the Prime Minister what is the eligibility criteria Fuel Charge Relief?

Prime Minister of Pakistan has announced Fuel Charge Adjustment Relief in August 22 billing month for Residential Non-ToU customers whose electricity consumption was between 200-300 units in June only across Pakistan.

Note that Non-ToU Residential customers with consumption above 300 units ToU Residential, Industrial  Commercial, and other categories (except Agriculture) are not eligible for this Fuel Charge Adjustment relief as such these customers are reminded to pay bills by due date to avoid Late Payment Surcharge.

Heidelberg Historical University & Red Castle Ruins

 




Heidelberg: Historical University & Red Castle Ruins


Heidelberg in Baden- Wurttemberg is best known for the Heidelberg Castle, which was first 
mentioned in writing in 1214. The former residence of the Electors Palatinate was built of red sandstone. Unfortunately, the original walls were destroyed and rebuilt several times. The exposed location of the castle offers you a wonderful view of the old town and the Neckar. This is “the place to be” in Heidelberg, especially at sunset. In addition to romantic corners, the city also has numerous historical buildings and places to offer, such as the Karl Theodor Bridge, which opened in 1788 and was named after the builder. Compared to its wooden predecessors, it has survived several centuries well.

The bridge gate even dates back to the Middle Ages and used to be part of the city fortifications. Even older than the bridge and the gate is the university. It was founded in 1368 by Elector Utrecht I and is therefore the oldest university in Germany. As a visitor, you should not miss the university library and the "student prison". The medieval old town with its 1.5 km long pedestrian zone is also well worth seeing. There you will find buildings steeped in history, such as the Gothic Church of the Holy Spirit, the Karlstad, and the Grand Ducal Palace.

Chicken Karahi Receipe

 




Chicken Karahi Receipe

The smoky aroma in food gives it a lips-smacking taste. Karahi Recipe is some variation in a chicken karahi. The cooking method is a simple as most of the Pakistani Food Recipes have. The use of karahi masala enhances the taste of the dish.

Keep in mind it also knows as chicken karahi dhaba style. You all must try it, you will love the taste. Check out how to get a smoky taste in foods.

 

Ingredients

  • Chicken 1 kg
  • Tomatoes ½ kg (chopped)
  • Ginger, garlic 2 tbsp (finely chopped)
  • Green chilies 8-10
  • Turmeric powder ½ tsp
  • Fresh crushed black pepper 1 tsp
  • Special karahi masala 2 tbsp
  • Garam masala powder 1 tsp
  • Ghee/oil ½ cup
  • Lemon juice 1 tbsp
  • Julian ginger

 Special Karahi Masala

o   Cumin seeds 1 tbsp

o   Coriander seeds 1 tbsp

o   Crushed red chili 1 tbsp

o   Qasoor methi 1 tsp

o   Khatai powder 1 tsp

o   Chaat masala 1 tbsp

o   Ajween ¼ tsp

 

Instructions

 

1.       Heat ghee or oil in a pan and fry chicken on high heat until changes color.

2.      Remove chicken from ghee or oil and keep aside.

3.      In the same ghee or oil add finely chopped ginger and garlic, fry them. When it gives aroma add chopped tomatos.

4.     Fry at high flame for 10 minutes and now add turmeric powder, fried chicken, salt, and ¼ cup water.

5.      Cover and cook it at medium flame. After 15 to 20 minutes, increase the flame to high and fry chicken.

6.      Now add crushed black pepper, karahi masala, garam masala powder and cook nicely until ghee or oil separates.

7.      Add lemon juice, green chilies, and Julian ginger etc. Give it to coal smoke for 5  minutes. Dish out and serve with roti/naan and raita as you wish.