NIAID-Sponsored Trial of a Universal Influenza Vaccine Begins

 

THE FOLLOWING SHOWS THE BEST OF GOVERNMENT

 

Influenza pandemics occur when a novel influenza strain for which people have little to no protection begins to spread among humans and present a greater public health threat than seasonal influenza. For example, the 1918 influenza pandemic killed at least 50 million people worldwide.

 

Influenza viruses mutate constantly, resulting in the emergence of viruses that may not always match those targeted by seasonal and pre-pandemic influenza vaccines. Seasonal influenza vaccines are made anew each year to match the strains predicted to circulate in the upcoming season. To receive the best protection against influenza, people must be vaccinated annually. However, if a particular influenza strain changes in an unanticipated way, or a different strain not included in the vaccine spreads widely, the seasonal influenza vaccine may not be sufficiently protective.

 

Each year, seasonal influenza sickens millions in the United States and results in 140,000 to 710,000 hospitalizations and between 12,000 and 56,000 deaths, according to the Centers for Disease Control and Prevention. An ideal universal influenza vaccine would provide durable protection for all age groups against multiple influenza strains, including those that might cause a pandemic.

 

A Phase 2 clinical trial of an investigational universal influenza vaccine intended to protect against multiple strains of the virus has begun in the United States. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being conducted at four U.S. sites that are part of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The trial is testing an experimental vaccine called M-001 for safety and its ability to produce potentially broad protective immune responses, both on its own and when followed by a standard, licensed seasonal influenza vaccine. The new trial is being led by principal investigator Robert L. Atmar, M.D., of Baylor College of Medicine in Houston. The trial will test the M-001 vaccine candidate, developed and produced by BiondVax Pharmaceuticals based in Ness Ziona, Israel. The experimental M-001 vaccine contains antigenic peptide sequences shared among many different influenza viruses. Theoretically, it could protect against many current and emerging strains of influenza. Six previous clinical trials involving a total of 698 participants conducted by BiondVax in Israel and Europe indicated that the vaccine candidate was safe, well-tolerated and produced an immune response to a broad range of influenza strains.

 

The new study will enroll up to 120 healthy volunteers between the ages of 18 and 49 years. Participants will be assigned randomly to receive either two doses of the experimental vaccine or a placebo. They will be vaccinated twice, receiving one dose (1 mg; 0.4 milliliters) of M-001 or placebo via intramuscular injection on the first day and a second dose 22 days later. Approximately 172 days later, all participants will receive an approved seasonal influenza vaccine. During periodic additional clinic visits throughout the course of the study, blood will be drawn from study volunteers to evaluate their immune responses to both the experimental vaccine and to the seasonal vaccine. Each participant will be followed for approximately seven months.

 

The trial will take place at four NIAID-funded VTEUs. Patients will be enrolled at the Baylor College of Medicine; the University of Iowa in Iowa City; and Cincinnati Children’s Hospital Medical Center. Laboratory support will be provided by Saint Louis University. For more information about the study, go to ClinicalTrials.gov, using the identifier NCT03058692.

 

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Essential Malaria Parasite Genes Revealed

 

According to an article published in Science (4 May 2018), a quirk in the genetic make-up of the deadly malaria parasite, Plasmodium falciparum, has been exploited to create 38,000 mutant strains and then determine which of the organism’s genes are essential to its growth and survival. P. falciparum is responsible for about half of all malaria cases and 90 percent of all malaria deaths. New information about the parasite’s critical gene repertoire could help investigators prioritize targets for future antimalarial drug development.

 

The complete genetic sequence of P. falciparum was determined more than a decade ago, but the functions of most of its genes remain unknown, and until now only a few hundred mutant strains had been created in the lab. The difficulties in manipulating P. falciparum stem in part from the extremely high percentage of adenine or thymine (two of the four chemical building blocks that make up DNA) in its genome. Standard methods for creating mutants rely on more variation in gene sequences and so do not work on P. falciparum. In the new research, the authors created mutated versions of nearly all the parasite’s 6,000 genes with a technique that preferentially targets areas rich in adenine and thymine, thus exploiting the very feature that had foiled previous attempts at genetic manipulation. The team used computational analysis to distinguish non-essential genes (those that could be mutated) from essential, non-mutable ones. About 2,600 were identified as indispensable for growth and survival during the parasite’s asexual, blood stage. These included ones associated with P. falciparum’s ability to resist antimalaria drugs, highlighting them as high-priority targets for new or improved antimalarial compounds, the researchers note.

 

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FDA Approves New Uses For Two Drugs Administered Together For The Treatment of BRAF-Positive Anaplastic Thyroid Cancer

 

Clearly, pharmaceutical companies must be viewed in part as chemical companies with multipurposed products.

 

Thyroid cancer is a disease in which cancer cells form in the tissues of the thyroid gland. Anaplastic thyroid cancer is a rare, aggressive type of thyroid cancer. The National Institutes of Health estimates there will be 53,990 new cases of thyroid cancer and an estimated 2,060 deaths from the disease in the United States in 2018. Anaplastic thyroid cancer accounts for about 1-2% of all thyroid cancers.

 

The FDA has approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive). This is the first FDA-approved treatment for patients with this aggressive form of thyroid cancer, and the third cancer with this specific gene mutation that this drug combination has been approved to treat. According to the FDA, this approval demonstrates that targeting the same molecular pathway in diverse diseases is an effective way to expedite the development of treatments that may help more patients.

 

Both Tafinlar and Mekinist are also approved for use, alone or in combination, to treat BRAF V600 mutation-positive metastatic melanoma. Additionally, Tafinlar and Mekinist are approved for use, in combination, to treat BRAF V600E mutation-positive, metastatic non-small cell lung cancer. The efficacy of Tafinlar and Mekinist in treating ATC was shown in an open-label clinical trial of patients with rare cancers with the BRAF V600E mutation. Data from trials in BRAF V600E mutation-positive, metastatic melanoma or lung cancer and results in other BRAF V600E mutation-positive rare cancers provided confidence in the results seen in patients with ATC. The trial measured the percent of patients with a complete or partial reduction in tumor size (overall response rate). Of 23 evaluable patients, 57% experienced a partial response and 4% experienced a complete response; in nine (64%) of the 14 patients with responses, there were no significant tumor growths for six months or longer.

 

The side effects of Tafinlar and Mekinist in patients with ATC are consistent with those seen in other cancers when the two drugs are used together. Common side effects include fever (pyrexia), rash, chills, headache, joint pain (arthralgia), cough, fatigue, nausea, vomiting, diarrhea, myalgia (muscle pain), dry skin, decreased appetite, edema, hemorrhage, high blood pressure (hypertension) and difficulty breathing (dyspnea). Severe side effects of Tafinlar include the development of new cancers, growth of tumors in patients with BRAF wild-type tumors, serious bleeding problems, heart problems, severe eye problems, fever that may be severe, serious skin reactions, high blood sugar or worsening diabetes, and serious anemia. Severe side effects of Mekinist include the development of new cancers; serious bleeding problems; inflammation of intestines and perforation of the intestines; blood clots in the arms, legs or lungs; heart problems; severe eye problems; lung or breathing problems; fever that may be severe; serious skin reactions; and high blood sugar or worsening diabetes. Both Tafinlar and Mekinist can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.

 

The FDA granted Priority Review and Breakthrough Therapy designation for this indication. Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases, was also granted for this indication.

 

The FDA granted this approval to Novartis Pharmaceuticals Corporation.

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Hollandaise Sauce with a Zillion Uses

Delicious, easy and just right with tender Spring asparagus, which is still at its peak. ©Joyce Hays, Target Health Inc.

 

Serve tender stalks in a crepe or on a pancake with yummy Hollandaise. ©Joyce Hays, Target Health Inc.

Or 

Asparagus with Smoked Salmon, Poached Egg, Hollandaise Sauce

This was a tasty lunch last week. It could easily be Sunday brunch or a wonderful appetizer with a chilled glass of white wine. Here, smoked salmon was wrapped around each asparagus stalk. A poached egg was placed on top of the stalks; then the hollandaise sauce was carefully spooned over the egg. ©Joyce Hays, Target Health Inc.

 

Here is an appetizer, where the effort of wrapping the salmon around each stalk was avoided. Fresh smoked salmon was placed on the plate, followed by two tender stalks of asparagus that had been sauteed for one minute. Next, a poached egg, drizzled with freshly made hollandaise sauce. This was so delicious, that instead of an entree, more appetizers were quickly assembled. ©Joyce Hays, Target Health Inc.

 

Here’s what this recipe looks like, a few minutes after serving. ©Joyce Hays, Target Health Inc.

 

Of course, there’re always variations on Eggs Benedict to try out with the hollandaise.

 

Ingredients

4 egg yolks

2 Tablespoons freshly squeezed lemon juice

1 stick of unsalted butter, melted

Pinch chili flakes

Pinch salt

 

This is an easy recipe to shop for. Tender local asparagus is everywhere. ©Joyce Hays, Target Health Inc.

  

Directions

1. Melt the butter in a small pan over lowest heat, then set aside

 

I’ve had this little pan for many years; it’s perfect for many things. Here, for melting butter. ©Joyce Hays, Target Health Inc.

 

2. Squeeze the lemon juice, so it’ll be ready when you need it.

 

Use a lemon squeezer that catches the pits and squeeze the juice into a small cup. ©Joyce Hays, Target Health Inc.

 

3. If you don’t have a double boiler, use a steel bowl.

4. Vigorously whisk the egg yolks and lemon juice together in a stainless steel bowl. Keep whisking until you feel like your arm will fall off, or until the mixture is thickened and still has become twice as much liquid. It could take 5 minutes.

 

Here is what the consistency should look like. And, yes, your arm will feel a temporary ache. (sorry) ©Joyce Hays, Target Health Inc.

 

5. If you don’t have a double boiler, find just the right size saucepan, add water to the bottom of this pan. On low heat, bring the water to a simmer. If you do have a double boiler, then do all the egg yolk whisking in the top of the double boiler.

6. Now, place the mixing bowl with egg & lemon, over the saucepan with simmering water. The trick here, is do NOT let the simmering water touch the bottom of the bowl, or the eggs will cook more than you want them to and you will have to start all over again. You do NOT want little particles of cooked egg floating in this sauce, or all your time will have been wasted.

7. Continue to whisk rapidly. And continue to watch that the eggs do not get too hot or you will have scrambled eggs and not a sauce.

8. Slowly drizzle in the melted butter and continue to whisk until the sauce is thickened and doubled in volume. You do NOT want the heat from the melted butter to cook the eggs in any way. That’s why you must add the melted butter in a very slow trickle.

9. Remove from heat, whisk in chili flakes and salt.

10. Cover and place in a warm spot until ready to use for the asparagus and eggs. If the sauce gets too thick, whisk in a few drops of warm water before serving.

 

If you don’t have an egg poacher, fill a small saucepan with water and add a small glug of white vinegar or apple vinegar to the water. ©Joyce Hays, Target Health Inc.

  

11. Swirl the water & vinegar around and bring it to a simmer.

12. Break an egg into a small cup, to be sure that the yolk will not be broken before you add it to the pan.

13. Then, carefully slip the egg into the simmering water.

14. Keep your eye on the yolk. In about 2 or 3 minutes the egg will be done, with a semi-soft yolk.

15. If you like a more runny yolk, keep it in the simmering water for 1.5 to 2 minutes.

 

Have ready and next to the stove, the plate with asparagus and/or asparagus with smoked salmon. With a slotted spoon, remove the poached egg, when done. Allow the water to drip from the spoon, before you place the egg over the asparagus or over the smoked salmon. After placing the egg, have the hollandaise ready to spoon over the food you’ve prepared, then serve immediately.

 

The only limit to the use of Hollandaise Sauce, is your own creativity.

  1. Consider serving hollandaise over broccoli sauteed with sliced garlic; or spinach.
  2. Serve hollandaise over any fish cooked the way you like it.
  3. Serve a poached egg on avocado toast, then spoon some hollandaise over this yummy combo.
  4. Serve shrimp over saffron rice and hollandaise over this dish.Etc. Etc. Etc.

 

Hundreds of options for eggs and hollandaise sauce; veggies and hollandaise, etc.

On a medium size plate, place one pancake. On top of the pancake, put two or three big whole asparagus. Over the asparagus add one or two poached eggs. On one side of the asparagus pancake, put a turkey sausage or regular sausage (optional). Over the top of the egg, spoon the Hollandaise Sauce.

 

Springtime and Stag’s Leap Cellars, go together. Chilled, light but distinctive, this sauvignon blanc went well with all the uses of hollandaise, on this recipe page. The recent Napa Valley fires came very close to this vineyard, which is one of our favorites. Here’s hoping there was minimal to no damage. We’ll drink to that. ©Joyce Hays, Target Health Inc.

 

We saw our last opera for the season, Romeo and Juliet conducted by Placido Domingo. We were in tears when the curtain dropped on the last act.

 

Have a great week everyone!

From Our Table to Yours

Bon Appetit!

 

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Date:
May 3, 2018

Source:
University of South Florida (USF Health)

Summary:
Antimalarial drugs and vaccines are expected to be far more superior with the uncovering of Plasmodium falciparum’s full genome, the parasite that makes malaria so deadly.

 

A microscopic look at Plasmodium falciparum, the parasite that makes malaria so deadly.
Credit: University of South Florida

 

 

Ninety-percent of people killed by malaria are infected with the parasite Plasmodium falciparum. Now, for the first time, researchers have learned exactly what is essential in the parasite’s genetic makeup, paving the way to the development of stronger antimalarial drugs.

A research team led by public health scientists at the University of South Florida in Tampa created a new technique that mutated most of P. falciparum‘s 6,000 genes, providing a far superior understanding of how each gene functions. In the study published in Science, the authors successfully targeted adenine and thymine, two of the four chemical building blocks that make up DNA. This is significant as P. falciparum‘s high percentage of adenine and thymine previously limited efforts to manipulate the parasite’s genome, resulting in only a few hundred mutant strains.

“This is a transformative advance,” said lead author John H. Adams, PhD, Distinguished Professor, University of South Florida College of Public Health. “The genome of this malaria parasite has been resistant to most methods in the modern genetics toolbox. Consequently, functional importance of only a few hundred genes was determined. Using piggyBac mutagenesis, our new genetic tool, we have functionally characterized nearly all of the parasite’s genes. Identifying essential genes and pathways will help guide and accelerate future drug and vaccine development.”

With funding from the National Institutes of Health (NIH), the research team used advanced computational analyses to identify about 2,600 genes that are essential to the parasite’s growth and resistance to antimalarial drugs. This critical information is expected to have a dramatic impact on the fight against malaria, which infects 220 million people worldwide and claims 500,000 lives each year.

Story Source:

Materials provided by University of South Florida (USF Health)Note: Content may be edited for style and length.


Journal Reference:

  1. Min Zhang, Chengqi Wang, Thomas D. Otto, Jenna Oberstaller, Xiangyun Liao, Swamy R. Adapa, Kenneth Udenze, Iraad F. Bronner, Deborah Casandra, Matthew Mayho, Jacqueline Brown, Suzanne Li, Justin Swanson, Julian C. Rayner, Rays H. Y. Jiang, John H. Adams. Uncovering the essential genes of the human malaria parasitePlasmodium falciparumby saturation mutagenesisScience, 2018; 360 (6388): eaap7847 DOI: 10.1126/science.aap7847

 

Source: University of South Florida (USF Health). “Unlocking the genome of the world’s deadliest parasite.” ScienceDaily. ScienceDaily, 3 May 2018. <www.sciencedaily.com/releases/2018/05/180503142722.htm>.

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Date:
May 2, 2018

Source:
Yale University

Summary:
Physicists have uncovered hints of a time crystal — a form of matter that ‘ticks’ when exposed to an electromagnetic pulse — in the last place they expected: a crystal you might find in a child’s toy.

 

Yale physicists looked for a signature of a discrete time crystal within a crystal of monoammonium phosphate.
Credit: Michael Marsland/Yale University

 

 

Yale physicists have uncovered hints of a time crystal — a form of matter that “ticks” when exposed to an electromagnetic pulse — in the last place they expected: a crystal you might find in a child’s toy.

The discovery means there are now new puzzles to solve, in terms of how time crystals form in the first place.

Ordinary crystals such as salt or quartz are examples of three-dimensional, ordered spatial crystals. Their atoms are arranged in a repeating system, something scientists have known for a century.

Time crystals, first identified in 2016, are different. Their atoms spin periodically, first in one direction and then in another, as a pulsating force is used to flip them. That’s the “ticking.” In addition, the ticking in a time crystal is locked at a particular frequency, even when the pulse flips are imperfect.

Scientists say that understanding time crystals may lead to improvements in atomic clocks, gyroscopes, and magnetometers, as well as aid in building potential quantum technologies. The U.S. Department of Defense recently announced a program to fund more research into time crystal systems.

Yale’s new findings are described in a pair of studies, one in Physical Review Letters and the other in Physical Review B. The studies represent the second known experiment observing a telltale signature for a discrete time crystal (DTC) in a solid. Previous experiments led to a flurry of media attention in the past year.

“We decided to try searching for the DTC signature ourselves,” said Yale physics professor Sean Barrett, principal investigator for the two new studies. “My student Jared Rovny had grown monoammonium phosphate (MAP) crystals for a completely different experiment, so we happened to have one in our lab.”

MAP crystals are considered so easy to grow that they are sometimes included in crystal growing kits aimed at youngsters. It would be unusual to find a time crystal signature inside a MAP crystal, Barrett explained, because time crystals were thought to form in crystals with more internal “disorder.”

The researchers used nuclear magnetic resonance (NMR) to look for a DTC signature — and quickly found it. “Our crystal measurements looked quite striking right off the bat,” Barrett said. “Our work suggests that the signature of a DTC could be found, in principle, by looking in a children’s crystal growing kit.”

Another unexpected thing happened, as well. “We realized that just finding the DTC signature didn’t necessarily prove that the system had a quantum memory of how it came to be,” said Yale graduate student Robert Blum, a co-author on the studies. “This spurred us to try a time crystal ‘echo,’ which revealed the hidden coherence, or quantum order, within the system,” added Rovny, also a Yale graduate student and lead author of the studies.

Barrett noted that his team’s results, combined with previous experiments, “present a puzzle” for theorists trying to understand how time crystals form.

“It’s too early to tell what the resolution will be for the current theory of discrete time crystals, but people will be working on this question for at least the next few years,” Barrett said.

The National Science Foundation supported the research.

Story Source:

Materials provided by Yale University. Original written by Jim Shelton. Note: Content may be edited for style and length.


Journal References:

  1. Jared Rovny, Robert L. Blum, Sean E. Barrett. Observation of Discrete-Time-Crystal Signatures in an Ordered Dipolar Many-Body SystemPhysical Review Letters, 2018; 120 (18) DOI: 10.1103/PhysRevLett.120.180603
  2. Jared Rovny, Robert L. Blum, Sean E. Barrett. P31 NMR study of discrete time-crystalline signatures in an ordered crystal of ammonium dihydrogen phosphatePhysical Review B, 2018; 97 (18) DOI: 10.1103/PhysRevB.97.184301

 

Source: Yale University. “Physicists find signs of a time crystal.” ScienceDaily. ScienceDaily, 2 May 2018. <www.sciencedaily.com/releases/2018/05/180502120013.htm>.

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‘Hygiene hypothesis’ likely applies to psychiatric disorders too

Date:
April 30, 2018

Source:
University of Colorado at Boulder

Summary:
Children raised in a rural environment, surrounded by animals and bacteria-laden dust, grow up to have more stress-resilient immune systems and might be at lower risk of mental illness than pet-free city dwellers, according to new research.

 

City living may increase risk of mental illness.
Credit: © olly / Fotolia

 

 

Children raised in a rural environment, surrounded by animals and bacteria-laden dust, grow up to have more stress-resilient immune systems and might be at lower risk of mental illness than pet-free city dwellers, according to new research published in the Proceedings of the National Academy of Sciences (PNAS).

The study, co-authored by researchers from the University of Ulm in Germany and the University of Colorado Boulder, adds to mounting evidence supporting the “hygiene hypothesis,” which posits that overly sterile environments can breed health problems.

The research also suggests that raising kids around pets might be good for mental health — for reasons people might not expect.

“It has already been very well documented that exposure to pets and rural environments during development is beneficial in terms of reducing risk of asthma and allergies later in life,” said co-author Christopher Lowry, a professor of integrative physiology at CU Boulder. “This study moves the conversation forward by showing for the first time in humans that these same exposures are likely to be important for mental health.”

For the study, led by University of Ulm Professor Stefan Reber, the scientists recruited 40 healthy German men between 20 and 40 years old. Half had grown up on a farm with farm animals. Half had grown up in a large city without pets.

On test day, all were asked to give a speech in front of a group of stone-faced observers and then asked to solve a difficult math problem while being timed.

Blood and saliva were taken five minutes before and five, 15, 60, 90 and 120 minutes after the test.

Those who grew up in cities had significantly higher levels of immune system components called peripheral blood mononuclear cells (PBMCs) after the stressful experience.

They also showed prolonged elevation of the inflammatory compound interleukin 6 and muted activation of the anti-inflammatory compound interleukin 10.

“People who grew up in an urban environment had a much-exaggerated induction of the inflammatory immune response to the stressor, and it persisted throughout the two-hour period,” Lowry said.

Surprisingly, while their bodies launched a hair-trigger response to the stress, the former city kids reported feeling less stressed than their rural counterparts did.

“This exaggerated inflammatory response is like a sleeping giant that they are completely unaware of,” Lowry said.

Previous studies have shown that those with an exaggerated inflammatory response are more likely to develop depression and post-traumatic stress disorder (PTSD) later in life.

Research has also shown that our immunoregulatory response to stress develops in early life and is shaped largely by our microbial environment.

More than 50 percent of the world’s population now lives in a urban areas, meaning humans are exposed to far fewer microorganisms than they evolved with, the authors note.

“If you are not exposed to these types of organisms, then your immune system doesn’t develop a balance between inflammatory and anti-inflammatory forces, and you can develop a chronic, low-grade inflammation and exaggerated immune reactivity that makes you vulnerable to allergy, autoimmune disease and, we propose, psychiatric disorders,” Lowry said.

Reber said he hopes to expand the study to larger samples, women and new locations, and try to parse out how much of the benefit is coming from exposure to animals and how much is coming from rural living.

For now, the authors advise eating foods rich in healthy bacteria, or probiotics, spending time in nature and getting a furred pet.

“A lot of research still needs to be done. But it looks as if spending as much time as possible, preferably during upbringing, in environments offering a wide range of microbial exposures has many beneficial effects,” Reber said.

Story Source:

Materials provided by University of Colorado at Boulder. Original written by Lisa Marshall. Note: Content may be edited for style and length.


Journal Reference:

  1. Till S. Böbel, Sascha B. Hackl, Dominik Langgartner, Marc N. Jarczok, Nicolas Rohleder, Graham A. Rook, Christopher A. Lowry, Harald Gündel, Christiane Waller, Stefan O. Reber. Less immune activation following social stress in rural vs. urban participants raised with regular or no animal contact, respectivelyProceedings of the National Academy of Sciences, 2018; 201719866 DOI: 10.1073/pnas.1719866115

 

Source: University of Colorado at Boulder. “City upbringing, without pets, boosts vulnerability to mental illness: ‘Hygiene hypothesis’ likely applies to psychiatric disorders too.” ScienceDaily. ScienceDaily, 30 April 2018. <www.sciencedaily.com/releases/2018/04/180430160419.htm>.

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Date:
April 27, 2018

Source:
Penn State

Summary:
Warm, nurturing parents may pass along strategies for building and maintaining positive relationships to their kids, setting them up for healthier, less-violent romantic relationships as young adults, according to researchers. In a study, adolescents who reported a positive family climate and their parents using more effective parenting strategies tended to go on to have better relationship problem-solving skills and less-violent romantic relationships as young adults.

 

Warm, nurturing parents may pass along strategies for building and maintaining positive relationships to their kids, setting them up for healthier, less-violent romantic relationships as young adults, according to researchers.

Researchers found that when adolescents reported a positive family climate and their parents using more effective parenting strategies — like providing reasons for decisions and refraining from harsh punishments — those adolescents tended to go on to have better relationship problem-solving skills and less-violent romantic relationships as young adults.

Mengya Xia, graduate student in human development and family studies, Penn State, said the results — recently published in the Journal of Youth and Adolescence — give insight on how early family relationships can have long-term impacts on young adult romantic relationships.

“During adolescence, you’re starting to figure out what you want in a relationship and to form the skills you need to have successful relationships,” Xia said. “The family relationship is the first intimate relationship of your life, and you apply what you learn to later relationships. It’s also where you may learn how to constructively communicate — or perhaps the inverse, to yell and scream — when you have a disagreement. Those are the skills you learn from the family and you will apply in later relationships.”

Xia said the ability to form close relationships is an important skill for adolescents and young adults to learn. Previous research has found that when young adults know how to form and maintain healthy relationships, they tend to go on to be more satisfied with their lives and be better parents.

Hoping to learn more about how early family experiences affects later romantic relationships, the researchers recruited 974 adolescents for the study.

At three points in time between sixth and ninth grade, the participants answered several questions about their families and themselves. They reported their family climate (if they tend to get along and support each other or fight often), their parents’ discipline strategies (how consistent and harsh they were), how assertive they were, and if they had positive interactions with their parents.

When the participants reached young adulthood, at an average age of 19.5, the researchers asked them about their romantic relationships. They answered questions about their feelings of love for their partner, if they could constructively solve problems in the relationship, and if they were ever violent with their partner, either physically or verbally.

The researchers found that a positive family climate and effective parenting in adolescence were associated with better problem-solving skills in young adults’ romantic relationships. Additionally, kids who had more positive engagement with their parents during adolescence reported feeling more love and connection in their young adult relationships.

“I think it was very interesting that we found that positive engagement with parents in adolescence was linked with romantic love in early adulthood,” Xia said. “And this is important because love is the foundation for romantic relationships, it’s the core component. And if you have a predictor for that, it may open up ways to help adolescents to form the ability to love in romantic relationships.”

The researchers also found that a more cohesive and organized family climate and more effective parenting during adolescence was associated with a lower risk of violence in young adult relationships.

“Adolescents from families that are less cohesive and more conflictual may be less likely to learn positive-problem solving strategies or engage in family interaction affectionately,” Xia said. “So in their romantic relationships, they are also less likely to be affectionate and more likely to use destructive strategies when they encounter problems, like violence.”

Xia said the findings suggest ways to help adolescents build positive relationship skills at an early age, including encouraging assertiveness.

“In the study, we saw kids who were more assertive had better problem-solving skills in their later relationships, which is so important,” Xia said. “If you can’t solve a problem constructively, you may turn to negative strategies, which could include violence. So I think it’s important to promote constructive problem solving as a way to avoid or diminish the possibility of someone resorting to destructive strategies in a relationship.”

Story Source:

Materials provided by Penn StateNote: Content may be edited for style and length.


Journal Reference:

  1. Mengya Xia, Gregory M. Fosco, Melissa A. Lippold, Mark E. Feinberg. A Developmental Perspective on Young Adult Romantic Relationships: Examining Family and Individual Factors in AdolescenceJournal of Youth and Adolescence, 2018; DOI: 10.1007/s10964-018-0815-8

 

Source: Penn State. “Parents may help prep kids for healthier, less violent relationships.” ScienceDaily. ScienceDaily, 27 April 2018. <www.sciencedaily.com/releases/2018/04/180427155748.htm>.

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Transitioning Clinical Trial Paper Source Records to the Digital World

 

We would appreciate any thoughts on the following.

 

Back in the “old days,“ data collected from paper source records were transcribed to paper case report forms, which were then “mailed“ to the pharma company to perform data entry. When EDC systems were established, the pharmaceutical industry transferred the transcription of these data, by the sites, to the EDC systems. As a result, with the concept of the need to perform 100% source document verification (SDV), the workload for both the sites and CRAs did not change. What did change was that data entry into electronic databases no longer was performed by pharmaceutical companies or CROs, but was now performed by the sites.

 

The whole idea behind efficiencies of electronic systems is interoperability. Nevertheless, there is a new phenomenon on the horizon which is perhaps being perceived as an advantage by clinical research sites. The sites are now being being told that they can create their own electronic source documentation, not dissimilar from creating a paper source record. The big question is not about the validation of these systems, which of course could be an issue, but how these data are mapped and eventually transferred to the study database. We were told recently, that sites are re-entering these electronically collected source data into EDC systems by opening 2 screens, and then entering the data a second time. Are we going to end up with just another version of SDV? Imagine having to deal with transferring these data from multiple site source systems into one or more EDC systems. This challenge is also not different where source data are collected within multiple EMR systems.

 

There are several alternative solutions to support the paperless clinical trial by eliminating or reducing paper source records generated by the sites. Target Health has developed and implemented a patented bring-your-own-device (BYOD) web-based system, that allows for direct data at the time of the office visit, with the simultaneous creation of  electronic source documents. This user friendly system allows for the generation of read-only files maintained under the control of the sites, prior to the data being transferred to the EDC database. There now both FDA and EMA approval of products developed using our system. Other systems include dedicated tablets that are distributed to the clinical sites that also allow for direct data entry at the time of the patient encounter. In addition, real-time transfer of data from multiple EMR systems into one EDC data base is in the very near future, as well as direct capture and integration of data coming from mobile devices.

 

Springtime in NYC

Finally Spring has arrived in NYC. ©Target Health Inc. April 2018

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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What Are Genome Editing and CRISPR-CAS9?

This file is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported license. Wikipedia

 

Genome editing (also called gene editing) is a group of technologies that give scientists the ability to change an organism’s 1) ____. These technologies allow genetic material to be added, removed, or altered at particular locations in the 2) ____. Several approaches to genome editing have been developed. A recent one is known as CRISPR-Cas9, which is short for clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9. The CRISPR-Cas9 system has generated a lot of excitement in the scientific community because it is faster, cheaper, more accurate, and more efficient than other existing genome editing methods.

 

CRISPR-Cas9 was adapted from a naturally occurring genome editing system in 3) ____. The bacteria capture snippets of DNA from invading viruses and use them to create DNA segments known as CRISPR 4) ____. The CRISPR arrays allow the bacteria to “remember“ the viruses (or closely related ones). If the viruses attack again, the bacteria produce RNA segments from the CRISPR arrays to target the viruses’ DNA. The bacteria then use Cas9 or a similar enzyme to cut the DNA apart, which disables the virus.

 

The CRISPR-Cas9 system works similarly in the lab. Researchers create a small piece of RNA with a short “guide“ sequence that attaches (binds) to a specific target sequence of DNA in a genome. The RNA also binds to the Cas9 enzyme. As in bacteria, the modified RNA is used to recognize the DNA sequence, and the Cas9 enzyme cuts the DNA at the targeted location. Although Cas9 is the enzyme that is used most often, other enzymes (for example Cpf1) can also be used. Once the DNA is cut, researchers use the cell’s own DNA repair machinery to add or delete pieces of genetic material, or to make changes to the DNA by replacing an existing segment with a customized DNA 5) ____.

 

Genome editing is of great interest in the prevention and treatment of human diseases. Currently, most research on genome editing is done to understand diseases using cells and animal models. Scientists are still working to determine whether this approach is safe and effective for use in people. It is being explored in research on a wide variety of diseases, including single-gene disorders such as 6) ____ ____, hemophilia and 7) ____ cell disease. It also holds promise for the treatment and prevention of more complex diseases, such as cancer, heart disease, mental illness, and human immunodeficiency virus (HIV) infection.

 

Ethical concerns arise when genome editing, using technologies such as CRISPR-Cas9, is used to alter human genomes. Most of the changes introduced with genome editing are limited to somatic cells, which are cells other than egg and sperm cells. These changes affect only certain tissues and are not passed from one generation to the next. However, changes made to genes in egg or sperm cells (8) ____ cells) or in the genes of an embryo could be passed to future generations. Germline cell and embryo genome editing bring up a number of 9) ____ challenges, including whether it would be permissible to use this technology to enhance normal human traits (such as height or intelligence). Based on concerns about ethics and safety, germline cell and embryo genome editing are currently 10) ____ in many countries. Source: NIH.gov

 

ANSWERS: 1) DNA; 2) genome; 3) bacteria; 4) arrays; 5) sequence; 6) cystic fibrosis; 7) sickle; 8) germline; 9) ethical; 10) illegal

 

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