Satjana Medical Blog

Invitation for Live CME Webcast - International Conference of Neuroscience on Stroke & Cerebral Haemodynamics

2012-02-24T19:43:00.002-08:00

We are pleased to invite you to participate in our live CME Webcast titled 'International Conference of Neuroscience on Stroke & Cerebral Haemodynamics'. The live programme of the Conference will be Webcast across the globe to anyone who wants to watch it - including you!

You can watch the live Webcast from your personal computer on 26th Feb' 2012 from 9.30 am (GMT) onwards via the links below:

http://codecsoft.in/yashodahospitals

http://www.codecsoftlive.com/yashodahospitals

For any technical queries during the live Webcast please call please call Mr. Kuldeep Sharma 98492 43779 or Mr. N. Naveen Kumar 90006 36395

What you will need :

In order to watch the Webcast, via your computer, you will need plug-ins, Adobe Flash Media Player. Free version of Adobe Flash Media Player is available for download from the Internet or inwww.adobe.com.

You will also need the following:

A computer with a good Internet connect and fast download speed (minimum internet speed required is 256 kbps). If your connection is too slow, then you will not be able to watch the Webcast Internet browser-based interface e.g., Internet Explorer, Firefox (Recommended), or Chrome.

Recommended resolution on your desktop is 1024 x 768 pixels for optimal viewing. The resolution can be adjusted by going to your desktop properties, under "Settings" and sliding the screen resolution to 1024 x 768.

PLEASE CLOSE ALL OTHER APPLICATIONS, prior to clicking on the Webcast url link. PLEASE TURN ALL SPEAKERS ON AND UP/OR UNMUTE YOUR SYSTEM TO ALLOW SOUND.

Please help us get the word out about the programme and encourage everyone you know to watch it and share the experience.

Note: If you have missed the live Webcast, you can still watch it by following the link for the next 6 months

Warm Regards,

Department of Neuroscience
Yashoda Hospitals

Mano-a-Mano with Insomnia – Up, Up, and throwing your sleep away? Intermezzo to the rescue…

2012-01-11T07:38:00.000-08:00

What are your relaxing tactics to hit the bed and keep your sleep mode on?

In this modern day of gearing up for a tight time schedule, Insomnia, a common sleep disorder, disrupts many people’s daily night routine to wind down to their biological clock. People who suffer from insomnia have trouble falling asleep, staying asleep, or both. Due to the reason of getting too little sleep or poor-quality sleep, they may not feel ready to start a new day when they wake up. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.

Insomnia can be acute (short-term) or chronic (ongoing). Acute insomnia is common and often is brought on by situations such as stress at work, family pressures, or a traumatic event. Acute insomnia lasts for days or weeks. Chronic insomnia lasts for a month or longer. Most cases of chronic insomnia are secondary, which means they are the symptom or side effect of some other problem. Certain medical conditions, medicines, sleep disorders, and substances can cause secondary insomnia.

Lifestyle changes often can give a helping hand in relieving acute (short-term) insomnia. A type of counseling called cognitive-behavioral therapy (CBT) can help relieve the anxiety linked to chronic (ongoing) insomnia. Anxiety tends to prolong insomnia. Several medicines also can help relieve insomnia and reassure a regular sleep routine. One important fact is, if your insomnia is the symptom or side effect of another problem, it’s imperative to treat the underlying cause (if possible).

The U.S. Food and Drug Administration has approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia signaled by middle-of the-night waking followed by difficulty returning to sleep.

It is noteworthy to say that this is the first time the FDA has approved a drug for this condition. However, Intermezzo should only be used when a person has at least four hours of bedtime remaining. It is important to remember that it should not be taken if alcohol has been consumed or with any other sleep aid.

Zolpidem tartrate was initially approved in the United States in 1992 as the drug Ambien. Intermezzo is nothing but a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” said Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”

The most commonly reported adverse reactions in the clinical trials were headache, nausea, and fatigue. Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy. Intermezzo is a federally controlled substance because it can be abused or lead to dependence.

This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Source:

FDA

Related References:

Sleeping Pills, Natural Sleep Aids & Medications - Help Guide.org

Valerian - an herb used for anxiety and sleeplessness – American Cancer Society

What can you do to get better sleep : American Cancer Society (pdf)

How Much Sleep Do I Need? – Centers for Disease Control and Prevention

Study Shows Children With Sleeping Problems Are Frequently Treated With Medication

Losing by Not Snoozing, Says the CDC

Warnings/Precautions for AMBIEN

Meridia Recalled

Sleep-Wake Cycle: Its Physiology and Impact on Health – Sleep Foundation.org

Autonomic Activation in Insomnia: The Case for Acupuncture - PubMed

What Is the Treatment for Insomnia? – WebMD

Sleep Disturbance in Cancer Patients – National Cancer Institute

Sleep Problems (Insomnia) in the Cancer Patient – OncoLink.org

Insomnia Medications - Are They Helpful? – Insomnia-cure-guide.com

Sources of Pictures:

http://www.squidoo.com/icantsleep

http://www.dailykos.com/story/2011/03/29/961277/-Sleepless:-A-Lifetime-of-Insomnia

http://www.indianhindunames.com/tamil-thalattu-paatu-lullabies-songs.htm

http://www.onlinerelaxingmusic.net/

Mark IV strategies to Eliminate Healthcare-associated Infections (HAI) in Out-Patient Settings

2011-12-04T20:10:00.000-08:00

What is your big idea of incepting safety to pave resistance to healthcare-associated infections?
The significance of healthcare-associated infections has to be understood contextually rather than conceptually. Based on the health-care setting such as outpatient settings, dialysis settings, long-term care settings, dental settings, correctional and detention facilities, the precautions to be undertaken differs for each environment. The underlying notion to ratify the infection prevention guidance has arisen from the over-alarming outbreak of disease-causing organisms such as the gram-negative and gram-positive bacteria, mycobacteria, viruses, and parasites looming the health-care facilities.

CDC has sustained to contribute national leadership in surveillance, outbreak investigations, laboratory research, and prevention of healthcare-associated infections. By using the knowledge gained through these activities, CDC has unfolded new strategies to detect infections to prevent healthcare-associated infections. Public health action by CDC and other healthcare partners has led to improvements in clinical practice, medical procedures, and the ongoing development of evidence-based infection control guidance and prevention successes. The motive strengthened by U.S Department of Health and Human Services (HHS), HHS Action Plan was devised to combat HAIs.

The infection prevention checklist should be used for two purposes:

1. To put forth appropriate infection prevention policies and procedures effectively in the facility and ensure supplies to allow healthcare personnel to provide safe care.

2. To systematically assess infection prevention practices of individual healthcare personnel.

Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care condenses existing infection prevention guidance from the Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

Over the past several decades, a significant paradigm shift has transitioned healthcare delivery from the acute, inpatient hospital setting to a variety of ambulatory and community-based settings. Americans have frequent encounters with ambulatory care. For example, more than three-quarters of all operation in the United States are administered in settings outside the hospital. In addition, between 1995 and 2007, the average person made three visits each year to physician offices. By 2007, the total number of physician offices visits incremented to one billion. Vulnerable patient populations seek frequent and intensive use of ambulatory care to maintain or improve their health. For example, each year more than one million cancer patients receive outpatient chemotherapy, radiation therapy, or both.

Compared to inpatient acute care settings, ambulatory care settings have traditionally lacked infrastructure and resources to support infection prevention and surveillance activities. All healthcare settings, regardless of the level of care provided, must make infection prevention a priority and must be equipped to observe Standard Precautions.

Key administrative recommendations for ambulatory care settings:

I. Develop and maintain infection prevention and occupational health programs.

II. Assure sufficient and appropriate supplies necessary for adherence to Standard Precautions (e.g., hand hygiene products, personal protective equipment, injection equipment).

III. Assure at least one individual with training in infection prevention is employed by or regularly available to the facility.

IV. Develop written infection prevention policies and procedures appropriate for the services provided by the facility and based upon evidence-based guidelines, regulations, or standards.

Those with primary administrative oversight of the ambulatory care facility/setting must ensure that sufficient fiscal and human resources are available to develop and maintain infection prevention and occupational health programs. This considers the availability of sufficient and appropriate equipment and supplies essential for the consistent observation of Standard Precautions, including hand hygiene products, injection equipment, and personal protective equipment (e.g., gloves, gowns, face and eye protection).

Infection prevention programs must protract beyond Occupational Safety and Health Administration (OSHA) blood borne pathogen training to strive for patient protection. Facilities should ascertain that at least one individual with training in infection prevention is employed by or regularly available to the facility. This individual should be involved in the development of written infection prevention policies and have regular communications with HCP (Healthcare Personnel) to address specific issues or concerns related to infection prevention. The development and ongoing refinement of infection prevention policies and procedures should be concocted based on evidence-based guidelines, regulations, or standards. These policies and procedures should be programmed according to their respective silos and re-evaluated on a regular basis (e.g., annually), taking into consideration the types of services provided by the facility and the patient population that is served.

This process (referred to as risk assessment by the Infection Prevention profession) will enable facilities to better prioritize resources and infuse extra attention on those areas that are determined to pose greater risk to their patients. For example, an ambulatory surgical center, which carries out on site sterilization of surgical equipment, would be expected to have more detailed policies regarding equipment reprocessing than a substance abuse clinic, where on-site sterilization is unlikely to be undertaken. However, both facilities should have policies and procedures addressing handling of reusable medical equipment. Similarly, a clinic primarily caring patients infected with tuberculosis will have infection prevention needs beyond those of a pediatric office.

Facility administrators should also instill that facility policies and procedures focus on occupational needs including vaccination of HCP, management of exposures or infections in personnel requiring post-exposure prophylaxis and/or work restrictions, and compliance with OSHA blood borne pathogen standards.

Approximately, 1 out of every 20 hospitalized patients will contract an HAI. These infections related to medical care can be devastating and even deadly. As the nation’s health protection agency, CDC is committed to helping all Americans receive the best and safest care when they receive healthcare services.

Source: Infection Prevention Checklist – Minimum Expectations for Safe Care for Outpatient Settings

Reference:

HHS Action Plan to Prevent Healthcare-Associated Infections

Dialysis Safety

Long-Term Care Settings

Guidelines for infection control in dental healthcare settings, 2003.

Prevention and Control of Tuberculosis in Correctional and Detention Facilities: Recommendations from CDC 2006 [PDF - 588 KB]

Prevention Epicenters Program

Recession or Research?

2011-10-11T20:06:00.000-07:00

With the Recession fueling Uncertainty, would Mighty America remain mighty anymore as a Main Hub for Medical Innovations? What health sectors do you think needs Imperative Research for Sustained Remedies?

Question: How does the NIH decide which medical research to fund?

Francis Collins: The process that NIH goes through to decide which research to fund is complex; there’s a lot of factors. Certainly the burden of the disease has to be one of those, but if that was all you paid attention to, rare diseases would get neglected so that can’t be the only story.

Scientific opportunity has to be a big part of it. There’s no point throwing money at a problem if nobody had any ideas about how to move the ball forward. And you can see then sometimes when a rare disease which may not affect that many people hits that moment of scientific opportunity, and oftentimes rare diseases teach you a thing about common diseases as well. So, it’s a complicated mix.

NIH depends very heavily on the scientific community to come forward with their best and brightest ideas, and they send us their grant proposals in an unsolicited way and that’s where the majority of our money goes. But we also identify areas which are ripe for exploration, where something is really starting to go great guns and we don’t want to slow that down, in fact, we want to speed it up. So in that situation, NIH would issue what’s called a "Request for Applications" saying, we think there’s opportunity here scientifically so we’re gonna set aside some money and we want people who have skills and interest in that area to come forward with some ideas and we’ll pay for the best in the group.

Question: How has the recession affected the NIH's funding priorities?

Francis Collins: Having the economy struggling at the level that it is and having rising concerns, understandably so, about the federal deficit has certainly had an impact on funding for biomedical research through the National Institutes of Health. When you look at the support we’ve had, we are grateful that even in tough economic times there has been a willingness to try to keep up at least with what we were doing before. But we haven’t gained much in terms of buying power over the last 10 years, we’ve been pretty much flat—even though the dollars being put in medical research have gone up a big, inflation has eroded that. The one exception was a $10 billion dollar increment as part of the Recovery Act, which needed to be spent in two years and which was invested in ways that I think are truly exciting. But science doesn’t operate on two-year cycles, so now that the Recovery Act money is running out, we are facing what could be very lean times indeed for medical research.

That forces us to be even more specific about how we set priorities. It forces us to say, we can’t do everything. It forces us in some instances to close down programs that have been reasonably productive, but compared to what we’d like to do now in terms of new an innovative projects aren’t quite as compelling as if we had unlimited resources. It makes the job of a science manager a lot tougher, but is the reality of what we are currently living with.

Question: Does the tight budget make it less likely that unorthodox or creative studies will get funding?

Francis Collins: I think there’s been a lot of concern that when budgets get tight, the peer review process can tend to be a little more conservative. And budgets are tight right now. If you send a grant to the NIH that’s got your best ideas in it, the chances that you’ll get funded is less than 20%. In some of our institutes, it’s down around 10%. That’s a terrible stress on the system. That means that investigators are having to write and rewrite grants over and over again in order to just keep their labs going. That means that reviewers who come to look at those grants spend time going into the details of a big pile of exciting applications knowing that probably they’re only going to be able to fund a small number.

And if you were a reviewer, and you’re looking at a pile of grants and amongst them are some very solid applications from very well-established investigators who have a really amazing track record. And then there’s another pile of new investigators you haven’t heard of who are just getting into the scientific arena, and don’t have as much preliminary data and haven’t published as much. There is a tendency, I think, to go with the proven entities and that may mean you are missing out on the innovative stuff from the new investigators.

To try to counter that, NIH has established a number of programs which can only be applied to if you have a slightly wacky idea. So those include things like the Pioneer Awards, and the New Innovator Awards, and the Transformative R01 Awards. All of those have a pretty high bar for innovation and a pretty limited requirement for preliminary data. And they are some of the most exciting science that we are currently supporting, but it’s a small fraction of the total. But it is an effort to try to avoid the conservatism that might otherwise become more prominent in times of difficult budget support.

Recorded September 13, 2010
Interviewed by David Hirschman

Source: http://bigthink.com/ideas/24149 - Video

Francis Collins, Director, NIH – Full Interview Video

About Francis Collins

Dr. Francis Collins has served as the director of the National Institutes of Health since August, 2009. He is the former director of the National Human Genome Research Institute, where he led the successful effort to complete the Human Genome Project—which mapped and sequenced all of the human DNA and determined aspects of its function. The project built the foundation upon which subsequent genetic research is being performed. He is a member of the Institute of Medicine and the National Academy of Sciences. In 2007 Collins received the Presidential Medal of Freedom, the nation's highest civilian honor, and in 2009 Pope Benedict XVI appointed him to the Pontifical Academy of Sciences.

Collins has also published several books about the intersection of science and faith, including the New York Times bestseller "The Language of God: A Scientist Presents Evidence for Belief."

Related Links:

Medical research funding boost in UK

After the debt deal: NIH in jeopardy?
Budget 2012: NIH and CDC
The Jimmy V Foundation for Cancer Research – Grants awarded
Jimmy V grant aids UNC doctors with pediatric cancer research - Video
CDMRP Research Funding for 2011
National Center for Research Resources
Where to Search for Funding
Recession Proves Tough for Medical Device Cos.
Recession takes toll on grants from medical research charities
Is Clinical Research Recession Proof?
Cancer Services And Research Spending Affected By Global Recession
Medical Research Recession: Funding Flatlined for Diabetes, Cancer, Alzheimer's

What is the Difference Between Heartburn and GERD?

2011-09-29T11:59:00.000-07:00

Frequently Asked Questions About GERD and Heartburn

GERD stands for Gastroesophageal Reflux Disease. Gastroesophageal reflux describes a backflow of acid from the stomach into the swallowing tube or esophagus. Almost everyone experiences gastroesophageal reflux at some time. The usual symptom is heartburn, an uncomfortable burning sensation behind the breastbone, most commonly occurring after a meal. In some individuals this reflux is frequent or severe enough to cause more significant problems, that is a disease. Thus, gastroesophageal reflux disease is a clinical condition that occurs when reflux of stomach acid into the esophagus is severe enough to impact the patient's life and/or damage the esophagus.

2. I have never heard of GERD. Is it a new disease?

No. GERD has probably been around as long as heartburn. The term is relatively new (about 20 years), however, and has really come into common usage over the past few years. GERD is often called "reflux," "reflux esophagitis," or sometimes even "hiatus hernia" (although hiatus hernia is a specific diagnosis that may or may not have anything to do with GERD). GERD is the preferred term because it accurately describes the problem - reflux of stomach acid up into the esophagus where it can produce symptoms and sometimes damage. Many patients and health care professional are not familiar with GERD and its potential consequences, and thus may not have heard the term previously.

3. What are some symptoms of GERD?

The four major symptoms of GERD are: 1. Heartburn (uncomfortable, rising, burning sensation behind the breastbone). 2. Regurgitation of gastric acid or sour contents into the mouth. 3. Difficult and/or painful swallowing. 4. Chest pain. Heartburn is the most common symptom of GERD. In some patients it may be accompanied by other GERD symptoms, such as regurgitation of gastric contents into the mouth, chest pain and difficulty swallowing. Pulmonary manifestations, such as asthma, coughing, or intermittent wheezing and vocal cord inflammation with hoarseness, occur in some GERD patients. In addition, acid can be regurgitated into the lungs in some GERD patients, causing wheezing or cough. Acid refluxed into the throat can cause sore throat. If acid reaches the mouth, it can dissolve enamel of the teeth.

4. How do people get GERD?

What causes GERD? GERD is caused by reflux of stomach acid into the esophagus. In most patients this is due to a transient relaxation of the "gate" or sphincter that keeps the lower end of the esophagus closed when a person is not swallowing food or liquids. This transient relaxation happens a few times each day in people without GERD. Why it happens more frequently in GERD patients isn't known. The esophagus is not able to cope with acid as well as the stomach and is easily injured. It's the acid refluxing into the esophagus that produces the symptoms and potentially damages the esophagus.

5. How many people are afflicted with GERD?

Recent statistics from the US Department of Health and Human Services indicate that about seven (7) million people in the US alone suffer from GERD. (Source: Digestive Diseases in the United States: Epidemiology and Impact, National Digestive Diseases Data Working Group, James E. Everhart, MD, MPH, Editor, US Department of Health and Human Services, Public Health Service, National Institutes of Health, NIH Publication No. 94-1447, May 1994)

6. Who is afflicted with GERD?

GERD afflicts people of every socioeconomic class, ethnic group and age. However, the incidence does seem to increase quite dramatically above the age of 40. Greater than 50 percent of those afflicted with GERD are between the ages of 45-64 (both male and female).

7. Do children get GERD?

Yes. GERD is most common in adults over age 40 but virtually anyone can get GERD, even infants.

8. What is the difference between GERD and GORD?

The British spelling of esophagus is oesophagus. Hence, GERD is GORD in many European countries.

9. What is the difference between heartburn and GERD?

GERD is a disease and heartburn is its most common symptom. Heartburn is defined as a rising, burning sensation behind the breastbone caused by reflux of stomach acid into the esophagus. Nearly everyone has or will experience heartburn on occasion. Frequent heartburn that disrupts one's lifestyle suggests the diagnosis of

GERD.

10. What is the difference between GERD and a hiatus hernia?

Hiatus hernia refers to dislocation of the stomach through the "hiatus" of the diaphragm and into the chest. This is a common condition that increases in frequency with age. It may or may not be associated with GERD. When GERD is severe enough to be complicated by erosive esophagitis, seen as breaks in the lining of the esophagus, a hiatus hernia is usually present. However, most patients with a hiatus hernia do not have GERD.

11. What is endoscopy and when is it used in GERD patients?

Endoscopy is a diagnostic test wherein a thin, flexible tube is swallowed by the patient to allow the physician to directly inspect the lining of the upper gastrointestinal tract. This procedure can be used to identify complications of GERD and to take small samples (biopsies) for further analysis. GERD patients who have certain symptoms, such as difficulty in swallowing or painful swallowing, should be considered for endoscopy. Patients who fail to respond to therapy are also candidates for endoscopy. Some physicians advocate endoscopy for all patients with long-standing GERD in order to rule out Barrett's esophagus.

Gwinnett Digestive Clinic

Dr. Indran Indrakrishnan, MD

FRCP (London), FRCP(C), FACP, FACG

Clinical Associate Professor of Medicine

Emory University School of Medicine, Atlanta, GA

Address: 475 PHILLIPS BLVD # 304

LAWRENCEVILLE, GA 30046

12. What are the complications of GERD?

Only a minority of patients develop complications of GERD. These complications include breaks in the lining of the esophagus (esophageal erosions), esophageal ulcer, and narrowing of the esophagus (esophageal stricture). In some patients, the normal esophageal lining or epithelium may be replaced with abnormal (Barrett's) epithelium. This condition (Barrett's esophagus) has been linked to cancer of the esophagus and must be carefully watched. Lung(pulmonary) aspiration, asthma and inflammation of the vocal cords or throat may also be caused by GERD.

13. What makes GERD symptoms worse?

The major factor is meals. Meals stimulate the stomach to produce more acid that can reflux up into the esophagus. In some patients, lying down or taking certain medications can worsen acid reflux.

14. Does eating spicy food cause GERD or make GERD worse?

Spicy foods do not cause GERD, although they do seem to worsen GERD symptoms in some people. Food (in general) can make GERD worse. This is because food fills the stomach and induces more transient relaxations of the lower esophageal sphincter. In addition, all meals stimulate acid production in the stomach to aid digestion and can increase reflux into the esophagus in GERD sufferers. Any very large meal might be expected to produce heartburn in some people. The spicy food story is so compelling, however, that GERD sufferers often relate a spicy (or greasy) meal to their symptoms. Often they are told to avoid certain foods whether or not these foods have anything to do with their symptoms. In this way, many GERD sufferers end up on a very restricted diet or end up blaming their symptoms on dietary indiscretion. If avoiding spicy foods and/or other dietary advice helps, that's great. If it doesn't, GERD sufferers shouldn't feel that they are doing something wrong. They should seek medical advice on managing their disease.

15. What about GERD and smoking?

Smoking doesn't cause GERD and there is little evidence that smoking significantly worsens GERD. Stopping smoking is a good idea anyway.

16. Do any medications make GERD worse?

Yes. Medicines that delay emptying of acid from the stomach or that increase acid backup into the esophagus can worsen GERD. If you have, or suspect you have, GERD and you require medication for other conditions, you should make sure you inform your doctor about all medications you are taking including prescription and over-the-counter medications.

17. What should people with GERD avoid?

GERD is a disease that is caused by gastric acid. However, certain foods can trigger symptoms in some patients. Lying down after a meal, wearing tight-fitting clothing, and even performing certain activities, such as bending over, can also trigger symptoms in patients. A good way to identify these "triggers" is to keep a diary of GERD symptoms noting when they occur. If symptoms follow a pattern and occur after certain foods or activities, these foods or activities should be avoided. A diary will also help patients continue to enjoy those foods or activities that do not seem to provoke symptoms, so that their lifestyle is not restricted unnecessarily. Patients should review their symptoms with their doctor, who can evaluate their condition and advise an appropriate treatment plan.

18. Can GERD cause cancer?

Severe, long-standing GERD can damage the esophagus and cause a condition known as Barrett's esophagus wherein the normal lining of the esophagus is replaced by a lining more like that of the stomach or intestine. It is thought that this replacement may be an attempt by the body to protect itself from further injury by acid. The risk of esophageal cancer appears to increase significantly in patients with Barrett's esophagus. The only way to diagnose Barrett's esophagus is by endoscopy. Some studies suggest that intensive treatment of Barrett's esophagus can reduce the amount of abnormal lining in the esophagus. It is not yet clear whether such treatment will prevent esophageal cancer in GERD patients, but this is under active investigation.

19. Are there long-term consequences of GERD?

Long-standing GERD can lead to damage of the esophagus. This damage usually consists of breaks in the lining of the esophagus. In some cases ulcers can develop. In some patients, such damage can result in scarring and narrowing of the esophagus, making swallowing painful or difficult. A condition called Barrett's esophagus is thought to result from long-standing GERD in some patients. Barrett's esophagus is a risk factor for the development of esophageal cancer. In some patients, acid backup caused by GERD is thought to result in damage to the vocal cords or teeth and may even cause asthma.

20. Is there relationship between GERD and asthma?

Many investigators believe that there is a link between asthma and reflux of stomach acid up into the throat and then down into the lungs in some patients. It appears that some patients who suffer from asthma might benefit from treatment of GERD. This is a topic of active research at the moment.

21. Can GERD cause inflammation of the throat?

In some patients, acid can reflux into the throat causing inflammation of the back of the throat which can lead to pharyngitis, or into the vocal cords, which can lead to laryngitis and hoarseness. Although there are many other causes for sore throat and laryngitis, GERD should be suspected in a patient with chronic sore throat or other GERD symptoms or when no other cause can be found.

22. Can GERD be cured?

Unfortunately, GERD, in general, cannot be cured at present. In some cases, it may be a temporary condition associated with a specific aggravating factor such as pregnancy. In such cases, GERD will go away on its own when the pregnancy has ended. In most cases GERD is a chronic condition. However, it can be effectively managed with medications and lifestyle modifications in almost everybody. In severe cases, surgery is an option. Surgery does not cure the underlying problem, but wraps part of the stomach around the lower end of the esophagus to help keep acid from getting back up into the esophagus. A doctor can evaluate the condition and advice on an appropriate treatment plan.

23. I think I have GERD. What should I do?

See your doctor. Your doctor can establish the diagnosis and work with you to get you symptom-free.

24. Are there any doctors who specialize in GERD?

Yes. Primary care and physicians of many specialties are becoming increasingly familiar with GERD. Gastroenterologists and some gastrointestinal surgeons are usually very familiar with GERD and its treatment.

25. Where can I go for more information about GERD?

If you think you might have GERD - see your doctor who can determine if you have GERD and, if so, can evaluate its severity.

Source:

Caring for the Older Adults - GERD

Reference:

Burning Issues in Heart Burn : A Scientific Approach to GERD - By Dr. Indran Indrakrishnan, MD

GERD Treatments and drugs

Reflux and Laryngitis

American Gastroenterological Association on the Management of Gastroesophageal Reflux Disease

Journal References:

· Shaheen NJ, Hansen RA, Morgan DR, et al. The burden of gastrointestinal and liver diseases, 2006. Am J Gastroenterol. 2006;101:2128–2138 MEDLINE CrossRef

· Sontag SJ, Sonnenberg A, Schnell TG, et al. The long-term natural history of gastroesophageal reflux disease. J Clin Gastroenterol. 2006;40:398–404 MEDLINE CrossRef

· Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease (A global evidence-based consensus). Am J Gastroenterol. 2006;101:1900–1920 MEDLINE CrossRef

· Wiklund I, Carlsson J, Vakil N. Gastroesophageal reflux symptoms and well-being in a random sample of the general population of a Swedish community. Am J Gastroenterol. 2006;101:18–28 MEDLINE CrossRef

· Kahrilas PJ, Miner P, Johanson J, et al. Efficacy of rabeprazole in the treatment of symptomatic gastroesophageal reflux disease. Dig Dis Sci. 2005;50:2009–2018 MEDLINE CrossRef

· Guidance for Industry: patient-reported outcome measures: use in medical product development to support labeling claims. http://www.fda.gov/cder/guidance/index.htm2006;

· Nebel OT, Castell DO. Lower esophageal sphincter pressure changes after food ingestion. Gastroenterology. 1972;63:778–783

· Pehl C, Waizenhoefer A, Wendl B, et al. Effect of low and high fat meals on lower esophageal sphincter motility and gastroesophageal reflux in healthy subjects. Am J Gastroenterol. 1999;94:1192–1196 MEDLINE CrossRef

· Waring JP, Eastwood TF, Austin JM, et al. The immediate effects of cessation of cigarette smoking on gastroesophageal reflux. Am J Gastroenterol. 1989;84:1076–1078 MEDLINE

· Harvey RF, Gordon PC, Hadley N, et al. Effects of sleeping with the bed-head raised and of ranitidine in patients with severe peptic oesophagitis. Lancet. 1987;2:1200–1203 MEDLINE

How To Use an Automated External Defibrillator

2011-09-17T19:59:00.000-07:00

Do you know how to perform a CPR?

Sudden Cardiac Arrest usually causes death if it's not treated within minutes. Automated external defibrillators (AEDs) can be used by bystanders to save the lives of people who are having SCA.

Before using an automated external defibrillator (AED) on someone who you think is having sudden cardiac arrest (SCA), it's important to check him or her.

If you see a person suddenly collapse and lose consciousness, or if you find a person already unconscious, confirm that the person can't respond. Shout at and shake the person to make sure he or she isn't sleeping.

Never shake an infant or young child. Instead, you can pinch the child to try to wake him or her up.

Call 9–1–1 or have someone else call 9–1–1. If two rescuers are present, one can provide CPR (cardiopulmonary resuscitation) while the other calls 9–1–1 and gets the AED.

Check the person's breathing and pulse. If breathing and pulse are absent or irregular, prepare to use the AED as soon as possible. (SCA causes death if it's not treated within minutes.)

If no one knows how long the person has been unconscious, or if an AED isn't readily available, do 2 minutes of CPR. Then use the AED (if you have one) to check the person.

After you use the AED, or if you don't have an AED, give CPR until emergency medical help arrives or until the person begins to move. Try to limit pauses in CPR. After 2 minutes of CPR, you can use the AED again to check the person's heart rhythm and give another shock, if needed. If a shock isn't needed, continue CPR.

Using an Automated External Defibrillator

AEDs are user-friendly devices that untrained bystanders can use to save the life of someone having SCA.

Before using an AED, check for puddles or water near the person who is unconscious. Move him or her to a dry area and stay away from wetness when delivering shocks (water conducts electricity).

Turn on the AED's power. The device will give you step-by-step instructions. You'll hear voice prompts and see prompts on a screen.

Expose the person's chest. If the person's chest is wet, dry it. AEDs have sticky pads with sensors called electrodes. Apply the pads to the person's chest as pictured on the AED's instructions.

Place one pad on the right center of the person's chest above the nipple. Place the other pad slightly below the other nipple and to the left on the ribcage.

Automated External Defibrillator

The illustration shows a typical setup using an automated external defibrillator (AED). The AED has step-by-step instructions and voice prompts that enable an untrained bystander to use the machine properly.

Make sure the sticky pads have good connection with the skin. If the connection isn't good, the machine may repeat the phrase "check electrodes."

If the person has a lot of chest hair, you may have to trim it. (AEDs usually come with a kit that includes scissors and/or a razor.) If the person is wearing a medication patch that's in the way, remove it and clean the medicine from the skin before applying the sticky pads.

Remove metal necklaces and underwire bras. The metal may conduct electricity and cause burns. You can cut the center of the bra and pull it away from the skin.

Check the person for implanted medical devices, such as a pacemaker or implantable cardioverter defibrillator. (The outline of these devices is visible under the skin on the chest or abdomen, and the person may be wearing a medical alert bracelet.) Also check for body piercings.

Move the defibrillator pads at least 1 inch away from implanted devices or piercings so the electric current can flow freely between the pads.

Check that the wires from the electrodes are connected to the AED. Make sure no one is touching the person, and then press the AED's "analyze" button. Stay clear while the machine checks the person's heart rhythm.

If a shock is needed, the AED will let you know when to deliver it. Stand clear of the person and make sure others are clear before you push the AED's "shock" button.

Start or resume CPR until emergency medical help arrives or until the person begins to move. Stay with the person until medical help arrives, and report all of the information you know about what has happened.

Source: National Heart, Lung, and Blood Institute

How to do CPR when the heart suddenly stops: Press hard, press fast, don’t stop

Hispanic Americans Less Likely to Recognize Signs and Symptoms of Stroke American College of Emergency

Physicians (ACEP)

Automated External Defibrillators and CPR Are Equally Helpful for Sudden Cardiac Arrest in the Home NIH News

Philips Heartstart Fr2+ Automated External Defibrillators - Recall FDA

Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall

The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models:

Powerheart 9300A, 9300E, 9300P, 9390A, 9390E
CardioVive 92532
CardioLife 9200G and 9231

Defibrillator Reviews and Buying Guide

Angioplasty or Coronary Bypass Surgery?

A Gene Variant projecting Connection to Lone Atrial Fibrillation - Cardiac Arrhythmia

Angioplasty or Coronary Bypass Surgery?

2011-08-23T08:58:00.000-07:00

Which one Resuscitated your Rebirth. What were your Post-natal Celebrations?

The American Heart Association (AHA), the Centers For Disease Control and Prevention and the National Institutes of Health (NIH) reported that coronary heart disease was responsible for 1 in every 6 deaths in the U.S. in 2007— according to the most recent statistics. In that same year, 1 in 9 death certificates cited heart failure as the mortality culprit. Fortunately, there are lifestyle changes one can make to reduce their risk of heart attack or prevent the occurrence of a second one. The primary causes ofheart attack have not changed over the last decade. Smoking, obesity and lack of exercise all contribute to the risk of heart disease.

Coronary angioplasty (AN-jee-o-plas-tee), also called percutaneous coronary intervention (PCI), is a procedure used to open clogged heart arteries. Angioplasty involves temporarily inserting and blowing up a tiny balloon where your artery is clogged to help widen the artery.

In angioplasty procedures, a balloon is fed through a catheter and used to prop open an artery that has become narrowed or blocked. In cases where stenting is appropriate, a stent mounted on a balloon is inserted and inflation of the balloon expands the stent against the blocked artery wall to hold the vessel open. The balloon is then deflated and the catheter is withdrawn. Stent treatment of arteries holds them open and improves blood flow to the heart. In cases where post-dilatation is needed, a high-pressure balloon is inflated inside a stent to help better place the stent against the vessel wall. More than two million balloon angioplasty procedures are performed per year globally, including nearly 1.3 million procedures annually in the United States.

What Are the Risks of Coronary Angioplasty?

Coronary angioplasty is a common medical procedure. Serious complications don't occur often. However, they can happen no matter how careful your doctor is or how well he or she does the procedure. Serious complications include:

Bleeding from the blood vessel where the catheters were inserted.
Blood vessel damage from the catheters.
An allergic reaction to the dye given during the angioplasty.
An arrhythmia (irregular heartbeat).
The need for emergency coronary artery bypass grafting during the procedure (2–4 percent of people). This may occur if an artery closes down instead of opening up.
Damage to the kidneys caused by the dye used.
Heart attack (3–5 percent of people).
Stroke (less than 1 percent of people).

Sometimes chest pain can occur during angioplasty because the balloon briefly blocks blood supply to the heart.

As with any procedure involving the heart, complications can sometimes, though rarely, cause death. Less than 2 percent of people die during angioplasty.

The risk of complications is higher in:

People aged 75 and older
People who have kidney disease or diabetes
Women
People who have poor pumping function in their hearts
People who have extensive heart disease and blockages in their coronary (heart) arteries

Research on angioplasty is ongoing to make it safer and more effective, to prevent treated arteries from closing again, and to make the procedure an option for more people.

Complications From Stents

Restenosis

After angioplasty, the treated coronary artery can become narrowed or blocked again, often within 6 months of angioplasty. This is called restenosis (RE-sten-o-sis). When a stent (small mesh tube) isn't used during angioplasty, 4 out of 10 people have restenosis.

The growth of scar tissue in and around a stent also can cause restenosis. When a stent is used, 2 out of 10 people have restenosis.

Coronary bypass Surgery

Coronary bypass surgery is a procedure that restores blood flow to your heart muscle by diverting the flow of blood around a section of a blocked artery in your heart. Coronary bypass surgery uses a healthy blood vessel taken from your leg, arm, chest or abdomen and connects it to the other arteries in your heart so that blood is bypassed around the diseased or blocked area. After a coronary bypass surgery, normal blood flow is restored. Coronary bypass surgery is just one option to treat heart disease.

Coronary bypass surgery can help reduce your risk of having a heart attack. For many people who have coronary bypass surgery, symptoms such as chest pain and shortness of breath are reduced after having the surgery.

Risks

Because coronary bypass surgery is an open-heart surgery, you may have complications during or following your procedure. The most common complications of coronary bypass surgery are:

Bleeding
Heart rhythm irregularities (arrhythmias)

Less common complications include:

Heart attack, if a blood clot breaks loose soon after surgery
Kidney failure
Infections of the chest wound
Memory loss or troubles with thinking clearly, which often go away within six to 12 months
Stroke

Your risk of developing these complications depends on your health before the surgery. Talk to your doctor to get a better idea of the likelihood of experiencing these risks.

If you're having a scheduled coronary bypass surgery, your risk of complications is usually low, but still depends on your overall health. The risk is higher if the operation is done as an emergency or if you have other medical conditions such as emphysema, kidney disease, diabetes or blocked arteries in your legs (peripheral artery disease, or PAD).

Reference :

Mayoclinic.com

Journal Reference :

Angioplasty. National Heart, Lung, and Blood Institute. http://www.nhlbi.nih.gov/health/dci/Diseases/Angioplasty/Angioplasty_All.html. Accessed Aug. 19, 2010.

Related Articles :

Heart attack patients winning the race to angioplasty treatment – Aug 22, 2011

Angioplasty with stents may be safe for heart patients – June 22, 2011

Alternative angioplasty route gains favor – April 05, 2011

Video: Coronary angioplasty Video

Coronary artery bypass graft Video

3D Heart Attack animation Video

Angioplasty Not for All Heart Patients... But Do They Know?

Is Angioplasty Worth The Risk?

Wish there was a Genetic Vaccine against Diabetes to Decode it away?

2011-06-28T05:30:00.000-07:00

Stem Cell therapy or Gene therapy, which one has the genesis of Idealistic solution to unbind the Diabetic Chain in the near future with affordability at its pivotal point. Would this also light the possibility of engraving the epigenetics of treated islet cells for subsequent offsprings of diabetic mothers?

Genetic revolution: Human Genome Project finally offers help against diseases

“In the next few years, we should be closer to effective drug therapies for Alzheimer’s, diabetes, multiple sclerosis, autism, Parkinson’s disease. We should be able to determine who’s at greater risk so we can get earlier diagnoses and start treatments sooner,” says Dr. Margaret Pericak-Vance, director of the John P. Hussman Institute for Human Genomics at the University of Miami Miller School of Medicine.

With little fanfare, pieces of the research puzzle are falling into place.

Today, Pericak-Vance and her husband, Dr. Jeffery Vance, director of genomic medicine at the Institute, are using results from the U.S.-led international Human Genome Project to study more than a dozen diseases. Among the most promising areas: macular degeneration, deafness, Lou Gehrig’s disease.

After the death of the patient at the University of Pennsylvania 12 years ago, gene therapy seemed like a distant goal. But now, gene therapies for genetic causes of diabetes, melanoma, Parkinson’s disease and HIV are in human or animal trials, and some are expected to win FDA approval shortly. In Europe, the first such approval, for a therapy against pancreatitis, is expected this year. More…

Made-in-Edmonton diabetes treatment offers hope around the world

The procedure involves the introduction of healthy islet cells - cells that produce insulin in people whose own bodies can't - which are harvested from a donor pancreas.

The one-hour procedure, which has now been performed hundreds of times around the world, involves no cutting and no blood - just a thin tube inserted into the patient's portal vein.

Shapiro is now working with a U.S. team to find a safe way to use stem cells to make insulin. The next step, he says, may not be transplantation - but regeneration - using hormones to make the pancreas re-grow its own islet cells. More

Gene therapy reverses type 1 diabetes in mice

From left: Drs. Vijay Yechoor, Lawrence Chan, JoAnne Richard, Gregory Ira and Christophe Herman

"With just one injection of this gene therapy, the mice remain diabetes-free long term and have a return of normal insulin levels in the body," said Vijay Yechoor, MD, the principal investigator and an assistant professor at Baylor College of Medicine in Houston.

Yechoor and his co-workers used their new gene therapy in a nonobese mouse model of Type 1 diabetes. The therapy attempts to counter the two defects that cause this autoimmune form of diabetes: autoimmune attack and destruction of the insulin-producing beta cells by T cells. First, the researchers genetically engineer the formation of new beta cells in the liver using neurogenin3. This gene defines the development of pancreatic islets, which are clusters of beta cells and other cells. Along with neurogenin3, they give an islet growth factor gene called betacellulin to stimulate growth of these new islets.

The second part of the therapy aims to prevent the mouse's immune system from killing the newly formed islets and beta cells. Previously the research team combined neurogenin3 with the gene for interleukin-10, which regulates the immune system. However, with that gene, they achieved only a 50 percent cure rate in diabetic mice, Yechoor said.

In the new study, the investigators added a gene called CD274 or PD-L1 (programmed cell death 1 ligand-1). It inhibits activity of the T cells only around the new islets in the liver and not in the rest of the body, he explained.

"We want the gene to inactivate T cells only when they come to the new islet cells. Otherwise, the whole body would become immunocompromised," Yechoor said.

This treatment reversed diabetes in 17 of 22 mice, or 78 percent. Diabetic mice that otherwise live only six to eight weeks were growing normally and were free of diabetes as long as 18 weeks after injection of the gene therapy, Yechoor said. More…

San Diego company studies stem cell implant as a Type 1 diabetes treatment

Over the last decade, ViaCyte has learned how to make what it calls pro-islet cells: ones that are on the way to becoming islet cells but haven't fully matured. The company started with stem cells from blastocysts — very early stage embryos — that were destined for destruction at a fertility clinic. It then used natural growth factors to encourage the cells to turn into pancreatic cells. Once under a mouse's skin, the cells mature into beta islet cells. After a couple of months, they start making insulin.

Brandon hopes the implants would work the same in people.

But simply dropping stem cells into a person is fraught with uncertainty. The cells might become the wrong type. Many researchers worry that stem cells could form tumors. Additionally, the recipient's immune system will attack the new cells.

To sidestep those issues, ViaCyte has developed a thin membrane envelope that allows sugar in and insulin out. But the cells can't escape, and cells of the immune system can't get in to attack them. Doctors could monitor the cells via ultrasound and remove the device if there were any problem.

"The safety factor is pretty high," says Alan Trounson, president of CIRM. More….

Stem Cell Therapy for Type 1 Diabetes Mellitus

A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.

The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus. ClinicalTrials.gov

Stem Cells To Fight Diabetes

"The crux of this research is to change the whole paradigm," says Georgetown's Dr. Stephen Clement. "So instead of giving shots in response to what the person needs, to basically develop cells that can make insulin again that are autologous, which means we actually start with cells from a person's own body."

Scientists have transplanted islets from one person to another in the past, but patients were required to be on strong anti-rejection medications and that can take more of a toll on the body than the diabetes itself.

Clement says creating islets from a person's own stem cells would prevent the need for that kind of medication.

"The next step is to have to grow a lot of islets, a half billion to cure diabetes in a human," he says.

Doctors are now figuring out the best way to grow the new cells. More….

Jetten to investigate a novel stem cell treatment for diabetes

Jetten pointed to new technologies for reprogramming adult cells to an induced pluripotent state for generating iPS cells from an individual's readily accessible skin or blood cells. Reprogramming adult cells into insulin-producing beta cells offers an alternative to human embryonic stem cell approaches, and it also eliminates the need for immunosuppressive therapies.

The proposal outlines an elegant series of experiments to test protocols for inducing differentiation in iPS cells, and to determine whether Glis3 might provide a new target for managing diabetes in a therapy designed to produce cells capable of maintaining near-normal regulation of blood sugar.

NCRM is serving as a stem cell resource for the research community. As part of its award, the Center will perform an interim review of Jetten's project to determine continued funding for fiscal year 2012. More…

Related Links:

April 11, 2007 Diabetics cured in stem-cell treatment advance

Stem Cells and Diabetes 2001

Parents have positive effect on diabetes treatment in teens

Eye Examination Provides Clues to Diabetic Nerve Damage

Mayo Clinic Developing Artificial Pancreas to Ease Diabetes Burden

Genetic Testing for Diabetes?

Diabetic patients, Is your Health on Board? You may be Heading out for Alzheimer’s disease.

List of Oral Diabetic Medications - 2010 Update

Tread to mill Your Calories

Don't find Yourself at the Dead-End!

Wonder Technology to excavate Wonder Drugs – Is it Medllurgy?

2011-06-08T21:00:00.000-07:00

Journal of the American Medical Informatics Association

How exactly does Data Mining postulate Drug Safety better than a Human Body?

May 16, 2011 - Data mining of the medical literature could help uncover drug side effects before they cause serious harm to patients, a new study suggests.

Researchers from Santa Monica, Calif., think tank Rand surmised that a review of published studies could help regulators, like the U.S. Food and Drug Administration, spot dangerous uses of drugs earlier and prevent situations like the 2004 recall of rofecoxib--sold under the brand name Vioxx--following revelations that the arthritis drug could increase the risk of heart attack and stroke.

"Regulatory agencies and drug safety researchers may be able to use these techniques to improve decision-making about drug safety," Rand CTO Siddhartha Dalal and researcher Dr. Kanaka D Shetty wrote in a new article published in the Journal of the American Medical Informatics Association.

Shetty and Dalal developed an algorithm to mine PubMed, the free portal for Medline, the National Library of Medicine's bibliographies of medical literature. They looked for mentions of least one of 38 specific drugs and 55 adverse effects, then determined the relevance of the articles and forecast expected rates of adverse effects (AEs). While others have processed large databases to find evidence of side effects, including the FDA's Adverse Events Reporting System, such analyses have tended to be inaccurate.

Drug Information Association

"Prior work suggested that up to 98% of search results are irrelevant to [adverse effects]; including such articles would skew results toward false positive drug-AE linkages," they wrote.

With this in mind, the Rand team initially found more than 119,000 articles published between 1949 and September 2009, then excluded articles that didn't test whether a drug caused an AE. They ended up analyzing about 9,100 articles, plus a wider set of articles that took into account side effects from classes of drugs rather than individual compounds.

"We aimed to prototype a process for collecting and analyzing relevant literature while minimizing false positive and false negative drug-AE associations," Shetty and Dalal said. "We first improved the data collection process by excluding irrelevant articles using supervised statistical learning techniques that automatically filter citations using Medline indexing terms. We then used statistically valid machine learning algorithms ... to identify significant drug-AE links from the several thousands of such pairs while controlling the overall probability of errors.

"Finally, we evaluated whether the literature-mining process might have detected drug-AE associations that were the subjects of FDA warnings. We used the entire literature in some analyses and simulated prospective analyses by restricting the data to literature available prior to the warnings."

They ended up finding evidence of heart disease caused by Vioxx as early as 2001, from literature published by 2002, and Merck pulled the drug from the market in 2004. "We dramatically improved [positive prediction] and sensitivity rates with respect to major known drug-AE associations by applying successive filters and incorporating drug class effects," the researchers wrote.

"Regulatory agencies and drug safety researchers may be able to use these techniques to improve decision-making about drug safety," Shetty and Dalal concluded. "Furthermore, we detected numerous associations prior to FDA warning, suggesting that literature mining did not simply provide a lagging indicator of widely known drug-AE associations."

Phase forward.com

Source: Medical Data Mining Strengthens Drug Safety

Journal Reference: Using information mining of the medical literature to improve drug safety - May 05, 2011

Related Links:

PubMed

Adverse Events Reporting System

Changing the Future of Drug Safety: FDA Initiatives to Strengthen and Transform the Drug Safety System - 2009

Personalized Health Care - U.S. Department of Health and Human Services - Nov 2008

WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems – 2004

When the Adverse Event sirens Red Alert during a Clinical Trial Process

Definition of pharmacovigilance (WHO, 2002)

Issues in the Practical Application of Data Mining Techniques to Pharmacovigilance – Merck Research Laboratories – ppt file- 2005

When the Adverse Event sirens Red Alert during a Clinical Trial Process,

2011-06-02T19:52:00.001-07:00

Demarcating the Anticipated and Unanticipated problem is not a Serendipitous Issue.

Projections Research, Inc

An Adverse Event (AE): is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an experimental medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

An Adverse Event is any experience that has taken place during the course of a research project, which, in the opinion of the investigators, was harmful to a participant, increased the risk of harm, or had an unfavorable impact on the risk/benefit ratio of the study.

Thelin Recall

Serious Adverse Event (SAE): Serious adverse events are defined by regulatory criteria and include any of the following:

· Any hospital admission (unless hospitalization is preplanned).

· Unanticipated or life-threatening drug reaction including but not limited to one that necessitates discontinuation of study participation or that results in death.

· Congenital anomaly occurring in the offspring of a research participant who had taken a study drug

· Exceeding the nature, severity, or frequency described in the investigator’s brochure or protocol

· Prolongs a stay in a health care facility

· Significant, persistent, or permanent harm or disability, either physical or psychological

· Death

The NIH Web site detailing serious adverse events/effects is at: http://www.nhlbi.nih.gov/funding/policies/adverse.htm

Quorum Review.com

How to Determine If an AE is an Unanticipated Problem that Needs to Be Reported

In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were unexpected, serious, and would have implications for the conduct of the study (e.g., requiring a significant, and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure). An individual AE occurrence ordinarily does not meet these criteria because, as an isolated event, its implications for the study cannot be understood.

Many types of AEs generally require an evaluation of their relevance and significance to the study, including an aggregate analysis of other occurrences of the same (or similar) event, before they can be determined to be an unanticipated problem involving risk to human subjects. For example, an aggregate analysis of a series of AEs that are commonly associated with the underlying disease process that the study intervention is intended to treat (e.g., deaths in a cancer trial), or that are otherwise common in the study population independent of drug exposure (e.g., cardiovascular events in an elderly population) may reveal that the event rate is higher in the drug treatment group compared to the control arm. In this case, the AE would be considered an unanticipated problem. In the absence of such a finding, the event is uninterpretable.

‘Better monitoring leading to more reporting of vaccine-related deaths’

The major exceptions to the general rule that an isolated event is not informative are serious AEs that are uncommon and strongly associated with drug exposure, such as angioedema, agranulocytosis, anaphylaxis, hepatic injury, or Stevens Johnson syndrome. In most cases, a single, unexpected occurrence of this type of event would be considered an unanticipated problem involving risk to human subjects and, thus, must be reported to the IRB. Similarly, one or a small number of serious events that are not commonly associated with drug exposure, but are otherwise uncommon in the study population (e.g., tendon rupture, progressive multifocal leukoencephalopathy) should be considered an unanticipated problem involving risk to human subjects.

Because they have been previously observed with a drug, the AEs listed in the investigator’s brochure would, by definition, not be considered unexpected and thus would not be unanticipated problems. Possible exceptions would include situations in which the specificity or severity of the event is not consistent with the description in the investigator’s brochure, or it can be determined that the observed rate of occurrence for a serious, expected AE in the clinical trial represents a clinically important increase in the expected rate of occurrence.

Therefore, FDA recommends that there be careful consideration of whether an AE is an unanticipated problem that must be reported to IRBs. In summary, FDA believes that only the following AEs should be considered as unanticipated problems that must be reported to the IRB.

• A single occurrence of a serious, unexpected event that is uncommon and strongly associated with drug exposure (such as angioedema, agranulocytosis, hepatic injury, or Stevens-Johnson syndrome).

• A single occurrence, or more often a small number of occurrences, of a serious, unexpected event that is not commonly associated with drug exposure, but uncommon in the study population (e.g., tendon rupture, progressive multifocal leukoencephalopathy).

• Multiple occurrences of an AE that, based on an aggregate analysis, is determined to be an unanticipated problem. There should be a determination that the series of AEs represents a signal that the AEs were not just isolated occurrences and involve risk to human subjects (e.g., a comparison of rates across treatment groups reveal higher rate in the drug treatment arm versus a control). We recommend that a summary and analyses supporting the determination accompany the report.

• An AE that is described or addressed in the investigator’s brochure, protocol, or informed consent documents, but occurs at a specificity or severity that is inconsistent with prior observations. For example, if transaminase elevation is listed in the investigator’s brochure and hepatic necrosis is observed in study subjects, hepatic necrosis would be considered an unanticipated problem involving risk to human subjects. We recommend that a discussion of the divergence from the expected specificity or severity accompany the report.

• A serious AE that is described or addressed in the investigator’s brochure, protocol, or informed consent documents, but for which the rate of occurrence in the study represents a clinically significant increase in the expected rate of occurrence (ordinarily, reporting would only be triggered if there were a credible baseline rate for comparison). We recommend that a discussion of the divergence from the expected rate accompany the report.

• Any other AE or safety finding (e.g., based on animal or epidemiologic data) that would cause the sponsor to modify the investigator’s brochure, study protocol, or informed consent documents, or would prompt other action by the IRB to ensure the protection of human subjects. We recommend that an explanation of the conclusion accompany the report.

How to Report Unanticipated Problems to IRBs

In a multicenter study, it is clear that individual investigators must rely on the sponsor to provide them information about AEs occurring at other study sites. It is also clear that the sponsor receives AE information from all study sites and typically has more experience and expertise with the study drug than an investigator. Accordingly, the sponsor is in a better position to process and analyze the significance of AE information from multiple sites and—when the determination relies on information from multiple study sites or other information not readily accessible to the individual investigators (e.g., a sponsor’s preclinical data that supports the determination)—to make a determination about whether an AE is an unanticipated problem. Furthermore, the regulations require the sponsor of an IND to promptly review all information relevant to the safety of the drug and to consider the significance of the report within the context of other reports (§ 312.32)

The regulations state that for studies conducted under 21 CFR part 312, investigators must report all "unanticipated problems" to the IRB (§§ 312.66, 312.53(c)(1)(vii),and 56.108(b)(1)). However, as discussed above, we recognize that for multicenter studies, the sponsor is in a better position to process and analyze adverse event information for the entire study and to assess whether an adverse event occurrence is both unanticipated and a problem for the study.

Accordingly, to satisfy the investigator’s obligation to notify the IRB of unanticipated problems, an investigator participating in a multicenter study may rely on the sponsor’s assessment and provide to the IRB a report of the unanticipated problem prepared by the sponsor. In addition, if the investigator knows that the sponsor has reported the unanticipated problem directly to the IRB, because the investigator, sponsor, and IRB made an explicit agreement for the sponsor to report directly to the IRB, and because the investigator was copied on the report from the sponsor to the IRB, FDA intends to exercise its enforcement discretion and would not expect an investigator to provide the IRB with a duplicate copy of the report received from the sponsor.

Angioedema - An allergic skin disease characterized by patches of confined swelling involving the skin the layers beneath the skin, the mucous membranes, and sometimes the viscera.

Agranulocytosis - An acute disease characterized by high fever, lesions of the mucous membranes and skin, and a sharp drop in circulating granular white blood cells.

Stevens-Johnson syndrome - It is a rare, serious disorder in which the skin and mucous membranes react severely to a medication or infection. Often, it begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of the skin to die and shed.

Progressive multifocal leukoencephalopathy: A rapidly progressive, often fatal viral infection of the brain. Commonly abbreviated as PML. PML is believed to be due to the Jacob-Creutzfeldt (JC) papovavirus. The virus infects oligodendrocytes (support cells in the brain).

Source: Adverse Event Reporting to IRBs – FDA.gov

What Every Researcher Needs to Know – University of Minnesota

Evaluating Adverse Event Risk with Propoxyphene - Quintiles

CRO Industry Glossary - Quintiles

i3 Drug Safety

Breast Cancer Yoga

2011-05-24T05:54:00.001-07:00

Breast Cancer Yoga is a Restorative Yoga Therapy with a holistic approach to Breast Cancer Recovery and Lymphedema Management. Breast Cancer Yoga is a family owned and operated website.

We feel that Breast Cancer Yoga is an inspired calling to share our knowledge and favorite things. Our web site lends much knowledge on “how to heal” both physical and mentally.

Certified & Registered Yoga Therapist
Diana is a KaliRay TriYoga teacher that has over 10,000 teaching hours and over 1500 hours of teacher training. Her credentials, certifications and experience has made her an expert in her field of study.

http://www.breastcanceryoga.com

4611 South Congress Ave.
Suite 304
Lake Worth, Fl 33461

info@breastcanceryoga.com

Main Business Listings Page

Mitro Group Pty Ltd

2011-05-24T05:51:00.000-07:00

A medical writing, and consulting company based in Australia.

We have experience in the following:

Documentation is produced in accordance with relevant global and/or local regulatory guidelines.
1. Clinical Study Reports and Clinical Expert Reports
2. Investigator's Brochures
3. Investigational New Drug applications
4. Ethics Committee applications (Australia, New Zealand, Asia, India)
5. Clinical Trial Notification / Clinical Trial Exemption submissions (Australia)
6. Consumer Product Information and Product Information

We can also assist with production of policies and standard operating procedures (SOPs) and other internal documentation.

We also specialize in:

1. Project Management - regulatory and development activities e.g. manufacturing
2. Regulatory - marketing approval applications
3. Medical Information
4. Pharmacovigilance - safety reporting
5. Systems Development and Implementation e.g. quality/document management
6. Business Process Improvement - procedures to improve performance
7. Training - face-to-face and online training

Carolyn Trower

www.mitrogroup.com

Main Business Listings Page

Information Universe

2011-05-24T05:48:00.001-07:00

Services - Indexing books, journals and technical documents, creating and using controlled vocabularies and taxonomies.

Specialties - aerospace, astronomy, general computer topics, business related books and library science topics. Will occasionally handle new topics.

Email address - lksloan@informationuniverse.com

Home state - California

Linda Kenny Sloan

Main Business Listings Page

Svaasa Wellness Clinic & Organics

2011-05-24T05:44:00.001-07:00

Svaasa Wellness Clinic & Organics with alternative biomeridian testing and high quality organic nutritional supplements and herbal extracts for different health ailments.

For detailed info pl. see the website www.svaasa.com

Aruna Ramana

Main Business Listings Page

VAC3 Clinical Services

2011-05-24T05:39:00.000-07:00

VAC3 Clinical Services is Gandhinagar, India, based Clinical Service Organization with passion to provide clinical and medico marketing services of global standard.

Value! Action! Commitment! 3 Pillars of our foundation fulfill the expectations of each of our customer.

SERVICES:

(A) Clinical Research
1) Training & Workshop
2) Medical Writing
• Protocol/CRF/ICF
• Investigator Brochure
• Clinical Study Report
• SmPCs
• Patient Information Leaflet
• Summary Documents for Regulatory Submissions
• PSUR
• Case Narratives
• Value Dozier
• SOPs
3) Investigator Selection
4) Site Feasibility
5) KOLs

(B) Medico Marketing
1) Training to field staff of Pharmaceutical/Biopharma companies
2) Content Search and Writing
• Newsletter and E-Zines
• Journal Digest
• Promotional Inputs
• Leave Behind Literature
• Patient Education Brochure
• Poster
• Product Monograph
• Scientific Booklets
• Visual Aids
• Case Studies
• Manuscript
• Training Modules

(C) Consulting Services
• Protocol Design
• Regulatory Affairs
• Clinical Audit - BA/BE Study
• Audit of Clinical Sites
• Drug Development Plan
• Clinical Trials in specialized Therapeutics Areas- Anesthesia, Dialysis, Transplantation, Hematology, Clinical Immunology, Biopharmaceutics.
• Pharmacovigilance and Risk Management Plan

Specialties
1) Clinical Research
2) Medico Marketing
3) Consultation
4) Training program & Workshops

Chitresh A S

Main Business Listings Page

Proper Medical Writing (PMW)

2011-05-24T05:35:00.001-07:00

PMW services offer professional support at every stage of the drafting process for preparation papers and research results intended for publication in either English or Polish.

Our services include:

* clinical study design
* preparing clinical study reports (CSR), clinical study protocols, case report forms (CRF), SAE narratives, clinical investigator brochures and other regulatory submission documents
* preparing the publication in the format required by the journal, including the preparation of drawings for print
* assistance in selecting the most appropriate journal for the themes of the work, its level and the impact factor of journals. We conduct a review of journals, as a result of which comes the list of recommended titles presented for your final approval.
* "letter to the editor" with emphasis on the most important elements of your paper, so as to arouse the interest of the reviewer.
* searching and creating bibliographies
* language correction (English and polish language)
* development of research results
* describing the research methodology
* interpretation of the statistical analysis
* translation of academic medical papers and articles from any language into English and from English into Polish

Help with editing the scientific text is fully adapted to your needs and depends on the scope of the required corrections. This includes every step: from the linguistic corrections in completed publications by assisting with editing, to the complete preparation of the scientific work.

The service is provided at the three levels, which reflect the quality and extent of the source materials from which the publication would be prepared:

* comprehensive editorial support, including text origination
* intermediate editorial work to improve an existing draft paper
* final editing and submission preparation

Our team consists of professional writers, reviewers, and editors of scientific texts (Medical Writers). They have years of relevant experience writing and editing scientific texts in all areas of medicine for international journals.

During the preparation process close contact is maintained with the author at all times. This ensures that the publication reflects the authors true intention. At the same time, thanks to close cooperation with medical writers, the author has a chance to improve his/her skills in writing scientific papers in English.

Please contact us for details:
Proper Medical Writing
infrared group s.c.
Plac Solny 6/7a, suite 4
PL-50-061 Wroclaw

http://propermedicalwriting.com

Julia Kosela

mail@propermedicalwriting.com

tel: +48 71 344 25 65
fax: +48 22 488 12 22

Main Business Listings Page

Ziven Consulting

2011-05-24T05:32:00.000-07:00

A full service clinical research consultancy having expertise across multiple phases of the clinical development process.

Our Specialized services include:
1. Operational Assistance
2. Functional Office Support
3. Regulatory Affairs and Pharmacovigilance
4. Medical Writing
5. Manpower Resourcing

For further details visit: www.zivenconsulting.com

contact priyanka@zivenconsulting.com

Main Business Listings Page

Herbal Analgesic Ointment "PainFoe"

2011-05-24T05:14:00.000-07:00

Its amazingly effective to relief : Arthritis, Backache, Goute, Lumbago, Neuralgia, Rheumatisim, Sprain, and Strains. This even brings back life to muscles / tissues affected by mild Paralysis.

Ingredient:- Winter Green, Menthol, Cardamom oil, Eucalyptus oil, Acacia Gum etc

The best part is that by first application one will feel relief to backache or mild pain to muscles and joints and for typical Arthritis and other severe pain, it shows results within 2 - 3 days, so its easy to recognize its efficacy.

On humanitarian ground, I keep the price very low @ US$2.50 Per 45 grams Tube . For transport by Courier US$60.- to add upto weight of 15 tubes, so finally 1 Tube will cost only US$6.50 including Fedex or DHL courier charges .

Anybody interested can email me at : navedherb@yahoo.com

Navaid Ashraf
www.herbariumhenna.com

Main Business Listings Page

Kaemmerer Group, LLC

2011-05-24T05:06:00.000-07:00

Carol J. Kaemmerer, Kaemmerer Group, LLC, Minneapolis, MN: With special skill in interviewing subject matter experts and a knack for making the complex understandable, Carol helps clients tell their stories by writing white papers, case studies, and marketing collateral, especially for new product launches.

With 20+ years of experience writing for medical and other high-tech clients, she is familiar with the constraints of writing for highly regulated industries. Carol and her design team can take your marketing communications project from beginning concept to final polished form, in print or web-based format, or work with your in-house resources.

www.kaemmerergroup.com, http://www.linkedin.com/in/carolkaemmerer ,carol@kaemmerergroup.com

Carol J. Kaemmerer

Main Business Listings Page

Clarity Writing and Editing

2011-05-21T10:56:00.000-07:00

My niche is translating medicalese in regular English and writing about medical/health topics. I have Plain Language training and 18 years of experience. I particularly like writing for low literacy audiences.

If you are planning to have health materials translated into other languages, I can save you money by cleaning them up and simplifying them before sending them for translation. I work with an illustrator to produce zero literacy or ultra low literacy health information. I can also translate legalese and geekspeak. I love to explain complicated topics.

301-213-9533 (USA East Coast time zone) or beth@claritywritingandediting.com

Beth Pulsifer Anderson

Main Business Listings Page

Michael Shaw Medical Writing Services

2011-05-21T10:51:00.000-07:00

With over 20 years' experience in medical communications, I can offer a knowledgeable, prompt, and reliable solution to your medical writing needs.

My experience covers most medical specialties, and encompasses a diverse range of print-based and computer-based formats. Further details can be found on my web site,http://www.michael-shaw.co.uk. Contact me on +44 (0)1273 416892 or by e-mail atmichael@rivercourt.demon.co.uk

Michael Shaw

Main Business Listings Page

Choices Unlimited for Health & Wellness

2011-05-20T18:51:00.000-07:00

Considering that much of ADHD/ADD appears to be related to toxicity and inflammation in the brain and in the liver -

glutathione accelerators work awesome - required by every cell in the body - utilized in almost every process of the body, ie.,synthesis, regulation, etc. Immensely important foundation molecule of every cell - and we are virtually all deficient. Have tremendous success with it. If interested let me know.

PS My brother had ADHD and I had ADD (now have umpteen degrees and designations)

Dr. Holly Fourchalk

President at Choices Unlimited for Health & Wellness

Main Business Listings Page

Marcus & Associates Senior Living, LLC

2011-05-20T18:47:00.000-07:00

I provide marketing consulting services to developers and providers in the Long Term Care and Assisted Living industries (having served in executive level corporate roles in both domains for over 20 years).

My company Marcus & Associates Senior Living, LLC, is experiencing growth and I am seeking to align with small to medium size companies in both domains.

http://www.marcusandassociatesseniorliving.com.

Marcus Van Ameringen
Principal
Marcus & Associates Senior Living, LLC
"Growing profitable revenues for healthcare providers"
770-365-2197
Marietta, GA

Main Business Listings Page

NC-CME

2011-05-20T18:23:00.001-07:00

Medical Writers - Give your career a boost: check out the Certification for CME Professionals (CCMEP™) program at www.NC-CME.org

NC-CME is a nonprofit, peer-to-peer organization; CCMEP is the only credential that designates qualified individuals as Certified CME Professionals.

Judy Ribble jribble@NC-CME.org

Main Business Listings Page

Catskills Medical Writing

2011-05-20T18:12:00.001-07:00

Dr. Carrie Thomson is a medical writer in Toronto, Canada. Her writing experience encompasses a wide range of therapeutic areas, including cancer, rheumatology, cardiovascular disease, nutrition, asthma, and immunology.

She has provided major pharmaceutical companies and medical groups in Canada and the US with content for educational projects for patients, physicians, pharmaceutical training reps, and the general public.

Trained as a food scientist, Dr. Thomson also has extensive writing experience in food chemistry, food science, and human and companion animal nutrition. Her five years as a product development manager for veterinary diets with an international food company in Canada and Europe provided her with a thorough understanding of the product development process and international work experience.

Visit Catskills Medical Writing at www.catskillsmedicalwriting.com

E-mail: carrie@catskillsmedicalwriting.com

Main Business Listings Page