Questions to Ask Before Participating in a Clinical Trial

 

The following are some questions to ask the research team when thinking about a clinical trial. Write down any questions you might have and bring your list with you when you first meet with the research team.

Older man asking a researcher questions about clinical trials

  • What treatment or tests will I have? Will they hurt?
  • What are the chances I will get the experimental treatment?
  • What are the possible risks, side effects, and benefits of the study treatment compared to my current treatment?
  • How will I know if the treatment is working?
  • How will you protect my health while I am in the study?
  • What happens if my health problem gets worse during the study?
  • How will the study affect my everyday life?
  • How long will the clinical trial last?
  • Where will the study take place? Will I have to stay in the hospital?
  • Will you provide a way for me to get to the study site if I need it?
  • Will being in the study cost me anything? If so, will I be reimbursed? Will my insurance cover my costs?
  • Can I take my regular medicines while in the trial?
  • Who will be in charge of my care while I am in the study? Will I be able to see my own doctor?
  • Will you follow up on my health after the end of the study?
  • Will you tell me the results of the study?
  • Whom do I call if I have more questions?
  • How will you keep my doctor informed about my participation in the trial?
  • Does the study compare standard and experimental treatments?
  • If I withdraw, will this affect my normal care?
  • What are the chances that I will receive a placebo?
  • What steps ensure my privacy?

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Immunotherapy and Triple Negative Breast Cancer – Mayo Clinic

A promising new study from Mayo Clinic, in conjunction with Caris Life Sciences, points to immunotherapy as a possible treatment option for patients with the difficult-to-treat triple negative breast cancer mutation. The study was presented this week at the 50th annual meeting of the American Society of Clinical Oncology in Chicago.

“This study may change our ability to treat triple negative breast cancer patients,” says Barbara Pockaj, M.D., lead investigator of the study and Mayo Clinic surgeon. “We may have signs that these patients can be treated with immunotherapy. We don’t have a lot of options for these patients and this would really expand our options.”

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Clinical Trials: Benefits, Risks, and Safety

 

You may ask yourself, “Why should I try something that researchers are not sure will work?” That is a good question. Being part of a clinical trial may have risks, but it may also have benefits.Older couple listening about the benefits, risks, and safety protections of clinical trials

Benefits of a Clinical Trial

  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • You may be able to get information about support groups and resources.

Risks of a Clinical Trial

  • The new treatment may cause serious side effects.
  • The new treatment may not work or it may not be better than the standard treatment.
  • You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
  • The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.

How Will My Safety Be Protected?

This is a very important question. The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research. Research abuses like the Tuskegee Syphilis Experiment, which began in 1932, before safeguards were in place, will NOT happen again.

Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed.

An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors, scientists, and lay people, like yourself, who are dedicated to making sure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants are as low as possible.

Along with the IRB, many clinical trials are closely supervised by a Data and Safety Monitoring Committee. The Committee is made up of experts in your condition who periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away.

The informed consent process also helps protect participants. Before joining a clinical trial, you will be told what to expect as a participant and all the things that might happen. For example, someone from the research team will explain possible side effects or other risks of the treatment. As part of the informed consent process, you will have a chance to ask questions about the trial. The clinical trial coordinator will be happy to answer your questions.

After getting all this information, you can think about whether or not you want to participate. If you decide to join the trial, you will be given an informed consent form to sign. By signing the form, you show that you have been told all the details and want to be part of the study. The informed consent form is NOT a contract. You can leave the trial at any time and for any reason without being judged or put in a difficult position regarding your medical care. Researchers must keep health and personal information private.

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How to Get Rid of Ear and Nose Hair

Hair in your ears and nose is a good thing. It keeps junk in the air from getting in your body. It can start getting a little crazy as we get older, though – and no one knows why exactly. If you’re tempted to trim that unruly nose and ear hair, here are some of the best tips on how to go about it.

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Chronic Daily Headaches in Children – Mayo Clinic

Kenneth Mack, M.D., Ph.D., a Mayo Clinic pediatric neurologist, describes symptoms, diagnosis and treatment options for chronic daily headaches in children. For more information, see http://www.mayoclinic.org/migraine/children.html.

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Mental Health Basics and NIMA’s CureStigma Campaign

Mental Illness Awareness Week

Each year, millions of Americans face the reality of living with a mental health condition. However, mental illness affects everyone directly or indirectly through family, friends or coworkers. It has impacted our family and, more than likely, yours.  Despite the reach and prevalence of mental illnesses, stigma and misunderstanding are also, unfortunately, widespread.

That is why each year, during the first full week of October, the National Alliance on Mental Illness (NAMI) and participants across the country raise awareness of mental illness. Since this week was set aside by Congress in 1990, efforts to educate the public, fight stigma and provide support have grown stronger.

It is important to discuss mental health illnesses year-round, but highlighting them during Mental Illness Awareness Week provides a dedicated time for mental health advocates across the country to come together as one unified voice. Advocates are working together to sponsor activities, large or small, to educate the public about mental illness.

 

What Is Mental Health?

Mental health refers to your emotional and psychological well-being. Having good mental health helps you lead a relatively happy and healthy life. It helps you demonstrate resilience and the ability to cope in the face of life’s adversities.

Your mental health can be influenced by a variety of factors, including life events or even your genetics.

There are many strategies that can help you establish and keep good mental health. These can include:

  • keeping a positive attitude
  • staying physically active
  • helping other people
  • getting enough sleep
  • eating a healthy diet
  • asking for professional help with your mental health if you need it
  • socializing with people whom you enjoy spending time with
  • forming and using effective coping skills to deal with your problems

What is Mental Illness?

A mental illness is a broad term which encompasses a wide variety of conditions which affect the way you feel and think. It can also affect your ability to get through day-to-day life. Mental illnesses can be influenced by numerous factors, including:

  • genetics
  • environment
  • daily habits
  • biology

Continue reading “Mental Health Basics and NIMA’s CureStigma Campaign”

Discussing Financial and Life Changes with Your Doctor

 

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It helps the doctor—and you—if he or she knows about the non-medical parts of your life. Where you live, how you get around, and what activities are important to you—these are all things that can make a difference in decisions about your health care. The following are some examples of practical matters you might want to discuss with your doctor. For additional information and resources on these topics, see the resources at the end of this article. Close up of calculator and pen on a pad of paper

Planning for Care in the Event of a Serious Illness

You may have some concerns or wishes about your care if you become seriously ill. If you have questions about what choices you have, ask your doctor. You can specify your desires through documents called advance directives, such as a living will or healthcare proxy. One way to bring up the subject is to say: “I’m worried about what would happen in the hospital if I were very sick and not likely to get better. Can you tell me what generally happens in that case?”

In general, the best time to talk with your doctor about these issues is while you are still relatively healthy. Medicare and private health insurance may cover these discussions with your doctor. If you are admitted to the hospital or a nursing home, a nurse or other staff member may ask if you have any advance directives.

Learn more about advance care planning.

Driving

Driving is an important part of everyday life for many people, and making the decision to stop driving can be very difficult. Tell your doctor if you or people close to you are concerned about your driving and why. He or she can go over your medical conditions and medications to see if there are treatable problems that may be contributing to driving difficulties.

Find out more about older drivers.

Moving to Assisted Living

Another hard decision that many older people face is whether or not to move to a place where they can have more help—often an assisted living facility. If you are considering such a move, your doctor can help you weigh the pros and cons based on your health and other circumstances. He or she may be able to refer you to a social worker or a local agency that can help in finding an assisted living facility.

Read more information about long-term care.

Paying for Medications

Don’t hesitate to ask the doctor about the cost of your medications. If they are too expensive for you, the doctor may be able to suggest less expensive alternatives. You can ask if there is a generic or other less expensive choice. You could say, for instance: “It turns out that this medicine is too expensive for me. Is there another one or a generic drug that would cost less?”

Learn more about saving money on medicines.

For More Information About Discussing Non-Medical Concerns with Your Doctor

Centers for Medicare & Medicaid Services
1-800-633-4227 (toll-free)
1-877-486-2048 (TTY/toll-free)
www.medicare.gov

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What Are Heart Palpitations?

What Are Heart Palpitations

Does your heart race or skip a beat? Those are heart palpitations, and they can be a little scary. What causes them, and when should you see a doctor?

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How to Get Relief for Joint Pain

Osteoarthritis causes pain in your joints and can make it hard to move. Although OA can be painful, you can get relief with a number of treatments from pain relievers to surgery. Find what these treatments are and how they work.

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Beware the Fungus Among Us – 10 Questions to Ask

Today marks the end of Fungal Disease Awareness Week, sponsored by the Centers for Disease Control and Prevention.  The CDC organized this week to raise awareness about the importance of recognizing serious fungal diseases early enough in the course of a patient’s illness to provide life-saving treatment.

Fungal Disease Awareness Week highlights the grave reality some fungal diseases go undiagnosed and cause serious infections in people in the United States and around the world, leading to illness and even death. Increased awareness about fungal diseases is one of the most important ways to improve early recognition and reduce delays in diagnosis and treatment. A key clue to when a sick person may have a fungal infection is that he or she is being treated with medications for other types of infection without expected improvement.

Healthcare providers and their patients are encouraged to Think Fungus when symptoms of infection do not get better with treatment.  Fungal diseases range from relatively minor superficial and mucosal infections to severe, life-threatening systemic infections. Delayed diagnosis and treatment can lead to poor patient outcomes and high medical costs. The overall burden of fungal diseases in the United States is challenging to quantify because they are likely substantially underdiagnosed.

 

Facts

It is estimated that fungal diseases cost more than $7.2 billion in 2017, including $4.5 billion from 75,055 hospitalizations and $2.6 billion from 8,993,230 outpatient visits. Hospitalizations for Candida infections (n=26,735, total cost $1.4 billion) and Aspergillus infections (n=14,820, total cost $1.2 billion) accounted for the highest total hospitalization costs of any disease. Over half of outpatient visits were for dermatophyte infections (4,981,444 visits, total cost $802 million), and 3,639,037 visits occurred for non-invasive candidiasis (total cost $1.6 billion).[1]

Fungal diseases are often misdiagnosed as their symptoms sometimes resemble other conditions. For example, Valley fever — an inhaled fungal infection that incites cough, fever and a distinctive rash on the upper body or legs — is often misdiagnosed as bacterial pneumonia. While an estimated 150,000 cases of Valley fever occur every year, only 10,000 cases are diagnosed.

About 46,000 healthcare-associated invasive fungal infections occur in the U.S. annually. Growing drug resistance is also making certain fungal strains more difficult to treat.

 

The fungus is among us.

Fungi are everywhere. There are millions of distinct species of fungi on Earth, but only about 300 of those are known to make people sick. Fungal infections are often caused by microscopic fungi that are common in the environment. Fungi live outdoors in soil and on plants and trees as well as on many indoor surfaces and on human skin.

Mild fungal skin infections can look like a rash and are very common. For example, ringworm is a skin infection that’s caused by a fungus, not a worm! Fungal infections in the lungs can be more serious and often cause symptoms that are similar to other illnesses, such as the flu or tuberculosis.

Fungal meningitis and bloodstream infections are less common than skin and lung infections but can be life-threatening. Because the symptoms of fungal infections can be similar to other illnesses, proper diagnosis and treatment are often delayed. The more you know about fungal infections and your chances of getting one, the better prepared you can be to protect your health.

 

10 questions you can use to understand fungal infections, learn how you can get sick, and know what you need to do to stay healthy.

 

Where do you live and travel? Fungi that can cause serious infections are more common in some parts of the United States and world. For example, the fungus that causes Valley fever (also called coccidioidomycosis) is found mainly in the southwestern United States. Histoplasmosis and blastomycosis occur most often in the eastern United States. These infections usually cause a lung infection that is often mistaken for flu or a bacterial infection.

What types of activities are you doing? Harmful fungi can be found in air, dust, and soil. Histoplasma grows especially well in soil that contains bird or bat droppings. Activities like digging, gardening, cleaning chicken coops, and visiting caves can result in you breathing in fungi that may cause infection.

Do you have a dog or cat? People can get ringworm from their pets. Dogs and cats with ringworm sometimes have circular, hairless patches on their skin or other types of rashes. Adult animals do not always show signs of ringworm infection.

Have you recently taken antibiotics? Antibiotics can make women more likely to get vulvovaginal candidiasis, also known as a vaginal yeast infection. Women who are pregnant and have weakened immune systems also are more likely to get this condition. Men also can get genital candidiasis.

Are you taking any medications that affect your immune system? Medications used to treat conditions like rheumatoid arthritis or lupus may weaken your immune system and increase the chance of getting a fungal infection.

Are you living with HIV/AIDS? People living with HIV/AIDS may be more likely to get fungal infections. Two well-known fungal infections associated with HIV/AIDS in the United States are oral candidiasis (thrush) and Pneumocystis pneumonia. Worldwide, cryptococcal meningitis is a major cause of illness in people living with HIV/AIDS.

Will you be hospitalized? In the United States, one of the most common bloodstream infections in hospitalized patients is caused by a fungus called Candida. Candida normally lives in the gastrointestinal tract and on skin without causing any problems, but it can enter the bloodstream during a hospital stay and cause infection.

Have you recently had a transplant? People who have recently had an organ transplant or a stem cell transplant have a greater chance of developing a fungal infection while their immune systems are weakened. Doctors prescribe antifungal medication for some transplant patients to prevent fungal infections from developing.

Are you receiving chemotherapy or radiation treatments? Cancer treatment, such as chemotherapy and radiation, weakens your immune system and may increase the chance you will get a fungal infection.

Do you have symptoms of pneumonia that are not getting better with antibiotics? Fungal infections, especially lung infections like Valley fever, histoplasmosis, and aspergillosis, can have similar symptoms as bacterial infections. However, antibiotics don’t work for fungal infections. Early testing for fungal infections reduces unnecessary antibiotic use and allows people to start treatment with antifungal medication, if necessary.

 

Conclusions

Anyone can get a fungal infection, and fungal diseases impose a considerable economic burden on the healthcare system. Since they are often under-diagnosed, it is important to learn more about the signs, symptoms, and treatment of fungal infections and get prevention tips by visiting CDC’s fungal diseases website and by talking with your healthcare provider.

To connect quickly with the right healthcare provider in your area, go to HealthLynked.com – the FUTURE OF CONNECTED HEALTHCARE.  There, you will find one comprehensive platform that connects doctors, families and medical data to Improve HealthCare.

 


Adapted from the CDC pages on fungal infections.

 

[1] Estimation of direct healthcare costs of fungal diseases in the United States

Kaitlin Benedict  Brendan R Jackson  Tom Chiller  Karlyn D Beer

Clinical Infectious Diseases, ciy776, https://doi.org/10.1093/cid/ciy776

Published: 10 September 2018