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Archive for the ‘Hormone Physician’ Category

Forum Health, LLC adds Healing Arts Center to its growing community of Integrative and Functional Medicine practitioners – PRNewswire

FLINT, Mich., Jan. 8, 2021 /PRNewswire/ --Forum Health, LLC, a nationwide provider of personalized functional and integrative medicine, has acquired Healing Arts Center, a functional medicine practice based in Valparaiso, Indiana.

This multidisciplinary practice is comprised of an experienced team of providers including a physician, board-certified traditional Naturopath, licensed acupuncturist, nutritionist, chiropractor, and massage therapist. The clinic delivers a broad scope of complementary health services designed to encourage well-being and health in a caring and compassionate environment.

"We are thrilled to welcome the Healing Arts Center team to the Forum Health family. The clinic's patient-focused mission for helping people overcome chronic conditions and lead healthier lives, directly aligns with our philosophy. Healing Arts Center is dedicated to providing the highest level of care possible using Forum Health's holistic and personalized medicine approach," said Forum Health CEO, Phil Hagerman.

With a focus on complementing traditional medicine with alternative health treatments, Healing Arts Center offers a wide variety of services including IV, Chelation and Ozone therapies, acupuncture, reflexology, reiki, craniosacral therapy, massage therapy, hormone testing, allergy elimination, hypnotherapy, and more. They specialize in treating Lyme disease, Parkinson's, dementia, ADD, autism, anxiety, depression, weight loss, allergies, and other specific conditions.

"My team and I are excited to join the growing network of nationwide providers at Forum Health and to offer even more to our existing patients and community," said Dr. Kimberling, founder and lead practitioner of Healing Arts Center.

About Forum Health

Forum Health, LLC is a nationwide provider of personalized healthcare. Steeped in the powerful principles of functional and integrative medicine, Forum Health providers take a root-cause approach to care. They listen and dig deep exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Members have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships. To learn more, visitforumhealth.com.

To learn more, visit our practice location page.

SOURCE Forum Health, LLC

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Forum Health, LLC adds Healing Arts Center to its growing community of Integrative and Functional Medicine practitioners - PRNewswire

Sparse Eyebrows Treatment, Home Remedies, and Precautions – Healthline

Big brows are all the rage on runways. But sparse or thinning eyebrows arent uncommon everywhere else. A 2012 research review showed that there are many possible causes of thinning or sparse eyebrows, including:

Lets cover some strategies for filling in and treating eyebrows that have lost some of their fullness.

The easiest way to treat thin eyebrows is to use makeup to make them look thicker and fuller. There are several types of makeup products that you can use to do this, including:

You may want to experiment with a few products, mixing and matching to find the beauty routine that gives you the eyebrow look you want.

To try filling in your eyebrows to make them look fuller, start with these steps:

If you want a remedy thats more permanent than makeup, you can consider these other techniques and treatments for filling in your eyebrows.

You can use semipermanent or permanent hair dye to add a darker pigment to your eyebrows. This can give the illusion of brows that are thicker and fuller.

You can DIY this treatment yourself with drugstore hair dye or go to an esthetician.

A 2017 research review showed that hair loss has been linked to some vitamin deficiencies, including vitamin D and iron deficiencies.

So, it makes sense to think that taking nutritional supplements for vitamin D and iron may help regrow your hair, including at your eyebrows.

Additionally, the same research review above showed that if you dont have a nutritional deficiency, dietary supplements likely wont be effective.

Anecdotally, some essential oils are said to promote hair growth on your head and at your eyebrows.

Be sure to always dilute them with a carrier oil, and do not use oils too close to your eye and on your eyelid. Castor oil and peppermint oil are two anecdotal favorites for hair growth.

Microblading is a cosmetic procedure performed by a licensed provider. The goal of microblading is to make your brows look full and even.

Microblading (and its cousin procedure, nanoblading) does this by making tiny, feather-like strokes that mimic real hair and filling these strokes with a semipermanent pigment.

The results of microblading last 8 to 30 months, after which you will have to get a touch-up if you like the result.

Similar to microblading, microshading is a procedure also performed by a licensed provider.

Unlike microblading, microshading mimics the appearance of a powdered makeup application (in other words, it looks like makeup and not like real eyebrows). Microshading lasts 3 to 6 months.

Semipermanant eyebrow tattoos (such as henna) and regular, permanent tattoos have been around for many years. They often do not look as realistic as microblading.

According to a 2016 study, bimatoprost (Latisse) has not yet been approved by the FDA for the use of eyebrow restoration and would be considered off-label use. The dosage is a topical application to your eyebrows once or twice daily.

This FDA-approved medication for eyelash growth stimulation is by prescription only, and it may take several months to see full results.

Minoxidil (Rogaine) is available as both an over-the-counter and prescription-strength medication. It can be used as a topical foam, a concentrated solution, or be given orally.

In a small 2014 study, 39 participants were asked to use a lotion containing minoxidil on one side of their faces, and a placebo product on the other side in an attempt to treat eyebrow thinning.

The study found that the minoxodil side saw significantly better results than the placebo.

You can talk with a dermatologist or cosmetic surgeon about hair grafts that target your eyebrows. These types of grafts use your existing hair follicles to fill in thin spots and encourage regrowth.

These eyebrow transplant procedures can be quite expensive, require a few weeks of recovery, and there is a risk of serious side effects and infection.

Sparse eyebrows can have several causes.

Overplucking or tweezing your eyebrows can damage your hair follicles and lead to poor hair regrowth. Other causes of sparse eyebrows include:

Hair loss from your eyebrows can be frustrating, but there are lots of available treatments. You can also look into cosmetic procedures and even hair grafts to make your brows look bigger.

If youre concerned about hair loss or cant figure out whats causing it, talk with a doctor.

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Sparse Eyebrows Treatment, Home Remedies, and Precautions - Healthline

Heres an idea for experiencing restful days sleep on it – Cleveland Jewish News

A good nights sleep can do wonders for anyone.

However, this is especially true for aging adults, according to Brandy Delp, executive director of Windsor Heights Assisted Living and Memory Care in Beachwood, and Dr. Mark Levy, owner and founder of Sleep Better Columbus in Columbus.

Hormones tend to change as we get older, which affects all kinds of things like sleep cycles and bathroom needs, Levy said. The hormone changes make you have to use the bathroom more and those needs cause you to have to get up, which disturbs sleep and ultimately wakes you up.

Delp said, As we age, changes in our hormone production occurs such as a decrease in melatonin, which helps promote sleep. Older adults have a harder time falling asleep, have frequent nighttime awakenings and increased difficulty returning to sleep once awakened.

Delp added that age-related sleep patterns also involve earlier bedtimes and early morning rising times, and frequent naps during the daytime hours.

Another change seniors may observe in their sleep patterns stems from breathing issues and changes, Levy said.

As you get older, the tissues in the back of your throat get a little slack and not as firm, he explained. That leads to snoring and sleep apnea. All of that snoring and related events can cause you to stop breathing, which are micro-arousals, and bring you up out of deep sleep.

Sleeping well allows one to start the day refreshed and rested. But why does having enough sleep make people feel so good?

Delp said it is closely related to the processes bodies go through while were at rest, which can be especially important as we age.

Several processes occur during sleeping, such as acceleration of protein synthesis and tissue repair, increased production of growth hormone, as well as cognitive function and memory formation, she said. Sleep plays a vital role in brain function and the immune system along with several other bodily processes.

Levy said, Physically, you need to heal. But mentally, sleep allows you to regroup and process the days events. Your brain needs that time.

For aging adults, lack of sleep can lead to serious health conditions like cognitive issues, Delp noted. Fatigued people also put themselves at risk for falls, as well as mood issues like anxiety, depression and irritability. Levy said lack of sleep can lead to brain fog, which can cause confusion in daily tasks for seniors.

At Sleep Columbus, Levy said patients seek oral appliance solutions for sleep apnea and snoring. Though they cant dispense CPAP machines, they also offer sleep testing out of the office to determine if a patient has sleep apnea.

We do a lot of hand holding and guiding, and were the connector between the things they do to make it better, he said. Were a lot more accessible and basically are the sleep tour guide.

As for Windsor Heights, staff works daily to ensure an optimal nights sleep for residents, according to Delp.

We keep routines for our residents, offer bedtime snacks, close the curtains in the evening, increase physical activity during the daytime and plan quiet activities in the evening, Delp said.

She had other suggestions for seniors struggling with sleep issues.

Exercise regularly, avoid stimulants three to four hours before bedtime such as coffee, chocolate, cigarettes and soda, and dont use electronic devices at least an hour before bed, Delp said.

Those experiencing sleep issues should also consult a physician.

First thing to do is have a conversation with their primary care doctor, and if they suspect sleep apnea, they can call someone like us, Levy said. Recommendation is always the best place to start the process of getting help for any health issue.

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Heres an idea for experiencing restful days sleep on it - Cleveland Jewish News

Side Effects of Drinking Caffeine, According to Science | Eat This Not That – Eat This, Not That

There's a lot to love about caffeine. First, because it's found in plants, it can actually be said to be all-natural, and those plants, including the ones used to make coffee, tea, and cocoa, are rich in sources of antioxidants and phytonutrients. Caffeine, itself, is a phytonutrient that can help reduce your risk of Parkinson's, dementia, and certain oral cancers, according to the University of Michigan Health Service.

One of caffeine's immediate physiological effects is to speed up your central nervous system, which can help you feel alert and focused. Another is that it increases levels of dopaminewhich is one of those "feel-good" chemicals your body produces that improves your mood.

Consuming moderate amounts of caffeine (up to 400 milligrams per day, or the equivalent of four cups of coffee) has never been scientifically linked to long-term harm in healthy adults. However, that's not to say it doesn't have side effects.

For example, to the extent it can improve your mood, it can also be addictive. And while it can keep you focused, it can also leave you feeling overstimulated, according to registered dietitian Amy Goodson. Read on to learn more about the side effects of drinking caffeine, according to science. And don't forget to check out the 7 Healthiest Foods to Eat Right Now.

"Because caffeine is a stimulant, it increases your heart rate while it's in your system," says general practice physician, Leann Poston, MD. "At the same time, it causes the blood vessels to narrow, which increases the pressure the heart must exert to circulate blood." This sets you up for a temporary spike in blood pressure.

That said, high blood pressure is a serious condition that, over time, can put you at increased risk for heart disease, stroke, and kidney failure, among others. It's also associated with the most serious and even life-threatening presentation of the COVID-19 infection.

The good news is that the rise in blood pressure attributable to consuming caffeine is temporary, according to Sheldon G. Sheps, M.D., via Mayo Clinic. However, if you've been diagnosed with high blood pressure, it's not a bad idea to ask your doctor if you need to limit your intake of caffeinated beverages.

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Most people associate headaches with caffeine-withdrawal. However, a 2004 study published in the scientific journal Neurology found that among people who suffer from chronic daily headaches, a condition in which headaches are suffered at least 15 times per month, a significant percentage had been heavy caffeine drinkers prior to the onset of their chronic daily headaches.

Similarly, among migraine sufferers, caffeine overuse has been associated with an increase in migraine frequency. If you get frequent headaches, you might want to consider cutting some of these headache-triggering foods out of your diet.

"If you are already stressed or anxious, caffeine can make it worse," according to registered dietitian Elisa Bremner. In fact, as little as 100 milligrams of caffeinethe equivalent of one cup of coffeemay exacerbate pre-existing feelings of stress and anxiety. The scientific community offers several reasons for this. One is that the natural effects of caffeine as a stimulant cause a number of physical symptoms that we tend to associate with anxiety, including increased heart and breathing rates. Our bodies may experience those symptoms as anxiety.

In addition, caffeine stimulates the release of adrenaline, Dr. Poston tells Eat This, Not That! Adrenaline is a hormone that prepares us for "fight or flight" when we're faced with stressors. It does so by increasing alertness and raising heart rate, respiration, and blood flow. And because caffeine competes with a chemical called adenosine, which leads to feelings of fatigue and relaxation, the whole combination of all of these effects can lead to distinct feelings of nervousness, jitteriness, and anxiety.

Nevertheless, here is why you might want to consider drinking coffee before taking a nap.

Caffeine consumption has been linked to an increased risk of miscarriage, according to this paper published in 2020 in the scientific journal BMJ. The paper, which consisted of a meta-analysis of 48 existing studies addressing the link between caffeine consumption and negative pregnancy outcomes such as miscarriage, found that drinking coffee while pregnant is, in fact, associated with pregnancy loss.

The reason, according to OB/GYN, Jodie Horton, MD, may be linked to the fact that caffeine narrows blood vessels, which can diminish the transfer of nutrients to the fetus. It's worth pointing out, however, that these findings are at odds with the current recommendations from the American College of Obstetrics and Gynecology, which state that "moderate consumption" of caffeine does not present a miscarriage risk, according to OB/GYN Brittany Noel Robles, MD. Nevertheless, Dr. Robles recommends keeping caffeine to a minimum during pregnancy. (Related: Don't miss these 8 pregnancy myths, busted.)

Caffeine's stimulant effect can help ensure that you'll keep your digestive system "moving."However, for some people, caffeine is too stimulating, which is to say, it can have a laxative effect. In other words, caffeine can cause loose bowels and evendiarrhea. Diarrhea is a major symptom of irritable bowel syndrome, according to Johns Hopkins Medicine's Health Blog.

If you're running to the bathroom every time you have caffeine, it may be worth talking to your doctor about whether you might be suffering from irritable bowel syndrome. Whether or not you are diagnosed, the discussion could lead to you deciding to limit your caffeine intake until you find a level at which consumption does not equal digestive distress.

For more on caffeine, here are 11 surprising ways that drinking tea can heal you.

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Side Effects of Drinking Caffeine, According to Science | Eat This Not That - Eat This, Not That

Tagrisso receives FDA approval as adjuvant therapy for NSCLC with EGFR mutations – The Cancer Letter

publication date: Jan. 8, 2021

FDA has approved Tagrisso (osimertinib) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Tagrisso is sponsored by AstraZeneca Pharmaceuticals LP.

Efficacy was demonstrated in a randomized, double-blind, placebo-controlled trial (ADAURA, NCT02511106) in patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC who had complete tumor resection, with or without prior adjuvant chemotherapy.

Eligible patients with resectable tumors (stage IB IIIA) were required to have predominantly non-squamous histology and EGFR exon 19 deletions or exon 21 L858R mutations identified prospectively from tumor tissue in a central laboratory by the cobas EGFR Mutation Test. A total of 682 patients were randomized (1:1) to receive osimertinib 80 mg orally once daily or placebo following recovery from surgery and standard adjuvant chemotherapy, if given.

The major efficacy outcome measure was disease-free survival in patients with stage II IIIA NSCLC determined by investigator assessment. Median DFS was not reached (38.8, NE) in patients on the osimertinib arm compared with 19.6 months (16.6, 24.5) on the placebo arm (HR 0.17 95% CI: 0.12, 0.23; <0.0001). DFS in the overall study population was a secondary efficacy outcome measure; the median was not reached (NE, NE) in patients on the osimertinib arm compared with 27.5 months (22, 36) on the placebo arm (HR 0.20 95% CI: 0.15, 0.27; <0.0001).

Iclusig receives FDA sNDA approval for adult patients with resistant or intolerant chronic-phase CML

FDA has approved the supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.

Iclusig is sponsored by Takeda Pharmaceutical Company Ltd.

The updated label includes an optimized, response-based ICLUSIG dosing regimen in CP-CML with a daily starting dose of 45 mg and, upon achieving 1% BCR-ABL1IS, dose reduction to 15 mg. This dosing regimen aims to maximize benefit-risk by providing efficacy and decreasing the risk of adverse events, including arterial occlusive events.

The sNDA approval is based on data from the phase II OPTIC (Optimizing Ponatinib Treatment In CML) trial, as well as five-year data from the phase II PACE (Ponatinib Ph+ ALL and CML Evaluation) trial.

The OPTIC trial included patients with CP-CML whose disease was highly-resistant to their immediate prior TKI, the majority of whom (65%) did not achieve a response greater than complete hematological response on immediate prior therapy.

At 12 months, 42% of 88 patients utilizing the newly approved response-based dosing regimen (45 mg to 15 mg) achieved 1% BCR-ABL1IS, the primary endpoint of OPTIC, and at a median follow up time of 28.5 months, 73% of these patients maintained their response. In these patients, 13% experienced an AOE of any Grade, 7% experienced Grade 3 or higher. Risk factors such as uncontrolled hypertension or diabetes should be managed, and caution should be exercised when treating patients with active or substantial history of clinically significant, uncontrolled cardiovascular disease.

Xpovio receives FDA approval for refractory or relapsed multiple myeloma

FDA has approved Xpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Xpovio is sponsored by Karyopharm Therapeutics Inc.

FDA granted Xpovio accelerated approval in 2019 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Efficacy of Xpovio in combination with bortezomib and dexamethasone was evaluated in the BOSTON Trial (KCP-330-023, NCT03110562), a randomized (1:1) open-label, multicenter, active comparator-controlled trial in patients with RRMM who had previously received at least one and at most three prior therapies.

Patients received once-weekly selinexor orally in combination with once-weekly bortezomib subcutaneous and low-dose dexamethasone twice-weekly orally compared to the standard twice-weekly bortezomib plus low-dose dexamethasone.

The main efficacy outcome measure was progression free survival assessed by an independent review committee using International Myeloma Working Group response criteria. The estimated median PFS was 13.9 months (95% CI: 11.7, Not Estimable) for the SVd arm and 9.5 months (95% CI: 7.6, 10.8) for the Vd arm (estimated hazard ratio 0.70; 95% CI: 0.53, 0.93).

Orgovyx receives FDA approval for advanced prostate cancer

FDA has approved the first oral gonadotropin-releasing hormone receptor antagonist, Orgovyx (relugolix) for adult patients with advanced prostate cancer.

Orgovyx is sponsored by Myovant Sciences inc.

Efficacy was evaluated in HERO (NCT03085095), a randomized, open label trial in men requiring at least one year of androgen deprivation therapy with either prostate cancer recurrence following radiation or surgery or newly diagnosed castration-sensitive advanced prostate cancer. Patients (N=934) were randomized (2:1) to receive relugolix 360 mg oral loading dose on the first day, followed by daily oral doses of 120 mg, or leuprolide acetate 22.5 mg injection subcutaneously every 3 months for 48 weeks.

The main efficacy outcome measure was medical castration rate defined as achieving and maintaining serum testosterone suppression to castrate levels (< 50 ng/dL) by day 29 through 48 weeks of treatment. The medical castration rate was 96.7% (95% CI: 94.9%, 97.9%) in the relugolix arm.

Margenza receives FDA approval for metastatic HER2-positive breast cancer

FDA has approved Margenza (margetuximab-cmkb) in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Margenza is sponsored by MacroGenics.

Efficacy was evaluated in SOPHIA (NCT02492711), a randomized, multicenter, open-label trial of 536 patients with IHC 3+ or ISH-amplified HER2+ metastatic breast cancer who had received prior treatment with other anti-HER2 therapies. Patients were randomized (1:1) to margetuximab plus chemotherapy or trastuzumab plus chemotherapy. Randomization was stratified by chemotherapy choice (capecitabine, eribulin, gemcitabine, or vinorelbine), number of lines of therapy in the metastatic setting ( 2, > 2), and number of metastatic sites ( 2, > 2).

The main efficacy outcome measures were progression-free survival by blinded independent central review and overall survival. Additional efficacy outcome measures were objective response rate and duration of response assessed by BICR.

Median PFS in the margetuximab arm was 5.8 months (95% CI: 5.5, 7.0) compared with 4.9 months (95% CI: 4.2, 5.6) in the control arm (HR 0.76; 95% CI: 0.59, 0.98; p=0.033). Confirmed ORR was 22% (95% CI: 17, 27) with a median DOR of 6.1 months (95% CI: 4.1, 9.1) in the margetuximab arm compared to an ORR of 16% (95% CI: 12, 20) and median DOR of 6.0 months (95%CI: 4.0, 6.9) in the control arm.

CPI-613 receives FDA Fast Track Designation for treatment of AML

FDA has granted Fast Track designation to CPI-613 (devimistat) for the treatment of acute myeloid leukemia.

CPI-613 is sponsored by Rafael Pharmaceuticals Inc.

Rafael Pharmaceuticals received Fast Track designation for devimistat for the treatment of metastatic pancreatic cancer in November 2020. The company also received Orphan Drug Designation for the treatment of soft tissue sarcoma for devimistat, and the initiation of a phase II clinical trial of devimistat in combination with hydroxychloroquine in patients with clear cell sarcoma of soft tissue.

EU CHMP issues positive opinion for Keytruda as first-line treatment in adult patients in colorectal cancer indication

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Keytruda is sponsored by Merck.

This recommendation is based on results from the pivotal phase III KEYNOTE-177 trial, in which Keytruda, as a monotherapy, demonstrated a significant improvement in progression-free survival compared to chemotherapy (investigators choice: mFOLFOX6 with or without bevacizumab or cetuximab; or FOLFIRI with or without bevacizumab or cetuximab), a current standard of care.

Data from KEYNOTE-177 were presented at the virtual scientific program of the 2020 American Society of Clinical Oncology Annual Meeting and were published in The New England Journal of Medicine. The CHMPs recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021.Servier and Celsius Therapeutics collaborate on colorectal cancer research

Servier and Celsius Therapeutics have formed a strategic collaboration focused on the identification and validation of novel colorectal cancer drug targets.

Through this collaboration, we will leverage Celsius single-cell genomics platform, machine learning capabilities, and target validation expertise to refine our understanding of the different subtypes of CRC and discover new drug targets with the goal of developing novel precision therapies for specific patient subsets, Hugues Dolgos, global head of oncology research and development at Servier, said in a statement. Servier will discover and develop candidate drugs leveraging our end-to-end small molecule and large molecule capabilities.

Under the terms of collaboration, Celsius will analyze hundreds of samples from defined CRC patient populations using its proprietary single-cell genomics platform and will work to identify and validate new drug targets during the three-year research period. Servier will receive an exclusive option to research, develop, and commercialize products directed to up to three of the targets.

Celsius would receive an upfront payment and research funding, and would be eligible to receive over $700 million in potential discovery, development, and commercialization milestone payments, along with tiered royalties.

Bayer and Veracyte collaborate on precision oncology in thyroid cancer

Bayer and Veracyte have entered a collaboration to advance the Precision Oncology Patient Identification Program in thyroid cancer.

Through the program, Bayer will offer testing with Veracytes Afirma Xpression Atlas to identify underlying genomic drivers, including NTRK gene fusions, within patients tumors. The program will focus on patients with advanced or metastatic thyroid cancer that is radioactive iodine refractory who may potentially benefit from biomarker-driven therapies.

Patients whose thyroid cancer contains actionable alterations and no longer responds to traditional radioactive iodine therapy now have targeted treatment options available to them. Our goal is to identify such patients so physicians can make more informed treatment decisions for their patients, Bhavesh Ashar, senior vice president and head of U.S. Oncology at Bayer, said in a statement. With its comprehensive ability to identify broad genomic alterations through its Afirma XA test and its widespread reach among physicians who diagnose thyroid cancer, Veracyte is an ideal collaborator for this program.

The Afirma XA uses RNA whole-transcriptome sequencing to identify 905 DNA variants and 235 RNA fusions in 593 genes, including novel NTRK fusions, on fine needle aspirates taken from thyroid nodules or lymph nodes.

Through this collaboration, Bayer will provide Afirma XA testing at no cost to all eligible patients when ordered by the physician, regardless of the final results and treatment decision. Additionally, physicians of patients found to harbor NTRK gene fusions as an underlying driver in their thyroid cancer will be alerted of the results. The companies anticipate the program to launch in the first quarter of next year.

Servier to acquire Agios Pharmaceuticals oncology business

Servier has entered into an agreement for the acquisition of Agios Pharmaceuticals oncology business including its commercial, clinical and research-stage oncology portfolio for up to $2 billion, including an upfront payment of $1.8 Billion and a potential $200 million in regulatory milestone, plus royalties.

The transaction has been approved by both companies respective boards of directors. Subject to receipt of regulatory clearances and approval by Agios shareholders, the acquisition is expected to close in Q2 2021.

Servier has made oncology one of its strategic priorities, allocating 50% of its overall research and development budget to this therapeutic area. The acquisition will reinforce Serviers presence in the U.S., where the group has been operating since 2018.

The transaction includes the transfer of Agios oncology portfolio and associated employees, including its marketed medicine Tibsovo, which is approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia and for adults with newly diagnosed IDH1-mutant AML who are 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

Tibsovo is also under investigation in two phase III combination trials in newly diagnosed AML, and as a potential treatment for previously treated IDH1-mutant cholangiocarcinoma and IDH1-mutant myelodysplastic syndrome. Servier will also acquire Agios co-commercialization responsibilities for Bristol Myers Squibbs Idhifa (enasidenib) and conduct certain clinical development activities within the Idhifa development program.

In addition, the transaction includes Agios oncology pipeline and clinical programs, including vorasidenib, an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 which is currently being studied in the registration-enabling phase III INDIGO study in patients with IDH-mutant low-grade glioma; AG-270, an investigational first-in-class methionine adenosyltransferase 2a inhibitor being evaluated in combination with taxanes in patients with methylthioadenosine phosphorylase-deleted non-small cell lung cancer and pancreatic cancer; AG-636, a novel inhibitor of dihydroorotate dehydrogenase; and Agios oncology research programs.

All of Agios U.S.-based employees who primarily support the oncology business will receive a comparable offer at Servier.

Kite and Oxford BioTherapeutics establish cell therapy research collaboration in blood cancers and solid tumors

Kite, a Gilead Company, and Oxford BioTherapeutics Ltd. have entered into a research collaboration to evaluate five novel targets for a number of hematologic and solid tumor indications.

Through this collaboration, OBT will validate five novel oncology drug targets, previously identified using OBTs OGAP discovery platform, and generate antibodies against these targets. Kite and Gilead will have the exclusive right to develop and commercialize therapies based on these targets or antibodies.

Under the terms of the agreement, OBT will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain discovery, clinical and regulatory milestones, as well as royalties on future potential sales.

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Tagrisso receives FDA approval as adjuvant therapy for NSCLC with EGFR mutations - The Cancer Letter

The best products and tips for getting a better night’s sleep – Fast Company

It has not been a good year for sleep. Between a pandemic, social unrest, an election, and the stresses of working (or learning, or teaching) from home, millions of us are experiencing coronasomnia. Thats why two months ago, I started to take a CBN tincture, in hopes that it would combat the hours of blue light exposure and heightened holiday-related anxiety that were plaguing my sleep habits.

With one 50-milliliter drop of Ned Sleep Blendhalf the recommended doseI drifted into a peaceful, uninterrupted sleep for eight full hours (two more hours than usual, for me). Ive since incorporated a half-dropper of Ned into my bedtime routineand while it lacks the instant catalyst that melatonin or over-the-counter medications provide, it settles my mind into a restful, deep sleep as soon as I shut my eyes.

[Photo: courtesy Ned]

We all have hectic days and tend to stay up really late, and our brains get confused about when to be alert, when to be sleepy, and when to be sleeping deeply, explains Dr. Nitun Verma, a San Francisco sleep physician and spokesperson for the American Academy of Sleep Medicine. Once upon a time when we all used to work outdoors, the sun would go down over a period of hours. It would get cooler, darker, quieter, and your brain would get the sense that it was time to go to sleep.

If youre in search of a good nights sleep, dont worryyou can still help your brain recognize its time to wind down just by building out a routine, Verma says. For example, he recommends cleaning up your workstation when youre done with work for the day. That concept helps your brain understand, Hey this activity is over. And now I get to have personal time and to relax. It shows your brain that youre getting ready to sleep.

For the rest of your evening, here are some of our best suggestions for calming down, cozying up, and getting some shut-eye.

[Photo: courtesy Prismatic Plants]Prismatic Plants Goodnight TincturePrismatic Plants Goodnight Tincture combines all the relaxing elements of cannabis without the unwanted side effects: CBD by itself is not sedativewhat it does do is help calm a busy, racing mind, says founder Sarah Polansky. If you need assistance in making your mind and body tired, then CBN is what you will want to take. Good Night features a blend of adaptogens, MCT oil, and terpenes with 300 milligrams of full-spectrum CBD and 10 milligrams of CBNenough to help you doze off, but not so much that you get a cannabis hangover the next morning, Polansky says.

[Photo: courtesy THE WELL]The Well Relax BundleWhether you believe in the power of aromatherapy or just like the scent of lavender, the Wells Relax self-care bundle is an excellent way to wind down at the end of a long day. Staff editor Lara Sorokanich says: Before I get into bed, I spray this all over my pillows and sheets. It feels so luxurious and relaxing to get into a lavender-scented bed. Clinically backed or not, the smell definitely makes me feel happy as Im dozing off.

[Photo: courtesy Oura]Oura RingWhile the Oura Ring might not put you into a deep sleep, it can certainly tell you what happens once you get there. Slip this unintrusive smart band onto your finger to track health progress throughout the day and night; it monitors everything from step count to sleep quality. By automatically measuring your sleep balance against your daily activities via the accompanying Oura app, you can be one step closer to determining daytime habits (looking at you, afternoon coffee) that keep you up at night.

[Photo: courtesy Dohm]Dohm Natural Sound MachinesWhite noise is a city dwellers best friend. The dull hum of a sound machine can help drown out disruptions like construction during the day or noisy neighbors at night without adding to the chaos. The mechanical whirling of white noise works by creating a higher-volume baseline, meaning loud, jarring noises dont make you jump. We like these simple, space-conscious Dohm sound machines that enhance an atmosphere with gentle sleep-inducing noise and sleek, inoffensive design.

[Photo: courtesy The Nue Co.]The Nue Co. Sleep DropsPlant-driven supplement brand the Nue Co.s Sleep Suite includes a tincture, capsules, and a magnesium spray thats absorbed through the skin and can be taken individually or in tandem to best tackle your level of restlessness. My approach to a good nights sleep is to relax and unwind, limiting any screen usage an hour before bed and following the same nightly routine, says Jules Miller, founder and CEO of the Nue Co. I use our Magnesium Ease spray on my joints and stomach. Half an hour before bed, I place 12 Sleep Drops under my tongue to help me to fall asleep. I also like to ensure that the room is in complete darkness to minimize any disruption caused by light.

[Photo: courtesy Uncommon Goods]Moon Beam Sleep AidThis clever, flat disc acts as a sleep-inducing metronome, projecting gentle pulses of blue light onto your ceiling for 8 or 20 minutes. Moon Beams process has a dual purpose: calming your busy mind through distraction and slowing down your breathing and metabolism, readying your body for sleep. Users inhale and exhale in time with the dimming and brightening of the blue glow, eventually drifting from 11 breaths per minute to 6.

[Photo: courtesy Bearaby]Bearaby Cotton NapperWe love the deliciously heavy comfort of the chunky knit Bearaby Cotton Napper. The hype of weighted blankets comes from studies that found the all-encompassing pressure can help release serotonin in the body while reducing the stress hormone cortisol. But unlike fellow weighted blankets on the market, Bearabys beautiful, sustainable throws get their heft from thick woven cord that also serves as a mechanism to keep sleepers from getting sweaty.

[Photo: courtesy Riley Home]RileyReversible Flannel Sheet SetThese cotton flannel sheets from Riley are thick and plush, but breathable enough for those who sleep hot. While perfect sleep temperature is subjective, a layer of lightweight warmth can keep you comfortable all night long in chillier months.

[Photo: courtesy Brooklinen]Brooklinen Mulberry Silk Eye MaskDont underestimate the power of a pitch-black room. While blackout curtains certainly help, the glow of charging electronics and late-night rumblings of my partner and cat can shake me out of a deep sleep in an instant. As far as simple solutions go, a sleep mask makes a huge difference by minimizing disruptions. Even better if its made of luxurious silk, like this one from Brooklinen, that doesnt tug my skin and lashes through a night of tossing and turning.

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The best products and tips for getting a better night's sleep - Fast Company

When a little bit of poison is good for you: Inside the theory of dose response – Salon

"For if one drinks much from a bottle marked 'poison,'it's almost certain to disagree with one sooner or later."Lewis Carroll, "Alice's Adventures in Wonderland"

In the early 16th century, a Swiss physician named Paracelsus changed the course of the healing arts with his theories on chemical treatments for disease. A literal renaissance man given the era, he was part scientist, part alchemist, and part philosopher. Three hundred years before the advent of Pasteur's germ theory, Paracelsus advised patients to keep their wounds clean to avoid infection. His study of chemicals revealed both their curative and harmful properties, and he noted that any treatment turns toxic once the dose is high enough. Paracelsus' simple yet profound insight that "the dose makes the poison" challenged the prevailing wisdom that poisons were inherently toxic. He noted that the known poisons of the day were substances that were toxic at low-doses. Yet, dilute these substances enough and they could be rendered harmless or, in some cases, even beneficial.

This theory is now known as dose response. It has become one of the key frameworks of environmental science, modern medicine, and public health. Put simply, it states that the larger the dose of a chemical or exposure, the greater the magnitude of its effect. Thus, low doses of a toxin can have zero to minimal effect, while large doses become deadly. For therapeutic chemicals, or "drugs," benefits initially rise with increasing doses before crossing a threshold toward toxicity, or overdose.

In modern medicine, dose response theory is foundational for both toxicology and pharmacology, and also carries over to the worlds of microbiology, virology, and oncology. Although in each scenario, the theory is labelled "dose response," its application differs according to the properties of the substance. In recent months, for example, dose response has been hotly debated alongside speculation on the exposure risk of COVID-19. What is the potential for virus exposure via the groceries you buy? What about the mail delivered to your home? Could you get sick from takeout food? The answer lies in the question: how much 'dose' is required to get ill?

A brief history ofdose response theory

For many chemical substances, the dose response theory of toxicity depends on five important variables that predict a subject's response to an exposure:

If you plot the administered dose of a substance versus its effect on a living organism, you often get a "dose response" curve that typically resembles the letter 'S'.

As you can see in the curve, low level exposures may have no effect on an organism up to a certain threshold. For example, many adults are familiar with the toxic effects of drinking alcohol just ask any college student how they feel on Sunday morning. Ripe bananas also contain trace amounts of alcohol, but few individuals eat a banana and worry about their ability to drive home. While a certain dose of alcohol causes intoxication, it has no harmful effect beneath its toxic threshold. As intoxication rises past a second threshold, its effect turns deadly.

Poisons and the canary in the coal mine

The "canary in a coal mine"is a well-known idiom that has a historical antecedent. In the early 20th century, miners brought captive birds with them into the mine shafts. The humble canary would fall dead as a result of increasing toxins particularly carbon monoxide in the air. Being a small creature with rapid respiration and a fast metabolism, toxins accumulate in a bird's system much faster than they would in larger animals. Thus, the miners received advanced warning of an exposure of which they would otherwise be unaware. In other words, the canary had a lower dose response threshhold than humans.

Animals that are prone to showing toxic effects and serve as harbingers of environmental degradation have come to be known as "sentinel species." Cats are susceptible to mercury poisoning, crayfish to water pollution, and bees to air pollution. Even in antiquity, people recognized that when the plague arrived, the rats were the first to die.

The dose also makes the medicine

If the dose makes the poison, it also makes the medicine. For medicines, small doses will have minimal to no effect. Larger doses begin to demonstrate their beneficial effect above a threshold often referred to by clinicians as the "effective" or "therapeutic" dose. Increasing doses from this threshold increases the magnitude of the therapeutic effect up until it approaches toxic levels. This range is known as the therapeutic window.

Acetaminophen, for example, is safely metabolized by liver enzymes within its therapeutic window. Metabolism is a multi-stage process that, at an intermediate stage, generates a toxic metabolite known as N-acetyl-p-benzoquinone imine (NAPQI). If a person has chronic liver disease, or if they take too much of the drug, NAPQI accumulates in their bloodstream and eventually causes permanent liver failure.

Over several centuries, medical researchers have used a process of trial and error to find therapeutic functions of substances long regarded as toxins. The bark, leaves, and seeds of the yew tree (Taxus baccata) have been known to be poisonous for centuries. The witches' brew from Shakespeare's "Macbeth" even cited "slips of yew, silvered in the moon's eclipse" as a main ingredient. Yet, the compound Paclitaxel, derived from the same plant, treats opportunistic infections in AIDS patients as well as a variety of cancers.

For cancer chemotherapy treatments in particular, one must walk a fine line, using the toxicity of a substance to preferentially destroy cancer cells without killing the patient. In this way, tumors are similar to sentinel species. The rapid rate of cellular metabolism that makes cancer cells dangerous also makes them susceptible to toxic exposures as they more quickly incorporate the dose. Cancer treatments then exploit the differential uptake of chemotherapy between healthy and tumor cells to deliver a targeted dose.

Is dose response theory always right?

Paracelsus' doctrine may have been profound, but does that mean it is universally correct? There are at least four cases that complicate dose-response theory as succinctly stated by Paracelsus:

Carcinogens. It is generally believed that there is no "safe" dose for exposure to cancer causing agents and hence, carcinogens are inherently poisonous. Although the likelihood of cancer increases with the exposure dose, a single mutation to a single DNA base pair can be enough to result in cancer.

A cancerous cell, through its uncontrolled growth, escalates its own dose. The seemingly harmless single cancer cell divides to give rise to two such cells, then four, then eight, triggering a geometric expansion towards a cancerous tumor.

Even this line of reasoning however, is disputed by additional nuance. Communities that live at high altitudes are exposed to greater levels of cosmic radiation. Assuming a linear relationship between carcinogen dose (UV radiation) and cancer even at low doses, one would expect these communities to demonstrate higher rates of certain cancers. Yet, no such evidence exists to reveal this expected cancer cluster. This has led to the hypothesis that low-doses of radiation stimulate mechanisms in the body that serve to repair DNA damage. The body's mechanism for culling dead or dangerous cells may effectively limit these micro dose exposures before they give rise to cancerous masses.

Bioaccumulators. In 1958, after noting rising mortality in birds of prey following the widespread spraying of insecticide in New England, conservation biologist Rachel Carson identified the agricultural pesticide DDT as the highly toxic culprit. This finding was published in her influential book Silent Spring. Because raptors were at the top of the food pyramid, the fish they preyed on had in turn eaten smaller fish, which had nibbled on plants contaminated by runoff. At each level of the feeding chain, DDT levels became further concentrated in the organism.

This process, known as "bioaccumulation," arises from the fact that some toxins cannot be metabolized or excreted, and thus become increasingly concentrated up the food chain. Consequently, although there may be a safe dose for a single exposure, bioaccumulation results in the exposure becoming more pronounced over time until a harmful dose is reached. Applying this principle of bioaccumulation to people, particularly those who eat meat and are, therefore, exposed to higher accumulated doses, led to the wide-scale ban of DDT in the US and other high-income countries.

Endocrine Disruptors. Compounds that disrupt the human endocrine system are another example where the apparent simplicity of the dose response curve begins to break down. Endocrine disruptors are chemicals that are similar in structure to the hormones circulating in the human body. Hormone imbalances can have dire health consequences, particularly for the human fetus. Fetal exposure to a microdose of a certain sex hormone can lead to the malformation of sex organs, while the same dose exposure would have zero impact on an adult. Even stranger, the dose response curve for endocrine disruptors may be "non-monotonic" that is, not show a consistent relationship between increasing dose and increasing effect. Small doses may yield significant effects, medium doses may have no effect, and high doses again may show an effect. Any number of puzzling curves have been proposed by toxicologists and researchers in order to explain these phenomena. They all call into question the dose response relationship conceived of by Paracelsus.

Viruses and bacteria. Like cancer, viruses and bacteria have the innate capability to escalate their own dose. A single viral particle that infects a host cell can make millions of copies of itself. This implies that, in theory, there is no lower limit or no truly safe dose. Yet, like cancers, we also do not typically see this play out. Some noroviruses may cause an infection in 50% of people exposed to as low a dose as 20 viral particles. Meanwhile, other viruses and bacteria may be harmless, or in some cases symbiotic, at much higher numbers. The human gut, for example, is a celebration of the therapeutic benefit of many bacteria and even some viruses that work to maintain the body's homeostasis.

What about for the novel coronavirus?

Studies of swab samples demonstrate that New York subways are populated by all manner of viruses and microbes, including everything from anthrax to the plague. And yet exposure of millions of subway riders to these pathogens do not lead to clinical cases of exotic diseases. Similarly, more and more evidence suggests handling a bag of groceries with traces of SARS-CoV-2 virus is not going to make most people sick.

Although in theory there may be no safe dose, as a practical matter, many humans are quite resilient to all kinds of exposures. Recent evidence demonstrates that wearing masks protects wearers by reducing the exposure dose of COVID-19.

Of course, some of us may be the proverbial 'canary in the coal mine' for certain exposures based on our increased susceptibility to the disease. And in the case of many chemicals on the market today, we are all canaries in the coal mine. The experiment, as it were, is ongoing.

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Broken heart syndrome is real here’s how physical and emotional stress can affect your heart – Insider – INSIDER

A broken heart may conjure up bittersweet stories and love songs but experiencing a traumatic event may actually cause cardiac consequences.

Broken heart syndrome, also known as Takotsubo cardiomyopathy, occurs when someone experiences sudden and acute physical or emotional stress, which can rapidly weaken the heart's left ventricle.

Here's what you need to know about the causes, symptoms, and treatment for broken heart syndrome.

Broken heart syndrome, which was first described in Japan during the 1990s, is a condition where the left ventricle the heart's primary pumping chamber balloons out, while the base of the heart contracts. This may be dangerous because it negatively impacts the heart's ability to pump blood properly.

Conversely, a heart attack happens when blood flow, which brings oxygen to the heart, is restricted or entirely cut off. Although heart attacks and Takotsubo cardiomyopathy are both types of muscle heart failure that can cause similar symptoms, there are some key differences worth noting.

According to Jay Woody, MD, an emergency medicine physician and chief medical officer of Intuitive Health, heart attacks are often caused by blockage from fatty build-up known as plaque in the wall of the arteries which can lead to a clot in the blood vessel that impedes blood flow to the heart muscle. Takotsubo cardiomyopathy, meanwhile, is triggered by a severe emotional or physical response that affects the heart muscle directly.

Broken heart syndrome can set in even if you're otherwise healthy, according to the American Heart Association, which is why it's important to understand the causes and symptoms.

According to Woody, the name "broken heart syndrome" refers to the fact that the condition can be brought on by emotionally traumatic events that negatively impact the physical heart.

He says the most common example of a stressor that can lead to this condition is grief from losing a loved one but notes that intense feelings of fear, anger, surprise, and other emotions can also be a trigger.

Some other events that might cause this condition include:

A 2020 study discovered an uptick in patients diagnosed with Takotsubo cardiomyopathy since the coronavirus outbreak reaching 7.8% compared to 1.7% before the COVID-19 pandemic. Additionally, patients with this condition during the pandemic were found to have a longer hospital stay than those hospitalized pre-pandemic.

Researchers noted that the COVID-19 pandemic has added multiple layers of stress into people's lives not only are many dealing with economic changes, emotional issues, loneliness, and isolation, but they're also grappling with constant concerns about themselves or their loved ones becoming ill. They concluded that this additional stress can have physical effects, as evidenced by the increasing diagnoses of Takotsubo cardiomyopathy.

Broken heart syndrome can also be caused by physical stressors, including:

Even positive events, like walking into a surprise party or winning the lottery, can bring on Takotsubo cardiomyopathy.

"Regardless of the cause of stress, the body's response is similar: to secrete a large amount of the stress hormone adrenaline," says Jennifer Haythe, MD, a critical care cardiologist at Columbia University Center. "In some instances, this can lead to Takotsubo cardiomyopathy, which can mimic a heart attack."

While Takotsubo cardiomyopathy is seen in men and younger women, a 2015 study found that a staggering 89.8% of cases occurred in women between the ages of 58 and 75. The most common triggers were found to be physical (36%), followed by emotional shock (27.7%). Notably, a trigger could not be found in 28.5% of patients. The study also revealed that patients with Takotsubo cardiomyopathy were almost twice as likely as those with acute coronary syndrome (such as heart attack) to have a psychiatric or neurological disorder.

"Patients who have broken heart syndrome may experience chest pain, shortness of breath, and low blood pressure very shortly after an extremely stressful event," says Woody.

According to Johns Hopkins Medicine and the American Heart Association, other symptoms and signs of Takotsubo cardiomyopathy include:

These symptoms may set in anywhere from minutes to hours after someone has gone through a physically or emotionally stressful event.

"Some people describe it as feeling like an elephant is sitting on their chest," says Haythe. "Sweating, jaw pain, left arm pain, nausea, vomiting, lightheadedness, palpitations, and mid-epigastric discomfort are all possible symptoms as well."

If you feel any new symptoms in your chest, or have crushing chest pain or shortness of breath, experts urge you to seek medical attention immediately.

"Heart attacks have similar symptoms as broken heart syndrome, so it's important to get a diagnosis because heart attacks can be fatal," says Woody.

When a patient experiences symptoms similar to broken heart syndrome, medical professionals will typically rely on imaging studies, blood tests, and cardiac biomarkers to observe any potential abnormalities before making an official diagnosis.

Woody says that clinicians often use a cardiac MRI or administer an echocardiogram (cardiac ultrasound) that determines whether or not there is ballooning in the left ventricle, thus signifying Takotsubo cardiomyopathy. They may also use coronary angiograms, a procedure that uses X-ray imaging, to rule out a heart attack.

While it can take up to two to three months to recover after a heart attack, Woody says a person will typically recover from broken heart syndrome within one to six weeks, making a full recovery within one to two months.

A 2015 study revealed that the rate of death for patients with Takotsubo cardiomyopathy was 5.6% per year. While death is rare, heart failure occurs in roughly 20% of patients.

Treatment for broken heart syndrome will depend largely on which symptoms the patient is experiencing, and that, according to Woody, will dictate the severity of the condition. He states that clinicians will often recommend medications like beta-blockers, ACE inhibitors, and diuretics. They may also give aspirin to patients who show plaque buildup in their artery walls.

Beta-blockers and ACE inhibitors can be effective in reducing the effects of stress hormones, thereby helping to prevent a recurrence. Meditation and exercise are also proven to be effective strategies for reducing stress, which may play a role in triggering the disorder.

Some of the complications that can result from broken heart syndrome, according to Woody, include fluid in the lungs, or irregular heartbeat. Obstruction of blood flow from the left ventricle, and rupture of the ventricle wall, are also possible, though rare.

"Symptoms can be treated effectively by medical professionals and are usually not long-lasting," he adds. "Broken heart syndrome can be dangerous, but the condition improves rapidly, which means patients with a naturally strong heart shouldn't experience lasting effects."

Broken heart syndrome can be brought on by both physical and emotional stressors. The most common signs of this condition are chest pain and shortness of breath and you can experience these symptoms regardless of whether or not you have any history of heart disease .

Although broken heart syndrome is short-term and easily treatable, Woody says it's still important to seek medical support to prevent it from causing lasting heart damage, which can lead to other symptoms.

Haythe says that people who have experienced one episode of Takotsubo cardiomyopathy are at risk for a recurrence. However, with quick recognition, exclusion of other causes, and proper treatment, she says this condition has an "excellent prognosis," with most patients making a complete recovery.

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I’m a doctor who tried to plan an extremely safe Thanksgiving for 3 people. It wasn’t worth the scare it put u – Business Insider India

I'm a physician in Boston, and I've been obsessed with the coronavirus pandemic since the first stories trickled out of China into my consciousness. Every day I listen to podcasts and medical lectures by a long line of virologists, epidemiologists, and infectious-disease doctors. Every week, I write an essay for my friends and family in my area about what we've learned about COVID-19 and how to protect ourselves.

My sons - Mackenzie, 24, and Cooper, 21 - live nearby and have been what I call "COVID-conscious" since the start. Both kids work and study from their apartments, have small friend pods, have excellent COVID-19 hygiene, particularly with me and anyone who falls into a high-risk group, and both had stayed mostly bubbled at home the previous two weeks.

In fact, we were masked except when actively putting food in our mouths, pulling our masks back up into place between servings and when chatting during the meal.

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But then on Saturday morning, while I was walking with a friend, Kenzie texted me saying, "Sooooo, I have bad news." Half a minute later he sent a second text that read, "I feel horrible."

Read more: COVID-19 threatens to create a 'lockdown generation' in Europe: Here's why young people could be the ones paying for yet another crisis

All I could think was, "Why, why, why didn't we just skip Thanksgiving this year? And now it's too late to stop whatever tsunami is coming our way."

This is exactly how COVID-19 spreads: A person, like my beloved son, can have it, be contagious, but have no symptoms at all, not a single clue, for several days before getting sick.

This is why we were so meticulously careful about our Thanksgiving. We knew it was possible one of us could be that asymptomatic contagious person - not likely, not even probable. Kenzie has five friends in his bubble. All had been tested the week before for travel and were negative. All have been tested since and stayed negative, and all were asymptomatic. He had shopped, carefully, at only a couple of large stores.

And as it turned out, the precautions we did have in place worked. Cooper and I are COVID-19 negative. And Kenzie had a rough week but is getting better. We're all getting better.

Was it worth it to have Kenzie feel immense guilt about potentially exposing us? Was it worth the discomfort of having to tell his contacts they needed to be tested and then go into 10 days of quarantine?

And Christmas in 2020?

No possible way. Not a bit. Not a chance.

This story originally appeared on Schoenthaler's Facebook page and on The Boston Globe website. It has been republished with permission.

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I'm a doctor who tried to plan an extremely safe Thanksgiving for 3 people. It wasn't worth the scare it put u - Business Insider India

Tips for staying healthy and managing stress over the holidays – WYDaily

Feeling stressed out around the holidays? These tips might help. (WYDaily/ Courtesy of Unsplash)

As we head into the holidays, W&M News spoke with Dr. Elizabeth De Falcon to learn about ways relieve stress and practice self-care over winter break, to strengthen our collective immune systems. Dr. De Falcon is a practicing physician with William & Marys Health Services. She is a licensed pediatrician and Fellow of the American Academy of Pediatrics.

In the simplest terms, stress is just your bodys reaction to any change that requires response. So, it could be anything: a mental strain, a physical strain or even an emotional strain. Honestly, its different for every person. What stresses me out may not stress you out, but if were talking about physiology, then our stress response would be mostly the same.

Without going into the specific names of all the different parts of your brain, its just that your brain perceives stress or danger or threat. Then it sends out a signal from what is essentially the command center of your brain to the rest of your body, through the nervous system. Then the nervous system starts acting on a fight or flight response and all these different neurotransmitters and hormones get released. All these different substances start flowing through your body just to get you prepared to respond to that stressor.

A lot of times, youre not even aware of it. Most of the time the threat comes and goes, and as the threat goes away, the stress response decreases. Think of a car whizzing past you on the street. Its stressful for a second, but the feeling is very short-lived. Its important to understand that not all stress is bad. It serves an important biological purpose. The stress response has been vital to our survival and evolution. When the saber-toothed tigers were hunting us down, our bodies learned how to respond to that.

If you translate that to now, lets say youre taking a test and you feel a little bit stressed. Youre supposed to have a certain level of stress, because its your bodys way of motivating you to focus on something important. After the test is done, theres this sigh of relief because that stress is gone and your body just goes back to a kind of homeostasis where its feeling ok.

But sometimes that stress hangs around for a little while. Thats when you start running into problems. You may find that even though the threat is gone, youre not feeling better. You may be experiencing increased heart rate and breathing or generally feeling edgy all the time. Thats a sign that youre bumping over into a low-level, acute stress or chronic stress state.

Thats when we start to think about cortisol. Youve probably heard about cortisol as a stress hormone. In the moment, it actually helps your body boost its immune system and decrease inflammation, but if its there for a long time, then you start to get into different problems.

I always tell people to seek medical help if they start seeing signs of chronic stress. Some of the red flags would be that you feel in a low mood all the time. You may stop hanging out with your friends or your family. Youre just kind of retreating and not interested in the things you used to be interested in. You may be sleeping too much or too little. Some people experience physical symptoms. They have an upset stomach or heartburn or headaches, because their blood pressure is up. They might feel a knot in their chest. All of those things could be signs that youre experiencing anxiety, so you would definitely want to see your doctor at that point.

It comes down to the basics of general healthy living. For example, if youve not been on a good sleep schedule over the semester, you really need to prioritize getting on a healthy sleep scheduleand make it a realistic schedule that you can keep doing once we get back on campus. If you were not addressing your dietary needs during the semester, start to incorporate healthy, nutrient-dense types of foods into your diet.

Also, exercise is super important. Just from a perspective of improving your cardiovascular health and improving your circulation, regular exercise will help get all those immune cells pumped around your body. You dont want to smoke and try to minimize your alcohol intake.

Then, of course, what weve all been focused on over these last nine month is taking steps to minimize infections. So, being very diligent about washing your hands, keeping your distance from pretty much anyone who doesnt live in your house, and wearing a mask if you have to go out and about.

When you have a healthy immune system, when its functional, you dont even know its there. Its protecting you from things that are trying to kill you, viruses and bacterial infections, but you arent even aware of it.

But just like a car runs out of gas when left idling, if you are not fully addressing the things that boost your immune system, eventually that car will run out of gas and then that leads to a whole host of problems. You might start noticing that youre getting more colds or struggling to get over minor illnesses. Thats really just because when your stress response is revved up all the time, it has the opposite effect on your health and it starts down-regulating your immune system.

This is something I always recommend to my patients: practice gratitude. Its such a simple, easy thing that anyone can do. It doesnt have to be complicated. Just get a little notebook, or even make mental notes, and focus on three things that youre grateful for in a day. No matter how crummy the day is, theres always something that we can find that we can be grateful for.

Studies show that if you practice gratitude, there are positive changes in your brain that actually change your outlook on things. Along those lines, theWellness Centerhas all kinds of wonderful mindfulness, meditation and exercise resources available online. They make it really easy to access, so Id also recommend trying out some of those offerings.

Adrienne Berard is a research communications specialist at William & Mary News and this story was published on Dec. 18.

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Tips for staying healthy and managing stress over the holidays - WYDaily

5 tips to get thicker hair and common causes of hair loss or thinning – Insider – INSIDER

There is no proven way to permanently thicken hair if you are healthy and have no underlying health conditions. But, there are lifestyle adjustments to improve your overall hair health and prevent breakage.

Here are common causes of thin hair and five tips for healthier, thicker hair.

The causes of thin hair include:

If you are concerned about frequent hair loss, reach out to a dermatologist, says Sara Wasserbauer, MD, a hair restoration surgeon and President of the Board of Directors for the American Board of Hair Restoration Surgery.

"The earlier someone starts therapies, the more likely they are to be effective," Wasserbauer says. "If you are losing more than 100 hairs per day, or if your hair is less thick when you run your hand through it, it is worth seeing a hair expert."

A doctor can determine if you can treat thin hair without medical intervention, or if it is a sign of alopecia a more severe condition in which hair falls out in patches or causes balding.

If your hair loss is not due to an underlying health condition, you may be able to thicken your hair with the following lifestyle changes:

A nutritious diet is critical to hair health, says Sanusi Umar, MD, CEO and medical director of Dr. U Skin and Hair Clinic in Manhattan Beach, California. This is because adequate nutrition ensures hair follicles construct hair shafts of normal thickness.

According to Umar, certain nutrients are essential to the thickness and growth of hair, like:

Cortisol, the stress hormone, disrupts the functioning of the hair follicle and contributes to thinning hair. A 2016 study found high levels of cortisol can cause certain proteins in hair to break down.

It is important to differentiate between different types of stress, Wasserbauer says. If you experience a stressful event, you may notice a period of hair loss and accelerated thinning, but the hair usually recovers within a year. Ongoing hair loss is more serious, and unless it is caught, diagnosed, and treated, it may result in permanent loss.

If you're concerned stress may be causing hair thinning, you can alleviate stress and lower cortisol levels by:

A hormone imbalance, such as during pregnancy or menopause, can cause thinning hair. A decrease in estrogen or an increase in testosterone levels can thin hair as well, Umar says.

Research found an imbalance of hormones like estrogen, progesterone, and prolactin can all contribute to hair loss. Hair loss can also be due to an imbalance of thyroid hormones, Umar says.

Signs of a hormone imbalance, like a thyroid condition, include:

If you think a hormone imbalance may be causing thin hair, reach out to your doctor, Umar says. A primary care physician may refer you to a dermatologist, who specializes in skin and hair, or an endocrinologist who specializes in hormonal imbalances.

Heat styling products, like blow dryers, straighteners, and curling irons all weaken the hair shaft and fiber, Umar says. These products damage the cuticle on the outer layer of the hair, especially if the heat setting is set too high or you use a heating product daily.

"Using heating styling products excessively can cause breakage and cause the scalp to become stressed thus leading to thinning hair," Umar says.

A 2004 study found using a curling iron causes hair to weaken and break, though hair treated with a conditioner showed less damage than hair that was not.

Another 2011 study found using a blowdryer caused more surface damage to hair than natural drying, but how you use a blowdryer matters. For instance, the study found blow drying hair at a distance of 15 cm with continuous motion caused less damage than letting hair air dry or using a hair dryer without motion very close to your hair.

If you use heat styling products regularly and have noticed your hair thinning, try reducing how often you use these products. To prevent damage, you should also limit other treatments, like hair dye, bleach, and chemical treatments.

Sulfates are chemicals found in most shampoos and soaps that provide the "sudsy" effect when you lather them up.

Sulfates also strip hair of its natural oils and moisture, Umar says, causing it to become dry and brittle, which makes it break more easily.

However, switching to a sulfate-free shampoo won't stop hair loss, Umar says. Using a sulfate-free shampoo can help preserve the natural oils in your hair, reduce irritation, and potentially prevent future damage, like hair breakage.

If you have no underlying health conditions causing hair loss, there is no proven way to thicken your hair. However, you can improve overall hair health by eating a nutritious diet, limiting heat styling, and using a sulfate-free shampoo. Healthier hair means less damage and breakage, which can help hair grow longer and thicker.

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How to Break a Sugar Addiction | INTEGRIS – Integris

Those cookies you smell at the holidays, the ice cream that makes your eyes light up in the summertime and the candy jar full of tempting chocolates all have one thing in common they're loaded with sugar.

There's something about sugar that speaks to your brain, evoking feelings of happiness with each bite of food or each sip of your favorite sugary drink you consume. It's part nostalgia and part chemical reaction. The more you eat, the more you crave, which can lead you down a road of long-term health problems.

We're here to discuss what makes sugar so habit-inducing, how you can kick your cravings and which foods you can substitute to please your sweet tooth.

What's wrong with sugar, you ask? Everything. Outside of making things taste better, sugar has no nutritional value and is full of empty calories. These calories can create weight problems and, in turn, heighten your risk of heart disease and stroke.

That's only the physical downside. The psychological component is real, too. Sugar releases dopamine and can increase serotonin production, a hormone that can boost your mood.

In reality, sugar isn't any different than comfort food or a satisfying fast food meal loaded with simple carbohydrates. These carbohydrates are high on the glycemic index, meaning it takes less time to turn them into glucose. During this quicker digestion process, you may feel good in the short term, but hunger will quickly set in since sugary foods lack nutrients and leave you unsatisfied.

It can turn into a vicious cycle. At first, the sugar you eat tastes good, bringing on a "high" when your brain initiates the dopamine release. Then, the sugar causes your insulin levels to increase, leading to a drop in blood sugar levels. As your blood sugar falls, your appetite and hunger levels increase. Your body then craves sugar again to fix any hunger deficiencies or feelings of unease, even if the fix is only temporary.

According to the American Heart Association, eight out of 10 adults are trying to lower their sugar intake. On average, adults consume around 77 grams of sugar a day. That equals about 60 pounds of sugar over the course of a year. Imagine lugging around a dozen five-pound sacks of sugar. That's what you're putting in your body!

If you're determined to kick your sugar habit, it's OK to stop cold turkey. The Mayo Clinic recommends taking a two-week break from sugar to reset your body. This doesn't have to be an outright cleanse, but try to limit yourself to foods with little to no added sugars or sweeteners shoot for less than 5 grams of added sugars per serving.

Start by cutting out sugary drinks. They are the biggest culprit, accounting for almost half of the added sugars Americans consume. A 12-ounce can of soda can contain as much as 10 teaspoons of sugar. Think of it this way: The American Heart Association recommends men eat only nine teaspoons of added sugar each day, while women and children should consume six teaspoons. Just like that, you can exceed your daily sugar allotment in five or six gulps of your favorite soda.

The spoonfuls and spoonfuls of sugar in soda explain why there are so many calories in a drink the size of your hand. There are four calories in a gram, so a soda containing 40 grams of sugar has 160 calories. It's easy to see how calories add up when that 12-ounce soda turns into a 44-ounce drink at your favorite fast food restaurant.

You should also stay away from any baked goods, desserts and candy. Cereals, even the so-called "healthier" options, still have added sugars that can creep up on you. Then there are unassuming foods, such as pizza or pasta sauces, that you wouldn't normally associate with having added sugars. A half-cup of a store-bought marinara sauce contains anywhere from 2 to 4 grams of added sugar, which amounts to a teaspoon.

As a general rule, look for words that end in "ose" sucrose, fructose, glucose, maltose, lactose or dextrose. This is an easy indicator to spot added sugars. Don't let ingredients that sound better for you fool you, either. Honey, agave, maple syrup, brown rice syrup and juice concentrate are still added sugars.

Now that you've reduced your sugar intake, what comes next? For starters, introduce more whole foods whole grains, fruits, vegetables and lean meats to your diet. Many fruits and vegetables still contain natural sugars, but the starch and fiber in these foods slows the digestion process and leaves you feeling more full. You can learn more by reading our blog post on healthy carbs.

Eating fruit for an after-dinner snack can satisfy your cravings for sugar without leaving you feeling like you've cheated. Certain fruits, such as grapes and bananas, have high sugar contents. Berries are generally a low-sugar choice, so sneak some blueberries, raspberries or blackberries into your yogurt or oatmeal.

Ditching sugary drinks isn't easy, but try swapping them for water or sparkling water. Better yet, try flavored sparkling water. The carbonation will mimic the fizz from soda without the added sugar or calories. For more on sparkling water, check out our blog post on carbonated drinks.

When making food selections at the grocery store, be wary of hidden sugars that are often added to low-fat products. Things with fat tend to have flavor, so removing fat from products can leave them bland. Food manufacturers add sugars back into products to make them more enjoyable. Any benefit you think you're getting from a product with less fat may be just as bad for you if it's loaded with additives or sugars.

It's important to remember correcting bad sugar habits doesn't mean an outright boycott of sweet foods. Instead, take control by adding small amounts of sugar. For example, drizzle a small amount of honey on your yogurt to treat yourself. It's better than the alternative, which is pre-packaged flavored yogurts loaded with added sugar.

If you place an order at your local coffee shop, it's no longer a question of if you want cream or sugar added. Artificial sweetenersare just as popular of an option nowadays to help curb sugar habits.

These synthetic sugar substitutes received a bad reputation years ago for their link to cancer, but subsequent studies haven't found a clear connection to causing cancer in humans, according to the National Cancer Institute.

With those concerns out of the way for now, the FDA has approved five artificial sweeteners for use: aspartame (Equal), acesulfame-K (Sweet One), neotame, saccharin (Sweet'N Low) and sucralose (Splenda).

But just because the FDA approves their use doesn't mean you should swap sugar for artificial sweeteners and keep the same diet. Artificial sweeteners can temporarily help by weaning you off added sugars, but long-term use could play a role in how you view foods.

Think of artificial sweeteners as a concentrated version without the calories a little goes a long way. According to Harvard Health, the sweetness from artificial additives can make you more likely to develop a sweet tooth and crave sweets even more. Plus, the psychological component can alter the way you think. For example, if you tell yourself you're saving calories by drinking a diet soda instead of a regular soda, you may be more inclined to eat cake for dessert. In this case, you cancel out any benefits of drinking a diet soda with something full of added sugars.

Before you make any dietary changes or consider cutting sugar from your daily routine, connect with an INTEGRIS Health primary care physicianto learn more about how to implement changes.

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How to Break a Sugar Addiction | INTEGRIS - Integris

5 tips to get thicker hair and common causes of hair loss or thinning – Business Insider India

There is no proven way to permanently thicken hair if you are healthy and have no underlying health conditions. But, there are lifestyle adjustments to improve your overall hair health and prevent breakage.

Here are common causes of thin hair and five tips for healthier, thicker hair.

"The earlier someone starts therapies, the more likely they are to be effective," Wasserbauer says. "If you are losing more than 100 hairs per day, or if your hair is less thick when you run your hand through it, it is worth seeing a hair expert."

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If your hair loss is not due to an underlying health condition, you may be able to thicken your hair with the following lifestyle changes:

Cortisol, the stress hormone, disrupts the functioning of the hair follicle and contributes to thinning hair. A 2016 study found high levels of cortisol can cause certain proteins in hair to break down.

It is important to differentiate between different types of stress, Wasserbauer says. If you experience a stressful event, you may notice a period of hair loss and accelerated thinning, but the hair usually recovers within a year. Ongoing hair loss is more serious, and unless it is caught, diagnosed, and treated, it may result in permanent loss.

A hormone imbalance, such as during pregnancy or menopause, can cause thinning hair. A decrease in estrogen or an increase in testosterone levels can thin hair as well, Umar says.

Research found an imbalance of hormones like estrogen, progesterone, and prolactin can all contribute to hair loss. Hair loss can also be due to an imbalance of thyroid hormones, Umar says.

Heat styling products, like blow dryers, straighteners, and curling irons all weaken the hair shaft and fiber, Umar says. These products damage the cuticle on the outer layer of the hair, especially if the heat setting is set too high or you use a heating product daily.

A 2004 study found using a curling iron causes hair to weaken and break, though hair treated with a conditioner showed less damage than hair that was not.

Sulfates are chemicals found in most shampoos and soaps that provide the "sudsy" effect when you lather them up.

Sulfates also strip hair of its natural oils and moisture, Umar says, causing it to become dry and brittle, which makes it break more easily.

If you have no underlying health conditions causing hair loss, there is no proven way to thicken your hair. However, you can improve overall hair health by eating a nutritious diet, limiting heat styling, and using a sulfate-free shampoo. Healthier hair means less damage and breakage, which can help hair grow longer and thicker.

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5 tips to get thicker hair and common causes of hair loss or thinning - Business Insider India

A late period: things that might happen to your body – Omega Underground

Menstruation or monthly period is the most familiar phenomenon of a female body going through the reproductive age. At a particular time of each month, our uterus sheds off the ovarys unfertilized egg and all other residual chemical and biological waste materials. Usually, every healthy female has a menstrual cycle of twenty days, and it lasts for three to seven days. The time may come forward or halt for two to five days due to normal physiological conditions. But, if it exceeds more than a week or goes over a month, there is a reason to worry. What do you think first when you miss a period date? Most appropriately, a married female will think about pregnancy. Pregnancy causes a physiological halt of the menstrual cycle for nine months. But, other than that, there several more reasons for a . Here in this article, we will focus on some critical health conditions that may cause delayed menstruation in females. These conditions require immediate physicians attention.

Pregnancy

We already mentioned earlier that if your cycle is one or two days different from the last process, it is not a menstruation delay. But, some legit health conditions push the menstruation future later. For example, suspected pregnancy is one of the most common causes. If you are a married or sexually active female and miss more than seven days after the expected menstruation date, there is a good chance of pregnancy. You may complete the strip test to detect pregnancy at home. But, these procedures do not give accurate results all the time. So, taking a physicians advice will be the best option. Because taking any step without the right precaution can harm your health.

PCOS

Polycystic ovary syndrome or PCOS is one of the most common gynecological problems nowadays in the world. There are multiple cysts of bulge formation on the wall of the uterus, both inside and outside. Cysts or these bulges remain harmless initially, but they suck out blood from the surroundings to ensure the nutrients. That is why the patients body does not get enough blood supply or fails to excrete the unfertilized egg. Delayed menstruation and anemia is an overall presentation of a patient with PCOS.

Obesity

Obesity is the main culprit for most of the diseases in the human body. Extra fat accumulation alters the enzymatic and hormonal activities in the body that may cause delayed menstruation or complete amenorrhea at some time. Low body weight (LBW) is another major cause of delayed menstruation, similar to obesity. Eating disorders such as anorexia nervosa or bulimia, are pervasive in people, especially teenagers and models. But, trying to be thinner than ever may cost you more than the external beauty.

Stress

Stress and tension throw your hormones into a frenzy. Excessive cortisol, also known as the stress hormone, causes alterations in estrogen and progesterone secretion. Rhythmical alteration in the concentration of these two hormones is essential to keep up the normal menstruation cycle. The same thing goes with alcohol consumption and smoking too. These narcotic objects cause delayed and painful menstruation very often. Hormonal imbalances like thyroid storm, thyrotoxicosis, and low thyroid hormone are also responsible for delayed menstruation.

Delayed menstruation brings a lot of tension with it. It can be due to regular physiological alternation or merely a change in food habits. But, there can be deadly underlying diseases behind it. You cant be sure without proper examination and tests. So, consult your doctor if you are facing delayed menstruation frequently.

Laila Azzahra is a professional writer and blogger that loves to write about technology, business, entertainment, science, and health.

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A late period: things that might happen to your body - Omega Underground

Heavy menstrual bleeding What you should know – Times of India

Heavy menstrual bleeding (HMB) or menorrhagia is one of the most common reasons for which women seek a Gynaecologists help. There are over 355 million menstruating women in India and about 60% of them may need medical help at some time in their lives to deal with heavy periods.Why do women have periods?Imagine a life without periods - no bleeding, no pain, no sanitary napkins and no tampons .freedom. Before you get too carried away with that utopian thought have you ever wondered why women have periods? Well, because we are special of course! Every month the womb prepares for a possible pregnancy and when this does not happen it sheds the lining of the womb which results in a period or menses. This usually happens once a month and a woman bleeds on an average for 5 days. The normal cycle varies from 21 to 35 days and the bleeding can last from 2 to 7 days. So, having a regular period most often indicates that a woman is ovulating every month. So ladies the next time you moan about your periods remember it is your monthly reminder that you are capable of having a baby!

How do I know if I have HMB?Do have heavy periods, needing constant change of menstrual hygiene wear, staining of clothes, cramps and severe pain in your tummy? Are you personal and professional life affected during your period days such that you cannot maintain your usual activities? Do you dread that time of the month? If the answer to most of the questions is yes, you are suffering from heavy periods and you need to see a doctor.

Symptoms of HMB

If you have any of the following symptoms you may be suffering from heavy menstrual bleeding and may need medical help:Soaking through one or more sanitary pads or tampons every hour for several consecutive hoursNeeding to use double sanitary protection to control your menstrual flowNeeding to wake up to change sanitary protection during the nightBleeding for longer than a weekPassing blood clots larger than a quarterRestricting daily activities due to heavy menstrual flowSymptoms of anemia, such as tiredness, fatigue or shortness of breath

What are the causes of HMB?About 60% of the women who consult me, do so because they have a menstrual problem. Heavy periods can be caused by hormone problems, uterine problems and other causes. Given below is a brief overview of the causes of heavy bleeding.

Hormone imbalanceIn a normal menstrual cycle, a balance between the hormones estrogen and progesterone regulates the buildup of the lining of the uterus (endometrium), which is shed during menstruation. If a hormone imbalance occurs, the endometrium develops in excess and eventually sheds by way of heavy menstrual bleeding.A number of conditions can cause hormone imbalances, including polycystic ovary syndrome (PCOS), obesity, insulin resistance and thyroid problems.Uterine fibroids - These are benign tumors of the uterus which may cause heavier than normal or prolonged menstrual bleeding.

Uterine Polyps - Small, benign growths on the lining of the womb cause heavy or prolonged or irregular menstrual bleeding.Adenomyosis - This condition usually affects women in their forties. Glands of the lining of the uterus become embedded in the muscle of the uterus and cause heavy, painful periodsIntrauterine device (IUD) - Menorrhagia is a side effect of using a nonhormonal intrauterine device for birth control.

Cancer - Uterine cancer and cervical cancer can cause excessive menstrual bleeding, especially if you are postmenopausal or have had an abnormal Pap test in the past.Inherited bleeding disorders - Some bleeding disorders such as von Willebrand's disease, a condition in which an important blood-clotting factor is deficient or impaired can cause abnormal menstrual bleeding.Medications - Certain medications like anticoagulants or blood thinners, can cause heavy menstrual bleeding.

Other medical conditions - A number of other medical conditions, including liver or kidney disease, may be associated with menorrhagia.

HMB Treatment options in the 21st Century

Treatment depends on the under lying cause of HMB can be divided into Medical, Surgical and Non-Surgical Procedures.

Medical

Drugs: The most commonly used non-hormonal drugs are Tranexamic Acid and Mefenamic Acid.

The Combined oral Contraceptive pill and Progesterones are hormonal drugswhich are used to treat this condition.

A hormonal Intra uterine device or system (IUS) has a small amount of progesterone hormone impregnated into it and releases it locally. It is inserted into the uterus and acts by thinning the lining of the womb, thus reducing the amount of blood lost during menstruation. Research has shown that this is the most effective form of medical treatment in suitable women.

Surgical and non-surgical proceduresHysteroscopy and/or Laparoscopy: If the HMB is due to fibroids or polyps these can be surgically removed by Hysteroscopy and/or Laparoscopy or by the traditional open method.

Endometrial Ablation: This procedure involves destroying (ablating) the lining of the womb (endometrium). The procedure uses a laser, radiofrequency or heat applied to the endometrium to destroy the tissue.

Endometrial resection: In this procedure an electrosurgical wire loop is used to remove the lining of the womb.This results in lighter bleeding. However, in women considering a pregnancy this procedure is not recommended.

Uterine artery embolization: When HMB is caused by large fibroids (more than 3 cm) this procedure helps shrink the fibroids (in selected cases) by blocking the uterine arteries and cutting off the blood supply to the fibroids. During this procedure, the doctor passes a catheter through the large artery in the thigh (femoral artery) and guides it to the uterine arteries, where the blood vessel is injected with materials that decrease blood flow to the fibroid.

HIFU: High Intensity Focused ultrasound is a non-invasive way to treat uterine fibroids. Using this treatment method in conjunction with image guidance, the physician directs a focused beam of energy through the patients skin, superficial fat layer, and abdominal muscles to heat and destroy the fibroid tissue without damaging nearby tissue or the tissues that the beam passes through on its way to the target.The treatment is conducted with the patient awake and uses either magnetic resonance (MR) or ultrasound (US) guidance.

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Heavy menstrual bleeding What you should know - Times of India

Winter Got You Down? Here’s How to Combat Seasonal Blues, According to Experts – TIME

When the long summer days begin to slip away and temperatures begin to drop, its not uncommon to feel down in the dumps. Many may begin to feel resigned and sad as early as the fall when facing bone-chilling weather and increased isolation during the darkest time of any year, but its possible many more may feel affected by the challenges that this winter may bring.

The lethargy and cabin fever can range from mild winter blues to seasonal episodes of depression called seasonal affective disorder (SAD)

There are certain people who are susceptible to these changes when you get to the autumn and winter when the daylight gets shorter and its darker, explains Dr. Norman Rosenthal, a clinical professor of psychology at Georgetown University School of Medicine who lead the team that first described SAD in 1984 at the National Institute of Mental Health.

Rosenthal, who wrote a book about the seasonal depression titled Winter Blues, says that people in winter often over-eat, over-sleep and experience loss of energy, interest and more as the days grow shorter.

They can have difficulty in their relationships because they get socially withdrawn. They can have trouble at work because they dont concentrate and function as well. And this can all accumulate to the point that they feel quite depressed, Rosenthal tells TIME.

While many are able to stave off these creeping seasonal mood swings by spending quality time with loved ones or participating in activities that boost their mood, looming COVID-19 restrictions and lockdowns may make this years winter blues the most brutal yet. To help keep your mental health at its best, here are some possible, expert-approved ways to lift your spirits during the darkest time of year.

Lack of light is widely recognized as a trigger that affects peoples moods as they get less exposure to natural sunlight. A study of North America found that the prevalence of SAD increased the further north the subjects lived, as the hours of daylight decrease the further away one lives from the equator.

Both Rosenthal and Dr. Kelly Rohan, a professor and director of clinical training at the University of Vermont, recommend increasing your exposure to light every day, whether its inside or outside of your home.

Walk or do activities outside

Instead of staying cooped up at home, Rohan advises that you bundle up and get outside before those fleeting rays of sunshine disappear.

As long as youre not in a complete lockdown, get outside and walk, spending some time in nature breathing fresh air, Rohan advises, adding that you should make sure to adhere to CDC and local public health guidelines.

Seeing color in nature, like the little bit of greenery and getting direct sunlight exposure, all of these things are good for mental health. You just need to maintain a reasonable amount of distance between yourself and other people, she says.

If youre looking for a way to stay warm, dont forget to add layers. Windbreaker jackets for men or women can keep the chill out of your bones outside, and a reusable face mask will help protect you and everyone around you from infection.

Bright Light Therapy

If going for a walk outside simply isnt enough or you cant leave your home, Rosenthal recommends getting your daily dose of light with therapeutic light boxes.

Bring light into your home, Rosenthal advises. Use them for as little as 20 to 30 minutes in the morning, and you can start to feel a lot better.

Rosenthal, who pioneered bright light therapy after studying seasonal affective disorder, noted that its important to do your research before purchasing any bright light therapy lamp.

Lux is a measurement of light; 10,000 lux is how much was used in the research studies that showed the beneficial effects of lux. And [the bright light therapy lamps] need to be from established companies and screen out the ultraviolet light, Rosenthal explains. According to Rosenthal, the lights used in research studies often measure about one-foot by 18 inches. Having a larger lamp gives you more room to move around and ensures you get enough light exposure, he adds.

I like ones that are angled down towards the eyes, theyre the most comfortable he notes.

If youre in the market for a therapeutic lamp, the Carex Day-Light Classic is a way to bring extra light into your life.

Many experts believe that we can often feel deflated and lethargic during the darkest time of year because of lights influence over our sleep and circadian rhythms.

The most popular theory is that a later dawn in the winter triggers a slower-running circadian clock that is out of sync with the dark and light cycle, Rohan explains. This is our central biological timekeeper in the brain that changes and regulates our bodys 24-hour circadian rhythm which includes sleep, our core body temperature and melatonin releasethe hormone of darkness, she adds.

For this reason, Rohan and Rosenthal emphasize that regulating sleep is vital to getting your winter blues under control.

Natural sleeping aids

If you have trouble falling asleep at night, many people take melatonin supplements, a hormone your brain produces in response to darkness, to help get them on a regular sleeping schedule. Rosenthal recommends taking between one to three milligrams at night. If youd rather not ingest a sleeping aid, slip a lavender sachet inside your pillow covers to help you fall fast asleep.

Dawn simulator

Rosenthal also recommends a dawn simulator to help regulate your sleep cycle. A daylight or dawn simulator helps you wake up in the morning, says Rosenthal. I find it much nicer to awaken to an illuminated room than to awaken to darkness.

But the Hatch Restore, one of TIMEs Best Inventions of 2020, does more than just getting you up in the morning. Its designed to help you establish a sleep routine from the morning to night. During your waking hours, a dawn simulator helps you get out of bed and start your day. And at night, the device has a soft light to help you read and relax before bed or you can listen to soothing, meditative sounds to gently lull yourself to sleep.

Another way to reset your circadian rhythms is to establish and maintain a routine, says Rohan. Maintain a sense of normalcy as much as possible by following a schedule. Get up. Shower. Get dressed. Make your meals at the times that you usually do, she advises. Maintaining a schedule in this way can help regulate the circadian clock.

Keeping a daily planner, for example, might help you establish a schedule and hold yourself accountable for sticking with it.

Panda Planner Pro Daily Planner

Rohan also notes that its important to make time to do a hobby or something that you can enjoy.

This is really important for mental health because theres a very strong relationship between doing fun things and mood, Rohan says. She recommends finding simple pleasures that you can enjoy inside like playing a game or reading a book.

In addition to light, Rosenthal adds that stress also has a major impact on feeling down in the winter.

Add stress to the equation, and you will bring out the symptoms, Rosenthal says. As COVID-19 continues to affect so many lives and communities, stress and anxiety may feel inescapable this winter. And individuals who struggle with seasonal affective disorder are particularly sensitive to life events.

I think its the perfect storm because, by definition, their issue is recurrent depression, Rohan says. And then you couple that with a global pandemic, anxiety and very real issues that are associated with that uncertainty over jobs, finances, health, themselves and other people, and familyits kind of a double whammy.

Exercise

Rohan and Rosenthal recommended one easy stress-reliever that anyone can do at home: exercise.

Exercises are a wonderful way to decrease stress and so is meditation, Rosenthal says. Whether youre doing an hour-long workout or a quick 15-minute session, here are some home-workouts for a long and socially distant winter, recommended by fitness experts.

Skipping rope or using non-slip resistance bands are an excellent way to get some quick movement and keep the cabin fever at bay.

Yoga and meditation

Rosenthal also recommended yoga and meditation as a way to fight stress and find serenity during these turbulent times. So hit the mat for several sun salutations every day or if youre new to yoga and are looking for a guided practice, a monthly membership with Glo will fit your meditation and yoga needs. Additionally, if you need a comfortable way to move on the floor, Ewedoos has a great, eco-friendly yoga mat.

Read More: The Best At-Home Workouts for a Long and Socially-Distant Winter, According to Fitness Experts

If youre familiar with the winter blues, you may know people who swear by taking a daily dose of vitamin D. With less exposure to the sun, many have equated their seasonal mood swings to a deficiency in the essential vitamin. However, theres not a lot of data that shows that vitamin D improves mood.

There is surprisingly little research on vitamin D and seasonal affective disorder. And most of them have a teeny tiny sample size, Rohan says.

Most people in the U.S. have insufficient levels of vitamin D. Interestingly, researchers have noted that the groups who are at risk for vitamin D deficiency are also groups that are at risk of suffering from major depressive disorders. Rosenthal believes its the placebo effect of taking natural supplements and feeling healthy that lifts our spirits. While there may not be evidence of its efficacy as a mood booster, he says it cant hurt to take a supplement.

A lot of these vitamins may have a placebo, Rosenthal says. But, I wouldnt discount it if somethings making you feel better. It certainly shouldnt hurt you in the long run. If you do decide to take some supplements, Rosenthal recommends having your physician monitor your levels and intake. Vitamin D supplements are relatively inexpensive and available on Amazon.

Some self-help for the winter blues is necessary, especially during a time when mental health professionals are in high demand due to anxiety around the pandemic. However, Rohan stresses that you should seek out help if you are struggling to get your depression under control.

There are psychiatrists, psychologists, community health and mental health workers who are prepared to recommend an effective treatment because seasonal depression is very treatable, Rohan says.

Like many other major depressive disorders, antidepressant medications that require a prescription from a physician are proven to help treat SAD. Rohan has found that certain methods of cognitive-behavioral talk therapy can be extremely effective in treating SAD, a field that she herself has developed and studied.

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Winter Got You Down? Here's How to Combat Seasonal Blues, According to Experts - TIME

The coronavirus pandemic is killing people with diabetes or Alzheimer’s who didn’t even contract the virus – LancasterOnline

Dec. 22The coronavirus has so far killed about 325,000 people in this country, but that staggering toll does not include the multitudes who have died because of disruptions, isolation, and destitution related to the pandemic.

People with diabetes or Alzheimer's disease are particularly vulnerable.

An Inquirer analysis of federal data found that from mid-March through November, Pennsylvania had 753 more deaths attributed to Alzheimer's and diabetes than would be expected based on the last four years, a 14% increase for each cause. In New Jersey, there were 634 more deaths than expected for the two causes, an increase of 11% for Alzheimer's and 33% for diabetes.

The same trends occurred across the country, according to the Inquirer analysis, which aligns with other studies this year of "excess deaths" the gap between actual and expected deaths. The biggest deviation from the norm for Alzheimer's and diabetes was in April, but every month had excess deaths attributed to these causes.

Even in the best of times, diabetes can be a costly, complex, frustrating condition to manage. Sugar builds up in the blood, either because the body can't properly use or doesn't make enough insulin, the hormone that regulates sugar. If not controlled with diet, exercise, and often, medication, diabetes can cause devastating complications including heart disease, blindness, kidney failure, and lower-extremity amputations. Diabetes is the seventh leading cause of death in the United States.

Because Type 2 diabetes, the most common type, is closely linked to obesity, incidence has been soaring over the last decade. About 34 million American adults and children just over one in 10 have diabetes, and 88 million more adults about one in three have higher than normal blood sugar, called prediabetes.

Barbara Simon, an endocrinologist at Thomas Jefferson University Hospital, sees "multiple layers and multiple factors" related to the pandemic eroding the health and welfare of her diabetes patients.

"From my experience, the No. 1 issue is economic stress," she said. "Many are out of work and not able to afford their already expensive medicines."

Even the price of insulin, a decades-old generic drug, has increased dramatically over the last decade. (For those with Medicare, some Part D plans will cap the monthly copay for insulin at $35 beginning in January.)

"Studies have shown that prior to the COVID pandemic, up to 25% of insulin-dependent diabetics rationed supplies to save money," area physician Jennifer N. Goldstein wrote in September in The Inquirer. "The dramatic rise in unemployment and the loss of employer-sponsored health insurance due to the COVID-19 pandemic is likely to bring this crisis to a breaking point. This is particularly true in Pennsylvania, where unemployment rates hover around 13%, and almost 700,000 residents are uninsured."

As the U.S. Postal Service has struggled with pandemic-related turmoil including historic volumes of mail and funding gaps lost and late mail has been an issue for people ordering diabetes medication or blood sugar test strips. In June, when Cherry Hill resident Gerald Katz went to his local post office to ask what happened to his box of strips, he was told, "Well, we can't find out."

At the same time, the civil unrest and vandalism that led some Philadelphia pharmacies to shut down for weeks in the spring left many patients struggling to get their medications, said Simon at Jefferson.

People with diabetes are at elevated risk of severe COVID-19 if they get infected. But the isolation of staying home to avoid the virus also has dangers.

"Patients who used to go to the gym can't anymore," Simon said. "So they are more sedentary. Their eating habits have also changed. A lot of my patients report weight gains."

"Patients are also unsure about coming in for medical care, perhaps because of fear of traveling or overburdening the medical system," Simon added. "We try to assure them that diabetes is one of the diseases we can address well with telemedicine."

Lisa Walke, chief of geriatrics at the University of Pennsylvania's Perelman School of Medicine, said people with diabetes face a double whammy as the pandemic complicates their lives.

"Stress causes your sugars to be less well-controlled and, obviously, this has been a stressful time," Walke said.

It is possible that some of the excess deaths of Alzheimer's patients were actually due to undiagnosed COVID-19, experts said. Particularly in the early months, testing was not widespread in nursing homes, where many with advanced dementia live, and people without obvious symptoms may have been overlooked. Moreover, people with dementia were probably less likely than others to talk about feeling sick.

Walke, at Penn, said COVID-19 cases among frail dementia patients who live in the community are probably still being underdiagnosed. These patients may find it difficult to access testing, or may not be strong enough to wait in line.

Another possible factor behind the excess deaths: some Alzheimer's patients could not withstand the social isolation and changes in their routines that were meant to protect them from the virus.

"Routine is an Alzheimer's patient's best friend," said Carol Lippa, director of the Cognitive Disorders and Comprehensive Alzheimer's Disease Center at Jefferson University Hospitals. "They do better when they know what to expect."

Patients in facilities were suddenly surrounded by staff wearing masks, gowns, and face shields. People with dementia "don't have the capacity to understand that, and that's just stressful," Lippa said.

At the same time, family members have been prohibited from visiting, cutting off the interactions that mean the most. That compounds the effects of isolation. "The quality of interactions is not as good," Lippa said. "It's not with the people who love them and are familiar with them."

Walke and Lippa said dementia patients in the community also have felt their worlds shrink and change in harmful ways.

Maybe they couldn't go to adult day care or church or take their daily walk. Visiting their doctors and getting home care has been more difficult. If dementia patients needed hospitalization for an illness other than COVID-19, many hospitals still don't allow family visitors. Penn has changed that policy for dementia patients, Walke said, not only because they need loving contacts, but also because they need advocates who can communicate for them.

(c)2020 The Philadelphia Inquirer

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Women’s Health Market to Touch USD 41.05 Billion at 3.2% CAGR by 2027; Growing Focus on Women’s Health Worldwide to Positively Impact the Market:…

Pune, India, Dec. 21, 2020 (GLOBE NEWSWIRE) -- The global womens health market size is projected to reach USD 41.05 billion by 2027, exhibiting a CAGR of 3.2% during the forecast period. The COVID-19 pandemic is likely to reemphasize the importance of woman health and boost the market, observes Fortune Business Insights in its report. The infection caused by the coronavirus, which has affected more men than women across the globe, has brought the issue of health of women in the spotlight. A UN policy brief released in April 2020 stated that women hold less secure jobs and earn lower wages, which makes them highly vulnerable to the adverse effects of this pandemic. More importantly, as the pandemic intensifies, womens health will inevitably suffer.

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Increasing Prevalence of Women-centric Diseases to Aid Growth

A leading factor aiding the womens health market growth is the rising incidence of women-specific diseases and disorders around the globe. For example, the 2018 GLOBOCAN report by the International Agency for Research on Cancer (IARC) revealed that female breast cancer diagnoses stood at 2.1 million in 2018, accounting for approximately 11.6% of the total global cancer burden.

Further, female breast cancer was the fifth leading cause of death, contributing to 6.6% of the total global deaths in 2018. Another prime example is osteoporosis in women, a disease that generally afflicts menopausal women, causing reduction in bone density. The National Osteoporosis Foundation, for example, estimates that 20% of Caucasian women aged 50 and above have osteoporosis.

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As a result of their complex internal body dynamics, management of womens health, especially post-pregnancy and post-menopause, when hormone imbalances are known to occur, requires high level of efficiency and accuracy. Products designed to facilitate effective management of women-centric diseases will, thus, play a crucial in augmenting this market in the forthcoming years.

Robust Spending on Womens Healthcare to Stoke Market Growth in North America

North America is expected to emerge as a major revenue generator for this market during the forecast period, having registered a market size of USD 18.00 billion in 2019. The primary reason for the regions dominance in the market share is the large amount of funds allocated to enhance womens healthcare across the US and Canada. This is a result of the spreading awareness about health issues and the growing prevalence of women-specific diseases in the region.

Improving healthcare infrastructure, especially in Eastern European countries, is anticipated to bolster Europes position as the second-largest region in this market. Asia Pacific is expected to grow at the highest CAGR on account of the rising awareness about the importance women health.

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Launch of Digital Health Solutions for Women to Fuel Innovation

Some of the leading players in this market that specialize in female wellness and health are coming out with path-breaking digital solutions to address the unique health issues faced by women. These solutions are aimed at enabling women to take care of their independently without affecting their daily routines.

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How to Find the Best CBD Gummies – Cincinnati CityBeat

How to Find the Best CBD Gummies

When it comes to choosing the best CBD Gummies, thorough research of reputable brands and every ingredient, extracting method, and recommended dosage will undoubtedly help ensure you get precisely what you hope and pay for. Its main ingredient is cannabidiol or CBD, the most active cannabinoid in hemp plants that carries many health benefits for users.

Many health enthusiasts see CBD as a holistic health supplement. Its popularity is in part because while it is derived from a cannabis plant, it has no intoxicating side effect, unlike its sister-cannabinoid, tetrahydrocannabinol THC. You can also find it in various forms, including CBD oil tinctures, capsules, flowers, topicals, vapes, and a lot more.

If youre thinking about dipping your toes into the world of cannabis but are hesitant about the infamous marijuana high, try out hemp-derived products instead. Most of which are low in THC and wont have any undesired side effects if taken correctly. CBD gummies are a great start; they taste delicious and dont look so daunting as other products.

There are various things to look for when shopping for the best CBD gummies. Of course, it is important to always know more about a product before purchasing it and using it for yourself. Cannabidiol has been named a generally safe substance by the World Health Organization because of its lack of potential abuse and dependency.

Due to the influx of hemp products in the market recently, not everything undergoes the Food and Drug Administration (FDA). As demands go up, so does the supply, but you have to be careful not to fall into the trap of CBD oil brands selling themselves as the panacea for everyone.

Each type of CBD product is unique and can serve you differently if you know which ones to look for. Listed below are some factors to consider before making any major purchase and incorporating the cannabinoid into your daily health routine.

Not all hemp CBD products are made the same. Most use CBD oil to infuse gummies, pills, or topicals, but these extracts are also categorized into three main types: full-spectrum , broad-spectrum CBD, or CBD isolate. The first two contain many cannabinoids, with the full-spectrum containing a meager amount of THC while the broad-spectrum stays THC-free.

Isolates are potent, coming up to around 99% of pure CBD. This one is usually the most expensive out of the three because it is more challenging to produce. Full-spectrum CBD gummies are taken by those who want to experience the entourage effect. The legal limit of 0.3 percent THC by dry weight is still observed, so no worries about any psychoactive side effects.

The entourage effect gives users the benefit of enjoying the other compounds present in the raw plant material and formula, such as terpenes, flavonoids, and other cannabinoids like CBC, CBG, and CBN. Some studies suggest that using CBD and hemp extracts with these other compounds makes the cannabinoid even more effective and long-lasting.

No matter the type of hemp oil extract, the best CBD gummies or a gummy bear are always the ones you prefer. Try out all of the above by asking your local hemp store if they sell trial size products, and see which ones serve you best.

Try looking up best CBD gummies on search engine platforms, and you will usually be linked to websites of reputable cannabis or organic hemp brands. These companies pride themselves in producing the best quality of cannabidiol in the market, with impeccable customer service, and some of their buyers might be inclined to agree.

If you head on over to their product page, try and look for a section that states the CBD oil has undergone third-party laboratory testing. It is even better if there is a link to the result of said testing somewhere on the site. These tests are done by an accredited laboratory not associated with the brand for an unbiased review of the products potency and efficiency.

Third-party lab test results also make sure you are getting CBD gummies safe from unwanted chemicals, pesticides, chemical fertilizers, and toxins. The test report also states the methods used in extracting the hemp oil extract, such as Supercritical CO2 Extraction Method. This one is considered the safest standard of extraction in the industry producing high quality cannabidiol for each product.

The hemp and CBD market can be confusing, so be sure to ask questions first and purchase later. Companies or independent labs that refuse to disclose such valuable information to their customers are not worth spending a dime on, so be careful in researching a brands background and business ethics.

Most manufacturers and avid users would agree that the secret to making the best CBD gummy packs is organically home-grown hemp of the highest quality. As the raw plant material where the oil is extracted, it is important that the hemp planted, cultivated, and harvested is done using safe and sustainable farming methods.

Not only that, but all subsequent ingredients must also be as organic, GMO-free, and vegan-friendly as possible. Premium companies help hemp farmers in breeding and harvesting the best quality of raw hemp to be used in their full-spectrum and broad-spectrum CBD gummies. This practice also boosts the local farming communities income and employment rate.

In addition to this, reputable brands always put every ingredient on their labels. These labels should always be true to the products composition, and the only way to ensure this is to be vigilant at the ingredients listed therein. Youll want your gummies to contain only natural flavorings and sweeteners made possible by infusing them with real fruit juice extracts.

One hemp brand, BlosumCBD, promises all of the aforementioned good qualities and best values listed above. Blosum CBD products are made from locally and organically-grown hemp, the cannabidiol extracted using the safest and most meticulous methods, mixed only with compounds that would enhance CBDs health benefits, undergone third-party lab testing, and packed securely.

This CBD brand also offers great deals to customers and offers discounts, sales, and free shipping within the United States with a minimum amount of purchase. Depending on your preference, Blosum does not only provide the best CBD gummies but have varying products available as well. These include their flavored oil tinctures, softgels, topicals, and pet treats.

CBD Gummies Vegan Full-Spectrum

Price: Starting at $74.99

Strength: 10 mg or 25 mg of CBD

Flavor: Mixed Fruit (Watermelon, Orange, and Strawberry)

BlosumCBDs Vegan Full-spectrum Gummies have it all! These all-natural ingredient treats are not only delicious but beneficial for a better quality of life. Each of these full-spectrum gummies contains 0.3% THC, meaning you can get the full effects of benefits like the entourage effect from the high potency level. Blosums Vegan Full-Spectrum Gummies are:

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CBD Gummies Vegan Broad-Spectrum

Price: $74.99

Strength: 25 mg of CBD

Flavor: Strawberry

If youre looking for a great gift for beginners using CBD or are just hesitant on THC, look no further than BlosumCBDs Vegan Broad-Spectrum Gummies! This 25 mg gummy is gluten-free as well as being vegan. Each of these broad-spectrum chewy treats contains zero THC, meaning you can still get the full effects of benefits like the entourage effect without the worry of consuming any THC remnants. Blosums Vegan Broad-Spectrum Gummies are:

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Much like other CBD products, CBD gummies work by having the body absorb the cannabidiol compound and work with the endocannabinoid system or ECS. The ECS is responsible for maintaining an overall balance in the body that regulates your mood, pain receptors, sleep cycle, stress levels, hormone production, and other vital processes needed to keep healthy.

When orally ingested via an edible like gummies, CBD is deposited into the bloodstream and distributed throughout the body through your natural cannabinoid receptors. It may help with many seemingly inconsequential but occurring conditions in your body, such as backaches, inflammation, migraines, difficulty sleeping, and anxiety symptoms.

There are several ways to take CBD edibles, as you may be well-informed by now. As mentioned before, CBD is considered a generally safe substance as there has been no recorded overdose on the compound to date. However, it is important to note that there is no universal dosage for any hemp product, including CBD gummies.

On average, users take one to two of the soft candies per dose, sometimes up to three times a day. This does not mean that you need to go dose it up this high, especially if it is your first time introducing the cannabinoid into your system. There are other factors to consider when doing the dosing guesswork, including your body mass and the products bioavailability.

The amount of CBD in each gummy could also affect how your body will metabolize the compound, along with its other ingredients. Different studies suggest varying dosages but listen to how your body reacts and work from there at the end of the day. Increase or decrease intake according to your desired effect.

Although it may take longer even for the best CBD gummy candy to start working, stay consistent in your product. Stay with a routine for at least 4-6 weeks. Compared to oil tinctures taken via sublingual absorption, gummies need to be digested so their absorption will be gradual. Take one gummy for your first dose and see how long it takes to take effect.

Most hemp products are relatively new to the market. Admittedly, even the science behind cannabis side effects and health benefits are fairly new and young in theory at best. There has been substantial evidence regarding CBDs anti-inflammatory, antibacterial, and antioxidant properties, but these still need a wider test audience and clinical trials.

This resulted from the decades-long cannabis ban worldwide that put a screeching halt to many scientific studies on the plant and its great potential. It is only recently that policymakers have started listening to their constituents and health experts that hemp, marijuana, and its many cannabinoids contain many modern medicine possibilities.

Now, CBD is used to help treat many conditions such as chronic pain, anxiety, and stress symptoms, sleeping difficulties, skin problems, among many others. In a more controlled space, hemp and CBD have also been used and are currently being used to help treat the symptoms of

long-term conditions like Dravet syndrome, certain types of cancer, and multiple sclerosis.

With the passage of the 2018 Farm Bill, industrial hemp was declared legal on a federal level. This comes with a restriction that no product must contain more than 0.3% THC by dry weight to be allowed for manufacturing and distribution to local stores and groceries. The hemp industry was also handed over to the jurisdiction of the Department of Agriculture and the FDA.

While federally legal, some states still abide by their strict medical marijuana programs. They prohibit any cannabis-derived products open use unless they have qualifying conditions that need the plants benefits for treatment and medicine.

Additionally, the FDA added its own set of safety nets that both hemp sellers and consumers should keep in mind. These included being aware that no CBD product in existence has been approved nor evaluated by the FDA, and any brand claiming so is playing their customers false. No hemp product is also intended to treat, cure, or diagnose any medical condition.

If you are thinking of adding the best CBD gummies to your wellness routine, it may very well be the best thing you do, considering its many wondrous health benefits. Gummies are a delicious and discreet way of trying out CBD and seeing if it agrees with you. You can take them anywhere, eat them at any time of the day, and not worry about any harsh side effects.

CBD oil is also a good, long-term supplement that is organic and all-natural. It could help maintain homeostasis in the body, give your immune system a good boost, and help with any discomforts you may be currently experiencing. The added support to the body could do you wonders, but only if you take heed of the information and tips listed above.

Be sure to inform your attending physician first before making any significant changes to your diet and health routines. Pregnant, nursing, or people with complicated medical histories may react to CBD. Cannabidiol gummies may not be for everyone but try them to find out for yourself.

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How to Find the Best CBD Gummies - Cincinnati CityBeat

Hearing loss, hormone therapy and menopause – Healthy Hearing

The decision to take hormone therapy (HT) to tame symptoms of menopause can be complex. There are benefits and risksthat you must weigh with your healthcare provider. One area of emerging research is the relationship between hearing loss, menopause and hormonetherapy.

Researchers are still teasing out how menopause affects hearing. The same is true of HT:Research with mice and preliminaryhuman studies suggest that taking estrogen can have protective effects on your hearing. However, ananalysis with the largest data pool to date on the topic actually found the opposite.

If you dont currently have hearing loss, HT could increase your risk, according to a team led by Dr. Sharon Curhan, MD, a physician and epidemiologist at Brigham and Womens Hospital in Boston. This was true for both pills and patches, and for formulas with estrogen onlyor combined with progesterone.

To get down to the numbers: When Curhans team analyzed data for more than 47,000 female nurses spanning 22 years, theyconcluded that a course of HT for five to ten years increased a woman'srisk of hearing loss by 15 percent compared to a woman not taking HT.

Risk increased the longer a woman stayed on HT. The analysis also found thatwomen who undergo menopause at an older age have a higher risk of hearing loss.

Youve probably heard that drops in estrogen can trigger symptoms like hot flashes. Estrogen, a hormone, plays a role throughout the bodyin your muscles and bones, heart and brain as well as reproductive system. Scientists know we have estrogen receptors in ear cellsand in auditory pathways, but its still unknown exactly how estrogen affects hearing.

Sex hormone levels change during a menstrual cycle, and during menstruation, your hearing can become less sensitive.During perimenopausethe years before your ovaries stop releasing eggs and your period endsyour ovaries gradually produce less estrogen. In the last one to two years of perimenopause, the drop in estrogen speeds up. After your period ends, typically after age 45, the ovaries produce little estrogen but you still get some from your adrenal glands and fat tissue.

As Curhans team reports, both human and animal studies have shown that low estrogen levels can impair hearing, possibly through alterations in blood flow to the cochlea, the hollow tube in the inner ear. A separate study that measured hearing and blood levels of estradiol (a form of estrogen) in 1,830 post-menopausal women found that the volunteers with less estradiol were more likely to have hearing loss.

Another key reproductive hormone, progesterone, begins to drop in your thirties. Progesterone, which regulates pregnancy, is the yin to estrogens yang: It reduces receptor cells for estrogen. Progesterone doesnt affect the cochlea directly but it could by reducing estrogen receptors and therefore blood flow to the ear.

The link between low estrogen and impaired hearing suggests that women who arrive at menopause later, at 50 or older51 is the average age of menopause in the United Statesmight have a lower risk of hearing loss. After all, it would make sense that women who reach menopause sooner experienced earlier drops in estrogen.

However, when Curhans team looked at a pool of data on nearly 81,000 nurses, the opposite was true: The women with late natural menopause surprisingly had a 10 percent higher chance of hearing loss. The reason for this finding is unclear, since we dont have a full picture of all the factors that affect the age of menopause, Dr. Curhan told Healthy Hearing.

If you are about to start hormone therapyDr. Curhan suggests monitoring your hearing and taking HT only as long as needed.Some women have reacted to HT with sudden hearing loss, tinnitus and vertigo. Contact your provider right away if this happens to you.

If youre considering HT, youre likely to be offered a combination with progestin (a medication like progesterone) if you still have your uterus.Estrogen alone could stimulate growth of the uterus lining and increases your risk of endometrial cancer, so it's more commonly used for women who have had a hysterectomy.

If you do opt for HT, Dr. Curhan suggests monitoring your hearing and taking HT only as long as needed.Some people have reacted to HT with sudden hearing loss, tinnitus and vertigo.

The relationship between menopause, hormone replacement therapy and tinnitus is a topic that also needs more study. Some women may experience tinnitus when starting hormone therapy for perimenopause. Butstudies have also shown that hormone therapy can actually lower the rate of tinnitus in women who are perimenopausal.

We are looking forward to understanding more about risk factors for tinnitus, Dr. Curhan told Healthy Hearing. She is studying its relation to menopause and HT.

Diet, exercise, and maintaining a healthy weight all count. We found that people who ate diets that most closely resembled the Mediterranean or DASH [Dietary Approaches to Stop Hypertension] patterns had a substantially lower risk of hearing loss, Dr. Curhan said. That means eating more fish, vegetables, and whole grainsand less meat and junk food. More: How a healthy diet helps your hearing.

Also be mindful of medications linked to hearing loss. Curhans research with the same big data pool found that using the over-the-counter pain-relievers ibuprofen and acetaminophen two or more times a week may be linked to hearing loss (aspirin is OK). But there was no tie to alcohol.

Lastly, steer clear of loud or constant background noise, get your hearing checked and wear prescribed hearing aids regularly, and youll know youve done your best to prevent hearing lossas you age.

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Tips for staying healthy and managing stress over the holidays – William & Mary News

by Adrienne Berard | December 18, 2020

As we head into the holidays, W&M News spoke with Dr. Elizabeth De Falcon to learn about ways relieve stress and practice self-care over winter break, to strengthen our collective immune systems. Dr. De Falcon is a practicing physician with William & Marys Health Services. She is a licensed pediatrician and Fellow of the American Academy of Pediatrics.

In the simplest terms, stress is just your body's reaction to any change that requires response. So, it could be anything: a mental strain, a physical strain or even an emotional strain. Honestly, it's different for every person. What stresses me out may not stress you out, but if were talking about physiology, then our stress response would be mostly the same.

Without going into the specific names of all the different parts of your brain, it's just that your brain perceives stress or danger or threat. Then it sends out a signal from what is essentially the command center of your brain to the rest of your body, through the nervous system. Then the nervous system starts acting on a fight or flight response and all these different neurotransmitters and hormones get released. All these different substances start flowing through your body just to get you prepared to respond to that stressor.

A lot of times, you're not even aware of it. Most of the time the threat comes and goes, and as the threat goes away, the stress response decreases. Think of a car whizzing past you on the street. Its stressful for a second, but the feeling is very short-lived. Its important to understand that not all stress is bad. It serves an important biological purpose. The stress response has been vital to our survival and evolution. When the saber-toothed tigers were hunting us down, our bodies learned how to respond to that.

If you translate that to now, lets say you're taking a test and you feel a little bit stressed. You're supposed to have a certain level of stress, because its your bodys way of motivating you to focus on something important. After the test is done, theres this sigh of relief because that stress is gone and your body just goes back to a kind of homeostasis where it's feeling ok.

But sometimes that stress hangs around for a little while. Thats when you start running into problems. You may find that even though the threat is gone, youre not feeling better. You may be experiencing increased heart rate and breathing or generally feeling edgy all the time. Thats a sign that you're bumping over into a low-level, acute stress or chronic stress state.

Thats when we start to think about cortisol. Youve probably heard about cortisol as a stress hormone. In the moment, it actually helps your body boost its immune system and decrease inflammation, but if it's there for a long time, then you start to get into different problems.

I always tell people to seek medical help if they start seeing signs of chronic stress. Some of the red flags would be that you feel in a low mood all the time. You may stop hanging out with your friends or your family. You're just kind of retreating and not interested in the things you used to be interested in. You may be sleeping too much or too little. Some people experience physical symptoms. They have an upset stomach or heartburn or headaches, because their blood pressure is up. They might feel a knot in their chest. All of those things could be signs that you're experiencing anxiety, so you would definitely want to see your doctor at that point.

It comes down to the basics of general healthy living. For example, if youve not been on a good sleep schedule over the semester, you really need to prioritize getting on a healthy sleep scheduleand make it a realistic schedule that you can keep doing once we get back on campus. If you were not addressing your dietary needs during the semester, start to incorporate healthy, nutrient-dense types of foods into your diet.

Also, exercise is super important. Just from a perspective of improving your cardiovascular health and improving your circulation, regular exercise will help get all those immune cells pumped around your body. You don't want to smoke and try to minimize your alcohol intake.

Then, of course, what weve all been focused on over these last nine month is taking steps to minimize infections. So, being very diligent about washing your hands, keeping your distance from pretty much anyone who doesn't live in your house, and wearing a mask if you have to go out and about.

When you have a healthy immune system, when it's functional, you don't even know it's there. It's protecting you from things that are trying to kill you, viruses and bacterial infections, but you arent even aware of it.

But just like a car runs out of gas when left idling, if you are not fully addressing the things that boost your immune system, eventually that car will run out of gas and then that leads to a whole host of problems. You might start noticing that you're getting more colds or struggling to get over minor illnesses. Thats really just because when your stress response is revved up all the time, it has the opposite effect on your health and it starts down-regulating your immune system.

This is something I always recommend to my patients: practice gratitude. Its such a simple, easy thing that anyone can do. It doesn't have to be complicated. Just get a little notebook, or even make mental notes, and focus on three things that you're grateful for in a day. No matter how crummy the day is, there's always something that we can find that we can be grateful for.

Studies show that if you practice gratitude, there are positive changes in your brain that actually change your outlook on things. Along those lines, the Wellness Center has all kinds of wonderful mindfulness, meditation and exercise resources available online. They make it really easy to access, so Id also recommend trying out some of those offerings.

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Global Prostate Cancer Disease Forecast and Market Analysis 2020-2036: Prescribing of Next-Generation Hormone Therapies in Earlier Treatment Settings…

DUBLIN, Dec. 18, 2020 /PRNewswire/ -- The "Prostate Cancer Disease Coverage Forecast and Market Analysis to 2036" report has been added to ResearchAndMarkets.com's offering.

Newly approved therapies for castration-resistant prostate cancer are set to create a shift in the way that the disease is treated, while creating a competitive environment for new market entrants.

Latest Key Takeaways

The report estimates that in 2018, there were 1.3 million incident cases of prostate cancer worldwide in males aged 40 years and older, and forecasts that number to increase to 1.5 million cases by 2027.

In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.

The overall likelihood of approval of a Phase I prostate cancer asset is 4.9%, and the average probability a drug advances from Phase III is 51.5%. Prostate cancer drugs, on average, take 9.0 years from Phase I to approval, compared to 9.5 years in the overall oncology space.

Pfizer's next-generation androgen receptor (AR) inhibitor Xtandi is the market leader in prostate cancer due to its established efficacy across prostate cancer segmentations and a lack of near-term generic competition. Bolstered by recent and planned expansions into additional prostate cancer segments, Xtandi will continue to be the leading option in this indication. Future expansion opportunities include potential use in combination with PARP inhibitors Talzenna or Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients.

Xtandi is also being trialed in combination with leuprolide in the Phase III EMBARK study for non-metastatic hormone-sensitive prostate cancer patients progressing on definitive therapy. Potential expansion into this segment represents a significant opportunity to improve outcomes earlier in the treatment paradigm, but the combination will have to demonstrate a significant benefit over existing localized treatment options to justify the additional clinical and financial toxicity of Xtandi treatment.

Since the launch of generic abiraterone in the US in November 2018, sales of Johnson & Johnson's cytochrome P450c17 inhibitor Zytiga have begun to erode. Further generic erosion is expected in the EU and Japanese markets in the next few years, decimating sales of the multi-blockbuster. Although branded Zytiga will continue to decrease in market share, use of abiraterone as part of standard regimens will continue and may expand to include several novel combinations.

The PARP inhibitors Rubraca and Lynparza were both approved in the US in May 2020 for the treatment of mCRPC patients following AR inhibitor therapy. Rubraca received accelerated conditional approval in mCRPC with a deleterious BRCA mutation (germline and/or somatic), while Lynparza received full approval for use in the broader homologous recombination deficient (HRD) population. To potentially differentiate the PARP assets, both are being trialed in the first-line setting of mCRPC; Rubraca in combination with Xtandi against Xtandi alone, and Lynparza with abiraterone against abiraterone alone. There is potential synergy with these combinations as its hypothesized that AR inhibitors may sensitize tumors to PARP treatment by reducing DNA damage repair (DDR) expression.

Late-phase PARP inhibitors Zejula and Talzenna are also being developed in combination with next-generation treatments and will join a crowded PARP treatment space. Zejula is being tested in combination with abiraterone against abiraterone alone as first-line therapy for mCRPC patients. Similarly, Talzenna is being studied in combination with physician's choice of Xtandi or enzalutamide in mCRPC patients, also as a first-line option. The potential synergy of the PARP inhibitors with AR modulators is promising, but a strong benefit will have to be seen to justify use in the front-line setting of mCRPC. If approved, it is likely that these regimens will be limited to the HRD or even BRCA populations, where they will have strong utility but somewhat limited commercial impact due to the relatively small prevalence of these biomarkers.

Next-generation AR inhibitors Nubeqa and Erleada have shifted the treatment paradigm to include these therapies in earlier segments of disease such as non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Expansion into earlier segments and lines of therapy is ongoing. Bayer is looking to expand Nubeqa's label to include use in very high-risk localized patients and metastatic hormone-sensitive patients. Johnson & Johnson will continue to try and differentiate Erleada with an aggressive development plan that includes potential expansions into chemotherapy-naive mCRPC patients as part of a combination with abiraterone, as well as into the localized setting for patients treated with prostatectomy or radiation therapy.

Akt inhibitors ipatasertib and capivasertib are a potential new mechanistic addition to the prostate cancer space, but the efficacy/tolerability profile of these PI3K/Akt/mTOR pathway inhibitors may prevent approval and potential usage. Ipatasertib is a pan-Akt inhibitor from Roche currently in development for asymptomatic or mildly symptomatic mCRPC patients with PTEN loss as part of a combination with abiraterone. PTEN loss is not a standard target in this indication, but represents a significant market opportunity as it is estimated to occur in approximately 20% of primary prostate cancers and up to 50% of castration-resistant tumors. However, ipatasertib is beset by known class toxicities of PI3K/Akt/mTOR pathway inhibitors such as diarrhea, rash, and ALT/AST elevations that could be detrimental to its regulatory chances. AstraZeneca's Akt inhibitor capivasertib has also demonstrated mixed results in prostate cancer.

In the Phase I/II ProCAID trial, capivasertib in combination with docetaxel failed to meet the primary endpoint of improved progression-free survival in mCRPC patients. However, the combination did improve overall survival in these patients irrespective of PI3K/Akt/mTOR pathway mutations. This has led to initiation of the Phase III CAPItello-281 trial testing capivasertib in combination with abiraterone in de novo mHSPC with PTEN loss.

Several checkpoint inhibitors are in development for prostate cancer, but late-phase data from ongoing combination trials are needed to fully determine their relative outlook in the indication. Merck is pursuing an aggressive late-phase development strategy for Keytruda in prostate cancer that includes combinations with Lynparza, Xtandi, and docetaxel for the treatment of mCRPC patients. Opdivo is also in late-phase development as part of a combination with docetaxel in mCRPC patients after failure on a next-generation hormone therapy. Finally, Roche's Tecentriq, the lone anti-PD-L1 antibody in late-phase development for prostate cancer, is currently in Phase III development in combination with Xtandi or in combination with Cabometyx in mCRPC patients after failing on a next-generation hormone therapy.

Myovant's relugolix is a GnRH receptor antagonist that is differentiated from available GnRH antagonist Firmagon by its oral formulation, which will facilitate use in patients undergoing localized definitive therapy who also need ADT and may also allow use of an intermittent ADT option in advanced hormone-sensitive patients looking to mitigate side effects and maintain quality of life.

Key Topics Covered:

OVERVIEW

DISEASE BACKGROUND

TREATMENT

EPIDEMIOLOGY

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

CLINICAL TRIAL LANDSCAPE

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY

APPENDIX

For more information about this report visit https://www.researchandmarkets.com/r/z438b

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Research and Markets Laura Wood, Senior Manager [emailprotected]

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Global Prostate Cancer Disease Forecast and Market Analysis 2020-2036: Prescribing of Next-Generation Hormone Therapies in Earlier Treatment Settings...

Need to Remove Your IUD at Home? These 18 Safety Tips Will Help – Healthline

A long lasting birth control option, IUDs can remain inside your body for anywhere between 3 and 10 years, depending on the type.

But when times up, that sucker has to come out! Ditto goes if you decide you want to get pregnant.

IUD removal is usually easy-freaking-peasy. Typically, a healthcare provider just pulls on the string that hangs from the device, the T arms fold in, and the little bugger comes out.

Given that, you may be wondering if its OK to remove the device on your own at home.

The short answer: Its best to have your IUD removed by a healthcare provider.

As Kimberly Langdon, an OB-GYN and medical adviser at telehealth provider Medzino puts it, IUD removal is a medical procedure.

But if thats not feasible, at-home removal can be an option.

PSA: Its possible to get your IUD removed for free or low cost, and by an affirming provider. And that stands even if your IUD insertion was costly or done by a provider who was not (ugh sorry, loves) affirming.

To find an affordable and affirming provider, check out your local:

That said, if getting to a provider isnt possible because you cant afford the removal or child care for when youre at the appointment, or some other reason, there are safe and less safe ways to remove the IUD at home.

Well walk you through how to do it as safely as possible below.

Just know before going into it that should a complication occur, youre going to have to get to a doctor ASAP.

Quick refresher: The IUD is a T-shaped device (about the size of a quarter) that gets inserted into the uterus through the cervix.

The cervix is known as the anatomical stopping point of the vagina. Its what you or your partner bumps up against when it feels like youre as deep as can be during sex.

Its also as far back as youll need to reach to grab the IUD string thats attached.

If youre squeamish about reaching that far back, you may consider asking a trusted friend or partner to lend a hand.

Due to the angle of entry, their hand will likely be able to reach further into your vagina than youd be able to.

Yes, youll need a set of hands.

But youll also probably want:

If your pal or partner is the one doing the removal, youll also probably want nitrile gloves, ring forceps, or both, which can help The Remover do said removal.

When the IUD is safely out, youll probably want some downtime.

So, be sure to have some comfy clothes, blankets and pillows, and your fave book or TV show within reach. Oh, and youll probably want some additional ibuprofen, water, and snacks, and a heating pad, too.

If theres anything that living through a pandemic has taught you, hopefully its how to wash your hands. Welp, time to draw on that new skill set, babes!

Wash your hands with warm water and fragrance-free soap. Keep on washing them until youve finished singing Happy Birthday. K?

Fail to wash your hands correctly and you could introduce bacteria to your bits that disrupt your pH, which could lead to:

Hard pass.

When your hands are dry, slip those nitrile gloves on.

Youve got two options: reclined or standing.

Which you choose will depend on a variety of factors, such as:

Lie on your back. If youre going to be removing the device yourself, pop your firmest pillow under your hips. This will bring your vaginal opening closer to your hands.

(Even better: Use a sex wedge, which will be even firmer than your sleeping pillow.)

Next, spread your knees wide and tuck them in toward your belly, suggests Langdon.

From a standing position, prop one of your feet on a tub ledge or toilet. Then take a stance similar to the one youd usually use to insert a tampon, Langdon says.

Once you get into position, youre going to bare down, which is going to bring your cervix (and uterus) closer to the vaginal opening.

To bare down, think about pushing a fart out of your vagina. Seriously, it works.

When your provider first inserted the IUD, they likely left 1 to 2 inches of string hanging for the purposes of removal, explains Kecia Gaither, MD, whos double board certified in OB-GYN and maternal fetal medicine, and the director of perinatal services at NYC Health + Hospitals/Lincoln.

Youre going to pull this string straight down in one fluid motion when you find it.

Ready to go fishing? Slide one finger into your vagina and see if you can feel the string.

The string is very, very thin. Its not like a tampon string, Langdon says. So dont be discouraged if it takes you a minute to locate.

Really cant find the string? Stop.

IUD strings can sometimes work their way up to the uterus. If this happens, removal must be done by a healthcare provider.

While rare, a missing IUD string could also be a sign of a larger issue like expulsion or perforation.

Once you find it, slide your forefinger and middle finger together and pinch the string between them. Pull straight down.

IUDs are supposed to come out pretty darn easily. If its not, something could be wrong.

The IUD, for example, could have become embedded into the uterus tissue or traveled outside of where it was initially planted, says Felice Gersh, MD, author of PCOS SOS: A Gynecologists Lifeline to Naturally Restore Your Rhythms, Hormones, and Happiness.

The doctor will know exactly how to navigate these slight complications, but you at home cant, she says.

If you try to, you risk really injuring yourself. You could tear or puncture the uterus, says Langdon.

This could result in scarring and make an infection, such a pelvic inflammatory disease, more likely to occur, Langdon says.

Yep!

Orgasms can cause muscle contractions in the pelvic floor. Those contractions may help the uterus release the IUD more easily.

The cervix naturally opens slightly during ovulation and menstruation. Removing the device during these moments in your cycle may be easier.

Just note: As soon as the IUD is removed, pregnancy is possible, Gersh says.

So, if youre going to have P-in-V intercourse and dont want to get pregnant, avoid removing the device around ovulation, which is when pregnancy is most likely.

As the IUD passes out of the uterus and into the cervix, you may experience cramping.

Expect that! Dont be alarmed by it.

Instead, keep pulling the device out. Slight cramping isnt a sign that something is wrong.

Congrats! Your uterus is free! But before you junk the little bugger, though, look at it.

Like, really look at it.

Are all the parts still there? Google the brand of device you have and compare your IUD to pictures to make sure.

Its possible for a part of the IUD to snap off and remain in the body, says Huong Nghiem-Eilbeck, MD, MPH, a provider at Pandia Health and board certified OB-GYN in Los Angeles, California.

Save all of the parts of the IUD that did come out in a baggie and then come in for an evaluation by a doctor, Nghiem-Eilbeck says.

The missing pieces can get embedded into the uterus or travel elsewhere in the reproductive tract causing things like discomfort, scarring, or even internal bleeding.

Very mild discomfort, mild cramping, and maybe some spotting are normal symptoms after removal, Nghiem-Eilbeck says. Typically, these last a few hours.

If you do experience cramping, Gaither says another dose of an NSAID like ibuprofen should be enough to relieve the pain.

Without a prescription, you can easily get and start using:

If youre looking to avoid a doctors office, you can still get access to certain prescription birth control options like the pill, patch, or ring via telemedicine companies.

Any persistent discomfort, uncomfortable symptoms, fever, or changes in your discharge arent normal, Nghiem-Eilbeck says.

If you experience these symptoms, avoid penetrative sex and see a doctor ASAP.

Its best to go to a medical professional to get your IUD removed if at all possible.

But as Nghiem-Eilbeck says, While typically not advised, self-removal is something that can be done, so long as the patient can learn how and reach the device.

Gabrielle Kassel is a New York-based sex and wellness writer and CrossFit Level 1 Trainer. Shes become a morning person, tested over 200 vibrators, and eaten, drunk, and brushed with charcoal all in the name of journalism. In her free time, she can be found reading self-help books and romance novels, bench-pressing, or pole dancing. Follow her on Instagram.

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Need to Remove Your IUD at Home? These 18 Safety Tips Will Help - Healthline

Qualigen Therapeutics Announces Issuance of US Patent for Expanded Applications of ALAN Anticancer Platform Technology – PRNewswire

CARLSBAD, Calif., Dec. 15, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (Nasdaq: QLGN),a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, today announced that the United States Patent and Trademark Office has issued a patent entitled "Anti-Nucleolin Agent-Conjugated Nanoparticles as Radio-Sensitizers and/or MRI Contrast Agents" regarding the Company's ALAN (Aptamer-Linked Anti-Nucleolin) technology. This patent issued to the University of Louisville (UofL) protects the ALAN technology for use with cancer radiation therapy and for imaging tumors utilizing magnetic resonance imaging (MRI). The novel ALAN technology has several other potential applications, including its use as a monotherapy for the treatment of cancer and as a vehicle to deliver other anticancer compounds directly to tumors. In 2018, Qualigen obtained exclusive worldwide rights from the UofL for the use of the ALAN technology.

The gold nanoparticle component of ALAN is believed to enhance radiation therapy by "magnifying" the effects of radiation on the targeted tumor cells with the potential to justify lower radiation exposure and, in turn, decrease side effects. ALAN may also potentially be used in combination with MRIs to provide higher-resolution images of solid tumors and tumor cells as special imaging dyes attach to the gold nanoparticle compound.

"With the issuance of this patent, we continue to build our intellectual property portfolio as a key component to protect our technologies under development," stated Michael Poirier, Qualigen's Chairman, Chief Executive Officer and President. "ALAN is a valuable therapeutic platform technology that may be applied in numerous indications. Currently, we are evaluating strategic options on how to develop and monetize these additional applications while we continue to advance ALAN in our development pipeline against acute myeloid leukemia."

ALAN is a DNA aptamer-based anticancer drug candidate that combines the DNA aptamer AS1411 with a gold nanoparticle to dramatically increase its potency. This drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company plans to commence Phase 1 human trials with ALAN in 2021 in patients with acute myeloid leukemia, its lead indication.

"The issuance of this patent for ALAN further protects this technology's potential broad applicability as a treatment for cancer," added Paula Bates, PhD, Professor of Medicine at UofL. "We look forward to our continued collaboration with Qualigen as we plan to enter this drug candidate into clinical trials as a therapeutic next year. We believe ALAN has the potential to be more targeted than available cancer treatments with the ability not to harm normal healthy cells resulting in less side effects for the patient."

Qualigen currently has 58 issued and pending patents and has in-licensed rights to a further 42 issued and pending patents.

About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational nucleolin-targeting DNA aptamer of ALAN, AS1411, is also a drug candidatefor use in treating COVID-19 and other viral-based infectious diseases. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Forward-Looking Statements This news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to prospects for ALAN, and the timing of the Company's proposed Phase 1 clinical trial of ALAN against acute myeloid leukemia. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices (or ALAN for imaging); that preclinical or clinical development of the Company's drugs or therapeutic devices (or ALAN for imaging) will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices (or ALAN for imaging) will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (or ALAN for imaging); that the Company will be able to maintain or expand market demand and/or market share for the Company's FastPack diagnostic products generally, particularly in view of COVID-19-related deferral of patients' physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPackinstruments on which the Company's SARS-CoV-2 IgGtest kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company's SARS-CoV-2 IgG test. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available atwww.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Qualigen, Inc.

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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival,…

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, KEYTRUDA plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in OS, PFS and ORR versus chemotherapy (treatment of physicians choice [TPC] of doxorubicin or paclitaxel). The safety profile of the KEYTRUDA plus LENVIMA combination was consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, and plan to present these results at an upcoming medical meeting.

Women with advanced endometrial cancer are faced with high mortality rates and limited treatment options following initial systemic therapy, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. These are the first results from a Phase 3 trial of a combination regimen including immunotherapy in advanced endometrial carcinoma that have shown a statistically significant improvement in overall survival, progression-free survival and objective response rate versus chemotherapy. Merck and Eisai are dedicated to continuing to research the KEYTRUDA plus LENVIMA combination and discover new approaches to address unmet needs for devastating diseases such as endometrial carcinoma.

We are encouraged by the data observed in KEYNOTE-775/Study 309, which represent a possible step forward for patients impacted by advanced endometrial carcinoma and support the results seen in the advanced endometrial cancer cohort of KEYNOTE-146/Study 111, said Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. As more clinical data from the LEAP (LEnvatinib And Pembrolizumab) program are revealed, we cannot help but be energized by the trajectory of our collaboration with Merck and the benefits we hope to provide to patients together. Most importantly, we are grateful for the trust that the patients and healthcare professionals who participated in this trial have shown us.

KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administrations (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This accelerated approval was based on tumor response rate and durability of response and was the first approval granted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Under Project Orbis, Health Canada and Australias Therapeutic Goods Administration (TGA) granted conditional and provisional approvals, respectively, for this indication.

Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in 13 different tumor types across 20 clinical trials, including a Phase 3 trial evaluating the combination in the first-line setting for patients with advanced endometrial carcinoma (LEAP-001).

About KEYNOTE-775/Study 309

KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following at least one prior platinum-based regimen. The dual primary endpoints are OS and PFS, as assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version (RECIST) v1.1. Select secondary endpoints include objective response rate (ORR) by BICR per RECIST v1.1 and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were non-MSI-H or pMMR, and 130 patients had tumors that were MSI-H or dMMR. Patients were randomized 1:1 to receive:

About Endometrial Cancer

Endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. In 2018, it was estimated there were more than 382,000 new cases and nearly 90,000 deaths from uterine body cancers worldwide (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). In the U.S., it is estimated there will be almost 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,300 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

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