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Dale Toney: A ‘wake up call’ for diabetes talk to your doctor about prevention and treatment – User-generated content

An estimated 88 million Americans have prediabetes, and just over 1 in 10 have been diagnosed with type 2 diabetes. In Kentucky, nearly 12 percent of the adult population is affected by this disease. Week after week, Kentucky physicians care for patients with type 2 diabetes and the potentially debilitating complications it can cause. Unfortunately, it is also well-documented that pre-existing conditions such as diabetes can put patients at high-risk for complications should they contract COVID-19.

March 23, is American Diabetes Alert Day, and the Kentucky Medical Association (KMA) and its thousands of physician members are encouraging Kentuckians to learn more about their risk factors and family history of the disease, and to talk to their doctor about prevention and treatment options.

Dr. Dale Toomey

Diabetes is the condition in which the body does not properly process food for use as energy. Most of the food we eat is turned into glucose, or sugar, for our bodies to use for energy. The pancreas makes a hormone called insulin to help glucose get into the cells of our bodies. When you have diabetes, your body either doesnt make enough insulin or cant use its own insulin as well as it should. This causes too much sugar to build up in your blood. In those with type 1 diabetes, the body completely stops producing insulin, and this usually occurs in childhood or early adulthood. With type 2 diabetes, the body produces insulin, but the cells dont respond to insulin the way they should.

Prediabetes occurs when a patient has a higher-than-normal blood sugar level. Its not high enough to be considered type 2 diabetes yet, but without lifestyle changes, adults with prediabetes are more likely to develop type 2 diabetes. More than 8 in 10 American adults with prediabetes dont know they have it. These patients are also at risk for developing other serious health problems like heart disease and stroke.

The first step in preventing or delaying type 2 diabetes and related health problems is to screen and test for prediabetes. Patients are encouraged to talk to their physician during their annual well-visits about being screened for type 2 diabetes. Your physician can order a simple blood test for patients with risk factors for prediabetes and type 2 diabetes, which include anyone 45 years of age or older, those who are overweight or obese, people with a family history of type 2 or gestational diabetes, and those who are physically active less than three times per week.

Patients diagnosed with prediabetes can be referred to the National Diabetes Prevention Program (DPP) lifestyle change program to prevent or delay type 2 diabetes. Programs are conducted by lifestyle coaches who are trained on an evidence-based curriculum. The coach can engage and guide you through makingand sticking withlifestyle changes. When patients join the program, they get a full year of support to make their new, healthy habits stick and keep them from slipping back into old habits. Kentucky also offers diabetesself-management education and support (DSME) groups, which can help you learnto manage your diabetes as part of your daily life. More information on these programs is available here.

Type 2 diabetes prevention is a priority of Kentucky physicians. As a focus of its AIM for Better Care: Administrative Improvements in Medicine initiative, KMA seeks to eliminate barriers to care for diabetes and to provide patients with the most updated resources and education to help prevent and manage this disease.

On American Diabetes Alert Day, consider this a wake up call to talk to your physician about diabetes prevention and treatment and get on the right path to a healthier tomorrow.

Dale Toney, M.D. is President of the Kentucky Medical Association. He is a board-certified internist in Lexington and is employed by the University of Kentucky Albert B. Chandler Hospital, is an Associate Professor at the University of Kentucky College of Medicine and serves as the Division Chief of General Internal Medicine and Womens Health.

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Dale Toney: A 'wake up call' for diabetes talk to your doctor about prevention and treatment - User-generated content

Milford OB/GYN to close womens health care practice after over 30 years – Milford Daily News

MILFORD Pelvic exams, in vitro fertilization and childbirth typically aren't comfortable procedures for any woman, but Dr.Mitchell Bellucci seeks toensure that patients are secure and that he is positive but especially calm.

So calm thatpatients sometimes askhim if he'sabout to head out for vacation after work.

Everyone would always say, Well, geez, you look like youre going on vacation, said Bellucci during an interview in his office on Friday afternoon, wearing a loose-fitting button-up shirt withthe top fourbuttons undone. For me, it was convincing myself that everything was cool, even if sometimes it wasnt.

Hes been the doctor to more than 10,000 patients and has helped deliver more than 3,500 babies in his career, he said.Known for his cowboy boots, Bellucci, 66, also frequently wore flip flops and casual Hawaiian shirts.

He has a faded 1988 newspaper clipping from the Daily Newsof himself wearinga pair offull-quill ostrich boots. Those cost him around $400, he said. He wore cowboy boots so much, he ended up developing plantar fasciitis, which causes a lot of pain in the heel.

Thecowboy boots have been retired, and Bellucci is poised to do the same.

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Bellucci is retiring next month after 40 years as an OB/GYN. He'splanning to close hiswomens health care practice at 192 West St. after opening it 33 years ago. He's selling the space, which is part of the Westview Professional Building.

Over four decades, Bellucci has made his mark in advancingwomens health care, including setting up the first bone density unit at Milford Regional Medical Center, bringing womens health innovations to local television, patenting medical devices for newborns, training medical doctors on advanced laparoscopyand establishing scholarships for nurses and pre-med students.

He's gone from the swimming pool into the delivery room a few times, too.

Ive delivered no less than two dozen kids in my Speedos... well, they were swim trunks, said Bellucci, who moved to Milford to be close to the hospital (and his practice) if he was needed immediately. He has a pool athome, and has raced from there to Milford Regional several timeswith just enough time to towel off.

It's a career field he never intended to enter, but he's glad he did, he said.

Training as a medical studentwas a pivotal time for Bellucci. While growing up onLong Island, New York, knew he wanted to be surgeon, but didn't want to docancer surgery, which he thought was depressing.

From there, it was process of elimination. He thought he would be an orthopedist performing bone surgery, but found most of his time would be spentdoing hip surgery for elderly patients who stayed at the hospital for weeks, he said. Hand surgery was too long to train forand general surgery seemed too boring, he said. He considered urology, but "didnt want to look at penises and prostates all day."

Then he tried obstetrics and gynecology.

Reproduction and bringing new life into the world especially intrigued Bellucci, who has a daughter, Laura, who's 33 and a bartender in New Orleans. But on abulletin board in the hallway of his office, she's a child, peeringinto the lensof anunderwater camera. Surrounding her are photos of dozens of other babies Belluccihas helped deliver, some also now in their 30s.

Youre there at the most important timeof their lives, man. And youre part of it, he said. What other doctor gets to be with a woman in pain for eight hours, she pushes for two hours, you catch the baby, and youre the hero?Its such a neat thing to experience.

Plus, most if not all of the patients he sees are healthy and have insurance.

I like explaining things, and you have to be direct and have to not overreact, he said about making patients feel comfortable and reassured. The office even has a therapy dog "Charlie," a cockapoo who comes in occasionallyand is adored by patients, said Bellucci.

He also has aletter froma patient, written in 1994, that still makes him smile.

Hehelped a woman deliver her first baby, but she moved and delivered her second baby elsewhere. That experiencewas very upsetting, she wrote him, and said her doctor lacked a sympathetic bedside manner.

But her experience with Bellucci in Milford,by contrast, was wonderful, she wrote.She said he remained positive throughout the ordeal and joked with her to make her feel more relaxed. She wrote that she and her husbandstill laugh years later recalling when a nurse in the delivery room strapped a maxi pad to Belluccis forehead to soak up some of his sweat.

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When I went into it, there were five guys to one woman. Now theres five women and no guys, said Bellucci.

In the 1970s, about 7% of American gynecologists were female, according to the American College ofObstetricians and Gynecologists.Today, about 82%of OB/GYN residents throughout the nation are women.

About a decade ago, Bellucci wasapproached by Bryant University in Rhode Island to teach male physician assistant students who weredenied access to learn inside other women's health care practices. For about nine years, he taught one student a month.

Moremen are turning away fromobstetrics and gynecology, said Bellucci, and its still difficult for them togain accessinto that space. The upside is that physician assistants aren't going into delivery rooms anymore with positions like midwives and nurse practitioners. Rather, male physician assistants today are going into settings like emergency rooms or family practices, he said.

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When most women hit age 50 many of his patients are about thatage their estrogen drops, he said. He realized bone density was an important component to womens health, because while estrogenis the key regulator ofbonemetabolism in both men and women, menopause leads to decreased estrogen, which is associated with decliningbonemineraldensity.

Milford Regional Medical Center didnt have a bone density unit at that time, so he helped create one, he said, and he taught primary care doctors the value of testing for it.

He also helped developthe CO2 Surgical Laser,designed to treat pre-cancerous conditions like warts and lesions, and is known for his Mona Lisa Touch.

That machine, created inItaly, is a laser treatment for symptoms somewomen experience after menopause, such as painful sex. It's an alternative to hormone treatment, which can be risky for some.

A lot of women who have these problems have had breast cancer, and what do (many doctors)do? They put you on anti-estrogen and they save your life, he said. But then you say, 'Well, what about my sex life?' I think we should address that.

If you didn't see "Dr. B" at his medical practice, you might have seen him on "Pasta Playoffs," a cooking show that aired on community access television.

I used to say, If you think you can cook good food, you should go one-on-one against Grandma," said Bellucci, who enjoys cooking Italian food. "And that was the premise of the show."

Various "grandmas" competed against Bellucci in making a pasta sauce, which was thenjudged by three randomly selected customers at Caff Sorrento in Milford, said Bellucci. The showlasted five episodes, and eventually morphed into "Cooking Against Cancer," specificallybreast cancer.

Opinion: We need to help women during the pandemic and beyond

Bellucci isexcited aboutretirement and has had a rewarding career, but said itll be a tough goodbye to his practice. After closing and selling it, he's moving toRhode Island to be with his girlfriend Mary, where hell spend most of his time boating, fishing, possibly offering consulting services in the medical device industry and writing screenplays drawing from his medical knowledge.

And finally, the next time he wears a Hawaiian shirt and pair of flip flops, he really will be on vacation an extended one.

Lauren Young writes about business and pop culture. Reach her at 774-804-1499 orlyoung@wickedlocal.com. Follow her on Twitter @laurenwhy__.

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Milford OB/GYN to close womens health care practice after over 30 years - Milford Daily News

Beshear ceremonially signs 13 health bills, including one that caps price of insulin – Hoptown Chronicle

Gov. Andy Beshear signed 13 health bills into law Monday, highlighting one that caps insulin costs for about 30% of Kentuckians who need the life-preserving hormone.

The limit is $30 for a 30-day supply. This is the right thing to do and its a game-changer for those who rely on insulin to live, Beshear said. Until now, a single dose of insulin which cost between $2 and $7 to manufacture could sell for an average wholesale price of around $300 per vial.

Beshear noted that in a lawsuit he filed against insulin companies while attorney general over their unconscionable overpricing,revealed that over 10 years, the price of one insulin product went up 311%, and another rose 285%, including a rise from $325 per package in 2011 to $530 in 2017.

While these companies work to increase bottom lines and sustain market shares, he said. Kentucky families hit hardest by this price gouging can be paying more than $1,000 a month on insulin just to stay alive.

House Bill 95, co-sponsored by Reps. Danny Bentley, R-Russell, and Patti Minter, D-Bowling Green, will cap the monthly out-of-pocket cost for a 30-day supply of insulin at $30 for Kentuckians covered by state-regulated employer health plans or plans purchased on the marketplace exchange.

Minter, whose son has Type 1 diabetes,has saidthe bill will cover about 30% of insulin-dependent Kentuckians. It doesnt cover Medicare, Medicaid or self-funded employer plans except the one for state employees.

I want to be very clear, this is only a first step, Minter said. There is much more work to do but today is a very big deal. It will save lives and it will give people hope. She said that for many families, it will make the difference between bankruptcy and keeping a child alive.

In a video, Angela Lautner,Kentucky #insulin4alllegislative lead, expressed her gratitude to the lawmakers for the bill, but she too warned that more work needs to be done, saying it will help about 22,000 people.

Much more has to be done, butHB 95is a step forward, said Lautner, My chapter is here for insulin for all and thats why we must continue this momentum into the next session with urgency, with priority.

More than half a million Kentuckians have diabetes, and Kentucky ranks seventh-highest in the U.S. for diabetes prevalence. Lautner said more than one in four insulin-dependent people ration insulin due to cost.

The price cap will apply regardless of the amount or type of insulin the person with diabetes needs.

In addition to capping the price, HB 95requires health plans to provide the equipment, supplies and outpatient training and education needed to help diabetics stay healthy, and forbids any reductions from this coverage by others involved in coverage.

Thefiscal impact statementattached to the bill says it will increase premiums for health benefit plans, not including the state employee plan, by about 80 cents a month.

Bentley said thats a small price to pay to make sure diabetics keep getting their insulin because without it they can suffer amputations, loss of vision, neuropathy, ketoacidosis and even death. The costs on the medical side is much more than the cost that were going to have by helping people with insulin, he said.

Beshear also signed bills addressing these health topics:

HB 140, sponsored by Rep. Deanna Frazier, R-Richmond, will permittelehealth servicesthat were allowed to expand due to the pandemic to remain in place. The bill requires reimbursement for telehealth to be equivalent to reimbursement for the same service provided in person. I think its one of the most important bills that have been passed, Beshear said.

HB 219, sponsored by Bentley, allows pharmacies to sell hypodermic syringes and needles without a prescription. The aim is to increase access to clean supplies for people who inject drugs, which will help to decrease the risk of blood-borne diseases such as hepatitis C and HIV/AIDS.

SB 55, sponsored by Sen. Stephen Meredith, R-Leitchfield, abolishes co-payments required by Medicaid.

HB 183, sponsored by Rep. Brandon Reed, R- Hodgenville,will allowKentucky hospitals to get more money from Medicaid, based on an average commercial rate instead of the current Medicaid rate, which is often below that amount. The program would not cost the state anything, because Kentuckys hospitals have agreed to cover the cost. To get the money, hospitals will have to abide by higher quality standards that are still being decided by theKentucky Hospital Associationand theCabinet for Health and Family Services.The bill is expected to help many of the states rural hospitals; arecent reportshows that 16 of them are at risk of closing.

HB 108, sponsored by Melinda Gibbons Prunty, R-Belton (Muhlenberg County), codifies current Medicaid coverage of colorectal cancer, including screenings starting at 45 for most people and genetic cancer-risk testing, to align Medicaid and commercial coverage.

HB 50, sponsored by Rep. Kim Moser, R-Taylor Mill, will make health-insurance plans comply with a 2008 federal law that requires them to treat mental health conditions and substance use disorders the same as physical health. It also requires health insurers to file annual reports with the state to show how they are complying with federal law.

HB 276, sponsored by Moser, allows Kentuckians trained as temporary COVID-19 personal-care attendants under an executive order to apply their supervised training toward their Registered Nurse Aide certification. About 300 personal-care attendants work in Kentucky long-term care facilities, Moser said while presenting the bill to the House in February.

SB 154, by Sen. Tom Buford, R-Nicholasville, lets advanced practice registered nurses and physician assistants prescribe and supervise home-health services, as federal law has allowed them to do in the pandemic. An emergency clause ensures there would be no gap in care if the federal rule ended.

HB 448, sponsored by Rep. Bill Wesley, R-Ravenna, expands the definition of qualified mental-health professional so that it fits the states juvenile code, allowing those who work in private agencies to testify in child-welfare hearings, especially around issues of emotional injury.

SB 74, by Sen. Ralph Alvarado, R-Winchester,createsbut does not fund a dementia services coordinator in the heath cabinet to manage theAlzheimers Disease and Related Disorders Council, the state plan to address Alzheimers in Kentucky, and apply for federal funding.

HB 75, sponsored by Rep. Shawn McPherson, R-Scottsville, prohibits insurance companies from increasing rates on organ donors or dropping their coverage. It would also encourage the cabinet to develop educational materials relating to organ donation.

SB 163, sponsored by Sen. Alice Forgy Kerr, R-Lexington, expands the definition of charitable health care provider to include those that provide invasive or surgical procedures. This change was needed to allow the non-profit surgery program Surgery on Sunday in Lexington to be reimbursed for liability insurance premiums.

Beshear alsovetoed five billsthat would strip power from the governor or the executive branch. None were related to health.

(Kentucky Health Newsis an independent news service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Media at the University of Kentucky, with support from the Foundation for a Healthy Kentucky.)

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Beshear ceremonially signs 13 health bills, including one that caps price of insulin - Hoptown Chronicle

A potential role for insulin treatment during pregnancy in reducing postpartum psychological distress in maternal obesity: an administrative…

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A potential role for insulin treatment during pregnancy in reducing postpartum psychological distress in maternal obesity: an administrative...

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in…

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the first presentation of investigational data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial in an oral plenary session (Plenary Session #10191) at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Womens Cancer. The trial evaluated the combination of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer following one prior platinum-based regimen in any setting.

The study met the dual primary endpoints of progression-free survival (PFS), as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS) as well as the secondary efficacy endpoint of objective response rate (ORR), as assessed by BICR per RECIST v1.1, in the all-comer population (mismatch repair proficient [pMMR] and mismatch repair deficient [dMMR]) and in the pMMR subgroup. Median follow-up was 11.4 months for both the all-comer population and the pMMR subgroup. A statistically significant and clinically meaningful improvement in PFS was seen in the all-comer population, in which KEYTRUDA plus LENVIMA (n=411) reduced the risk of disease progression or death by 44% (HR=0.56 [95% CI: 0.47-0.66]; p<0.0001), with a median PFS of 7.2 months (95% CI: 5.7-7.6; number of events=281) versus 3.8 months (95% CI: 3.6-4.2; number of events=286) for patients who received chemotherapy (treatment of physicians choice [TPC] of doxorubicin or paclitaxel; n=416). Additionally, a statistically significant and clinically meaningful improvement in OS was seen in the all-comer population, in which KEYTRUDA plus LENVIMA reduced the risk of death by 38% (HR=0.62 [95% CI: 0.51-0.75]; p<0.0001), with a median OS of 18.3 months (95% CI: 15.2-20.5; number of events=188) versus 11.4 months (95% CI: 10.5-12.9; number of events=245) for patients who received TPC. The safety profile of KEYTRUDA plus LENVIMA was generally consistent with the established safety profiles of the individual monotherapies.

Patients diagnosed with endometrial cancer, the most common type of gynecologic cancer in the U.S., face low survival rates when diagnosed at an advanced stage or at recurrence, especially once the disease progresses after prior platinum-based therapy and is not amenable to curative surgery or radiation, said Dr. Vicky Makker, Principal Investigator and Medical Oncologist, Memorial Sloan Kettering Cancer Center. With a 38% reduction in risk of death regardless of mismatch repair status, KEYTRUDA plus LENVIMA significantly improved overall survival compared with chemotherapy in the all-comer group of patients with advanced, metastatic or recurrent endometrial carcinoma, which is very encouraging, as this arm included an investigational patient population for which more data have been sought after by the gynecologic oncology community.

In the all-comer population, the secondary efficacy endpoint of ORR was 31.9% (95% CI: 27.4-36.6), with a complete response (CR) rate of 6.6% and a partial response (PR) rate of 25.3%, for patients who received KEYTRUDA plus LENVIMA versus 14.7% (95% CI: 11.4-18.4), with a CR rate of 2.6% and a PR rate of 12.0% for patients who received TPC (ORR difference versus TPC: 17.2 percentage points; p<0.0001). For patients who responded, the median duration of response (DOR) was 14.4 months (range: 1.6-23.7) for patients who received KEYTRUDA plus LENVIMA versus 5.7 months (range: 0.0-24.2) for patients who received TPC.

In this confirmatory Phase 3 study, KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in progression-free survival, overall survival and objective response rate versus chemotherapy, said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. We are encouraged by these results that reaffirm Mercks and Eisais commitment to explore the potential of the combination to help more patients with difficult-to-treat types of cancer.

The positive results seen in KEYNOTE-775/Study 309 help confirm the currently approved use of the KEYTRUDA plus LENVIMA combination in certain patients with advanced endometrial carcinoma, said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. As this stage of disease has been notoriously difficult to treat, Eisai and Merck remain committed to addressing the unmet need of advanced endometrial carcinoma. We are grateful to the patients and healthcare providers whose participation and persistence amid a global pandemic have made this milestone possible.

Results were similar across the all-comer population and the pMMR subgroup. In the pMMR subgroup, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI: 0.50-0.72]; p<0.0001), with a median PFS of 6.6 months (95% CI: 5.6-7.4; number of events=247) versus 3.8 months (95% CI: 3.6-5.0; number of events=238) for patients who received TPC. KEYTRUDA plus LENVIMA reduced the risk of death by 32% (HR=0.68 [95% CI: 0.56-0.84]; p=0.0001), with a median OS of 17.4 months (95% CI: 14.2-19.9; number of events=165) versus 12.0 months (95% CI: 10.8-13.3; number of events=203) for patients who received TPC. The secondary endpoint of ORR was 30.3% (95% CI: 25.5-35.5), with a CR rate of 5.2% and a PR rate of 25.1%, for patients who received KEYTRUDA plus LENVIMA versus 15.1% (95% CI: 11.5-19.3), with a CR rate of 2.6% and a PR rate of 12.5%, for patients who received TPC (ORR difference versus TPC: 15.2 percentage points; p<0.0001). For patients who responded, the median DOR was 9.2 months (range: 1.6-23.7) for patients who received KEYTRUDA plus LENVIMA versus 5.7 months (range: 0.0-24.2) for patients who received TPC.

In the all-comer population, in the KEYTRUDA plus LENVIMA arm (n=406), treatment-emergent adverse events (TEAEs) of any grade led to discontinuation of KEYTRUDA in 18.7% of patients, of LENVIMA in 30.8% of patients, and of both in 14.0% of patients. In the TPC arm (n=388), TEAEs of any grade led to discontinuation of chemotherapy in 8.0% of patients. Grade 5 TEAEs of any cause occurred in 5.7% of patients in the KEYTRUDA plus LENVIMA arm and in 4.9% of patients in the TPC arm. Grade 3 TEAEs occurred in 88.9% of patients in the KEYTRUDA plus LENVIMA arm and in 72.7% of patients in the TPC arm. In the KEYTRUDA plus LENVIMA arm, the most common TEAEs of any grade occurring in at least 25% of patients were hypertension (64.0%), hypothyroidism (57.4%), diarrhea (54.2%), nausea (49.5%), decreased appetite (44.8%), vomiting (36.7%), weight decrease (34.0%), fatigue (33.0%), arthralgia (30.5%), proteinuria (28.8%), anemia (26.1%), constipation (25.9%) and urinary tract infection (25.6%). In the TPC arm, the most common TEAEs of any grade occurring in at least 25% of patients were anemia (48.7%), nausea (46.1%), neutropenia (33.8%), alopecia (30.9%), and fatigue (27.6%). Median treatment duration was 231 days (range: 1-817) with KEYTRUDA plus LENVIMA and 104.5 days (range: 1-785) with TPC.

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.

KEYNOTE-775/Study 309 Trial Design (Plenary Session #10191)

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 one prior platinum-based regimen in any setting. The dual primary endpoints are PFS, as assessed by BICR per RECIST v1.1, and OS. Select secondary endpoints include ORR, as assessed by BICR per RECIST v1.1, and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were pMMR, and 130 patients had tumors that were 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 2020, it was estimated there were more than 417,000 new cases and more than 97,000 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 more than 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2021. The five-year survival rate for 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 1,400 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.

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. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

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. Of the patients who developed pneumonitis, 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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West Virginians considering abortion need good information about the procedure; bill might keep them from getting the facts – Beckley Register-Herald

While some people whove had abortions in West Virginia regret them, and others say those decisions were best for them, they agree on the importance of accurate information.

But a bill working its way through the West Virginia Legislature would require health care professionals to provide them with one piece of information that isnt supported by research and could amount to, in the words of one state medical group, unmonitored experimentation on West Virginians seeking abortions.

Under House Bill 2982, those people would hear that it may be possible to stop a medical abortion after taking the first of two pills required for such an abortion. The bill doesnt require they be told that the assertion isnt supported by research, that its based on taking a medication that isnt approved by the U.S. Food and Drug Administration for the purpose of stopping abortions, or about the potential harm of attempting to stop an abortion.

Supporters of the bill, including some people whove had abortions, say the bill is needed because some women have regrets after beginning the procedure.

Opponents of the bill, also including people whove had abortions, say that its important for people seeking abortions to understand theyre making permanent decisions.

The bill, if it becomes law, would tell people they dont have to make a decision, that they can be wishy-washy about it, said Hunter Starks, who had an abortion while in an abusive relationship.

And you cant, Starks said. You have to make that decision, whether thats easy or hard for you. You have to make that decision.

Starks, a transgender non-binary person, said if they hadnt had that abortion, they would have been tied to that abuser for life.

Opponents of the bill also warn that its based on the unproven idea that taking progesterone after the first pill in a medication abortion can reverse the process. They note the FDA has not approved progesterone for this use, and that limited research suggests patients health and safety could be put at risk.

What does the bill do?

When a patient seeks a medical abortion, health care providers provide them with two pills. Mifepristone, the first pill, blocks the hormone progesterone. This thins the uterine lining, so the embryo wont stay implanted and continue growing. Misoprostol, the second pill, causes the uterus to contract and expel the embryo through the vagina.

The original version of House Bill 2982, sponsored by Delegate Kayla Kessinger, R-Fayette, said that providers had to tell patients that their abortion could be reversed. Lawmakers in the House of Delegates Health and Human Resources Committee changed that wording last week, so the bill now would require health care providers to tell patients that it may be possible to stop an abortion.

Delegate Todd Longanacre, R-Greenbrier and a bill co-sponsor, said the bill would help a young lady [who] realizes the error of her ways, by taking that first pill to terminate a babys life.

Its an opportunity for that young lady who may have, in a knee-jerk, emotional state-of-mind decided to take an RU-486 pill, and then woke up the next morning and thought, Oh, my gosh, what have I done? he said. This is her opportunity to save that babys life.

Its not a perfect bill, Longanacre said. But you know what, an old general from the World War II era once said and that guys name was General Patton he said a less-than-perfect plan violently executed now is better than the perfect plan executed next week. People are dying; babies are dying. This is an opportunity to save lives.

House Bill 2982 is based on the unproven idea that taking progesterone after the first pill will reverse its effects.

Research on progesterone for this use is so weak, according to a statement from the West Virginia American College of Obstetricians and Gynecologists chapter, that administering it to patients in an effort to reverse or stop abortions potentially subjects women to unmonitored experimentation, which is in direct violation of a physicians oath to care.

The bill is supported by West Virginians for Life and the National Right to Life Committee. It is opposed by both the national and West Virginia chapters of the American College of Obstetricians and Gynecologists, Planned Parenthood and the state-level reproductive rights group, WV Free.

Democrats in the House committee last week noted that a study on the effectiveness of progesterone in stopping an abortion mid-procedure was halted early because several women experienced severe bleeding, possibly because they had taken the first pill but not the second.

Researchers aimed to determine whether progesterone could be used to reverse the effects of mifepristone, preventing pregnancy termination, but three patients experienced severe hemorrhaging and had to be taken to the hospital, according to the study, published in a 2019 edition of Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists.

Delegate Barbara Fleischauer, D-Monongalia, wanted to amend the bill in committee to warn patients about possible side effects, but that amendment was rejected.

Delegate Ric Griffith, D-Wayne and a pharmacist who said he is anti-abortion, was concerned enough to oppose the bill, saying he worried taking the first pill, but not the second, could lead to birth defects.

In our desire to protect the unborn, we are potentially causing harm to the unborn, he said.

No medical professionals were called to testify during the meeting.

Karen Cross, who is from West Virginia and lobbies for the National Right to Life Committee, was present but did not testify.

Ive had two abortions, and I regret mine, Cross said in an interview following the meeting. I know so many women, who are involved in the pro-life movement even, actively, because of the decision they made to abort their children, so that they can help other women not make that mistake.

Delegate Heather Tully, R-Nicholas and an anti-abortion family nurse practitioner, voted for the bill during that meeting, but said in an interview that she did have concerns.

I would be very concerned about a non-approved FDA medication, but obviously, this procedure has been done in some places, maybe not necessarily within the state of West Virginia, or within the confines of the border, she said.

Tully, who noted that she doesnt work in reproductive medicine, said abortion pills also come with risk. Shes had patients change their minds about other procedures, she said. And patients have a right to withdraw consent, she noted.

I think that this bill, it really quite honestly strengthens the informed consent process for a patient that may change their mind, she said.

Ten states have passed similar legislation, and others are working on their own bills, according to Cross. Courts have blocked implementation in several states. Six states have the law in place, according to a March 1 statement from the pro-abortion rights Guttmacher Institute.

The House of Delegates Judiciary Committee, where delegates would normally discuss the legality of bills, passed the bill with no discussion of those court cases Thursday.

The bill is up for second reading in the House on Tuesday, during which time delegates may offer amendments. Its tentatively scheduled for a final House vote on Wednesday, and would then have to pass the state Senate and get the approval of Gov. Jim Justice to become law.

Lived experiences

While some West Virginians whove had abortions made the right decision for them and others have regrets, several people interviewed agreed on the important of being informed.

But while the bill does require doctors to tell patients about an option, it doesnt tell them anything about the lack of research supporting that option and the potential harmful effects of it.

Suzi Bragg, of Morgantown, still supports the bill. She regrets her two abortions, and would rather anti-abortion lawmakers become involved than rely on doctors.

Im 63 and to this day, I do not trust when doctors tell me things, she said.

Bragg said when she was 16 and in foster care, a young man blackmailed her into sex. She said her social workers took her to Pittsburgh for the abortion when she was about 18 weeks pregnant.

She said they injected saline into her abdomen, which was extremely painful, and held her down when she yelled for them to stop. She said the experience was extremely traumatic, because I wasnt told the truth about what would occur.

She said she was told the experience would be no more painful than menstrual cramps, and the fetus was a clump of cells. She didnt realize until seeing a Newsweek magazine later on that a fetus is more developed than that at about 18 weeks.

I remember just screaming, They lied to me, she said.

Bragg said she went on to develop post-traumatic stress disorder. She didnt want to eat. She didnt want to socialize with friends. She said the trauma was due in part to being coerced into both the act of sex, and the abortion. During a second abortion in her 20s, she declined pain medication. She felt like she deserved the pain.

Back then, information about abortion was less readily available to women, she said.

Hunter Starks, of Charleston, was 19 and in an abusive relationship when they sought their first of two abortions in 2012.

Starks, who was assigned female at birth, took pain pills for the first abortion, which was medical, so pain wasnt significant, they said, and they experienced no pain for the second, which was surgical.

Starks said they were in a fragile mindset at the time and it was mainly their partners decision, but they still dont regret the choice.

While Longanacre, the bill co-sponsor, said some abortions may be knee-jerk reactions, ACOG-WV and some West Virginians whove had abortions say the bill itself would actually encourage people to see abortion as something they dont have to be sure about.

In their statement, leaders of the state OB/GYN group wrote that if the bill becomes law, it would create an environment of confusion and stigma.

Starks already felt confused and scared going into the abortion, without doctors telling them that the decision could be stopped or reversed.

Everyone should have agency over their own decisions with their body, and doctors shouldnt be making that any more confusing or difficult, they said.

Starks does regret one thing going to the clinic alone. Protestors screamed and name-called.

Maggie McCabe, whose mother worked to start the last remaining abortion clinic in West Virginia, the Womens Health Center in Charleston, was 16 when her mother flew her to Washington, D.C., for an abortion in the days before the U.S. Supreme Court legalized abortion in its Roe v. Wade decision in 1973.

A professor at BridgeValley Community and Technical College who worked for a health insurance provider for 28 years, McCabe was just getting ready to start her life.

She said she wouldnt have wanted wishy-washy information when seeking an abortion, and said patients deserve concrete, appropriate information.

My abortion had no negative effect on me, she said. Its made me a stronger woman, because I believe in helping others in any way that I can. Telling my story is my contribution to helping other women in their decisions.

McCabe, of Charleston, criticized lawmakers for involving themselves in health care decisions and called abortion bills a form of sex discrimination.

She noted people with fewer resources and less support couldnt have flown to D.C., like she did.

The right-to-lifers are using a very offensive, very un-Christian campaign to keep women oppressed, and to keep women in a lower class controlled, she said.

Jamie Miller, an abortion rights advocate who lives in South Charleston, was almost 17 when she received an abortion.

She had already gotten approval from a mental health professional for the abortion to avoid telling her family, and saved up money.

Miller said if after all that, she arrived at her appointment and providers told her the process could be stopped or reversed, she would have wondered whether she could trust them and if she needed to attempt a possibly deadly abortion on her own.

I would have felt like they werent on my side, she said.

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West Virginians considering abortion need good information about the procedure; bill might keep them from getting the facts - Beckley Register-Herald

BV Isn’t a Sign of Cheating Here’s Why – Healthline

Although many people think otherwise, bacterial vaginosis (BV) isnt a sexually transmitted infection (STI).

Any person who has a vagina can develop it, and there are a number of factors that may lead to such an infection.

Yes, exposure to a new sexual partner is one of them. But the list also includes things like smoking and douching.

So theres no way that anyone can definitively say BV is linked to cheating.

No, BV isnt considered to be an STI even though some people have reported being told this by a clinician.

The confusion likely comes from the fact that BV can be associated with sexual activity.

For example, penetrative sexual activity can affect the natural bacterial balance in your vagina, leading to extra bacterial growth and eventually BV.

But theres little evidence that the infection can be passed between people through sexual contact, so it isnt on the STI list.

However, BV can increase your chances of contracting an STI, as the bacterial changes may lower the vaginas natural defenses.

The exact cause of BV is unknown, but its characterized by an unbalanced bacterial balance in the vagina.

However, experts have found a number of factors that may increase your risk of developing it.

This includes anything that affects the vaginas pH levels, such as douching or using irritating vaginal products.

Youre also more likely to develop BV if:

Unfortunately, there isnt an easy answer to this. Theres still much more for researchers to learn about the infection.

From using an IUD as contraception to taking up smoking or even changing the way you clean your genital area, all of these factors can lead to BV.

Because of this, theres a chance that you may not know why or even when youve suddenly developed it.

BV can go away on its own after a few days.

But if you need medical treatment, youll likely have to take a weeklong course of antibiotics. If the infections persistent, your provider may prescribe a second round.

Half of people with BV dont have any symptoms, so you may have little to deal with.

But strong-smelling vaginal discharge and irritation when urinating are typical symptoms of the infection.

Although you should seek medical advice from a doctor or other healthcare professional, you can try the following at home to lessen symptoms:

If your partner has a penis, its unlikely that theyll need treatment.

But the infection can be passed between people who have vaginas.

So if your partner has a vagina, its worth seeking medical advice for the both of you.

As doctors arent sure how bacterial vaginosis occurs or spreads, its hard to say how to prevent a recurring infection.

But there are a few simple steps you can take to help reduce your risk of developing a second bout of BV. (Most of these steps are similar to the ones you may have taken to relieve symptoms at home.)

First, its advisable to avoid putting anything that may cause irritation in or around your vagina.

This includes douches, deodorants, and perfumed cleansing products.

Instead, use water and plain soap to clean the area, sticking to showers rather than baths where possible.

When it comes to your underwear, stick to breathable, moisture-wicking fabrics, such as cotton, to avoid unwanted bacterial growth.

And wash underwear using a mild detergent, rather than a strong formula.

Finally, when having intercourse or any kind of sexual activity, ensure sex toys are clean before contact and use condoms or dental dams.

Unfortunately, recurrence is quite common, but it wont hurt to follow the above tips.

If youre worried about STIs, its better to book a test to put your mind at rest.

Symptoms to look out for include:

Thinking that your partner has been unfaithful is a little more complex.

Its natural to want to confront them, but try to take some time to think things through.

After all, your worries could be nothing more than a misunderstanding.

If you do want to speak with your partner, its often a good idea to write down the kinds of things you want to say beforehand.

You may also want to think about whether youd like to try and move forward if it turns out they have been unfaithful, or whether the relationship will have to end.

Speaking with a neutral person who has little connection to you or your partner can also help you get things straight.

When youre ready to talk, let your partner know that youd like to discuss something thats concerning you.

Try to set the conversation up in an environment that suits the both of you, whether thats in private or in public.

Start off by talking about how much the relationship means to you, as well as honesty and trust.

You can then say that you feel there might be a problem in the relationship, bringing up specific examples if needed.

Try not to be accusatory and listen to what your partner has to say. But if something doesnt feel right, dont be afraid to press them on it.

If the shoes on the other foot and your partner thinks that youre the guilty party, try to stay calm.

We tend to get defensive when were being confronted with something thats not true.

But try to put yourself in their shoes and realize that theyre likely only acting this way because they care about the relationship.

Let them talk through the issue and then attempt to understand why they think the way they do.

For example, have you been paying them less attention than usual?

Or is there something going on in their life that could be affecting their emotional state?

I hear you is a good way to start off your end of the conversation. It lets them know that youre listening and understanding where theyre coming from.

At the same time, dont be afraid to let them know if theyve upset you with such an accusation. Remember, its important for both of you to be open and honest.

Asking if youre able to move past the issue is often a good way to end things.

Itll leave you both with an understanding of where youre currently at and clear steps to take to improve the relationship if needed.

If their concern is about contracting an STI, explain that BV isnt an STI. And if theyd still like an STI test, be supportive.

Offer to go with them and get one too if youre comfortable doing so.

Most doctors recommend booking an appointment if you think you have BV, even though it can go away on its own.

This is because, if left untreated, BV can lead to pregnancy complications, pelvic inflammatory disease, or an increased risk of STIs.

So any unusual discharge, itching, burning, swelling, or soreness around the genital area warrants a call.

A healthcare professional can test vaginal discharge and fluid for the infection and prescribe the right treatment, if necessary.

Treatment usually involves a course of antibiotics, either in a pill, capsule, or cream form.

Although much more research is needed into BV, the infection is most definitely not a clear-cut sign of cheating.

So if you or a partner do experience it, try not to blame yourself or others. The cause may have nothing to do with your sex life.

Lauren Sharkey is a U.K.-based journalist and author specializing in womens issues. When she isnt trying to discover a way to banish migraines, she can be found uncovering the answers to your lurking health questions. She has also written a book profiling young female activists across the globe and is currently building a community of such resisters. Catch her on Twitter.

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BV Isn't a Sign of Cheating Here's Why - Healthline

Qualigen Therapeutics, Inc. to present at the Benzinga Biotech Small Cap Conference – GlobeNewswire

CARLSBAD, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today that Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen, and Amy Broidrick, EVP, Chief Strategy Officer will present on March 24, 2021 at the Benzinga Biotech Small Cap Conference being held March 24-25, 2021.

Qualigen Therapeutics, Inc. Presentation Details are as follows:

Investors and others invited to attend this conference event may request one-on-one meetings with representatives of the Company through the respective conference hosts or via email to Tony Schor, tony@investorawareness.com or David Kugelman, dk@atlcp.com.

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 candidate for 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. Actual events or results may differ from the Companys expectations. For example, there can be no assurance that any 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; that preclinical or clinical development of the Company's drugs or therapeutic devices 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 will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Companys owned and in-licensed patent applications; that such patents, if any, and the Companys 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 Companys prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Companys 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 FastPack instruments on which the Company's SARS-CoV-2 IgG test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgG test kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG test kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Companys SARS-CoV-2 IgG test. The Companys 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 at http://www.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.

Investor Relations:

David Kugelman, President and CEOAtlanta Capital Partners, LLC(404) 856-9157 Office(866) 692-6847 Toll Free - U.S. & Canadadk@atlcp.com

Tony Schor, PresidentInvestor Awareness, Inc.(847) 971-0922tony@investorawareness.com

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Qualigen Therapeutics, Inc. to present at the Benzinga Biotech Small Cap Conference - GlobeNewswire

Minoxidil and Shedding: Why it Happens and What to Expect – Healthline

Minoxidil (Rogaine) is a popular product for people with thinning hair. The product comes as a gel or a foam, and is meant to be applied topically to your scalp on a daily basis.

When people first start using minoxidil to restore their hair, some notice that they actually start losing more of it at least for a short period of time.

There are plenty of clinical trials and medical evidence that support the use of minoxidil for moderate hair loss caused by alopecia. But how do you know if its actually working, especially if it looks like youre losing more hair than before?

Lets cover hair loss caused by Rogaine so you can understand how common it is, what causes it, and whether you should be concerned.

Minoxidil was a drug originally developed to treat hypertension.

Researchers observed that people who had alopecia and used minoxidil for hypertension experienced hair regrowth, and the worlds most popular over-the-counter treatment for alopecia was born. People have been using minoxidil to treat hair loss since 1986.

The way that minoxidil works isnt completely clear. Whats apparent is that minoxidil decreases hair loss in some people while also increasing hair growth. It doesnt work for everyone.

Minoxidil is also classed as a vasodilator, meaning that it dilates your blood vessels so that blood flows more easily where its applied. An increase in blood circulation to your scalp could be part of why minoxidil increases hair growth.

Your hair follicles go through four phases of growth. Not every follicle is in the same phase at once. Minoxidil is believed to affect two stages of hair growth.

The anagen phase of hair growth is its growing phase. This is when the hair is being pushed out from the root. Applying minoxidil may extend the length of the anagen phase.

The telogen phase of your hair is its resting phase, when its done growing but not yet ready to fall out. In clinical trials on rats, minoxidil shortened the telogen phase of hair from 20 days to 1 to 2 days.

Minoxidils side effects are typically mild. Common side effects include mild itching and burning as well as flaky skin. Minoxidil can also cause your hair to shed, especially when you first start using it.

As minoxidil speeds up the resting phase of your hair, sometimes it falls out more quickly than it normally would.

However, minoxidil also extends the growth phase of your hair. That means that even though some hair shedding is to be expected at first, new hair growth should soon replace the hair that youve lost.

Not everyone will experience shedding as a side effect of minoxidil, while some may experience it severely. There arent statistics currently available that explore how common this particular side effect is.

You cant do much to prevent minoxidil-related shedding or even predict if youll experience it when you first start using the product.

One thing to be aware of is that the higher the concentration of minoxidil you use, the more powerful the side effect is likely to be. Using a foam with 2 percent concentration of minoxidil, for example, could cause fewer side effects than with a 5 percent concentration.

If youre seeing a lot of hair loss, you might want to switch to a less powerful dose of minoxidil. If youre concerned about hair loss and havent started using minoxidil yet, start with a lower concentration and work up to a higher one if you need it.

Results of minoxidil vary from person to person. Generally speaking, it takes about 8 weeks of consistent use to start to see results with minoxidil. After 4 months of use, you should start to see the end of hair loss and start to see hair growth.

If its been 4 months and youre still seeing hair shedding, it may not be related to minoxidil. Its also possible that minoxidil isnt the right product for you. If you see a lot of your hair falling out after 4 months of use, speak with your doctor about alternative treatments.

Minoxidil does have some other side effects in addition to hair shedding. Side effects may include:

If youre experiencing strong side effects as a result of minoxidil, call your doctor and discontinue use.

If youve been using minoxidil for several weeks and youre still seeing more hair loss than growth, see your primary care doctor or a dermatologist. They may be able to determine if hair loss is being caused by another underlying health condition.

You should always seek medical attention if you experience the following:

Some shedding is normal when you start using any topical product that contains minoxidil. If youre concerned about hair loss, this might be alarming, but its typically no cause for concern.

If shedding doesnt stop within 4 months of starting a hair regimen with minoxidil, discontinue use and speak with your doctor about other hair regrowth options.

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Minoxidil and Shedding: Why it Happens and What to Expect - Healthline

The Problem with COVID-19 Clinical Trials | In the Pipeline – Science Magazine

Lets talk about a painful subject. I am of the opinion and Im far from alone that the most reliable way to determine if a possible therapy has any usefulness is a randomized, double-blinded controlled clinical trial. I can be a bit more specific than that, even: lets make that a trial that is run with sufficient statistical power to have a good chance of providing a meaningful readout.

The worldwide coronavirus pandemic has featured some well-run trials that have truly advanced our knowledge of the disease and how to treat it. But it has featured far, far more garbage. That word was chosen deliberately. There have been too many observational trials, too many uncontrolled (or poorly controlled) ones, too many open-label ones, and above all, there have been way too many trials whose number of patients would be insufficient to tell us much of anything even if everything else had been run properly.

I am not revealing any hidden tricks of the trade here. Clinical trial design is a subject with a very large literature, and there are any number of people and organizations who can provide useful guidance on both its theoretical and practical aspects. Among these aspects are the calculations that should be made for how many patients a trial is likely to need to be well-powered enough for a clean read on its clinical endpoints. You can start to learn the basic outlines of the subject online. Now, thats not to say that its an easy subject to get ahold of. Youre going to have to estimate some of your key parameters as well as you can, among them what you think the effect size of your treatment might be, what the patient-to-patient variability might be like, the time course of treatment that might be needed, and more. Just picking the proper clinical endpoints is a subject all in itself (and its one that can have a huge effect on a trials design and on its chances for success). And at the other end of things, your inclusion criteria and patient enrollment process is a place for serious thought, too. Who should be evaluated (or definitely not evaluated) in your trial, and how long will it take you to round those people up? Where are you thinking about doing all this, anyway?

There are a wide variety of trial designs out there as well, and you can find yourself sorting through some that are clearly inappropriate to the problem at hand, some that would be great if you had about ten times as much money and time as you do, and several that at first glance look like they could all work out, but which have real-world differences that its crucial that you be aware of. You would be well advised to consult with experience practitioners before you start, to make sure youre on the right track.

Unfortunately, underpowered, badly-run, and badly designed trials have been with us for a long time. Here are some well-justified concerns from 2002, for starters, and various fields of clinical research undergo periodic bouts of soul-searching over the years about these issues. But the pandemic year has really made some of our problems more obvious. Not only do we have trouble with badly run trials, but mixing in with that is a bandwagon effect. Clinicians all over the world just piled onto some of the coronavirus ideas, and kept piling on for months and months and months.Think, for example, about the hydroxychloroquine situation. Now, I still get messages condemning me as an implacable, irrational foe of the One True Coronavirus Therapy. But its worth remembering that I started out as a Huh, I dont know how that would work, but lets look into it person, which I really think should be the default setting. And in that spirit, I was all for running trials and getting more hard data.

But what did we get? A search through clinicaltrials.gov for hydroxychloroquine|coronavirus gives you 113 trials. Whats more, thirty-six of those are still listed as recruiting patients. This is ridiculous, but its not amusing. There are some large, well-controlled data sets available that indicate that HCQ is very likely not a useful therapy, but as you can see, there are also dozens of other smaller ones that say Yes! No! Maybe! Sorta! Kinda! Kinda Not! Depends! Could Be! Who Knows? And that adds up not just to a lack of knowledge, it turns into an actual hindrance to knowledge as you try to sort through the data. The heap of fuzzy indeterminate results also fuels the extrascientific political and cultural arguments about the drug, since everyone can find some sort of support for whatever opinion they might have.

You have to think that there were other therapies that deserved a look in the clinic as compared to the forty-third, sixty-seventh, or ninety-eighth hydroxychloroquine study. Youll recall that for a while, HCQ ended up mixed into other clinical trials just because everyone wanted it or imagined that it was some sort of standard of care, and that did no one much good, either. Now, HCQ isnt the only offender, but its a big one, and I think it illustrates what we should try not to do next time.

How, then, should we try not to do that? (Update: some thoughts here on this problem from a distinguished team of authors with exactly the same concerns). Its not like the US (to pick a big example) has a National Clinical Trial Authority that passes judgment on these things. To be honest, the downsides of having such an agency might worry me even more. But letting everyone go into Headless Poultry Mode and pile up overlapping crap in the clinic isnt such a good way to go, either. You would hope for a little more coordination among major medical research centers, and youd also hope for some local university/research hospital review boards to be aware that greenlighting the East Porkford Covid-19 Treatment Study with 47 patients isnt really going to advance medical science very much. Especially when its covering the same ground as the trials kicking off in Mashed Potato Falls, Rancho Malario, and Kidneystone Pass. But Im being unfair to East Porkford some of these lackluster trials were conducted at larger institutions that should have known better. The way were set up, its down to the review boards and the sources of funding to police things better, and to keep their heads while all about them are losing theirs.

And its also down to the NIH and the CDC to lead the way more than they did during 2020. The RECOVERY trial in the UK has been an example of what can be accomplished in that line. The NIH has helped run some good trials, but weve had nothing that comprehensive in the US as compared to the UK effort, and I really wish we had. I fear that some day, eventually, were going to have a chance to do better, and I hope that we take it.

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The Problem with COVID-19 Clinical Trials | In the Pipeline - Science Magazine

Expert Speak: Hypothyroidism And Its Effect On An Unborn Child – Femina

Even studies have presented that those children, who were born out of hypothyroidism mothers during pregnancy, have lower IQ and impaired psycho-motor (mental and motor) development. But, fret not! If the condition is properly controlled and treated well, then those women with hypothyroidism can also have healthier babies.

Since the thyroid gland of the unborn child takes time to function on its own, its completely dependent on the mother for the thyroid hormones. Development and functioning of babys thyroid gland do not take place until about the end of the first trimester of pregnancy. Therefore, its suggested that women should start getting their thyroid disorder managed before conceiving so that impaired neurological functioning, stunted growth and physical deformities in the children can be avoided.

There is always best to plan for pregnancy and to consult with your physician to ensure your thyroid status and treatment are optimised prior to becoming pregnant and monitored throughout your pregnancy. However, if this does not happen and you find out you are pregnant, you should contact your physician immediately to arrange for increased testing of your thyroid functions and a potential change in your medication.

Untreated or poorly controlled hypothyroidism can also lead to:- Miscarriage- Premature birth- Pre-eclampsia - StillbirthSo, it is vital for pregnant women with hypothyroidism to take the recommended thyroid medication consistently.

How Is Hypothyroidism Treated During Pregnancy? The treatment of hypothyroidism in pregnant women is similar to that of the regular treatment. Doctors recommend synthetic T4 so that it compensates the presence of essential hormones in the body. The medication should be taken regularly so that a steady blood level of thyroid hormone gets adjusted within the normal range as the requirement of thyroid hormones increases during pregnancy. Therefore, it is a routine practice to monitor the blood level of the thyroid stimulating hormone (TSH) during pregnancy. Hyperthyroidism women can have healthy pregnancy by getting early prenatal care and working with their healthcare providers in the management of their disease.

Also read: Expert Speak: How To Lower The Risk Of Neural Birth Defects

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Expert Speak: Hypothyroidism And Its Effect On An Unborn Child - Femina

Dr. Neeraj Agarwal discusses the ongoing phase 3 CONTACT-02 study of atezolizumab/ cabozantinib in mCRPC – Urology Times

The ongoing trial is enrolling patients at 62 locations in the United States and worldwide.

Neeraj Agarwal, MD, discusses the rationale for the ongoing phase 3 randomized, open-label, CONTACT-02 study (NCT04446117) of the multikinase inhibitor cabozantinib (Cabometyx) plus the PD-L1 inhibitor atezolizumab (Tecentriq) versus second novel hormone therapy (NHT; abiraterone acetate [Zytiga] or enzalutamide [Xtandi], etc) in patients with metastatic, castration-resistant prostate cancer (mCRPC) who previously received 1 NHT to treat metastatic castration-sensitive prostate cancer, non-metastatic CRPC, or mCRPC.

Primary outcomes measures are overall survival and progression-free survival, with objective response rate as a secondary outcome measure. The target enrollment is 580 patients, and there are 62 study locations for the trial in the United States and worldwide.

Agarwal is a professor of Medicine, physician and investigator at the Huntsman Cancer Institute, University of Utah. He directs the Genitourinary Oncology Program and the Center of Investigational Therapeutics, and co-leads the Experimental Therapeutic Program.

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Dr. Neeraj Agarwal discusses the ongoing phase 3 CONTACT-02 study of atezolizumab/ cabozantinib in mCRPC - Urology Times

Letter: Sad to see Romney objecting to transgender youth participating in sports – Salt Lake Tribune

Sen. Mitt Romney, R-Utah, returns to the chamber from a short break as House impeachment managers present their second day of arguments in the Senate trial of former President Donald Trump, at the Capitol in Washington, Thursday, Feb. 11, 2021. (AP Photo/J. Scott Applewhite)

By Christine B. Helfrich | The Public Forum

| Feb. 13, 2021, 1:00 p.m.

I am sad to see Sen. Mitt Romney joining Sen. Rand Paul in objecting to transgender youth participating in school sports. Romney said, They shouldnt be competing with people who are physiologically in an entirely different category, and I think boys should be competing with boys and girls should be competing with (girls) on the athletic field.

My niece is 62 and athletically gifted. I am 55 and am blessed with double vision. We are physiologically in an entirely different category. My nieces large public school volleyball team took a state championship. My tiny private schools team did not.

Should students be subjected to humiliating physical exams to determine their fitness to participate in team sports?

Sixteen states already allow student trans athletes to compete according to their gender identification in current school records and daily-life activities. The world has not come to an end.

Just because a physician or midwife pronounces a gender at birth, based on a view of external genitalia, doesnt mean that the baby will neatly conform to that designation.

There are many variations in sexual characteristics that include internal genitals, external genitals, gonads, chromosomes, gene expression, hormone levels, and brain structure.

In fact 1.7% of the population meets the definition of intersex, which is about as common as having red hair.

Sen. Romney please get your medical information from someone who doesnt present himself as a board certified ophthalmologist despite his self-created board being out of business since 2011.

Christine B. Helfrich, Millcreek

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Letter: Sad to see Romney objecting to transgender youth participating in sports - Salt Lake Tribune

The race to treat a rare, fatal syndrome may help others with common disorders like diabetes – Science Magazine

Misfolded proteins (orange) in the endoplasmic reticulum may play a role in Wolfram syndromes many symptoms.

By Mitch LeslieFeb. 11, 2021 , 2:00 PM

Maureen Marshall-Doss says the first sign that her vision was deteriorating came when she misidentified the color of a dress. At a backyard get-together about 20 years ago, the Indianapolis resident pointed out an attractive yellow dress another woman was wearing. You see that as yellow? Shes wearing a pink dress, Marshall-Doss recalls her husband responding.

Today, Marshall-Doss is virtually blind. With help from custom made eyeglasses that magnify objects 500 times, I can see shapes, she says. But she can no longer drive and had to quit the job she loved as a school librarian. Along with her dimming vision, she has type 1 diabetes and has lost her sense of taste and smell.

Marshall-Doss is one of 15,000 to 30,000 people around the world with Wolfram syndrome, a genetic disease. For decades, the condition remained enigmatic, untreatable, and fatal. But in the past few years, insights into its mechanism have begun to pay off, leading to the first clinical trials of drugs that might slow the illness and sparking hopes that gene therapy and the CRISPR DNA-editing tool might rectify the underlying genetic flaws. Here is a rare disease that the basic science is telling us how to treat, says physiologist Barbara Ehrlich of the Yale School of Medicine.

The research could also aid more than the relatively few patients with Wolfram syndrome. Driving the diseases many symptoms is a malfunction of the endoplasmic reticulum (ER), the multichambered organelle that serves as a finishing school for many cellular proteins. Known as ER stress, the same problem helps propel far more common illnesses, including type 2 diabetes, amyotrophic lateral sclerosis (ALS), Parkinsons disease, and Alzheimers disease. Wolfram syndrome is the prototype of an endoplasmic reticulum disorder, says medical geneticist Fumihiko Fumi Urano of Washington University School of Medicine in St. Louis. Because Wolfram syndrome is simpler, says Scott Oakes, a cell biologist and pathologist at the University of Chicago, researchers think it could illuminate the mechanisms of other ER-disrupting diseases, which affect hundreds of millions of people worldwide.

In the late 1930s,four children with diabetes were going blind, and doctors were stumped. Like many other people in the United States struggling through the Great Depression, the siblings ate a paltry diet, subsisting on potatoes, bread, oatmeal, and a little milk. But after examining three of the children, Donald Wolfram, a physician at the Mayo Clinic in Rochester, Minnesota, and an ophthalmologist colleague ruled out malnutrition as the cause of their puzzling condition. Lead poisoning and syphilisthough common enoughwerent to blame, either. When Wolfram and his partner wrote up the cases in 1938, they concluded that the symptoms could be manifestations of an hereditary or acquired cerebral lesion.

The physicians were right that the syndrome eventually named for Wolfram is hereditary. Recessive mutations in the gene for a protein called wolframin are responsible for most cases, with glitches in a second gene causing most of the rest. However, the pair was wrong to think the defect lies only in the brain. Instead, the symptoms stem from widespread cell death. Its definitely a disease that affects the whole body, Marshall-Doss says.

The first sign of the illness, appearing when patients are children, is usually diabetes mellitus, or faulty sugar metabolism, sparked by the demise of insulin-secreting beta cells in the pancreas. Most patients also develop the unrelated condition diabetes insipidus, in which the pituitary gland doesnt dole out enough of a hormone that helps control the bodys fluid balance, causing the kidneys to produce huge amounts of urine.

Mutations in the gene for wolframin disrupt the endoplasmic reticulum and lead to cell death throughout the body, causing a range of symptoms.

V. Altounian/Science

Ellie White, 19, of Centennial, Colorado, who was diagnosed with Wolfram syndrome 12 years ago, says she hasnt had a full night of sleep since she was 3 years old. She gets up again and again to use the bathroom and monitor her blood sugar.

Yet she and other patients say that as disruptive as those problems are, they are not the diseases most dismaying consequence. The biggest symptom of Wolfram syndrome that affects me the most is my vision, White says. Because neurons in the optic nerve perish, patients usually go blind within 10 years of their first visual symptoms.

Other neurons die as well. As the disease progresses, brain cells expire, and walking, breathing, and swallowing become difficult. Most people with Wolfram syndrome die before age 40, often because they can no longer breathe. At 57, Marshall-Doss is one of the oldest patients; one of her mutated genes may yield a partly functional version of wolframin, triggering a milder form of the disease, Urano says.

Two advanceshave made it possible to begin to tackle those symptoms. The first was Uranos discovery nearly 20 years ago that linked Wolfram syndrome to ER stress. The ER is where about one-third of a cells newly made proteins fold into the correct shapes and undergo fine-tuning. Cells can develop ER stress whenever they are under duress, such as when they dont have enough oxygen or when misfolded proteins begin to pile up inside the organelle.

In test tube experiments, Urano and his colleagues were measuring the activity of genes to pinpoint which ones help alleviate ER stress. One gene that popped up encodes wolframin, which scientists had shown in 1998 was mutated in patients with Wolfram syndrome. Following up on that finding, Urano and his team determined that wolframin takes part in whats known as the unfolded protein response, which is a mechanism for coping with ER stress in which cells take steps including dialing back protein production.

Scientists think wolframin plays a key role in the unfolded protein response, though they havent nailed down exactly how. When wolframin is impaired, cells become vulnerable to ER stress. And if they cant relieve that stress, they often self-destruct, which could explain why so many neurons and beta cells die in the disease.

Defective wolframin may harm cells in other ways. The ER tends the cells supply of calcium, continually releasing and absorbing the ion to control the amount in the cytoplasm. Changes in calcium levels promote certain cellular activities, including the contraction of heart muscle cells and the release of neurotransmitters by neurons. And wolframin affects calcium regulation.

Beta cells genetically engineered to lack functional wolframin brim with calcium, Ehrlich and colleagues reported in July 2020 in theProceedings of the National Academy of Sciences. When exposed to lots of sugar, the altered cells release less insulin and are more likely to die than healthy beta cells, the team found. The cells share that vulnerability with beta cells from patients with Wolfram syndrome. We think that excess calcium is leading to excess cell death, Ehrlich says.

ER malfunctions could hamstring other organelles as well. The ER donates calcium to the mitochondria, the cells power plants, helping them generate energy. In 2018, a team led by molecular biologist Ccile Delettre and molecular and cellular biologist Benjamin Delprat, both of the French biomedical research agency INSERM, discovered that in cells from patients with Wolfram syndrome, mitochondria receive less calcium from the ER and produce less energy. Those underpowered mitochondria could spur the death of optic nerve cells, the researchers speculate.

Fumihiko Urano holds dantrolene, a muscle relaxant drug he helped test as a treatment for Wolfram syndrome.

The link between ER stress and Wolfram syndrome has been crucial for identifying potential treatments because otherwise we would have nothing to target, Urano says. But a second development was also key, he says: the advocacy and support of patient organizations, such as the Snow Foundation and the Ellie White Foundation, headed by its namesakes mother. The foundations have stepped up with money for lab research and clinical trials when other sources, including government agencies, didnt come through.

Scientists, patients, and their advocates say Urano also deserves much of the credit. Besides treating patients, he heads the international registry of cases and has taken the lead in organizing clinical trials, screening compounds for possible use as treatments, and devising potential therapies. Fumi is clearly the driving force, says Stephanie Snow Gebel, co-founder of the Snow Foundation, who about 10 years ago helped persuade him to forgo a plum job as department chair at a Japanese university and take over the Wolfram program at Washington University.

Patients could soonstart to reap the benefits. In 2016, Urano and colleagues started the worlds first clinical trial for the disease: a phase 1/2 study of dantrolene, an approved muscle relaxant. The molecule was a top performer when they screened 73 potential treatments for their ability to save cells with terminal ER stress. Dantrolene didnt improve vision in the 22 participants, including White, the scientists reported in an October 2020 preprint. But in some patients, beta cells appeared to be working better and releasing more insulin. The drug is safe, but Urano says it will need to be chemically tweaked to target its effects before future trials are warranted.

Researchers are pursuing other possible treatments targeting ER stress or calcium levels. In 2018, U.K. scientists launched a trial that will include 70 patients to evaluate sodium valproate, a therapy for bipolar disorder and epilepsy that, in the lab, prevents cells with faulty wolframin from dying. Last year, another compound that emerged from Uranos screens, the diabetes drug liraglutide, entered a clinical trial. Also last year, an experimental drug developed by Amylyx Pharmaceuticals for Alzheimers disease and ALS received orphan drug designation from the U.S. Food and Drug Administration for Wolfram syndrome because it curbs ER stress. That designation offers tax breaks and other incentives, and it will get trials started sooner, Urano says.

Ehrlich and her team have a candidate of their own that they have begun to test in rodents: the drug ibudilast, which is approved in Japan to treat asthma. The researchers found it reduces calcium levels in beta cells lacking wolframin and boosts their survival and insulin output. New screening projects may reveal still more candidates.

But Urano knows that even if a treatment receives approval, it would be only a Band-Aid for Wolfram syndrome. Hoping to develop a genetic cure, he and colleagues are introducing replacement genes into cells from patients and from mice engineered to replicate the disease. The researchers are endowing the cells with healthy copies of the gene for wolframin or the gene for a protein that reduces ER stress to determine whether they restore cellular function and reduce cell death. At INSERM, Delettre and colleagues are also evaluating whether directing a working gene into optic nerve cells can curtail vision loss in mice with faulty wolframin. The scientists are still gathering data, but early results suggest the treatment can halt the deterioration.

Urano and his collaborators have also turned to the genome editor CRISPR, deploying it to correct the gene defect in patients stem cells and then growing them into beta cells. When the researchers transplanted the revamped cells into mice with diabetes, the animals blood sugar returned to healthy levels, the team reported in April 2020 inScience Translational Medicine.

Stem cell biologist Catherine Verfaillie of KU Leuven is collaborating on the CRISPR research. But she notes that because the faulty wolframin gene affects so many tissues, researchers will have to figure out how to deliver the CRISPR components to most cells in large organs such as the brain and livera prospect she calls pretty daunting. Urano agrees, predicting that CRISPR-based Wolfram therapies might take 10 to 20 years to develop. The alternative approach, gene therapy, could reach clinical trials more quickly, in 3 to 10 years, he says, because researchers have more experience with gene therapy and have created several treatments that have already been approved for other illnesses.

Because it stems from a single genetic glitch, Wolfram syndrome could also help scientists tease out the role of the ER in more complex diseases, including neurological conditions, type 2 diabetes, and cancer. The ER also falters in those diseases, causing cells to die, but the mechanism is harder to discern because they stem from myriad genetic and environmental factors. In Alzheimers disease, for instance, neurons develop ER stress as misfolded proteins accumulate inside and outside the cells.

Besides deepening researchers understanding of other conditions, the research on Wolfram syndrome might even deliver candidate treatments. Everyone would be very excited if we can make advances in targeting ER stress in Wolfram syndrome, Oakes says. It would open up the whole field to doing this in other degenerative diseases.

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The race to treat a rare, fatal syndrome may help others with common disorders like diabetes - Science Magazine

Ask a Castle Connolly Top Doctor: How Aging and Gravity Affect Your Skin – Everyday Health

Buckingham:For starters, I want to emphasize the importance of preventing your skin from aging in general, starting when youre young. When you go outside in the sun, wear protective hats, sunglasses, clothing, and sunscreen.

Your overall health impacts skin health too, so I recommend eating a healthy diet and exercising and not gaining excess weight.

People ask me what the most important components of skincare are, and I think its helpful to view those priorities in the same way we use the food pyramid to eat the right amount of certain foods for a healthy diet.

On that base layer of the pyramid is sunscreen, thats the most important thing. Put that on after using a good facial cleanser to wash away the dirt and oil on your face.

The middle box is a vitamin A derivative such as retinol or Retin-A. We have research that shows if you use these products consistently, you can increase your collagen production and your elastin as well as increasing the epidermal turnover. This can keep the skin looking healthy and less dull. The little box at the top of the pyramid is topical antioxidants like vitamin C, peptides, and pigment-reducing agents.

Once you have that good skincare foundation, there are interventions we can do to reverse the effects of aging.

These include neuromodulators, such as Botox, which can temporarily cause the muscle to not contract as robustly as it should, which reduces the appearance of wrinkles.

Microneedling uses a pen-shaped or roller device with fine needles that penetrate the dermal level and create very tiny punctures in the skin. It heals within a day and promotes the growth of new collagen and elastin. Radiofrequency microneedling uses an actual plastic plate that has needles embedded in it that are stamped or inserted into the skin. While the needles are in the face, it emits radio frequency heat energy, which amplifies the effect of microneedling.

There are several laser treatment options depending on the amount of intervention needed. By using concentrated light in different wavelengths, these treatments can rejuvenate skin by increasing the production of collagen and elastin.

Chemical peels can range from very light peels that cause just a small amount of flaking to more intense peels that can require up to 10 days of recovery and continuous application of healing ointment.

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Ask a Castle Connolly Top Doctor: How Aging and Gravity Affect Your Skin - Everyday Health

All You Need to Know About a Heart Doctor Before Your Visit – Chiang Rai Times

According to cardiologist the prevalence of heart disease has transcended most diseases worldwide to be the leading cause of death. With 17 million people perishing from cardiovascular diseases worldwide, every year, the need to visit a heart doctor is rapidly expanding.

Heart doctors or cardiologists specialize in treating cardiovascular diseases by first observing the heart from multiple levels. An extensive examination is done to determine the root cause of the problem and find ways to heal the patient. Heart doctors also educate their patients on how to best take care of their hearts through lifestyle and diet choices and preventive medicine.

Cardiologists or heart physicians go through medical school before focusing on the heart specialty. With four years of medical school below their belt, they should have an additional three years of medical training specific to cardiology. This training seeks to prepare them for their fellowship, which requires another three years. Overall, a typical cardiologist has the minimum practice of around ten years before they start working professionally. Some have longer due to research degrees or additional fellowships.

Additional skills and interests of heart doctors include the willingness to motivate the patient and make critical judgments about management often after a complex decision making process. Being able to communicate efficiently and effectively with patients and staff is also important. Heart doctors should be confident and always be willing to learn more about the heart and vascular system.

There are telltale symptoms of heart problems that individuals should look out for and aim to seek medical attention as soon as possible:

When experiencing trouble breathing, it is best to see a cardiologist for assessment. Breathing should come naturally, and shortness of breath is a reason for concern.

Low blood flow to the brain can cause loss of consciousness or dizziness and light-headedness. It is important to ensure this is not caused by the heart, ie a heart arrhythmia. A visit to the heart doctor will examine the reasons why the heart isnt pumping blood to the brain.

An unstable sensation, dizziness can indicate the lack of adequate blood flow to the brain, potentially indicating a heart problem.

The occurrence of irregular heartbeats such as palpitations or a racing or erratic heartbeat might indicate heart disorders, warranting the heart physicians visit all the most crucial. Heart flutters also indicate the need for immediate treatment.

This can be due to various reasons, one of which might be angina or heart attack, caused by lack of enough oxygen reaching the heart. It is best to see your physician immediately to correct the diagnosis before the chest pains escalate to something much worse. The pain can sometimes spread to the arm, back, or jaw. Patients can also sometimes experience sweating and shortness of breath alongside the pain.

When visiting the heart physician, the patient will first answer several questions to determine the condition of their heart. These questions range from drug and family history to lifestyle habits, and their list of symptoms.

Next, the physician will conduct a series of tests to try and identify the cardiovascular conditions that the patient might have. These tests include:

An electrocardiogram tests the electrical activity of the heartbeat. This test examines the reason for chestpains, dizziness, and irregular heartbeats. This procedure involves attaching electrodes on your chest, arms and legs, and attaching them to the EKG machine, which records the hearts activity and records the information on a graph. This procedure is painless and takes around ten to fifteen minutes.

This test seeks to understand how the heart performs at a time when it requires the most blood flow, stress. The patient is attached to an EKG machine while on a treadmill. The heart physician monitors the ECG or echocardiogram to determine whether enough oxygen through proper blood flow is directed towards the heart.

The patient lies on a bed and a technician or heart specialist uses an ultrasound machine to look at the structure and function of the heart, and its valves. The test takes 20-30 minutes and no X-rays are used.

This procedure involves introducing a catheter to the blood vessel until it reaches the heart to diagnose heart problems. The catheter is injected with a dye, which exposes irregularities or blockages of the heart arteries.

After these tests, the heart physician will diagnose the results and advise on a suitable treatment plan. Depending on the heart condition, the heart physician will prescribe medications and advice on preventive and lifestyle changes. More severe complications will require heart surgery, depending on the situation.

It is paramount to maintain healthy lifestyle practices that will help prevent a visit to the cardiologist. Such practices include:

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All You Need to Know About a Heart Doctor Before Your Visit - Chiang Rai Times

Yes, you can overdose on melatonin here’s how to find your proper dosage – Insider

Melatonin is a hormone your body naturally produces to induce sleep. It can also be purchased as an over-the-counter oral supplement to help ease insomnia or reset your body clock after traveling to a different time zone.

Melatonin is generally safe and effective in low doses, but you can overdose which can cause adverse side effects. Here is what you need to know about the side effects of melatonin and how to determine how much to take.

Low doses of melatonin cause relatively few side effects, but it is possible to take too much, says Nicole Avena, PhD, an assistant professor of neuroscience at Mount Sinai School of Medicine in New York City.

Melatonin supplements are not regulated by the US Food and Drug Administration (FDA) and therefore have no standardized dose. The typical dosage found in stores ranges from about one to five mg but can be found in doses as high as 10 mg.

Overdosing on melatonin can lead to side effects, including:

It's hard to say exactly how much melatonin is too much since there is no standardized dose, but it's best to start with the lowest dose possible and work up from there, says Alex Dimitriu, MD, founder of Menlo Park Psychiatry and Sleep Medicine in Menlo Park, California.

There is no known lethal dose of melatonin and no reports of death from taking too much melatonin, Dimitriu says, but taking too much can disrupt your natural circadian rhythm and internal body clock, causing you to actually have more trouble falling asleep.

What the research says: Some studies have shown that cancer patients can benefit from large doses of melatonin ranging from 20mg to 1,000mg, but these doses are generally not recommended for those with no underlying medical conditions.

The effects of taking large doses of melatonin don't appear to be lethal, Dimitriu says, but more research is needed to determine the long-term health implications of melatonin use and the effects of doses larger than 30mg.

The right dose of melatonin for you is the lowest possible dose that can help you sleep with minimal side effects, Dimitriu says. This can vary by individual.

General advice: For most people, a melatonin dose of 0.5 to 5 mg can effectively help them fall asleep. If you find this dose isn't effective, you can increase it from there under the guidance of your doctor.

Melatonin should only be used occasionally unless you have otherwise been instructed by a physician, Avena says. Melatonin is considered safe in low doses for short-term use, but there is little data available on its long-term effects and more research is needed to determine overall safety.

If you find you are relying on melatonin in order to fall asleep every night, Avena recommends lowering your dosage slowly. You may experience a few nights of less than great sleep as your body adjusts.

Relaxation techniques like meditation or breathing exercises can help you fall asleep without the help of a melatonin supplement.

"It is more important to have healthy sleep habits and a regular sleep schedule, exercise, and minimal stress, than to rely on any supplement, including melatonin for sleep," Dimitru says.

Melatonin is not addictive, but taking it every night can cause you to rely on it as part of your bedtime routine.

"People can become psychologically or biologically dependent on any supplement or medication they take, especially with sleep. People start associating substances and behaviors as part of the bedtime routine," Dimitriu says. "The bedtime routine may suffer if some of the parts are missing, whether it be a favorite blanket, bed, or supplement like melatonin."

It is impossible to become physically dependent on melatonin like you could with other substances, like alcohol, Avena says, but you can come to rely on it as a sleep association.

If you find you are needing to take melatonin every night to sleep, you may have another health condition, like anxiety or a sleep disorder that is affecting your ability to sleep, Dimitriu says.

"With melatonin, it is important to maintain healthy habits besides just using a supplement," Dimitriu says, "Our bodies and minds, if healthy and not anxious should be able to sleep naturally."

In small doses, melatonin supplements are a safe and effective way to help you fall asleep, but more research is needed to determine the long-term effects of taking melatonin regularly.

There is no known lethal dosage of melatonin, but taking more than 10 mg can cause side effects, like daytime drowsiness and headaches.

If you are relying on melatonin to sleep, talk with your doctor about ways to improve your sleep hygiene.

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Yes, you can overdose on melatonin here's how to find your proper dosage - Insider

Hooters Will Give You Free Wings For Shredding a Pic of Your Ex – q985online.com

Happy national "Satisfied With Being Single Day"!

I love that this falls right before Valentine's Day. It's a great way to embrace the solo life. It's also a great day to print out a picture of your ex. I know it sounds counter productive, but it's actually going to benefit you this weekend.

The benefit? Free wings. What's better than that? Hooters does this hilarious thing every year where they want to help you get over your ex, and in return they'll also give you some free food.

So I went to go check if the Hooters in Rockford is one of the participating locations, and it led me to a virtual survey about my ex. So of course I took it. Here's what the survey looked like -

So after I chose some of the hilarious options, they lead me here.

Then they made me pick a picture, and I wasn't really trying to shred an ex. So I picked a picture of the 97ZOK logo (oops).

Well, here we go.

I'M SORRY 97ZOK! I didn't mean it!

After all that virtual shredding, I was finally prompted to enter my information for a coupon to the Rockford location. So if you have an ex you're ready to get over, and you're also a wing lover, then this is the perfect way to celebrate Valentine's Day.

Also, I still recommend printing out a picture to ACTUALLY shred. Sounds like a great way to get over someone.

H/T DELISH

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Hooters Will Give You Free Wings For Shredding a Pic of Your Ex - q985online.com

More than 4.6 million US adults have peanut allergies, Northwestern University study finds – PhillyVoice.com

Though a peanut allergy is generally considered a pediatric issue, many people don't develop one until after turning 18 years old.

More than 800,000 of the 4.6 million U.S. adults who have peanut allergies didn't develop them until after reaching adulthood, according to a new study. That equates to 17% a larger percentage than previously believed.

The reasons behind late-onset peanut allergies are not completely understood, but the Northwestern University researchers who conducted the study suggest environmental factors and hormone fluctuations may play a role.

Other experts said a delayed or extended period of sensitization to peanuts could also be to blame or even a cross-reaction to some other allergens such as pollen. Research is ongoing to improve diagnosis, management and treatment of peanut allergies.

"Given the high prevalence of peanut allergy among U.S. adults, additional therapies are needed to help address this growing burden of disease,"Dr. Ruchi Gupta, director of the Center for Food Allergy and Asthma Research at Northwestern University,toldUPI.

The study's findings, published inThe Journal of Allergy and Clinical Immunology, stem from a survey of more than 40,000 adults.

Though 2.9% of respondents reported having peanut allergies, researchers found only 1.8% actually had convincing peanut allergies.Gupta said it is important for adults who think they have developed peanut allergies to be diagnosed by a physician instead of just avoiding peanuts.

Their doctors can teach them how best to avoid exposure and prescribe epinephrine, an emergency treatment for anaphylaxis, a severe allergic reaction.

Gupta also toldCNNthat more adults than children have peanut allergies. Only 15 to 20% of children with a peanut allergy will outgrow it by adulthood.

People who said they developed peanut allergies in adulthood were less likely to have been diagnosed by a physician compared to adults whose allergies emerged during childhood, researchers found.

They also were more likely to report multiple food allergies.They were less likely to have an epinephrine prescription 44% compared to 56%.

A food allergy develops when the immune system mistakenly labels the food as a threat and launches an attack against it, Harvard Health experts say.

For people with peanut allergies, even a small amount of peanuts can cause a serious, possibly life-threatening reaction. Symptoms usually start minutes after exposure, according to the Mayo Clinic.

The most common symptoms include skin reactions such as hives or redness, an itching or tingling in the mouth or throat, nausea or vomiting, tightening of the throat and wheezing.

Any severe reaction requires treatment with an epinephrine autoinjector and an emergency department visit. Anaphylaxis symptoms include trouble breathing, a sharp drop in blood pressure, a rapid pulse, dizziness and loss of consciousness.

Peanut allergies are a leading cause of fatal and near-fatal anaphylaxis. People who suspect they may have peanut allergies should get evaluated by their physicians as soon as possible.

The U.S. Food and Drug Administration has not approved any therapies for adults with peanut allergies, An oral immunotherapy has been approved for patients 4 to 17 years of age to help desensitize them to peanuts.

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More than 4.6 million US adults have peanut allergies, Northwestern University study finds - PhillyVoice.com

Causes and Signs of an Enlarged Thyroid – Health Topics, Men’s Health, Women’s Health – Hackensack Meridian Health

February 8, 2021

Theres a good reason medical checkups typically include a quick but gentle pat-down of your neck area by health care providers. Among other conditions, theyre looking for a goiter, an enlarged thyroid gland that may spell health problems but can also be harmless.

Goiters affect about 16 percent of people worldwide, ranging from just under 5 percent in the United States to 28.3 percent in Africa, according to the National Institutes of Health. But the most common cause of goiters globallya lack of the nutrient iodineisnt a significant issue in the U.S., where iodized salt is routinely used.

In our country, many goiters are idiopathic, meaning we dont know the reason why they occur, says Alexander Shifrin, M.D., an endocrine surgeon at Jersey Shore University Medical Center.

Still, various risk factors can make it more likely that youll develop a goiter. These include:

Located at the base of the neck, the thyroid produces hormones that regulate a variety of crucial bodily functions, ranging from helping us keep warm and use energy to fueling proper function of organs and muscles. The development of a goiter doesnt mean the gland isnt working. But this enlargement, which can happen slowly or quickly, may also signal the thyroid is making too much or too little hormone.

What signs of a goiter should you watch for? Dr. Shifrin says size matters. Watch for an enlargement of the thyroid, he says, including swelling at the base of your neck. Every enlarged gland should be checked for cancer.

According to the American Thyroid Association, you should also watch for these signs:

Most goiters arent cancerous, Dr. Shifrin says, but you should still have it checked by your primary physician or an endocrine specialist. Blood tests alone cant usually determine if thyroid cancer is present. Ninety percent of thyroid cancers are detected by palpating the gland and a thyroid ultrasound, Dr. Shifrin says.

The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.

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Causes and Signs of an Enlarged Thyroid - Health Topics, Men's Health, Women's Health - Hackensack Meridian Health

A Cue-to-Action Pilot Project to Increase Screening Mammography – AJMC.com Managed Markets Network

Study Design: Cohort study design with retrospective and prospective components.

Methods: Women were eligible to participate in accordance with the CMS Quality Rating System technical specification for breast cancer screening. Eligible women with no documented screening for a mammogram from January 1, 2016, through November 7, 2017, were invited to participate in a campaign that included outreach about screening mammography as a no-cost covered benefit, education about screening mammography to detect asymptomatic disease, and a gift card to a local grocery merchant if the member obtained screening mammography by December 31, 2017.

Results: During December 2017, 20.8% (27/130) of eligible women obtained a screening mammogram compared with 7.8% (5/64) of eligible women during the nonintervention reference period of December 2016. Mammography screening increased by 170% during the study period in comparison with the reference period of a year earlier (prevalence ratio [PR], 2.7; 95% CI, 1.1-6.6; P=.02).

Conclusions: A one-time, time-limited cue-to-action pilot project consisting of outreach, education, and incentive increased uptake of screening mammography by women enrolled in a community health insurance plan providing health insurance coverage as part of the Affordable Care Act. This increase is statistically significant in the intervention period compared with the reference period (PR, 2.7; 95% CI, 1.1-6.6; P=.02). Despite a small sample size, the magnitude of the effect for this pilot study is encouraging and warrants future studies in a larger population.

Am J Manag Care. 2021;27(2):In Press

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Takeaway Points

Managed care organizations (MCOs) can help members achieve positive health outcomes through the consistent use and application of quality improvement activities. We demonstrated that an MCO can effectively target members to improve uptake of a preventive service through a series of cues to actions. MCOs should consider the findings from this pilot project as evidence that outreach, education, and incentives play a role in member decision-making with regard to using preventive services. This research also demonstrates that MCOs can effectively encourage members to use free, covered benefits available to them as part of the Affordable Care Act.

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Breast cancer is the most common cancer among women in the United States.1 The National Cancer Institute estimated that the number of new breast cancer cases and the number of deaths from breast cancer among women would approach 268,600 and 41,760, respectively, in 2019.2 However, despite these numbers, the population-adjusted mortality rate for breast cancer decreased by 36% from 1989 through 2012.3 This reduction is due to a variety of factors, including improved chemotherapeutic treatments, reduced hormone replacement use among women, and the continued use of screening mammography to identify breast cancer among asymptomatic women.3 Case-control studies show a reduction in breast cancerrelated mortality ranging from 36% to 70% for women who obtain screening mammography.4

In the United States,5 as in many countries around the world,6-8 national health officials have developed evidence-based guidelines to promote screening mammography among asymptomatic women. Guidelines from the US Preventive Services Task Force (USPSTF) indicate that women of average risk aged 50 through 74 years will receive the most benefit from regular biennial screening.5 With the introduction of the Patient Protection and Affordable Care Act (ACA), screening mammography became a covered, no-cost, preventive service.9

METHODS

Study Setting

Sendero Health Plans is a community-based health insurance plan serving an 8-county area of central Texas that offers health insurance on the ACA federal marketplace. In 2017, as part of its ongoing quality improvement focus, Sendero sought to increase uptake of screening mammography for members enrolled in its ACA line of business based on the USPSTF recommendation for mammography screening.10

Theoretical Basis

We used both the health belief model and the transtheoretical model as a basis for this pilot project. The health belief model includes a variety of theoretical constructs, such as perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action, to guide health promotion activities.11 The health belief model has been used to predict health behaviors for a variety of clinical issues, including screening for asymptomatic disease12 and helping to improve breast cancer screening rates among asymptomatic women.13-15 In this pilot project, we used cues to action to provide an overt action (ie, outreach and education) as a stimulus to asymptomatic women aged 52 to 74 years to undertake a known preventive intervention to identify breast cancer. In addition, a financial incentive, which is rooted in the transtheoretical model, was used to encourage women who may otherwise be ambivalent to undertake this health-seeking behavior to undergo screening mammography.16

Study Design

We conducted a pilot project using a cohort study design to determine if cues to action involving outreach about screening mammography as a no-cost benefit, education about screening mammography to detect asymptomatic disease, and a financial incentive using a gift card to a local grocery merchant would encourage women to obtain a screening mammogram. We focused on a time-limited, 6-week pilot project from November 17, 2017, through December 31, 2017. Women were identified and eligible to participate in this study based on the following inclusion and exclusion criteria (Figure 1).

Women had to be eligible to receive a screening mammogram based on the CMS Quality Rating System technical specification for breast cancer.17 Using this technical specification, we identified 277 women aged 52 to 74 years who were continuously enrolled in the Sendero IdealCare plan for the period October 1, 2015, to December 31, 2017.

We adjusted this group to include only 2 full years of data for analysis, removing 10 women who were eligible in the period from October 1, 2015, through December 31, 2015. This resulted in 267 women eligible for screening mammography in calendar years 2016 and 2017.

We identified all women in the 2016 and 2017 time period who had not received a screening mammogram by November 7, 2017, based on submission of a medical claim for Current Procedural Terminology code 77067 or Healthcare Common Procedure Coding System code G0202. One hundred women were identified. These women are defined as the population eligible for this study.

Women were not randomized or otherwise allocated to an intervention or nonintervention group, as it was deemed unethical to restrict individuals from receiving a secondary prevention examination with known positive health benefits.

Study Intervention

This study consisted of 3 interventions, all of which were targeted at women aged 52 to 74 years. The interventions were (1) outreach to inform women that screening mammography is a benefit available to them at no additional out-of-pocket cost as part of their Sendero health insurance; (2) educational information about the exam (adapted from material produced by the CDC), the benefits of screening mammography, and how to prepare for and what to expect on the day of the exam11; and (3) an incentive of a $50 gift card to a local grocery merchant to women who completed the screening mammography exam by December 31, 2017.

Materials were mailed to eligible women on November 17, 2017, just prior to the US Thanksgiving holiday period. Follow-up text messages were sent 12 days later on November 29, 2017. Follow-up phone calls were initiated between December 4 and December 21, 2017, some 17 days after the initial mailing, to assist women with scheduling a mammogram appointment or to answer questions about screening mammography. All written materials, texts, and phone calls were provided in English and Spanish.

A member of the research team (N.T.) who is bilingual in English and Spanish made follow-up phone calls to women eligible for the campaign. A script was developed, and the research team member was trained on how to use the script, how to address comments or questions not in the script, and how to provide scheduling assistance if requested. Calls were recorded for quality assurance purposes but were not monitored or reviewed at a later date. After identity verification, the member was asked if she:

Statistical Analyses

Data were obtained from medical claim submissions and included the date on which screening mammography occurred, the county and zip code of the individuals residence, and the individuals age in years. Data on income and federal poverty levels by county were obtained from the US Census; such data are not reported to Sendero by federal officials and, therefore, we do not have the ability to provide member-level data analysis on this information.18 Similarly, data on race and ethnicity are not provided to Sendero by federal officials.

Descriptive statistics included age and proportion of women eligible to participate in the health promotion campaign and were based on full-year data in 2016 and 2017, respectively. Chi-square goodness of fit tests were used to test the hypothesis that there is no difference by month when women choose to obtain a screening mammogram. A separate 2 test was conducted for each calendar year, as well as for the 2-year period of the study. A prevalence ratio (PR), the 95% CI, and a P value were calculated to compare the prevalence of women screened in the intervention period (December 2017) with the reference period of a year earlier (December 2016).

RESULTS

One hundred women were eligible to participate in the outreach, education, and incentive campaign. These 100 women were represented by 46 zip codes. Twenty-five zip codes were located in Travis County, 9 in Williamson County, 6 in Bastrop County, 3 in Hays County, 2 in Caldwell County, and 1 in Fayette County. Among these 46 zip codes, the median household income ranged from $38,100 to $136,138 and the percentage of people living at or below the federal poverty level ranged from 2.1% to 30.6%.18

Twenty-seven of the 100 individuals eligible for this intervention obtained a screening mammogram during the assessment month of December 2017. By comparison, 5 women obtained a screening mammogram during the reference period of December 2016. Women who received the intervention were 170% more likely to be screened in December 2017 compared with December 2016 (PR, 2.7; 95% CI, 1.1-6.6; P=.02).

During 2016 and 2017, 194 women obtained a screening mammogram (Table 1). The number of women who obtained a screening mammogram varied by month during 2016 (211=14; P=.23), during 2017 (211=42.62; P<.001), and across the 24-month reporting period of January 1, 2016, through December 31, 2017 (223=88.80; P<.001) (Table 2 and Figure 2). The difference was not significant in 2016, but it was statistically significant during 2017 and during the overall 2-year observation period. In both 2016 and 2017 the number of monthly screening mammograms varied: 2016 (range, 1-9) and 2017 (range, 4-27).

Follow-up texts were transmitted to 94 women based on contact preferences; 54 of the text messages were confirmed as having been received. Follow-up phone calls were initiated to 85 members based on contact preferences, with 145 attempted calls resulting in a conversation with 40 members. Of the 40 women contacted by phone, 15 had not scheduled a mammogram by the time of the call. Eight women (53.3%) accepted the offer of assistance to schedule an exam, 6 (40.0%) did not accept scheduling assistance, and 1 (6.7%) reported she had, unbeknownst to us, scheduled her mammogram prior to the call.

DISCUSSION

Two cues to action and 1 incentive component were used to encourage uptake of screening mammography among women aged 52 to 74 years. To our knowledge, no other health insurance plan in Texas has conducted a similar pilot project to increase uptake of a USPSTF preventive service as part of the ACA package of benefits.

Outreach and Education

The outreach and education cues to action informed women that screening mammography was a covered benefit of their health insurance policy, how screening mammography can identify breast cancer in its earliest stages when it is usually more effective to treat, and what screening mammography entails. Reminders tied to a specific date have been shown to improve uptake of screening mammography,19 which in our case were focused on a specific intervention time frame. Educational material has been shown to be a useful tool to encourage women to obtain screening mammography.20,21

The Incentive Component

The incentive component provided women with a $50 gift card to a local grocery merchant if they obtained their screening mammography between November 17, 2017, and December 31, 2017. The incentive was designed to encourage a healthy behavior among women for a known preventive service. However, the notion of a financial incentive sometimes prompts disquiet among those who believe that paying a person to obtain a known health benefit is somehow wrong or immoral, whereas others question the medium- or long-term viability of such an activity. We provide our insight into these notions from the health insurance company perspective.

First, we do not believe there is any reason to suggest or imply that providing a financial incentive to obtain a preventive service is somehow wrong; in fact, this notion strikes us as both paternalistic and judgmental. Financial incentives are a part of contemporary life and are used to guide people into making decisions. In health care, the goal is to encourage individuals to make healthy choices; therefore, it seems appropriate to provide incentives to encourage healthy behavior and thus maximize utility.22-24 As a form of trade, this is a voluntary action that, if implemented, benefits both parties.22 In this case, a woman obtains a preventive health service with demonstrated evidence of success and the health insurance company fulfills its obligations to promote the health and well-being of its members. If the woman chooses not to participate in the incentive program, which 73 did not for this campaign, then this is her right as would be expected of any type of voluntary transaction.

Second, with regard to the medium- and long-term viability, several items need to be considered. One is to identify the expected outcome of the financial incentive. The idea is not, as some might suggest, to pay a person to obtain a preventive service; rather, the idea is to use the incentive to introduce and support ongoing positive behavioral change. Further research on the impact of financial incentives and behavioral change within a community-based health insurance plan is needed.

Third, there may be a concern about the overall financial benefit of screening and early detection. Routine screening, simply put, is designed to identify disease in its earliest stage before it has had an opportunity to metastasize. Treating breast cancer in situ is more successful and less costly than treating metastatic cancer.25 For example, breast cancer in situ is reported to have mean per-patient costs of $48,477 and $71,909 at 0 to 6 months and 0 to 24 months post diagnosis, respectively. On the other hand, breast cancer that has spread beyond the breast tissue and may have entered the lymph node is reported to have mean per-patient costs of $84,481 and $159,442 at 0 to 6 months and 0 to 24 months post diagnosis, respectively.26 In our cue-to-action project, the maximum total expenditure for the financial incentive would have been $5000 if all women had participated in the pilot project. Had 1 case of breast cancer in situ been identified rather than waiting until regional lymph node involvement had occurred, the amount of money expended due to early treatment vs late-stage treatment would have more than offset the cost of the entire incentive program.

Women Who Choose Not to Be Screened

Women who choose not to be screened represent a small but important part of the overall population eligible for screening mammography. Of the 267 women eligible for screening, 73 (27.3%) in the 2-year period from January 1, 2016, to December 31, 2017, did not obtain screening mammography as part of their Sendero health insurance benefit. The research team member who made follow-up calls to members to encourage participation in this pilot project collected information about why women chose not to participate. Although this was not a primary outcome for this pilot study, we present here some of the qualitative findings from the conversations that took place with the 40 members who were contacted. (Each statement is from a specific person, with additional comment, if any, by the authors in brackets.)

This feedback indicates that primary care physicians play an important role in helping women make an informed decision about whether to obtain screening mammography. Further research on the impact of the role of the primary care physician and behavioral change to support secondary prevention campaigns is warranted.

Limitations

Several limitations have been identified with this study. The first limitation is the timing of the campaign and its potential impact on mammography screening uptake. The 6-week intervention time period included 3 major holidays, which may have limited participation and may have impacted service availability; however, based on discussions with our preferred mammography provider during the planning process, they did not indicate a lack of availability during the 6-week time period. Second, some campaign-eligible women may have already scheduled a mammogram before receiving campaign material in the mail. Third, although the campaign included 3 cues to action, we did not seek to, nor were we able to, ascribe variance to any particular cue to action. Fourth and finally, we are blinded to some data that could be useful in the analysis of these findings. Such data include income and race/ethnicity data, as this information is not provided by the federal Marketplace to health plans.

CONCLUSIONS

A one-time, time-limited cue-to-action pilot project consisting of outreach, education, and incentive increased uptake of screening mammography by women enrolled in a community health insurance plan providing health insurance coverage as part of the ACA. This increase is statistically significant in the intervention period compared with the reference period (PR, 2.7; 95% CI, 1.1-6.6; P=.02). Despite a small sample size, the magnitude of the effect for this pilot study is encouraging and warrants future studies in a larger population.

Acknowledgments

The authors would like to acknowledge the assistance and advice of current and former Sendero staff members and contractors Dr Avishek Kumar, Bryan Palma, Linda Burton, Tammy Liu, Norma Lozano, Rodolfo Ybarra, and Priscilla Gonzales in the development of this project. The authors would also like to thank Travis County taxpayers for their continued support of Sendero Health Plans.

Author Affiliations: The Litaker Group, LLC (JRL), Austin, TX; Sendero Health Plans (NT, WD), Austin, TX; University of Texas at Austin (RT), Austin, TX.

Source of Funding: Funding for this project was provided in the form of staff and contractor time by Sendero Health Plans.

Author Disclosures: Drs Litaker and Taylor are independent paid research consultants to Sendero Health Plans and received payment for their involvement in the preparation of this manuscript. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (JRL, NT, WD, RT); acquisition of data (JRL, NT, WD, RT); analysis and interpretation of data (JRL, NT, RT); drafting of the manuscript (JRL, RT); critical revision of the manuscript for important intellectual content (JRL, RT); statistical analysis (JRL, NT, RT); provision of patients or study materials (NT); obtaining funding (WD); administrative, technical, or logistic support (JRL, NT, RT); and supervision (JRL).

Address Correspondence to: John R. Litaker, PhD, MSc, MMedSc, The Litaker Group, LLC, PO Box 160505, Austin, TX 78716. Email: john.litaker@litakergroup.com.

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2. Cancer stat facts: female breast cancer. National Cancer Institute. Accessed March 22, 2020. https://seer.cancer.gov/statfacts/html/breast.html

3. DeSantis CE, Fedewa SA, Goding Sauer A, Kramer JL, Smith RA, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin. 2016;66(1):31-42. doi:10.3322/caac.21320

4. Puliti D, Zappa M. Breast cancer screening: are we seeing the benefit? BMC Med. 2012;10:106. doi:10.1186/1741-7015-10-106

5. Clinical summary: breast cancer: screening. US Preventive Services Task Force. January 11, 2016. Accessed August 1, 2017. https://www.uspreventiveservicestaskforce.org/Page/Document/ClinicalSummaryFinal/breast-cancer-screening1

6. Breast Screen Australia: policy. Australian Government Department of Health. Updated June 5, 2020. Accessed July 1, 2020. http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/policy

7. Overview: breast cancer screening. National Health Service. Updated March 27, 2018. Accessed August 1, 2018.https://www.nhs.uk/conditions/breast-cancer-screening/

8. Tonelli M, Gorber SC, Joffres M, et al; Canadian Task Force on Preventive Health Care. Recommendations on screening for breast cancer in average-risk women aged 40-74 years. CMAJ. 2011;183(17):1991-2001. doi:10.1503/cmaj.110334

9. Coverage of Preventive Health Services, 42 USC 300gg13 (2010).

10. What is a mammogram? CDC. Updated September 14, 2020. Accessed October 1, 2020. https://www.cdc.gov/cancer/breast/basic_info/mammograms.htm

11. Zheng Y, Mancino J, Burke LE, Glanz K. Current theoretical bases for nutrition intervention and their uses.In: Coulston AM, Boushey CJ, Ferruzzi MG, Delahanty LM, eds. Nutrition in the Prevention and Treatment of Disease. Elsevier; 2001:83-93. doi:10.1016/b978-012193155-1/50008-8

12. Urich A. The Health Belief Model. Pennsylvania State University Open Resource Publishing. Accessed March 10, 2020. https://psu.pb.unizin.org/kines082/chapter/the-health-belief-model/

13. Sohl SJ, Moyer A. Tailored interventions to promote mammography screening: a meta-analytic review.Prev Med. 2007;45(4):252-261. doi:10.1016/j.ypmed.2007.06.009

14. Yarbrough SS, Braden CJ. Utility of health belief model as a guide for explaining or predicting breast cancer screening behaviours.J Adv Nurs. 2001;33(5):677-688. doi:10.1046/j.1365-2648.2001.01699.x

15. Deavenport A, Modeste N, Marshak HH, Neish C. Closing the gap in mammogram screening: an experimental intervention among low-income Hispanic women in community health clinics.Health Educ Behav. 2011;38(5):452-461. doi:10.1177/1090198110375037

16. Slater JS, Parks MJ, Malone ME, Henly GA, Nelson CL. Coupling financial incentives with direct mail in population-based practice.Health Educ Behav. 2016;44(1):165-174. doi:10.1177/1090198116646714

17. 2018 Quality Rating System measure technical specifications. CMS. September 2017. Accessed October 1, 2017. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/Revised_QRS-2018-Measure-Tech-Specs_20170929_508.pdf

18. American FactFinder Community Facts. US Census Bureau. Accessed March 20, 2020. https://factfinder.census.gov/faces/nav/jsf/pages/community_facts.xhtml

19. Buist DSM, Gao H, Anderson ML, et al. Breast cancer screening outreach effectiveness: mammogram-specific reminders vs. comprehensive preventive services birthday letters.Prev Med. 2017;102:49-58. doi:10.1016/j.ypmed.2017.06.028

20. Michielutte R, Sharp PC, Foley KL, et al. Intervention to increase screening mammography among women 65 and older.Health Educ Res. 2004;20(2):149-162. doi:10.1093/her/cyg108

21. Boling W, Laufman L, Lynch GR, Weinberg AD. Increasing mammography screening through inpatient education.J Cancer Educ. 2005;20(4):247-250. doi:10.1207/s15430154jce2004_14

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24. Vlaev I, King D, Darzi A, Dolan P. Changing health behaviors using financial incentives: a review from behavioral economics.BMC Public Health. 2019;19(1):1059. doi:10.1186/s12889-019-7407-8

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Prostatectomy: Safe and Quick Ways to Recover – Voice Online – The Voice Online

Its a mans world is an iconic, soulful ballad co-written by the late James Brown and recorded in February 1966 at Bob Gallos Talent Masters studio in New York City. And it is a song that celebrates the virtues of being a man while simultaneously acknowledging the many virtues of women. Something to note about this iconic, soulful ballad that reached No. 1 on the Billboard R&B chart and No. 8 on the Billboard Hot 100 more than 50 years ago is how it called attention to the many differences between men and women. Along with emotional and psychological differences, men and women are also remarkably different from a physiological standpoint. To understand to what extent, it helps to know a little more about the endocrine system in both genders.

What Science Has Revealed About the Male and Female Endocrine System

For those not as well-versed in human physiology, the male and female body houses an endocrine system. And this system is comprised of a network of hormone-secreting glands that allow the body to function optimally. In both genders, the primary hormones that make up the endocrine system include the pineal, pituitary, hypothalamus, thyroid, parathyroid, adrenal, and thymus glands. The pancreas is also one of the many glands that make up the endocrine system in both men and women. One key difference between the male and female endocrine system has to do with the reproductive glands.

Male and female bodies alike have reproductive glands that make conception possible. In men, this would be the testes. And in women, it would be the ovaries. The testes are responsible for secreting testosterone. The ovaries, on the other hand, secrete estrogen. When these glands secrete adequate amounts of their respective hormones, they play a vital role in contributing to homeostasis and enabling men and women to realize the joys of parenthood. However, if these hormone levels fall too low, it can lead to fertility issues and other physical health problems in men and women alike. For example, women with low estrogen levels, which correlates with estrone and estradiol levels below 17 and 15 nanograms per deciliter (ng/dL), respectively, will usually experience the following:

Much like women, men with low testosterone levels, typically below 280 ng/dL, will see their fair share of ill-effects, some of which include the following:

One of the biggest misconceptions when it comes to the endocrine system is that its ability to secrete estrogen applies only to women. And this couldnt be any further from the truth. While the ovaries and adrenal glands secrete estrogen in women, the testes and adrenal glands secrete estrogen in men. Of course, the amount of this hormone secreted in men is much lower. When estrogen levels are too high, delineated by estradiol and estrone levels greater than 40 and 50 picograms per milliliter (pg/mL), respectively, men are more likely to suffer from prostate enlargement.

Common Causes of Prostate Cancer

Along with an enlarged prostate resulting from high estrogen levels, men who also have low testosterone levels are more likely to develop prostate cancer, say researchers with the National Institutes of Health. The sentiment is further echoed by the Centers for Disease Control and Prevention (CDC), which notes that prostate cancer is the most common cancer in men, especially among those age 40 and over. Further, a study published by Science Daily revealed that men with high testosterone and high human growth hormone (HGH) levels are also at risk of developing prostate cancer. And it does not end there as prostate cancer can also stem from inherited gene mutations, acquired gene mutations, and poor dietary habits. Men who have the misfortune of developing prostate cancer will often experience the following symptoms:

How Is Prostate Cancer Diagnosed?

While symptoms detailed in this article generally correlate with prostate cancer, the only way for men to know for sure if they have developed the disease is to schedule an appointment with a urologist or oncologist. Two of the screening tests that these practitioners will use to determine if an individual has prostate cancer include a digital rectal exam (DRE) and a prostate-specific antigen (PSA) test. Some practitioners will arrange an ultrasound, magnetic resonance imaging (MRI), and may even order a biopsy if they observe prostate abnormalities that might be cancerous. If prostate cancer is confirmed, some practitioners may advise undergoing a prostatectomy.

What Is a Prostatectomy?

In short, a prostatectomy, otherwise known as prostate surgery, is a procedure that involves the partial or complete surgical removal of the prostate. This type of surgical procedure is a go-to for men with cancer affecting the prostate, which has not metastasized to other parts of the body, or an enlarged prostate. According to the American Cancer Society, the following are the different types of prostatectomy surgery that a physician might recommend to men diagnosed with either of these two health problems:

Consequences of Undergoing a Prostatectomy

As with any surgery, there are risks associated with undergoing a prostatectomy of any kind. Some of the ones frequently reported by men who have gone through with such a procedure include the following:

Ways to Ensure a Safe and Quick Recovery Following Prostatectomy Surgery

Indeed, numerous side effects can stem from undergoing prostatectomy surgery. However, according to most urologists, men who do the following are much less likely to encounter them:

Close medical supervision One of the best ways to ensure a safe and speedy recovery following prostatectomy surgery is to immediately contact your physician if youre experiencing excessive pain or bleeding post-surgery. After all, neglecting these issues can pave the way for infections and other complications that could significantly slow down the healing process.

Positive attitude Having a positive attitude aids in speeding up recovery and minimizing complications after a surgical procedure, say most naturopathic physicians. And prostatectomy surgery is no exception as a positive attitude can tamp down feelings of stress that would otherwise weaken the immune system and, in turn, slow down healing.

Avoiding accidents Another way to minimize complications while speeding up healing following prostatectomy surgery is by avoiding trauma to the urethra or bladder. For this reason, physicians often advise against engaging in strenuous activities, such as biking, running, or even having sex, while the body is still healing.

Prevention of Prostate Cancer: Testosterone and Human Growth Hormone Therapy

According to a study published by cancer.net, over 190,000 men will likely be diagnosed with prostate cancer by the end of 2020. But this doesnt mean that such a grim reality is unavoidable. There are things that men can do to lower their chances of developing the disease. For example, addressing hormone imbalance problems as soon as possible can significantly reduce the likelihood of developing prostate cancer. And this generally means taking medication to help boost low testosterone (find more about results of depo-testosterone in reviews of patients) or human growth hormone levels. Similarly, taking medication to lower high estrogen levels can help in this regard as well.

Natural Ways to Boost Immunity That Also Protects Against Prostate Cancer

Many of the same things that strengthen the immune system, which, in turn, lowers the risk of infection, can also protect against prostate cancer. Generally speaking, this comes down to healthy lifestyle habits, such as exercising regularly, consuming a healthy, well-balanced diet, and keeping stress to a minimum. Quitting smoking and minimizing alcohol consumption can further lower the risk of developing prostate cancer.

Bottom Line

All in all, men and women are more the same than they are different in that both have a higher chance of encountering life-altering diseases as they get older. Fortunately, breakthroughs in science and modern medicine, coupled with positive lifestyle choices, can go a long way toward keeping many age-related diseases, including prostate cancer in men and breast cancer in women, at bay.

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11 Best Male Enhancement Pills and Products in 2021: Review of the Top-Rated Sex Pills for Men – Cleveland Scene

In recent years there have been many scientific advancements targeting the problems men face in the bedroom. Use of male enhancement pills increased 312% from 1998 to 2002 leading to massive amounts of money being poured into research.

The high demand and competition leads to new formulas addressing more specific problems such as arousal, erection intensity, and length of climax. In this article we go over what ingredients to look for, what sex pills work, and what the best male enhancement pills are by type.

Top Male Enhancement Pills by Category

1. Best ED pill subscription service - Hims ED Pills2. Best for boosting sex drive - VigRX Plus3. Best for increasing orgasm intensity - Semenax4. Best for increasing testosterone - Testogen5. A unique twist on male enhancement - SemEnhance6. Best natural supplement for stiffer erections - Max Performer 7. Best for longer erections - Male Extra 8. Best herbal supplement - Viasil 9. Best value-for-money - Huge.com10. Best premature ejaculation remedy - ProSolution Plus11. Best maximum strength formulation - ExtenZe

1. Hims ED Pills Most Powerful Male Enhancement Pill

Hims Inc. is a telemedicine company founded in 2017. Hims employs doctors that review a subscriber's personal health information. These doctors then prescribe ED medications that subscribers purchase through the Hims website.

When needed, Hims doctors can prescribe up to 100 mg of Viagra or 200 mg of Stendra. Aside from ED medication, Hims also offers medication for premature climax issues. A subscriber can access Sertraline for early ejaculation, which is available in pills of 25 mg, 50 mg, or 100 mg.

Hims ED pills are generic versions but theyve gone through the same stringent regulatory approval process as their brand-name counterparts. If you're looking for potent ED medication at an affordable price, Hims ED pills might be a good alternative.

2. VigRX Plus Best for Boosting Libido and Sex Drive

If you want to try an ED medication but are wary of possible side effects, you might want to give VigRX Plus a try. VigRX Plus uses natural ingredients that are not as concentrated as over the counter options.

Although there are no reported side effects because of its natural formulation, it is still best to read the complete list of ingredients to ensure that there won't be any allergic reactions.

VigRX Plus offers a 67-day money-back guarantee for subscribers who are not completely satisfied with its products.

3. Semenax - Best Sex Pill for More Intense Orgasms

Semenax also has Epimedium Sagittatum, Butea Superba, and L-Lysine. The combination of these ingredients can help boost libido and testosterone levels. On top of increased sexual performance, they can also help users who suffer from low sperm count and poor sperm motility.

Semenax gives customers a 67-day return period if they are not happy with the product. Semenax also has a 24/7 dedicated support line to assist customers with their questions or concerns.

4. Testogen - Best Male Enhancement for Increasing Testosterone

The herbal extracts in this medication can provide improved strength and stamina if you like working out. Combined with a healthy diet, Testogen can help the user maximize muscle mass growth.

Testogen also has Magnesium, Vitamin D3, and Vitamin B6 to improve mood and aid in better sleep. The medication also enhances desire so users can have a healthier sex life.

5. SemEnhance - Most Unique Male Enhancement

SemEnhance contains natural ingredients that neutralize molecules responsible for the sour, chemically, or salty pheromones released in sweat and throughout the body. The formula that SemEnhance uses include pineapple, Vitamin C, Bee pollen, and kiwi.

SemEnhance is from the same company that produces Semenax, a herbal supplement that increases semen volume. This somewhat assures customers that SemEnhance has undergone the same rigorous testing process as Semenax. Like Semenax, customers have a 67-day money-back guarantee if they try the product and are unhappy with its effects.

6. Max Performer - Best Natural Male Enhancement for Powerful Erections

Max Performer contains 1,000 mg of Horny Goat's Weed, which bolsters testosterone levels and increases blood circulation. It also has 1,000 mg of Maca that helps restore hormone levels and improve sperm count and motility.A key ingredient of Max Performer is Korean Red Ginseng, which can help; ease anxiety, increase desire and improve endurance.

Other natural ingredients in Max Performer include Cordyceps, Bioperine, selenium, and zinc. These ingredients can help boost self-esteem and improve sexual stamina, leading to a more satisfying performance.

7. Male Extra - Best Natural Male Enhancement for Longer Erections

If you want to have longer erections, you might want to give Male Extra a try. This natural male enhancement supplement might help increase size and hardness because of the full erection. It can also improve the sustainability of erections by increasing blood flow to the penis.Male Extra uses a potent mix of natural ingredients to help users improve the quality of their erections. It contains ellagic acid, L-Arginine HCL, niacin, MSM, and L-Methionine. Male Extra also has zinc that can help increase testosterone production and improve libido.Male Extra also has an infusion of cordyceps extract that acts as a natural aphrodisiac to increase sexual drive and function.

8. Viasil - Best Herbal Male Enhancement Supplement

Viasil has Horny Goat Weed and Ginkgo Biloba that can help increase blood flow to the penis. This can lead to bigger and harder erections.

Viasil also has Panax Ginseng Root that helps reduce stress. The high levels of ginsenosides in ginseng can help improve sexual performance.

One edge that Viasil has over other ED medication is the generous guarantee that it provides. Customers have a 100-day money-back guarantee when they purchase Viasil.

9. Huge.com Best Cheap Male Enhancement Pill

Huge.com only uses approved erectile dysfunction medication, including Tadalafil and Sildenafil. This medication helps improve blood supply to the male reproductive organs to enhance sexual performance.

Huge.com offers secretive specialized consultation to subscribers. These consultations help Huge.com's doctors formulate a plan that will help address your needs to combat ED and improve your sex life.

If you have your doubts about Huge.com's effectiveness, you can try their plan for one month since your first month will only cost you $1.

10. ProSolution Plus - Best Pill for Premature Ejaculation

ProSolution Plus contains Tribulus Terrestris. This traditional Chinese herb is a known aphrodisiac. It also contains Withania somnifera that helps increase nitric oxide.

With an increased nitric oxide, the blood flow to the penis increases, allowing for a larger erection.

ProSolution Plus also has asparagus adscendens that provide natural relief to stress. Additionally, the mucuna pruriens in ProSolution Plus helps increase erection frequency and sexual activity.

To top it off, this medication also has asteracantha longifilia that helps increase attraction to female sexual partners.

11. ExtenZe Natural Penis Enlargement Pill

ExtenZe contains Yohimbe. This is an herbal supplement commonly used in West African medicine as a treatment for male infertility. It blocks alpha-2 adrenergic receptors, which usually prevents erections. Yohimbe also helps produce nitric oxide to help improve blood flow to the male reproductive organs.

ExtenZe also uses a scientific formulation containing 26 pharmaceutical-grade compounds. These compounds can help a user boost vitality and energy to increase pleasure and performance.

Which Is Safest?We've mentioned VigRX as the safest pill on the list, and for good reasons. Compared to other male sex pills that contain fillers, VigRX has only essential ingredients that can improve a man's sexual health.

As an herbal pill, VigRX also prides itself on general health benefits among men. Users reported that the herbal pill could improve blood flow over a few weeks of intake.

We've listed VigRX's essential ingredients to help you understand how it works:

Do Male Enhancement Pills Make You Bigger?

However, many male enhancement supplements can increase the usable size of the penis by improving one's blood flow. A product like BlueChew can increase the erection's firmness so much that you get somewhat bigger.

An enzyme called Protein Phosphodiesterase Type 5 (PDE5) promotes erectile dysfunction. With this enzyme, the blood can't move through the penile arteries, which causes the dysfunction. Effective supplements suppress the PDE5's activity that blocks dilation of the arteries. This then results in a larger penis size because of a firmer erection.

How To Maximize the Effects of Male Enhancement Pills and Increase Sex Drive NaturallyManage Weight

For many years, we've known that physical conditions that go along with obesity can also affect one's sex drive. According to a study, around 30% of obese individuals indicated problems with sexual desire, drive, or performance in general.

Losing weight and getting in shape can stimulate sex hormones. It can make you look better, improve your confidence, and fortify your stamina during sex. For best results, you can focus your workouts on your pelvic area to get the blood flowing there.

Reduce StressWhen you're in a stressful situation, your body naturally prepares to fight or run away. This concept is called the "fight or flight response."

If you're constantly stressed, your hormone levels disrupt, and your arteries narrow. This results in blood flow restriction, which can cause erectile dysfunction.

You can perform some stress management techniques, including meditation, breathing exercises, or talking to a therapist.

A physical touch from your partner can also help alleviate stress. Cuddles, kisses, and hugs from a special someone can go a long way.

Refrain From Alcohol and Smoking

Meanwhile, too much alcohol disables your autonomic nervous system's natural sexual response. This then prevents you from getting or staying aroused. Loss of erection is also a common alcohol-related problem.You can smoke and drink, but always in moderation.

Healthy DietSome studies indicate that food high in Zinc and Vitamin B can fuel testosterone levels.

While there is no solid clinical data linking libido with food, a healthy diet can affect your overall energy and mood. Having high energy levels and a good mood can then positively impact your sexual drive.

Of course, you won't be able to notice the positive effects of a healthy diet on your libido right off the bat. However, it can help you stay fit, increasing your sexual stamina for the long haul.

Check Testosterone Levels

Testosterone is the most significant male sex hormone. Having low testosterone levels results in low sexual drive and erectile dysfunction.

You can always see a doctor for a testosterone test. Expect that you may need to make some lifestyle changes to increase your testosterone levels. You may also undergo supplementation and testosterone therapy.

Communication With a Partner About Any Worries in BedroomCommunication can be a potent aphrodisiac if you're confident enough to discuss your problems with your partner. Intimacy is more than what happens during sex. It's also what happens before and after.

If your partner is aware of your problems, disappointment may be unlikely to happen. You can discuss possible solutions together and be ultimately in sync in bed. You will be surprised at the spark communication can ignite in your sex life.

Frequently Asked Questions About Sex Pills for Guys (FAQs) What products can be used with sex pills?

Bathmate penis enhancement may be great to use along with sex pills. Bathmate is entirely safe to use and can deliver remarkable results in a short period.

Can you use creams for erectile dysfunction?

Currently, the U.S. Food and Drug Administration (FDA) has not approved medicated creams to treat erectile dysfunction.

What are the common side effects of erectile dysfunction medications?The usual side effects of ED drugs include headache, nasal congestion, upset stomach, diarrhea, and dizziness. Note that not all people experience this. Consulting a doctor before taking ED drugs is essential.

Best Sex Pills for Men: Key Takeaway

If you think taking one of our recommended sex pills can help you, consult your physician first. Above all, no two people are alike. What works for others may not work for you.

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11 Best Male Enhancement Pills and Products in 2021: Review of the Top-Rated Sex Pills for Men - Cleveland Scene

From NC Health News: Fat bias at the doctor’s office takes a serious toll – Mountain Xpress

By Liora Engel-Smith, North Carolina Health News

Alyssa McCord would rather not see a doctor at all. The upstate New York native who now lives in Jacksonville with her husband and daughter attributes some of her reluctance to upbringing. Her parents only went to the doctor when absolutely necessary, she said.

The other part of that reluctance, says the 38 year old, is how providers react to her weight.

McCord, who wears size 20 pants, is used to providers making demeaning comments about her body. Often, theyd blame her weight for every ailment from heavy periods to colds to numbness and tingling in her hands.

In September, McCord had an experience that surprised even her. Shed gone to a family doctor to discuss consistently heavy periods and constant exhaustion. The doctor said her stomach was cramping because she is fat. If she lost weight, he told her, the pain would go away.

The doctor did not order any of the customary tests, such as abdominal ultrasound or blood tests to confirm his assertion. He looked at her and made up his mind, McCord said.

McCord would later learn from another provider that an enlarged uterus caused the cramps and heavy bleeding. Blood loss from the heavy periods made her anemic, accounting for her fatigue.

Nearly every person in a bigger body has their own story of weight-based bias at the doctors office. It could be anything: a too-small blood pressure cuff or medical gown, a wince from a triage nurse during a weigh-in, a negative comment from a physician, or as in McCords case, blaming every symptom on weight.

Its impossible to know exactly how pervasive weight bias is in the health care system, especially because it involves provider attitudes, but its safe to say that fat discrimination is rather common, said Ya-Ke Grace Wu, assistant professor at the UNC Chapel Hills school of nursing.

Current estimates are that 19 to 24 percent of obese adults experience some form of discrimination because of their weight, from bullying at home or work to fat discrimination in clinical settings. The rates of weight bias are even higher in women and people with higher body mass index scores.

Wu, who studies weight discrimination, said the maltreatment can also be nonverbal, from flimsy chairs that cannot accommodate larger bodies in the clinic waiting rooms to weighing them in hallways, rather than in a room that offers some privacy from passers-by.

No matter how the bias is delivered, the message is clear to any person in a big body: Weight isnt just a number, its a moral failing and a cause for shame.

These negative attitudes from providers have far-reaching health implications, Wu said. Some fat people may avoid the doctor altogether, delaying diagnosis of conditions such as diabetes, high blood pressure, or more serious conditions, such as cancer. Sense of shame about body size can also lead to a host of mental illnesses, from depression to anxiety to suicidal thoughts. Its even correlated with weight gain and binge eating disorder, a condition that involves cycles of compulsive and restrictive eating.

The fat is bad lense kind of corrupts everything, said Lindo Bacon, author, researcher and a member of the Health at Every Size movement, a grassroots effort to eliminate weight stigma in all areas of society. And at this point, it just seems like its basic good health care or so it seems to the doctors, that everybodys supposed to get thinner.

Weight stigma isnt just about hurt feelings, it is also linked to higher mortality rates, in part because discrimination often leads to unhealthy behaviors, such as exercise avoidance, overeating and substance use. The stress of weight stigma is associated with metabolic changes that can make people sicker, including higher levels of the stress hormone cortisol and inflammation markers.

Evidence of harm is so robust that last spring, a panel of experts from universities and health care systems all over the globe published a call to end weight stigma in all areas of life in the prestigious journal Nature Medicine.

Weight bias and stigma can result in discrimination, and undermine human rights, social rights, and the health of afflicted individuals, the authors wrote.

As obesity rates in adults continue to rise, the public health consequences of fat discrimination could be significant. In North Carolina, for example, adult obesity rates more than doubled between 1990 and 2019.

While the scientific community has established that weight alone is not a predictor for health, societal understanding of obesity continues to lag. Many people, including health care providers, believe that diet and exercise are the only ways to manage obesity, despite evidence to the contrary.

Public health experts have known for years that obesity is a multifactorial condition, affected not only by behaviors but by the social determinants of health, including income, access to healthy food and neighborhoods that may discourage walking, to name a few. The focus on diet and exercise alone assumes that obesity is always within a persons control, said Bacon, the Health at Every Size advocate.

From a global perspective, we know that its the social determinants of health that play a much larger role [in obesity], Bacon said. So even our messages of bringing it down to individual behavior, are ignoring the really big issues in health, which is about inequity.

Rashelle Hamilton was used to providers taking her seriously. Hamilton, who had always been trim, had gained 30 pounds after the birth of her youngest daughter, Violet. She thought her birth control implant may be at fault.

Hamilton, who weighed 218 pounds late last year after the birth, was surprised to find that her new weight affected the quality of care she received.

Before they would mostly believe me when I said I had a problem, the Cary resident said. They believed me and listened to my symptoms and then went off of my symptoms.

But at an annual physical last December her first in a larger body the doctor looked at her and determined that she had Type 2 diabetes without a blood test or a review of diabetes symptoms, Hamilton said. The physician immediately prescribed Hamilton an $800-a week diabetes injection and then ordered tests to confirm what she thought was the correct diagnosis.

Hamilton didnt have diabetes, the blood tests later showed. The experience left her with a sense that she cannot trust medical providers. At the recommendation of a friend, Hamilton found a different doctor to go to. But the December physical cost her time, money and aggravation.

Wu, the UNC researcher, said that many overweight and obese people take the same route, moving from doctor to doctor until they find someone who would listen. But that approach can still cause damage, because of delayed diagnoses.

Some diseases have a golden window for treatment, Wu said. And so if you delay the treatment, you may delay the whole improvement [trajectory] of the disease.

The economic impact of repeated appointments for the same complaint is unknown, Wu said, but with rising health care costs and the lack of provider availability in rural areas, patients may not have the money or ability to find a provider who would listen.

If you walk into Aimee Festes clinic in Asheville, odds are, the word weight wont come up unless you say it. Feste, a body-positive nurse midwife with the Asheville-based Mountain Area Health Education Center, says she first learned about the weight discrimination from her patients.

People can be healthy in a larger body size, she said. I say to my own patients who are worried about their weight I could cut off your arm and you would lose 10 pounds and you can be a whole heck of a lot less healthy.

Feste says very few conditions, such as water retention during eclampsia, require in-office weight measurement. Instead, Feste focuses on the patients life as a whole, even when patients have chronic diseases, such as diabetes, that would traditionally trigger a discussion about weight.

She might talk to diabetic patients about their stress levels, their sleep, their ability to get medication and access food that nourishes them. That approach may take more conversation, Feste added, but its far kinder and respectful to patients who are already ashamed about their bodies.

Wu agrees with that approach. A provider is in a position of power, she said, and their job is to build trust with patients.

We dont have to push patients to talk about weight, we should just focus on whatever health issue they come in [with] for that days appointment, Wu added. If the patient wants to talk about weight, then we can talk about it, but I always suggest that the patient lead that conversation.

Feste said that rather than bringing up weight to patients with larger bodies, providers should educate themselves on approaching all patients, regardless of size, kindly and without judgment.

The more we shine light on it, the more its talked about, the more its going to be an open conversation, she said.

This article first appeared on North Carolina Health News and is republished here under a Creative Commons license. North Carolina Health News is an independent, non-partisan, not-for-profit, statewide news organization dedicated to covering all things health care in North Carolina. Visit NCHN at northcarolinahealthnews.org

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From NC Health News: Fat bias at the doctor's office takes a serious toll - Mountain Xpress

11 FAQs About Lovesickness: Signs, What to Do, More – Healthline

Love can feel pretty wonderful when all goes well, that is.

If your romance follows a rockier path, you might notice your inner compass needle swinging more toward abject misery than euphoric joy.

Maybe you havent yet found the courage to confess your love, or you have summoned the strength to share your feelings, only to face rejection.

Perhaps youve fallen for a person you know you cant be with, like your boss or a friends partner, or someone you just know will never return your feelings.

An unexpected and unwanted breakup can also give rise to emotional turmoil and physical distress.

Any of these situations can leave you feeling somewhat unwell in mind and body. For example:

Sound familiar? Heres a possible diagnosis: Lovesickness.

Below, youll find more details on exactly what it means to be lovesick and what you can do to recover.

People use the term lovesick in different ways.

You might hear it used to describe the range of feelings that accompany the early stages of being in love, such as:

These effects of love usually go by another name, though well get into that in more detail below.

Lovesickness generally refers to the more unpleasant aspects of love.

This ailment involves all those unwanted feelings you might experience when your passion doesnt play out as planned, without the enjoyable effects of a mutual attachment.

Its natural to feel sad and disappointed when you like someone who doesnt feel the same way. The pain and frustration of heartbreak or unrequited love affects everyone differently, but the sting often lessens within a few weeks or months.

Not everyone coping with rejection will become lovesick, but you can often recognize the condition by its more intense symptoms.

The effects of lovesickness might stick around until they begin to affect your day-to-day life, and these symptoms can have a very real impact on your health and wellness.

Some people also use the term lovesickness to refer to a phenomenon known as limerence.

Psychologist and professor Dorothy Tennov pioneered the research on this condition, introducing the term in her book Love and Limerence: The Experience of Being in Love.

Tennov defines limerence as an involuntary fixation on another person. This fixation can feel a lot like love, but it has more of an obsessive component.

In a state of limerence, you desperately long for the other person to return your feelings and feel terrified theyll reject you. Your mood often depends on how they treat you.

If they smile or speak to you, you might feel on top of the world. If they ignore you or seem indifferent, you might feel distressed or physically pained.

Other key symptoms of limerence include:

Lovesickness is nothing new. This malady dates back to some of the earliest writings, in fact, though it sometimes went by different names.

Youll find descriptions of the condition in ancient medical texts and classical literature, from Greek philosophy to Shakespeare to Jane Austen.

Research traces the concept of lovesickness to Hippocrates, who believed that lovesickness, like other illnesses, resulted from an excess or imbalance of certain bodily humors.

Galen, another notable ancient physician, was one of the first to diagnose lovesickness and other conditions where physical symptoms resulted from emotional causes.

From culture to culture and era to era, the general symptoms of lovesickness remain much the same.

If youre lovesick, youll probably notice some of the following signs:

You might also notice mood changes brought on by thoughts of the person you love.

Your emotions might range from a general sense of longing to frustration, anger, nervousness, and anxiety, and sometimes even hopelessness and despair.

Languishing over lost love can leave you feeling pretty rotten, to the point where you might begin to wonder whether youre coming down with some type of flu.

Running a fever, which can sometimes happen with lovesickness, might only reinforce your concerns.

Love cant give you the flu. But the hormone fluctuations associated with love and heartbreak particularly the stress hormone cortisol can prompt physical symptoms that affect your long-term health.

Lovesickness can also make you sick indirectly. A lack of sleep, good nutrition, or adequate hydration can absolutely worsen your health.

Whats more, changes in mood, such as irritability or a general sense of melancholy, can begin to affect your relationships with others or your performance at work and school.

Difficulties in these areas of life can eventually increase stress and affect your health, especially if your thoughts of love get in the way of regular self-care.

Serious cases of lovesickness can get intense. You might have trouble talking about anything besides the person you love and the relationship you want to develop.

Lovesickness can make it hard to concentrate and distract you from your responsibilities. You might forget important appointments, chores, errands, or plans with friends.

Its also common to feel anxious about the outcome of your love.

Lovesickness can also involve difficulty getting over someone after they reject you.

Whether thats an ex-partner who ended your relationship or someone you fell for who didnt return your love, trouble moving on from the heartbreak could prompt feelings of melancholy or depression. Some people even have thoughts of suicide.

For those in the throes of limerence, persistent intrusive thoughts can fuel anxiety and rumination.

Some people attempt to resolve these thoughts with avoidance strategies or compulsive behaviors. These might seem to offer some temporary relief, but they generally wont help long term.

Lovestruck and lovesick arent entirely unrelated concepts, but they do refer to separate states.

Falling in love prompts your brain to ramp up production of certain hormones, including dopamine, oxytocin, and norepinephrine.

So youll probably experience some level of surging emotions and temporary changes in mood and behavior as a natural consequence of falling head over heels.

When this happens, people might say youre lovestruck or struck by Cupids arrow. (Cher and Nicolas Cage offer another name for this state of mind: Moonstruck.)

Lovesickness, on the other hand, tends to follow heartbreak, rejection, or unrequited love, so it carries more of a negative connotation. It might also involve mental health symptoms, including anxiety and depression.

Not everyone who falls in love will experience lovesickness, even after rejection, but some degree of lovestruck-ness is pretty universal everyone has hormones, after all.

The early stages of a relationship usually involve some degree of infatuation. For example:

This fixation can show up in physical ways, too.

You might notice signs of arousal as soon as you see them or, lets be honest, whenever you think about them or remember your last encounter. When together, you might find it impossible to keep your hands off each other (or make it out of bed).

All of these things usually feel pretty good, and most people enjoy being in the honeymoon phase.

This stage can last anywhere from a few weeks to several months, but it usually passes once the relationship stabilizes and things become a little less rosy and a little more realistic.

If you think lovesickness sounds pretty awful, you might wonder whether pursuing love is really worth it.

Finding real, sustainable love can take time and effort, but romance isnt all rejection and misery.

Each time you develop a crush or more intense liking for someone and follow up on those feelings by confessing your love, youre making an attempt to find the romantic connection you desire.

You may not find this love without running the risk of potential rejection. For many people, the eventual outcome of lasting love is worth the risk of potential rejection or lovesickness.

Even if your crush doesnt pan out, it may not necessarily feel bad. People who love the butterflies, energy boost, and euphoria that accompany their crushes might feel pretty fantastic in the thick of a crush.

Crushes can also teach you more about what you want (and dont want) in a romantic partner. They can also lead to new friends.

Sometimes, the romance flops, but you find yourself connecting with your ex-crush in a completely platonic but still rewarding way.

In spite of lovesickness lengthy history, experts have yet to discover any real cure. Absent a vaccine or other quick fix, youre left in the healing hands of time itself.

Lovesickness generally does ease eventually, much like the common cold. Heres what you can do in the meantime to get some relief.

Turn your feelings into something tangible by getting in touch with your creative side.

Art, journaling, poetry or short-story writing, and making music are all great ways to experience and express difficult emotions.

Cheery, energizing music might lift your spirits, but if youd rather treat your senses to a favorite heartbreak playlist, go for it. Research suggests listening to sad music could also have a positive impact on your mood.

Giving yourself time to heal involves creating some space. In other words, youll want to avoid texting, calling, and checking up on them in person or on social media.

Its also wise to wait on friendship until youre feeling better.

You might not feel much like eating but try to plan balanced meals and snacks to help maintain good health.

Going to bed at the same time every night can make it easier to get the sleep you need.

Meditation and sunshine are other simple, low-cost methods to help boost a low mood.

Exercise, favorite hobbies, and time with friends can all help distract you from feelings of lovesickness and help improve your outlook.

A good book or favorite movie can also help you cope when you want to stay in and process your emotions alone.

We wont lie. Heartbreak can take weeks, even months, to heal. This length of time varies from person to person, so theres really no way to predict how long lovesickness will last.

If unwanted physical or emotional symptoms linger for more than a week or two, professional support can help.

Therapists are trained to help people navigate all the messy aspects of love, so your therapist wont laugh at you or tell you its all in your head.

They will:

If you experience obsessive or intrusive thoughts, compulsions, or thoughts of suicide along with lovesickness, its best to seek support right away.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours a day at 1-800-273-8255.

During a crisis, people who are hard of hearing should call 1-800-799-4889.

Click here for more links and local resources.

If youre feeling a little lovesick lately, take heart. It wont last forever.

To heal more quickly, treat yourself to some rest and relaxation, draw emotional support from friends, and remember to take care of your basic needs.

Crystal Raypole has previously worked as a writer and editor for GoodTherapy. Her fields of interest include Asian languages and literature, Japanese translation, cooking, natural sciences, sex positivity, and mental health. In particular, shes committed to helping decrease stigma around mental health issues.

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11 FAQs About Lovesickness: Signs, What to Do, More - Healthline

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