Skylight study

Fezolinetant significantly reduced the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, associated with menopause, according to a Phase 3 industry-sponsored study being presented Saturday at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Ga. The SKYLIGHT 2 trial was a 52-week study to investigate the safety and efficacy of fezolinetant (a neurokinin 3 receptor antagonist) on the frequency and severity of moderate-to-severe VMS and sleep disturbance. The mean change in patient-reported sleep disturbance, from baseline to week 12, was a key secondary endpoint in the study. “VMS associated with menopause, which are characterized by hot flashes and/or night sweats, affect millions of women worldwide and can impact daily activities and quality of life,” said Genevieve Neal-Perry, M.D, Ph.D., Distinguished Professor and Chair of Obstetrics and Gynecology at the University of North Carolina School of Medicine in Chapel Hill, N.C. The double-blind Phase 3 study randomized 501 post-menopausal women ages 40–65 with an average of seven or more moderate-to-severe hot flashes/day to placebo or one of two once-daily doses of fezolinetant—30mg or 45mg—for 12 weeks. In the extension period, those on placebo were re-randomized to fezolinetant 30mg or 45mg, and those originally on fezolinetant remained on their dose for the remaining 40 weeks. The extension period analysis comprised 484 women. Neal-Perry and colleagues evaluated the effic...

The Forbes Home editorial team is independent and objective. To help support our reporting work, and to continue our ability to provide this content for free to our readers, we receive compensation from the companies that advertise on the Forbes Home site. This compensation comes from two main sources. First, we provide paid placements to advertisers to present their offers. The compensation we receive for those placements affects how and where advertisers’ offers appear on the site. This site does not include all companies or products available within the market. Second, we also include links to advertisers’ offers in some of our articles; these “affiliate links” may generate income for our site when you click on them. The compensation we receive from advertisers does not influence the recommendations or advice our editorial team provides in our articles or otherwise impact any of the editorial content on Forbes Home. While we work hard to provide accurate and up to date information that we think you will find relevant, Forbes Home does not and cannot guarantee that any information provided is complete and makes no representations or warranties in connection thereto, nor to the accuracy or applicability thereof. How Much Does A Skylight Installation Cost In 2023? Skylights bring natural light, warmth and a unique look to a home. But the cost to install a skylight is often the deciding factor for homeowners. With the average skylight installation cost hovering around $1,75...

Astellas Pharma announced topline results from the Phase III SKYLIGHT 4 clinical trial investigating the long-term safety of ESN 364 (fezolinetant), an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause. SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase III clinical trial in over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women seeking treatment for relief of VMS associated with menopause. The study's primary objectives were to evaluate the effect of fezolinetant on endometrial health and the long-term safety and tolerability of fezolinetant. The primary endpoint assessing endometrial health was achieved and the most common treatment emergent adverse events (TEAE) were headache and COVID-19, consistent with placebo. The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. Detailed results will be submitted for publication and for consideration at upcoming medical meetings. The SKYLIGHT 4 findings, along with the results from two pivotal Phase III clinical trials, SKYLIGHT 1 and SKYLIGHT 2, will provide the foundational data for regulatory submissions in the U.S. and Europe. FDA approves Columv...

SALT LAKE CITY--( about ways they connect with God. Among its findings: while Americans have varied definitions and methods of prayer, those who pray spend an average of 18 minutes praying daily, with nearly half saying they pray on a regular basis. “These results make it clear that there is more praying taking place than people expect. People are praying in a variety of ways and in unexpected places throughout the day,” said John Dye, executive director of Skylight. "They are frequently exploring their spiritual side and using prayer to work through adversity, find meaning, and create connection with a Higher Power.” The National Day of Prayer Survey took a fresh look at how and why Americans pray. Despite recent statistics that suggest Americans are becoming less religiously affiliated, prayer appears to be a constant practice in people’s lives, with Americans spending 3.6 billion minutes each day praying. 53% of those who pray increased the frequency of their spiritual practice during COVID-19 lockdowns, while only 8% report praying less often. Praying for a loved one in crisis, prayer for someone who is ill, and praying for other people are the top three reasons Americans say they speak to a higher power through prayer. And 65% of Americans say they connect with a higher power regularly (at least a few times a week) through prayer, meditation, mindfulness, or reciting affirmations. "The majority of Americans are connecting with the Divine in diverse, beautiful ways,” a...

Hope is what allows us to feel excitement and joy, to move beyond the present moment. In the short story, ''The Skylight Room'' by O. Henry, a young woman uses hope to light up the darkness in her life. The story begins in second person. The narrator is speaking as if giving advice about talking to Mrs. Parker, a woman that owns a boarding house. The narrator takes you through the systematic way Mrs. Parker would show her rooms by price, and how she would get angrier and more judgmental if you could not afford an expensive room. On the tour, the skylight room was shown last, but not by Mrs. Parker. Instead, her colored maid was left with the task. The room was very small with storeroom closets. The room had the bare necessities and was two dollars to rent, but it had a small skylight that showed ''a square of blue infinity.'' The narrator recalls a day when an impoverished woman named Miss Elsie Leeson came looking for a room, and Mrs. Parker gave the usual contempt since she was not a wealthy doctor or a dentist. This meant she could only afford the bottom of the barrel. The tour eventually ended with the maid showing her the skylight room and Miss Leeson accepting the deal. Miss Leeson would go to work every day and come home and finish her work on the stairs in the company of the other boarders. The others, mainly men, would gather around her, thrilled to be in her joyful company. However, the women of the house did not feel the same. They were annoyed with her imaginat...

duction Daniel in the Den of Lions Darius, the king of the Medes, had it in view to place Daniel as chief officer over the whole of his realm, and thereby he awakened against Daniel (vv. 1-6 [ Daniel 5:31]) the envy of the high officers of state. In order to frustrate the king's intention and to set Daniel aside, they procured an edict from Darius, which forbade for the space of thirty days, on the pain of death, prayer to be offered to any god or man, except to the king (vv. 7-10 [ Daniel 6:6]). Daniel, however, notwithstanding this, continued, according to his usual custom, to open the windows of his upper room, and there to pray to God three times a day. His conduct was watched, and he was accused of violating the king's edict, and thus he brought upon himself the threatened punishment of being thrown into the den of lions (vv. 11-18 [ Daniel 6:10]). But he remained uninjured among the lions; whereupon the king on the following morning caused him to be brought out of the dean, and his malicious accusers to be thrown into it (vv. 19-25 [ Daniel 6:18]), and then by an edict he commanded his subjects to reverence the God of Daniel, who did wonders (vv. 26-28 [ Daniel 6:25]). As a consequence of this, Daniel prospered during the reign of Darius and of Cyrus the Persian (v. 29 [ Daniel 6:28]). From the historic statement of this chapter, that Darius the Mede took the Chaldean kingdom when he was about sixty-two years old (v. 1 [ Daniel 5:31]), taken in connection with the cl...

Banning fishing in a Mexican marine park did not reduce the fishing catch, according to a new study that says it has dispelled the “myth” spread by fishing companies that protecting marine areas leaves less fish available for people to eat. The before-and-after The answer was no, said the study’s authors, who said the finding showed that “large, fully protected MPAs [marine protected areas] can contribute to a more sustainable and equitable use of the ocean, without major economic repercussions on the fishing industry”. Fish shoaling in Revillagigedo national park. The study found compliance with the ban was unexpectedly high. Photograph: Cultura Creative RF/Alamy Before fishing in the MPA was banned in 2017, Mexico’s $1bn fishing sector had warned it could reduce their catch of tuna and other But catch data comparisons from the four years before and after the ban showed the MPA “had no causal effect on catches or area use, and therefore did not cause harm [to the Mexican fishing fleet]”, said Fabio Favoretto, a postdoctoral scholar at Scripps Institution of Oceanography in San Diego, California, and the lead author of the peer-reviewed study, published in the journal Science Advances. One reason for the MPA’s apparently minimal impact on commercial fishing, he said, might be that the protected area “was almost insignificant” compared with the expanse of ocean available to the Mexican fleet. Another “highly speculative” conclusion might be the existence of more fish in the...