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2. CVN424, a GPR6 inverse agonist, for Parkinson's disease and motor fluctuations: a double-blind, randomized, phase 2 trialResearch in context

Author

Nicola L. Brice, Mark Carlton, David H. Margolin, Martin Bexon, Kim L. Matthews, Lee A. Dawson, Aaron L. Ellenbogen, C. Warren Olanow, Jordan Dubow, and Karl Kieburtz

Subjects
Parkinson's disease, Motor fluctuations, CVN424, GPR6, Striatum, Indirect pathway, Medicine (General), R5-920
Abstract

Summary: Background: CVN424 is a GPR6 inverse agonist that provides selective pharmacological control of the indirect striatopallidal pathway. We assessed the safety and efficacy of CVN424 as an adjunctive treatment to levodopa for reducing OFF-time in individuals with Parkinson's disease (PD) experiencing motor-fluctuations. Methods: This was a randomised, double-blind, placebo-controlled study conducted at 21 sites across the United States to evaluate two doses of CVN424 (NCT04191577). Patients with PD (Hoehn and Yahr stages 2–4) who were on a stable dose of levodopa and experiencing ≥2 h of daily OFF-time were randomised (1:1:1) to receive either once-daily CVN424 (50 mg or 150 mg) or placebo for a 28-day treatment period. The primary endpoints were safety and tolerability. The key secondary endpoint was the change from baseline to Day 27 in OFF-time. Findings: The study was conducted from December 23, 2019, to October 14, 2021. Out of 198 participants screened, 141 eligible participants were randomised to one of the three treatment groups (n = 47 per group), and 127 participants completed the 28-day treatment period. The most common treatment emergent adverse events (TEAEs) were headache (2% with CVN424 50 mg, 9% with CVN424 150 mg, and 2% with placebo) and nausea (4% with CVN424 50 mg, 6% with CVN424 150 mg and 2% with placebo). No serious treatment-related adverse events were reported. On Day 27, the mean ± standard deviation (SD) change from baseline in daily OFF-time was −1.3 ± 3.0 h in the CVN424 50 mg group, −1.6 ± 2.5 h in the CVN424 150 mg group, and −0.5 ± 2.9 h in the placebo group. The placebo-adjusted LS mean ± standard error (SE) treatment difference was significant for the CVN424 150 mg dose (1.3 ± 0.56 h, [95 CI% −2.41 to −0.19], nominal p = 0.02). Interpretation: Treatment with CVN424 was safe and well-tolerated. Despite the short study duration and small sample size, the 150 mg CVN424 dose provided a clinically meaningful reduction in daily OFF-time. This study supports the development of CVN424 for the treatment of PD. Funding: Cerevance.

Published
2024
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4. RESTORE: Once-nightly oxybate dosing preference and nocturnal experience with twice-nightly oxybates

Author

Asim Roy, Thomas Stern, John Harsh, J. Douglas Hudson, Akinyemi O. Ajayi, Bruce C. Corser, Emmanuel Mignot, Adrian Santamaria, Anne Marie Morse, Brian Abaluck, Sally Ibrahim, Paula K. Schweitzer, Katie Lancaster, Jordan Dubow, and Jennifer Gudeman

Subjects
Narcolepsy, Sodium oxybate, Twice-nightly, Once-nightly, Adherence, Nocturnal adverse events, Specialties of internal medicine, RC581-951
Abstract

Objective/Background: Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE (NCT04451668). Patients/Methods: Participants aged ≥16 years with narcolepsy who completed the phase 3 REST-ON trial, were oxybate-naive, or were on a stable IR oxybate dose (≥1 month) were eligible for RESTORE. For participants who switched from twice-nightly dosing to ON-SXB, initial doses were closest or equivalent to their previous nightly IR oxybate dose. These participants completed a questionnaire at baseline about nocturnal adverse events associated with the middle-of-the-night IR oxybate dose in the preceding 3 months, a preference questionnaire after 3 months of stable-dose ON-SXB, and an end-of-study (EOS) questionnaire. Results: There were 130 switch participants; 92/98 (93.9 %) who completed the preference questionnaire preferred ON-SXB. At baseline, 69.2 % reported missing their second IR oxybate dose at least once; in these cases, 80 % felt worse the next day. Approximately 39 % reported taking a second nightly IR oxybate dose >4 h after the first dose, 51 % of whom felt somewhat to extremely groggy/unsteady the next morning; 120 participants (92 %) reported getting out of bed after their second oxybate dose. Of those, 9 (8 %) reported falls and 5 (4 %) reported injuries. Of the switch participants who completed the EOS questionnaire, 91.2 % felt better able to follow the recommended ON-SXB dosing schedule. Conclusions: The second nightly IR oxybate dose presents significant treatment burdens and adherence concerns. Participants overwhelmingly preferred the once-nightly dosing regimen of ON-SXB.

Published
2024
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8. 'And that misformed shape, misshaped more' : the stranger mathematics of 'The Faerie Queene'

Author

Dubow, Bethany and Alexander, Gavin

Subjects
fractals, mathematics, Neoplatonism, poetics, Renaissance, sixteenth century, The Faerie Queene, worldmaking
Abstract

This thesis reframes the normative poetic terminology which (today, as in Elizabethan England) allies poetic structures with humanist cosmic and mathematical ideals: 'number'; 'proportion'; 'measure'; 'unity'; 'harmony'; 'symmetry' (etc.). Arguing for 'the stranger mathematics' of The Faerie Queene, it proposes that this terminology, in prioritising the rational architecture of verse, has long occluded those structures (lexical, prosodic, imagistic) that manifest the more irrational and unpredictable geometries of material reality. Drawing on the tenets and tensions of sixteenth-century mathematics, as well as on those of modern mathematics and chaos theory, I show how Spenser translated the non-Pythagorean physics of space into a physics of syntax and syllables. This research revises the traditional reading of Spenserian form as obediently upholding Neoplatonist mathematics and cosmology. It also offers a new way of understanding the syntactic and prosodic foundations of poetic worldmaking. PART I, 'Sixteenth-Century Poetics and Mathematics', revisits the evolution of the idea of the poem as 'world', arguing that Elizabethan poets, emboldened by the claims of Aristotle's Poetics, reshaped the Neoplatonist idea of poetry-as-cosmography into one of poetry-as-worldmaking. Emphasising how Plato's Timaeus inspired the notion of a geometrically derived cosmos, it shows how humanist poets advanced an analogy between literary microcosm and mathematical cosmos: verse was 'numbers', metre was 'measure', and syllables were quantities to 'weigh'. Freighted with religious and epistemological significance, this terminology became crucial to how humanist poets defended their poetic worldmaking. PART II, 'Spenser's Poetics and the Limits of "Number"', points to the limits of this conceptual framing, revealing how Spenser and his peers struggled to organise words into quantitative schemes. It sets The Faerie Queene's Book V word-weighing scene in the context of contemporary disagreements over how to 'weigh' a syllable, and in relation to Spenser's attestations to the frustration of pinning down poetic 'numbers' (which, he observes, don't so much aggregate as 'flow'). Finally, it suggests that sixteenth-century poetic discourse, like that of music, tracked parallel developments in mathematics where a classical definition of 'number' as an aggregate of indivisible units was being replaced by a modern sense of 'number' as a continuum. PART III, on 'Errour and Irrationality in The Faerie Queene', posits a connection between Spenser's half-monster, half-woman 'Errour' and Plato's 'Errant Cause' - that recalcitrant aspect of matter which, in the Timaeus, interferes in the realisation of a perfectly Euclidean universe. I explore how halves in The Faerie Queene ('halfe' lines, 'halfe' things) seed unresolved fractions - contemporarily called 'broken numbers' - into the Faerie cosmos. I then show how Spenser's use of alliteration and rhyme engenders a poetics that is errant, opportunistic, and subject to accident. If the poem's metrical and syntactical symmetries belong to a Euclidean order that works to build a rational poetic cosmos, its proliferating networks of alliteration and rhyme enact an 'Errant' order which (cognate with the Errour-monster and her creatures) manifests an unruly materiality. The thesis ends with an exploration of the 'fractal' mathematics of Spenser's epic. Fractal systems are dynamical and nonlinear; deterministic, yet unpredictable. While clearly Spenser could never have studied fractal geometry, fractal forms (root systems, cloud patterns, jagged coastlines) were nonetheless constitutive of the world he knew.

Published
2022
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11. Preferences for Attributes of Sodium Oxybate Treatment: A Discrete Choice Experiment in Patients with Narcolepsy

Author

Dubow, Jordan, Avidan, Alon Y, Corser, Bruce, Athavale, Amod, Seiden, David, and Kushida, Clete

Subjects
Health Services and Systems, Health Sciences, Clinical Trials and Supportive Activities, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, narcolepsy, patient preference, adherence, sodium oxybate, discrete choice experiment, once-nightly, Clinical Sciences, Health services and systems
Abstract

PurposeCurrent US FDA-approved treatments for narcolepsy include sodium oxybate (SXB) and calcium, magnesium, potassium, and sodium oxybates (mixed-salt oxybates), which require 2 nightly doses, 1 at bedtime and another 2.5 to 4 hours later. Once-nightly SXB (ON-SXB; FT218) is under FDA review to treat adults with narcolepsy. This study quantitatively characterized attributes of SXB treatment preferred by individuals with narcolepsy via a discrete choice experiment (DCE) and evaluated preferences for the product profiles of once-nightly vs twice-nightly SXB treatment.Patients and methodsAdults with self-reported physician-diagnosed narcolepsy for ≥1 year and current or prior twice-nightly SXB treatment were eligible for this 30-minute, web-based study capturing patient experiences and a DCE. Participants responded to a survey instrument using 9-point scales; higher scores indicated greater severity/preference/satisfaction. In the DCE, hundreds of profiles were generated, each combining attributes of twice-nightly SXB and ON-SXB based on clinical trial data. The DCE was analyzed using a hierarchical Bayesian model.ResultsSeventy-five participants were surveyed (50 current and 25 past twice-nightly SXB users). Dosing frequency was the most important attribute of SXB treatment; once nightly was significantly preferred vs twice nightly. The most common reasons for overall product preference were lack of need to wake up in the middle of the night for a second dose (48%), fewer side effects (46%), and ease of administration (32%). Number of nightly doses was the most important driver of taking the medication exactly as directed and reduced anxiety/stress. Participants were significantly more likely to prefer the blinded product profile of once-nightly SXB over twice-nightly SXB (mean rating, 7.5 vs 4.3; P

Published
2022

14. KC stays undefeated with win over 49ers in Super Bowl rematch

Author

Dubow, Josh

Subjects
Football (Professional) -- Competitions, General interest, News, opinion and commentary, San Francisco Forty-Niners -- Competitions, Kansas City Chiefs -- Competitions
Abstract

Byline: JOSH DUBOW; THE ASSOCIATED PRESS SANTA CLARA, CALIF. -- Patrick Mahomes overcame two interceptions to deliver a few big plays with his feet and Kansas City remained the league's [...]

Published
2024

15. Safety, tolerability, and efficacy of NLY01 in early untreated Parkinson's disease: a randomised, double-blind, placebo-controlled trial

Author

McGarry, Andrew, Rosanbalm, Shane, Leinonen, Mika, Olanow, C Warren, To, Dennis, Bell, Adam, Lee, Daniel, Chang, Jamie, Dubow, Jordan, Dhall, Rohit, Burdick, Daniel, Parashos, Sotirios, Feuerstein, Jeanne, Quinn, Joseph, Pahwa, Rajesh, Afshari, Mitra, Ramirez-Zamora, Aldolfo, Chou, Kelvin, Tarakad, Arjun, Luca, Corneliu, Klos, Kevin, Bordelon, Yvette, St Hiliare, Marie-Helene, Shprecher, David, Lee, Seulki, Dawson, Ted M, Roschke, Viktor, and Kieburtz, Karl

Published
2024
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16. Which move is better when down 1 late? Kick the extra point or go for 2?

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

Inside the Numbers dives into NFL statistics, streaks and trends each week. For more Inside the Numbers, head https://apnews.com/hub/inside-the-numbers/. ___ Whenever a team is trailing by seven points late in [...]

Published
2024

18. The 49ers mourn the death of CB Charvarius Ward's 1-year-old daughter

Author

DUBOW, JOSH

Subjects
San Francisco Forty-Niners
Abstract

SANTA CLARA, Calif. (AP) — The 1-year-old daughter of San Francisco 49ers cornerback Charvarius Ward has died after battling heart problems since her birth. Ward https://www.instagram.com/p/DBt6-R4Jc8_/ that his daughter, Amani […]

Published
2024

19. Brock Purdy helps the 49ers bounce back with a 30-24 victory over the Cowboys

Author

DUBOW, JOSH

Subjects
Football teams, News, opinion and commentary, San Francisco Forty-Niners -- Competitions
Abstract

SANTA CLARA, Calif. (AP) — One dominant quarter against Dallas proved to be enough for the San Francisco 49ers to head into their bye week on a high note. Brock [...]

Published
2024

20. 49ers WR Deebo Samuel gets released from the hospital, AP source says

Author

DUBOW, JOSH

Subjects
The Associated Press, News agencies, News, opinion and commentary, San Francisco Forty-Niners
Abstract

SANTA CLARA, Calif. (AP) — San Francisco 49ers star receiver Deebo Samuel has been released from the hospital after being treated for a bout of pneumonia. A person with knowledge [...]

Published
2024

21. Tests confirm a season-ending knee injury for 49ers receiver Brandon Aiyuk

Author

DUBOW, JOSH

Subjects
Knee -- Injuries, News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — San Francisco 49ers https://apnews.com/article/49ers-ricky-pearsall-return-7889bafdf22f93f7ae2620812c30f131 will miss the rest of the season after tearing ligaments in his right knee. Coach Kyle Shanahan said tests Monday confirmed [...]

Published
2024

22. Patrick Mahomes and Chiefs stay undefeated, beat 49ers 28-18 in Super Bowl rematch

Author

DUBOW, JOSH

Subjects
Football teams, News, opinion and commentary, San Francisco Forty-Niners -- Competitions, Kansas City Chiefs -- Competitions
Abstract

SANTA CLARA, Calif. (AP) — The formula might look a bit different with the defense and running game carrying the Kansas City Chiefs. But the results are awfully familiar as [...]

Published
2024

23. 49ers rookie Ricky Pearsall will make his debut 50 days after being shot in the chest

Author

DUBOW, JOSH

Subjects
Football, Football coaches, News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — San Francisco 49ers rookie receiver Ricky Pearsall will be activated and make his NFL debut Sunday against Kansas City 50 days after he was https://apnews.com/article/49ers-ricky-pearsall-shooting-02910eafbbb65eef1dcd6fdb1fcaab77. [...]

Published
2024

26. Ricky Pearsall returns to the 49ers practice for the first time since shooting

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — San Francisco 49ers rookie receiver Ricky Pearsall returned to the field for practice on Monday for the first time since he was https://apnews.com/article/49ers-ricky-pearsall-shooting-02910eafbbb65eef1dcd6fdb1fcaab77 during an [...]

Published
2024

27. 18-year-old Macklin Celebrini scores a goal in his hyped debut for the Sharks

Author

DUBOW, JOSH

Subjects
Career development, News, opinion and commentary, San Jose Sharks, Boston University
Abstract

SAN JOSE, Calif. (AP) — Macklin Celebrini didn't take long to make an impact for the San Jose Sharks. The 18-year-old rookie https://www.nhl.com/video/macklin-celebrini-with-a-goal-vs-st-louis-blues-6363102714112 of the season and added an assist [...]

Published
2024

28. Kyler Murray rallies the Cardinals past the 49ers, 24-23

Author

DUBOW, JOSH

Subjects
Football teams, News, opinion and commentary, San Francisco Forty-Niners -- Competitions
Abstract

SANTA CLARA, Calif. (AP) — Kyler Murray's day started with a 50-yard touchdown run where he pointed to the end zone in celebration almost as soon as he crossed the [...]

Published
2024

29. No. 8 Miami rallies from 25 points down to beat California 39-38

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

BERKELEY, Calif. (AP) — Halfway through his first season at Miami, Cam Ward already has shown a knack for the dramatic. Ward threw a 5-yard touchdown pass to Elijah Arroyo [...]

Published
2024

30. Chaos hits AP Top 25 with 4 teams ranked in the top 11 losing to unranked opponents

Author

DUBOW, JOSH

Subjects
The Associated Press -- Rankings, News agencies -- Rankings, News, opinion and commentary
Abstract

https://apnews.com/article/alabama-vanderbilt-football-score-64f42b64a0f0c1c9d82513b97919d8f4 of No. 1 Alabama that led to crazed fans marching the goal posts through the streets of Nashville was just the appetizer. Saturday proved to be one of the [...]

Published
2024

32. Rookie QB Jayden Daniels leads Commanders to a record-setting performance

Author

DUBOW, JOSH

Subjects
Football teams, News, opinion and commentary
Abstract

Inside the Numbers dives into NFL statistics, streaks and trends each week. For more Inside the Numbers, head https://apnews.com/hub/inside-the-numbers/. ___ Jayden Daniels did far more than just deliver the first [...]

Published
2024

34. Gerrit Cole and Juan Soto lead the Yankees past the Athletics 4-2 in 10 innings

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

OAKLAND, Calif. (AP) — Gerrit Cole tuned up for the postseason by holding the Athletics to one run in nine innings and https://apnews.com/article/yankees-soto-639c43c277c9fa2718ff74bdf8db6e24 came off the bench to hit an [...]

Published
2024

35. Derek Carr and the Saints buck the NFL trend of early season offensive struggles

Author

DUBOW, JOSH

Subjects
Football (Professional), News, opinion and commentary
Abstract

Inside the Numbers dives into NFL statistics, streaks and trends each week. For more Inside the Numbers, head https://apnews.com/hub/inside-the-numbers/. ___ The worst start to a season for passing offenses in [...]

Published
2024

37. Christian McCaffrey will miss another game for the 49ers and could be headed to IR

Author

DUBOW, JOSH

Subjects
The Associated Press, News agencies, Football teams, News, opinion and commentary, San Francisco Forty-Niners -- Competitions
Abstract

SANTA CLARA, Calif. (AP) — All-Pro running back Christian McCaffrey has been ruled out of this weekend's game for the San Francisco 49ers because of his lingering calf and Achilles' [...]

Published
2024

38. Passing in Week 1 reached its lowest level for any week in the NFL since 2007

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

Inside the Numbers dives into NFL statistics, streaks and trends each week. For more Inside the Numbers, head https://apnews.com/hub/inside-the-numbers/. ___ From https://apnews.com/article/williams-daniels-nix-cousins-allen-fields-mayfield-carr-stroud-fe098a8a45d8c91c72735742ffc14935 in their first career starts to high-paid quarterbacks [...]

Published
2024

39. Christian McCaffrey could have played for 49ers if it was the playoffs, Shanahan says

Author

DUBOW, JOSH

Subjects
The Associated Press -- Reports, News agencies -- Reports, News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — San Francisco coach Kyle Shanahan said All-Pro running back https://apnews.com/article/mccaffrey-49ers-inactives-69ac1a19e0c98c652907c0e593b2c1bc could have played in the 49ers' opener if it had been a playoff game but [...]

Published
2024

40. The 49ers spoil Aaron Rodgers' return with a 32-19 win over the Jets

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — Fill-in back Jordan Mason took top billing in a game hyped as https://apnews.com/article/aaron-rodgers-return-jets-4b16a32fdbb8df549c81735de9c374e8. Mason ran for 147 yards and a touchdown in place of the [...]

Published
2024

41. Aaron Rodgers makes his return to the field for the Jets against the 49ers

Author

DUBOW, JOSH

Subjects
Football teams, News, opinion and commentary, San Francisco Forty-Niners, New York Jets
Abstract

SANTA CLARA, Calif. (AP) — Aaron Rodgers made his return to the field for the New York Jets one year after his highly anticipated debut with the team ended after [...]

Published
2024

42. NFL tries to tackle tackling with a new Next Gen statistic

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

Every offensive play in the NFL provides a trove of statistics accounting for the yards gained or lost on every throw or run. Quantifying defensive performance has always been a [...]

Published
2024

44. 49ers rookie receiver Ricky Pearsall watches practice 5 days after shooting

Author

DUBOW, JOSH

Subjects
Company business planning, News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — San Francisco 49ers rookie receiver Ricky Pearsall was at practice as a spectator five days after being https://apnews.com/article/ricky-pearsall-shot-robbery-san-francisco-49ers-3afececadc18b6b10d2df411a27c7d43 during an attempted robbery. Pearsall was hit [...]

Published
2024

45. NFL rookie QBs Caleb Williams, Jayden Daniels and Bo Nix set to start in Week 1

Author

DUBOW, JOSH

Subjects
News, opinion and commentary
Abstract

Inside the Numbers dives into NFL statistics, streaks and trends each week. For more Inside the Numbers, head https://apnews.com/hub/inside-the-numbers/. ___ The days of rookie quarterbacks waiting their turns before taking [...]

Published
2024

46. The 49ers place rookie Ricky Pearsall on the non-football injury list after shooting

Author

DUBOW, JOSH

Subjects
Juvenile offenders -- Injuries, Emergency medical services, Sports injuries, News, opinion and commentary
Abstract

SANTA CLARA, Calif. (AP) — San Francisco 49ers rookie receiver Ricky Pearsall was placed on the non-football injury list after https://apnews.com/article/ricky-pearsall-shot-robbery-san-francisco-49ers-3afececadc18b6b10d2df411a27c7d43 during an attempted robbery. The move made Monday clears [...]

Published
2024

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