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Article ; Online: Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy.

Thurman, A / Hull, L / Stuckey, B / Hatheway, J / Mauck, C / Zack, N / Friend, D

Climacteric : the journal of the International Menopause Society

2023 Volume 26, Issue 5, Page(s) 479–488

Abstract: Objective: This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy.: Methods: This was a randomized, ... ...

Abstract	Objective: This study aimed to measure safety, systemic pharmacokinetics and preliminary efficacy of a vaginal tamoxifen capsule (DARE-VVA1) among postmenopausal women with moderate-to-severe vulvovaginal atrophy. Methods: This was a randomized, placebo-controlled, double-blind, phase 1/2 study of DARE-VVA1, in four doses (1, 5, 10 and 20 mg). Results: Seventeen women were enrolled and 14 completed the 8-week treatment. DARE-VVA1 was safe. All adverse events were of mild or moderate severity and distributed similarly among active and placebo groups. Plasma tamoxifen concentrations were highest among women using DARE-VVA1 20 mg, but the maximum mean (standard deviation) plasma tamoxifen concentrations on day 1 (2.66 ± 0.85 ng/ml) and day 56 (5.69 ± 1.87 ng/ml) were <14% of those measured after one oral tamoxifen dose. Active study product users had significant decreases from pre-treatment baseline in vaginal pH and proportion of vaginal parabasal cells ( Conclusions: DARE-VVA1 is safe and results in minimal systemic exposure to tamoxifen. Preliminary efficacy data support further development of this product.
MeSH term(s)	Female ; Humans ; Atrophy/drug therapy ; Capsules/adverse effects ; Double-Blind Method ; Dyspareunia/drug therapy ; Gelatin/adverse effects ; Postmenopause ; Tamoxifen/adverse effects ; Treatment Outcome ; Vagina/pathology ; Vaginal Diseases/drug therapy ; Vulva/pathology
Chemical Substances	Capsules ; Gelatin (9000-70-8) ; Tamoxifen (094ZI81Y45)
Language	English
Publishing date	2023-06-08
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	1469153-x
ISSN	1473-0804 ; 1369-7137
ISSN (online)	1473-0804
ISSN	1369-7137
DOI	10.1080/13697137.2023.2211763
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Zs.A 5245: Show issues

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Article ; Online: The impact of Facebook's vaccine misinformation policy on user endorsements of vaccine content: An interrupted time series analysis.

Gu, Jiayan / Dor, Avi / Li, Kun / Broniatowski, David A / Hatheway, Megan / Fritz, Lailah / Abroms, Lorien C

Vaccine

2022 Volume 40, Issue 14, Page(s) 2209–2214

Abstract: Objectives: To evaluate the impact of Facebook's vaccine misinformation policy in March 2019 on user endorsements of vaccine content on its platform.: Methods: We identified 172 anti- and pro-vaccine Facebook Pages and collected posts from these ... ...

Abstract	Objectives: To evaluate the impact of Facebook's vaccine misinformation policy in March 2019 on user endorsements of vaccine content on its platform. Methods: We identified 172 anti- and pro-vaccine Facebook Pages and collected posts from these Pages six months before and after the policy. Using interrupted time series regression models, we evaluated the policy impact on user endorsements (i.e., likes) of anti- and pro-vaccine posts on Facebook. Results: The number of likes for posts on anti-vaccine Pages had decreased after the policy implementation (policy = 153.2, p < 0.05; policyday = -0.838, p < 0.05; marginal effect at the mean = -22.74, p < 0.01; marginal effect at the median = -24.56, p < 0.01). When the number of subscribers was considered, the policy effect on the number of likes for anti-vaccine posts was much smaller, but still statistically significant (policy = 4.849, p < 0.05; policyday = -0.027, p < 0.05; marginal effect at the mean = -0.742, p < 0.01; marginal effect at the median = -0.800, p < 0.01). There was no policy effect observed for posts on pro-vaccine Pages. Conclusions: Our analysis suggested that Facebook's March 2019 vaccine misinformation policy moderately impacted the number of endorsements of anti-vaccine content on its platform. Social media companies can take measures to limit the popularity of anti-vaccine content by reducing their reach and visibility. Future research efforts should focus on evaluating additional policies and examining policies across platforms.
MeSH term(s)	Communication ; Humans ; Interrupted Time Series Analysis ; Policy ; Social Media ; Vaccines
Chemical Substances	Vaccines
Language	English
Publishing date	2022-03-01
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.02.062
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Zs.A 1930: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial.

Kapural, Leonardo / Patterson, Denis G / Li, Sean / Hatheway, John / Hunter, Corey / Rosen, Steven / Fishman, Michael / Gupta, Mayank / Sayed, Dawood / Christopher, Anne / Burgher, Abram / McJunkin, Tory / Ross, Edgar L / Provenzano, David / Amirdelfan, Kasra

Neuromodulation : journal of the International Neuromodulation Society

2023 Volume 26, Issue 7, Page(s) 1400–1411

Abstract: Objective: This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial.: Materials and methods: This prospective, multicenter, randomized, ... ...

Abstract	Objective: This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. Materials and methods: This prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B (approximately 300-600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12-day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies. Results: A total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non-serious device-related AE was reported, and no infections occurred during the extended trial. Conclusions: Multiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation. Clinical trial registration: The Clinicaltrials.gov registration number for the study is NCT03594266.
MeSH term(s)	Humans ; Spinal Cord Stimulation/adverse effects ; Spinal Cord Stimulation/methods ; Chronic Pain/diagnosis ; Chronic Pain/therapy ; Leg ; Prospective Studies ; Single-Blind Method ; Treatment Outcome ; Spinal Cord
Language	English
Publishing date	2023-08-16
Publishing country	United States
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article
ZDB-ID	1500372-3
ISSN	1525-1403 ; 1094-7159
ISSN (online)	1525-1403
ISSN	1094-7159
DOI	10.1016/j.neurom.2023.05.006
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Zs.A 5912: Show issues

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Article ; Online: Using Lower Amplitudes to Maintain Effective High Dose Spinal Cord Stimulation Therapy (SCS Dosing Pilot Study).

El-Naggar, Amr O / Reis, Christopher L / Hatheway, John A / Schmidt, Todd E / Pico, Tristan C / Sanapati, Mahendra R / Abd-Elsayed, Alaa / Patel, Amit S / Calodney, Aaron / Johanek, Lisa / Tan, Ye / McCammon, Sheryl

Neuromodulation : journal of the International Neuromodulation Society

2020 Volume 24, Issue 3, Page(s) 532–539

Abstract: Background: Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. ...

Abstract	Background: Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. This study characterized the minimum amplitude level that maintained SCS therapy satisfaction and pain relief when stimulating at 1000 Hz and 90 μsec. Materials and methods: Qualified patients had back and leg pain, an implanted neurostimulator programmed to 1000 Hz and 90 μsec, and were very or somewhat satisfied with the therapy, and an average overall VAS pain score ≤ 4 from a daily diary. Patients received four blinded amplitudes (titrated from 80%, 60%, 40%, and 20% of baseline perception threshold), approximately two weeks each, with 1000 Hz and 90 μsec and position-adaptive stimulation enabled. Patients' satisfaction and overall VAS pain scores were collected for each period. All patients continued through the study, even after reporting lack of therapy satisfaction or pain relief. Results: The minimum amplitude, which maintained therapy satisfaction, was 80% of perception threshold for two patients, 60% for one patient, and 20% for 21 patients. Additionally, six patients lost satisfaction changing from their baseline amplitude to 80% perception threshold. The minimum amplitude level, which maintained overall pain relief, was 80% perception threshold for three patients, 60% perception threshold for one patient, 40% perception threshold for two patients, and 20% perception threshold for 19 patients. Five patients required the setting they were programmed to during the baseline period. Conclusion: The qualified study patients defined an implanted population reporting good pain relief and satisfaction using HD SCS therapy at baseline. The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude. Amplitudes below perception threshold could potentially maintain effective SCS therapy with HD stimulation in a subset of patients.
MeSH term(s)	Humans ; Pain ; Pain Management ; Pain Measurement ; Pilot Projects ; Spinal Cord ; Spinal Cord Stimulation ; Treatment Outcome
Language	English
Publishing date	2020-09-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	1500372-3
ISSN	1525-1403 ; 1094-7159
ISSN (online)	1525-1403
ISSN	1094-7159
DOI	10.1111/ner.13258
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Article ; Online: Options: A Prospective, Open-Label Study of High-Dose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain.

Benyamin, Ramsin / Galan, Vincent / Hatheway, John / Kim, Philip / Choi, Daniel / Falowski, Steven / Calodney, Aaron / Sweet, Jennifer / Yu, Cong / Kapural, Leonardo / Provenzano, David

Pain physician

2020 Volume 23, Issue 1, Page(s) 87–98

Abstract: Background: Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome.: Objectives: The aim of this study was to evaluate pain ... ...

Abstract	Background: Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome. Objectives: The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters. Study design: This was a prospective cohort study. Setting: This study took place at 11 centers in North America. Methods: Forty-four SCS-naive patients underwent trialing, starting with 1,000 Hz frequency, 90 µs pulse width followed by 300 Hz frequency, 800 µs pulse width, if pain relief was inadequate. Patients with 50% or greater pain relief were eligible for permanent implantation. Patient's pain rating, global impression of change, health-related quality of life, functional disability, satisfaction/recommendation, stimulation perception, device programming, and adverse events were assessed at 3 months postimplant. Results: There were significant improvements from baseline in mean Numeric Rating Scale (NRS-11) pain scores for overall pain (7.5 to 3.8; P < 0.01), back pain (7.2 to 3.4; P < 0.01), leg pain (7.2 to 3.1; P < 0.01), Oswestry Disability Index (ODI) score (51.5 to 32.1; P < 0.01), and European Quality of Life-Five Dimensions, version 5L score (EQ-5D-5L) (0.58 to 0.74; P < 0.01). Twenty-eight of 32 patients (88%) had significant, favorable improvement in Patient Global Impression of Change (PGIC). Eighty-four percent of patients were "satisfied," and 78.1% would "definitely" recommend SCS. Eighteen patients (56%) used 1,000 Hz frequency and 90 µs pulse width exclusively; these patients experienced mean NRS-11 overall pain score improvement of 4.7 points. Device-, therapy-, or procedure-related adverse events were experienced in 19 patients (40%, 19 of 48), and all events resolved without reoperation and were similar to those observed with traditional SCS systems. Limitations: There was no active or sham comparator group, and therefore the reported effects may not be solely attributable to therapy effects and may be related to other, nonspecific effects of SCS. Conclusions: Improvements in pain relief, PGIC, EQ-5D-5L, ODI, and patient satisfaction were all clinically relevant and statistically significant. Future studies are needed to understand how these high-dose parameters perform versus a standard comparator. Key words: Spinal cord stimulation, high-frequency electrical stimulation, failed back surgery syndrome, neurostimulation, prospective, nonrandomized study.
MeSH term(s)	Adult ; Aged ; Chronic Pain/therapy ; Failed Back Surgery Syndrome/therapy ; Female ; Humans ; Male ; Middle Aged ; Pain Management/methods ; Patient Satisfaction ; Prospective Studies ; Spinal Cord Stimulation/methods ; Treatment Outcome
Language	English
Publishing date	2020-02-03
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2146393-1
ISSN	2150-1149 ; 1533-3159
ISSN (online)	2150-1149
ISSN	1533-3159
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Zs.A 5930: Show issues

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Article: Botulism: the present status of the disease.

Hatheway, C L

Current topics in microbiology and immunology

1995 Volume 195, Page(s) 55–75

Abstract: ... limited to toxin types A, B, and E, while type C botulism predominates in avian and nonhuman mammalian ...

Abstract	The main form of human botulism throughout the world is the classic foodborne intoxication. Would botulism is very rare, and most of the documented cases have been found in the United States. While infant botulism remains rare throughout the world, it has become the most frequent form of the disease in the United States in recent years. On very rare occasions botulism results from growth and toxin production in humans other than infants. Botulism occurs in animals with much higher frequency. The causative organisms constitute a diverse group of clostridia, resulting in nomenclature problems. Human botulism is largely limited to toxin types A, B, and E, while type C botulism predominates in avian and nonhuman mammalian species. The diagnosis of botulism is made on the basis of the neurologic signs and symptoms that it causes in humans and animals. The diagnosis is confirmed by tests that identify the toxin and toxigenic organisms in patient and food specimens. Treatment includes supportive intensive care and use of therapeutic antitoxin.
MeSH term(s)	Animals ; Botulism/diagnosis ; Botulism/immunology ; Botulism/microbiology ; Botulism/therapy ; Clostridium botulinum ; Humans ; Immunization
Language	English
Publishing date	1995
Publishing country	Germany
Document type	Journal Article ; Review
ISSN	0070-217X
ISSN	0070-217X
DOI	10.1007/978-3-642-85173-5_3
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Article: Toxigenic clostridia.

Hatheway, C L

Clinical microbiology reviews

1990 Volume 3, Issue 1, Page(s) 66–98

Abstract: Toxigenic clostridia belonging to 13 recognized species are discussed in this review. Each species or group of organisms is, in general, introduced by presenting the historical aspects of its discovery by early investigators of human and animal diseases. ...

Abstract	Toxigenic clostridia belonging to 13 recognized species are discussed in this review. Each species or group of organisms is, in general, introduced by presenting the historical aspects of its discovery by early investigators of human and animal diseases. The diseases caused by each species or group are described and usually discussed in relation to the toxins involved in the pathology. Morphological and physiological characteristics of the organisms are described. Finally, the toxins produced by each organism are listed, with a presentation of their biological activities and physical and biochemical characteristics. The complete amino acid sequences for some are known, and some of the genes have been cloned. The term toxin is used loosely to include the various antigenic protein products of these organisms with biological and serological activities which have served as distinguishing characteristics for differentiation and classification. Some of these factors are not truly toxic and have no known role in pathogenicity. Some of the interesting factors common to more than one species or group are the following: neurotoxins, lethal toxins, lecithinases, oxygen-labile hemolysins, binary toxins, and ADP-ribosyltransferases. Problems in bacterial nomenclature and designation of biologically active factors are noted.
MeSH term(s)	Animals ; Bacterial Toxins/biosynthesis ; Bacterial Toxins/toxicity ; Botulism/microbiology ; Clostridium/metabolism ; Clostridium Infections/microbiology ; Clostridium botulinum/metabolism ; Clostridium perfringens/metabolism ; Clostridium tetani/metabolism ; Gas Gangrene/microbiology ; Humans ; Tetanus/microbiology
Chemical Substances	Bacterial Toxins
Language	English
Publishing date	1990-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	645015-5
ISSN	1098-6618 ; 0893-8512
ISSN (online)	1098-6618
ISSN	0893-8512
DOI	10.1128/CMR.3.1.66
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Zs.A 2409: Show issues

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Article: Detection and identification of Clostridium botulinum neurotoxins.

Hatheway, C L / Ferreira, J L

Advances in experimental medicine and biology

1996 Volume 391, Page(s) 481–498

MeSH term(s)	Animals ; Biosensing Techniques ; Botulinum Toxins/analysis ; Botulism/diagnosis ; Clostridium botulinum/isolation & purification ; Clostridium botulinum/metabolism ; Immunoassay ; Mice
Chemical Substances	Botulinum Toxins (EC 3.4.24.69)
Language	English
Publishing date	1996
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2214-8019 ; 0065-2598
ISSN (online)	2214-8019
ISSN	0065-2598
DOI	10.1007/978-1-4613-0361-9_39
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Article: Laboratory procedures for cases of suspected infant botulism.

Hatheway, C L

Reviews of infectious diseases

1979 Volume 1, Issue 4, Page(s) 647–651

Abstract: ... botulinal antitoxin. The presence of C. botulinum in the feces is detected by demonstrating the presence ... of botulinal toxin in enrichment culture supernatant by means of toxicity tests in mice. C. botulinum is isolated ... and C. botulinum are rarely, if ever, found in the feces of humans (infants or older people) not ...

Abstract	The recent development and evaluation of procedures for examination of fecal specimens for botulinal toxin and Clostridium botulinum have provided the means by which infant botulism can be recognized. The toxicity for mice of fecal extracts containing botulinal toxin can be neutralized with specific botulinal antitoxin. The presence of C. botulinum in the feces is detected by demonstrating the presence of botulinal toxin in enrichment culture supernatant by means of toxicity tests in mice. C. botulinum is isolated by streaking enrichment cultures on egg yolk agar and picking typical lipase-positive colonies. The experience of both the Center for Disease Control (CDC) Botulism Laboratory and other laboratories has been that botulinal toxin and C. botulinum are rarely, if ever, found in the feces of humans (infants or older people) not afflicted with botulism. Results of the examination in the CDC laboratory of specimens from 24 babies with infant botulism are given.
MeSH term(s)	Animals ; Botulinum Toxins/analysis ; Botulinum Toxins/blood ; Botulism/diagnosis ; Culture Techniques ; Feces/analysis ; Humans ; Infant ; Mice ; Mice, Inbred ICR
Chemical Substances	Botulinum Toxins (EC 3.4.24.69)
Language	English
Publishing date	1979-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	441228-x
ISSN	0162-0886
ISSN	0162-0886
DOI	10.1093/clinids/1.4.647
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Zs.A 1505: Show issues

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Article: Botulism in the United States: a clinical and epidemiologic review.

Shapiro, R L / Hatheway, C / Swerdlow, D L

Annals of internal medicine

1998 Volume 129, Issue 3, Page(s) 221–228

Abstract: Botulism is caused by a neurotoxin produced from the anaerobic, spore-forming bacterium Clostridium botulinum. Botulism in humans is usually caused by toxin types A, B, and E. Since 1973, a median of 24 cases of foodborne botulism, 3 cases of wound ... ...

Abstract	Botulism is caused by a neurotoxin produced from the anaerobic, spore-forming bacterium Clostridium botulinum. Botulism in humans is usually caused by toxin types A, B, and E. Since 1973, a median of 24 cases of foodborne botulism, 3 cases of wound botulism, and 71 cases of infant botulism have been reported annually to the Centers for Disease Control and Prevention (CDC). New vehicles for transmission have emerged in recent decades, and wound botulism associated with black tar heroin has increased dramatically since 1994. Recently, the potential terrorist use of botulinum toxin has become an important concern. Botulism is characterized by symmetric, descending, flaccid paralysis of motor and autonomic nerves, usually beginning with the cranial nerves. Blurred vision, dysphagia, and dysarthria are common initial complaints. The diagnosis of botulism is based on compatible clinical findings; history of exposure to suspect foods; and supportive ancillary testing to rule out other causes of neurologic dysfunction that mimic botulism, such as stroke, the Guillain-Barré syndrome, and myasthenia gravis. Laboratory confirmation of suspected cases is performed at the CDC and some state laboratories. Treatment includes supportive care and trivalent equine antitoxin, which reduces mortality if administered early. The CDC releases botulism antitoxin through an emergency distribution system. Although rare, botulism outbreaks are a public health emergency that require rapid recognition to prevent additional cases and to effectively treat patients. Because clinicians are the first to treat patients in any type of botulism outbreak, they must know how to recognize, diagnose, and treat this rare but potentially lethal disease.
MeSH term(s)	Antitoxins/therapeutic use ; Botulism/diagnosis ; Botulism/epidemiology ; Botulism/therapy ; Botulism/transmission ; Clostridium botulinum/classification ; Humans ; Incidence ; Population Surveillance ; Respiration, Artificial ; United States/epidemiology
Chemical Substances	Antitoxins
Language	English
Publishing date	1998-08-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/0003-4819-129-3-199808010-00011
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