scholarly journals Protocol Lead Investigator

2020 ◽  
Author(s):  
Keyword(s):  
Lead Investigator

Efficacy and Safety of Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty: STARS J-V trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3320-3320 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai ◽  
Yukihiro Koretsune ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Major Bleeding ◽  
Thromboembolic Events ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Primary Efficacy Outcome ◽  
Treatment Groups ◽  
Efficacy Outcome ◽  
Lead Investigator

Abstract Abstract 3320 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. The aim of this non-inferiority trial was to determine the efficacy and safety of edoxaban compared with enoxaparin sodium (enoxaparin) after total hip arthroplasty (THA) in Japan. Methods: This was a randomized, double-blind, double-dummy, enoxaparin-controlled, multicenter trial. Patients were randomized to oral edoxaban 30 mg once daily (QD) or subcutaneous enoxaparin 2,000 IU, equivalent to 20 mg, twice daily (BID) for 11 to 14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery which is the Japanese standard of care. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT), and pulmonary embolism (PE). The primary safety outcome was the incidence of major and clinically relevant non-major bleeding. Results: A total of 610 patients were randomized. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 62.8 years and mean body weight was 57.4 kg (Efficacy analysis set). The primary efficacy outcome occurred in 6 of 255 (2.4%) patients receiving edoxaban and 17 of 248 (6.9%) patients receiving enoxaparin (relative risk reduction=65.7%; absolute risk difference -4.5%, 95% CI, -8.6% to -0.9%; P<0.001 for non-inferiority; P=0.0157 for superiority). The thromboembolic events were all asymptomatic DVT (Table). No symptomatic DVT or PE was observed in both treatment groups. The incidence of major and clinically relevant non-major bleeding events was 2.6% (8/303) vs 3.7% (11/301) in the edoxaban and enoxaparin groups, respectively (P=0.475). Major bleeding occurred in 0.7% of the edoxaban group and 2.0% of the enoxaparin group. The rates of elevated serum aminotransferase levels of more than 3 times the upper limit of normal was 2.6% with edoxaban versus 10% with enoxaparin. Conclusions: The STARS J-V trial demonstrated that oral edoxaban 30 mg QD has efficacy superior to enoxaparin 2,000 IU BID in the prevention of thromboembolic events following THA and is associated with a similar incidence of major and clinically relevant non-major bleeding events. Disclosures: Fuji: Astellas: Consultancy; Showa Ikakogyo: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Fujita:Daiichi Sankyo: Consultancy; Astellas: Consultancy; GlaxoSmithkline: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy. Koretsune:Daiichi Sankyo: Consultancy, National Lead Investigator. Yamashita:Daiichi Sankyo: Consultancy, National Lead Investigator; Otsuka Pharmaceutical: Paid instructor; Sanofi-aventis: Paid instructor; Teijin Pharma: Paid instructor. Nakamura:Daiichi Sankyo: Consultancy; GlaxoSmithkline: Consultancy; Astellas: Consultancy.

Accuracy of the Fitbit Zip for Measuring Steps for Adolescents With Visual Impairments

2017 ◽  
Vol 34 (2) ◽  
pp. 195-200 ◽  
Author(s):  
Justin A. Haegele ◽  
Ali S. Brian ◽  
Donna Wolf
Keyword(s):  
Intraclass Correlation ◽  
Visual Impairments ◽  
Correlation Coefficients ◽  
Criterion Validity ◽  
Intraclass Correlation Coefficients ◽  
Paired Samples ◽  
Lead Investigator ◽  
Walking Speeds ◽  
Mobility Device ◽  
Study Participants

Our purpose in this study was to document the criterion validity of the Fitbit Zip for measuring steps taken by youth with visual impairments (VI). A secondary purpose was to determine whether walking pace, mounting position, or relative position to the user’s mobility device impacted the criterion validity of the device. Fourteen adolescent-aged individuals (Mage = 15.4; 13 male and 1 female) with VI participated in this study. Participants wore four Fitbit Zips at different mounting positions and completed two, 2-min walking trials while the lead investigator hand tallied steps. Measurement validity was analyzed using absolute percent error (APE), intraclass correlation coefficients estimated level of conformity, and paired samples t tests and Cohen’s d effect sizes assessed APE relative to mounting positions. Results supported the use of the Fitbit Zip during regular-paced walking; however, caution must be used during activities exceeding regular walking speeds, as devices consistently underestimated steps.

The Chokepoint

2017 ◽  
Author(s):  
Stephanie Elizondo Griest
Keyword(s):  
Cause Of Death ◽  
Immigration Policy ◽  
Undocumented Immigrants ◽  
South Texas ◽  
Lead Investigator

The year 2012 broke all records when tiny Brooks County in South Texas recovered the bodies of 129 undocumented immigrants found somewhere along its 942 square miles of ranches and roads. Lead investigator Danny Davila invites the author on the recovery of the 35th body found that year: a woman who had been abandoned by her coyote and left to die three days earlier. Her official cause of death, however, was listed as “hiking through ranch illegally.” In this chapter, the author expands on the history and consequence of U.S. immigration policy.

Francis I. Proctor, MD and his wife Elizabeth C. Proctor: Their lives and legacy

2018 ◽  
Vol 28 (3) ◽  
pp. 135-139
Author(s):  
George M Bohigian ◽  
Robert M Feibel
Keyword(s):  
Native American ◽  
New Mexico ◽  
Infectious Diseases ◽  
Research Laboratory ◽  
Santa Fe ◽  
Indian Reservations ◽  
Lead Investigator ◽  
American Indian Reservations ◽  
Francis I ◽  
Blinding Trachoma

The Francis I. Proctor Foundation for Research in Ophthalmology is internationally recognized for its research in the fields of ocular inflammatory and infectious diseases. Although the name of one of its founders, Francis I. Proctor, MD (1864–1936) is memorialized, the legacy of his wife, Elizabeth C. Proctor (1882–1975) is not as well known. They were both full partners in this endeavor. Francis, a successful and wealthy ophthalmologist, retired to Santa Fe, New Mexico. After their marriage, they became interested in the problem of blinding trachoma, then an endemic problem on the Native American Indian reservations. The couple selected Phillips Thygeson, MD (1903–2002), a young ophthalmologist with an interest in infectious diseases, as their lead investigator. Using their own funds, the Proctors paid for Thygeson and themselves to study trachoma in Egypt, and then establish a trachoma research laboratory in Arizona where the causative agent of trachoma was identified. Not only did the Proctors fund these studies, they also studied bacteriology so they could help in the laboratory themselves. After Francis’ death, Elizabeth endowed the Foundation in 1947 and continued to support it. She also established the Proctor Medal for The Association for Research in Vision and Ophthalmology.

Cognitive Impairment in Bipolar: Neurodevelopmental or Neuroprogressive?

2017 ◽  
Vol 41 (S1) ◽  
pp. S13-S13
Author(s):  
A. Young
Keyword(s):  
Cognitive Deficits ◽  
Early Stage ◽  
Cognitive Remediation ◽  
Bipolar Disorders ◽  
Cognitive Change ◽  
Pharmaceutical Companies ◽  
Advisory Boards ◽  
King's College ◽  
Lead Investigator ◽  
Research Findings

BackgroundBipolar Disorders (BD) are common and complex diseases. Recent findings have provided evidence that impairments in cognition are evident in the various sub-groups of Bipolar Disorder and persist after resolution of acute episodes.MethodAn opinion paper based on a narrative review of the field.ResultsQuantifiable cognitive deficits are clearly found in Bipolar 1 and Bipolar 2 Disorders. These persist after recovery from acute episodes. The aetiopathogenesis of these phenomena is likely to be multifactorial. It seems clear that these cognitive impairments are not in general neurodevelopmental and for most are related to repeated episodes of illness [1]. However, the issues of subgroups with differential profiles of impairment and the trajectory of cognitive change remain to be fully established. The effects of putative treatments (e.g., pharmacological, neurostimulation, cognitive remediation) are at an early stage of evaluation.ConclusionsFuture efforts should focus on further integrating the current and emerging research findings into a coherent model, which generates testable hypotheses and allows treatment effects to be tested.Disclosure of interestEmployed by King's College London Honorary Consultant SLaM (NHS UK)Paid lectures and advisory boards for all major pharmaceutical companies with drugs used in affective and related disordersNo share holdings in pharmaceutical companiesLead Investigator for Embolden Study (AZ), BCI Neuroplasticity study and Aripiprazole Mania StudyInvestigator initiated studies from AZ, Eli Lilly, Lundbeck, WyethGrant funding (past and present): NIMH (USA) CIHR (Canada) NARSAD (USA) Stanley Medical Research Institute (USA) MRC (UK) Wellcome Trust (UK) Royal College of Physicians (Edin) BMA (UK) UBC-VGH Foundation (Canada) WEDC (Canada) CCS Depression Research Fund (Canada) MSFHR (Canada) NIHR (UK).

Asymptomatic Intracranial Hemorrhage Among Japanese Patients Taking Edoxaban for Non-Valvular Atrial Fibrillation.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1066-1066
Author(s):  
Masahiro Yasaka ◽  
Hiroshi Inoue ◽  
Yohko Kawai ◽  
Takenori Yamaguchi ◽  
Shinichiro Uchiyama ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Intracranial Hemorrhage ◽  
Warfarin Dose ◽  
Japanese Patients ◽  
Primary Objective ◽  
Bleeding Events ◽  
Open Label ◽  
Chads2 Score ◽  
Lead Investigator ◽  
Otsuka Pharmaceutical

Abstract Abstract 1066 Poster Board I-88 Introduction: Edoxaban (the free base of DU-176b) is an oral, selective, reversible, direct factor Xa inhibitor in clinical development for the prevention of stroke in patients with non-valvular atrial fibrillation (AF). There is evidence that asymptomatic intracranial hemorrhage (ICH) may be a risk factor for symptomatic ICH in anticoagulated patients. A phase IIb study in Japanese AF patients compared the incidence of asymptomatic ICH with edoxaban and warfarin use. Patients and Methods: This was a multicenter, randomized, dose comparison study. Patients aged ≥20 years with CHADS2 score ≥1 were randomly assigned to receive 1 of 3 doses of edoxaban (30 mg, 45 mg, or 60 mg QD) or open-label warfarin dose-adjusted to a target international normalized ratio (INR) of 2.0 to 3.0 inclusive for patients aged <70 years and 1.6 to 2.6 inclusive for patients aged ≥70 years, for 12 weeks. The primary objective of the study was to assess the incidence of all bleeding events (major, clinically relevant non-major and minor bleeds) including asymptomatic ICH. Asymptomatic ICH was defined as newly detected hemorrhage on brain image (CT or MRI) by assessing pre- and post-treatment brain images and was obtained from all enrolled patients. All images were assessed by an Asymptomatic ICH Committee that was blinded to treatment assignment. Results: There were no clinically relevant differences in patient demographics and baseline characteristics between treatment groups. Overall, the time within the target INR range was 83% and 73% for patients aged ≥70 years and aged <70 years, respectively. The incidence of all bleeding events increased with increasing doses of edoxaban, but there were no statistically significant differences among the 3 edoxaban groups. The mean (95% confidence interval) incidences of all bleeding for edoxaban 30 mg, 45 mg, and 60 mg, and warfarin were 18.5% (12.7, 26.0), 22.4% (16.2, 30.2), 27.7% (20.7, 35.9), and 20.0% (13.9, 27.9), respectively. Of the total 536 patients enrolled, 17 patients did not fulfill the assessment criteria for asymptomatic ICH. Of the 17 patients, 1 patient in the edoxaban 60-mg group had symptomatic ICH. The remaining 519 (391 edoxaban, 128 warfarin) patients were evaluated for asymptomatic ICH. A total of 431 patients underwent CT (329 edoxaban, 102 warfarin), 81 patients underwent MRI (57 edoxaban, 24 warfarin), and 7 patients underwent CT/MRI (5 edoxaban, 2 warfarin). There were no asymptomatic ICH events in any treatment group. Conclusions: In this study of 3 fixed doses of edoxaban compared with well-controlled warfarin, edoxaban was safe and asymptomatic ICH was not detected. Disclosures: Yasaka: Nippon Boehringer lngelheim Co., Ltd.: Consultancy; Pfizer Japan Inc.: Consultancy; Daiichi Sankyo Co., LTD.: Consultancy. Kawai:Toyama Chemical: Consultancy; DaiichiSankyo: Consultancy. Yamaguchi:Mitsubishi Tanabe Pharma: Consultancy; Otsuka Pharmaceutical: Consultancy. Uchiyama:Bayer Yakuhin, LTD. : Consultancy; Nippon Boehringer lngelheim Co., Ltd.: Consultancy; Astellas Pharma Inc.: Consultancy. Ogawa:TEIJIN PHARMA LIMITED: Consultancy; Pfizer Japan Inc.: Consultancy; Bayer Yakuhin, LTD.: Consultancy; Astellas Pharma : Share Holder; Sanofi-aventis : Paid Instructor. Koretsune:Daiichi Sankyo: Consultancy, National Lead Investigator. Yamashita:Novartis: Consultancy; DaiichiSankyo: Consultancy, National Lead Investigator; Otsuka Pharmaceutical: Paid Instructor; Sanofi-aventis: Paid Instructor; TEIJIN PHARMA: Paid Instructor.

scholarly journals 477. Increased Referrals for New PFAPA (Aphthous Stomatitis, Pharyngitis, Adenitis) Diagnosis During the COVID-19 Pandemic

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S340-S341
Author(s):  
Bessey Geevarghese ◽  
Shan Sun ◽  
Ravi Jhaveri
Keyword(s):  
Infection Prevention ◽  
Periodic Fever ◽  
Diagnosis Code ◽  
Prevention Strategies ◽  
Health Crisis ◽  
Health Measures ◽  
Number Of Patients ◽  
Lead Investigator ◽  
Fever Syndromes ◽  
Monthly Distribution

Abstract Background COVID-19 pandemic caused by SARS-CoV-2 resulted in a global health crisis in 2020. Quarantining, wearing masks and physical distancing- key infection prevention strategies implemented to stop the spread of COVID-19, also led to dramatic decreases in rates of common respiratory viral infection seen in young children. Due to lack of school and daycare exposure, we evaluated a larger than usual number of patients with periodic fevers without any known infectious contacts. Based on this observation, we conducted an analysis of all suspected cases of periodic fevers seen at our institution during the COVID-19 lockdown compared to prior seasons. Methods The clinical charts were queried for all patients presenting to any Lurie Children’s Hospital outpatient specialty clinic or laboratory with ICD diagnosis code of MO4.1 and MO4.8 (all recurrent and periodic fever syndromes) from June 1, 2020 through September 30, 2020, and compared to similar months the previous 2 years (2018 and 2019). Each patient chart was reviewed by the lead investigator to verify all new diagnoses of PFAPA. The number of new patients with PFAPA diagnosis were tallied and analyzed. Statistical comparisons were made using Kruskal-Wallis tests for monthly distributions in different years. Results We noted a significant increase in patients with new PFAPA diagnosis between June through August 2020 compared to similar months in 2018 and 2019 (Figure1). Experienced pediatric infectious disease physicians and rheumatologists diagnosed majority of the cases. During these months, a monthly median (IQR) of 13 (11.5, 14.5) patients were diagnosed among different Lurie specialty clinics, which is more than 2.5 folds increase in new PFAPA patients from the previous two years which were about 5 (3.5, 6) (Figure 2). Number of Patients with New PFAPA Diagnosis There was a significant increase in number of new patients diagnosed with PFAPA between June through August 2020 compared to similar months in 2018 and 2019. Monthly Distribution Summary for New PFAPA Diagnosis Statistical comparisons were made using Kruskal- Wallis tests for monthly distributions in different years Conclusion We observed a significant increase in PFAPA patients referred to our institution soon after introduction of public health measures to slow spread of COVID-19. Given that most children were not in daycare, schools, or camps, we suspect that parents and pediatricians were able to recognize patterns of periodic fevers in children much quicker than preceding years, when fevers would typically be attributed to an infectious process. Disclosures Ravi Jhaveri, MD, AstraZeneca (Consultant)Dynavax (Consultant)Elsevier (Other Financial or Material Support, Editorial Stipend as Co-editor in Chief, Clinical Therapeutics)Seqirus (Consultant)

scholarly journals Frequency of Incidental Median Thenar Motor Nerve Branch Visualization During Mini-Open and Endoscopic Carpal Tunnel Release

Hand ◽  
2016 ◽  
Vol 12 (1) ◽  
pp. 60-63 ◽  
Author(s):  
Kevin F. Lutsky ◽  
Christopher M. Jones ◽  
Nayoung Kim ◽  
Juana Medina ◽  
Jonas L. Matzon ◽  
...  
Keyword(s):  
Median Nerve ◽  
Carpal Tunnel ◽  
Motor Nerve ◽  
Carpal Tunnel Release ◽  
Nerve Branch ◽  
Motor Branch ◽  
Volar Aspect ◽  
Lead Investigator ◽  
Ulnar Aspect ◽  
Mini Open

Background: Clinical studies using extensile approaches for carpal tunnel release (CTR) report a fairly high incidence of thenar motor branch (TMB) variants. As mini-open and endoscopic CTRs have become commonplace, the likelihood of encountering one of these variants in current practice is unknown. The purpose of the present study was to assess prospectively the frequency with which TMB variants are encountered during routine surgery. Methods: All patients who underwent a primary CTR between August 2014 and April 2015 by 11 hand fellowship–trained, orthopedic surgeons were prospectively evaluated. All surgeons performed releases in their usual technique and notified the lead investigator of any median nerve variations encountered. A total of 890 primary CTRs in 795 patients were performed during the study period. Results: Four TMBs seen were transligamentous variants (4/890 of procedures = 0.45%; 4/795 of patients = 0.50%). Three were identified during open CTR, and 1 during endoscopic CTR. In 2 cases, the transligamentous TMB originated from the volar aspect of the median nerve and penetrated the midportion of the transverse carpal ligament. One TMB originated from the volar and ulnar aspect of the median nerve. One TMB originated from the ulnar aspect of the median nerve proximal to the carpal tunnel. There were no cases of TMB injury during the course of the study. Conclusions: TMB variations are encountered infrequently during routine CTR. The most commonly encountered variant during routine mini-open or endoscopic CTR in our study was a transligamentous branch.

scholarly journals Time Investment of Medical Students during COVID19 Pandemic lockdown

2021 ◽  
Author(s):  
Mohajer Ibrahim Hassan ◽  
Mohammed Alfatih ◽  
MOHAMED SHARFALDEEN KHIDER TAHA ◽  
Radi Mohd Fawzey Rdi Tofaha Alhusseini ◽  
Mohanned Abdalfdeel Amahie Shaban ◽  
...  
Keyword(s):  
Medical Students ◽  
Primary Objective ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Medical College ◽  
Use Of Time ◽  
Time Investment ◽  
Lead Investigator ◽  
The Individual ◽  
Study Questionnaire

Abstract Background: As the world is fighting against the COVID19 outbreak most of the countries closed universities nationwide, impacting nearly 80% of students globally. In order to obtain information and to identify differences between medical students the study has been asset. The primary objective of this survey is to better understand the motivations and obstacles for medical students investing their time during COVID 19 obligatory home stay.Methods: Descriptive cross-sectional survey-based study in 333 medical students in medical college of Alzaeim al Azhari university in Sudan. Data from students was collected by using an online self-design questionnaire. The participants approached by the lead investigator through their social media groups by link enabling the individual willing to participate to access a google form containing the study questionnaire. Analyses was carried out using SPSS statistics package version 24 (IBM).Results: (57.1%) of the participants were females and (42.9%) were males. (37.8%) of medical students who participated in the study think that they make use of their time, while (38.1%) don’t think that and (24.1%) don’t know if they make use of their time or not during staying home due to COVID19 outbreak.Conclusion: There is a considerable variation in time investment (making use of time) during staying home due to COVID 19 outbreak according to medical student’s insight. The research results indicate that medical students need more encouragement and facilities to get benefits from their time during the quarantines and such situation in the future.

scholarly journals Time Investment of Medical Students during COVID19 Pandemic lockdown

2021 ◽  
Author(s):  
Mohajer Ibrahim Hassan ◽  
Mohammed Alfatih ◽  
Mohamed Sharfaldeen Khider Taha ◽  
Radi Mohd Fawzey Rdi Tofaha Alhussein ◽  
Mohanned Abdalfdeel Amahie Shaban ◽  
...  
Keyword(s):  
Medical Students ◽  
Primary Objective ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Medical College ◽  
Use Of Time ◽  
Time Investment ◽  
Lead Investigator ◽  
The Individual ◽  
Study Questionnaire

Abstract Background: As the world is fighting against the COVID19 outbreak most of the countries closed universities nationwide, impacting nearly 80% of students globally. In order to obtain information and to identify differences between medical students the study has been asset. The primary objective of this survey is to better understand the motivations and obstacles for medical students investing their time during COVID 19 obligatory home stay.Methods: Descriptive cross-sectional survey-based study in 333 medical students in medical college of Alzaeim al Azhari university in Sudan. Data from students was collected by using an online self-design questionnaire. The participants approached by the lead investigator through their social media groups by link enabling the individual willing to participate to access a google form containing the study questionnaire. Analyses was carried out using SPSS statistics package version 24 (IBM).Results: (57.1%) of the participants were females and (42.9%) were males. (37.8%) of medical students who participated in the study think that they make use of their time, while (38.1%) don’t think that and (24.1%) don’t know if they make use of their time or not during staying home due to COVID19 outbreak. Conclusion: There is a considerable variation in time investment (making use of time) during staying home due to COVID 19 outbreak according to medical student’s insight. The research results indicate that medical students need more encouragement and facilities to get benefits from their time during the quarantines and such situation in the future.

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