Search

Your search keyword '"Sugar, Elizabeth"' showing total 256 results
Start Over Author "Sugar, Elizabeth" Publication Type Academic Journals
256 results on '"Sugar, Elizabeth"'

6. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial.

Author

Thorne, Jennifer E, Sugar, Elizabeth A, Holbrook, Janet T, Burke, Alyce E, Altaweel, Michael M, Vitale, Albert T, Acharya, Nisha R, Kempen, John H, Jabs, Douglas A, and Multicenter Uveitis Steroid Treatment Trial Research Group

Subjects
Multicenter Uveitis Steroid Treatment Trial Research Group, Humans, Uveitis, Dexamethasone, Triamcinolone Acetonide, Drug Implants, Glucocorticoids, Tomography, Optical Coherence, Treatment Outcome, Drug Administration Routes, Retrospective Studies, Follow-Up Studies, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Macular Edema, Young Adult, Intravitreal Injections, Clinical Research, Clinical Trials and Supportive Activities, Eye Disease and Disorders of Vision, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI).DesignMulticenter, randomized clinical trial.ParticipantsPatients with uveitic ME.MethodsPatients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes.Main outcome measuresThe primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ≥20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks.ResultsAll treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in the PTA group at 8 weeks (P < 0.004). The risk of having IOP ≥24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups.ConclusionsIntravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

Published
2019

8. Test Performance Characteristics of the AIR, GAD-7 and HADS-Anxiety Screening Questionnaires for Anxiety in Chronic Obstructive Pulmonary Disease

Author

Baker, Anna M, Holbrook, Janet T, Yohannes, Abebaw M, Eakin, Michelle N, Sugar, Elizabeth A, Henderson, Robert J, Casper, Anne S, Kaminsky, David A, Rea, Alexis L, Mathews, Anne M, Que, Loretta G, Ramsdell, Joe W, Gerald, Lynn B, Wise, Robert A, Hanania, Nicola A, Hanania, Nicola, Sockrider, Marianna, Bertrand, Laura, Atik, Mustafa, Lopez, Blanca A, Reibman, Joan, DiMango, Emily, Rogers, Linda, Carapetyan, Karen, Rivera, Kristina, Scheuerman, Melissa, Fiorino, Elizabeth, Bryce-Robinson, Newel, Green, Deanna, Noveck, Robert, Foss, Catherine, Ghidorzi, Jessica, Wang, Zongyao, Pangborn, Elise, Robertson, V Susan, Eberlein, Nicholas, Stiles, Jane, Land, Michael, Vickery, Brian, Wu, Eveline, Jaggers, Denise, Allen, Stephanie, Mervin-Blake, Sabrena, Smith, Lewis, Kalhan, Ravi, Moy, James, Naureckas, Edward, Hixon, Jenny, Gonsalves, Zenobia, Zagaja, Virginia, Kustwin, Jennifer, Xu, Ben, Matthews, Thomas, Robinson, Lucius, Singh, Noopur, Happel, Kyle, Sandi, Marie C, Graham, Jennifer M, Sullivan, Katelyn, Poretta, Elizabeth, Katial, Rohit, Hoyte, Flavia, Rojas, Maria, Castro, Mario, Bacharier, Leonard B, Sumino, Kaharu, Yusen, Roger D, Tarsi, Jaime J, Patterson, Brenda, Montgomery, Terri, Busk, Michael, Weiss, Debra, Sundblad, Kimberly, Irvin, Charles, Dixon, Anne E, Teneback, Charlotte, Kanagalingam, Jothi, Burns, Stephanie M, Dwinell, Kathleen, Goodwin, James L, Brown, Mark A, Carr, Tara F, Berry, Cristine E, Bime, Christian, Goforth, Mark A, Ryan, Elizabeth A, Wences, Jesus A, Lopez, Silvia L, Priefert, Janette C, Provencio-Dean, Natalie S, Ogas, Destinee R, Bloss, Valerie R, Wasserman, Stephen I, Soler, Xavier T, Kinninger, Katie H, and Martineau, Amber J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lung, Mental Health, Brain Disorders, Chronic Obstructive Pulmonary Disease, Clinical Research, Mental health, Respiratory, Good Health and Well Being, test anxiety scale, chronic obstructive pulmonary disease, anxiety, psychometric properties, American Lung Association Airways Clinical Research Centers, Cardiovascular medicine and haematology, Clinical sciences
Abstract

Rationale: Anxiety is a common comorbidity of chronic obstructive pulmonary disease (COPD) that is associated with higher morbidity and mortality. We evaluated three anxiety screening questionnaires: the Generalized Anxiety Disorder 7-Item Scale (GAD-7), the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and the Anxiety Inventory for Respiratory Disease (AIR).Objectives: To evaluate and compare the test performance characteristics of three anxiety screening questionnaires, using the Mini-International Neuropsychiatric Interview (MINI), version 7.0, as the "gold standard."Methods: Individuals with COPD were recruited at 16 centers. The MINI and questionnaires were administered by trained research coordinators at an in-person visit and readministered by telephone 2-4 weeks later. A composite score for the presence of any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) anxiety disorder was computed, based on the MINI as the gold standard, compared with a participant screening positive on self-report measures for these analyses.Results: Two hundred and twenty eligible individuals with COPD were enrolled; 219 completed the study. Eleven percent were identified as having a DSM-V anxiety disorder, based on the MINI. Elevated anxiety symptoms based on questionnaires were 38% for the AIR, 30% for the GAD-7, and 20% for the HADS-A. Area under the receiver operating characteristic curve (AUC) was highest for the GAD-7 (0.78; 95% confidence interval [CI], 0.69-0.87), followed by the HADS-A (0.74; 95% CI, 0.64-0.84) and the AIR (0.66; 95% CI, 0.56-0.76). The AUC for the GAD-7 was significantly greater than for the AIR (P = 0.014). Sensitivity was not statistically different among the questionnaires: 77% for the GAD-7, 63% for the HADS-A, and 66% for the AIR. The HADS-A had the highest specificity, 85%, which was significantly higher than that of the GAD-7 (77%; P

Published
2018

9. Neoadjuvant cabozantinib and nivolumab convert locally advanced hepatocellular carcinoma into resectable disease with enhanced antitumor immunity

Author

Ho, Won Jin, Zhu, Qingfeng, Durham, Jennifer, Popovic, Aleksandra, Xavier, Stephanie, Leatherman, James, Mohan, Aditya, Mo, Guanglan, Zhang, Shu, Gross, Nicole, Charmsaz, Soren, Lin, Dongxia, Quong, Derek, Wilt, Brad, Kamel, Ihab R., Weiss, Matthew, Philosophe, Benjamin, Burkhart, Richard, Burns, William R., Shubert, Chris, Ejaz, Aslam, He, Jin, Deshpande, Atul, Danilova, Ludmila, Stein-O’Brien, Genevieve, Sugar, Elizabeth A., Laheru, Daniel A., Anders, Robert A., Fertig, Elana J., Jaffee, Elizabeth M., and Yarchoan, Mark

Published
2021
Full Text
View/download PDF

10. The association of medication use with clearance or persistence of oral HPV infection

Author

Lam, Jennifer O, Sugar, Elizabeth A, Cranston, Ross D, Weber, Kathleen M, Burk, Robert D, Wiley, Dorothy J, Reddy, Susheel, Margolick, Joseph B, Strickler, Howard D, Wentz, Alicia, Jacobson, Lisa, Coles, Christian L, Bream, Jay H, Rositch, Anne F, Guo, Yingshi, Xiao, Weihong, Gillison, Maura L, and D’Souza, Gypsyamber

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Infectious Diseases, Sexually Transmitted Infections, Clinical Research, Dental/Oral and Craniofacial Disease, HIV/AIDS, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Adult, Female, HIV Infections, Humans, Longitudinal Studies, Male, Middle Aged, Mouth Diseases, Oropharyngeal Neoplasms, Papillomaviridae, Papillomavirus Infections, Prevalence, Risk Factors, United States, Oral HPV, Prescription medication, Clearance, Antipsychotic, HIV, Immunomodulatory, Oncology and Carcinogenesis, Public Health and Health Services, Epidemiology, Oncology and carcinogenesis
Abstract

PurposePersistent oral human papillomavirus (HPV) infection increases risk for oropharyngeal carcinoma, and people living with HIV have higher rates of oral HPV infection and related cancers. Some prescription medications have immunomodulatory effects, but the impact of medication use on oral HPV natural history is unknown.MethodsScope® oral rinse-and-gargle samples were collected semi-annually from 1,666 participants and tested for 37 types of oral HPV DNA using PCR; 594 HPV-infected participants with 1,358 type-specific oral HPV infections were identified. Data were collected on recent (past 6 months) use of medications. The relationship between medication use and oral HPV clearance was evaluated using Wei-Lin-Weissfeld regression, adjusting for biologic sex, prevalent versus incident infection, age, HIV status and CD4+ T cell count.ResultsOut of 11 medications examined, oral HPV clearance was significantly reduced in participants reporting recent use of antipsychotics (HR 0.75, 95% CI 0.57-0.99), anxiolytics/sedatives (HR 0.78, 95% CI 0.63-0.96) and antidepressants (HR 0.82, 95% CI 0.67-0.999). Among antipsychotics users, effect modification by HIV status was observed, with reduced clearance in HIV-infected (HR 0.67, 95% CI 0.49-0.91), but not HIV-uninfected participants (p-interaction = 0.009). After adjusted analysis, antipsychotic use remained significantly associated with reduced oral HPV clearance overall (aHR 0.75, 95% CI 0.57-0.99), and when restricted to only HIV-infected participants (aHR 0.66, 95% CI 0.48-0.90). After adjustment, anxiolytic/sedative use and antidepressant use were no longer significantly associated with reduced oral HPV clearance.ConclusionsSome medications were associated with decreased oral HPV clearance, most notably antipsychotic medications. These medications are prescribed for conditions that may have immunomodulating effects, so characteristics of underlying illness may have partially contributed to reduced oral HPV clearance.

Published
2016

11. Biomarkers of Type 2 Airway Inflammation as Predictors of Loss of Asthma Control During Step-Down Therapy for Well-Controlled Disease: The Long-Acting Beta-Agonist Step-Down Study (LASST)

Author

Bose, Sonali, Bime, Christian, Henderson, Robert J., Blake, Kathryn V., Castro, Mario, DiMango, Emily, Hanania, Nicola A., Holbrook, Janet T., Irvin, Charles G., Kraft, Monica, Peters, Stephen P., Reibman, Joan, Sugar, Elizabeth A., Sumino, Kaharu, Wise, Robert A., and Rogers, Linda

Published
2020
Full Text
View/download PDF

12. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

Author

Holbrook, Janet T, Sugar, Elizabeth A, Burke, Alyce E, Vitale, Albert T, Thorne, Jennifer E, Davis, Janet L, Jabs, Douglas A, Jaffe, Glenn J, Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora M, Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha, Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A, Scott, Adrienne Williams, See, Robert F, Shuler, Robert K, Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F, Srivastava, Sunil, Dunn, James P, Begum, Hosne, Boring, Jeff, Brotherson, Kristen L, Burkholder, Bryn, Butler, Nicholas J, Cain, Dennis, Cook, Mary A, Emmert, David, Graul, Janis R, Herring, Mark, Laing, Ashley, Leung, Theresa G, Mahon, Michael C, Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L, Reed, Terry, Arnold, Ellen, Barnabie, Patricia M, Belair, Marie-Lynn, Bolton, Stephen G, Brodine, Joseph B, Brown, Diane M, Brune, Lisa M, Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A, Livingston, Alison G, Morton, Yavette, Nolan, Kisten, Peters, George B, Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C Stephen, Anesi, Stephen D, Bruner, Linda, Ceron, Olga, Hinkle, David M, Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q, Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S, Sprague, Janet, and Yilmaz, Taygan

Subjects
Clinical Trials and Supportive Activities, Brain Disorders, Eye Disease and Disorders of Vision, Bioengineering, Clinical Research, Prevention, Neurosciences, Eye, Adolescent, Adult, Aged, Aged, 80 and over, Drug Implants, Equipment Failure, Female, Fluocinolone Acetonide, Follow-Up Studies, Foreign-Body Migration, Glucocorticoids, Humans, Intravitreal Injections, Male, Middle Aged, Postoperative Complications, Reoperation, Risk Factors, Time Factors, Uveitis, Visual Acuity, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial.DesignRandomized clinical trial with extended follow-up.MethodsReview of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related.ResultsA total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5-9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%-9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%-48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P < .001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment.ConclusionThere is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.

Published
2016

13. Phase 2 study of vismodegib, a hedgehog inhibitor, combined with gemcitabine and nab-paclitaxel in patients with untreated metastatic pancreatic adenocarcinoma

Author

De Jesus-Acosta, Ana, Sugar, Elizabeth A., O’Dwyer, Peter J., Ramanathan, Ramesh K., Von Hoff, Daniel D., Rasheed, Zeshaan, Zheng, Lei, Begum, Asma, Anders, Robert, Maitra, Anirban, McAllister, Florencia, Rajeshkumar, N. V., Yabuuchi, Shinichi, de Wilde, Roeland F., Batukbhai, Bhavina, Sahin, Ismet, and Laheru, Daniel A.

Published
2020
Full Text
View/download PDF

14. Effect of a Soy Isoflavone Supplement on Lung Function and Clinical Outcomes in Patients With Poorly Controlled Asthma: A Randomized Clinical Trial

Author

Smith, Lewis J, Kalhan, Ravi, Wise, Robert A, Sugar, Elizabeth A, Lima, John J, Irvin, Charles G, Dozor, Allen J, and Holbrook, Janet T

Subjects
Complementary and Integrative Health, Pediatric, Lung, Asthma, Clinical Research, Nutrition, Clinical Trials and Supportive Activities, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Respiratory, Adolescent, Adult, Child, Dietary Supplements, Double-Blind Method, Female, Forced Expiratory Volume, Genistein, Humans, Isoflavones, Male, Middle Aged, Phytotherapy, Plant Extracts, Soybean Proteins, Young Adult, American Lung Association Asthma Clinical Research Centers, Medical and Health Sciences, General & Internal Medicine
Abstract

ImportanceSoy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control.ObjectiveTo determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease.Design, setting, and participantsMulticenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24.InterventionsParticipants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks.Main outcomes and measuresThe primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation.ResultsMean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, -0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, -0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42-2.54] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, -3.48 ppb [95% CI, -5.99 to -0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, -1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL (P

Published
2015

15. A longitudinal study of human papillomavirus 16 L1, e6, and e7 seropositivity and oral human papillomavirus 16 infection.

Author

Beachler, Daniel C, Viscidi, Raphael, Sugar, Elizabeth A, Minkoff, Howard, Strickler, Howard D, Cranston, Ross D, Wiley, Dorothy J, Jacobson, Lisa P, Weber, Kathleen M, Margolick, Joseph B, Reddy, Susheel, Gillison, Maura L, and D'Souza, Gypsyamber

Subjects
Humans, Papillomavirus Infections, Anus Neoplasms, Oropharyngeal Neoplasms, Oncogene Proteins, Viral, Repressor Proteins, Enzyme-Linked Immunosorbent Assay, Prevalence, Case-Control Studies, Longitudinal Studies, Adult, Middle Aged, Uterine Cervical Neoplasms, Female, Male, Papillomavirus E7 Proteins, Human papillomavirus 16, Sexually Transmitted Infections, Cervical Cancer, Cancer, HIV/AIDS, Dental/Oral and Craniofacial Disease, Infectious Diseases, Clinical Research, Aetiology, 2.1 Biological and endogenous factors, 2.2 Factors relating to the physical environment, Infection, Biological Sciences, Medical and Health Sciences, Public Health
Abstract

BackgroundIndividuals with human papillomavirus (HPV) infections can develop IgG antibodies to HPV proteins including the L1 capsid and E6 and E7 oncoproteins. Evidence on whether L1 antibodies reduce the risk of cervical HPV infection is mixed, but this has not been explored for oral HPV infections. Antibodies to HPV16's E6 oncoprotein have been detected in some oropharyngeal cancer cases years before cancer diagnosis, but it is unknown if these antibodies are associated with oral HPV16 DNA.MethodsEnzyme-linked immunosorbent assays tested for serum antibodies to HPV16's L1 capsid in 463 HIV-infected and 293 HIV-uninfected adults, and for antibodies to recombinantly expressed E6 and E7 oncoproteins to HPV16 in 195 HIV-infected and 69 HIV-uninfected cancer-free participants at baseline. Oral rinse samples were collected semiannually for up to 3 years and tested for HPV DNA using PGMY 09/11 primers. Adjusted Poisson, logistic, and Wei-Lin-Weissfeld regression models were used.ResultsHuman papillomavirus 16 L1 seroreactivity did not reduce the subsequent risk of incident oral HPV16 infection in unadjusted (hazard ratio, 1.4; 95% confidence interval, 0.59-3.3) or adjusted (adjusted hazard ratio = 1.1; 95% confidence interval, 0.41-3.0) analysis. Antibodies to HPV16 E6 and E7 oncoproteins were detected in 7.6% and 3.4% of participants, respectively, but they were not associated with baseline oral HPV16 DNA prevalence or oral HPV16 persistence (each P > 0.40).ConclusionsNaturally acquired HPV16 L1 antibodies did not reduce the risk of subsequent oral HPV16 infection. Human papillomavirus 16 E6 and E7 seropositivity was not a marker for oral HPV16 infection in this population without HPV-related cancer.

Published
2015

18. Fluorescein Angiography versus Optical Coherence Tomography for Diagnosis of Uveitic Macular Edema

Author

Kempen, John H, Sugar, Elizabeth A, Jaffe, Glenn J, Acharya, Nisha R, Dunn, James P, Elner, Susan G, Lightman, Susan L, Thorne, Jennifer E, Vitale, Albert T, Altaweel, Michael M, and Group, Multicenter Uveitis Steroid Treatment Trial Research

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Clinical Research, Eye Disease and Disorders of Vision, Biomedical Imaging, Prevention, Eye, Capillary Permeability, Cross-Sectional Studies, Drug Implants, Female, Fluocinolone Acetonide, Fluorescein Angiography, Glucocorticoids, Humans, Macular Edema, Male, Middle Aged, Panuveitis, Retina, Retinal Vessels, Sensitivity and Specificity, Tomography, Optical Coherence, Uveitis, Intermediate, Uveitis, Posterior, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

ObjectiveTo evaluate agreement between fluorescein angiography (FA) and optical coherence tomography (OCT) results for diagnosis of macular edema in patients with uveitis.DesignMulticenter cross-sectional study.ParticipantsFour hundred seventy-nine eyes with uveitis from 255 patients.MethodsThe macular status of dilated eyes with intermediate uveitis, posterior uveitis, or panuveitis was assessed via Stratus-3 OCT and FA. To evaluate agreement between the diagnostic approaches, κ statistics were used.Main outcome measuresMacular thickening (MT; center point thickness, ≥ 240 μm per reading center grading of OCT images) and macular leakage (ML; central subfield fluorescein leakage, ≥ 0.44 disc areas per reading center grading of FA images), and agreement between these outcomes in diagnosing macular edema.ResultsOptical coherence tomography (90.4%) more frequently returned usable information regarding macular edema than FA (77%) or biomicroscopy (76%). Agreement in diagnosis of MT and ML (κ = 0.44) was moderate. Macular leakage was present in 40% of cases free of MT, whereas MT was present in 34% of cases without ML. Biomicroscopic evaluation for macular edema failed to detect 40% and 45% of cases of MT and ML, respectively, and diagnosed 17% and 17% of cases with macular edema that did not have MT or ML, respectively; these results may underestimate biomicroscopic errors (ophthalmologists were not explicitly masked to OCT and FA results). Among eyes free of ML, phakic eyes without cataract rarely (4%) had MT. No factors were found that effectively ruled out ML when MT was absent.ConclusionsOptical coherence tomography and FA offered only moderate agreement regarding macular edema status in uveitis cases, probably because what they measure (MT and ML) are related but nonidentical macular pathologic characteristics. Given its lower cost, greater safety, and greater likelihood of obtaining usable information, OCT may be the best initial test for evaluation of suspected macular edema. However, given that ML cannot be ruled out if MT is absent and vice versa, obtaining the second test after negative results on the first seems justified when detection of ML or MT would alter management. Given that biomicroscopic evaluation for macular edema erred frequently, ancillary testing for macular edema seems indicated when knowledge of ML or MT status would affect management.Financial disclosure(s)Proprietary or commercial disclosure may be found after the references.

Published
2013

19. A Lethally Irradiated Allogeneic Granulocyte-Macrophage Colony Stimulating Factor-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma

Author

Eric, Lutz, Yeo, Charles J, Lillemoe, Keith D, Biedrzycki, Barbara, Kobrin, Barry, Herman, Joseph, Sugar, Elizabeth, Piantadosi, Steven, Cameron, John L, Solt, Sara, Onners, Beth, Tartakovsky, Irena, Choi, Miri, Sharma, Rajni, Illei, Peter B, H., Hruban Ralph, Abrams, Ross A, Le, Dung, Elizabeth, Jaffee, and Laheru, Dan

Subjects
Digestive Diseases, Pancreatic Cancer, Orphan Drug, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Immunization, Vaccine Related, Rare Diseases, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antigens, Neoplasm, Cancer Vaccines, Carcinoma, Pancreatic Ductal, Cell Line, Tumor, Combined Modality Therapy, Disease-Free Survival, Female, GPI-Linked Proteins, Granulocyte-Macrophage Colony-Stimulating Factor, Humans, Hypersensitivity, Delayed, Immunotherapy, Male, Mesothelin, Middle Aged, Pancreatic Neoplasms, Survival Rate, T-Lymphocytes, Transfection, Medical and Health Sciences, Surgery
Abstract

PurposeSurgical resection provides the only possibility of cure for pancreas cancer. A standard adjuvant approach has not been established. We tested the safety and efficacy of a granulocyte-macrophage colony-stimulating factor (GM-CSF)-based immunotherapy administered in patients with resected pancreatic adenocarcinoma.Patients and methodsA single institution phase II study of 60 patients with resected pancreatic adenocarcinoma was performed. Each immunotherapy treatment consisted of a total of 5 × 108 GM-CSF-secreting cells distributed equally among 3 lymph node regions. The first immunotherapy treatment was administered 8 to 10 weeks after surgical resection. Subsequently, patients received 5-FU based chemoradiation. Patients who remained disease-free after completion of chemoradiotherapy received treatments 2 to 4, each 1 month apart. A fifth and final booster was administered 6 months after the fourth immunotherapy. The primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses.ResultsThe median disease-free survival is 17.3 months (95% CI, 14.6-22.8) with median survival of 24.8 months (95% CI, 21.2-31.6). The administration of immunotherapy was well tolerated. In addition, the post-immunotherapy induction of mesothelin-specific CD8+ T cells in HLA-A1+ and HLA-A2+patients correlates with disease-free survival.ConclusionsAn immunotherapy approach integrated with chemoradiation is safe and demonstrates an overall survival that compares favorably with published data for resected pancreas cancer. These data suggest additional boost immunotherapies given at regular intervals beyond 1 year postsurgery should be tested in future studies, and provide the rationale for conducting a multicenter phase II study.

Published
2011

20. A lethally irradiated allogeneic granulocyte-macrophage colony stimulating factor-secreting tumor vaccine for pancreatic adenocarcinoma. A Phase II trial of safety, efficacy, and immune activation.

Author

Lutz, Eric, Yeo, Charles J, Lillemoe, Keith D, Biedrzycki, Barbara, Kobrin, Barry, Herman, Joseph, Sugar, Elizabeth, Piantadosi, Steven, Cameron, John L, Solt, Sara, Onners, Beth, Tartakovsky, Irena, Choi, Miri, Sharma, Rajni, Illei, Peter B, Hruban, Ralph H, Abrams, Ross A, Le, Dung, Jaffee, Elizabeth, and Laheru, Dan

Subjects
T-Lymphocytes, Cell Line, Tumor, Humans, Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms, Hypersensitivity, Delayed, Granulocyte-Macrophage Colony-Stimulating Factor, Cancer Vaccines, Antigens, Neoplasm, Disease-Free Survival, Immunotherapy, Combined Modality Therapy, Survival Rate, Transfection, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, GPI-Linked Proteins, Cell Line, Tumor, Carcinoma, Pancreatic Ductal, Hypersensitivity, Delayed, Antigens, Neoplasm, and over, Surgery, Medical and Health Sciences
Abstract

PurposeSurgical resection provides the only possibility of cure for pancreas cancer. A standard adjuvant approach has not been established. We tested the safety and efficacy of a granulocyte-macrophage colony-stimulating factor (GM-CSF)-based immunotherapy administered in patients with resected pancreatic adenocarcinoma.Patients and methodsA single institution phase II study of 60 patients with resected pancreatic adenocarcinoma was performed. Each immunotherapy treatment consisted of a total of 5 × 108 GM-CSF-secreting cells distributed equally among 3 lymph node regions. The first immunotherapy treatment was administered 8 to 10 weeks after surgical resection. Subsequently, patients received 5-FU based chemoradiation. Patients who remained disease-free after completion of chemoradiotherapy received treatments 2 to 4, each 1 month apart. A fifth and final booster was administered 6 months after the fourth immunotherapy. The primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses.ResultsThe median disease-free survival is 17.3 months (95% CI, 14.6-22.8) with median survival of 24.8 months (95% CI, 21.2-31.6). The administration of immunotherapy was well tolerated. In addition, the post-immunotherapy induction of mesothelin-specific CD8+ T cells in HLA-A1+ and HLA-A2+patients correlates with disease-free survival.ConclusionsAn immunotherapy approach integrated with chemoradiation is safe and demonstrates an overall survival that compares favorably with published data for resected pancreas cancer. These data suggest additional boost immunotherapies given at regular intervals beyond 1 year postsurgery should be tested in future studies, and provide the rationale for conducting a multicenter phase II study.

Published
2011

21. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial

Author

Hanley, Daniel F, Lane, Karen, McBee, Nichol, Ziai, Wendy, Tuhrim, Stanley, Lees, Kennedy R, Dawson, Jesse, Gandhi, Dheeraj, Ullman, Natalie, Mould, W Andrew, Mayo, Steven W, Mendelow, A David, Gregson, Barbara, Butcher, Kenneth, Vespa, Paul, Wright, David W, Kase, Carlos S, Carhuapoma, J Ricardo, Keyl, Penelope M, Diener-West, Marie, Muschelli, John, Betz, Joshua F, Thompson, Carol B, Sugar, Elizabeth A, Yenokyan, Gayane, Janis, Scott, John, Sayona, Harnof, Sagi, Lopez, George A, Aldrich, E Francois, Harrigan, Mark R, Ansari, Safdar, Jallo, Jack, Caron, Jean-Louis, LeDoux, David, Adeoye, Opeolu, Zuccarello, Mario, Adams, Harold P, Jr, Rosenblum, Michael, Thompson, Richard E, and Awad, Issam A

Published
2017
Full Text
View/download PDF

22. Patient-reported outcomes of a multicenter phase 2 study investigating gemcitabine and stereotactic body radiation therapy in locally advanced pancreatic cancer

Author

Rao, Avani D., Sugar, Elizabeth A., Chang, Daniel T., Goodman, Karyn A., Hacker-Prietz, Amy, Rosati, Lauren M., Columbo, Laurie, O'Reilly, Eileen, Fisher, George A., Zheng, Lei, Pai, Jonathan S., Griffith, Mary E., Laheru, Daniel A., Iacobuzio-Donahue, Christine A., Wolfgang, Christopher L., Koong, Albert, and Herman, Joseph M.

Published
2016
Full Text
View/download PDF

25. Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Author

Jaffe, Glenn J., Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora (Nora) M., Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha (Shah), Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A., Scott, Adrienne Williams, See, Robert F., Shuler, Robert K., Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F., Srivastava, Sunil, Dunn, James P., Begum, Hosne, Boring, Jeff, Brotherson, Kristen L., Burkholder, Bryn, Butler, Nicholas J., Cain, Dennis, Cook, Mary A., Emmert, David, Graul, Janis R., Herring, Mark, Laing, Ashley, Leung, Theresa G., Mahon, Michael C., Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L., Reed, Terry, Arnold, Ellen, Barnabie, Patricia M., Belair, Marie-Lynn, Bolton, Stephen G., Brodine, Joseph B., Brown, Diane M., Brune, Lisa M., Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A., Livingston, Alison G., Morton, Yavette, Nolan, Kisten, Peters, George B., Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C. Stephen, Anesi, Stephen D., Bruner, Linda, Ceron, Olga, Hinkle, David M., Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q., Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S., Sprague, Janet, Yilmaz, Taygan, Sen, H. Nida, Bono, Michael, Cunningham, Denise, Hayes, Darryl, Koutsandreas, Dessie, Nussenblatt, Robert B., Sherry, Patti R., Short, Gregory L., Smith, Wendy, Temple, Alana, Bamji, Allison, Coleman, Hanna, Davuluri, Geetaniali, Faia, Lisa, Gottlieb, Chloe, Jirawuthiworavong, Guy V., Lew, Julie C., Mercer, Richard, Obiyor, Dominic, Perry, Cheryl H., Potapova, Natalia, Weichel, Eric, Wroblewski, Keith J., Latkany, Paul A., Coonan, Corinne, Honda, Andrea, Lorenzo-Latkany, Monica, Masini, Robert, Morell, Susan, Nguyen, Angela, Badamo, Jason, Boyd, Kenneth M., Enos, Matthew, Gallardo, Jenny, Jarczynski, Jacek, Lee, Ji Yun, McGrosky, Mirjana, Nour, Ann, Sanchez, Meredith, Steinberg, Kate, Stawell, Richard J., Breayley, Lisa, D'Sylva, Carly, Glatz, Elizabeth, Hodgson, Lauren, Lim, Lyndell, Ling, Cecilia, McIntosh, Rachel, Morrison (Ewing), Julie, Newton, Andrew, Sanmugasundram, Sutha, Smallwood, Richard, Zamir, Ehud, Hunt, Nicola, Jones, Lisa, Koukouras, Ignatios, Williams, Suzanne, Merrill, Pauline T., Carns, Danielle, Richine, Len, Voskuil-Marre, Denise L., Woo, Kisung, Gaynes, Bruce, Giannoulis, Christina, Hulvey, Pam, Kernbauer, Elaine, Khan, Heena S., Levine, Sarah J., Toennessen, Scott, Tonner, Eileen, Wang, Robert C., Aguado, Hank, Arceneaux, Sally, Duignan, Karen, Fish, Gary E., Hesse, Nick, Jaramillo, Diana, Mackens, Michael, Arnwine, Jean, Callanan, David, Cummings, Kimberly, Gray, Keith, Howden, Susie, Mutz, Karin, Sanchez, Brenda, Lightman, Susan, Ismetova, Filis, Prytherch, Ashley, Seguin-Greenstein, Sophie, Tomkins, Oren, Bar, Asat, Edwards, Kate, Joshi, Lavanish, Moraji, Jiten, Samy, Ahmed, Stubbs, Timothy, Taylor, Simon, Towler, Hamish, Tronnberg, Rebecca, Holland, Gary N., Almanzor, Robert D., Castellanos, Jose, Hubschman, Jean Pierre, Johiro, Ann K., Kukuyev, Alla, Levinson, Ralph D., McCannel, Colin A., Ransome, Susan S., Gonzales, Christine R., Gupta, Anurag, Kalyani, Partho S., Kapamajian, Michael A., Kappel, Peter J., Arcinue, Cheryl, Chuang, Janne, Barteselli, Giulio, Currie, Glenn, Mendoza, Veronica, Powell, Debbie, Clark, Tom, Cochran, Denine E., Freeman, William R., Hedaya, Joshua, Kemper, Tiara, Kozak, Igor, LeMoine, Jacqueline M., Loughran, Megan E., Magana, Luzandra, Mojana, Francesca, Morrison, Victoria, Nguyen, Vivian, Oster, Stephen F., Acharya, Nisha, Clay, David, Lee, Salena, Lew, Mary, Margolis, Todd P., Stewart, Jay, Wong, Ira G., Brown, Debra, Khouri, Claire M., Goldstein, Debra A., Birnbaum, Andrea, Degillio, Andrea, Rosa, Gemma De la, Ramirez, Carmen, Simjanowski, Evica, Skelly, Mariner, Castro-Malek, Anna L., Crooke, Catherine E., Huntley, Melody, Nash, Katrina, Niec, Marcia, Pyatetsky, Dimitry, Ramirez, Misel, Rozenbajgier, Zuzanna, Tessler, Howard H., Davis, Janet L., Albini, Thomas A., Chin, Marie, Castaño, Daniela, Elizondo, Ariana, Ho, Macy, Kovach, Jaclyn L., Lin, Richard C-S., Mandelcorn, Efrem, Nguyen, Jackie K-D., Pacini, Aura, Pineda, Susan, Pinto, David A., Rebimbas, Jose, Stepien, Kimberly E., Teran, Claudia, Elner, Susan G., Bernard, Hillary, Fournier, Linda, Godsey, Lindsay, Goings, Linda, Hackel, Richard, Hesselgrave, Moella, Jayasundera, K. Thiran, Prusak, Robert, Titus, Pamela, Bergeron, Melissa, Blosser, Reneé, Brown, Rebecca, Chrisman-McClure, Carrie, Gothrup, Julie R., Saxe, Stephen J., Sizemore, Deanna, Kempen, John H., Berger, James, Drossner, Sheri, DuPont, Joan C., Maguire, Albert M., Petner, Janice, Engelhard, Stephanie, Hopkins, Tim, Lo, Jonathan, McCall, Dawn, McRay, Monique, Salvo, Rebecca, Will, Daniel, Xu, Wei, Windsor, Elizabeth, Weeney, Laurel, Pavan, Peter R., Albritton, Ken, Leto, JoAnn, Madow, Brian, Mayor, Lori, Pautler, Scott E., Saxon, Wyatt, Soto, Judy, Goldstein, Burton, Klukoff, Amy, Lambright, Lucy, McDonald, Kim, Ortiz, Maria, Scymanky, Susan, Szalay, Dee Dee, Rao, Narsing, Davis, Tamara, Douglass, Jackie, Linton, Judith, Padilla, Margaret, Ramos, Sylvia, Rao, Narsing A., Aguirre, Alexia, Chong, Lawrence, Cisneros, Lupe, Corona, Elizabeth, Eliott, Dean, Fawzi, Amani, Garcia, Jesse, Khurana, Rahul, Lim, Jennifer, Mead, Rachel, Tsai, Julie H., Vitale, Albert, Bernstein, Paul S., Carlstrom, Bonnie, Gilman, James, Hanseen, Sandra, Morris, Paula, Ramirez, Diana, Wegner, Kimberley, Sheppard, John D., Anthony, Brianne, Casper, Amber, Felix-Kent, Lisa, Fernandez, Jeanette, Johnson, Tari, Scoper, Stephen V., Cole, R. Denise, Crawford, Nancy, Franklin, Lisa, Hamelin, Krista, Martin, Jen, Marx, Rebecca, Schultz, Gregory, Webb, Joseph, Yeager, Pamela, Kim, Rosa Y., Benz, Matthew S., Brown, David M., Chen, Eric, Fish, Richard H., Kegley, Eric, Shawver, Laura, Wong, Tien P., De La Garza, Rebecca, Friday (Hay), Shayla, Rao, P. Kumar, Adcock, Eve, Apte, Rajendra S., Baladenski, Amy, Curtis, Rhonda, Gould, Sarah, Hebden, Amanda, Kambarian, Jamie, Meyer, Charla, Pistorius, Sam, Quinn, Melanie, Rathert, Greg, Blinder, Kevin J., Hartz, Ashley, Light, Pam, Shah, Gaurav K., VanGelder, Russell, Jabs, Douglas A., Altaweel, Michael M., Holbrook, Janet T., Kurinij, Natalie, Brown, Diane, Prusakowski, Nancy, Thorne, Jennifer E., Hubbard, Larry, Wittes, Janet, Barlow, William E., Hochberg, Marc, Lyon, Alice T., Palestine, Alan G., Simon, Lee S., Rosenbaum, James T., Smith, Harmon, Davis, Janet, Thorne, Jennifer, Acharya, Nisha R., Vitale, Albert T., Boring, Jeffrey A., Alexander, Judith, Ng, Wai Ping, Friedman, David S., Adler, Anna, Burke, Alyce, Katz, Joanne, Reed, Susan, Ansari, Husam, Cohen, Nicholas, Modak, Sanjukta, Sugar, Elizabeth A., Burke, Alyce E., Drye, Lea T., Van Natta, Mark L., Frick, Kevin, Katz, JoAnn, Louis, Thomas A., Shade, David, Pascual, Karen, Slutsky-Sanon, Jill S., Allen, Amanda, Glomp, Colby, Hilal, Yasmin, Nieves, Melissa A., Stevens, Maria, Abreu, Francis, Casper, Anne Shanklin, Ewing, Cathleen, Hart, Adante, Lears, Andrea, Li, Shirley, Meinert, Jill, Morrison, Vinnette, Nowakowski, Deborah, Reyes, Girlie, Shade, Dave M., Smith, Jacqueline, Steuernagle, Karen, Van Natta, Mark, Venugopal, Vidya, Yu, Tsung, Chen, Paul, Collins, Karen, Dodge, John, Frick, Kevin D., Jackson, Rosetta, Jimenez, Christian, Landers, Ariel, Livingston, Hope, Meinert, Curtis L., Rayapudi, Sobharani, Shen, Weijiang, Shiflett, Charles, Smith, Rochelle, Tieman, Ada, Tonascia, James A., Zheng, Richard, Allan, James, Benz, Wendy K., Domalpally, Amitha, Johnson, Kristine A., Myers, Dawn J., Won Pak, Jeong, Reimers, James L., Chambers, Geoffrey, Christianson, Debra J., Fleischli, Margaret A., Freund, Jacquelyn, Gama, Vonnie, Gangaputra, Sapna, Glander, Kathleen E., Goulding, Anne, Hafford, Dennis, Harris, Susan E., Hubbard, Larry D., Joyce, Jeffrey M., Kruse, Christina N., Nagle, Lauren, Padden-Lechten, Gwyn E., Pohlman, Alyson, Remm, Amy, Shaw, Ruth A., Sivesind, Peggy, Thayer, Dennis, Treichel, Erika, Warren, Kelly J., Watson, Sheila M., Webster, Mary K., White, James K., Wilhelmson, Tara, Zhang, Grace, and Lightman, Susan L.

Published
2015
Full Text
View/download PDF

33. Association of serum cytokines with oral HPV clearance☆

Author

Lam, Jennifer O., Bream, Jay H., Sugar, Elizabeth A., Coles, Christian L., Weber, Kathleen M., Burk, Robert D., Wiley, Dorothy J., Cranston, Ross D., Reddy, Susheel, Margolick, Joseph B., Strickler, Howard D., Wentz, Alicia, Jacobson, Lisa, Guo, Yingshi, Xiao, Weihong, Gillison, Maura L., and D’Souza, Gypsyamber

Published
2016
Full Text
View/download PDF

34. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial.

Author

Blake, Kathryn V, Antal, Holly, Bunnell, H Timothy, He, Jiaxian, Henderson, Robert, Holbrook, Janet T, McCahan, Suzanne M, Pennington, Chris, Rogers, Linda, Shade, David, Sugar, Elizabeth A, Taylor, Alexandra, Wise, Robert A, and Wysocki, Tim

Subjects
CAREGIVERS, INFORMED consent (Medical law), FACE-to-face communication, MULTIMEDIA systems, CLINICAL trials
Abstract

Background: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. Objective: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. Methods: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. Results: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33% (26/79) of all adolescents were Black, 57% (45/79) were male, and 61% (48/79) had a household income of

Published
2023
Full Text
View/download PDF

37. Early epigenetic changes and DNA damage do not predict clinical response in an overlapping schedule of 5-azacytidine and entinostat in patients with myeloid malignancies

Author

Fandy, Tamer E., Herman, James G., Kerns, Patrick, Jiemjit, Anchalee, Sugar, Elizabeth A., Choi, Si-Ho, Yang, Allen S., Aucott, Timothy, Dauses, Tianna, Odchimar-Reissig, Rosalie, Licht, Jonathan, McConnell, Melanie J., Nasrallah, Chris, Kim, Marianne K.H., Zhang, Weijia, Sun, Yezou, Murgo, Anthony, Espinoza-Delgado, Igor, Oteiza, Katharine, Owoeye, Ibitayo, Silverman, Lewis R., Gore, Steven D., and Carraway, Hetty E.

Published
2009
Full Text
View/download PDF

41. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma

Author

Herman, Joseph M., Chang, Daniel T., Goodman, Karyn A., Dholakia, Avani S., Raman, Siva P., Hacker-Prietz, Amy, Iacobuzio-Donahue, Christine A., Griffith, Mary E., Pawlik, Timothy M., Pai, Jonathan S., OʼReilly, Eileen, Fisher, George A., Wild, Aaron T., Rosati, Lauren M., Zheng, Lei, Wolfgang, Christopher L., Laheru, Daniel A., Columbo, Laurie A., Sugar, Elizabeth A., and Koong, Albert C.

Published
2015
Full Text
View/download PDF

46. Conundrum of Clinical Trials for the Uveitides: Appropriate Outcome Measures for One Treatment Used in Several Diseases.

Author

Jabs, Douglas A, Berkenstock, Meghan K, Altaweel, Michael M, Holbrook, Janet T, Sugar, Elizabeth A, and Group, for the ADVISE Research

Abstract

The uveitides consist of >30 diseases characterized by intraocular inflammation. Noninfectious intermediate, posterior, and panuveitides typically are treated with oral corticosteroids and immunosuppression, with a similar treatment approach for most diseases. Because these uveitides collectively are considered a rare disease, single-disease trials are difficult to impractical to recruit for, and most trials have included several different diseases for a given protocol treatment. However, measures of uveitis activity are disease specific, resulting in challenges for trial outcome measures. Several trials of investigational immunosuppressive drugs or biologic drugs have not demonstrated efficacy, but design problems with the outcome measures have limited the ability to interpret the results. Successful trials have included diseases for which a single uveitis activity measure suffices or a composite measure of uveitis activity is used. One potential solution to this problem is the use of a single, clinically relevant outcome, successful corticosteroid sparing, defined as inactive uveitis with a prednisone dose ≤7.5 mg/day coupled with disease-specific guidelines for determining inactive disease. The clinical relevance of this outcome is that active uveitis is associated with increased risks of visual impairment and blindness, and that prednisone doses ≤7.5 mg/day have a minimal risk of corticosteroid side effects. The consequence of this approach is that trial visits require a core set of measures for all participants and a disease-specific set of measures, both clinical and imaging, to assess uveitis activity. This approach is being used in the Adalimumab Versus Conventional Immunosuppression (ADVISE) Trial. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results