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1.
Obesity (Silver Spring) ; 28(3): 510-520, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31984668

RESUMEN

OBJECTIVE: Rural black communities bear a disproportionate burden of obesity. To increase reach among underserved groups, community-based weight loss and maintenance interventions are crucial. METHODS: The Diabetes Prevention Program (DPP) was adapted for rural black adults of faith to create The Wholeness, Oneness, Righteousness, Deliverance (WORD) trial, a group-based, community health worker-delivered weight loss intervention. A Weight Loss Only arm (16 sessions) was compared with a Weight Loss + Maintenance arm (16 + 12 sessions) in a cluster randomized controlled trial of 31 churches (n = 440). Weight and related behaviors were assessed at 0, 6, 12, and 18 months. RESULTS: The WORD produced weight loss from baseline to 6 months (percentage body weight change -2.47 [-3.13 to -1.80]). Among those who lost 5% of their baseline weight, there was a statistical trend of lower weight regain in the Weight Loss + Maintenance arm compared with control. Maintenance arm participants reported higher activity at 12 months. There were no between-arm differences at 18 months. CONCLUSIONS: The WORD produced weight loss from baseline to 6 months on par with that produced by other DPP adaptations for black communities, including adaptations using health professionals. Weight regain was also consistent with that reported in prior literature. Continuing sessions as part of the church's mission may foster adoption of DPP-based weight loss programs.

2.
Am J Health Promot ; 33(4): 549-557, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30309257

RESUMEN

PURPOSE: There is minimal information regarding the Reach and Adoption of evidence-based weight loss maintenance interventions for African Americans of faith. DESIGN: The WORD (Wholeness, Oneness, Righteousness, Deliverance) was an 18-month, cluster randomized trial designed to reduce and maintain weight loss in African American adults of faith. Participants received the Diabetes Prevention Program adapted core weight loss program for 6 months, and churches were subsequently randomized to 12-month maintenance treatment or control. All participants underwent body weight and associated behavioral and psychosocial assessments at baseline, 6, 12, and 18 months. The current article focuses on assessing Reach and Adoption at baseline and 6 months using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. SETTING: Lower Mississippi Delta. PARTICIPANTS: Thirty churches, 61 WORD Leaders (WLs), and 426 participants. INTERVENTION: Group delivered by trained community members (WLs). MEASURES: Body mass index and percentage weight lost from baseline to 6-month follow-up were measured. Reach was assessed at participant, WL, and church levels through calculating participation rates and sociodemographics of each level. Adoption was assessed at church and WL levels. ANALYSIS: Descriptive statistics summarized baseline characteristics of each level. Continuous and categorical end point comparisons were made. RESULTS: Participants' participation rate was 0.84 (n = 437 agreed to participate, n = 519 eligible invited to participate); they were predominantly female, employed, and had a mean age of 49.8. Dropouts by 6 months were younger, had differential marital status, and religious attendance compared with retained participants. Church participation rate was 0.63 (n = 30 enrolled, n = 48 eligible approached) and the majority reported ≤100 active members. The WL participation rate was 0.61 (n = 61 implemented intervention, n = 100 eligible approached); they were primarily female and aged 53.9 (mean). CONCLUSION: Recruitment, engagement, and delivery strategies employed by the WORD show promise of sustained engagement and adoption in other faith-based behavioral weight management programs for African Americans.

3.
Blood Coagul Fibrinolysis ; 29(7): 602-612, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30334816

RESUMEN

: For this pilot study, we leveraged metabolite patterns for warfarin patients to more accurately assess clinically relevant differences in drug metabolism. We tested our hypothesis that plasma metabolite levels correlate with the influence of clinical factors on R-warfarin and S-warfarin metabolism (warfarin metabolic phenotype). We recruited 29 patients receiving a maintenance dose and testing within targeted therapeutic range. We determined their CYP2C9 and vitamin K epoxide reductase genotype and profiled 14 isomeric forms of warfarin and its metabolites. We employed three novel types of clearance ratios using analyte levels to perform multiple-linear regression analyses with clinical factors impacting drug metabolism and dose-responses. Competitive clearance ratios correlated with seven clinical factors including lifestyle choices (smoking), genetics (CYP2C9 and vitamin K epoxide reductase 1), and drug interactions (omeprazole) along with age, weight, and malignancy. Significant competitive clearance ratio correlations (P = 0.04 to < 0.001) explained 21-95% variability. Their performances surpassed that of oxidative and metabolic clearance ratios based on the number and significance of correlations. Competitive clearance ratios may accurately assess significance of factors on maintaining levels of pharmacologically active forms of the drug and metabolites related to dose-responses and thus provide a strategy to minimize adverse events and improve safety during anticoagulant therapy. This unique capacity could provide a strategy in a future, higher power study with a larger cohort of patients to more accurately assess the significance of clinical factors on active drug levels contributing to warfarin dose-responses.


Asunto(s)
Anticoagulantes/metabolismo , Warfarina/metabolismo , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Fenotipo , Proyectos Piloto
4.
J Relig Health ; 2018 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-29790080

RESUMEN

Religion and body weight was explored at two time points among overweight and obese African-American adults. Baseline and follow-up data were collected from 26 adults participating in a weight loss intervention and analyzed using multiple regression analyses of religious measures, body weight, and other variables. Frequent church attendance was significantly associated with greater weight lost from baseline to 16-week follow-up. In this exploratory study, religious interactions and experiences may be involved in shaping body weight among African-Americans attempting to lose weight.

5.
Clin Lymphoma Myeloma Leuk ; 18(3): 180-190.e2, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29426719

RESUMEN

INTRODUCTION: Vorinostat (VOR), a histone deacetylase inhibitor, enhances the anti-tumor effects of rituximab (R) and cytotoxic chemotherapy, induces viral lytic expression and cell killing in Epstein-Barr virus-positive (EBV+) or human herpesvirus-8-positive (HHV-8+) tumors, and reactivates latent human immunodeficiency virus (HIV) for possible eradication by combination antiretroviral therapy (cART). PATIENTS AND METHODS: We performed a phase I trial of VOR given with R-based infusional EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin hydrochloride) (n = 12) and cART in aggressive HIV-associated B-cell non-Hodgkin lymphoma (NHL) in order to identify safe dosing and schedule. VOR (300 or 400 mg) was given orally on days 1 to 5 with each cycle of R-EPOCH for 10 high-risk patients with diffuse large B-cell lymphoma (1 EBV+), 1 EBV+/HHV-8+ primary effusion lymphoma, and 1 unclassifiable NHL. VOR was escalated from 300 to 400 mg using a standard 3 + 3 design based on dose-limiting toxicity observed in cycle 1 of R-EPOCH. RESULTS: The recommended phase II dose of VOR was 300 mg, with dose-limiting toxicity in 2 of 6 patients at 400 mg (grade 4 thrombocytopenia, grade 4 neutropenia), and 1 of 6 treated at 300 mg (grade 4 sepsis from tooth abscess). Neither VOR, nor cART regimen, significantly altered chemotherapy steady-state concentrations. VOR chemotherapy did not negatively impact CD4+ cell counts or HIV viral loads, which decreased or remained undetectable in most patients during treatment. The response rate in high-risk patients with NHL treated with VOR(R)-EPOCH was 100% (complete 83% and partial 17%) with a 1-year event-free survival of 83% (95% confidence interval, 51.6%-97.9%). CONCLUSION: VOR combined with R-EPOCH was tolerable and seemingly efficacious in patients with aggressive HIV-NHL.


Asunto(s)
Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Ciclofosfamida/uso terapéutico , Doxorrubicina/uso terapéutico , Etopósido/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Linfoma no Hodgkin/tratamiento farmacológico , Prednisona/uso terapéutico , Vincristina/uso terapéutico , Vorinostat/uso terapéutico , Antineoplásicos/farmacología , Protocolos de Quimioterapia Combinada Antineoplásica/farmacología , Ciclofosfamida/farmacología , Doxorrubicina/farmacología , Etopósido/farmacología , Femenino , Infecciones por VIH/patología , Humanos , Linfoma no Hodgkin/patología , Masculino , Prednisona/farmacología , Vincristina/farmacología , Vorinostat/farmacología
6.
J Cancer Educ ; 33(1): 29-36, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-27085550

RESUMEN

There are marked racial differences in breast cancer, the second leading cause of death among US women. Understanding the causes of these differences is essential to eliminate breast cancer inequities. More prevalent in African American than in Caucasian women, metabolic syndrome has been associated with breast cancer outcomes. Further research is needed to understand metabolic syndrome's role in breast cancer disparities, thus novel strategies to increase minority participation in research are important. We embedded two approaches (comprehensive, focused) to increase African American participation in breast cancer research in a state-wide service program and pilot tested both approaches in rural African American women. We conducted three comprehensive and three focused outreach programs (n = 48) and assessed research participation through consent and actual provision of data for four types of data: survey, anthropometric, blood, and mammography records. The majority of participants provided written consent for all data collection procedures (96 % survey; 92 % anthropometric; 94 %, blood; 100 % mammography). There were no between group differences in consent rates. There was variation in the overall proportion of participants who provided data (96 % survey; 92 % anthropometric; 73 % blood; 40 % mammography). Women in the comprehensive approach were less likely to return for a scheduled mammogram than women in the focused approach (19 % vs 64 %, p = 0.0236). Both outreach programs promoted African American engagement in research. Differences in the provision of data by type may have been due to participant burden (i.e., time required to provide data). Study designs that embed research in service programs have promise to increase minority research participation.


Asunto(s)
Afroamericanos , Actitud Frente a la Salud/etnología , Neoplasias de la Mama/etnología , Disparidades en el Estado de Salud , Selección de Paciente , Adulto , Anciano , Investigación Biomédica , Estudios de Factibilidad , Femenino , Promoción de la Salud , Humanos , Mamografía/estadística & datos numéricos , Persona de Mediana Edad , Grupos Minoritarios , Población Rural , Encuestas y Cuestionarios , Estados Unidos
7.
AIDS ; 32(5): 605-611, 2018 03 13.
Artículo en Inglés | MEDLINE | ID: mdl-29280762

RESUMEN

OBJECTIVE: Brentuximab vedotin is a Food and Drug Administration approved anti-CD30 antibody drug conjugate potently active in Hodgkin lymphoma. Trials of brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (AVD-BV) excluded patients with HIV. We studied the safety of AVD-BV in newly diagnosed HIV-associated classical Hodgkin lymphoma . DESIGN AND METHODS: Patients diagnosed with stage II-IV HIV-associated classical Hodgkin lymphoma received AVD-BV on days 1 and 15 every 28 days for six cycles. Anti-HIV medications with strong CYP3A4 inhibition were excluded. This phase 1 trial followed a 3+3 dose de-escalation design started with brentuximab vedotin at 1.2 mg/kg with standard dosing of AVD. Dose-limiting toxicities were defined in cycle one. RESULTS: Seven patients were enrolled with six being evaluable: five of six stage III/IV, three with an international prognostic score at least 4. With no dose-limiting toxicities identified, all six were treated at the 1.2 mg/kg dose. Only five grade (G) three nonhematological adverse events were noted in three patients: pulmonary infection, diarrhea, and peripheral neuropathy. No G4/5 adverse events occurred. PET/computer tomography was negative in five of six after cycle 2 and six of six post therapy. Progression-free survival was 100% at 25 months with all patients in remission. One patient was deemed ineligible for taking ritonavir, a strong CYP3A4 inhibitor, but developed G3/4 adverse events including febrile neutropenia, and pancreatitis and though consented was excluded from all evaluation. CONCLUSION: AVD-BV was well tolerated at recommended phase 2 dose of 1.2 mg/kg. Concurrent strong CYP3A4 inhibitors should be avoided. A phase 2 study of AVD-BV is currently enrolling (NCT01771107).


Asunto(s)
Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Enfermedad de Hodgkin/tratamiento farmacológico , Inmunoconjugados/administración & dosificación , Inmunoconjugados/efectos adversos , Linfoma Relacionado con SIDA/tratamiento farmacológico , Adulto , Quimioterapia Combinada/métodos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad
8.
Nephrol News Issues ; 30(4): 38-45, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-27257659

RESUMEN

We wanted to examine the predictors of annual estimated glomerular filtration rate (eGFR) decline during a five-year follow-up in elderly individuals with pre-existing chronic kidney disease (CKD) stage 3 or greater (defined as baseline eGFR of less than 60 ml/min per 1.73 m2 or a urinary albumin-to-creatinine ratio > 30 mg/g), and to examine the difference in risk factors when compared to a co-hort without CKD. Our research team identified 599 patients who were 65 years of age or older with and without CKD stage 3 or greater at baseline. Data regarding various predictors such as age, sex, race, proteinuria, medication use, contrast exposure, acute kidney injury episodes, coronary artery disease, congestive heart failure, dyslipidemia, gout etc. were obtained. Semi-partial correlations were used to determine the fac-tors providing the largest unique contribution to the overall variability in eGFR. Semi-partial correlations identified age, proteinuria, and intravenous contrast ex-posure as the most significant predictors of eGFR decline in this population. Overall, patients in the pre-existing CKD cohort were more likely to be older, Af-rican American and with co-morbidities like diabetes, hypertension, etc. In this group, the unadjusted rate of decline in eGFR varied from 0.5% to 8.3% per year. This study identifies important risk factors for eGFR decline in the population aged > 65 years. It also concludes that each episode of acute kidney injury, wheth-er related to contrast or other nephrotoxins, increases the risk for CKD progression and eGFR decline in the elderly.


Asunto(s)
Causas de Muerte/tendencias , Tasa de Filtración Glomerular , Valor Predictivo de las Pruebas , Insuficiencia Renal Crónica/mortalidad , Insuficiencia Renal Crónica/fisiopatología , Factores de Edad , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Estudios Epidemiológicos , Femenino , Predicción , Humanos , Masculino , Insuficiencia Renal Crónica/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Estados Unidos/epidemiología
10.
Sex Transm Dis ; 42(8): 434-9, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-26165435

RESUMEN

BACKGROUND: The US system for gonococcal antimicrobial susceptibility surveillance monitors trends exclusively among men with urethral infection, the population from whom the yield of gonococcal culture is highest. Little is known about the susceptibility of female urogenital isolates, and it is unclear whether gonococcal susceptibility among men who report sex exclusively with women (MSW) is representative of susceptibility among women. METHODS: Using isolates collected during a recent treatment trial in 5 US cities, we performed a secondary analysis to compare antimicrobial susceptibilities of Neisseria gonorrhoeae urogenital isolates obtained from women, MSW, and men who have sex with men (MSM). Pretreatment isolates were collected from trial participants; minimum inhibitory concentrations (MICs) were determined by agar dilution. Geometric mean MICs were adjusted for geographic location using general linear models. RESULTS: Susceptibility data for urogenital isolates from 56 women, 252 MSW, and 170 MSM were studied. The adjusted geometric mean ceftriaxone MIC was similar among women (0.0067 µg/mL; 95% confidence interval [CI], 0.0049-0.0092 µg/mL) and MSW (0.0060 µg/mL; 95% CI, 0.0053-0.0066 µg/mL). In contrast, the adjusted geometric mean ceftriaxone MIC was higher among MSM (0.0098 µg/mL; 95% CI, 0.0082-0.0119 µg/mL) than among MSW. This same pattern was observed for other antimicrobials, including cefixime and azithromycin CONCLUSIONS: Ceftriaxone, cefixime, and azithromycin MICs were higher among MSM than among MSW, but were similar among women and MSW. These findings suggest that gonococcal antimicrobial susceptibility surveillance based on urethral isolates from MSW may adequately represent susceptibility of urogenital N. gonorrhoeae in women.


Asunto(s)
Antiinfecciosos/administración & dosificación , Farmacorresistencia Bacteriana/efectos de los fármacos , Gonorrea/microbiología , Heterosexualidad , Homosexualidad , Neisseria gonorrhoeae/efectos de los fármacos , Adulto , Ciprofloxacino/administración & dosificación , Femenino , Gonorrea/tratamiento farmacológico , Humanos , Masculino , Pruebas de Sensibilidad Microbiana , Neisseria gonorrhoeae/aislamiento & purificación , Penicilinas/administración & dosificación , Vigilancia de Guardia , Tetraciclina/administración & dosificación , Estados Unidos/epidemiología , Población Urbana
11.
J Am Acad Audiol ; 25(6): 576-83, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25313547

RESUMEN

BACKGROUND: The middle latency response (MLR) is considered a valid clinical tool for assessing the integrity of cortical and subcortical structures. Several investigators have demonstrated that a rising frequency chirp stimulus is capable of eliciting not only larger wave V amplitudes but larger MLR components as well. However, the chirp has never been specifically examined in a hemispheric electrode montage setup that is typical for neurodiagnostic application and site-of-lesion testing. PURPOSE: The purpose of this study was to examine the effect of chirp, click, and toneburst stimuli on MLR waveform peak latency and peak-to-peak amplitude in a hemispheric electrode montage setup. RESEARCH DESIGN: This study used a repeated-measures design. STUDY SAMPLE: A total of 10 young adult participants (3 males, 7 females) with normal hearing were recruited and had negative histories of audiologic, otologic, and neurologic involvement, and no reported language or learning difficulties. DATA COLLECTION AND ANALYSIS: MLR latencies (Na, Pa, Nb, and Pb) and peak-to-peak amplitudes (Na-Pa, Pa-Nb, and Nb-Pb) were measured for all conditions and were statistically evaluated for left hemisphere-right ear (C3-A2) and right hemisphere-left ear (C4-A1) recordings. RESULTS: Statistical analyses revealed no significant difference between C3-A2 and C4-A1 peak-to-peak amplitudes; therefore, data were collapsed. Stimulus comparisons revealed that Na evoked by tonebursts were statistically prolonged compared with both chirp and click, and that both Na-Pa and Pa-Nb peak-to-peak amplitudes were statistically larger for chirps compared with both clicks and tonebursts, and for clicks compared with tonebursts. CONCLUSIONS: The results of this study support the hypothesis that a chirp would offer a clinical advantage to the click and toneburst in overall peak-to-peak amplitude. As expected, normal-hearing participants did not exhibit hemispheric differences when comparing C3-A2 and C4-A1 peak-to-peak amplitudes demonstrating symmetric auditory brain function. However, chirp-evoked MLRs will require further study to determine its usefulness in clinical practice.


Asunto(s)
Estimulación Acústica , Potenciales Evocados Auditivos/fisiología , Tiempo de Reacción , Adulto , Audición , Humanos , Masculino
12.
Clin Infect Dis ; 59(8): 1083-91, 2014 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-25031289

RESUMEN

BACKGROUND: Ceftriaxone is the foundation of currently recommended gonorrhea treatment. There is an urgent need for backup treatment options for patients with cephalosporin allergy or infections due to suspected cephalosporin-resistant Neisseria gonorrhoeae. We evaluated the efficacy and tolerability of 2 combinations of existing noncephalosporin antimicrobials for treatment of patients with urogenital gonorrhea. METHODS: We conducted a randomized, multisite, open-label, noncomparative trial in 5 outpatient sexually transmitted disease clinic sites in Alabama, California, Maryland, and Pennsylvania. Patients aged 15-60 years diagnosed with uncomplicated urogenital gonorrhea were randomly assigned to either gentamicin 240 mg intramuscularly plus azithromycin 2 g orally, or gemifloxacin 320 mg orally plus azithromycin 2 g orally. The primary outcome was microbiological cure of urogenital infections (negative follow-up culture) at 10-17 days after treatment among 401 participants in the per protocol population. RESULTS: Microbiological cure was achieved by 100% (lower 1-sided exact 95% confidence interval [CI] bound, 98.5%) of 202 evaluable participants receiving gentamicin/azithromycin, and 99.5% (lower 1-sided exact 95% CI bound, 97.6%) of 199 evaluable participants receiving gemifloxacin/azithromycin. Gentamicin/azithromycin cured 10 of 10 pharyngeal infections and 1 of 1 rectal infection; gemifloxacin/azithromycin cured 15 of 15 pharyngeal and 5 of 5 rectal infections. Gastrointestinal adverse events were common in both arms. CONCLUSIONS: Gentamicin/azithromycin and gemifloxacin/azithromycin were highly effective for treatment of urogenital gonorrhea. Gastrointestinal adverse events may limit routine use. These non-cephalosporin-based regimens may be useful alternative options for patients who cannot be treated with cephalosporin antimicrobials. Additional treatment options for gonorrhea are needed. Clinical Trials Registration. NCT00926796.


Asunto(s)
Antibacterianos/uso terapéutico , Azitromicina/uso terapéutico , Fluoroquinolonas/uso terapéutico , Gentamicinas/uso terapéutico , Gonorrea/tratamiento farmacológico , Naftiridinas/uso terapéutico , Administración Oral , Adolescente , Adulto , Antibacterianos/efectos adversos , Azitromicina/efectos adversos , Quimioterapia Combinada/efectos adversos , Quimioterapia Combinada/métodos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Fluoroquinolonas/efectos adversos , Enfermedades Gastrointestinales/inducido químicamente , Enfermedades Gastrointestinales/epidemiología , Enfermedades Gastrointestinales/patología , Gemifloxacina , Gentamicinas/efectos adversos , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Naftiridinas/efectos adversos , Neisseria gonorrhoeae/aislamiento & purificación , Resultado del Tratamiento , Estados Unidos , Adulto Joven
13.
Otol Neurotol ; 35(8): 1471-3, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24950141

RESUMEN

OBJECTIVE: To determine outcomes of type 1 cartilage tympanoplasty in a cohort of pediatric patients with a history of cleft palate repair. PATIENTS AND OUTCOME MEASURES: Retrospective chart review and comparison with a historical control group of patients with no cleft palate anomaly undergoing the same procedure by the same surgeon at a tertiary care pediatric hospital. A total of 37 patients between ages 4 and 19 years inclusive (45 ears), with a history of repaired cleft palate, underwent type 1 cartilage tympanoplasty with or without primary tube insertion from September 2004 to October 2012. Demographics, type of cleft palate, surgical indication, middle ear status, complications, history of myringotomy tube insertion, and auditory outcomes were collected. Results were compared with those for a non-cleft palate cohort that had undergone the same procedure, which had been previously published. RESULTS: The unadjusted average preoperative and postoperative pure-tone averages for patients with a history of cleft palate were 22.06 and 7.29, respectively, compared with 18.34 and 8.32, respectively, for non-cleft patients. Despite significantly worse preoperative hearing levels among the cleft palate group, there was no statistically significant difference in outcomes with regard to hearing results between the two groups. One patient in the cleft palate group required revision type 1 cartilage tympanoplasty for graft failure, which is comparable to that reported for non-cleft palate patients. Post-tympanoplasty secondary tympanostomy intubation was slightly higher for the cleft palate population. CONCLUSION: Type 1 cartilage tympanoplasty, when performed in a pediatric population with a history of cleft palate, can achieve closure and hearing results that are comparable of those in patients with no such anomaly.


Asunto(s)
Cartílago/trasplante , Fisura del Paladar/complicaciones , Timpanoplastia/métodos , Adolescente , Niño , Preescolar , Fisura del Paladar/cirugía , Femenino , Audición , Pruebas Auditivas , Humanos , Masculino , Complicaciones Posoperatorias/epidemiología , Estudios Retrospectivos , Resultado del Tratamiento , Timpanoplastia/efectos adversos , Adulto Joven
14.
Cancer ; 120(8): 1194-202, 2014 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-24474568

RESUMEN

BACKGROUND: The treatment of non-acquired immunodeficiency syndrome-defining cancers may be complicated by drug interactions between highly active antiretroviral therapy (HAART) and chemotherapy. This trial is the first by the AIDS Malignancy Consortium to assess targeted therapies and HAART in human immunodeficiency virus-positive patients (ClinicalTrials.gov identifier: NCT00890747). METHODS: In a modified phase 1 study of sunitinib, patients were stratified into 2 treatment arms based on whether they were receiving therapy with ritonavir, a potent CYP3A4 inhibitor. Patients in treatment arm 1 (non-ritonavir HAART) received standard sunitinib dosing (50 mg/day). Treatment arm 2 (ritonavir-based HAART) used a phase 1, 3 + 3 dose escalation design (from 25 mg/day to 50 mg/day). Cycles were comprised of 4 weeks on treatment followed by a 2-week break (6 weeks total). The pharmacokinetics of sunitinib and its active metabolite (N-desethyl sunitinib) were assessed. RESULTS: Nineteen patients were enrolled and were evaluable. Patients on treatment arm 1 tolerated treatment with no dose-limiting toxicity observed. In treatment arm 2, a dose-limiting toxicity was experienced at a dose of 37.5 mg, and an additional 3 of 5 patients experienced grade 3 neutropenia (toxicity graded as per National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]), an uncommon toxicity of sunitinib. No patient achieved a response, but 10 patients had stable disease, including 8 with prolonged disease stability. Efavirenz, a potent inducer of CYP3A4, resulted in increased exposure of N-desethyl sunitinib, whereas ritonavir caused decreased exposure of the metabolite. Hand-foot syndrome was associated with higher steady-state trough concentrations of sunitinib. CONCLUSIONS: Patients receiving non-ritonavir-based HAART regimens tolerated standard dosing of sunitinib. Patients receiving ritonavir-based therapy who were treated with a dose of 37.5 mg/day experienced higher toxicities. Dose reductions of sunitinib to 37.5 mg may be warranted in patients receiving ritonavir.


Asunto(s)
Inhibidores de la Angiogénesis/farmacocinética , Antineoplásicos/farmacocinética , Terapia Antirretroviral Altamente Activa , Infecciones por VIH/tratamiento farmacológico , Indoles/farmacocinética , Neoplasias/tratamiento farmacológico , Pirroles/farmacocinética , Adulto , Anciano , Interacciones de Drogas , Femenino , Humanos , Indoles/efectos adversos , Masculino , Persona de Mediana Edad , Pirroles/efectos adversos , Ritonavir/uso terapéutico , Sunitinib
15.
J Altern Complement Med ; 20(1): 48-52, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-23383975

RESUMEN

OBJECTIVES: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). DESIGN: Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. SETTINGS: The study was conducted at 11 clinical centers in North America. PARTICIPANTS: Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). OUTCOME MEASURES: Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. RESULTS: For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. CONCLUSIONS: Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.


Asunto(s)
Extractos Vegetales/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto/psicología , Sujetos de Investigación/psicología , Anciano , Método Doble Ciego , Humanos , Masculino , Persona de Mediana Edad , Placebos , Hiperplasia Prostática/tratamiento farmacológico
16.
Med Care ; 51(12): 1063-8, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24220684

RESUMEN

BACKGROUND: The incidence of lung cancer cases among HIV-infected individuals is increasing with time. It is unclear whether HIV-infected individuals receive the same care for lung cancer as immunocompetent patients because of comorbidities, the potential for interaction between antiretroviral agents and cancer chemotherapy, and concerns regarding complications related to treatment or infection. OBJECTIVES: The objective of this study was to assess the effect of HIV infection on receipt of guidance-concordant care, and its impact on overall survival among non-small cell lung cancer Medicare beneficiaries. DESIGN: The study design was a matched case-control design where each HIV patient was matched by age group, sex, race, and lung cancer stage at diagnosis with 20 controls randomly selected among those who were not HIV infected. SUBJECTS: The patients included in this study were Medicare beneficiaries diagnosed with non-small cell lung cancer between 1998 and 2007, who qualified for Medicare on the basis of age and were 65 years of age or older at the time of lung cancer diagnosis. HIV infection status was based on Medicare claims data. A total of 174 HIV cases and 3480 controls were included in the analysis. MEASURES: Odds ratios for receiving guidance-concordant care and hazard ratios for overall survival were estimated. RESULTS: HIV infection was not independently associated with the receipt of guidance-concordant care. Among stage I/II patients, median survival times were 26 and 43 months, respectively, for those with and without HIV infection (odds ratio=1.48, P=0.021). CONCLUSIONS: HIV infection was not associated with receipt of guidance-concordant care but reduced survival in early-stage patients.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas/epidemiología , Carcinoma de Pulmón de Células no Pequeñas/terapia , Adhesión a Directriz/estadística & datos numéricos , Infecciones por VIH/epidemiología , Neoplasias Pulmonares/epidemiología , Neoplasias Pulmonares/terapia , Anciano , Anciano de 80 o más Años , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Estudios de Casos y Controles , Comorbilidad , Femenino , Humanos , Neoplasias Pulmonares/mortalidad , Masculino , Medicare/estadística & datos numéricos , Estadificación de Neoplasias , Guías de Práctica Clínica como Asunto , Programa de VERF , Estados Unidos
17.
Otol Neurotol ; 34(9): 1670-4, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24232064

RESUMEN

OBJECTIVE: To evaluate the long-term adverse cochlear implant (CI) outcomes resulting in revision surgery including CI reimplantation (CIR). PATIENTS: Pediatric and adult patients requiring revision procedures after CI placement. INTERVENTION(S): Revision surgery on cochlear implant patients. MAIN OUTCOME MEASURES: Device type, length of total device follow-up, time to device failure, cause for failure, peak pre-CIR and post-CIR audiometric performance, rate of surgical site complications, and operative findings. RESULTS: A total of 317 patients, receiving 439 CIs between January 2000 and April 2012, met inclusion criteria for this series. For the patients implanted at our institution, the revision surgery rate was 4.1%, with a CIR rate of 3.0%. The CIR rates among the pediatric and adult populations were 5.0% and 1.3%, respectively (p = 0.0336). The rate of revision procedures because of failed fixation or device extrusion was 0.9%. Device failure was experienced in 8 patients in our series, with 75% occurring with the CI24R (CS) device. CONCLUSION: All reimplanted patients with available data had good audiometric outcomes, with the exception of those reimplanted for soft failure who had poor immediate auditory function. Using the manufacturers' recommended surgical technique, including drilling a bony recess with suture fixation, very low surgical revision rates were achieved. Pediatric patients experienced significantly higher complications requiring CIR. All hard failures in this series occurred in the pediatric group and in a single device. Continued follow-up will be needed to determine if additional devices will succumb to this mode of failure.


Asunto(s)
Implantación Coclear , Implantes Cocleares , Falla de Equipo , Pérdida Auditiva/cirugía , Adolescente , Anciano , Niño , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Reoperación , Estudios Retrospectivos
18.
Am J Prev Med ; 44(2): 154-7, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23332332

RESUMEN

BACKGROUND: Little information is available on geographic disparity of human papillomavirus (HPV) vaccination among women aged 18-26 years in the U.S. Genital HPV is the most common sexually transmitted infection in the U.S. Persistent HPV infection with oncogenic types can cause cervical cancer. PURPOSE: This study utilized data collected from the 2010 National Health Interview Survey (NHIS). It identified geographic variability and other factors contributing to the disparities in HPV vaccine series initiation in a nationally representative sample of women aged 18-26 years. METHODS: The study utilized data collected from 1867 women who participated in the Cancer Control Module Supplement of the 2012 NHIS. A multivariable logistic regression model was used to assess characteristics associated with initiation of the HPV series. Analyses were performed in 2012. RESULTS: After adjusting for other characteristics, women living in the West and North Central/Midwest had 54% and 20% greater odds of initiating the HPV series, respectively, compared with those living in the Northeast. Other factors associated with HPV series initiation were younger age, Hispanic background, being single/never married, childlessness, a history of HPV, and current alcohol use. Factors correlated with failure to initiate the HPV series were: not having insurance, living below the 200% poverty level, not being a high school graduate, not currently using hormone-based birth control, most recent Pap >1 year ago, no regular provider, last clinic visit ≥12 months ago, and never having received the hepatitis B vaccine. CONCLUSIONS: Results demonstrate disparity in HPV vaccine uptake by region of residence in the U.S. among young women. Further research is needed to understand the factors contributing to this geographic disparity. Evaluation of vaccination policies and practices associated with higher coverage regions might help characterize effective methods to improve HPV vaccination among women aged 18-26 years.


Asunto(s)
Disparidades en Atención de Salud/estadística & datos numéricos , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/administración & dosificación , Adolescente , Adulto , Factores de Edad , Femenino , Encuestas Epidemiológicas , Humanos , Modelos Logísticos , Análisis Multivariante , Proteínas Asociadas a Pancreatitis , Factores Socioeconómicos , Adulto Joven
19.
Clin Neurol Neurosurg ; 115(6): 695-8, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22910395

RESUMEN

BACKGROUND: One third of patients with intracerebral hemorrhage (ICH) require mechanical ventilation; in most, tracheostomy may be necessary. Limited data exist about predictors of tracheostomy in ICH. The aim of our study is to identify predictors of tracheostomy in ICH. METHODS: We reviewed medical records of patients seen in our institution between 2005 and 2009, using ICD-9 codes for ICH, for admission clinical and radiological parameters. A stepwise logistic regression model was used to identify tracheostomy predictors. RESULTS: Ninety patients with ICH were included in the analysis, eleven of which required tracheostomy. Patients requiring a tracheostomy were more likely to have a large hematoma volume (≥30mL) (63.4% vs. 29.1%, p=0.037), intraventricular hemorrhage (81.8% vs. 27.8%, p<0.0001), hydrocephalus (81.8% vs. 8.8%, p<0.0001), admission GCS<8 (81.8% vs. 5.1%, p<0.0001), intubation≥14 days (54.5% vs. 1.27%, p<0.0001) and pneumonia (63.6% vs. 17.7%, p=0.003). Stepwise logistic regression yielded admission GCS (OR=80.55, p=0.0003) and intubation days (OR=87.49, p<0.006) as most important predictors. CONCLUSION: We could potentially predict the need for tracheostomy early in the course of ICH based on the admission GCS score; duration of intubation is another predictor for tracheostomy. Early tracheostomy could decrease the time, and therefore risks of prolonged endotracheal intubation and length of hospital stay.


Asunto(s)
Hemorragias Intracraneales/terapia , Traqueostomía , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Extubación Traqueal , Cuidados Críticos , Femenino , Predicción , Escala de Coma de Glasgow , Humanos , Clasificación Internacional de Enfermedades , Modelos Logísticos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Respiración Artificial , Estudios Retrospectivos , Factores de Riesgo , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
20.
Otolaryngol Head Neck Surg ; 148(2): 297-301, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23223520

RESUMEN

OBJECTIVE: To justify the successful use of a patient selection algorithm based on age for primary cartilage tympanoplasty. STUDY DESIGN: Case series with chart review. SETTING: Tertiary care pediatric hospital. SUBJECTS AND METHODS: We performed a retrospective chart review of patients between ages 4 and 13 years who underwent cartilage tympanoplasty for tympanic membrane perforations from August 2005 to November 2011. Demographics, complication data, and auditory outcomes were collected. RESULTS: Patients were subdivided into 3 age groups. Group 1 consisted of patients younger than 7 years (n = 43); group 2, ages 7 to 10 years (n = 40); and group 3, ages 10 to 13 years (n = 36). Mean follow-up was 595 days (range, 48-1742). Complication rates respective to the 3 groups were as follows: remnant perforation (6.97%, 5.00%, 2.78%), revision tympanoplasty (2.33%, 2.50%, 0%), and need for tympanostomy tubes (4.65%, 2.50%, 0%). Logistic regression models were used to evaluate complication rates between groups. No significant differences were found (remnant perforation, P = .710; repeat tympanoplasty, P = .998; tympanostomy tubes, P = .875). No significance was found among audiological outcomes between the 3 groups. CONCLUSION: These data suggest cartilage tympanoplasty can be performed effectively in young children when appropriate conditions exist.


Asunto(s)
Selección de Paciente , Perforación de la Membrana Timpánica/cirugía , Timpanoplastia , Adolescente , Algoritmos , Audiometría de Tonos Puros , Niño , Preescolar , Cartílago Auricular/trasplante , Femenino , Humanos , Modelos Logísticos , Masculino , Complicaciones Posoperatorias , Estudios Retrospectivos , Resultado del Tratamiento
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