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1.
Ophthalmology ; 126(3): 428-437, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30316888

RESUMO

PURPOSE: To assess efficacy and safety of sarilumab, a human anti-interleukin-6 receptor antibody, for treatment of posterior segment noninfectious uveitis (NIU). DESIGN: Randomized, double-masked, placebo-controlled, phase 2 study. PARTICIPANTS: Fifty-eight patients (eyes) with noninfectious intermediate, posterior, or panuveitis. METHODS: Eyes received treatment every 2 weeks for 16 weeks with subcutaneous sarilumab 200 mg or placebo. MAIN OUTCOME MEASURES: The primary end point was the proportion of patients with ≥2-step reduction in vitreous haze (VH) on the Miami scale or with a reduction of systemic corticosteroids (prednisolone or equivalent) to a dose of <10 mg/day at week 16. Primary end point was based on VH evaluation by a central reading center. Investigator evaluation of VH was a prespecified, planned secondary analysis. RESULTS: At week 16, proportion of patients taking sarilumab or placebo with ≥2-step reduction in VH or corticosteroid dose <10 mg/day was 46.1% vs. 30.0% (P = 0.2354) based on central reading center assessment of VH and 64.0% vs. 35.0% (P = 0.0372) based on investigator assessment of VH, respectively. In the subgroup of eyes with VH grade ≥2 at baseline, the mean VH reduction from baseline to week 16 was significantly greater with sarilumab vs. placebo regardless of assessment by the central reading center (-2.1 [n = 11] vs. -1.7 [n = 3], respectively; P = 0.0255) or investigator (-2.5 [n = 19] vs. -1.2 [n = 11], respectively; P = 0.0170). The mean best-corrected visual acuity gain from baseline to week 16 was greater with sarilumab vs. placebo in the overall population (8.9 vs. 3.6 letters, respectively; P = 0.0333) and in the subgroup of eyes with central subfield thickness (CST) ≥300 µm at baseline (12.2 [n = 13] vs. 2.1 [n = 7] letters, respectively; P = 0.0517). Corresponding changes in CST were -46.8 vs. +2.6 µm (P = 0.0683) in the overall population and -112.5 [n = 13] vs. -1.8 [n = 6] µm (P = 0.1317) in the subgroup of eyes with CST ≥300 µm at baseline, respectively. The most common ocular adverse events were worsening of uveitis (0 [placebo] and 3 [sarilumab] patients) and retinal infiltrates (1 [placebo] and 2 [sarilumab] patients). CONCLUSIONS: Subcutaneous sarilumab may provide clinical benefits in the management of NIU of the posterior segment, especially in eyes with uveitic macular edema.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Uveíte Posterior/tratamento farmacológico , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Antirreumáticos/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Uveíte Posterior/diagnóstico , Uveíte Posterior/fisiopatologia , Acuidade Visual/fisiologia
2.
Ophthalmology ; 123(2): 330-336, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26522708

RESUMO

PURPOSE: To determine week 52 efficacy and safety outcomes in eyes with macular edema after branch retinal vein occlusion (BRVO) treated with 2 mg intravitreal aflibercept injection (IAI) compared with grid laser. DESIGN: VIBRANT was a double-masked, randomized, phase 3 trial. PARTICIPANTS: Eyes randomized and treated in VIBRANT were followed to week 52. METHODS: In the IAI group, eyes received IAI every 4 weeks through week 24 and IAI every 8 weeks through week 48 with rescue grid laser if needed at week 36. In the grid laser group, all eyes received grid laser at baseline and, if prespecified rescue criteria were met, 1 additional laser from week 12 to 20 and IAI every 8 weeks after 3 monthly doses from week 24 onward (the laser/IAI group). MAIN OUTCOME MEASURES: The primary outcome measure was percentage of eyes with improvement from baseline best-corrected visual acuity (BCVA) letter score ≥15 at week 24. All outcome measures at week 52 were exploratory, and P values are considered nominal. RESULTS: The percentage of eyes with improvement from baseline letter score ≥15 in the IAI and laser/IAI groups was 52.7% versus 26.7% (P = 0.0003) at week 24 and 57.1% versus 41.1% (P = 0.0296) at week 52. The corresponding mean change from baseline BCVA letter score was 17.0 versus 6.9 (P < 0.0001) at week 24 and 17.1 versus 12.2 (P = 0.0035) at week 52. The mean reduction from baseline central retinal thickness was 280.5 µm versus 128.0 µm (P < 0.0001) at week 24 and 283.9 µm versus 249.3 µm (P = 0.0218) at week 52. In the IAI group, 10.6% of eyes received rescue laser at week 36, and in the laser/IAI group, 80.7% received rescue IAI from week 24 to week 48. Traumatic cataract in 1 eye (1.1%) in the IAI group was the only ocular serious adverse event. CONCLUSIONS: After 6 monthly IAI, injections every 8 weeks maintained control of macular edema and visual benefits through week 52. In the laser group, rescue IAI given from week 24 onward resulted in substantial visual improvements at week 52.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Edema Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Oclusão da Veia Retiniana/tratamento farmacológico , Inibidores da Angiogênese/efeitos adversos , Método Duplo-Cego , Feminino , Angiofluoresceinografia , Humanos , Injeções Intravítreas , Fotocoagulação a Laser , Edema Macular/diagnóstico , Edema Macular/etiologia , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Receptores de Fatores de Crescimento do Endotélio Vascular/efeitos adversos , Proteínas Recombinantes de Fusão/efeitos adversos , Oclusão da Veia Retiniana/complicações , Oclusão da Veia Retiniana/diagnóstico , Perfil de Impacto da Doença , Inquéritos e Questionários , Tomografia de Coerência Óptica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade Visual/fisiologia
3.
Ophthalmology ; 122(3): 538-44, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25315663

RESUMO

PURPOSE: To compare the efficacy and safety of intravitreal aflibercept injection (IAI) with macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion (BRVO). DESIGN: The VIBRANT study was a double-masked, active-controlled, randomized, phase III trial. PARTICIPANTS: Treatment-naïve eyes with macular edema after BRVO were included in the study if the occlusion occurred within 12 months and best-corrected visual acuity (BCVA) was between ≤73 and ≥24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/40-20/320 Snellen equivalent). METHODS: Eyes (1 eye per patient) received either IAI 2 mg every 4 weeks (n=91) from baseline to week 20 or grid laser (n=92) at baseline with a single grid laser rescue treatment, if needed, from weeks 12 through 20. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of eyes that gained ≥15 ETDRS letters from baseline BCVA at week 24. Secondary end points included mean change from baseline BCVA and central retinal thickness (CRT) at week 24. RESULTS: The proportion of eyes that gained ≥15 ETDRS letters from baseline at week 24 was 52.7% in the IAI group compared with 26.7% in the laser group (P=0.0003). The mean improvement from baseline BCVA at week 24 was 17.0 ETDRS letters in the IAI group and 6.9 ETDRS letters in the laser group (P<0.0001). The mean reduction in CRT from baseline at week 24 was 280.5 µm in the IAI group and 128.0 µm in the laser group (P<0.0001). Traumatic cataract in an IAI patient was the only ocular serious adverse event (SAE) that occurred. There were no cases of intraocular inflammation or endophthalmitis. The incidence of nonocular SAEs was 8.8% in the IAI group and 9.8% in the laser group. One Anti-Platelet Trialists' Collaboration-defined event of nonfatal stroke (1.1%) and 1 death (1.1%) due to pneumonia occurred during the 24 weeks of the study, both in patients in the laser group. CONCLUSIONS: Monthly IAI provided significantly greater visual benefit and reduction in CRT at 24 weeks than grid laser photocoagulation in eyes with macular edema after BRVO.


Assuntos
Edema Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Oclusão da Veia Retiniana/tratamento farmacológico , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Idoso , Método Duplo-Cego , Feminino , Humanos , Injeções Intravítreas , Fotocoagulação a Laser , Edema Macular/etiologia , Edema Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Receptores de Fatores de Crescimento do Endotélio Vascular/efeitos adversos , Proteínas Recombinantes de Fusão/efeitos adversos , Oclusão da Veia Retiniana/complicações , Oclusão da Veia Retiniana/fisiopatologia , Perfil de Impacto da Doença , Inquéritos e Questionários , Acuidade Visual/fisiologia
4.
Prenat Diagn ; 34(2): 145-52, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24222397

RESUMO

OBJECTIVE: The objective of this study is to assess the opinions of Fellows of the American College of Obstetricians and Gynecologists on expanded carrier testing (molecular detection of >100 genetic diseases of variable severity) and noninvasive prenatal testing (NIPT). METHODS: A survey conducted between March and August 2012, assessed current use of testing, provision of genetic counseling, types of disorders that should be identified, preferences for future use, ethical aspects, and views on regulatory oversight. RESULTS: Expanded carrier testing was offered to all patients by 15% of the responders and 52.1% upon patient request. Most (67.3%) favored testing only for mutations of known significance. In this study, 79.1% supported the use of NIPT as a screen for Down syndrome for all women with 47.9% viewing NIPT as a complete substitution for invasive testing. Most supported expansion to other aneuploidies (97.5%) and severe early-onset Mendelian disorders (90.4%) but not for adult-onset disorders (29.8%) or nonmedical sex identification (15.7%). A majority (73.2%) believed that NIPT would increase pregnancy terminations for mild disease states. Respondents favored a role for professional societies in providing regulatory oversight. CONCLUSION: Rapid incorporation of new genetic technologies may be limited by the availability of genetic counseling, concerns regarding inclusion of clinically mild disorders, results of unknown significance, and costs.


Assuntos
Atitude do Pessoal de Saúde , Triagem de Portadores Genéticos , Testes Genéticos , Ginecologia , Obstetrícia , Padrões de Prática Médica , Diagnóstico Pré-Natal , Feminino , Humanos , Masculino , Gravidez , Inquéritos e Questionários
5.
Brain Cogn ; 81(2): 247-55, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23262179

RESUMO

Glucocorticoid administration has been shown to exert complex effects on cognitive and emotional processing. In the current study we investigated the effects of glucocorticoid administration on attention towards emotional words, using an Affective Go/No-go task on which healthy humans have shown an attentional bias towards positive as compared to negative words. Healthy volunteers received placebo and either low-dose (0.15mg/kg) or high-dose (0.45mg/kg) hydrocortisone intravenously during two separate visits in a double-blind, randomized design. Seventy-five minutes post-infusion, the subjects performed tests of attention (Rapid Visual Information Processing [RVIP]), spatial working memory (Spatial Span) and emotional processing (Affective Go/No-go task [AGNG]). On the attention task, performance was impaired under both hydrocortisone doses relative to placebo, though the effect on error rate was not significant after controlling for age; Spatial Span performance was unaffected by hydrocortisone administration. On the AGNG task, relative to the placebo condition the low-dose hydrocortisone infusion decreased response time to emotional words while high-dose hydrocortisone increased response time. In the females specifically, both high and low dose hydrocortisone administration attenuated the normal attentional bias toward positively valenced words. These data suggest that, in healthy women, the modulation of attention by the emotional salience of stimuli is influenced by glucocorticoid hormone concentrations.


Assuntos
Atenção/efeitos dos fármacos , Emoções/efeitos dos fármacos , Hidrocortisona/farmacologia , Memória de Curto Prazo/efeitos dos fármacos , Adolescente , Adulto , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Tempo de Reação/efeitos dos fármacos , Fatores Sexuais
6.
Am J Perinatol ; 29(8): 599-608, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22639353

RESUMO

OBJECTIVE: To survey generalist obstetrician-gynecologists about their satisfaction with and patterns of referral to maternal-fetal medicine (MFM) specialists. STUDY DESIGN: A survey was sent three times to 1030 randomly selected American Congress of Obstetricians and Gynecologists members across the country, and results were tabulated. RESULTS: A total of 516 surveys (50%) were returned; 68% of respondents were satisfied (S) with available MFM services and 31% were not satisfied (Not S). S and Not S respondents were similar with respect to age, gender, years in practice, type of practice, hours worked per week, proximity to MFM specialists, number of deliveries per year, and level of nursery in their hospital. Reasons for dissatisfaction included: MFM specialist not readily available (49%), during the day (26%), at night (35%), or on weekends (36%); MFM specialist unwilling to take care of hospitalized patients (26%); or MFM specialist does only ultrasound, chorionic villus sampling, and amniocentesis (32%). Although some generalists do not consult MFM specialists frequently, the majority of both S and Not S respondents would request an MFM consult or comanagement for 26 of 38 specific maternal, fetal, and obstetric diagnoses/complications. CONCLUSION: The majority of obstetrician-gynecologists are satisfied with their MFM support. The dissatisfaction expressed by 31% of generalists might be ameliorated if individual MFM specialists increased their availability and/or broadened their scope of practice.


Assuntos
Ginecologia , Relações Interprofissionais , Obstetrícia , Encaminhamento e Consulta , Adulto , Feminino , Doenças Fetais/diagnóstico , Doenças Fetais/terapia , Pesquisas sobre Atenção à Saúde , Acessibilidade aos Serviços de Saúde , Humanos , Padrões de Prática Médica , Gravidez , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/terapia , Encaminhamento e Consulta/estatística & dados numéricos
7.
Psychol Rep ; 111(1): 129-48, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23045855

RESUMO

Major depressive disorder (MDD) is associated with deficits in recalling specific autobiographical memories. The current study goal was to assess whether emotionally valenced cue words led to memories of similar emotional valence and whether this pattern differed between 12 unmedicated MDD and 14 healthy control participants. Both groups recalled autobiographical memories in response to positive, negative, and neutral cue words. Positive and neutral cues prompted recall of positive memories less often in the MDD group than in the controls. MDD participants recalled fewer specific and more categorical memories than controls; however, the proportion of specific memories didn't differ across memory valences. The MDD group had fewer specific memories in response to positive and neutral cues than the controls. These results suggest that the MDD participants may process positive stimuli differently than healthy controls and that their recall of specific autobiographical memories is impaired, regardless of the affective valence of those memories.


Assuntos
Afeto , Sinais (Psicologia) , Transtorno Depressivo Maior/psicologia , Memória Episódica , Adulto , Emoções , Feminino , Humanos , Masculino , Semântica , Adulto Jovem
9.
J Reprod Med ; 55(1-2): 25-30, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20337204

RESUMO

OBJECTIVE: To determine obstetrician-gynecologists' practice patterns of cesarean delivery on maternal request (CDMR) following the 2006 National Institutes of Health (NIH) State-of-the-Science conference on this topic, and compare them with those in their practice prior to the conference. STUDY DESIGN: Questionnaires were mailed to 612 American College of Obstetricians and Gynecologists fellows who participated in a 2006 preconference survey, with 59% responding. The survey assessed demographic characteristics, practice, attitudes, knowledge regarding potential risks and benefits, counseling practices, and department policies with regards to CDMR. RESULTS: The majority of obstetrician-gynecologists in our sample continues to believe that a woman has the right to CDMR, but fewer than in 2006 would agree to perform this procedure. In general, obstetrician-gynecologists associate more risks and fewer benefits with CDMR than in 2006. CONCLUSION: Some physicians have shifted their perception of CDMR risks and benefits since the NIH State-of-the-Science conference; however, practice patterns have not changed significantly.


Assuntos
Cesárea/tendências , Obstetrícia/tendências , Participação do Paciente/tendências , Cesárea/efeitos adversos , Cesárea/estatística & dados numéricos , Competência Clínica , Congressos como Assunto , Feminino , Pesquisas sobre Atenção à Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Relações Médico-Paciente , Padrões de Prática Médica , Gravidez , Medição de Risco
10.
Bipolar Disord ; 11(2): 178-89, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19267700

RESUMO

OBJECTIVES: Neuropsychological studies in subjects with bipolar disorder (BD) have reported deficits on a variety of cognitive measures. However, because the majority of subjects were medicated at the time of testing in previous studies, it is currently unclear whether the pattern of deficits reported is related to BD itself or to psychotropic medication. We addressed this issue by examining cognitive performance in a group of unmedicated, currently depressed subjects with BD. METHODS: Forty-nine unmedicated subjects who met DSM-IV criteria for BD, depressed phase, and 55 control subjects participated in this study. Most patients were diagnosed with bipolar II disorder. Performance on emotion-dependent, or 'hot', and emotion-independent, or 'cold', cognitive tasks was assessed using tests from the Cambridge Neuropsychological Test Automated Battery. RESULTS: The groups were well matched with respect to general intelligence and demographic variables. Deficits in the unmedicated depressed BD group were apparent on tests tapping 'hot' cognitive processing, for example the Cambridge Gamble task and the Probabilistic Reversal Learning task. However, other than a deficit on the Spatial Span test in the depressed BD subjects, the groups performed equivalently on most measures of 'cold' cognitive processing, for example visual memory, attention, and working memory. CONCLUSIONS: These data suggest that deficits on tests involving reward processing, short-term spatial memory storage, and sensitivity to negative feedback in depressed BD subjects represent an effect of the illness itself and not mood-stabilizing medication.


Assuntos
Transtorno Bipolar/complicações , Transtornos Cognitivos/etiologia , Transtornos Cognitivos/psicologia , Emoções , Adulto , Análise de Variância , Atenção/fisiologia , Estudos de Casos e Controles , Comportamento de Escolha/fisiologia , Processamento Eletrônico de Dados , Feminino , Humanos , Masculino , Memória/fisiologia , Testes Neuropsicológicos , Resolução de Problemas/fisiologia , Processos Psicoterapêuticos , Reversão de Aprendizagem/fisiologia
11.
Bipolar Disord ; 10(7): 806-15, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19032712

RESUMO

OBJECTIVE: Neuropsychological studies of bipolar disorder reveal deficits in a variety of domains, including affective processing, memory, and sustained attention. These findings are difficult to interpret due to the potential confounding effects of mood-stabilizing medications. The present study aims to compare the cognitive performance of medicated and unmedicated subjects with bipolar depression to healthy control subjects. METHOD: Unmedicated subjects with bipolar depression (UBD, n = 32), subjects with bipolar depression on therapeutic doses of lithium or valproic acid (MBD, n = 33), and healthy control subjects (HC, n = 52) performed neuropsychological tasks measuring affective processing, visual memory, and sustained attention. Performance measures were covaried with age and mood ratings, where applicable. RESULTS: With regard to affective processing, the MBD group exhibited greater response latency than the UBD and HC groups. For the same task, the MBD group made more omission errors during the happy condition than in the sad condition. On a task of sustained attention, the MBD group made more errors than the HC group. There were no significant group differences on measures of visual memory. CONCLUSIONS: Deficits in affective processing were found in the medicated group, while unmedicated subjects appear to be unaffected. In particular, the MBD group made more errors during happy conditions, indicating a potential attentional bias in subjects with bipolar depression on mood-stabilizing medications. The present study also implicates impairment in sustained attention for medicated subjects with bipolar disorder, particularly those with the type II variety.


Assuntos
Antimaníacos/uso terapêutico , Transtorno Bipolar/tratamento farmacológico , Transtorno Bipolar/fisiopatologia , Cognição/efeitos dos fármacos , Cloreto de Lítio/uso terapêutico , Ácido Valproico/uso terapêutico , Adulto , Afeto/efeitos dos fármacos , Análise de Variância , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Adulto Jovem
12.
Cornea ; 37(5): 596-601, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29384810

RESUMO

PURPOSE: The effects of repeated intravitreal aflibercept injection (IAI) on the corneal endothelium were studied in patients with unilateral neovascular age-related macular degeneration. METHODS: RE-VIEW was a phase 4, open-label, single-arm, multicenter study. Patients received IAI every 8 weeks after 3 monthly doses. Slit-lamp biomicroscopy was performed at all study visits. The central corneal endothelial health was evaluated by specular microscopy in the treated versus untreated fellow eyes at baseline and weeks 24 and 52. RESULTS: No slit-lamp abnormalities were noted in 154 enrolled patients (eyes). Baseline versus 52-week mean (±SD) endothelial morphometric values (n = 118) for the treated versus untreated fellow eyes were respectively as follows: endothelial cell density was 2410 ± 364 versus 2388 ± 384 cells/mm at baseline and remained unchanged at 2401 ± 353 versus 2376 ± 364 cells/mm at 52 weeks (P = 0.87); the coefficient of variation was 33.5 ± 4.4% versus 34.0 ± 5.0% at baseline and remained unchanged at 34.2 ± 4.7% versus 34.1 ± 4.9% at 52 weeks (P = 0.18); the percentage of hexagonal cells was 59.5 ± 5.8% versus 59.6 ± 6.4% at baseline and remained unchanged at 59.5 ± 6.0% versus 59.5 ± 5.8% at 52 weeks (P = 0.96). CONCLUSIONS: Repeated IAI for 52 weeks had no apparent corneal endothelial toxicity noted on specular microscopy in patients treated for neovascular age-related macular degeneration.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Endotélio Corneano/efeitos dos fármacos , Degeneração Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Idoso , Inibidores da Angiogênese/efeitos adversos , Contagem de Células , Endotélio Corneano/citologia , Feminino , Humanos , Injeções Intravítreas , Masculino , Proteínas Recombinantes de Fusão/efeitos adversos , Acuidade Visual
13.
Biol Psychiatry ; 62(8): 917-24, 2007 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-17825802

RESUMO

BACKGROUND: Studies have demonstrated neuropsychological deficits across a variety of cognitive domains in depression. Few studies have directly compared depressed subjects with major depressive disorder (MDD) and bipolar disorder (BD), and many are confounded by medication status across subjects. In this study, we compared the performance of unmedicated currently depressed MDD and BD groups on a battery of neuropsychological tests that included measures of risk taking and reflection impulsivity. METHODS: Twenty-two MDD, seventeen BDII, and 25 healthy control subjects (HC), matched for age and IQ, were assessed on a battery of neuropsychological tests. RESULTS: The depressed groups showed comparable ratings of depression severity and age of illness onset. The MDD group was impaired on tests of spatial working memory and attentional shifting, sampled less information on a test of reflection impulsivity, and was oversensitive to loss trials on a decision-making test. The BDII subjects were generally intact and did not differ significantly from control subjects on any test. CONCLUSIONS: These data indicate differing profiles of cognitive impairment in unmedicated depressed MDD versus BDII subjects. Moderately depressed BDII subjects displayed relatively intact cognitive function, whereas MDD subjects demonstrated a broader range of executive impairments. These cognitive deficits in depression were not attributable to current medication status.


Assuntos
Transtorno Bipolar/complicações , Transtornos Cognitivos/diagnóstico , Transtorno Depressivo/complicações , Discriminação Psicológica/fisiologia , Transtornos da Memória/diagnóstico , Adulto , Análise de Variância , Atenção/fisiologia , Transtorno Bipolar/psicologia , Estudos de Casos e Controles , Transtornos Cognitivos/complicações , Transtorno Depressivo/psicologia , Feminino , Humanos , Masculino , Análise por Pareamento , Memória/fisiologia , Transtornos da Memória/complicações , Valores de Referência , Enquadramento Psicológico , Índice de Gravidade de Doença , Comportamento Espacial/fisiologia , Estatísticas não Paramétricas
14.
Int J Pediatr Otorhinolaryngol ; 71(2): 217-30, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17097746

RESUMO

UNLABELLED: SUMMARY/OBJECTIVES: In accordance with the Joint Committee on Infant Hearing's (JCIH, 2000) position statement regarding Universal Newborn Hearing Screenings (UNHS), the state of Illinois enacted legislation requiring all birthing hospitals to conduct UNHS by 31 December 2002. Currently 100% of birthing facilities in the state of Illinois perform newborn infant hearing screenings using otoacoustic emissions (OAEs) and/or automated auditory brainstem response (AABR) measures. This study is an attempt to document current practices in hospital-based UNHS programs, as reported by program personnel, in the state of Illinois. The goal is to compare these reported practices to the recommended standards and identify factors that could lead to further refinement of the process. METHODS: A modified version of the Newborn Hearing Screening Survey from the Marion Downs National Center for Infant Hearing was used to gather practice- and protocol-related data for the 2004 calendar year via the World Wide Web. Data presented here are extracted from the online survey as reported by hospital staff presumably associated with the UNHS program. RESULTS: Fifty-nine of the 140 hospitals with UNHS programs responded to the Web-based survey. Nursing staff, followed by technicians, were most commonly reported to perform initial hearing screenings in both the well-baby nursery (WBN) and the neonatal intensive care unit (NICU). Audiologists appeared to participate in re-screenings at a greater number of the facilities. Automated ABR was the most common screening tool (80%) followed by Distortion Product OAEs (32%) and Transient Evoked OAEs (5%). Eighty-six percent reported referral rates that were less than 5%, with 32% reporting a referral rate less than 1%. CONCLUSIONS: At the beginning of 2004, 99% of all infants born in Illinois were being screened for hearing loss. Personnel involvement and screening measures employed were comparable to the few reports available from other states. The audiologist's role was found to be fairly limited in screening, re-screening, or managing UNHS programs. Referral rates were consistent with national standards ( approximately 1%). Management of UNHS programs in small, rural facilities, tracking/monitoring high-risk infants, and other services provided to families emerged as areas with room for improvement.


Assuntos
Perda Auditiva/diagnóstico , Testes Auditivos , Triagem Neonatal/normas , Coleta de Dados , Hospitais , Humanos , Illinois , Recém-Nascido
15.
Otol Neurotol ; 38(8): 1205-1212, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28692592

RESUMO

HYPOTHESIS: Internal jugular vein (IJV) compression influences not only intracranial but also intracochlear physiology and has demonstrated preclinical effectiveness in reducing acute audiological injury in a rodent blast model. However, the long-term effects in this model are unknown. BACKGROUND: Blast wave-induced audiological injury from an improvised explosive device is a leading cause of morbidity among service members in theater but there are limitations to the current protective measures. METHODS: For this study, we exposed 20 Sprague Dawley rats to a 16.8 ±â€Š0.3 PSI (195.3 dB SPL) right-sided shock wave in which 10 had application of a custom IJV compression collar in place at the time of injury. RESULTS: IJV compression at the time of injury was shown acutely to significantly reduce the incidence of tympanic membrane rupture and the initial temporary threshold shift on otoacoustic emissions in both the right and left ears of animals who had collar application immediately after and 7 days post injury. At 28 days from injury, collared animals demonstrated a return to baseline of otoacoustic emission values while the noncollared animals had persistent threshold shifts, signifying the presence of a permanent threshold shift only in those animals without collar application. IJV compression was also found to significantly reduce hair cell loss at the base of the cochlea secondary to mechanical trauma from the blast wind. CONCLUSION: Previously observed acute protective effects of IJV compression are sustained at chronic time points. IJV compression can potentially be used to reduce long-term permanent morbidity from blast-induced audiological trauma.


Assuntos
Traumatismos por Explosões/complicações , Transtornos da Audição/etiologia , Transtornos da Audição/prevenção & controle , Veias Jugulares/lesões , Emissões Otoacústicas Espontâneas/fisiologia , Animais , Cóclea/efeitos dos fármacos , Modelos Animais de Doenças , Células Ciliadas Auditivas , Veias Jugulares/fisiopatologia , Masculino , Pressão , Ratos , Ratos Sprague-Dawley , Roedores , Fatores de Tempo , Membrana Timpânica/patologia , Perfuração da Membrana Timpânica
16.
Ophthalmol Retina ; 1(4): 304-313, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-31047516

RESUMO

PURPOSE: To assess the long-term safety and vision change in patients who received intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration in an extension study after completing VIEW 1 trial. DESIGN: Prospective, open-label, multicenter, extension study. PARTICIPANTS: Three hundred twenty-three patients. METHODS: In VIEW 1, 1217 patients were randomized to receive fixed dosing of 0.5 mg IAI every 4 weeks (0.5q4), 2 mg IAI every 4 weeks (2q4), 2 mg IAI every 8 weeks after 3 initial monthly dosing (2q8), or 0.5 mg ranibizumab every 4 weeks (Rq4) from baseline through week 52, followed by modified quarterly injections of the same dose of anti-vascular endothelial growth factor agent from weeks 52 to 96. After completing VIEW 1 at week 96, patients (n = 323) enrolled in an extension study and received 2 mg IAI on a modified quarterly injection schedule followed by at least an every 8-week dosing through week 212. MAIN OUTCOME MEASURES: Long-term safety and vision change in patients followed for a median duration of 116 weeks in the extension study (total follow-up time of 212 weeks from the VIEW 1 baseline). RESULTS: Patients enrolled in the extension study gained a mean of 10.2 letters from the VIEW 1 baseline at week 96. These patients largely maintained vision over the extension study with a mean gain of 7.1 letters from the VIEW 1 baseline to week 212. The proportion of patients who lost ≥15 letters from the VIEW 1 extension baseline was 8.2% at week 212. Mean number of injections was 12.9 (range, 1-41) in the extension study. The most common serious ocular adverse event was endophthalmitis (0.9%). The overall incidence of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events was 6.2%. CONCLUSIONS: Vision gains achieved with anti-vascular endothelial growth factor therapy in VIEW 1 were largely maintained by continued treatment with IAI 2 mg in the extension study. Anti-vascular endothelial growth factor injections (including 4 years of IAI 2 mg) were well-tolerated with no new safety signals compared with the known profile of IAI.

17.
Otol Neurotol ; 38(4): 591-598, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28079681

RESUMO

HYPOTHESIS: Internal jugular vein (IJV) compression before blast injury will lead to reduced risk of traumatic hearing injury following exposure to a blast injury. BACKGROUND: IJV compression and its effects on not only intracranial, but also intracochlear pressure may potentiate blast induced hearing injury, therefore, precluding its use as a prophylactic therapy for blast induced traumatic brain injury. METHODS: Twenty Sprague Dawley rats were exposed to a 17.9 ±â€Š0.4 PSI (195.8 dB SPL) right sided shock wave in which 10 had application of a custom IJV compression collar before injury. All rodents received baseline and post blast injury otoacoustic emission (OAE) and auditory brainstem response (ABR) testing followed by cochlear histology. RESULTS: IJV compression was shown to significantly reduce ABR and OAE threshold shifts in comparison to the non-intervention group by: 14.9 ±â€Š4.8 dB (right ear ABR 0.5 kHz Day 1 post blast, p = 0.01), 13.1 ±â€Š4.9 dB (right ear ABR 4 kHz Day 1 post blast, p = 0.04), 16.5 ±â€Š4.5 dB (right ear ABR click Day 1 post blast, p = 0.003), 12.1 ±â€Š4.6 dB (right ear ABR click Day 6 post blast, p = 0.04), and 14.0 ±â€Š3.2 dB (both ears OAE 3.2-10 kHz, p < 0.0001). Also, those animals with collar application had a greater number of total hair cells per mm from 70 to 100% distance from the cochlear apex following blast injury in comparison to those without intervention (blast: 211.8 ±â€Š27.5 versus blast+collar: 355.5 ±â€Š39.5 [p = 0.0002]). CONCLUSION: This study supports the use of IJV compression in a pre-clinical model as a new prophylactic mechanism to combat blast induced hearing injury.


Assuntos
Traumatismos por Explosões/complicações , Potenciais Evocados Auditivos do Tronco Encefálico/fisiologia , Perda Auditiva Provocada por Ruído/etiologia , Veias Jugulares , Emissões Otoacústicas Espontâneas/fisiologia , Animais , Cóclea/patologia , Modelos Animais de Doenças , Perda Auditiva Provocada por Ruído/fisiopatologia , Masculino , Ratos , Ratos Sprague-Dawley
18.
J Affect Disord ; 95(1-3): 165-71, 2006 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16793143

RESUMO

BACKGROUND: Neuropsychological studies have provided evidence for deficits in psychiatric disorders, such as schizophrenia and mood disorders. However, neuropsychological function in Panic Disorder (PD) or PD with a comorbid diagnosis of Major Depressive Disorder (MDD) has not been comprehensively studied. The present study investigated neuropsychological functioning in patients with PD and PD + MDD by focusing on tasks that assess attention, psychomotor speed, executive function, decision-making, and affective processing. METHODS: Twenty-two unmedicated patients with PD, eleven of whom had a secondary diagnosis of MDD, were compared to twenty-two healthy controls, matched for gender, age, and intelligence on tasks of attention, memory, psychomotor speed, executive function, decision-making, and affective processing from the Cambridge Neuropsychological Test Automated Battery (CANTAB), Cambridge Gamble Task, and Affective Go/No-go Task. RESULTS: Relative to matched healthy controls, patients with PD + MDD displayed an attentional bias toward negatively-valenced verbal stimuli (Affective Go/No-go Task) and longer decision-making latencies (Cambridge Gamble Task). Furthermore, the PD + MDD group committed more errors on a task of memory and visual discrimination compared to their controls. In contrast, no group differences were found for PD patients relative to matched control subjects. LIMITATIONS: The sample size was limited, however, all patients were drug-free at the time of testing. CONCLUSIONS: The PD + MDD patients demonstrated deficits on a task involving visual discrimination and working memory, and an attentional bias towards negatively-valenced stimuli. In addition, patients with comorbid depression provided qualitatively different responses in the areas of affective and decision-making processes.


Assuntos
Tomada de Decisões , Transtorno Depressivo Maior/psicologia , Transtorno de Pânico/psicologia , Psicofisiologia , Adulto , Transtornos Cognitivos/complicações , Transtorno Depressivo Maior/complicações , Feminino , Humanos , Masculino , Testes Neuropsicológicos , Transtorno de Pânico/complicações
19.
Surg J (N Y) ; 2(4): e119-e125, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28825004

RESUMO

Objective To assess the frequency of surgical techniques at cesarean delivery (CD) among U.S. obstetricians. Methods Members of the American College of Obstetrician Gynecologists were randomly selected and e-mailed an online survey that assessed surgical closure techniques, demographics, and reasons. Data were analyzed using SPSS (IBM Corp., Armonk, New York, United States), descriptive statistics, and analysis of variance. Results Our response rate was 53%, and 247 surveys were analyzed. A similar number of respondents either "always or usually" versus "rarely or never" reapproximate the rectus muscles (38.4% versus 43.3%, p = 0.39), and close parietal peritoneum (42.5% versus 46.9%, p = 0.46). The most frequently used techniques were double-layer hysterotomy closure among women planning future children (73.3%) and suturing versus stapling skin (67.6%); the least frequent technique was closure of visceral peritoneum (12.2%). Surgeons who perform double-layer hysterotomy closure had fewer years in practice (15.0 versus 18.7 years, p = 0.021); surgeons who close visceral peritoneum were older (55.5 versus 46.4 years old, p < 0.001) and had more years in practice (23.8 versus 13.8 years practice; p < 0.001). Conclusion Similar numbers of obstetricians either reapproximate or leave open the rectus muscles and parietal peritoneum at CD, suggesting that wide variation in practice exists. Surgeon demographics and safety concerns play a role in some techniques.

20.
Am J Psychiatry ; 162(11): 2171-3, 2005 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-16263859

RESUMO

OBJECTIVE: Neuropsychological studies of major depressive disorder have described attentional biases for affectively laden stimuli, but these reports were based on measures obtained from medicated subjects. This study investigated performance of unmedicated depressed patients on the Affective Go/No-Go Task. METHOD: Twenty depressed patients and 20 healthy comparison subjects, matched for age, gender, and IQ, performed the Affective Go/No-Go Task as well as tests of attention and memory for nonaffective stimuli. RESULTS: Depressed patients did not differ from healthy subjects on memory task performance, but they made more omission errors on the attention task. On the Affective Go/No-Go Task, depressed patients made more omission errors during happy than sad word blocks and required more time to respond to happy than to sad words. In contrast, healthy subjects required more time to respond to sad than to happy words. CONCLUSIONS: Unmedicated depressed patients do not show a pattern of generalized cognitive impairment but, rather, specifically display an attentional deficit and a mood-congruent bias toward salient stimuli.


Assuntos
Afeto , Transtornos Cognitivos/diagnóstico , Transtorno Depressivo Maior/diagnóstico , Testes Neuropsicológicos/estatística & dados numéricos , Desempenho Psicomotor , Comportamento Verbal , Adulto , Atenção , Transtornos Cognitivos/psicologia , Transtorno Depressivo Maior/psicologia , Feminino , Humanos , Masculino , Transtornos da Memória/diagnóstico , Transtornos da Memória/psicologia , Reconhecimento Visual de Modelos , Tempo de Reação , Semântica , Índice de Gravidade de Doença
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