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1.
Cancers (Basel) ; 16(5)2024 Feb 22.
Artigo em Inglês | MEDLINE | ID: mdl-38473239

RESUMO

Increasing efforts are focusing on natural killer (NK) cell immunotherapies for AML. Here, we characterized CC-96191, a novel CD33/CD16a/NKG2D immune-modulating TriNKET®. CC-96191 simultaneously binds CD33, NKG2D, and CD16a, with NKG2D and CD16a co-engagement increasing the avidity for, and activation of, NK cells. CC-96191 was broadly active against human leukemia cells in a strictly CD33-dependent manner, with maximal efficacy requiring the co-engagement of CD16a and NKG2D. A frequent CD33 single nucleotide polymorphism, R69G, reduced CC-96191 potency but not maximal activity, likely because of reduced CD33 binding. Similarly, the potency, but not the maximal activity, of CC-96191 was reduced by high concentrations of soluble CD33; in contrast, the soluble form of the NKG2D ligand MICA did not impact activity. In the presence of CD33+ AML cells, CC-96191 activated NK cells but not T cells; while maximum anti-AML efficacy was similar, soluble cytokine levels were 10- to >100-fold lower than with a CD33/CD3 bispecific antibody. While CC-96191-mediated cytolysis was not affected by ABC transporter proteins, it was reduced by anti-apoptotic BCL-2 family proteins. Finally, in patient marrow specimens, CC-96191 eliminated AML cells but not normal monocytes, suggesting selectivity of TriNKET-induced cytotoxicity toward neoplastic cells. Together, these findings support the clinical exploration of CC-96191 as in NCT04789655.

2.
J Community Health ; 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38466490

RESUMO

Children from diverse ethnic groups are at significantly increased risk for dental caries. In particular, American Indian (AI) children have the highest incidence of detal caries of any ethnic group. The COVID-19 pandemic dramatically restricted health care access, including preventive oral health care. Given this context, it is unclear whether or not preventive oral health care for AI children has resumed since lockdown. To address this question, we surveyed adult AI caregivers (N = 152) of children aged 0-5 years, assessing recent (12-month) and pre-COVID (for caregivers of children aged 3-5 years) preventive oral and medical health services. We also examined medical health care access and utilization among caregivers. Among children aged 3-5 years old, both pre-pandemic and past year medical care utilization were generally high (80 and 90%, respectively) as was any oral health care utilization (64 & 78%, respectively). Oral health check-ups were more common over the last year (62%) compared to pre-COVID (44%). Recent health care utilization among children 1-5 years old in this sample were generally comparable to national estimates, except for higher reported preventive medical care (99% vs. 87.6%, respectively) and higher preventive oral care (96% vs. 59.6%, respectively). More caregivers reported delaying or foregoing needed health care due to COVID (28-38%) versus due to cost (8-17%). In this survey of AI caregivers, recent child preventive health care utilization was high, and changes in utilization following the lockdown phases of the pandemic were comparable for oral and medical health care.

3.
Am J Perinatol ; 2023 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-37286183

RESUMO

OBJECTIVE: This article describes the experience in the planning and development of a special delivery unit (SDU) at our free-standing children's hospital in Austin, Texas. STUDY DESIGN: Description of various aspects of the development of the SDU. In addition, telephone surveys were obtained from five other institutions regarding the planning and current status of their SDUs. RESULTS: Since the advent of the SDU at Children's Hospital of Philadelphia in 2008, several free-standing children's hospitals have opened similar units at their institutions. Developing an obstetrical unit in a children's hospital can be a daunting task on many fronts. The costs of providing 24-hour obstetrical, nursing, and anesthesiology coverage must be considered. Although most SDUs are associated with a fetal center and fetal surgery/interventions, some units function exclusively for the delivery of pregnancies complicated by major fetal conditions where the neonate will require immediate surgical care or other interventions. CONCLUSION: Research on the cost-effectiveness and the effect of SDUs on clinical outcome, teaching, and patient satisfaction is warranted. KEY POINTS: · Specialized delivery units are becoming more common at free-standing children's hospitals.. · The primary aim of the SDU is to maintain mother-baby continuity in cases of congenital anomalies.. · Developing an obstetrical unit at a pediatric hospital is a daunting task..

4.
J Public Health Dent ; 82 Suppl 1: 79-82, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35726469

RESUMO

American Indian and Alaska Native (AI/AN) communities have experienced a history of systemic racism and still face significant oral health disparities. These disparities extend to the youngest community members in the form of early childhood caries (ECC). Although behavior and biology contribute to ECC, the conditions where people live, grow, and work, and the systems and political and economic forces that shape individual health outcomes, are thought to greatly impact ECC among AI/AN populations. To address ECC in AI/AN communities, we used a community based participatory approach that incorporated social determinants of health. We found that implementing culturally-tailored, culturally-centered, and AI/AN-created materials for ECC interventions is viewed favorably by community members and tribal leaders. Because of the complexity of ECC in AI/AN communities we adopted a bundled approach of best practices to reduce ECC including: (1) incorporating locally, contextually, and culturally relevant strategies to present recommended ECC prevention approaches; (2) employing AI/AN community members as educators; (3) utilizing motivational interviewing with expectant mothers; and (4) providing fluoride varnish. Our work underscores the importance of developing trusting partnerships with each other and with our communities, drawing upon the insights of community advisory board members, and eliciting formative assessment data from tribal members to gain a more holistic understanding of our participants' lived experience to design relevant intervention materials. Incorporating local knowledge and situating Western oral health prevention approaches within culturally aligned frameworks can enhance partnerships and create sustainable materials for community work.


Assuntos
Cárie Dentária , Indígenas Norte-Americanos , Pré-Escolar , Pesquisa Participativa Baseada na Comunidade , Cárie Dentária/prevenção & controle , Desigualdades de Saúde , Humanos
5.
Subst Use Misuse ; 55(9): 1552-1559, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32569544

RESUMO

Background: Areca nut (AN) and betel quid (BQ) are classified as Group 1 carcinogens. There are approximately 600 million AN/BQ users globally; the majority of users live in the Asia-Pacific region which, correspondingly, has the highest rates of oral cancer. Despite significant disease burden associated with AN/BQ use, there have been no systematic reviews of interventions to reduce product use. Objectives: To analyze interventions that prevent use of AN/BQ, present a basis for a future systematic review on the topic, and provide decision makers with examples of strategies that have demonstrated reduced AN/BQ use. Methods: To identify publications, we searched the literature using terms for AN/BQ and related synonyms in three databases: PubMed, Embase, and Scopus. Interventions that prevent AN/BQ use, that are published in English and that provide original data analysis, were included in this review. Interventions focused primarily on disease outcomes e.g. oral cancers (secondary prevention) were excluded. Results: Our search revealed 21 interventions targeting AN/BQ use between 1990 and 2018. Strategies include product bans, media campaigns, education, cessation, and taxation at individual and population levels, with varying evidence of impact. While these studies yielded some novel and promising findings, particularly regarding the impact of product bans, mass media campaigns, and cessation interventions, research on interventions specific to AN/BQ use remains limited. Conclusions: We have assessed published interventions that reduce AN/BQ use and identified future research priorities. These findings can be used to develop evidence-based interventions and help guide policymakers in implementing evidence-based policy to regulate these products.


Assuntos
Epidemias , Neoplasias Bucais , Areca/efeitos adversos , Ásia , Humanos , Neoplasias Bucais/epidemiologia , Neoplasias Bucais/prevenção & controle , Nozes
6.
Can Urol Assoc J ; 14(9): E432-E434, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32223878

RESUMO

INTRODUCTION: Practitioners have anecdotally hinted at a possible association between gastroesophageal reflux disease (GERD) and vesicoureteral reflux (VUR). We sought to identify an association in diagnosis between GERD and VUR using a population-based dataset in a well-defined geographic area covered by a single-payer healthcare system. METHODS: A retrospective review of individuals aged 0-16 years registered in the Nova Scotia Medical Service Insurance database from January 1997 to December 2012 was completed. Presence of GERD and VUR were ascertained based on billing codes. The baseline prevalence of GERD and VUR was calculated for this population for the same time period. Proportions of VUR patients with and without GERD were compared. The risk of being diagnosed with VUR in patients with GERD controlling for sex was calculated. RESULTS: Of 404 300 patients identified, 6.6% had a diagnosis of GERD (n=27 092), 0.33% had a diagnosis of VUR (n=1348), and 0.08% were diagnosed with both (n=327). Among patients with VUR, the prevalence of GERD was 24.3% compared to 6.6% in patients without VUR (p<0.0001). Among patients with GERD, the prevalence of VUR was 1.2% compared to 0.27% in patients without (p<0.0001). The risk of being diagnosed with VUR was higher in the presence of GERD (odds ratio [OR] 4.49; 95% confidence interval [CI] 3.96-5.09; p<0.0001), irrespective of sex. CONCLUSIONS: The odds of being diagnosed with VUR is more than 4.5 times higher in an individual with GERD. The clinical significance of this association remains to be explored.

7.
Can J Surg ; 62(6): 475-481, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31782645

RESUMO

Background: Venous thromboembolism (VTE) is a common and serious complication seen in patients with trauma. Guidelines recommend the routine use of pharmacologic prophylaxis; however, compliance rates vary widely. The aim of this study was to describe the clinical practice related to VTE prophylaxis in the first 24 hours after injury at our level 1 Canadian trauma centre and the impact of a thrombosis consultation service. Methods: We performed a retrospective review of the health records of adult patients with trauma admitted between Jan. 1, 2012, and June 30, 2013. The rate of VTE was ascertained. The use of an initial prophylactic regimen, potential contraindications to prophylaxis and involvement of the thrombosis service were determined. Results: A total of 633 patients were included, 459 men and 174 women with a mean age of 47.4 years. The mean Injury Severity Score was 15.8. The overall VTE rate was 2.8%. A total of 514 patients (81.2%) received VTE prophylaxis, mechanical in 302 (47.7%) and pharmacologic in 231 (36.5%) (19 patients received both types). The thrombosis service was involved in the care of 164 patients (25.9%). Patients seen by the thrombosis service were more likely to receive VTE prophylaxis than those not seen by the service (145 [88.4%] v. 369 [78.7%], p < 0.01). Conclusion: Compliance with VTE prophylaxis administration was suboptimal, and opportunities for improvement exist. The involvement of a thrombosis consultation service appears to improve compliance with VTE prophylaxis, and augmented use of this service may improve clinical outcomes.


Contexte: La thromboembolie veineuse (TEV) est une complication grave et fréquente chez les patients vus en traumatologie. Les lignes directrices recommandent l'utilisation systématique d'une prophylaxie pharmacologique; par contre, les taux de conformité aux lignes directrices varient beaucoup. Le but de cette étude était de décrire la pratique clinique en matière de thromboprophylaxie dans notre centre de traumatologie canadien de niveau 1 au cours des 24 premières heures suivant un traumatisme et l'impact d'un service de prévention des thromboses. Méthodes: Nous avons procédé à une revue rétrospective des dossiers médicaux de patients adultes hospitalisés en traumatologie entre le 1er janvier 2012 et le 30 juin 2013. Le taux de TEV a été mesuré et nous avons vérifié si un schéma prophylactique initial avait été utilisé, s'il y avait des contre-indications potentielles à la prophylaxie et si le service de prévention des thromboses avait été mis à contribution. Résultats: En tout, 633 patients ont été inclus, 459 hommes et 174 femmes âgés en moyenne de 47,4 ans. L'indice moyen de gravité de la blessure (IGB) était de 15,8. Le taux global de TEV a été de 2,8 %. En tout 514 patients (81,2 %) ont reçu une thromboprophylaxie (mécanique chez 302 [47,7 %] et pharmacologique chez 231 [36,5 %]; 19 patients ont reçu les 2 types de prophylaxie). Le service de prévention des thromboses a été impliqué dans 164 dossiers (25,9 %). Les patients vus par le service de prévention des thromboses étaient plus susceptibles que les autres patients de recevoir une thromboprophylaxie (145 [88,4 %] c. 369 [78,7 %], p < 0,01). Conclusion: La conformité aux lignes directrices sur la thromboprophylaxie a été sous-optimale, et il est possible de l'améliorer. L'implication d'un service de prévention des thromboses semble améliorer la conformité aux lignes directrices sur la thromboprophylaxie et y faire appel plus souvent pourrait améliorer les résultats cliniques.


Assuntos
Padrões de Prática Médica , Encaminhamento e Consulta , Centros de Traumatologia , Tromboembolia Venosa/prevenção & controle , Ferimentos e Lesões/complicações , Adulto , Canadá , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiologia , Ferimentos e Lesões/terapia
8.
J Relig Health ; 58(6): 2086-2094, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31650380

RESUMO

Hospital chaplains often visit critically ill patients, but neurosciences critical care unit (NCCU) staff beliefs surrounding chaplains have not been characterized. In this study, we used Qualtrics® to survey 70 NCCU healthcare workers about their attitudes toward chaplains in the NCCU. Chaplains were seen positively by staff but were less likely to be viewed as part of the care team by staff with more than five years of NCCU experience. The results of this study will allow chaplaincy programs to target staff education efforts in order to enhance the care provided to patients in critical care settings.


Assuntos
Atitude do Pessoal de Saúde , Serviço Religioso no Hospital , Neurociências , Assistência Religiosa , Clero , Cuidados Críticos , Humanos , Unidades de Terapia Intensiva
11.
J Med Syst ; 42(11): 214, 2018 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-30269237

RESUMO

Electronic health records (EHRs) have emerged among health information technology as "meaningful use" to improve the quality and efficiency of healthcare, and health disparities in population health. In other instances, they have also shown lack of interoperability, functionality and many medical errors. With proper implementation and training, are electronic health records a viable source in managing population health? The primary objective of this systematic review is to assess the relationship of electronic health records' use on population health through the identification and analysis of facilitators and barriers to its adoption for this purpose. Authors searched Cumulative Index of Nursing and Allied Health Literature (CINAHL) and MEDLINE (PubMed), 10/02/2012-10/02/2017, core clinical/academic journals, MEDLINE full text, English only, human species and evaluated the articles that were germane to our research objective. Each article was analyzed by multiple reviewers. Group members recognized common facilitators and barriers associated with EHRs effect on population health. A final list of articles was selected by the group after three consensus meetings (n = 55). Among a total of 26 factors identified, 63% (147/232) of those were facilitators and 37% (85/232) barriers. About 70% of the facilitators consisted of productivity/efficiency in EHRs occurring 33 times, increased quality and data management each occurring 19 times, surveillance occurring 17 times, and preventative care occurring 15 times. About 70% of the barriers consisted of missing data occurring 24 times, no standards (interoperability) occurring 13 times, productivity loss occurring 12 times, and technology too complex occurring 10 times. The analysis identified more facilitators than barriers to the use of the EHR to support public health. Wider adoption of the EHR and more comprehensive standards for interoperability will only enhance the ability for the EHR to support this important area of surveillance and disease prevention. This review identifies more facilitators than barriers to using the EHR to support public health, which implies a certain level of usability and acceptance to use the EHR in this manner. The public-health industry should combine their efforts with the interoperability projects to make the EHR both fully adopted and fully interoperable. This will greatly increase the availability, accuracy, and comprehensiveness of data across the country, which will enhance benchmarking and disease surveillance/prevention capabilities.


Assuntos
Registros Eletrônicos de Saúde , Saúde da População , Humanos , Uso Significativo
12.
J Pediatr Surg ; 53(5): 942-945, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29526351

RESUMO

PURPOSE: The "cut and push" technique for removal of percutaneous endoscopic gastrostomy (PEG) tubes with collapsible bumpers offers an alternative to the standard traction method of removal. This study compared the outcomes of these techniques. METHODS: We completed a research ethics board-approved retrospective cohort study, identifying all patients less than 18years of age who underwent PEG tube removal at a children's hospital between December 2013 and December 2016. Outcomes included need for sedation and complications. RESULTS: We identified 127 children who had PEG tubes removed. Significantly fewer children required sedation with the cut and push group (1.1% vs. 60.6%, p≤0.001). Ten complications occurred, including 9 in the cut and push group (9.6% vs. 3%, p=0.23). Mean age at time of complication was significantly younger in the cut and push group (2.2 vs. 6.3years p=0.004). CONCLUSION: This is the largest reported series comparing the cut and push vs. traction removal methods. The cut and push technique significantly reduced the need for procedural sedation but was associated with increased risk of complications. While these data suggest that the technique is safe in older children, caution should be taken in younger children who appear to be more likely to vomit the residual bumper. LEVELS OF EVIDENCE: Level III-Treatment study, Retrospective comparative study.


Assuntos
Remoção de Dispositivo/métodos , Endoscopia Gastrointestinal/métodos , Nutrição Enteral/instrumentação , Gastrostomia/métodos , Intubação Gastrointestinal/instrumentação , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Estudos Retrospectivos
14.
Vet J ; 225: 16-22, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28720293

RESUMO

Prompt diagnosis and treatment of claw horn lesions in cattle affects the likelihood of recovery; however, it is unknown if the type of lesion influences the likelihood of recovery. The aim of this study was to investigate whether the type, severity and frequency of claw horn lesions in newly lame cows (lame for no more than 2 weeks) at the time of corrective foot trimming affects the probability of recovery from lameness after treatment. The images of 112 feet (224 claws) from newly lame cows (n=112; lame in only one hind foot), which were treated with a standardised therapeutic hoof trim only, were used to score claw horn lesions (sole ulcer, sole haemorrhage, white line haemorrhage or white line separation). Most cows (n=107/112; 95.5%) were classified as mildly lame at the time of treatment. The proportion of cows that recovered 2 weeks after therapeutic hoof trimming was 88/112 (78.6%). Results of a multilevel logistic regression model indicated that severely lame cows were less likely to recover than those that were mildly lame (odds ratio, OR, 0.16; P=0.04). White line haemorrhage had a significant negative impact on the likelihood of recovery from lameness (OR 0.14; P>0.01); however, recovery of cows with white line haemorrhage was positively associated with the length of the lesion (OR 1.05; P=0.03). This latter finding may be associated with the severity of the lesion, since mild claw horn lesions affected a significantly larger area of the claw than more severe lesions. The length and type of claw horn lesion were associated with recovery from lameness.


Assuntos
Doenças dos Bovinos/terapia , Doenças do Pé/veterinária , Casco e Garras , Coxeadura Animal/terapia , Animais , Bovinos , Doenças dos Bovinos/patologia , Doenças dos Bovinos/fisiopatologia , Feminino , Doenças do Pé/terapia , Casco e Garras/patologia , Casco e Garras/fisiopatologia , Coxeadura Animal/etiologia , Modelos Logísticos , Resultado do Tratamento
15.
Public Health Nutr ; 20(13): 2406-2415, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28653598

RESUMO

OBJECTIVE: An absence of food literacy measurement tools makes it challenging for nutrition practitioners to assess the impact of food literacy on healthy diets and to evaluate the outcomes of food literacy interventions. The objective of the present scoping review was to identify the attributes of food literacy. DESIGN: A scoping review of peer-reviewed and grey literature was conducted and attributes of food literacy identified. Subjects included in the search were high-risk groups. Eligible articles were limited to research from Canada, USA, the UK, Australia and New Zealand. RESULTS: The search identified nineteen peer-reviewed and thirty grey literature sources. Fifteen identified food literacy attributes were organized into five categories. Food and Nutrition Knowledge informs decisions about intake and distinguishing between 'healthy' and 'unhealthy' foods. Food Skills focuses on techniques of food purchasing, preparation, handling and storage. Self-Efficacy and Confidence represent one's capacity to perform successfully in specific situations. Ecologic refers to beyond self and the interaction of macro- and microsystems with food decisions and behaviours. Food Decisions reflects the application of knowledge, information and skills to make food choices. These interdependent attributes are depicted in a proposed conceptual model. CONCLUSIONS: The lack of evaluated tools inhibits the ability to assess and monitor food literacy; tailor, target and evaluate programmes; identify gaps in programming; engage in advocacy; and allocate resources. The present scoping review provides the foundation for the development of a food literacy measurement tool to address these gaps.


Assuntos
Dieta Saudável , Conhecimentos, Atitudes e Prática em Saúde , Letramento em Saúde , Modelos Psicológicos , Cooperação do Paciente , Adolescente , Adulto , Austrália , Canadá , Criança , Comportamento de Escolha , Comportamento do Consumidor , Preferências Alimentares , Humanos , Avaliação das Necessidades , Nova Zelândia , Reino Unido , Estados Unidos
16.
Disabil Rehabil ; 39(20): 2071-2080, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-27549899

RESUMO

PURPOSE: Traumatic brain injury (TBI) is prevalent in Kentucky and comes with a high cost in care and quality of life for individuals and caregivers affected. Many people living with the condition of TBI have unmet needs. Research among people living with TBI in rural areas is limited. The purposes of this study were to (1) increase understanding of the lived experience of people with TBI and caregivers in rural regions of Kentucky across the continuum of their care and (2) provide their perspectives on barriers and facilitators of optimal function and well-being. METHODS: A qualitative descriptive interview study was conducted by a multidisciplinary team. Content analysis was completed with data-derived coding and iterative modifications to analysis, coalescing codes into categories and themes. RESULTS: Thirteen people with TBI and six caregivers participated in the interview. Categories that emerged in analysis included the experiences under each locus of care; themes included relationships, functional competence, and participation in meaningful activity. CONCLUSION: Relationships represented both barriers and facilitators of well-being. Major unmet needs persisted in terms of medical problems, support for caregivers, community linkages, and participation in meaningful activities. Recommendations are made regarding avenues for addressing unmet needs. Implications for Rehabilitation People with TBI are living with chronic conditions and may need intensive rehabilitation after the injury and intermittent rehabilitation throughout life to develop and maintain functional competence. Rehabilitation providers need to understand the unique aspects of the rural home environment to which a patient will be discharged (e.g., mountainous terrain, lack of transportation, dimensions of home) and communicate with rural providers directly. Rehabilitation providers need additional focus on improving patient's and caregiver's abilities to advocate for themselves. Patients with TBI should be referred to vocational rehabilitation as soon as possible to make the transition to meaningful activity at home more of a possibility.


Assuntos
Lesões Encefálicas Traumáticas/psicologia , Continuidade da Assistência ao Paciente , População Rural , Adulto , Lesões Encefálicas Traumáticas/reabilitação , Cuidadores , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Entrevistas como Assunto , Kentucky , Masculino , Pessoa de Meia-Idade , Avaliação das Necessidades , Satisfação do Paciente , Qualidade de Vida , Isolamento Social , Participação Social , Apoio Social , Adulto Jovem
17.
BioDrugs ; 30(4): 339-51, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27422671

RESUMO

BACKGROUND: Due to the complex molecular structure and proprietary manufacturing processes of monoclonal antibodies (mAbs), differences in structure and function may be expected during development of biosimilar mAbs. Important regulatory requirements for approval of biosimilar products involve comprehensive assessments of any potential differences between proposed biosimilars and reference mAbs, including differences in all known mechanisms of action, using sensitive and relevant methods. Any identified structural differences should not result in differences in biofunctional or clinical activity. OBJECTIVE: A comprehensive assessment comparing the Amgen biosimilar candidate ABP 501 with FDA-licensed adalimumab (adalimumab [US]) and EU-authorized adalimumab (adalimumab [EU]) was conducted to demonstrate similarity in biofunctional activity. METHODS: The functional similarity assessment included testing of binding kinetics to soluble tumor necrosis factor α (TNFα) and relative binding to transmembrane TNFα. The neutralization of TNFα-induced caspase activation, TNFα- and lymphotoxin-α (LTα)-induced chemokine production, and cytotoxicity was also tested. Binding to Fc-gamma receptors FcγRIa, FcγRIIa (131H), FcγRIIIa (158V and 158F), and neonatal Fc receptor (FcRn) was compared with the reference mAbs, as was antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. RESULTS: The data demonstrate that ABP 501 is similar to both adalimumab (US) and adalimumab (EU) with respect to evaluated biofunctional activities. CONCLUSION: Similarity in biofunctional activity is a critical component of the totality of evidence required for demonstration of biosimilarity. The functional similarity demonstrated for ABP 501 comprehensively assesses the known mechanisms of action of adalimumab, supporting the conclusion that ABP 501, adalimumab (US), and adalimumab (EU) are likely to be clinically similar.


Assuntos
Adalimumab/farmacologia , Medicamentos Biossimilares/farmacologia , Fator de Necrose Tumoral alfa/metabolismo , Adalimumab/metabolismo , Animais , Citotoxicidade Celular Dependente de Anticorpos , Medicamentos Biossimilares/metabolismo , Células CHO/efeitos dos fármacos , Cricetulus , Antígenos de Histocompatibilidade Classe I/metabolismo , Humanos , Linfotoxina-alfa/farmacologia , Receptores Fc/metabolismo , Receptores de IgG/metabolismo , Ressonância de Plasmônio de Superfície , Fator de Necrose Tumoral alfa/genética , Fator de Necrose Tumoral alfa/farmacologia
18.
Neurourol Urodyn ; 34(1): 37-43, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24133005

RESUMO

AIMS: To assess the efficacy and safety of oxybutynin transdermal gel 3% (OTG3%), with propylene glycol for enhanced skin permeation, in patients with urinary incontinence (UI). METHODS: In this phase 3 study, 626 patients ≥18 years old with urgency and/or mixed UI symptoms and predominantly urgency UI for ≥3 months were randomized 1:1:1 to receive 12 weeks of OTG3% 84 mg, OTG3% 56 mg, or placebo gel applied once daily to abdomen, inner/upper thigh, or upper arm/shoulder. Primary efficacy endpoint was change from baseline to Week 12 in weekly UI episodes recorded in 3-day bladder diaries. Results were compared using analysis of covariance. Adverse events (AEs) were monitored. RESULTS: Efficacy was assessed in 601 (intent-to-treat) and safety in 626 patients. At 12 weeks, OTG3% 84 mg/day achieved significantly greater improvement versus placebo in weekly UI episodes (mean change from baseline: -20.4 vs. -18.1; P < 0.05(a)), daily urinary frequency (-2.6 vs. -1.9; P = 0.001(b)), and urinary void volume (32.7 vs. 9.8; P < 0.0001(b)). Dry mouth, the most common treatment-related AE, occurred more often with OTG3% 84 mg/day (26/214 [12.1%]) vs. placebo (10/202 [5.0%]) (P = 0.028); 4 OTG3% patients withdrew because of dry mouth. Application site erythema occurred more often with OTG3% 84 mg/day (8/214 [3.7%]) versus placebo (2/202 [1.0%]) (P = NS); 12 OTG patients withdrew because of skin irritation. No serious treatment-related AEs occurred. CONCLUSIONS: OTG3% 84 mg/day was well tolerated and effective in improving urge incontinence or mixed UI symptoms with a predominance of UI in adults with overactive bladder.


Assuntos
Ácidos Mandélicos/uso terapêutico , Incontinência Urinária/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Administração Cutânea , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Feminino , Géis , Humanos , Masculino , Ácidos Mandélicos/administração & dosagem , Ácidos Mandélicos/efeitos adversos , Pessoa de Meia-Idade , Qualidade de Vida , Resultado do Tratamento , Agentes Urológicos/administração & dosagem , Agentes Urológicos/efeitos adversos , Adulto Jovem
19.
Can J Diet Pract Res ; 74(3): 114-8, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24018002

RESUMO

PURPOSE: Fruit and vegetable (FV) consumption was examined among children aged seven to 10 years in a London, Ontario, neighbourhood. The goal was to determine areas requiring targeted programs to promote healthy lifestyles. METHODS: Data were gathered from 136 students in grades 2 to 4. Each student attended one of four elementary schools within a neighbourhood designated a priority by the City of London Child and Youth Network. The Day in the Life Questionnaire was used to collect the data. Instances of FV consumption were compared with Eating Well with Canada's Food Guide (CFG) guidelines. RESULTS: Ninety-eight percent of participants did not follow the CFG-recommended minimum guidelines; they had fewer than five instances of FV consumption daily. Eighty-seven percent had fewer than two instances of FV consumption daily. CONCLUSIONS: These data support national findings of low FV consumption among children.


Assuntos
Frutas , Verduras , Populações Vulneráveis , Criança , Fenômenos Fisiológicos da Nutrição Infantil , Comportamento Alimentar , Feminino , Preferências Alimentares , Humanos , Estilo de Vida , Masculino , Atividade Motora , Avaliação Nutricional , Ontário , Projetos Piloto , Recomendações Nutricionais , Características de Residência , Fatores Socioeconômicos , Estudantes , Inquéritos e Questionários
20.
Can J Diet Pract Res ; 74(1): 14-20, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23449209

RESUMO

PURPOSE: We examined the facilitators of and barriers to participants' application of cooking skills beyond Cook It Up!, a pilot community-based cooking program targeting at-risk youth aged 13 to 18. METHODS: Photovoice is a qualitative research method using still-picture cameras to document participants' health and community realities. Four participants photographed items they perceived as facilitators of or barriers to the application of cooking skills. At a facilitated discussion group, youth discussed why they took certain pictures and how the photos best exemplified facilitators and barriers. Participants agreed upon the themes arising from the dialogue. Data trustworthiness tools were used to ensure that themes arising from the dialogue truly represented participants' perspectives. RESULTS: Four major themes emerged as facilitators: aptitude, food literacy, local and fresh ingredients, and connectedness. Access to unhealthy foods was the only barrier that participants identified. Participants and researchers decided to advocate for the sustainability of community-based cooking programs offered for high school credit. Participants' photos would enhance advocacy efforts with education stakeholders. CONCLUSIONS: Cook It Up! provided youth with cooking techniques for healthy, economical, homemade meals, but proof was needed of the transferability of skills outside the program environment. Youth in this study identified important facilitators that enabled the continued use of their cooking skills, and one barrier. Findings underscore the importance of community-based cooking programs tailored to at-risk youth.


Assuntos
Culinária/métodos , Promoção da Saúde/métodos , Adolescente , Fast Foods , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Necessidades e Demandas de Serviços de Saúde/organização & administração , Humanos , Masculino , Fotografação , Projetos Piloto
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