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1.
Artigo em Inglês | MEDLINE | ID: mdl-38960910

RESUMO

Mentalizing, or theory of mind (ToM), impairments and self-referential hypermentalizing bias are well-evident in schizophrenia. However, findings compared to individuals with at-risk mental states (ARMS) are inconsistent, and investigations into the relationship between social cognitive impairments and social anxiety in the two populations are scarce. This study aimed to examine and compare these deficits in first-episode schizophrenia-spectrum disorder (FES) and ARMS, and to explore potential specific associations with neurocognition and symptomatology. Forty patients with FES, 40 individuals with ARMS, and 40 healthy controls (HC) completed clinical assessments, a battery of neurocognitive tasks, and three social cognitive tasks. The comic strip and hinting tasks were used to measure non-verbal and verbal mentalizing abilities, and the gaze perception task was employed to assess self-referential hypermentalizing bias. FES and ARMS showed comparable mentalizing impairments and self-referential hypermentalizing bias compared to HC. However, only ambiguous self-referential gaze perception (SRGP) bias remained significantly different between three groups after controlling for covariates. Findings suggested that self-referential hypermentalizing bias could be a specific deficit and may be considered a potential behavioral indicator in early-stage and prodromal psychosis. Moreover, working memory and social anxiety were related to the social cognitive impairments in ARMS, whereas higher-order executive functions and positive symptoms were associated with the impairments in FES. The current study indicates the presence of stage-specific mechanisms of mentalizing impairments and self-referential hypermentalizing bias, providing insights into the importance of personalized interventions to improve specific neurocognitive domains, social cognition, and clinical outcomes for FES and ARMS.

2.
Eur Arch Psychiatry Clin Neurosci ; 272(7): 1335-1345, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35079856

RESUMO

Mentalizing impairment is one of the core features of schizophrenia, and bias judgement of others' gaze as self-directing is common to schizophrenia patients. In this case-control study, 30 patients with first-episode schizophrenia (FES) and 30 matched healthy controls were assigned gaze perception tasks with variable stimulus presentation times (300 ms and no time limit) to determine the presence of self-referential gaze perception (SRGP) bias. The eye movement pattern during the task were tracked and data were analysed using hidden Markov models (HMMs). The SRGP involves reporting of others' gaze intent and was used as a measurement of explicit mentalizing process. Eye movement measurement represents automated visual attention pattern and was considered as a measurement of implicit mentalizing process. The patients with FES had significantly more SRGP bias than the controls in the 300 ms condition but not in the no-time-limit condition. Social cognitive function was related to SRGP bias in the patient group. Two distinct eye movement patterns were identified: eye-focused and nose-focused. Significant group differences in eye movement patterns in the 300 ms condition were found with more controls had eye-focused pattern. Social anxiety symptoms were related to the nose-focused pattern, positive psychotic symptoms were related to the eye-focused pattern, and depressive symptoms were related to less consistent eye movement patterns. No significant relationship was found between SRGP bias and eye movement patterns. The dissociation between explicit and implicit mentalizing processes with different cognitive and symptom dimensions associated with the two processes suggests the presence of different mechanisms.


Assuntos
Mentalização , Esquizofrenia , Estudos de Casos e Controles , Movimentos Oculares , Humanos , Esquizofrenia/complicações , Percepção Social
3.
J Med Syst ; 46(7): 47, 2022 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-35635621

RESUMO

My Turn is software used to manage several Covid-19 mass vaccination campaigns in California. The objective of this article is to describe the use of My Turn at two points of dispensing in California and comment on process improvements to reduce manual tasks of six identified processes of vaccination-registration, scheduling, administration, documentation, follow-up, and digital vaccine record-and paper. We reviewed publicly available documents of My Turn and patients vaccinated at George R. Moscone Convention Center in San Francisco and Oakland Coliseum Community Vaccination Clinic. For publicly available documents of My Turn, we examined videos of My Turn on YouTube, and documentation from EZIZ, the website for the California Vaccines for Children Program. For patients, we examined publicly available vaccination record cards on Instagram and Google. At the George R. Moscone Convention Center, 329,608 vaccines doses were given. At the Oakland Coliseum Community Vaccination Clinic, more than 500,000 vaccine doses were administered. The use of My Turn can be used to reduce manual tasks and paper for mass vaccinating patients against Covid-19.


Assuntos
COVID-19 , Vacinação em Massa , COVID-19/prevenção & controle , California , Criança , Humanos , Vacinação
4.
J Med Ethics ; 45(4): 219-224, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30796090

RESUMO

In this article, we discuss the ethical dimensions for the prescribing behaviours of opioids for a chronic pain patient, a scenario commonly witnessed by many physicians. The opioid epidemic in the USA and Canada is well known, existing since the late 1990s, and individuals are suffering and dying as a result of the easy availability of prescription opioids. More recently, this problem has been seen outside of North America affecting individuals at similar rates in Australia and Europe. We argue that physicians are also confronted with an ethical crisis where a capitalist-consumerist society is contributing to this opioid crisis in which societal, legal and business interests push physicians to overprescribe opioids. Individual physicians often find themselves unequipped and unsupported in attempts to curb the prescribing of opioid medications and balance competing goals of alleviating pain against the judicious use of pain medications. Physicians, individually and as a community, must reclaim the ethical mantle of our profession, through a more nuanced understanding of autonomy and beneficence. Furthermore, physicians and the medical community at large have a fiduciary duty to patients and society to play a more active role in curbing the widespread distribution of opioids in our communities.


Assuntos
Analgésicos Opioides/administração & dosagem , Dor Crônica/tratamento farmacológico , Prescrição Inadequada/ética , Manejo da Dor/ética , Relações Médico-Paciente/ética , Padrões de Prática Médica/ética , Analgésicos Opioides/efeitos adversos , Beneficência , Dor Crônica/psicologia , Epidemias/prevenção & controle , Humanos , Prescrição Inadequada/estatística & dados numéricos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Papel do Médico/psicologia , Responsabilidade Social
5.
Cancer ; 124(10): 2151-2160, 2018 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-29508899

RESUMO

BACKGROUND: Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior clinical activity versus standard-of-care (SOC) chemotherapies for relapsed/refractory B-cell acute lymphoblastic leukemia in the phase 3 randomized controlled INO-VATE trial. The authors assessed patient-reported outcomes (PROs) from that study. METHODS: Patients were randomized to receive either InO (1.8 mg/m2 per cycle for ≤6 cycles) or SOC (fludarabine/cytarabine [ara-C]/granulocyte colony-stimulating factor, or ara-C plus mitoxantrone, or high-dose ara-C for ≤4 cycles) and completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the EuroQoL 5 Dimensions Questionnaires at baseline, on day 1 of each cycle, and at the end of treatment. Treatment differences in PROs were assessed using longitudinal mixed-effects models with random intercepts and slopes. RESULTS: Questionnaire completion rates in the InO (n = 164) and SOC (n = 162) arms were 85% and 65%, respectively. Baseline scores were similar between arms. Patients who received InO reported better quality of life (QoL), functioning, and symptom scores (except for constipation and emotional functioning). Least-squares mean (95% confidence interval [CI]) differences in physical, role, and social functioning and in appetite loss were significant (6.9 [95% CI, 1.4-12.3], 11.4 [95% CI, 3.2-19.5], 8.4 [95% CI, 0.7-16.1], and -8.7 [95% CI, -16.0 to -1.4], respectively; all P < .05) and had exceeded the minimally important difference of 5. Mean treatment differences in favor of InO on the EuroQoL visual analog scale and the global health status/QoL, dyspnea, and fatigue scales reached or approached the minimally important difference of 5, although without statistical significance. No dimensions were significantly worse with InO versus SOC. CONCLUSIONS: The current PRO data support the favorable benefit/risk ratio of InO for the treatment of relapsed/refractory acute lymphoblastic leukemia, with superior clinical efficacy and better QoL. Cancer 2018;124:2151-60. © 2018 American Cancer Society.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Recidiva Local de Neoplasia/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Anticorpos Monoclonais Humanizados/farmacologia , Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Resistencia a Medicamentos Antineoplásicos , Dispneia/induzido quimicamente , Dispneia/epidemiologia , Fadiga/induzido quimicamente , Fadiga/epidemiologia , Feminino , Seguimentos , Nível de Saúde , Humanos , Inotuzumab Ozogamicina , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/mortalidade , Leucemia-Linfoma Linfoblástico de Células Precursoras/microbiologia , Leucemia-Linfoma Linfoblástico de Células Precursoras/patologia , Qualidade de Vida , Lectina 2 Semelhante a Ig de Ligação ao Ácido Siálico/antagonistas & inibidores , Lectina 2 Semelhante a Ig de Ligação ao Ácido Siálico/metabolismo
6.
Genes (Basel) ; 15(7)2024 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-39062600

RESUMO

The process of developing therapies to treat rare diseases is fraught with financial, regulatory, and logistical challenges that have limited our ability to build effective treatments. Recently, a novel type of therapy called antisense therapy has shown immense potential for the treatment of rare diseases, particularly through single-patient N-of-1 trials. Several N-of-1 antisense therapies have been developed recently for rare diseases, including the landmark study of milasen. In response to the success of N-of-1 antisense therapy, the Food and Drug Administration (FDA) has developed unique guidelines specifically for the development of antisense therapy to treat N-of-1 rare diseases. This policy change establishes a strong foundation for future therapy development and addresses some of the major limitations that previously hindered the development of therapies for rare diseases.


Assuntos
Oligonucleotídeos Antissenso , Doenças Raras , United States Food and Drug Administration , Humanos , Doenças Raras/genética , Doenças Raras/tratamento farmacológico , Doenças Raras/terapia , Oligonucleotídeos Antissenso/uso terapêutico , Estados Unidos , Terapia Genética/métodos , Medicina de Precisão/métodos
7.
Artigo em Inglês | MEDLINE | ID: mdl-36673773

RESUMO

OBJECTIVE: In this study, we investigated the effects of a mindfulness-based family psychoeducation (MBFPE) program on the mental-health outcomes of both caregivers and young adults with first-episode psychosis with an onset in the past three years through a multi-site randomized controlled trial. We also studied the outcomes of three potential mediating effects of interpersonal mindfulness, expressed emotions, and non-attachment on the program. METHOD: We randomly assigned 65 caregivers of young adults with psychosis to MBFPE (n = 33) or an ordinary family psychoeducation (FPE) program (n = 32); among them, 18 young adults in recovery also participated in the evaluation of outcomes. RESULTS: Intent-to-treat analyses were conducted. No significant time × group interaction effects of MBFPE and FPE programs were found in any of the caregivers' outcomes. However, the young adults with psychosis reported higher levels of recovery after the MBFPE program than after the ordinary FPE program (F = 8.268, p = 0.012, d = 1.484). They also reported a larger reduction in over-involvement of their caregivers (F = 4.846, p = 0.044, d = 1.136), showing that MBFPE had a superior effect to FPE in promoting recovery and reducing over-involvement. CONCLUSIONS: A brief psychoeducation program may not reduce the burden on or improve the mental-health outcome of caregivers of individuals with recent-onset psychosis. However, integrating mindfulness into a conventional family psychoeducation program may reduce the expressed emotions of caregivers, especially over-involvement. Further studies should explore how psychoeducation programs can reduce the impact of psychosis on family through sustainable effects in terms of reducing their burden and expressed emotions, using a rigorous study and adequate sample size.


Assuntos
Atenção Plena , Transtornos Psicóticos , Humanos , Adulto Jovem , Cuidadores/psicologia , Transtornos Psicóticos/terapia , Transtornos Psicóticos/psicologia , Saúde Mental , Sistemas de Apoio Psicossocial
8.
Ophthalmology ; 119(9): 1867-73, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22683252

RESUMO

OBJECTIVE: To evaluate the efficacy of different dosing paradigms of PF-04523655 (PF) versus ranibizumab (comparator) in subjects with neovascular age-related macular degeneration (AMD). DESIGN: Multicenter, open-label, prospective, randomized, comparator-controlled exploratory study. PARTICIPANTS: A total of 151 patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD who were naive to AMD therapy. METHODS: In this phase 2 study, patients were randomized to 1 of 5 treatment groups with equal ratio. All groups received ranibizumab 0.5 mg at baseline and (a) PF 1 mg every 4 weeks (Q4W) from week 4 to week 12; (b) PF 3 mg Q4W from week 4 to week 12; (c) PF 3 mg every 2 weeks (Q2W) from week 4 to week 12; (d) PF 1 mg + ranibizumab (combination) Q4W from baseline to week 12; and (e) ranibizumab Q4W to week 12. All study treatments were given as intravitreal injections. MAIN OUTCOME MEASURES: The primary end point was the mean change in best-corrected visual acuity (BCVA) from baseline at week 16; secondary end points included the percentage of patients gaining ≥ 10 and ≥ 15 letters in BCVA and mean change in retinal central subfield thickness, lesion thickness, and CNV area. RESULTS: At week 16, the PF 1 mg + ranibizumab combination group achieved numerically greater improvement in mean BCVA from baseline (9.5 letters) than the ranibizumab group (6.8 letters). The difference was not statistically significant. The BCVA improvement in the PF monotherapy groups was less than in the ranibizumab group. Similar trends were observed in the percentage of patients who gained ≥ 10 and ≥ 15 letters. From baseline to week 16 (last observed carried forward), the combination and ranibizumab groups had similar mean reductions in central subfield retinal thickness and total CNV area, which were greater than in all PF monotherapy groups. There were no clinically meaningful differences in reduction of lesion thickness among treatment groups. CONCLUSIONS: In this early, underpowered study evaluating treatments for neovascular AMD, the combination of PF with ranibizumab led to an average gain in BCVA that was more than with ranibizumab monotherapy. No safety concerns were identified.


Assuntos
Inibidores da Angiogênese/administração & dosagem , Anticorpos Monoclonais Humanizados/uso terapêutico , RNA Interferente Pequeno/administração & dosagem , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/administração & dosagem , Neovascularização de Coroide/patologia , Quimioterapia Combinada , Feminino , Angiofluoresceinografia , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Interferência de RNA , RNA Interferente Pequeno/genética , Ranibizumab , Retina/patologia , Tomografia de Coerência Óptica , Resultado do Tratamento , Acuidade Visual/fisiologia , Degeneração Macular Exsudativa/fisiopatologia
9.
Ann Tour Res ; 95: 103424, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35600093

RESUMO

This study explores whether vaccination coverage, social distancing rules, and COVID-19 death rate affect tourism recovery using data from 249 countries/territories. We used panel data regression techniques-namely Fixed-effects, Hausman-Taylor, and Instrumental Variables regressions for the empirical analysis. Results show that a higher vaccination coverage is not necessarily accompanied by a higher tourism recovery. Similarly, a higher level of stringency restriction hinders tourism recovery. Results also indicate that a lower death rate helps to promote tourism recovery in developed economies. These results suggest that vaccination coverage alone is not the magic bullet for restarting the tourism industry. Policymakers should consider a mix of effective vaccination administration accompanied by the use of therapeutics to lower the COVID-19 death rate.

10.
Ophthalmology ; 118(10): 2014-21, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21680022

RESUMO

OBJECTIVE: To compare the efficacy and safety of latanoprost versus timolol in pediatric patients with glaucoma. DESIGN: Prospective, randomized, double-masked, 12-week, multicenter study. PARTICIPANTS: Individuals aged ≤18 years with glaucoma. METHODS: Stratified by age, diagnosis, and intraocular pressure (IOP) level, subjects were randomized (1:1) to latanoprost vehicle at 8 am and latanoprost 0.005% at 8 pm or timolol 0.5% (0.25% for those aged <3 years) twice daily (8 am, 8 pm). At baseline and weeks 1, 4, and 12, IOP and ocular safety were assessed and adverse events were recorded. Therapy was switched to open-label latanoprost pm and timolol am and pm for uncontrolled IOP. MAIN OUTCOME MEASURES: Mean IOP reduction from baseline to week 12. Latanoprost was considered noninferior to timolol if the lower limit of the 95% confidence interval (CI) of the difference was >-3 mmHg. A proportion of responders (subjects with ≥15% IOP reduction at weeks 4 and 12) were evaluated. Analyses were performed in diagnosis subgroups: primary congenital glaucoma (PCG) and non-PCG. RESULTS: In total, 137 subjects were treated (safety population; 12-18 years, n=48; 3-<12 years, n=55; 0-<3 years, n=34). Mean age was 8.8±5.5 years, and mean baseline IOP was 27.7±6.17 mmHg; 125 subjects completed the study, and 107 subjects were in the per protocol population. Mean IOP reductions for latanoprost and timolol at week 12 were 7.2 and 5.7 mmHg, respectively, with a difference of 1.5 mmHg (95% CI, -0.8 to 3.7; P=0.21). Responder rates were 60% for latanoprost and 52% for timolol (P=0.33). Between-treatment differences in mean IOP reduction for PCG and non-PCG subgroups were 0.6 mmHg (95% CI, -2.3 to 3.4) and 2.6 mmHg (95% CI, -0.8 to 6.1), respectively. Responder rates for latanoprost versus timolol were 50% versus 46% for the PCG group and 72% versus 57% for the non-PCG group. Both therapies were well tolerated. CONCLUSIONS: Latanoprost 0.005% is not inferior (i.e., is either more or similarly effective) to timolol and produces clinically relevant IOP reductions across pediatric patients with and without PCG. Both latanoprost and timolol had favorable safety profiles over the duration of this 3-month trial. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Assuntos
Anti-Hipertensivos/administração & dosagem , Glaucoma/tratamento farmacológico , Hidroftalmia/tratamento farmacológico , Pressão Intraocular/efeitos dos fármacos , Prostaglandinas F Sintéticas/administração & dosagem , Timolol/administração & dosagem , Adolescente , Anti-Hipertensivos/efeitos adversos , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Glaucoma/fisiopatologia , Humanos , Hidroftalmia/fisiopatologia , Lactente , Latanoprosta , Masculino , Soluções Oftálmicas/administração & dosagem , Soluções Oftálmicas/efeitos adversos , Estudos Prospectivos , Prostaglandinas F Sintéticas/efeitos adversos , Fatores de Tempo , Timolol/efeitos adversos , Tonometria Ocular , Resultado do Tratamento
11.
Simul Healthc ; 16(4): 295-300, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32890320

RESUMO

INTRODUCTION: Surgical simulation is valuable in neurovascular surgery given the progressive rarity of these cases and their technical complexity, but its use has not been well described for pediatric vascular pathologies. We herein review the use of surgical simulation at our institution for complex pediatric aneurysmal malformations. METHODS: A retrospective review of patients treated for middle cerebral artery aneurysmal malformations with surgical simulation assistance (SuRgical Planner [SRP]; Surgical Theater, Mayfield Village, OH) during a 2-year period at Rady Children's Hospital of San Diego was performed. RESULTS: In 5 pediatric patients with complex MCA aneurysmal malformations (mean age = 33.2 ± 49.9 months), preoperative 3-dimensional (3D) interactive modeling informed treatment planning and enhanced surgeon understanding of the vascular pathology. Availability of intraoperative simulation also aided real-time anatomical understanding during surgery. Specific benefits of simulation for these cases included characterization of involved perforating vessels, as well as an enhanced understanding of flow patterns within associated complex arteriovenous fistulas and feeding vessel/daughter branch anatomy. Despite the complexity of the lesions treated, use of simulation qualitatively enhanced surgeon confidence. There were no perioperative complications for patients treated with open surgery. CONCLUSIONS: Surgical simulation may aid in the treatment of complex pediatric aneurysmal malformations.


Assuntos
Aneurisma Intracraniano , Realidade Virtual , Criança , Pré-Escolar , Humanos , Imageamento Tridimensional , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Estudos Retrospectivos , Interface Usuário-Computador
12.
Nutr J ; 9: 72, 2010 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-21194471

RESUMO

BACKGROUND: There is concern that recommending protein-enriched meal replacements as part of a weight management program could lead to changes in biomarkers of liver or renal function and reductions in bone density. This study was designed as a placebo-controlled clinical trial utilizing two isocaloric meal plans utilizing either a high protein-enriched (HP) or a standard protein (SP) meal replacement in an outpatient weight loss program. SUBJECTS/METHODS: 100 obese men and women over 30 years of age with a body mass index (BMI) between 27 to 40 kg/m2 were randomized to one of two isocaloric weight loss meal plans 1). HP group: providing 2.2 g protein/kg of lean body mass (LBM)/day or 2). SP group: providing 1.1 g protein/kg LBM/day. Meal replacement (MR) was used twice daily (one meal, one snack) for 3 months and then once a day for 9 months. Body weight, lipid profiles, liver function, renal function and bone density were measured at baseline and 12 months. RESULTS: Seventy subjects completed the study. Both groups lost weight (HP -4.29 ± 5.90 kg vs. SP -4.66 ± 6.91 kg, p < 0.01) and there was no difference in weight loss observed between the groups at one year. There was no significant change noted in liver function [AST (HP -2.07 ± 10.32 U/L, p = 0.28; SP 0.27 ± 6.67 U/L, p = 0.820), ALT (HP -1.03 ± 10.08 U/L, p = 0.34; SP -2.6 ± 12.51 U/L, p = 0.24), bilirubin (HP 0.007 ± 0.33, U/L, p = 0.91; SP 0.07 ± 0.24 U/L, p = 0.120), alkaline phosphatase (HP 2.00 ± 9.07 U/L, p = 0.240; SP -2.12 ± 11.01 U/L, p = 0.280)], renal function [serum creatinine (HP 0.31 ± 1.89 mg/dL, p = 0.380; SP -0.05 ± 0.15 mg/dL, p = 0.060), urea nitrogen (HP 1.33 ± 4.68 mg/dL, p = 0.130; SP -0.24 ± 3.03 mg/dL, p = 0.650), 24 hour urine creatinine clearance (HP -0.02 ± 0.16 mL/min, p = 0.480; SP 1.18 ± 7.53 mL/min, p = 0.400), and calcium excretion (HP -0.41 ± 9.48 mg/24 hours, p = 0.830; SP -0.007 ± 6.76 mg/24 hours, p = 0.990)] or in bone mineral density by DEXA (HP 0.04 ± 0.19 g/cm2, p = 0.210; SP -0.03 ± 0.17 g/cm2, p = 0.320) in either group over one year. CONCLUSIONS: These studies demonstrate that protein-enriched meals replacements as compared to standard meal replacements recommended for weight management do not have adverse effects on routine measures of liver function, renal function or bone density at one year.


Assuntos
Densidade Óssea , Dieta Redutora/efeitos adversos , Proteínas Alimentares/efeitos adversos , Alimentos Formulados/efeitos adversos , Rim/fisiopatologia , Fígado/fisiopatologia , Obesidade/dietoterapia , Absorciometria de Fóton , Adulto , Biomarcadores/sangue , Índice de Massa Corporal , Feminino , Alimentos Formulados/análise , Humanos , Lipídeos/sangue , Masculino , Obesidade/sangue , Obesidade/fisiopatologia , Fatores de Tempo
13.
JAMA Netw Open ; 2(11): e1914988, 2019 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-31702802

RESUMO

Importance: Vomiting resulting from acute gastroenteritis is commonly treated with intravenous antiemetics in acute care settings. If oral treatment were beneficial, patients might not need intravenous administered hydration or medication. Furthermore, a long-acting treatment could provide sustained relief from nausea and vomiting. Objective: To determine whether an experimental long-acting bimodal release ondansetron tablet decreases gastroenteritis-related vomiting and eliminates the need for intravenous therapy for 24 hours after administration. Design, Setting, and Participants: This placebo-controlled, double-blind, randomized clinical trial included patients from 19 emergency departments and 2 urgent care centers in the United States from December 8, 2014, to February 17, 2017. Patients 12 years and older with at least 2 vomiting episodes from presumed gastroenteritis in the previous 4 hours and symptoms with less than 36 hours' duration were randomized using a 3:2 active to placebo ratio. Analyses were performed on an intent-to-treat basis and conducted from June 1, 2017, to November 1, 2017. Intervention: Bimodal release ondansetron tablet containing 6 mg of immediate release ondansetron and 18 mg of a 24-hour release matrix for a total of 24 mg of ondansetron. Main Outcomes and Measures: Treatment success was defined as no further vomiting, no need for rescue medication, and no intravenous hydration for 24 hours after bimodal release ondansetron administration. Results: Analysis included 321 patients (mean [SD] age, 29.0 [11.1] years; 195 [60.7%] women), with 192 patients in the bimodal release ondansetron group and 129 patients in the placebo group. Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), with an 11.4% (95% CI, 0.3%-22.4%) absolute probability difference. The proportion of treatment success was 21% higher among patients who received bimodal release ondansetron compared with those who received a placebo (relative risk, 1.21; 95% CI, 1.00-1.46; P = .04). In an analysis including only patients with a discharge diagnosis of acute gastroenteritis and no major protocol violations, there were 123 treatment successes (69.5%) in the bimodal release ondansetron group compared with 67 treatment successes (54.9%) in the placebo group (relative risk, 1.27; 95% CI, 1.05-1.53; P = .01). Adverse effects were infrequent and similar to the known safety profile of ondansetron. Conclusions and Relevance: This randomized clinical trial found that a long-acting bimodal release oral ondansetron tablet was an effective antiemetic among adolescents and adults with moderate to severe vomiting from acute gastroenteritis. The drug benefits extended to 24 hours after administration. Bimodal release ondansetron may decrease the need for intravenous access and emergency department care to manage acute gastroenteritis. Trial Registration: ClinicalTrials.gov identifier: NCT02246439.


Assuntos
Gastroenterite/tratamento farmacológico , Ondansetron/normas , Administração Oral , Adolescente , Adulto , Antieméticos/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Ondansetron/uso terapêutico , Resultado do Tratamento , Vômito/tratamento farmacológico
14.
Nutr J ; 7: 23, 2008 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-18752682

RESUMO

BACKGROUND: While high protein diets have been shown to improve satiety and retention of lean body mass (LBM), this study was designed to determine effects of a protein-enriched meal replacement (MR) on weight loss and LBM retention by comparison to an isocaloric carbohydrate-enriched MR within customized diet plans utilizing MR to achieve high protein or standard protein intakes. METHODS: Single blind, placebo-controlled, randomized outpatient weight loss trial in 100 obese men and women comparing two isocaloric meal plans utilizing a standard MR to which was added supplementary protein or carbohydrate powder. MR was used twice daily (one meal, one snack). One additional meal was included in the meal plan designed to achieve individualized protein intakes of either 1) 2.2 g protein/kg of LBM per day [high protein diet (HP)] or 2) 1.1 g protein/kg LBM/day standard protein diet (SP). LBM was determined using bioelectrical impedance analysis (BIA). Body weight, body composition, and lipid profiles were measured at baseline and 12 weeks. RESULTS: Eighty-five subjects completed the study. Both HP and SP MR were well tolerated, with no adverse effects. There were no differences in weight loss at 12 weeks (-4.19 +/- 0.5 kg for HP group and -3.72 +/- 0.7 kg for SP group, p > 0.1). Subjects in the HP group lost significantly more fat weight than the SP group (HP = -1.65 +/- 0.63 kg; SP = -0.64 +/- 0.79 kg, P = 0.05) as estimated by BIA. There were no significant differences in lipids nor fasting blood glucose between groups, but within the HP group a significant decrease in cholesterol and LDL cholesterol was noted at 12 weeks. This was not seen in the SP group. CONCLUSION: Higher protein MR within a higher protein diet resulted in similar overall weight loss as the standard protein MR plan over 12 weeks. However, there was significantly more fat loss in the HP group but no significant difference in lean body mass. In this trial, subject compliance with both the standard and protein-enriched MR strategy for weight loss may have obscured any effect of increased protein on weight loss demonstrated in prior weight loss studies using whole food diets.


Assuntos
Composição Corporal/efeitos dos fármacos , Colesterol/sangue , Proteínas Alimentares/administração & dosagem , Alimentos Formulados , Obesidade/dietoterapia , Redução de Peso/efeitos dos fármacos , Tecido Adiposo/efeitos dos fármacos , Tecido Adiposo/metabolismo , Adulto , Idoso , Composição Corporal/fisiologia , LDL-Colesterol/sangue , Relação Dose-Resposta a Droga , Feminino , Alimentos Fortificados , Humanos , Masculino , Pessoa de Meia-Idade , Músculo Esquelético/efeitos dos fármacos , Músculo Esquelético/metabolismo , Obesidade/sangue , Cooperação do Paciente , Método Simples-Cego , Resultado do Tratamento , Redução de Peso/fisiologia
15.
Am J Emerg Med ; 26(5): 555-60, 2008 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-18534284

RESUMO

BACKGROUND: Amino-terminal pro-brain natriuretic peptide (NT-proBNP) is useful for the triage of patients with dyspnea. Our aim was to determine whether NT-proBNP levels could predict in-hospital outcome in breathless elderly patients. METHODS: At admission, NT-proBNP plasma concentrations were determined in 324 dyspneic patients aged 75 years and older. The association between NT-proBNP values and in-hospital mortality was assessed. RESULTS: Median NT-proBNP concentrations were not different in deceased patients (n = 43, 13%) compared to that of survivors (n = 281, 87%) (4354 vs 2499 pg/mL, respectively; P = .06). To predict in-hospital mortality, the optimum threshold of NT-proBNP was 3855 pg/mL, as defined by the receiver operating characteristic (ROC) curve, with a nonsignificant area under the ROC curve of 0.59. Mortality was significantly higher in patients (n = 139) with NT-proBNP levels 3855 pg/mL or higher (17.9% vs 9.7%, P = .045). After multivariate analysis, NT-proBNP level 3855 pg/mL or higher at admission was predictive of mortality (odds ratio, 2.41; 95% confidence interval, 1.02-5.68; P = .04). CONCLUSION: NT-proBNP higher than 3855 pg/mL is associated with in-hospital mortality in patients aged 75 years and older admitted for dyspnea.


Assuntos
Dispneia/mortalidade , Mortalidade Hospitalar , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Idoso , Idoso de 80 Anos ou mais , Serviço Hospitalar de Emergência , Feminino , França/epidemiologia , Insuficiência Cardíaca/diagnóstico , Humanos , Tempo de Internação , Masculino , Valor Preditivo dos Testes , Prognóstico , Curva ROC , Insuficiência Respiratória/diagnóstico , Troponina I/sangue
16.
Surg Obes Relat Dis ; 4(2): 137-43, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18359454

RESUMO

BACKGROUND: Roux-en-Y gastric bypass patients often undergo preoperative dieting and psychological assessment before surgery. We examined preoperative weight loss, binge eating disorder (BED), and sexual abuse history and the interactions of these predictors to determine whether a cautionary approach to Roux-en-Y gastric bypass is warranted. METHODS: Consecutive subjects undergoing Roux-en-Y gastric bypass at our institution from January 1997 to December 2002 were reviewed. The postoperative excess weight loss (EWL) at 1, 3, 6, 12, 18, and 24 months and the perioperative complications were measured. EWL was compared at 12 and 24 months postoperatively in the categories of the presence/absence of preoperative weight loss, BED, and sexual abuse history. The perioperative complications were examined in the preoperative weight change groups. RESULTS: Of 154 patients, 121 were included. No significant difference in EWL or perioperative complications was observed between those who lost or gained weight preoperatively. Of the 121 patients, 32% and 17% reported a history of BED and sexual abuse, respectively. No statistically significant difference was observed in the EWL between those with and without BED at 12 and 24 months postoperatively. The EWL in those with and without a sexual abuse history at 12 and 24 months was 57.67% and 66.32% (P <.05) and 64.40% and 70.97% (P = NS). No statistically significant interaction between EWL and sexual abuse*BED/sexual abuse*preoperative weight loss was observed. CONCLUSION: Only sexual abuse history at postoperative month 12 had a negative effect on EWL. Otherwise, physicians can expect to see successful EWL in these subjects up to 24 months postoperatively. We recommend that additional investigation be done of those with BED and a sexual abuse history.


Assuntos
Bulimia Nervosa/psicologia , Derivação Gástrica/métodos , Delitos Sexuais/psicologia , Redução de Peso , Adulto , Idoso , Anastomose em-Y de Roux/psicologia , Feminino , Derivação Gástrica/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do Tratamento
17.
Macromolecules ; 51(20): 8332, 2018 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-31186588

RESUMO

[This corrects the article DOI: 10.1021/acs.macromol.7b01567.].

18.
Nutr Rev ; 65(8 Pt 1): 376-84, 2007 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-17867371

RESUMO

Nonalcoholic fatty liver disease (NAFLD) encompasses a spectrum of liver diseases in the absence of significant alcohol consumption, and its incidence is paralleling the increasing numbers of overweight and obese individuals worldwide. This review discusses the pathogenesis of NAFLD, including the roles potentially played by specific adipokines, such as TNF-alpha, leptin, and adiponectin. Clinical features, diagnosis, and potential methods of management are also addressed to assist practitioners with the management of this growing population of patients.


Assuntos
Fígado Gorduroso/patologia , Fígado Gorduroso/terapia , Hipolipemiantes/uso terapêutico , Redução de Peso , Progressão da Doença , Fígado Gorduroso/epidemiologia , Humanos , Estresse Oxidativo , Prevalência , Prognóstico , Fatores de Risco
19.
Macromolecules ; 50(21): 8637-8646, 2017 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-30174341

RESUMO

We have investigated PLLA crystallization in lamellae-forming PS-b-PLLA confined to straight cylindrical nanopores under weak confinement (nanopore diameter D/equilibrium PS-b-PLLA period L0 ≥ 4.8). Molten PS-b-PLLA predominantly forms concentric lamellae along the nanopores, but intertwined helices occur even for D/L0 ≈ 7.3. Quenching PS-b-PLLA melts below TG(PS) results in PLLA cold crystallization strictly confined by the vitrified PS domains. Above TG(PS), PLLA crystallization is templated by the PS-b-PLLA melt domain structure in the nanopore centers, while adsorption on the nanopore walls stabilizes the outermost cylindrical PS-b-PLLA shell. In between, the nanoscopic PS-b-PLLA melt domain structure apparently ripens to reduce frustrations transmitted from the outermost immobilized PS-b-PLLA layer. The onset of PLLA crystallization catalyzes the ripening while transient ripening states are arrested by advancing PLLA crystallization. Certain helical structure motifs persist PLLA crystallization even if PS is soft. The direction of fastest PLLA crystal growth is preferentially aligned with the nanopore axes to the same degree as for PLLA homopolymer, independent of whether PS is vitreous or soft.

20.
J Glaucoma ; 22(8): 614-9, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23524858

RESUMO

PURPOSE: To evaluate the impact of age, glaucoma-specific diagnosis, and history of prior glaucoma surgery on outcomes in pediatric patients treated with latanoprost monotherapy. PATIENTS AND METHODS: Prospective, randomized, double-masked 12-week, multicenter study included individuals 18 years or younger with glaucoma. Subjects stratified by age (0 to <3, 3 to <12, 12 to 18 y), diagnosis [primary congenital glaucoma (PCG) vs. non-PCG], and baseline intraocular pressure (IOP; 22 to <27, 27 to 31, >31 mm Hg), and randomized (1:1) to latanoprost vehicle (8 AM) and latanoprost 0.005% (8 PM) or timolol 0.5% (or 0.25% for those less than 3 y old; 8 AM/8 PM). IOP and safety assessments performed and adverse events recorded at baseline, weeks 1, 4, 12. Post hoc analyses in age-specific and diagnosis-specific groups of latanoprost-treated subjects were conducted (intent-to-treat population). RESULTS: Sixty-eight subjects were treated with latanoprost (0 to <3, n=17; 3 to <12, n=26; 12 to 18, n=25); 82%, 42%, and 24%, respectively, had a primary diagnosis of PCG. Among Non-PCG subjects, 0% (0/3), 47% (7/15), and 63% (12/19) had a primary diagnosis of juvenile open-angle glaucoma in the 0 to <3, 3 to <12, and 12 to 18 year cohorts, respectively. Mean percent IOP reductions from baseline at week 12 were 22%, 24%, and 30% in the youngest through oldest age groups, respectively (P=0.3600). At week 12, a higher responder rate (≥15% IOP reduction) was observed in the non-PCG than in the PCG group (70% vs. 45%, respectively; P=0.0361). Latanoprost was well tolerated. CONCLUSION: All age and diagnosis subgroups showed clinically relevant (>20%) mean IOP reduction at week 12 with latanoprost monotherapy.


Assuntos
Anti-Hipertensivos/uso terapêutico , Cirurgia Filtrante/estatística & dados numéricos , Glaucoma de Ângulo Aberto/diagnóstico , Hidroftalmia/diagnóstico , Pressão Intraocular/efeitos dos fármacos , Prostaglandinas F Sintéticas/uso terapêutico , Adolescente , Fatores Etários , Anti-Hipertensivos/efeitos adversos , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Glaucoma de Ângulo Aberto/tratamento farmacológico , Humanos , Hidroftalmia/tratamento farmacológico , Lactente , Latanoprosta , Masculino , Estudos Prospectivos , Prostaglandinas F Sintéticas/efeitos adversos , Timolol/efeitos adversos , Timolol/uso terapêutico , Tonometria Ocular
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