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1.
Artículo en Inglés | PAHO-IRIS | ID: phr-51949

RESUMEN

[ABSTRACT]. The World Health Organization (WHO) was informed on December 2019 about a coronavirus pneumonia outbreak in Wuhan, Hubei province (China). Subsequently, on March 12, 2020, 125,048 cases and 4,614 deaths were reported. Coronavirus is an enveloped RNA virus, from the genus Betacoronavirus, that is distributed in birds, humans, and other mammals. WHO has named the novel coronavirus disease as COVID-19. More than 80 clinical trials have been launched to test coronavirus treatment, including some drug repurposing or repositioning for COVID-19. Hence, we performed a search in March 2020 of the clinicaltrials.gov database. The eligibility criteria for the retrieved studies were: contain a clinicaltrials.gov base identifier number; describe the number of participants and the period for the study; describe the participants' clinical conditions; and utilize interventions with medicines already studied or approved for any other disease in patients infected with the novel coronavirus SARS-CoV-2 (2019-nCoV). It is essential to emphasize that this article only captured trials listed in the clinicaltrials.gov database. We identified 24 clinical trials, involving more than 20 medicines, such as human immunoglobulin, interferons, chloroquine, hydroxychloroquine, arbidol, remdesivir, favipiravir, lopinavir, ritonavir, oseltamivir, methylprednisolone, bevacizumab, and traditional Chinese medicines (TCM). Although drug repurposing has some limitations, repositioning clinical trials may represent an attractive strategy because they facilitate the discovery of new classes of medicines; they have lower costs and take less time to reach the market; and there are existing pharmaceutical supply chains for formulation and distribution.


[RESUMEN]. En diciembre de 2019 fue informado a la Organización Mundial de la Salud (OMS) un brote de neumonía por coronavirus en Wuhan, provincia de Hubei, China. Al 12 de marzo de 2020, se habían notificado 125 048 casos y 4 614 muertes. El coronavirus es un virus ARN envuelto del género Betacoronavirus distribuido en aves, seres humanos y otros mamíferos. La OMS ha denominado a la nueva enfermedad por coronavirus COVID- 19. Se han puesto en marcha más de 80 ensayos clínicos para evaluar un tratamiento para el coronavirus, que incluyen algunos ensayos de reposicionamiento de medicamentos para la COVID-19. En marzo de 2020 se llevó a cabo una búsqueda de los ensayos clínicos registrados en la base de datos clinicaltrials.gov. Los criterios de elegibilidad para los estudios recuperados fueron tener un número de identificación de la base de datos clinicaltrials.gov; describir el número de participantes y el período del estudio; describir las condiciones clínicas de los participantes; y emplear intervenciones con medicamentos ya estudiados o aprobados para cualquier otra enfermedad en pacientes infectados con el nuevo coronavirus SARS-CoV-2 (2019-nCoV). Es esencial destacar que este artículo solo recoge los ensayos que figuran en la base de datos clinicaltrials. gov. Se identificaron 24 ensayos clínicos relacionados con más de 20 medicamentos, como inmunoglobulina humana, interferones, cloroquina, hidroxicloroquina, arbidol, remdesivir, favipiravir, lopinavir, ritonavir, oseltamivir, metilprednisolona, bevacizumab y medicina tradicional china. Aunque el reposicionamiento de medicamentos tiene algunas limitaciones, el reposicionamiento de los ensayos clínicos puede representar una estrategia atractiva porque facilita el descubrimiento de nuevas clases de medicamentos; estos tienen costos más bajos y tardan menos en llegar al mercado; y existen cadenas de suministro farmacéutico que apoyan la formulación y la distribución.


[RESUMO]. A Organização Mundial da Saúde (OMS) foi informada, em dezembro de 2019, sobre um surto de pneumonia por coronavírus em Wuhan, província de Hubei (China). Posteriormente, em 12 de março de 2020, 125 048 casos e 4 614 mortes haviam sido registrados. O coronavírus é um vírus RNA envelopado do gênero Betacoronavírus, distribuído em aves e em humanos e outros mamíferos. A OMS designou a nova doença por coronavírus como COVID-19. Mais de 80 ensaios clínicos foram iniciados para testar tratamentos para o coronavírus, incluindo alguns de reposicionamento de medicamentos para o COVID-19. Assim, em março de 2020 realizou-se uma busca na base de dados clinicaltrials.gov. Os critérios de elegibilidade para os estudos recuperados foram: conter o número identificador da base de dados clinicaltrials.gov; descrever o número de participantes e o período do estudo; descrever as condições clínicas dos participantes; e utilizar intervenções para tratamento de doentes infectados com o novo coronavírus SARS-CoV-2 (2019-nCoV) com medicamentos já estudados ou aprovados para qualquer outra doença. É essencial salientar que este artigo apenas capturou ensaios listados na base de dados clinicaltrials.gov. Foram identificados 24 ensaios clínicos envolvendo mais de 20 medicamentos, tais como imunoglobulina humana, interferons, cloroquina, hidroxicloroquina, arbidol, remdesivir, favipiravir, lopinavir, ritonavir, oseltamivir, metilprednisolona, bevacizumabe e medicamentos chineses tradicionais. Embora o reposicionamento de medicamentos tenha algumas limitações, os ensaios clínicos de reposicionamento podem representar uma estratégia atraente, porque facilitam a descoberta de novas classes de medicamentos, têm custos mais baixos, levam menos tempo para chegar ao mercado e se beneficiam de cadeias de fornecimento farmacêutico já existentes para formulação e distribuição.


Asunto(s)
Reposicionamiento de Medicamentos , Ensayos Clínicos como Asunto , Infecciones por Coronavirus , Virosis , Neumonía , Pandemias , Reposicionamiento de Medicamentos , Ensayos Clínicos como Asunto , Infecciones por Coronavirus , Virosis , Neumonía Viral , Pandemias , Reposicionamiento de Medicamentos , Ensayos Clínicos como Asunto , Infecciones por Coronavirus , Virosis , Neumonía Viral
2.
Stud Health Technol Inform ; 268: 97-112, 2020 Mar 02.
Artículo en Inglés | MEDLINE | ID: mdl-32141882

RESUMEN

Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.


Asunto(s)
Encéfalo , Enfermedad de Alzheimer , Ensayos Clínicos como Asunto , Humanos , Mantenimiento , Investigación , Factores de Riesgo
3.
Zhonghua Zhong Liu Za Zhi ; 42(2): 127-132, 2020 Feb 23.
Artículo en Chino | MEDLINE | ID: mdl-32135647

RESUMEN

Objective: To deliver macro understanding of the latest research progress on clinical trials and approved products of cancer drugs in China in 2019. Methods: The number of clinical trials and related investigational products by domestic and foreign enterprises in 2019 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies, while listed drugs were obtained in the China Food and Drug Administration Query System for Domestic and Imported Drug. Characteristics on stage, scope, indication of those trials, classification and mechanism of involved products, as well as listed anticancer drugs were summarized and depicted. Results: There were 474 cancer drug trials registered in China in 2019, accounting for 21.8% of the total, and 397 (83.8%) were initiated by domestic pharmaceutical enterprises. Overall, international multicenter trials accounted for 13.1%, and phase I trials accounted for 47.3%. Compared with global enterprises, the proportion of international multi-center trials initiated by domestic companies is lower (4.8% vs. 55.8%, P<0.001), and the proportion of phase I clinical trials and bioequivalence trials is higher (51.9% vs. 23.4%, 19.4% vs. 1.3%, P<0.001). An accumulative of 27 cancer types were involved for all the cancer drug trials, and lung cancer, solid tumor, and breast cancer were the most common cancer types, with 103, 95 and 49 trials, respectively. For the three cancer types unique to Chinese population, gastric, liver and esophageal cancer, the total number of initiated trials was 47. For all those trials, there were 335 cancer drug varieties, with 86.0% developed by domestic pharmaceutical enterprises, including 300 therapeutic drugs, 30 adjunctive drugs and 5 preventive drugs. In terms of mechanism, targeted drugs and immune drugs were the most popular, accounting for 74.6% and 20.3%, respectively. In addition, 17 anticancer drugs targeting on 11 cancer types were approved in China in 2019. Conclusions: Clinical trials on cancer drugs in China have ushered a booming era, with large number of innovative agents represented by targeted drugs and immune drugs under clinical development or putting into clinical practice. Those local enterprises are playing more and more critical roles. Strengthening clinical research and development on Chinese unique cancer types is the key direction of future work.


Asunto(s)
Antineoplásicos/uso terapéutico , Neoplasias Pulmonares/tratamiento farmacológico , China , Ensayos Clínicos como Asunto , Humanos , Estados Unidos
4.
Lancet ; 395(10226): 817-827, 2020 03 07.
Artículo en Inglés | MEDLINE | ID: mdl-32145796

RESUMEN

The development and approval of cyclin-dependent kinase (CDK) 4 and 6 inhibitors for hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer represents a major milestone in cancer therapeutics. Three different oral CDK4/6 inhibitors, palbociclib, ribociclib, and abemaciclib, have significantly improved progression-free survival by a number of months when combined with endocrine therapy. More recently, improvement in overall survival has been reported with ribociclib and abemaciclib. The toxicity profile of all three drugs is well described and generally easily manageable with dose reductions when indicated. More myelotoxicity is observed with palbociclib and ribociclib, but more gastrointestinal toxicity is observed with abemaciclib. Emerging data is shedding light on the resistance mechanisms associated with CDK4/6 inhibitors, including cell cycle alterations and activation of upstream tyrosine kinase receptors. A number of clinical trials are exploring several important questions regarding treatment sequencing, combinatorial strategies, and the use of CDK4/6 inhibitors in the adjuvant and neoadjuvant settings, thereby further expanding and refining the clinical application of CDK4/6 inhibitors for patients with breast cancer.


Asunto(s)
Neoplasias de la Mama/tratamiento farmacológico , Quinasa 4 Dependiente de la Ciclina/antagonistas & inhibidores , Quinasa 6 Dependiente de la Ciclina/antagonistas & inhibidores , Inhibidores de Proteínas Quinasas/uso terapéutico , Ciclo Celular/efectos de los fármacos , Ensayos Clínicos como Asunto , Femenino , Predicción , Humanos , Receptores Estrogénicos , Receptores de Progesterona
5.
Lancet ; 395(10225): 735-748, 2020 02 29.
Artículo en Inglés | MEDLINE | ID: mdl-32113502

RESUMEN

Globally, as populations age there will be challenges and opportunities to deliver optimal health care to senior citizens. Epilepsy, a condition characterised by spontaneous recurrent seizures, is common in older adults (aged >65 years) and yet has received comparatively little attention in this age group. In this Review, we evaluate the underlying causes of epilepsy in older people, explore difficulties in establishing a diagnosis of epilepsy in this population, discuss appropriate antiseizure medications, and evaluate potential surgical treatment options. We consider cognitive, psychological, and psychosocial comorbidities and the effect that epilepsy might have on an older person's broader social or care network in high-income versus middle-income and low-income countries. We emphasise the need for clinical trials to be more inclusive of older people with epilepsy to help inform therapeutic decision making and discuss whether measures to improve vascular risk factors might be an important strategy to reduce the probability of developing epilepsy.


Asunto(s)
Anticonvulsivantes/uso terapéutico , Epilepsia/terapia , Procedimientos Neuroquirúrgicos/métodos , Anciano , Enfermedad de Alzheimer/complicaciones , Enfermedades Autoinmunes del Sistema Nervioso/complicaciones , Neoplasias Encefálicas/complicaciones , Trastornos Cerebrovasculares/complicaciones , Toma de Decisiones Clínicas , Ensayos Clínicos como Asunto , Disfunción Cognitiva/epidemiología , Comorbilidad , Países Desarrollados , Países en Desarrollo , Epilepsia/diagnóstico , Epilepsia/epidemiología , Epilepsia/etiología , Humanos , Incidencia , Trastornos Mentales/epidemiología , Prevalencia , Estado Epiléptico/epidemiología , /epidemiología
6.
Medicine (Baltimore) ; 99(9): e19311, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32118756

RESUMEN

BACKGROUND: A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. A considerable amount of trials did not report essential outcomes or outcomes measurement methods, which makes it challenging to evaluate the efficacy and safety of treatment strategies for pressure injury (PI) and produced significant heterogeneity of reported outcomes. It is necessary to develop a COS, which can be used for clinical trials in PI treatment. METHODS/DESIGN: The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. We will search six databases and 2 registry platforms to identify currently reported PI treatment outcomes and outcome measurement instruments in randomized controlled trials, meta-analysis, and systematic reviews. We will also conduct a semi-structured interview with clinicians, nurses, and adult PI patients to collect their opinions on important outcomes. Each outcome of the initial list generated from systematic review and interviews will be scored and reach a consensus through two rounds of international Delphi survey with all key stakeholders. A face-to-face consensus meeting with key stakeholders will be conducted to finish a final COS and recommend measurement instruments for each outcome. RESULTS: We will develop a COS that should be reported in future clinical trials to evaluate the effectiveness of PI treatment. DISCUSSION: The COS will follow current guidance to develop a high-quality COS in the field of PI treatment to reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies, and improve the quality of clinical trials.


Asunto(s)
Ensayos Clínicos como Asunto/instrumentación , Pesos y Medidas/instrumentación , Protocolos Clínicos , Ensayos Clínicos como Asunto/métodos , Técnica Delfos , Determinación de Punto Final/métodos , Determinación de Punto Final/tendencias , Humanos , Proyectos de Investigación
8.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(3): 245-249, 2020 Mar 06.
Artículo en Chino | MEDLINE | ID: mdl-32187930

RESUMEN

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we puts forward a series of thoughts and suggestions on the common problems of safety study on vaccine, including the hypothesis of safety study, the consideration of inclusion/exclusion criteria and suspension/termination criteria for study; the routine requirements of safety study and some special issue such as medical laboratory test index, vaccine virus shedding and safety of adjuvant, and further clarifies the requirements of safety observation on sequential enrollment; also emphasized the scientific judgment of causality and the quality of safety monitoring. It can be used for reference by vaccine researchers and to explore appropriate solutions to promote vaccine research & development and risk control in China.


Asunto(s)
Ensayos Clínicos como Asunto , Proyectos de Investigación , Vacunas , China
9.
Zhonghua Yu Fang Yi Xue Za Zhi ; 54(3): 250-255, 2020 Mar 06.
Artículo en Chino | MEDLINE | ID: mdl-32187931

RESUMEN

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we summarized the common problems in safety analysis and report and accordingly puts forward a series of thoughts and suggestions, including discussing the role of statistics in safety analysis, putting forward the framework of safety analysis and report involved analysis content, analysis index and analysis dimension, in which attention is paid to the severity analysis; emphasizing the initiative analysis on risk signal and encouraging the evidence-based initiative safety evaluation. At the same time, this paper discusses the basic principles of the presentation of safety data in the package inserts, as well as the comprehensive consideration of the safety data of each phase of the trial and different subjects. It can be used for reference by sponsor to promote vaccine clinical research and evaluation in China.


Asunto(s)
Investigación Biomédica , Ensayos Clínicos como Asunto , Vacunas , China , Análisis de Datos
11.
Int J Infect Dis ; 92: 261-268, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32147023

RESUMEN

OBJECTIVE: Geographic region can be an important source of variation in the immune response to pneumococcal conjugate vaccines (PCV). The aim of this study was to collate data from available PCV clinical trials in order to characterize the differences in antibody responses in different countries. METHODS: A systematic review and meta-analysis was conducted to examine the difference in antibody responses after primary series of PCVs in infants, associated with geographic regions, compared with each other and with the different PCVs using random-effects models. RESULTS: A total of 69 trials were included. Studies conducted in the Western Pacific Region (WPR) showed higher geometric mean concentrations (GMC) compared to studies conducted in Europe. The pooled GMC for serotype 4 after three doses of PCV7 in the WPR was 5.19 µg/ml (95% confidence interval 4.85-5.53 µg/ml), while for studies conducted in Europe this was 2.01 µg/ml (95% confidence interval 1.88-2.14 µg/ml). The IgG GMC ratios among the WPR versus European regions ranged from 1.51 to 2.87 for PCV7, 1.69 to 3.22 for PCV10, and 1.49 to 3.08 for PCV13. CONCLUSIONS: Studies conducted in the WPR generally showed greater antibody responses than the studies conducted in Europe. Indications of differences among geographic regions highlight the fact that further research is needed to compare the biological factors contributing to immune responses, which may affect vaccination schedules.


Asunto(s)
Infecciones Neumocócicas/inmunología , Vacunas Neumococicas/inmunología , Formación de Anticuerpos , Australasia , Ensayos Clínicos como Asunto , Lejano Oriente , Femenino , Vacuna Neumocócica Conjugada Heptavalente/administración & dosificación , Vacuna Neumocócica Conjugada Heptavalente/inmunología , Humanos , Esquemas de Inmunización , Lactante , Masculino , Infecciones Neumocócicas/prevención & control , Vacunas Neumococicas/administración & dosificación , Serogrupo , Streptococcus pneumoniae/inmunología
15.
Artículo en Chino | MEDLINE | ID: mdl-32062890

RESUMEN

Objective: To investigate the registration characteristics and development trend of clinical trials of pneumoconiosis, analyze the clinical research characteristics and current situation of prevention and treatment pneumoconiosis. Methods: In December 2018, the databases of primary registries certified by International Clinical Trials Registry Platform (ICTRP) , such as Chinese Clinical Trial Registry (ChiCTR) , Clinical Trials. gov, and Japan Primary Registries Network (JPRN) were retrieved. All clinical trials related to pneumoconiosis were included from the database establishment until December 1, 2018, and the characteristics of registered clinical trials were analyzed. Results: A total of 23 clinical trials related to pneumoconiosis were inclued. The number of registrations in China and Brazil are 9 and 3 respectively, while the registration numbers of Clinical Trials. gov and ChiCTR are 10 and 5 respectively. Fourteen trials have been completed; five trials are ongoing, and four trials are unknown for the research progress. Ten trials were for silicosis patients. Eight trials with a sample size less than 50. Twelve trials were randomized controlled trials. Interventions of five clinical trial are pulmonary rehabilitation. There were six trials with a 12-month course of treatment. Conclusion: At present, the number of registered studies in clinical trials of pneumoconiosis is relatively less; the proportion of published clinical research results is low, and some clinical research status is unknown. It should increase the publicity of the registration of clinical trials for pneumoconiosis, improve the awareness of registration and the intensity of research design to promote the development of high-quality clinical trials.


Asunto(s)
Ensayos Clínicos como Asunto/estadística & datos numéricos , Neumoconiosis , Sistema de Registros , China , Bases de Datos Factuales , Humanos , Japón , Ensayos Clínicos Controlados Aleatorios como Asunto
16.
Medicine (Baltimore) ; 99(8): e19229, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32080122

RESUMEN

OBJECTIVES: The aim of this meta-analysis is to investigate the comparative efficacy between supervised- and home-based programs in patients with ankylosing spondylitis (AS). METHOD: A systematic search in PubMed, Web of Science, EMBASE, and the Cochrane Library was electronically performed by 2 independent investigators in order to capture all potential studies comparing supervised- with home-based in patients with AS from inception to April 2018. After extracted essential information, apprised risk of bias, statistical analysis was performed with Review Manager (RevMan) software (version 5.3.0). The protocol was registered at PROSPERO platform with an identifier of CRD42018097046. RESULTS: A total of 7 studies comprising 271 patients were included finally. Meta-analyses showed that, compared to home-based program, supervised-based program was associated with reduced bath ankylosing spondylitis metrology index (BASMI) scores (mean difference [MD], -0.45; 95% confidence interval [CI], -0.73, -0.17), bath ankylosing spondylitis disease activity index (BASDAI) scores (MD, -0.48; 95% CI, -0.88, -0.08), and bath ankylosing spondylitis functional index (BASFI) scores (MD, -0.78; 95% CI, -1.19, -0.37). However, depression scores (standard mean difference, -0.22; 95% CI, -0.58, 0.14) between the 2 groups showed no significant defference. CONCLUSIONS: Both supervised- and home-based programs can benefit to reduce BASMI, BASDAI, and BASFI scores in AS patients. However, short-term, supervised exercise program may be more effective than home-based exercises at decreasing disease activity with AS.


Asunto(s)
Terapia por Ejercicio/métodos , Servicios de Atención de Salud a Domicilio/organización & administración , Espondilitis Anquilosante/rehabilitación , Ensayos Clínicos como Asunto , Depresión/epidemiología , Humanos , Índice de Severidad de la Enfermedad , Espondilitis Anquilosante/epidemiología
17.
Bull Cancer ; 107(2): 148-156, 2020 Feb.
Artículo en Francés | MEDLINE | ID: mdl-32057466

RESUMEN

Over the past years, planet oncology has kept changing and moving forward. Recent results of important clinical trials are challenging our daily practices. With modesty, the Editorial Board of BulletinduCancer has selected some clinical trials they consider as "must-know about" even if they go beyond our medical fields.


Asunto(s)
Ensayos Clínicos como Asunto , Neoplasias/terapia , Aminopiridinas/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias del Sistema Digestivo/terapia , Femenino , Neoplasias de los Genitales Femeninos/terapia , Humanos , Neoplasias Pulmonares/terapia , Masculino , Terapia Molecular Dirigida , Neoplasias Primarias Desconocidas/terapia , Neoplasias de la Próstata/terapia , Purinas/uso terapéutico
20.
Zhonghua Wei Chang Wai Ke Za Zhi ; 23(2): 109-114, 2020 Feb 25.
Artículo en Chino | MEDLINE | ID: mdl-32074788

RESUMEN

As early as in the 1960s, China has begun to conduct exploratory clinical researches on gastric cancer. In the past 10 years, the research projects have increased significantly. Among them, the minimally invasive surgery represented by laparoscopy (CLASS Trial), the hot spot of the esophagogastric junction cancer (5010 Trial), the perioperative adjuvant treatment of advanced gastric cancer (CGOG1001 and RESOLVE Trials), the conversion treatment of late gastric cancer (DRAGON Trial) and high quality clinical research such as real-world research based on large database have made great progress. But there are still many deficiencies, such as few multi-center prospective research, limited research return, and the quality and innovation of scientific research data need to be further improved. However, it should also be noted that the clinical researches of gastric cancer in China have greater advantages and development space. The characteristics of large population base, rich cases and large proportion of advanced gastric cancer are conducive to real-world research. In the future, we should follow the international frontier and combine with national conditions to deepen clinical research, so that more "Chinese elements" can be introduced into the international guidelines for gastric cancer, and promote the overall level of diagnosis and treatment of gastric cancer in China.


Asunto(s)
Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/terapia , China , Ensayos Clínicos como Asunto , Gastrectomía , Humanos , Laparoscopía
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