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1.
Arq. gastroenterol ; 58(2): 227-233, Apr.-June 2021. tab
Article in English | LILACS | ID: biblio-1285313

ABSTRACT

ABSTRACT BACKGROUND: Primary sclerosing cholangitis (PSC) is a rare hepatobiliary disorder, whose etiology remains not fully elucidated. Given how rare PSC is in childhood, until the recent publication of a multicenter international collaboration, even data on its characteristics and natural history were scarce. Symptomatic cholelithiasis has not been previously reported as the presentation of PSC. OBJECTIVE: The aim of this study was the diagnosis of PSC following the initial unusual presentation with symptomatic cholelithiasis, that followed an atypical clinical course that could not be explained by cholelithiasis alone. A literature review was also conducted. METHODS: We conducted a retrospective chart review of three patients, who were diagnosed and/or followed at the Clinics Hospital, University of Campinas - Sao Paulo/ Brazil, between 2014 and 2020. Data analyzed included gender, age of presentation, past medical history, imaging findings, laboratory results, endoscopic evaluation, response to medical therapy and follow-up. RESULTS: Age at time of presentation with cholelithiasis varied from 10 to 12 years. In two of the cases reported, a more subacute onset of symptoms preceded the episode of cholelithiasis. Two patients were managed with cholecystectomy, not followed by any surgical complications, one patient was managed conservatively. Percutaneous liver biopsy was performed in all three cases, showing histological findings compatible with PSC. Associated inflammatory bowel disease (IBD) was not seen in any of the patients. The patients have been followed for a mean time of 3.4 years. CONCLUSION: PSC and cholelithiasis are both rare in the pediatric population. This study reports on symptomatic cholelithiasis as a presentation of PSC and raises the importance of suspecting an underlying hepatobiliary disorder in children with cholelithiasis without any known predisposing factors and/or that follow an atypical clinical course for cholelithiasis alone.


RESUMO CONTEXTO: A colangite esclerosante primária (CEP) é uma doença hepatobiliar rara, cuja etiologia ainda não está totalmente elucidada. Dada a raridade do CEP na infância, até a recente publicação de uma colaboração multicêntrica internacional, mesmo dados sobre suas características e história natural eram escassos. A colelitíase sintomática não foi relatada anteriormente como a apresentação inicial de CEP na infância. OBJETIVO: O objetivo deste estudo foi o diagnóstico de CEP após a apresentação inicial incomum com colelitíase sintomática, que seguiu um curso clínico atípico que não poderia ser explicado apenas pela colelitíase. Também foi realizada uma revisão da literatura. MÉTODOS: Foi realizada uma revisão retrospectiva dos prontuários de três pacientes, que foram diagnosticados e/ou acompanhados no Hospital das Clínicas da Universidade Estadual de Campinas - São Paulo / Brasil, entre 2014 e 2020. Os dados analisados incluíram sexo, idade de apresentação, história médica pregressa, achados de imagem, resultados laboratoriais, avaliação endoscópica, resposta à terapia médica e acompanhamento. RESULTADOS: A idade no momento da apresentação da colelitíase variou de 10 a 12 anos. Em dois dos casos relatados, um início mais subagudo dos sintomas precedeu o episódio de colelitíase. Dois pacientes foram tratados com colecistectomia, não seguida de qualquer complicação cirúrgica, e um paciente foi tratado de forma conservadora. Biópsia hepática percutânea foi realizada em todos os três casos, mostrando achados histológicos compatíveis com CEP. Doença inflamatória intestinal associada não foi observada em nenhum dos pacientes. Os pacientes foram acompanhados por um tempo médio de 3,4 anos. CONCLUSÃO: CEP e colelitíase são raras na população pediátrica. Este estudo relata a colelitíase sintomática como uma apresentação de CEP e levanta a importância da suspeita de doença hepatobiliar subjacente em crianças com colelitíase sem quaisquer fatores predisponentes conhecidos e/ou que seguem um curso clínico atípico.


Subject(s)
Humans , Child , Cholangitis, Sclerosing/complications , Cholangitis, Sclerosing/diagnosis , Cholangitis, Sclerosing/therapy , Inflammatory Bowel Diseases , Cholelithiasis/complications , Cholelithiasis/diagnostic imaging , Brazil , Retrospective Studies , Multicenter Studies as Topic
2.
Article in Chinese | WPRIM | ID: wpr-879081

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Humans , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
9.
Einstein (Säo Paulo) ; 19: eRW6186, 2021. tab, graf
Article in English | LILACS | ID: biblio-1286295

ABSTRACT

ABSTRACT The objective of this study was to highlight the global scientific effort to fight the SARS-CoV-2, addressing the preliminary results of passive immunization through convalescent plasma. We performed a search at the major databases of interventional clinical trial protocols about the transfusion of convalescent plasma in patients with COVID-19, as well as, published articles (n≥25), using the following search strategy: [(COVID-19 OR SARS-CoV-2 OR nCoV-2019) AND (Convalescent plasma OR Plasma exchange) AND (Treatment OR Therapy)]. A total of 24 interventional clinical trial protocols (advanced in phases II-III, III, and IV) were included in this review, as well as three studies that had enough outcomes to evaluate the efficacy of convalescent plasma therapy for patients with COVID-19. All interventional clinical trial protocols applied approximately 500mL of convalescent plasma (from single or more donations) in hospitalized patients, mainly in patients with severe disease associated with standard therapy for COVID-19, and compared to placebo or standard therapy plus specific drugs. Most of interventional clinical trial protocols are multicenter, and the phase IV studies are recruiting at intercontinental centers of North America, Oceania, Europe, but most are recruiting center inside their own county. The three studies published reported similar approach of convalescent plasma intervention with decrease in length of stay, mortality, with less than 4% of adverse events, mainly for treating critical cases with life-threatening disease. All advanced clinical trials focused on convalescent plasma therapy in patients with COVID-19 hospitalized in severe conditions, and the preliminary results provide strong evidence for therapy for the COVID-19 patients.


RESUMO O objetivo deste estudo foi destacar o esforço científico global para combater o SARS-CoV-2 abordando os resultados preliminares da imunização passiva por plasma convalescente. Foi realizada uma busca nas principais bases de dados dos protocolos de ensaios clínicos intervencionistas sobre transfusão de plasma convalescente em pacientes com COVID-19, bem como artigos publicados (n≥25), utilizando a seguinte estratégia de busca: [(COVID-19 OR SARS-CoV-2 OR nCoV-2019) AND (Convalescent plasma OR Plasma exchange) AND (Treatment OR Therapy)]. Um total de 24 protocolos de ensaios clínicos intervencionistas (avançados nas fases II-III, III e IV) foi incluído nesta revisão, assim como três estudos que tiveram resultados suficientes para avaliar a eficácia da terapia com plasma convalescente para pacientes com COVID-19. Todos os protocolos de ensaios clínicos intervencionistas aplicaram cerca de 500mL de plasma convalescente (de uma ou mais doações) em pacientes hospitalizados, principalmente naqueles com grau grave de doença associada à terapia-padrão para COVID-19 em comparação com placebo ou terapia-padrão mais medicamentos específicos. A maioria dos protocolos de ensaios clínicos intervencionistas é multicêntrica, e os estudos de fase IV estão recrutando em centros intercontinentais da América do Norte, Oceania e Europa, mas a maior parte dos centros de recrutamento está dentro de seu próprio país. Os três estudos publicados relataram abordagem semelhante de intervenção para plasma convalescente com redução do tempo de internação, mortalidade e menos de 4% de eventos adversos, principalmente para o tratamento de casos críticos com risco de vida. Todos os ensaios clínicos avançados focaram na terapia com plasma convalescente em pacientes com COVID-19 hospitalizados em condições graves, e os resultados preliminares fornecem fortes evidências para a terapia para esses pacientes com COVID-19.


Subject(s)
Humans , COVID-19/therapy , Plasma , Multicenter Studies as Topic , Immunization, Passive , Treatment Outcome , Critical Illness , SARS-CoV-2
10.
Braz. oral res. (Online) ; 35: e033, 2021. tab
Article in English | LILACS, BBO | ID: biblio-1153604

ABSTRACT

Abstract The aim of this study was to investigate the epidemiological and clinical characteristics of chronic inflammatory periapical diseases in different regions of Brazil and to compare with data from the literature. A multicenter study was carried out in four Brazilian referral centers in oral diagnosis. Histopathological records were reviewed, and all cases diagnosed microscopically as periapical granuloma, radicular cyst, and periapical abscess were included. Demographic and clinical data were collected. Descriptive statistics and Pearson's chi-square test were performed. A total of 10,381 cases of chronic inflammatory periapical diseases were found (13.8% of 74,931 archived specimens) over a period of 65 years. Radicular cysts were the most common lesion (59.9%). Women (56.1%) with a mean age of 37.01 years old (range 13 to 100 ± 14.42) and people of white skin color (59.2%) were the most affected individuals by chronic inflammatory periapical diseases. The lesions were generally asymptomatic (28.1%), located in the maxilla (60.1%), and posterior region (49.8%). The radicular cysts were larger when compared to periapical granulomas (p < 0.001). The disagreement between the clinical and histopathological diagnoses was higher when the final diagnosis was a periapical granuloma (p < 0.001). Chronic inflammatory periapical diseases continue to be common lesions affecting mainly adults. This should be a consequence of the burden of untreated caries in permanent teeth. Women are more affected and radicular cyst was the most common lesion.


Subject(s)
Humans , Female , Adolescent , Adult , Young Adult , Periapical Abscess/epidemiology , Periapical Diseases/epidemiology , Periapical Granuloma/epidemiology , Radicular Cyst/epidemiology , Brazil/epidemiology , Chronic Disease , Multicenter Studies as Topic
11.
Rev. colomb. cancerol ; 24(3): 140-145, jul.-set. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1144333

ABSTRACT

Resumen El desarrollo y la innovación de nuevas tecnologías ha permitido mejorar la detección de la infección por el virus del papiloma humano de alto riesgo. La captura de híbridos II es un ensayo que se basa en hibridación y quimioluminiscencia. Cobas VPH Test es una PCR cualitativa y Aptima VPH Assay permite detectar la expresión de ARN mensajero de las oncoproteínas E6/E7 del VPH de alto riesgo. Estas técnicas presentan ventajas en comparación con la citología convencional, que se utiliza como prueba de rutina para la detección temprana del cáncer de cuello uterino. En el estudio ESTAMPA se realizaron 13.691 procesamientos que permitieron identificar que para el planteamiento de proyectos de investigación o para la implementación de pruebas de tamizaje de VPH es necesario analizar las ventajas y desventajas de las pruebas del mercado.


Abstract The development and innovation of new technologies has improved the detection of high-risk human papillomavirus infection. Hybrid capture II is an assay that is based on hybridization and chemiluminescence. Cobas HPV Test is a qualitative PCR and Aptima HPV Assay allows to detect the expression of messenger RNA of the high- risk HPV E6 / E7 oncoproteins. These techniques have advantages, in comparison, with conventional cytology that is routinely used for the detection of cervical cancer. In the ESTAMPA study, 13,691 prosecutions were carried out that allowed to identify that for the planning of research projects or for the implementation of HPV screening tests, it is necessary to analyze the advantages and disadvantages of market tests.


Subject(s)
Humans , Female , Papillomaviridae/isolation & purification , Research Design , Uterine Cervical Neoplasms/diagnosis , Papillomavirus Infections/diagnosis , Molecular Diagnostic Techniques/methods , Papillomaviridae/genetics , DNA, Viral , RNA, Messenger , Uterine Cervical Neoplasms/genetics , Mass Screening , Multicenter Studies as Topic , Triage , Papillomavirus Infections/genetics , Human Papillomavirus DNA Tests , Luminescent Measurements , Nucleic Acid Hybridization
12.
Ciênc. Saúde Colet ; 25(4): 1421-1432, abr. 2020. tab, graf
Article in Portuguese | LILACS | ID: biblio-1089528

ABSTRACT

Resumo A dieta DASH (Dietary Approach to Stop Hypertension) é considerada um padrão alimentar saudável, sendo preconizada para o controle da hipertensão arterial. O objetivo do artigo foi revisar a literatura sobre a dieta DASH e verificar sua adesão pela população brasileira. Realizou-se revisão integrativa nas bases Medline/PubMed, SciELO e LILACS, nos idiomas inglês e português. A literatura sobre dieta DASH é extensa, entretanto quatro estudos mostrando a adesão pela população brasileira foram encontrados. A dieta DASH representa uma intervenção potencialmente acessível e aplicável que poderia melhorar a saúde da população. Os estudos diferiram entre si nos métodos de avaliação utilizados e a baixa adesão evidencia a necessidade de implementação de ações no âmbito da atenção nutricional ao hipertenso. Estratégias inovadoras serão necessárias para determinar a melhor forma de minimizar as barreiras para disseminação e adesão a esse padrão alimentar saudável. Sugere-se planos alimentares e orientações flexíveis, pouco restritivas, compatíveis, com objetivos claros, direcionados para mudanças graduais, com monitoramento frequente de equipe multiprofissional de saúde.


Abstract The DASH (Dietary Approach to Stop Hypertension) diet is considered a healthy eating standard and has been recommended for the control of arterial hypertension. The scope of this article was to review the scientific literature regarding the DASH diet and to verify the adherence to this food standard by the Brazilian population. An integrative review of the literature in the Medline/PubMed, SciELO and LILACS databases was conducted in English and Portuguese. The literature on the DASH diet is extensive. However, only four studies showing adherence to the DASH diet by the Brazilian population were found. Findings from this review show that the DASH diet represents a potentially accessible and applicable intervention, which could improve the health of the population. The studies differed in the methods of evaluation. The low adherence to the diet in the Brazilian population reveals the need for nutritional actions to deal with hypertension. Innovative strategies are called for to determine how best to minimize the barriers to dissemination and greater adherence to this healthy food standard. Food plans and flexible, non-restrictive, compatible guidelines with clear objectives directed towards gradual changes with frequent monitoring by a multiprofessional health team, are suggested.


Subject(s)
Humans , Public Health , Patient Compliance/statistics & numerical data , Dietary Approaches To Stop Hypertension/statistics & numerical data , Hypertension/diet therapy , Brazil , Randomized Controlled Trials as Topic , Cross-Sectional Studies , Multicenter Studies as Topic
13.
Article in English | WPRIM | ID: wpr-827472

ABSTRACT

BACKGROUND@#Neck pain caused by cervical spondylosis (CS) is a chronic pain condition, with an increasingly high incidence in the general population. Electroacupuncture is a common analgesic modality that has been widely applied in neck pain treatment. However, current electroacupuncture instruments used in the clinic have low intelligence levels and obscure parameter standards. We here designed this study for assessing the effect and safety of a new, intelligent electroacupuncture instrument, the CX-DZ-II, in treating neck pain.@*METHODS@#The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial for CX-DZ-II on treating neck pain caused by CS. Totally 160 eligible patients will be included in this trial and randomly assigned to an experimental group and a control group in a 1:1 ratio. A semi-standard acupoint selection strategy will be employed. In the experimental group, selected acupoints will be stimulated by CX-DZ-II. Electroacupuncture treatment will be accomplished by a pre-existing electroacupuncture instrument in the control group. The duration of treatment will be 2 weeks. The primary outcome is the change of Visual Analog Scale (VAS) score after one course of treatment. The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument.@*DISCUSSION@#This study will evaluate the effect and safety of the CX-DZ-II intelligent electroacupuncture therapeutic instrument in comparison with a pre-existing non-intelligent instrument in the treatment of neck pain caused by CS. The results will hopefully demonstrate a more optimal electroacupuncture instrument for the treatment of neck pain. (Trial registration No. gov NCT03005301).


Subject(s)
Adolescent , Adult , Aged , Electroacupuncture , Methods , Equivalence Trials as Topic , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Neck Pain , Therapeutics , Pain Measurement , Prospective Studies , Spondylosis , Therapeutics , Young Adult
14.
Korean Circulation Journal ; : 317-327, 2020.
Article in English | WPRIM | ID: wpr-811369

ABSTRACT

BACKGROUND AND OBJECTIVES: Recently, Genoss drug-eluting stent (DES)™ stent comprising cobalt-chromium platform with an ultrathin strut thickness, sirolimus, and an abluminal biodegradable polymer was developed. Owing to the lack of substantial evidence for the safety and efficacy of this stent, we report 12-month results of the Genoss DES™ stent.METHODS: We analyzed subjects who were eligible for a 12-month follow-up from the ongoing Genoss DES™ registry, which is a prospective, single-arm, observational, multicenter trial to investigate the clinical outcomes after the successful Genoss DES™ stent implantation among all-comers. The primary endpoint was a device-oriented composite outcome, defined as cardiac death, target vessel-related myocardial infarction, and target lesion revascularization at 12-month follow-up.RESULTS: Among 622 subjects, the mean age of subjects was 66.5±10.4 years, 70.6% were males, 67.5% had hypertension, and 38.3% had diabetes. The implanted stent number, diameter, and length per patient were 1.5±0.8, 3.1±0.4 mm, and 36.0±23.3 mm, respectively. At 12-month clinical follow-up, the primary endpoint occurred only in 4 (0.6%) subjects.CONCLUSIONS: The novel Genoss DES™ stent exhibited excellent safety and efficacy in real-world practice.


Subject(s)
Death , Drug-Eluting Stents , Follow-Up Studies , Humans , Hypertension , Male , Multicenter Studies as Topic , Myocardial Infarction , Percutaneous Coronary Intervention , Polymers , Prospective Studies , Registries , Sirolimus , Stents
17.
Braz. arch. biol. technol ; 63: e20190179, 2020. tab, graf
Article in English | LILACS | ID: biblio-1132181

ABSTRACT

Abstract (1) Background: The Commercial Kit SIRE Nitratase® PlastLabor, is a drug susceptibility test kit used to detect Mycobacterium tuberculosis resistance to first-line TB treatment drugs. The present study aimed at evaluating its performance in a multicenter study. (2) Methods: To determine its accuracy, the proportion methods in Lowenstein Jensen medium or the BACTECTMMGITTM960 system was used as a gold standard. (3) Results: The study revealed that the respective accuracies of the kit with 190 M. tuberculosis clinical isolates, using the proportion methods in Lowenstein Jensen medium or BACTECTMMGITTM960 system as a gold standard, were 93.9% and 94.6%, 96.9% and 94.6%, 98.0% and 97.8%, and 98.0% and 98.9%, for streptomycin, isoniazid, rifampicin, and ethambutol, respectively. (4) Conclusion: Thus, the kit can rapidly screen resistance to streptomycin, isoniazid, rifampicin, and ethambutol. Additionally, it does not require sophisticated equipment; hence, it can be easily used in the laboratories of low and middle income countries.


Subject(s)
Humans , Tuberculosis, Multidrug-Resistant/microbiology , Antibiotics, Antitubercular/pharmacology , Mycobacterium tuberculosis/isolation & purification , Mycobacterium tuberculosis/drug effects , Microbial Sensitivity Tests , Multicenter Studies as Topic , Sensitivity and Specificity , Tuberculosis, Multidrug-Resistant/drug therapy , Antibiotics, Antitubercular/classification
20.
Rev. bras. cir. cardiovasc ; 34(4): 396-405, July-Aug. 2019. tab, graf
Article in English | LILACS | ID: biblio-1020497

ABSTRACT

Abstract Objective: To evaluate whether there is any difference on the results of patients treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in the setting of ischemic heart failure (HF). Methods: Databases (MEDLINE, Embase, Cochrane Controlled Trials Register [CENTRAL/CCTR], ClinicalTrials.gov, Scientific Electronic Library Online [SciELO], Literatura Latino-americana e do Caribe em Ciências da Saúde [LILACS], and Google Scholar) were searched for studies published until February 2019. Main outcomes of interest were mortality, myocardial infarction, repeat revascularization, and stroke. Results: The search yielded 5,775 studies for inclusion. Of these, 20 articles were analyzed, and their data were extracted. The total number of patients included was 54,173, and those underwent CABG (N=29,075) or PCI (N=25098). The hazard ratios (HRs) for mortality (HR 0.763; 95% confidence interval [CI] 0.678-0.859; P<0.001), myocardial infarction (HR 0.481; 95% CI 0.365-0.633; P<0.001), and repeat revascularization (HR 0.321; 95% CI 0.241-0.428; P<0.001) were lower in the CABG group than in the PCI group. The HR for stroke showed no statistically significant difference between the groups (random effect model: HR 0.879; 95% CI 0.625-1.237; P=0.459). Conclusion: This meta-analysis found that CABG surgery remains the best option for patients with ischemic HF, without increase in the risk of stroke.


Subject(s)
Humans , Male , Female , Aged , Coronary Artery Bypass/mortality , Myocardial Ischemia/surgery , Stroke/etiology , Percutaneous Coronary Intervention/mortality , Heart Failure/surgery , Postoperative Complications/etiology , Postoperative Complications/mortality , Brazil/epidemiology , Review Literature as Topic , Randomized Controlled Trials as Topic , Meta-Analysis as Topic , Coronary Artery Bypass/adverse effects , Epidemiologic Methods , Multicenter Studies as Topic , Treatment Outcome , Practice Guidelines as Topic , Myocardial Ischemia/mortality , Evidence-Based Medicine , Stroke/mortality , Percutaneous Coronary Intervention/adverse effects
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