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  1 / 23339 MEDLINE  
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[PMID]:29489696
[Au] Autor:Ren H; Ma L; Wei M; Li J; Yu M; Yin L
[Ad] Endereço:Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China.
[Ti] Título:Duplicated middle cerebral artery origin with an aneurysm.
[So] Source:Medicine (Baltimore);97(9):e9947, 2018 Mar.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Middle cerebral artery (MCA) anomalies are relatively rare and often related to aneurysms. Familiarity with these anomalies is important in resolving problems that arise in the complex angioarchitecture. Reports often describe that aneurysms that are related to accessory or duplicated MCA are often located at its origin. PATIENT CONCERNS: A 59-year-old man presented with a headache for 10 days, without nausea and vomiting. The physical examination was negative. DIAGNOSIS: A computed tomography (CT) scan revealed an intracerebral hematoma in the deep right frontal lobe, near the caudate nucleus. Digital subtraction angiography (DSA) revealed an anomalous duplicated origin of the right MCA, with occlusion of the main MCA trunk as well as twisting and dilation of the accessory MCA trunk. A wide-necked aneurysm was located at a sharp curve of the tortuous accessory MCA trunk. A ruptured aneurysm related to a duplicated MCA origin was diagnosed. INTERVENTIONS: Open surgery was rejected by the patient; hence, palliative endovascular coil embolization of the larger daughter sac was performed. OUTCOMES: The postoperative course was uneventful. There was no rebleeding at 8-months follow-up. LESSONS: MCA anomalies are relatively rare and often related to aneurysms. It is important to be familiar with these anomalies as related lesions often manifest within a complex angioarchitecture. Aneurysms at the trunk of an anomalous MCA are a rare entity and open surgery may be recommended.
[Mh] Termos MeSH primário: Aneurisma Roto/diagnóstico por imagem
Aneurisma Intracraniano/diagnóstico por imagem
Artéria Cerebral Média/anormalidades
[Mh] Termos MeSH secundário: Aneurisma Roto/complicações
Angiografia Digital
Angiografia Cerebral
Cefaleia/diagnóstico por imagem
Cefaleia/etiologia
Seres Humanos
Aneurisma Intracraniano/complicações
Masculino
Meia-Idade
Artéria Cerebral Média/diagnóstico por imagem
Tomografia Computadorizada por Raios X
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180301
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009947


  2 / 23339 MEDLINE  
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[PMID]:29489658
[Au] Autor:Huang KH; Tai MC; Lee LC; Weng TH; Chen YH; Lin LF; Chen JT; Lu DW; Chen CL
[Ad] Endereço:Department of Ophthalmology, Tri-Service General Hospital.
[Ti] Título:Positron emission tomography/computed tomography scan of Vogt-Koyanagi-Harada syndrome with associated autoimmune thyroid disease: A case report and literature review.
[So] Source:Medicine (Baltimore);97(9):e0047, 2018 Mar.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Vogt-Koyanagi-Harada (VKH) syndrome is a rare disease and could be associated with autoimmune thyroid disease (AITD). This report was aimed to investigate the utility of F-fludeoxyglucose positron emission tomography/computed tomography (F-FDG PET/CT) for the diagnosis of VKH syndrome with AITD and to perform a literature review on the association between the 2 diseases. PATIENT CONCERNS: A 55-year-old woman without the history of ocular trauma suffered from chronic headache. She was presented with painful blurred vision of both eyes with headache for 2 weeks. Ophthalmic evaluations revealed panuveitis, exudative retinal detachment, and papilloedema in both eyes. The clinical symptoms and presentations are compatible with the diagnosis of VKH syndrome. Other examinations for intraocular infection, malignancy, and lupus choroidopathy were of negative results. The result of contrast-enhanced computed tomography (CT) of the brain was normal. Due to the history of cancer in the patient's families, a F-FDG PET/CT whole-body scan was performed. The result indicated a focal of 2-fluoro-2-deoxy-D-glucose (FDG) uptake at the right upper lobe of the thyroid. Therefore, the patient's thyroid function was examined and the result indicated euthyroidism with detectable thyroid peroxidase/thyroglobulin antibodies. DIAGNOSES: VKH syndrome with associated AITD. INTERVENTIONS: Treatment with intravenous pulse systemic methylprednisolone (1000 mg daily) was prescribed for 3 days and then shifted gradually to tapered oral steroid medication. OUTCOMES: Symptoms of papillitis and serous retinal detachment of VKH syndrome was relieved after steroid treatment LESSONS:: F-fludeoxyglucose positron emission tomography/computed tomography (F-FDG PET/CT) can be used for the effective diagnosis of VKH syndrome with AITD.
[Mh] Termos MeSH primário: Tomografia Computadorizada com Tomografia por Emissão de Pósitrons
Tireoidite Autoimune/complicações
Tireoidite Autoimune/diagnóstico por imagem
Síndrome Uveomeningoencefálica/complicações
Síndrome Uveomeningoencefálica/diagnóstico por imagem
[Mh] Termos MeSH secundário: Feminino
Fluordesoxiglucose F18
Glucocorticoides/uso terapêutico
Cefaleia/etiologia
Seres Humanos
Metilprednisolona/uso terapêutico
Meia-Idade
Tireoidite Autoimune/tratamento farmacológico
Síndrome Uveomeningoencefálica/tratamento farmacológico
Transtornos da Visão/etiologia
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Glucocorticoids); 0Z5B2CJX4D (Fluorodeoxyglucose F18); X4W7ZR7023 (Methylprednisolone)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180301
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000010047


  3 / 23339 MEDLINE  
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[PMID]:29223275
[Au] Autor:Correa V; Vintch J; Lanks C
[Ad] Endereço:Division of Pulmonary and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center, Torrance, CA.
[Ti] Título:A 26-Year-Old Man From Mexico With Headaches, Dysuria, and a Right Scrotal Mass.
[So] Source:Chest;152(6):e147-e150, 2017 12.
[Is] ISSN:1931-3543
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:CASE PRESENTATION: A 26-year-old man with no medical history was admitted to the hospital for evaluation of his change in mental status. He was noted to be agitated at work and had difficulty walking for 2 days before being brought in to the ED by his family. According to his uncle, the patient had been complaining of a headache and pain with urination for approximately 1 week. He was born in Guerrero, Mexico (a small farm town), and moved to Los Angeles, California, in 2008.
[Mh] Termos MeSH primário: Disuria/etiologia
Cefaleia/etiologia
Hidrocefalia/complicações
Mycobacterium bovis/isolamento & purificação
Escroto/diagnóstico por imagem
Tuberculose dos Genitais Masculinos/diagnóstico
[Mh] Termos MeSH secundário: Adulto
DNA Bacteriano/análise
Diagnóstico Diferencial
Disuria/diagnóstico
Cefaleia/diagnóstico
Seres Humanos
Hidrocefalia/diagnóstico
Imagem por Ressonância Magnética
Masculino
Mycobacterium bovis/genética
Escroto/microbiologia
Tuberculose dos Genitais Masculinos/microbiologia
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (DNA, Bacterial)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171211
[St] Status:MEDLINE


  4 / 23339 MEDLINE  
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[PMID]:29466149
[Au] Autor:Knuesel SJ; Guseh JS; Karp Leaf R; Ciaranello AL; Eng GM
[Ad] Endereço:From the Departments of Medicine (S.J.K., J.S.G., R.K.L., A.L.C.) and Pathology (G.M.E.), Massachusetts General Hospital, and the Departments of Medicine (S.J.K., J.S.G., R.K.L., A.L.C.) and Pathology (G.M.E.), Harvard Medical School - both in Boston.
[Ti] Título:Case 6-2018: A 35-Year-Old Woman with Headache, Subjective Fever, and Anemia.
[So] Source:N Engl J Med;378(8):753-760, 2018 Feb 22.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Anemia Hemolítica Autoimune/diagnóstico
Anemia/etiologia
Eritema Infeccioso/diagnóstico
[Mh] Termos MeSH secundário: Adulto
Anemia Hemolítica Autoimune/etiologia
Doença de Crohn/complicações
Doença de Crohn/tratamento farmacológico
Diagnóstico Diferencial
Eritema Infeccioso/complicações
Feminino
Morte Fetal/etiologia
Febre/etiologia
Cefaleia/etiologia
Seres Humanos
Hospedeiro Imunocomprometido
Parvovirus B19 Humano/isolamento & purificação
Gravidez
Complicações Infecciosas na Gravidez
Viremia
[Pt] Tipo de publicação:CASE REPORTS; CLINICAL CONFERENCE; JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180222
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMcpc1712223


  5 / 23339 MEDLINE  
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[PMID]:29390256
[Au] Autor:Yu W; Qu W; Wang Z; Xin C; Jing R; Shang Y; Zou H; Wang H; Feng S
[Ad] Endereço:Hematology Department, Yantai Affiliated Hospital, Binzhou Medical University, Yantai.
[Ti] Título:Sjogren's syndrome complicating pancytopenia, cerebral hemorrhage, and damage in nervous system: A case report and literature review.
[So] Source:Medicine (Baltimore);96(50):e8542, 2017 Dec.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Sjogren's syndrome(SS) is a chronic autoimmune disease, which damages exocrine glands especially salivary and lacrimal glands, with xerostomia and xerophthalmia as common symptoms. PATIENT CONCERNS: We report a case of a 49-year-old woman presented with pancytopenia. Her laboratory examinations lead us diagnose her as Sjogren's syndrome complicating pancytopenia. She had neurological symptoms during her treatment, which represent only 4.5% of Sjogren's syndrome complicating damage in nervous system. DIAGNOSES: Sjogren's syndrome complicating pancytopenia. INTERVENTIONS: Dexamethasone (40mg QD for 4 days) and immunoglobulin (25g QD for 2 days) were administered for intensive treatment followed by oral methylprednisolone 40mg QD as maintenance treatment. Total glucosides of paeony 0.6g TID and danazol 0.2g BID per os were given. We also gave her Piperacillin-tazobactam and moxifloxacin for anti-infection and Fluconazole for anti-fungal therapy, as well as other supportive treatments. OUTCOMES: Follow-up of the patient observed the normalization of peripheral blood cell count, immunity indices and neurological examinations 6 months after discharge. LESSONS: For patients presented with blood system abnormalities unilineage or multiple-lineage cytopenia in particular, history investigations and relevant examinations should be considered to exclude the existence of autoimmune diseases like Sjogren's syndrome.
[Mh] Termos MeSH primário: Hemorragia Cerebral/etiologia
Pancitopenia/etiologia
Síndrome de Sjogren/complicações
[Mh] Termos MeSH secundário: Dexametasona/uso terapêutico
Equimose/etiologia
Feminino
Glucocorticoides/uso terapêutico
Cefaleia/etiologia
Seres Humanos
Imunoglobulinas Intravenosas/uso terapêutico
Metilprednisolona/uso terapêutico
Meia-Idade
Convulsões/etiologia
Síndrome de Sjogren/tratamento farmacológico
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Glucocorticoids); 0 (Immunoglobulins, Intravenous); 7S5I7G3JQL (Dexamethasone); X4W7ZR7023 (Methylprednisolone)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180203
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000008542


  6 / 23339 MEDLINE  
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[PMID]:29360844
[Au] Autor:Beggs CB; Giaquinta A; Veroux M; De Marco E; Mociskyte D; Veroux P
[Ad] Endereço:Institute for Sport, Physical Activity and Leisure, School of Sport, Leeds Beckett University, Leeds, United Kingdom.
[Ti] Título:Mid-term sustained relief from headaches after balloon angioplasty of the internal jugular veins in patients with multiple sclerosis.
[So] Source:PLoS One;13(1):e0191534, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: Multiple sclerosis (MS) patients frequently suffer from headaches and fatigue, and many reports have linked headaches with intracranial and/or extracranial venous obstruction. We therefore designed a study involving MS patients diagnosed with obstructive disease of internal jugular veins (IJVs), with the aim of evaluating the impact of percutaneous transluminal angioplasty (PTA) on headache and fatigue indicators. METHODS: 286 MS patients (175 relapsing remitting (RR), 75 secondary progressive (SP), and 36 primary progressive (PP)), diagnosed with obstructive disease of IJVs, underwent PTA of IJVs during the period 2011-2015. This included 113 headache positive patients (82 RR, 22 SP, and 9 PP) and 277 fatigue positive patients (167 RR, 74 SP, and 36 PP). Migraine Disability Assessment (MIDAS), and the Fatigue Severity Scale (FSS) were evaluated: before PTA; 3-months after PTA; and at final follow-up in 2017. Patients were evaluated with Doppler sonography of the IJVs at 1, 6 and 12 months after PTA and yearly thereafter. Non-parametric statistical analysis was performed using a combination of the Friedman test and Spearman correlation analysis. RESULTS: With the exception of the PP patients there were significant reductions (all p < 0.001) in the MIDAS and FSS scores in the 3-month following PTA. The improvement in MIDAS score following PTA was maintained throughout the follow-up period in both the RR (p < 0.001; mean of 3.55 years) and SP (p = 0.002; mean of 3.52 years) MS cohorts. With FSS, significant improvement was only observed at 2017 follow-up in the RR patients (p < 0.001; mean of 3.37 years). In the headache-positive patients, post-PTA MIDAS score was significantly negatively correlated with the change in the blood flow score in the left (r = -0.238, p = 0.031) and right (r = -0.250, p = 0.023) IJVs in the RR patients and left IJV (r = -0.727, p = 0.026) in the PP patients. In the fatigue-positive cohort, post-PTA FSS score was also significantly negatively correlated with the change in blood flow in the right IJV in the PP patients (r = -0.423, p = 0.010). In addition, the pre and post-PTA FSS scores were significantly positively correlated in the fatigue-positive RR (r = 0.249, p = 0.001) and SP patients (r = 0.272, p = 0.019). CONCLUSIONS: The intervention of PTA was associated with a large and sustained (>3 years) reduction in MIDAS score in both RR and SP MS patients. While a similar initial post-PTA reduction in FSS score was also observed, this was not maintained in the SP and PP patients, although it remained significant at follow-up (>3 years) in the RR MS patients. This suggests that venoplasty might be a useful intervention for treating patients with persistent headaches and selected concomitant obstructive disease of the IJVs.
[Mh] Termos MeSH primário: Angioplastia com Balão/utilização
Cefaleia/terapia
Veias Jugulares/diagnóstico por imagem
Esclerose Múltipla/complicações
[Mh] Termos MeSH secundário: Adulto
Feminino
Cefaleia/complicações
Seres Humanos
Masculino
Meia-Idade
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180124
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0191534


  7 / 23339 MEDLINE  
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[PMID]:29384937
[Au] Autor:Zhang W; Huang Z; Jin Y
[Ad] Endereço:Department of Rehabilitation Medicine, Panyu Central Hospital, Guangzhou, China.
[Ti] Título:Acupuncture as a primary and independent treatment for a patient with chronic insomnia: One-year follow-up case report.
[So] Source:Medicine (Baltimore);96(52):e9471, 2017 Dec.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Insomnia is a common disease. Till date, no study has reported the long-term (up to 1 year) outcomes of acupuncture as a primary and independent treatment in patients with insomnia. This report aims to present response of patient who was treated by acupuncture. This patient was evaluated with polysomnography. PATIENT CONCERNS: A 40-year-old patient had been diagnosed with insomnia for 2 years and getting worse since 1 month ago. He had undergone depression and anxiety emotion, but refused to take medical treatment for chronic insomnia. DIAGNOSES: In this study, the diagnosis of chronic insomnia was based on the International Classification of Sleep Disorders insomnia. The patient had no obvious differential diagnosis. INTERVENTIONS: Acupuncture treatment was planned for this patient who refused to take medical treatment with chronic insomnia. So the patient received 1 hour of acupuncture treatment for 12 weeks. OUTCOME: Polysomnographic evaluation was performed at baseline and 3 months, and 1 year after acupuncture treatment. He was asked to keep a diary of all his insomnia-related symptoms. All outcome measures substantially improved. Moreover, during the observation period, the patient's sleep quality did not worsen. LESSONS: After acupuncture treatment, improvements of subjective symptoms such as unrefreshing sleep, sleep disturbances, accompanied symptoms (morning headache, fatigue, and mood worsening) were observed. Remarkable improvement was recorded by polysomnographic parameters. The costs of the treatment of insomnia may be reduced, if this therapy was proved useful in future controlled studies.
[Mh] Termos MeSH primário: Terapia por Acupuntura/métodos
Distúrbios do Início e da Manutenção do Sono/terapia
[Mh] Termos MeSH secundário: Adulto
Doença Crônica
Fadiga/etiologia
Seguimentos
Cefaleia/etiologia
Seres Humanos
Masculino
Polissonografia
Distúrbios do Início e da Manutenção do Sono/complicações
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180201
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009471


  8 / 23339 MEDLINE  
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[PMID]:28467570
[Au] Autor:Azman F; Erkilinç B; Çabalar M; Çagirici S; Yayla V
[Ti] Título:[A rarely known headache: Airplane travel headache].
[Ti] Título:Az taninan bir basagrisi: Uçak yolculugu basagrisi..
[So] Source:Agri;29(1):47-48, 2017 Jan.
[Is] ISSN:1300-0012
[Cp] País de publicação:Turkey
[La] Idioma:tur
[Ab] Resumo:Recently, headache associated with airplane travel has gained importance with case reports and took its place in the classification of headache in 2013. This rare condition has different spesific characteristic from the primary headaches and its pathophysiology is not clear yet. In this case report, a 27-years-old female patient was diagnosed with the headache associated with airplane travel by history, examination and imaging findings. The possible pathophysiology and treatment were discussed.
[Mh] Termos MeSH primário: Aeronaves
Cefaleia/diagnóstico
Viagem
[Mh] Termos MeSH secundário: Adulto
Diagnóstico Diferencial
Feminino
Cefaleia/etiologia
Cefaleia/fisiopatologia
Seres Humanos
Medição da Dor
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180220
[Lr] Data última revisão:
180220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170504
[St] Status:MEDLINE
[do] DOI:10.5505/agri.2015.79037


  9 / 23339 MEDLINE  
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[PMID]:29381990
[Au] Autor:Zheng RW; Liu D; Eric TE; Ning YZ; Chen LL; Hu H; Ren Y
[Ad] Endereço:Department of Acupuncture and Moxibustion, Dongfang Hospital, The Second Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China.
[Ti] Título:A case study of Ramsay Hunt Syndrome in conjunction with cranial polyneuritis.
[So] Source:Medicine (Baltimore);96(47):e8833, 2017 Nov.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Ramsay Hunt syndrome in conjunction with cranial polyneuritis is not extensively documented, and is very easily misdiagnosed. PATIENT CONCERNS: A case of a 53-year-old male with Ramsay Hunt syndrome in conjunction with cranial polyneuritis is presented with early symptoms of vertigo, cephalalgia, and facial palsy, followed by zoster oticus 10 days later. DIAGNOSES: Diagnosis was challenging as this condition presents with multiple neuropathies, and attempting to diagnose based on clinical symptoms was often misleading. Polymerase chain reaction can be used to test for presence of the virus in the cerebrospinal fluid, followed by targeted drug therapy. INTERVENTIONS: Acupuncture, in conjunction with fire cupping, bloodletting around the afflicted region on the face, as well as oral consumption of herbal medicine and vitamins for nerve nourishment was given to treat this disease. OUTCOMES: Due to misdiagnosis resulting in delayed treatment, peripheral facial paralysis was left as the main sequelae, while other symptoms responded quickly to treatment. After a 6-month follow-up, facial palsy was still present. LESSONS: Considering that targeted antiviral therapy can be used to increase the effectiveness of treatment, early diagnosis, and timely use of medication is critical.
[Mh] Termos MeSH primário: Doenças dos Nervos Cranianos/diagnóstico
Erros de Diagnóstico/efeitos adversos
Herpes Zoster da Orelha Externa/diagnóstico
Neurite (Inflamação)/diagnóstico
[Mh] Termos MeSH secundário: Antivirais/uso terapêutico
Doenças dos Nervos Cranianos/virologia
Paralisia Facial/diagnóstico
Paralisia Facial/virologia
Cefaleia/diagnóstico
Cefaleia/virologia
Herpes Zoster da Orelha Externa/virologia
Seres Humanos
Masculino
Meia-Idade
Neurite (Inflamação)/virologia
Vertigem/diagnóstico
Vertigem/virologia
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antiviral Agents)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180209
[Lr] Data última revisão:
180209
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180201
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000008833


  10 / 23339 MEDLINE  
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[PMID]:29319940
[Au] Autor:Food and Drug Administration, HHS
[Ti] Título:Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.
[So] Source:Fed Regist;82(247):61168-9, 2017 Dec 27.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Terapia por Estimulação Elétrica/classificação
Terapia por Estimulação Elétrica/instrumentação
Segurança de Equipamentos/classificação
Estimulação do Nervo Vago/classificação
Estimulação do Nervo Vago/instrumentação
[Mh] Termos MeSH secundário: Cefaleia/terapia
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE



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BIREME/OPAS/OMS - Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde