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[PMID]:29432461
[Au] Autor:Weenk M; van Goor H; van Acht M; Engelen LJ; van de Belt TH; Bredie SJH
[Ad] Endereço:Department of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands.
[Ti] Título:A smart all-in-one device to measure vital signs in admitted patients.
[So] Source:PLoS One;13(2):e0190138, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Vital sign measurements in hospitalized patients by nurses are time consuming and prone to operational errors. The Checkme, a smart all-in-one device capable of measuring vital signs, could improve daily patient monitoring by reducing measurement time, inter-observer variability, and incorrect inputs in the Electronic Health Record (EHR). We evaluated the accuracy of self measurements by patient using the Checkme in comparison with gold standard and nurse measurements. METHODS AND FINDINGS: This prospective comparative study was conducted at the Internal Medicine ward of an academic hospital in the Netherlands. Fifty non-critically ill patients were enrolled in the study. Time-related measurement sessions were conducted on consecutive patients in a randomized order: vital sign measurement in duplicate by a well-trained investigator (gold standard), a Checkme measurement by the patient, and a routine vital sign measurement by a nurse. In 41 patients (82%), initial calibration of the Checkme was successful and results were eligible for analysis. In total, 69 sessions were conducted for these 41 patients. The temperature results recorded by the patient with the Checkme differed significantly from the gold standard core temperature measurements (mean difference 0.1 ± 0.3). Obtained differences in vital signs and calculated Modified Early Warning Score (MEWS) were small and were in range with predefined accepted discrepancies. CONCLUSIONS: Patient-calculated MEWS using the Checkme, nurse measurements, and gold standard measurements all correlated well, and the small differences observed between modalities would not have affected clinical decision making. Using the Checkme, patients in a general medical ward setting are able to measure their own vital signs easily and accurately by themselves. This could be time saving for nurses and prevent errors due to manually entering data in the EHR.
[Mh] Termos MeSH primário: Desenho de Equipamento
Monitorização Fisiológica/instrumentação
Admissão do Paciente
Sinais Vitais
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Seres Humanos
Meia-Idade
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180213
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0190138


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[PMID]:29346431
[Au] Autor:Pollack TM; Duong HT; Truong PT; Pham TT; Do CD; Colby D
[Ad] Endereço:The Partnership for Health Advancement in Vietnam, Beth Israel Deaconess Medical Center, Hanoi, Vietnam.
[Ti] Título:Sensitivity and specificity of two dried blood spot methods for HIV-1 viral load monitoring among patients in Hanoi, Vietnam.
[So] Source:PLoS One;13(1):e0191411, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The use of dried blood spot (DBS) specimens for HIV viral load (VL) monitoring is recommended to support the roll-out of routine VL monitoring in low and middle income countries (LMICs). To better understand the use of DBS for VL monitoring, we evaluated two DBS testing methods, Roche TaqMan® Free Virus Evolution protocol (DBS-FVE) and Roche TaqMan® SPEX protocol (DBS-SPEX)) in patients receiving ART at an HIV clinic in Hanoi, Vietnam. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for each DBS testing method at the thresholds of 1000 and 5000 copies/ml compared to plasma VL. At a threshold of 1000 copies/ml, sensitivity, specificity, PPV and NPV of the DBS-SPEX method were 98.8% (95% CI: 93.3%-100%), 74.3% (95% CI: 70.8%-77.5%), 31.5% (95% CI: 25.8%-37.6%), and 99.8% (95% CI: 98.9%-100%), respectively. Increasing the VL threshold value to 5000 copies/ml improved specificity (97.9% CI: 96.6%-98.9%) and PPV (83.9% CI: 74.5%-90.9%). Using the DBS-FVE method, at the threshold of 1000 copies/ml and with a correction factor of +0.3 log copies/ml, sensitivity was 95.1% (87.8%-98.6%) and specificity was 98.8% (97.7%-99.5%). Sensitivity decreased at the threshold of 5000 copies/ml (65.8%, 95% CI: 54.3%-76.1%). With a correction factor of +0.7 log copies/ml, the sensitivity was 96.3% (89.6%-99.2%) and specificity was 98.2% (96.9%-99.1%) at the threshold of 1000 copies/ml. We found that the Roche DBS-FVE method, with a +0.7 log copies/ml correction factor, performed well with sensitivity and specificity greater than 96% at a VL threshold of 1000 copies/m. These findings add to the growing body of evidence supporting the use of DBS VL testing for ART monitoring. Future research should evaluate the association between VL results by DBS and clinical outcome measures such as HIV drug resistance, morbidity, and mortality.
[Mh] Termos MeSH primário: Infecções por HIV/sangue
Monitorização Fisiológica/métodos
Carga Viral
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Feminino
Infecções por HIV/virologia
HIV-1/isolamento & purificação
Seres Humanos
Masculino
Meia-Idade
Sensibilidade e Especificidade
Vietnã
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180119
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0191411


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[PMID]:29441917
[Ti] Título:Analysis of the necessity of serum electrolyte monitoring for up to eight weeks after the completion of anti-epidermal growth factor receptor antibody administration.
[So] Source:Pharmazie;71(7):402-407, 2016 Jul 07.
[Is] ISSN:0031-7144
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Electrolyte disturbances are a known side effect of cetuximab (cmab) and panitumumab (pmab) administration and monitoring is recommended during and for at least 8 weeks after pmab administration. However, the recommended duration of electrolyte monitoring is not stated on the cmab package insert in the EU or Japan and no previous studies have investigated the appropriate monitoring period for cmab and pmab. We retrospectively investigated electrolyte levels in 16 cmab-treated patients and 7 pmab-treated patients between 1 June 2009 and 31 December 2014. The mean minimum levels of serum magnesium, potassium, and calcium were analyzed in these patients before administration (baseline) and in period A (during administration), period B (time of the last administration), period C (from the completion of administration to 4 weeks after), and period D (from 4-8 weeks after administration). Hypokalemia persisted until period D in 1 cmab-treated patient. Hypomagnesemia persisted until period D in two pmab-treated patients and hypokalemia persisted until period D in 1 pmab-treated patient. In addition, the serum magnesium levels in periods A, B, and C in the cmab-treated patients were significantly lower than the baseline level (P < 0.05). In pmabtreated patients, the serum magnesium levels in periods A, C, and D, and the serum calcium levels in periods A, B, and C were lower than the baseline levels (P < 0.05). These findings indicate that it is necessary to monitor electrolyte levels for at least 8 weeks after the completion of administration of cmab or pmab.
[Mh] Termos MeSH primário: Anticorpos Monoclonais/efeitos adversos
Cetuximab/efeitos adversos
Eletrólitos/sangue
Receptor do Fator de Crescimento Epidérmico/antagonistas & inibidores
Desequilíbrio Hidroeletrolítico/induzido quimicamente
[Mh] Termos MeSH secundário: Adulto
Idoso
Anticorpos Monoclonais/uso terapêutico
Anticorpos Monoclonais Humanizados/efeitos adversos
Anticorpos Monoclonais Humanizados/uso terapêutico
Cálcio/sangue
Cetuximab/uso terapêutico
Feminino
Seres Humanos
Hipopotassemia/sangue
Hipopotassemia/induzido quimicamente
Deficiência de Magnésio/sangue
Deficiência de Magnésio/induzido quimicamente
Masculino
Meia-Idade
Monitorização Fisiológica
Estudos Retrospectivos
Desequilíbrio Hidroeletrolítico/sangue
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antibodies, Monoclonal, Humanized); 0 (Electrolytes); 6A901E312A (panitumumab); EC 2.7.10.1 (Receptor, Epidermal Growth Factor); PQX0D8J21J (Cetuximab); SY7Q814VUP (Calcium)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE
[do] DOI:10.1691/ph.2016.6537


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[PMID]:29444390
[Au] Autor:Goode J; Veyckemans F; Tourtchaninoff M; Grosu I
[Ti] Título:The use of alpha 2 agonists during idiopathic scoliosis repair : a narrative review of the literature.
[So] Source:Acta Anaesthesiol Belg;67(2):53-62, 2016.
[Is] ISSN:0001-5164
[Cp] País de publicação:Belgium
[La] Idioma:eng
[Ab] Resumo:Alpha 2 agonists are appreciated drugs designed for the peri-operative period, because of their anxiolytic, sedative and analgesic properties. However, they are usually avoided during scoliosis surgery, a longlasting major procedure involving healthy patients, because of their potential effects on Somatosensory and Motorevoked potentials. The absence ofrecommendations suggests that their effects on evoked potentials are still unclear. Thus, we tried in this narrative review to identify the literature representative of the effects of clonidine and dexmedetomidine on evoked potentials, on human beings, published between 1988 and 2015 in English or French, using GOOGLE SCHOLAR and PUBMED. Paucity of literature prevented any conclusion about Clonidine's effects on evoked potentials, but no data suggested a noxious effect of Clonidine on evoked potentials, used in oral premedication (300 µg) or during the procedure (2 to 5 µg/kg). If literature was more extensive for dexmedetomidine, studies were still controversial. Although the majority of the studies did not find statistically significant differences concerning the effects of this drug on evoked potentials (loading dose of 0.3 to 1 µg/ kg followed by continuous infusion of 0.3 to 0.8 µg/kg/h), 2 case reports and 2 studies described substantial decreases. However, dexmedetomidine's shorter duration of action allowed a quick return to basal situation within an hour. In conclusion, more studies are needed in order to evaluate the effects of alpha 2 agonists on evoked potentials and to assess the safety of their use in this setting.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos alfa 2/farmacologia
Clonidina/farmacologia
Dexmedetomidina/farmacologia
Potencial Evocado Motor/efeitos dos fármacos
Potenciais Somatossensoriais Evocados/efeitos dos fármacos
Escoliose/cirurgia
[Mh] Termos MeSH secundário: Agonistas de Receptores Adrenérgicos alfa 2/efeitos adversos
Seres Humanos
Monitorização Fisiológica
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Adrenergic alpha-2 Receptor Agonists); 67VB76HONO (Dexmedetomidine); MN3L5RMN02 (Clonidine)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE


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[PMID]:29374922
[Au] Autor:Wang DY; Xie WG; Xi MM; Li Z; Wang B
[Ad] Endereço:Department of Burns, Tongren Hospital of Wuhan University & Wuhan Third Hospital, Wuhan 430060, China.
[Ti] Título:[Effects of application of pulse contour cardiac output monitoring technology in early treatment of patients with large area burns].
[So] Source:Zhonghua Shao Shang Za Zhi;34(1):14-20, 2018 Jan 20.
[Is] ISSN:1009-2587
[Cp] País de publicação:China
[La] Idioma:chi
[Ab] Resumo:To analyze the changes and relationship of early hemodynamic indexes of patients with large area burns monitored by pulse contour cardiac output (PiCCO) monitoring technology, so as to assess the guiding value of this technology in the treatment of patients with large area burns during shock period. Eighteen patients with large area burns, confirming to the study criteria, were admitted to our unit from May 2016 to May 2017. Pulse contour cardiac output index (PCCI), systemic vascular resistance index (SVRI), global end-diastolic volume index (GEDVI), and extravascular lung water index (EVLWI) of patients were monitored by PiCCO instrument from admission to post injury day (PID) 7, and they were calibrated and recorded once every four hours. The fluid infusion coefficients of patients at the first and second 24 hours post injury were calculated. The blood lactic acid values of patients from PID 1 to 7 were also recorded. The correlations among PCCI, SVRI, and GEDVI as well as the correlation between SVRI and blood lactic acid of these 18 patients were analyzed. Prognosis of patients were recorded. Data were processed with one-way analysis of variance, single sample test and Bonferroni correction, Pearson correlation analysis, and Spearman rank correlation analysis. (1) There was statistically significant difference in PCCI value of patients from post injury hour (PIH) 4 to 168 ( =7.428, <0.01). The PCCI values of patients at PIH 4, 8, 12, 16, 20, and 24 were (2.4±0.9), (2.6±1.2), (2.2±0.6), (2.6±0.7), (2.8±0.6), and (2.7±0.7) L·min(-1)·m(-2,) respectively, and they were significantly lower than the normal value 4 L·min(-1)·m(-2)( =-3.143, -3.251, -11.511, -8.889, -6.735, -6.976, <0.05 or <0.01). At PIH 76, 80, 84, 88, 92, and 96, the PCCI values of patients were (4.9±1.5), (5.7±2.0), (5.9±1.7), (5.5±1.3), (5.3±1.1), and (4.9±1.4) L·min(-1)·m(-2,) respectively, and they were significantly higher than the normal value ( =2.277, 3.142, 4.050, 4.111, 4.128, 2.423, <0.05 or <0.01). The PCCI values of patients at other time points were close to normal value ( >0.05). (2) There was statistically significant difference in SVRI value of patients from PIH 4 to 168 ( =7.863, <0.01). The SVRI values of patients at PIH 12, 16, 20, 24, and 28 were (2 298±747), (2 581±498), (2 705±780), (2 773±669), and (3 109±1 215) dyn·s·cm(-5)·m(2,) respectively, and they were significantly higher than the normal value 2 050 dyn·s·cm(-5)·m(2)( =0.878, 3.370, 2.519, 3.747, 3.144, <0.05 or <0.01). At PIH 4, 8, 72, 76, 80, 84, 88, 92, and 96, the SVRI values of patients were (1 632±129), (2 012±896), (1 381±503), (1 180±378), (1 259±400), (1 376±483), (1 329±385), (1 410±370), and (1 346±346) dyn·s·cm(-5)·m(2,) respectively, and they were significantly lower than the normal value ( =-4.593, -0.112, -5.157, -8.905, -7.914, -5.226, -6.756, -6.233, -7.038, <0.01). The SVRI values of patients at other time points were close to normal value ( >0.05). (3) There was no statistically significant difference in the GEDVI values of patients from PIH 4 to 168 ( =0.704, >0.05). The GEDVI values of patients at PIH 8, 12, 16, 20, and 24 were significantly lower than normal value ( =-3.112, -3.554, -2.969, -2.450, -2.476, <0.05). The GEDVI values of patients at other time points were close to normal value ( >0.05). (4) There was statistically significant difference in EVLWI value of patients from PIH 4 to 168 ( =1.859, <0.01). The EVLWI values of patients at PIH 16, 20, 24, 28, 32, 36, and 40 were significantly higher than normal value ( =4.386, 3.335, 6.363, 4.391, 7.513, 5.392, 5.642, <0.01). The EVLWI values of patients at other time points were close to normal value ( >0.05). (5) The fluid infusion coefficients of patients at the first and second 24 hours post injury were 1.90 and 1.39, respectively. The blood lactic acid values of patients from PID 1 to 7 were 7.99, 5.21, 4.57, 4.26, 2.54, 3.13, and 3.20 mmol/L, respectively, showing a declined tendency. (6) There was obvious negative correlation between PCCI and SVRI ( =-0.528, <0.01). There was obvious positive correlation between GEDVI and PCCI ( =0.577, <0.01). There was no obvious correlation between GEDVI and SVRI ( =0.081, >0.05). There was obvious positive correlation between blood lactic acid and SVRI ( =0.878, <0.01). (7) All patients were cured except the one who abandoned treatment. PiCCO monitoring technology can monitor the changes of early hemodynamic indexes and volume of burn patients dynamically, continuously, and conveniently, and provide valuable reference for early-stage comprehensive treatment like anti-shock of patients with large area burns.
[Mh] Termos MeSH primário: Queimaduras/terapia
Débito Cardíaco
Monitorização Fisiológica/métodos
Ressuscitação
[Mh] Termos MeSH secundário: Água Extravascular Pulmonar
Hidratação
Hemodinâmica
Seres Humanos
Choque/terapia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180306
[Lr] Data última revisão:
180306
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180129
[St] Status:MEDLINE
[do] DOI:10.3760/cma.j.issn.1009-2587.2018.01.004


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[PMID]:29176887
[Au] Autor:Ramírez JC; Parrado R; Sulleiro E; de la Barra A; Rodríguez M; Villarroel S; Irazu L; Alonso-Vega C; Alves F; Curto MA; García L; Ortiz L; Torrico F; Gascón J; Flevaud L; Molina I; Ribeiro I; Schijman AG
[Ad] Endereço:Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres" (INGEBI-CONICET), Buenos Aires, Argentina.
[Ti] Título:First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease.
[So] Source:PLoS One;12(11):e0188550, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.
[Mh] Termos MeSH primário: Doença de Chagas/tratamento farmacológico
Nitroimidazóis/uso terapêutico
Reação em Cadeia da Polimerase em Tempo Real/métodos
Triazóis/uso terapêutico
Tripanossomicidas/uso terapêutico
[Mh] Termos MeSH secundário: Doença de Chagas/sangue
Seres Humanos
Monitorização Fisiológica/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Nitroimidazoles); 0 (Triazoles); 0 (Trypanocidal Agents); 6TK1G07BHZ (posaconazole); YC42NRJ1ZD (benzonidazole)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0188550


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[PMID]:29210766
[Au] Autor:Hassan E
[Ad] Endereço:Clinical Affairs, Patient Care and Monitoring Solutions, Philips HealthCare, Baltimore, Maryland.
[Ti] Título:Tele-ICU and Patient Safety Considerations.
[So] Source:Crit Care Nurs Q;41(1):47-59, 2018 Jan/Mar.
[Is] ISSN:1550-5111
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The tele-ICU is designed to leverage, not replace, the need for bedside clinical expertise in the diagnosis, treatment, and assessment of various critical illnesses. Tele-ICUs are primarily decentralized or centralized models with differing advantages and disadvantages. The centralized model has sufficiently powered published data to be associated with improved mortality and ICU length of stay in a cost-effective manner. Factors associated with improved clinical outcomes include improved compliance with best practices; providing off-hours implementation of the bedside physician's care plan; and identification of and rapid response to physiological instability (initial clinical review within 1 hour) and rapid response to alerts, alarms, or direct notification by bedside clinicians. With improved communication and frequent review of patients between the tele-ICU and the bedside clinicians, the bedside clinician can provide the care that only they can provide. Although technology continues to evolve at a rapid pace, technology alone will most likely not improve clinical outcomes. Technology will enable us to process real or near real-time data into complex and powerful predictive algorithms. However, the remote and bedside teams must work collaboratively to develop care processes to better monitor, prioritize, standardize, and expedite care to drive greater efficiencies and improve patient safety.
[Mh] Termos MeSH primário: Comportamento Cooperativo
Unidades de Terapia Intensiva/organização & administração
Segurança do Paciente
Telemedicina/utilização
[Mh] Termos MeSH secundário: Cuidados Críticos/métodos
Seres Humanos
Monitorização Fisiológica/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:171207
[St] Status:MEDLINE
[do] DOI:10.1097/CNQ.0000000000000185


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[PMID]:28746164
[Au] Autor:Husnik MJ; Brown ER; Marzinke M; Livant E; Palanee-Phillips T; Hendrix CW; Matovu Kiweewa F; Nair G; Soto-Torres LE; Schwartz K; Hillier SL; Baeten JM; MTN-020 ASPIRE Study Team
[Ad] Endereço:*Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA; †University of Washington, Seattle, WA; ‡Johns Hopkins University School of Medicine, Baltimore, MD; §Magee-Womens Research Institute & Foundation, University of Pittsburgh Medical Center, Pittsburgh, PA; ‖Wits Reproductive Health and HIV Institute, University of Witwatersrand, Hillbrow Health Precinct, Johannesburg, South Africa; ¶Makerere University-John Hopkins University Research Collaboration, Kampala, Uganda; #Center for AIDS Programme of Research in South Africa, Durban, South Africa; **Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health Rockville, MD; ††FHI 360, Durham, NC; and ‡‡Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA.
[Ti] Título:Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.
[So] Source:J Acquir Immune Defic Syndr;76(3):330-337, 2017 11 01.
[Is] ISSN:1944-7884
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. METHODS: During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. RESULTS: An upward trend in adherence was observed (P < 0.0001); the proportion of samples from subjects in the active arm with dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. CONCLUSIONS: Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.
[Mh] Termos MeSH primário: Fármacos Anti-HIV/uso terapêutico
Infecções por HIV/prevenção & controle
HIV-1
Adesão à Medicação/estatística & dados numéricos
Pirimidinas/uso terapêutico
[Mh] Termos MeSH secundário: Administração Intravaginal
Adulto
Fármacos Anti-HIV/sangue
Estudos de Viabilidade
Feminino
Seres Humanos
Monitorização Fisiológica/métodos
Profilaxia Pré-Exposição
Pirimidinas/sangue
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Anti-HIV Agents); 0 (Pyrimidines); TCN4MG2VXS (Dapivirine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:IM; X
[Da] Data de entrada para processamento:170727
[St] Status:MEDLINE
[do] DOI:10.1097/QAI.0000000000001503


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[PMID]:29298008
[Au] Autor:Novik GA; Khaleva EG; Bychkova NV; Zdanova MV
[Ti] Título:Evaluation of Efficacy and Safety of Longterm Feeding with Amino Acid-Based Formula in Infants with Cow's Milk Protein Allergy: Results of the Open-Label Prospective Controlled Post-Registration Trial.
[So] Source:Vestn Ross Akad Med Nauk;71(6):446-57, 2016.
[Is] ISSN:0869-6047
[Cp] País de publicação:Russia (Federation)
[La] Idioma:eng
[Ab] Resumo:Background: The cow's milk allergy (CMA) prevalence is 2−3% in children under one year. Approximately in 5% of cases transferring to extensively hydrolysed formula (eHF) doesn't lead to disappearance of CMA symptoms. Aims: Evaluation of efficacy and safety of amino-acid formula (AAF) longterm feeding in children under one year and development of predictors of successful transfer from AAF to eHF. Materials and Methods: In open-label prospective post-registration trial duration of 365 days were included 43 children aged from 3 to 12 months with CMA. CMA was based on Russian and international guidelines. When a patient was included in the trial, child received eHF for 4 weeks with the evaluation of the effect of elimination diet (ED): in case of absence of effect, for diagnostic purposes child feed with AAF for 2 weeks and upon receiving the effect, child continued to receive it for at least 6 months. Diet was considered effective if there were observed disappearance of clinical manifestations of CMA during of formula using. Results: Children fed with AAF gain weight and increased height statistically higher during the first 6 months, compared with children receiving eHF, but without subsequent difference in a year. After 4 weeks' of AAF feeding, there was a significant decrease in SCORAD index from 46.84 (SD 4.164) to 2.52 (SD 2.204) (p=0.005); disappearance of gastrointestinal manifestations of CMA from 3 to 14 day. After 4 weeks, the 100% normalization of previously elevated faecal calprotectin (p<0.05) was observed; and after 6months. ED, in 60% of children normalization of the index of activation of basophils with milk was observed. 38.7% of children were transferred to eHF in 6 months, 12.9% and 25.8% in 9 and 12 months respectively. Conclusions: Use of AAF for children with CMA is an effective and safe treatment without lengthening the period of elimination, which is necessary for the formation of tolerance to cow's milk protein and has a positive impact on weight and height. Normalization of specific activation of basophils with milk could be considered as a predictor of successful transfer from AAF to eHF in children with CMA.
[Mh] Termos MeSH primário: Aminoácidos/farmacologia
Fórmulas Infantis
Hipersensibilidade a Leite
Hidrolisados de Proteína/farmacologia
[Mh] Termos MeSH secundário: Antropometria/métodos
Desenvolvimento Infantil/fisiologia
Feminino
Seres Humanos
Imunoglobulina E/análise
Lactente
Fórmulas Infantis/análise
Fórmulas Infantis/química
Fórmulas Infantis/classificação
Masculino
Hipersensibilidade a Leite/diagnóstico
Hipersensibilidade a Leite/dietoterapia
Hipersensibilidade a Leite/etiologia
Hipersensibilidade a Leite/fisiopatologia
Monitorização Fisiológica/métodos
Vigilância de Produtos Comercializados/métodos
Estudos Prospectivos
Federação Russa
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Amino Acids); 0 (Protein Hydrolysates); 37341-29-0 (Immunoglobulin E)
[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:180104
[St] Status:MEDLINE
[do] DOI:10.15690/vramn757


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[PMID]:29390531
[Au] Autor:Tu Y; Gao F
[Ad] Endereço:Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, PR China.
[Ti] Título:Dexmedetomidine-based monitored conscious sedation combined local anesthesia for levator resection in a 10-year-old child with Marcus Gunn jaw-winking synkinesis: A case report.
[So] Source:Medicine (Baltimore);96(51):e9369, 2017 Dec.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Levator resection has become a routine procedure for patients with severe Marcus Gunn jaw-winking synkinesis (MGJWS). To optimize the surgical outcome, adult patients need to be kept awake, or easily aroused and responsive to verbal commands during the operation. However, levator resection is commonly performed under general anesthesia in pediatric patients. In the present case, we described a successful anesthetic protocol of conscious sedation with local anesthesia for levator resection in a child. PATIENT CONCERNS: A 10-year-old boy with MGJWS was admitted to our hospital and scheduled for levator resection. The patient was born through a normal delivery and had no previous history of allergy, no comorbidity, and no history of receiving anesthesia or operation. The laboratory tests of the patient were unremarkable. DIAGNOSES: The diagnosis of MGJWS was made by two experienced ophthalmologists. INTERVENTIONS: A 10-year-old boy with MGJWS was admitted to our hospital and scheduled for levator resection. The levator resection was performed under monitored conscious sedation with dexmedetomidine and local anesthesia. OUTCOMES: Patient with spontaneous breathing responded normally to verbal commands throughout the operation, and no adverse events occurred. The patient and ophthalmologist reported high satisfaction with anesthesia management. LESSONS: Dexmedetomidine-based monitored conscious sedation with local anesthesia is a feasible alternative to general anesthesia for levator resection in collaborative patients.
[Mh] Termos MeSH primário: Blefaroptose/diagnóstico
Blefaroptose/terapia
Dexmedetomidina/administração & dosagem
Cardiopatias Congênitas/diagnóstico
Cardiopatias Congênitas/terapia
Anormalidades Maxilomandibulares/diagnóstico
Anormalidades Maxilomandibulares/terapia
Monitorização Fisiológica/métodos
Doenças do Sistema Nervoso/diagnóstico
Doenças do Sistema Nervoso/terapia
Músculos Oculomotores/cirurgia
[Mh] Termos MeSH secundário: Anestesia Local
Criança
Sedação Consciente/métodos
Seguimentos
Seres Humanos
Masculino
Doenças Raras
Reflexo Anormal
Resultado do Tratamento
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
67VB76HONO (Dexmedetomidine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180219
[Lr] Data última revisão:
180219
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180203
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009369



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