EBOLA and FDA: reviewing the response to the 2014 outbreak, to
... A B ST R A CT In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EV ...
... A B ST R A CT In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EV ...
Collecting Empirical Physician Time Data
... EHRs is difficult because EHR systems vary and are not consistently employed across departments within a single health system. Fifth, EHR data are likely to be available only for certain types of services and not for others (e.g., office-based procedures or tests), and direct observation is more fea ...
... EHRs is difficult because EHR systems vary and are not consistently employed across departments within a single health system. Fifth, EHR data are likely to be available only for certain types of services and not for others (e.g., office-based procedures or tests), and direct observation is more fea ...
For sale by the Superintendent of Documents, U.S . ... Internet: bookatore .gpo.gov Phone: toll free (866)...
... + The FDA has not ensured that the public has all of the accurate, science-based information regarding the VNS Therapy System for TRD it needs . Health care providers relying on the FDA's public information on the safety and effectiveness of this device may not be able to convey complete risk inform ...
... + The FDA has not ensured that the public has all of the accurate, science-based information regarding the VNS Therapy System for TRD it needs . Health care providers relying on the FDA's public information on the safety and effectiveness of this device may not be able to convey complete risk inform ...
Neuroanatomy through Clinical Cases, Second Edition
... © Sinauer Associates, Inc. This material cannot be copied, reproduced, manufactured or disseminated in any form without express written permission from the publisher. ...
... © Sinauer Associates, Inc. This material cannot be copied, reproduced, manufactured or disseminated in any form without express written permission from the publisher. ...
Jeffrey S. Barkin, MD 97 A Exchange Street Suite 401 Portland
... use of a placebo, and there is the possibility of selection bias. In this example, if the study showed that the women who had been receiving antidepressants had adverse pregnancy outcomes, we would be unable to conclude that this was due to exposure to the antidepressants. Instead, it is quite possi ...
... use of a placebo, and there is the possibility of selection bias. In this example, if the study showed that the women who had been receiving antidepressants had adverse pregnancy outcomes, we would be unable to conclude that this was due to exposure to the antidepressants. Instead, it is quite possi ...
Develop and Implement Criteria-Based Privileging for Nonphysician
... the certification program for credentials verification organizations. During that time, she also presented programs as an NCQA faculty member on CVO Certification and the NCQA credentialing standards. For the past 18 years, Cairns has been an advisor to healthcare attorneys, including providing expe ...
... the certification program for credentials verification organizations. During that time, she also presented programs as an NCQA faculty member on CVO Certification and the NCQA credentialing standards. For the past 18 years, Cairns has been an advisor to healthcare attorneys, including providing expe ...
clinical practice guidelines management of sore throat
... Epidemiological data from Western countries on sore throat in general and specifically GABHS infections, both community and hospital-based, are more readily available. However, there is considerable variation in the prevalence of GABHS sore throats from one country to another (4-9). For example, in ...
... Epidemiological data from Western countries on sore throat in general and specifically GABHS infections, both community and hospital-based, are more readily available. However, there is considerable variation in the prevalence of GABHS sore throats from one country to another (4-9). For example, in ...
Health Insurance Appeal Letters Health Insurance Appeal Letters
... Internal Review. The formal process of appeal of an adverse determination at the first or second levels. Medical Necessity. The determination of whether health services provided to a patient are required to maintain health according to accepted medical practice, current research and efficiency consi ...
... Internal Review. The formal process of appeal of an adverse determination at the first or second levels. Medical Necessity. The determination of whether health services provided to a patient are required to maintain health according to accepted medical practice, current research and efficiency consi ...
Extract from the Clinical Evaluation Report for macitentan
... In this evaluation report, Study AC-055-302 (conducted in a PAH patient population) will be evaluated as the pivotal efficacy/safety study, and Study AC-055-201 (conducted in essential hypertension patient population) as a dose-finding study. As per instructions in the TGA’s ‘statement of requiremen ...
... In this evaluation report, Study AC-055-302 (conducted in a PAH patient population) will be evaluated as the pivotal efficacy/safety study, and Study AC-055-201 (conducted in essential hypertension patient population) as a dose-finding study. As per instructions in the TGA’s ‘statement of requiremen ...
GYNO-DAKTARIN™ Janssen Pharma
... Capsules, and Vaginal Ovules during lactation (see Interactions with Other Medicinal Products and Other Forms of Interaction). Effects on Ability to Drive and Use Machines Not applicable. Undesirable Effects Clinical trial data The safety of GYNO-DAKTARIN was evaluated in a total of 537 women with m ...
... Capsules, and Vaginal Ovules during lactation (see Interactions with Other Medicinal Products and Other Forms of Interaction). Effects on Ability to Drive and Use Machines Not applicable. Undesirable Effects Clinical trial data The safety of GYNO-DAKTARIN was evaluated in a total of 537 women with m ...
Intergroup Study (EORTC protocol 30994)
... agent cisplatin, and others have used combination therapy. Most of the trials appear to show no difference, but they may not have enrolled sufficient numbers of patients to detect realistic differences in survival. The EORTC/MRC study enrolled 976 patients from 106 institutions in 20 countries. Accr ...
... agent cisplatin, and others have used combination therapy. Most of the trials appear to show no difference, but they may not have enrolled sufficient numbers of patients to detect realistic differences in survival. The EORTC/MRC study enrolled 976 patients from 106 institutions in 20 countries. Accr ...
Macrolid es, Ketolid es, a nd Glyc ylc yclines : Azithromyc in,
... than their respective serum concentrations. Telithromycin also has excellent penetration into bronchopulmonary tissues. Levels in alveolar macrophages (median concentration 81 mg/L) significantly exceeded plasma levels 8 hours after dosing and maintained elevated levels 24 and 48 hours after dosing ...
... than their respective serum concentrations. Telithromycin also has excellent penetration into bronchopulmonary tissues. Levels in alveolar macrophages (median concentration 81 mg/L) significantly exceeded plasma levels 8 hours after dosing and maintained elevated levels 24 and 48 hours after dosing ...
Streamlining Staging of Colorectal Cancer with Whole Body MRI
... 4.1.1. Selection of Principal Investigator and other investigators at sites ................................................... 14 ...
... 4.1.1. Selection of Principal Investigator and other investigators at sites ................................................... 14 ...
effects of cytochrome p450 enzyme inhibitors and inducers
... Drugs are used in combination to improve the effectiveness of therapy or to treat coexisting diseases making multiple drug therapy common in current clinical practice (Bucsa et al. 2012). However, some combinations may alter the exposure to drug or drugs with consequential undertreatment causing adv ...
... Drugs are used in combination to improve the effectiveness of therapy or to treat coexisting diseases making multiple drug therapy common in current clinical practice (Bucsa et al. 2012). However, some combinations may alter the exposure to drug or drugs with consequential undertreatment causing adv ...
Lorena-Botero-Calderon et al. Advances in the
... 75 days). Of the fluconazole group, 67% (8 of 12 patients) survived versus 55% (6 of 11 infants) for the amphotericin group. Additionally, infants receiving amphotericin B had significantly higher values of total and direct bilirubin and alkaline phosphatase compared with fluconazole recipients [36] ...
... 75 days). Of the fluconazole group, 67% (8 of 12 patients) survived versus 55% (6 of 11 infants) for the amphotericin group. Additionally, infants receiving amphotericin B had significantly higher values of total and direct bilirubin and alkaline phosphatase compared with fluconazole recipients [36] ...
Clinical features and determinants of COPD exacerbation in the Hokkaido COPD
... In this study, the intention was to clarify the clinical characteristics and determinants of COPD exacerbations using the Hokkaido COPD cohort study population. The strongest point of this cohort study was that it was very carefully designed and performed, thus making it possible to collect accurate ...
... In this study, the intention was to clarify the clinical characteristics and determinants of COPD exacerbations using the Hokkaido COPD cohort study population. The strongest point of this cohort study was that it was very carefully designed and performed, thus making it possible to collect accurate ...
TAZORAC® Cream Prescribing Information
... age of 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Currently there is no other clinical experience on the differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot b ...
... age of 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Currently there is no other clinical experience on the differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot b ...
Eliglustat (as tartrate) - Therapeutic Goods Administration
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
IMITREX® Nasal Spray Tear Sheet
... headache severity from moderate or severe pain to mild or no pain, was assessed up to 2 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of IMITREX Nasal Spray or o ...
... headache severity from moderate or severe pain to mild or no pain, was assessed up to 2 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of IMITREX Nasal Spray or o ...
Investigator experience
... Lesions in Small Diameter Native Coronary Arteries (300 patient, prospective, multicenter, open-label trial) Sponsors include: Medtronic. OSIRIS – A Phase II, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of PROCHYMAL® intravenous infusion follo ...
... Lesions in Small Diameter Native Coronary Arteries (300 patient, prospective, multicenter, open-label trial) Sponsors include: Medtronic. OSIRIS – A Phase II, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of PROCHYMAL® intravenous infusion follo ...
applied - University of Washington
... AB: In spite of many available studies on bleomycin and cryotherapy in treating warts, little head to head research is done to compare efficacy of these treatments. Our aim was to compare the therapeutic effects of intralesional bleomycin and cryotherapy on common warts of the hands and feet. In thi ...
... AB: In spite of many available studies on bleomycin and cryotherapy in treating warts, little head to head research is done to compare efficacy of these treatments. Our aim was to compare the therapeutic effects of intralesional bleomycin and cryotherapy on common warts of the hands and feet. In thi ...
N-Acetylcysteine—a safe antidote for cysteine/glutathione deficiency
... levels. Further, aerosol delivery can result in NAC oxidation, which may have negative consequences [27]. Intravenous administration of NAC transiently increases plasma NAC to very high levels (during administration) and is known to cause adverse effects. Although clinical situations sometimes dicta ...
... levels. Further, aerosol delivery can result in NAC oxidation, which may have negative consequences [27]. Intravenous administration of NAC transiently increases plasma NAC to very high levels (during administration) and is known to cause adverse effects. Although clinical situations sometimes dicta ...
Celebrating 30 years - Breast Cancer Institute of Australia
... research program for breast cancer. This is particularly so because of the Group’s healthy financial position. We are working on the development of an increased ‘footprint’ (geographical and multidisciplinary spread), active engagement with stakeholders, a branding and communications review and furt ...
... research program for breast cancer. This is particularly so because of the Group’s healthy financial position. We are working on the development of an increased ‘footprint’ (geographical and multidisciplinary spread), active engagement with stakeholders, a branding and communications review and furt ...
2011 CDC Guidelines for the Prevention of Intravascular Catheter
... conventional soap and water or with alcohol-based hand rubs (ABHR). Hand hygiene should be performed before and after palpating catheter insertion sites as well as before and after inserting, replacing, accessing, repairing, or dressing an intravascular catheter. Palpation of the insertion site shou ...
... conventional soap and water or with alcohol-based hand rubs (ABHR). Hand hygiene should be performed before and after palpating catheter insertion sites as well as before and after inserting, replacing, accessing, repairing, or dressing an intravascular catheter. Palpation of the insertion site shou ...