Top PDF Efficacy and Safety of Fingolimod in an Unselected Patient Population.

Efficacy and Safety of Fingolimod in an Unselected Patient Population.

Efficacy and Safety of Fingolimod in an Unselected Patient Population.

inflammatory 9-plex electrochemiluminescent (ECL) assay (MSD: Meso Scale Discovery, Gai- thersburg, MD) according to the manufacturer’s guidelines. Samples were analyzed in dupli- cate and the plates were read in a SECTOR Imager instrument (Meso Scale Discovery). The longitudinal evolution of cytokines was correlated with clinical and MRI parameters to look for potential predictive biomarkers, the results were compared using the Mann-Whitney U-test. Since 9 cytokines were analyzed we corrected for multiple testing with the Bonferroni correc- tion. Statistical analysis was done using the Student’s paired t-test for routine lab parameters, cardiac parameters durinf first dose monitoring, MRI parameters and the comparison between patients formerly under highly active pretreatment and treatment naïve patients. The annual- ized relapse rate in the year before and during the first year of Fingolimod treatment was ana- lyzed by the Wilcoxon test. The correlation between ARR and lymphocyte counts was calculated using the Pearson correlation test. The evolution of the EDSS with the percentages of patients that improved, remained stable or worsened during the observation period and the proportion of patients with no evidence of disease activity (NEDA) were compared using the chi square test.
Mostrar mais

10 Ler mais

EFFICACY AND SAFETY OF LUMBAR ARTHROPLASTY IN DEGENERATIVE DISC DISEASE

EFFICACY AND SAFETY OF LUMBAR ARTHROPLASTY IN DEGENERATIVE DISC DISEASE

The retrospective data were collected from the clinical records of the patients who had undergone single-level lumbar arthroplas- ty, with or without a history of previous surgery for degenerative disc disease. These data were collected for patients who had been operated between 2000 and 2016. The devices used in all of them were the ProDisc-L and the Activ-L artificial discs. The patients ranged from 23 to 56 years of age. The indication for arthroplasty was rigorous and it was only performed in patients with chronic low back pain of discogenic origin with or without any root component in one of the L3-L4, L4-L5, or L5-S1 segments. All the patients had experienced symptoms for more than a year prior to the arthroplasty and failed conservative treatment during this period and none of those with a record of previous surgery had been operated on in the six months prior to the arthroplasty. These patients were selected based on the MRI findings, which included loss of disc height, low intensity in T2, changes in the endplates, and disc protrusion. No patients with osteoporosis, spi- nal stenosis, spondylolisthesis, chronic infections, metal allergies, pregnancy, severe facet joint arthropathy, multi-level degenerative changes, body mass index higher than 35, or previously submit- ted to fusion technique were selected for arthroplasty (Table 1). All patients underwent a complete radiological study of the lum- bosacral segment that included anterior-posterior and lateral (flexion and extension) view X-rays, CAT, and MRI. The latter two exams were used to estimate the grade of disc degeneration and the magnitude of the changes at the level of the facet joints (Figures 2, 3 and 4). The preoperative demographic data for all patients were collected retrospectively, in addition to the clinical parameters, which included whether there was only low back pain or low back pain with an associated radicular component, the frequency of the pain, the use of analgesic drugs; the Oswestry disability index (ODI) and visual analog scale (VAS) for pain sco- res, and the level of patient satisfaction (Table 2).
Mostrar mais

7 Ler mais

Treatment of cutaneous leishmaniasis with thermotherapy in Brazil: an efficacy and safety study

Treatment of cutaneous leishmaniasis with thermotherapy in Brazil: an efficacy and safety study

New therapeutic options have been sought. However, de- spite good results, none of them was considered convenient or suffi- ciently effective to replace conventional treatment. Among the local- ized treatment options, radiofrequency thermotherapy appears as a viable option, since it is effective and requires only one session, im- proving patient adherence. One of the main advantages of this ther- apy is that the device is easy to use, light and works with recharge- able batteries, making it possible to be used in rural areas or areas with no electricity. Another advantage of this treatment modality is that it does not require monitoring with laboratory tests, saving additional costs for health institutions. Although the thermotherapy device is still relatively expensive, making it of difficult access in endemic countries, the costs related to conventional treatment are higher. Another possibility to be investigated is the association of thermotherapy to new oral treatment options, such as miltefosine, for example. All these advantages make this therapy a good alterna- tive for the treatment of localized CL, particularly in patients who have absolute or relative contraindications to the conventional ther- apy, such as heart, kidney and liver conditions, pregnant women and HIV-positive patients.
Mostrar mais

9 Ler mais

Efficacy and safety of biological treatments of multiple sclerosis

Efficacy and safety of biological treatments of multiple sclerosis

Multiple Sclerosis is a CNS chronic demyelinating disease primarily characterized by an immune process, attacking and destroying myelin. This conceptualisation of MS as an immune and inflammatory disease let clinicians to believe that, once inflammation was resolved, the disease could be controlled. The first MS treatment approach aimed the resolution of inflammation, managing acute relapses as they occur. With the first DMT approval, the MS treatment paradigm changed from just only the treatment of acute exacerbations to their prevention and disease course modification. However, those are only partially effective and the disease continues its course aggressively. In these cases, there are other more effective therapeutic options. The tendency is to switch the therapeutics to the second-line agent Natalizumab and it must be done as early as possible, while the patient’s incapacity isn’t significant. Despite the favourable efficacy profile, the safety and tolerability of new MS modifying agents must be carefully considered by clinicians, supported by patient’s opinion and preferences, to enhance their compliance. It’s clear that there is lack of safety evaluations and there is no long-term experience in these drugs and the adverse events are not already well known. Thereby, it’s crucial to define safety profiles for the new and emerging therapies and, more than convenience and efficacy, neurologists must pay attention to safety and tolerability profiles to select the best therapeutic option, since some of them may be harmful or even life threatening.
Mostrar mais

85 Ler mais

Design And Implementation Of Smart Living Room Wireless Control For Safety Purpose

Design And Implementation Of Smart Living Room Wireless Control For Safety Purpose

This section includes the total hardware overview where in the first subsection, the connections of arduino with keypad, DC motor driver circuit, DC motor, switching circuit and serial LCD are explained. Then, after that how to communicate between the PIC and the control circuits such as fan speed control circuit, dim light control circuit, lighting ON/OFF control circuit and window angle control circuit is described. In the next sub-section, it is presented how to connectBluetooth module and android apk from mobile. The
Mostrar mais

7 Ler mais

PRINCÍPIOS DE TERAPÊUTICA ANTIBIÓTICA NA DOENÇA CRÍTICA

PRINCÍPIOS DE TERAPÊUTICA ANTIBIÓTICA NA DOENÇA CRÍTICA

Introduction: Several reports have shown marked heterogeneity of antibiotic pharmacokinetics (PK) in patients admitted to ICUs, which might potentially affect outcomes. Therefore, the pharmacodynamic (PD) parameter of the efficacy of b-lactam antibiotics, that is, the time that its concentration is above the bacteria minimal inhibitory concentration (T > MIC), cannot be safely extrapolated from data derived from the PK of healthy volunteers. Methods: We performed a full review of published studies addressing the PK of intravenous b-lactam antibiotics given to infected ICU patients. Study selection comprised a comprehensive bibliographic search of the PubMed database and bibliographic references in relevant reviews from January 1966 to December 2010. We selected only English-language articles reporting studies addressing b-lactam antibiotics that had been described in at least five previously published studies. Studies of the PK of patients undergoing renal replacement therapy were excluded. Results: A total of 57 studies addressing six different b-lactam antibiotics (meropenem, imipenem, piperacillin, cefpirome, cefepime and ceftazidime) were selected. Significant PK heterogeneity was noted, with a broad, more than twofold variation both of volume of distribution and of drug clearance (Cl). The correlation of antibiotic Cl with creatinine clearance was usually reported. Consequently, in ICU patients, b-lactam antibiotic half-life and T > MIC were virtually unpredictable, especially in those patients with normal renal function. A better PD profile was usually obtained by prolonged or even continuous infusion. Tissue penetration was also found to be compromised in critically ill patients with septic shock.
Mostrar mais

208 Ler mais

J. Pediatr. (Rio J.)  vol.83 número3 en v83n3a06

J. Pediatr. (Rio J.) vol.83 número3 en v83n3a06

When the first vaccine dose was administered and until one year of age, each child was visited weekly at home by trained field workers, to detect acute GE episodes (defined as three or more liquid or semiliquid stools in a 24-hour period). An episode was considered to be terminated when the infant, during five days or more, passed less than three looser-than-normal stools in each 24-hour period. Instructions were stressed to parents/guardians to make a telephone call to the study staff whenever they considered that their child had developed diarrhea. During diarrheal episodes symptoms were recorded by parents/guardians in appropriate diary cards and checked for completion by field workers. The severity of RVGE was graded by a 20-point scoring system. 14 Cases of RVGE with scores of 0 to 6, 7 to 10
Mostrar mais

8 Ler mais

Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial.

Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial.

parasite clearance were significant, even though total administered doses up to this time point were comparable in both arms (10 versus 9 mg/kg, respectively). This suggests a possible role for the frequency of administration. This would need to be confirmed by further studies, but is supported by the relatively high cure rate achieved in single dose patients rescued by additional standard multiple dose regimen. Even in India, where efficacy of single doses was shown to be good, it was lower than multiple dose regimens [21,22]. In eastern Africa, there might be no optimal montherapy dosing regimen of AmBisomeH for VL but combina- tion therapies including AmBisome H are still of interest and under investigation [23]. In this respect, qRT-PCR results are interest- ing, although its use in Africa might be hampered by relatively low blood parasitaemia at baseline and the prohibitive cost of the test. More sensitive prognostic pharmacodynamic biomarkers, appli- cable in all patients, are needed to monitor treatment response.
Mostrar mais

9 Ler mais

The Impact of E-Commerce Securi ty, and National Environment  on Consumer adoption of Intern et Banking in Malaysia and  Singapore

The Impact of E-Commerce Securi ty, and National Environment on Consumer adoption of Intern et Banking in Malaysia and Singapore

views an innovation as offering an advantage over previous ways of performing the same task (Roger, 1983; Agarwal & Prasad, 1997). Internet experience and banking need is defined as the degree to which an innovation is viewed as being consistent with the existing values, needs and experiences of a user (Rogers, 1983; Taylor & Todd, 1995). Trialability is the extent to which users would like an opportunity to experiment with an innovation prior to committing to its usage (Roger, 1983; Agarwal & Prasad, 1997). Subjective norm refers to a person’s perception that most people who are important to him or her think he or she should or should not perform the behavior in question (Fishbein & Ajzen, 1975; Tan & Teo, 2000). Self-efficacy is defined as an individual’s self-confidence in his or her ability to perform a behavior (Bandura, 1982; Taylor & Todd, 1995). While, facilitating condition refers to the easy access of technological resources and infrastructure. Government support is consistent with the national systems of innovation theory that posits that government policies may encourage or mandate technology development and adoption (King et. al., 1994; Wolcott et. al., 2001).
Mostrar mais

20 Ler mais

Effect Of Perception Use Of Information Technology Safety And Perception Of Interest Trust Online Trading System Using Internet Banking Study Empris In Bri Bank Branch Office Tangerang 2014

Effect Of Perception Use Of Information Technology Safety And Perception Of Interest Trust Online Trading System Using Internet Banking Study Empris In Bri Bank Branch Office Tangerang 2014

not have specific regulations. Everything is still shaded regulations of a general nature. As a result, a provision for the protection of customers are less targeted. Some of the questions that arise, for example how setting responsibilities related parties between the banking and telecommunications as well as other parties, in which case there is a loss of customer funds at the time of internet banking? The extent to which the protection granted the users of internet banking customers?In terms of security token device or internet banking system collapse, the extent of protection of the injured parties? Application of Internet banking can be a strategic tool to encourage competition among banks. In addition, Indonesia is also the fourth country in the world where the population is most widely used Internet services. Not only that, internet banking also stimulate the economy more effectively and efficiently. Therefore, adoption of internet banking should be encouraged. Banks should improve the quality of service. Government completes its legal provisions, whereas customers need to start learning to get used to using the service. Based on the phenomena, researchers want to know and examine the "Influence Perception Use of Information Technology, Leisure Perception and Belief Against Interests Online Transaction System Using Internet Banking (Studies empiricalat Bank BRI Branch Office Tangerang 2014)"
Mostrar mais

12 Ler mais

Synthesis of nanoparticeles in ductile iron with small additions of vanadium and niobium and its mechanical properties

Synthesis of nanoparticeles in ductile iron with small additions of vanadium and niobium and its mechanical properties

mechanical grinding and polishing. Back scattered electrons (BSE) were utilized in SEM in order to reveal difference in chemical compositions of microcomponents present in particular samples. The SEM investigations were used to reveal the distribution of graphite and other big particles. Transmission electron microscopy (TEM), on the other hand, was applied for examination of nanosized secondary precipitates, i.e. vanadium or niobium carbides and/or nitrides (or carbonitrides). The thin foil technique was implemented for this purpose. The 3 mm disks were ground down on sand papers and then dimpled to about 0.1 mm thickness. Afterwards the disks were further thinned in an ion mill until a perforation had appeared. The TEM investigation was carried out by means of a JEOL 2010 ARP analytical scanning transmission electron microscope operating at acceleration voltage of 200 kV. Imaging was performed by conventional transmission mode while for chemical analysis (X-ray Energy Dispersive Spectroscopy - EDS) the nanoprobe mode was utilized. The nanoprobe mode enabled to obtain electron probes approaching a few nanometers in diameter (practically about 10 nm because at smaller electron probes the number of X-ray counts is usually too low for analysis). The EDS analysis was performed by Oxford-Link system attached to the microscope. The Oxford- Link system was equipped with Si(Li) detector. This system detects all elements down to boron. In order to examine the crystallography of precipitates the Selected Area Diffraction (SAD) patterns analysis was also performed.
Mostrar mais

8 Ler mais

Safety climate in the operating room: translation, validation and application of the safety attitudes questionnaire

Safety climate in the operating room: translation, validation and application of the safety attitudes questionnaire

Results: The internal consistency test yielded values around 0.9 for all 73 items. The CFA and its goodness-of-fit indices (SRMR 0.05, RMSEA 0.002, CFI 0.90) showed an acceptable model fit. Inter-correlations between the factors safety climate, teamwork climate, job satisfac- tion, perceptions of management, and working conditions showed moderate correlation with each other. 82 valid questionnaires were analyzed revealing significant differences in communication ratings between different jobs, mainly between surgeons (4.2) and between nurses and surgeons (2.9). Working conditions and job satisfaction have the highest score with 3.8 and 3.5, respectively, and perceptions of management have the lowest score (2.8). Conclusion: The Portuguese translation of the SAQ-OR reveals good psychometric proper- ties for studying the organizational safety climate, however larger and further studies are required to compensate the lack of subjects in some items. Like other studies, this scale seems to be an acceptable to adequate tool to evaluate the safety climate. Results allowed
Mostrar mais

10 Ler mais

Explicit and implicit approach of sensitivity analysis in numerical modelling of solidification

Explicit and implicit approach of sensitivity analysis in numerical modelling of solidification

Keywords: Application of Information Technology to the Foundry Industry: Solidification Process: Numerical Tcchniqucs: Sensitivity Analysis; Borzndary Elcmcnt Mcthod.. Introd[r]

6 Ler mais

en 0102 6933 rgenf 1983  68778

en 0102 6933 rgenf 1983 68778

In the last category, Surgical risk, the CVI of the ques- tion, “Preoperative patient?” went from 78.3% to 100% between the first and second round after the descrip- tive item on the note was removed. The second ques- tion, “Patient in fasting?” got 91.3% in the first round and 95% in the second round after the descriptive field on the record referring to the start of fasting was excluded. The third question, “Surgical site marked?” had a CVI of 91.3%, which changed to 100% after the intervention, “Marking of surgical site requested” was added. The fourth and last question, “Blood typing performed?” had a con- cordance of 95.7% to 100% after inclusion of the response
Mostrar mais

8 Ler mais

The Concept of Early Vascular Ageing – An Update in 2015

The Concept of Early Vascular Ageing – An Update in 2015

When should EVA be suspected? One approach is to consider a positive family history of early onset of obesity, hypertension, T2D, and CVD, and to screen relatives. Another approach is simply to use clinical skills and look for general signs of early biological ageing (facial appearance, gait, skin turgor, etc.), as was tested in a Danish study of identical twins which found that older-looking twins (as judged by lay people provided with facial photos) displayed a higher risk-factor burden, shorter telomere length, and a worse prognosis during follow-up. 22 A limitation of this study was
Mostrar mais

7 Ler mais

Patient safety atmosphere in a teaching hospital

Patient safety atmosphere in a teaching hospital

The professional categories were divided in three groups: nursing group, medical group and other pro- fessionals group. Multiple comparisons, in fact, revealed that physicians had a higher perception of safety when compared to nursing professionals and to the other pro- fessionals group. Statistically significant associations were observed regarding the general score (p=0.003) and the domains Atmosphere of teamwork (p<0.001), Work satis- faction (p=0.02) and Stress Perception (p<0.001) (Table 2). Table 1 - Descriptive analysis of the general score and of the score per SAQ domain. Uberaba, Minas Gerais, Brazil, 2017
Mostrar mais

7 Ler mais

Rev. Bras. Enferm.  vol.70 número1

Rev. Bras. Enferm. vol.70 número1

Objective: summarize the dissertations and theses produced by nurses available in the Catalog of Theses and Dissertations of the Brazilian Nursing Association, from volume XIX to XXXII, that address patient safety. Method: this is a documentary study. After data collection, the following variables were analyzed: academic level, educational institutions, year, place, type of service, study object, study method, subjects, priority protocol of patient safety, implications and fi nal recommendations. Results: 8,720 abstracts were found, 53 (0.61%) of which were analyzed. There was a predominance of dissertations (n=19; 35.85%) regarding the reduction of risks for fall and pressure ulcer (n=24; 45.28%), of descriptive type (n=21; 39.62%), quantitative type (n=16; 30.19%), in hospital environments (n=16; 30.19%), using scales and protocols (n=6; 11.32%). Conclusion: there is a tendency towards the development of studies related to patient safety in hospital environments, with an emphasis on the reduction of risk for pressure ulcer.
Mostrar mais

8 Ler mais

Premarket safety and efficacy studies for ADHD medications in children.

Premarket safety and efficacy studies for ADHD medications in children.

We reviewed the approval documents and identified the clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy or safety in the review process. If the agent was not a New Molecular Entity (and thus prior trials and FDA review had been performed), we reviewed the clinical trials in the original FDA approval package in order to identify any pediatric patients who may have been studied in safety or efficacy assessments. Thus, for drugs representing new formulations or drugs repurposed for the indication of ADHD and for which the FDA approval process might be modified and possibly less stringent given the prior review, we analyzed all clinical trials that had been conducted for approval at any stage. Several drugs had FDA approvals that either recommended or required the conduct of additional, post-marketing clinical trials. When the approval packages did not include supplemental information on these trials, we searched the online trial registry ClinicalTrials.gov to determine whether additional trials had been performed. We also contacted the pharmaceutical companies who had sponsored the drug applications to inquire about clinical trials performed in response to the FDA requests.
Mostrar mais

8 Ler mais

Innovation in cosmetics - innovative makeup products: efficacy and safety

Innovation in cosmetics - innovative makeup products: efficacy and safety

Formulation can simply be defined as a mixture prepared according to a formula. Innovation in this case means coming up with a new or reformulated formula inexistent in the market. This area has so many different notable examples of innovation. Imagine something as simple as a lipstick, you picture it being a bright colour like pink or red, in a black and gold case, with that classic lipstick shape. Well today a lipstick can be so much more, you now have a million colours, from the classic red to the green, blue, and even black. You have glittered lipstick, fluorescent lipstick, matte lipstick, nail polish like lipstick, colour changing lipstick and the list goes on. Nowadays you can imagine a product and think that it is impossible that it exists just to find out that it not only exists but it’s available on the market.
Mostrar mais

60 Ler mais

Levosimendan efficacy and safety : 20 Years of SIMDAX in clinical use

Levosimendan efficacy and safety : 20 Years of SIMDAX in clinical use

Levosimendan is given as a continuous infusion of 0.05 or 0.1 or 0.2 mg/kg/min for 24 hours, which may be preceded by a loading dose (bolus) of 6–12 mg/kg in 10 minutes. The loading dose was used in the active-controlled regulatory studies LIDO and SURVIVE, in which dobutamine served as comparator. Given that the elimination half-life of dobut- amine is a few minutes while that of levosimendan is approx- imately 1 hour, the hemodynamic effects of dobutamine are seen almost immediately after the infusion is started, whereas a bolus of levosimendan is needed to see immediate effects. For consistency, all other studies in the regulatory clinical program were designed to include a bolus dose, followed by a maintenance infusion. It was later found that, in the case of hypovolemia or initial low blood pressure, a levosimendan bolus could be associated with hypotension or arrhythmias. Therefore, use of an initial bolus of levosimendan is now generally not recommended, and it has often been avoided in clinical practice and used only if an instant effect is sought and the systolic blood pressure is adequate. 73,74
Mostrar mais

19 Ler mais

Show all 10000 documents...

temas relacionados