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Infect Control Hosp Epidemiol. Author manuscript; available in PMC Oct 1. Published in final edited form as:. For residents without an indwelling catheter both criteria 1 and 2 must be present UTI should be diagnosed when there are localizing genitourinary signs and symptoms and a positive urine culture result.

A diagnosis of UTI can be made without localizing symptoms if a blood culture isolate is the same as the organism isolated from the urine and there is no alternate site of infection.

In the absence of a clear alternate source of infection, fever or rigors with a positive urine culture result in the noncatheterized resident or acute confusion in the catheterized resident will often be treated as UTI.

However, evidence suggests that most of these episodes are likely not due to infection of a urinary source.

At least 1 of the following sign or symptom subcriteria Acute dysuria or acute pain, swelling, or tenderness of the testes, epididymis, or prostate.

Fever or leukocytosis see Table 2 and at least 1 of the following localizing urinary tract subcriteria.

In the absence of fever or leukocytosis, then 2 or more of the following localizing urinary tract subcriteria. Either acute change in mental status or acute functional decline, with no alternate diagnosis and leukocytosis.

Purulent discharge from around the catheter or acute pain, swelling, or tenderness of the testes, epididymis, or prostate.

Changes in glycemic parameters over time. Mean change from baseline in A1C after adjustment for baseline value. Mean change from baseline in FPG after adjustment for baseline value.

Mean change from baseline in body weight after adjustment for baseline value. Reductions in FPG were apparent as early as week 1.

Throughout the study, FPG reductions were more marked in 5 and 10 mg dapagliflozin arms and were statistically significant at week 24 Fig.

Mean body weight decreases were greater with all dapagliflozin doses than with placebo, although they did not reach statistical significance Fig.

Changes from baseline at week 24 in efficacy parameters, vital signs, and laboratory values. In the exploratory evening dose cohort, changes from baseline in A1C, FPG, and body weight at week 24 were similar to those seen in the main patient cohort Table 2.

In the exploratory high-A1C cohort Subgroup analyses of the main patient cohort by baseline A1C were consistent with the ability of dapagliflozin to cause greater A1C reductions in patients with high baseline A1C.

Treatment with dapagliflozin did not result in any clinically meaningful changes from baseline in serum electrolytes including serum sodium Table 2.

There were no clinically relevant changes in any renal function parameter including serum creatinine, blood urea nitrogen, or cystatin C. In addition, there were no clinically relevant changes in mean serum albumin with dapagliflozin treatment.

Small, dose-ordered mean increases in hematocrit up to 2. A decrease in mean seated blood pressure with no notable increase in orthostatic hypotension was observed in the dapagliflozin arms Table 2.

Treatment with dapagliflozin did not alter the lipid profile of patients, although small numerical increases in HDL cholesterol were noted in all dapagliflozin arms placebo-subtracted adjusted mean change from baseline value [SE] ranged from 0.

Glucose-to-creatinine ratios were higher with dapagliflozin than with placebo Table 2. Higher values with the evening dose presumably reflect the pharmacokinetic half-life of dapagliflozin.

Adverse events are summarized in Table 3. There was one death due to a motor vehicle accident in the 10 mg dapagliflozin group. There were no major episodes of hypoglycemia in this study, and none of the patients discontinued the study medication due to hypoglycemia.

An increased incidence in signs and symptoms and other reports suggestive of UTIs and genital infections was noted with dapagliflozin treatment.

Safety data in the exploratory evening dose cohort were similar to those in the morning dose cohort. There were no other notable differences in the number or type of adverse events reported with the evening dose.

Administration of dapagliflozin as monotherapy to treatment-naive patients with type 2 diabetes resulted in clinically meaningful decreases in A1C and FPG, along with favorable effects on weight, blood pressure, and other metabolic parameters.

Although the decrease in body weight in our study did not reach statistical significance compared with placebo, dapagliflozin treatment did lead to increased renal glucose excretion.

It should also be noted that the progressive decrease in weight over time had not reached a plateau by the end of study; thus, long-term studies are needed to more precisely gauge the effect of dapagliflozin on weight in the monotherapy setting.

Furthermore, in exploratory analysis of pooled data greater increments in fractional renal glucose excretion were associated with greater decrements in body weight, suggesting a link between the mechanism of action of dapagliflozin and clinical outcome.

Data from the high-A1C cohort are of particular relevance given the mechanism of action of dapagliflozin as an SGLT2 inhibitor. Patients with high A1C at enrollment are likely already to present with glycosuria as their filtered glucose load may exceed the absorption capacity of the kidney.

However, dapagliflozin was able to elicit a considerable improvement in glycemia in the exploratory high-A1C cohort.

There were no major episodes of hypoglycemia in this study. After prospectively defined monitoring see research design and methods , signs and symptoms suggestive of UTIs and genital infections were more frequently reported in the dapagliflozin arms.

The decrease in mean systolic and diastolic blood pressure noted in this study is in keeping with the diuretic effect of dapagliflozin. Also consistent with this effect is the increase in hematocrit levels noted in the dapagliflozin arms.

In addition to blood pressure, favorable, albeit small, effects were also noted in several other clinical parameters including HDL cholesterol, uric acid, and high-sensitivity C-reactive protein.

Although effects on weight, blood pressure, and other metabolic risk factors were small, they may have a cumulative benefit in the long term.

Most notably, lowering of plasma glucose with dapagliflozin is accompanied by a urinary loss of calories, suggesting a shift toward negative net energy balance.

This effect of dapagliflozin is unlike that of other antidiabetic agents, which often cause weight gain as they lower plasma glucose concentrations.

Given its effect on net energy balance and its insulin-independent mechanism, dapagliflozin is likely to have beneficial effects in a wide spectrum of patients with diabetes 17 , No other potential conflicts of interest relevant to this article were reported.

We thank the investigators and contributors from each of the study sites. We also thank Sudha Vemuri, Ph.

The costs of publication of this article were defrayed in part by the payment of page charges. Section solely to indicate this fact.

National Center for Biotechnology Information , U. Journal List Diabetes Care v. Published online Jun Find articles by Weihua Tang. Author information Article notes Copyright and License information Disclaimer.

Received Mar 30; Accepted Jun Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

This article has been cited by other articles in PMC. Abstract OBJECTIVE Dapagliflozin, a highly selective inhibitor of the renal sodium-glucose cotransporter-2, increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner.

End points and assessments The primary efficacy end point was change from baseline in A1C at week 24 in the main patient cohort.

Open in a separate window. Table 1 Demographics and baseline characteristics. Table 2 Changes from baseline at week 24 in efficacy parameters, vital signs, and laboratory values.

Table 3 Adverse events. Footnotes Clinical trial reg. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes UKPDS N Engl J Med ;

A prolonged pharmacokinetic half-life due to the C-aryl glucoside-derived chemical structure, as well as a nearly 3,fold selectivity for SGLT2 versus SGLT1, make it possible wettbüro zu verkaufen dapagliflozin to be administered in an unmodified oral form without affecting SGLT1-mediated glucose transport in other tissues 12 — Beste Spielothek in Sandwig finden from white-light interferometry for in vivo ocular eye measurements [3] [4] imaging of biological tissue, especially of book of ra deluxe demo human eye, was investigated by multiple groups worldwide. Secondary efficacy measures included change from baseline at week 24 in FPG and body weight. For Netflix | Euro Palace Casino Blog without an indwelling catheter paysafe karte kaufen criteria 1 and 2 must be present UTI should be diagnosed Beste Spielothek in Kanin finden there are localizing genitourinary signs and symptoms and a positive urine culture result. Changes from baseline at week 24 in efficacy parameters, vital signs, and laboratory values. This was a week parallel-group, double-blind, Oct-33 phase 3 trial. In conventional imaging, this diffusely scattered light contributes background that obscures an image. Enucleation of the eye. The combination of reflected light from the sample arm and reference light from the reference arm gives rise to an interference pattern, but only if light from both arms have traveled the "same" optical distance "same" meaning a difference of less than a coherence length. Patients with high A1C at enrollment are likely already to present with glycosuria as their filtered glucose load may exceed the absorption capacity of the kidney. Adverse events are summarized in Table 3.

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Mit zwei Kollegen gründete er eine Vereinigung zur Bekämpfung des Kurpfuschertums. Ansichten Lesen Bearbeiten Quelltext bearbeiten Versionsgeschichte. Therefore, much effort is needed to improve the knowledge and awareness of this insidious adverse effect by well-documented case reports. April um Oct-4 Oktamer-bindender Transkriptionsfaktor ; engl. In anderen Sprachen Links hinzufügen. Navigation Hauptseite Themenportale Zufälliger Artikel. Osiander, Tübingen , S. Thirteen ACE inhibitors gained more widespread application worldwide. Dabei wird Oct-4 selektiv in den Bereichen des Embryos exprimiert , in denen sich später das fötale Gewebe aufbaut. Navigation Hauptseite Themenportale Zufälliger Artikel. Navigation Hauptseite Themenportale Zufälliger Artikel. Schöler an der University of Pennsylvania am Tiermodell Maus entdeckt, dass die korrekte Expression von Oct-4 direkt mit der Lebensfähigkeit von Maus-Klonen korreliert. Durch die Nutzung dieser Website erklären Sie sich mit den Nutzungsbedingungen und der Datenschutzrichtlinie einverstanden. Möglicherweise unterliegen die Inhalte jeweils zusätzlichen Bedingungen. Versuche über die Wirkungen des Mutterkorns auf den tierischen Organismus und seine Entstehungsart. Geringfügig zu niedrige, aber auch zu hohe Aktivitäten, führten zum Tod der Versuchstiere. Dabei wird Oct-4 selektiv in den Bereichen des Embryos exprimiert , in denen sich später das fötale Gewebe aufbaut. Möglicherweise unterliegen die Inhalte jeweils zusätzlichen Bedingungen. Für die Entwicklung aller Säugetiere ist Oct-4 ein lebensnotwendiges Gen. Schöler an der University of Pennsylvania am Tiermodell Maus entdeckt, dass die korrekte Expression von Oct-4 direkt mit der Lebensfähigkeit von Maus-Klonen korreliert.

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UTIs and genital infections are reported here as an adverse event of special interest and include any of the prospectively defined 20 preferred terms relating to possible upper UTI events, 44 preferred terms relating to possible non—upper UTI events, and 49 preferred terms relating to possible genital infections including bacterial and mycotic infections.

Patients were instructed to self-monitor their blood glucose daily and to report any unusually high or low blood glucose event or any symptoms suggestive of hypoglycemia.

Per the study design, no P values were generated for end points in exploratory cohorts. A total of patients were randomly assigned to the main morning dose and exploratory evening dose cohorts Fig.

In addition, 74 patients were randomly assigned to the exploratory, high-A1C cohort, of which 73 patients took at least one dose of study medication.

Demographic and baseline characteristics are shown in Table 1. In the main cohort, mean A1C reductions were dose ordered and apparent by week 4 and maintained thereafter Fig.

Changes in glycemic parameters over time. Mean change from baseline in A1C after adjustment for baseline value. Mean change from baseline in FPG after adjustment for baseline value.

Mean change from baseline in body weight after adjustment for baseline value. Reductions in FPG were apparent as early as week 1. Throughout the study, FPG reductions were more marked in 5 and 10 mg dapagliflozin arms and were statistically significant at week 24 Fig.

Mean body weight decreases were greater with all dapagliflozin doses than with placebo, although they did not reach statistical significance Fig.

Changes from baseline at week 24 in efficacy parameters, vital signs, and laboratory values. In the exploratory evening dose cohort, changes from baseline in A1C, FPG, and body weight at week 24 were similar to those seen in the main patient cohort Table 2.

In the exploratory high-A1C cohort Subgroup analyses of the main patient cohort by baseline A1C were consistent with the ability of dapagliflozin to cause greater A1C reductions in patients with high baseline A1C.

Treatment with dapagliflozin did not result in any clinically meaningful changes from baseline in serum electrolytes including serum sodium Table 2.

There were no clinically relevant changes in any renal function parameter including serum creatinine, blood urea nitrogen, or cystatin C. In addition, there were no clinically relevant changes in mean serum albumin with dapagliflozin treatment.

Small, dose-ordered mean increases in hematocrit up to 2. A decrease in mean seated blood pressure with no notable increase in orthostatic hypotension was observed in the dapagliflozin arms Table 2.

Treatment with dapagliflozin did not alter the lipid profile of patients, although small numerical increases in HDL cholesterol were noted in all dapagliflozin arms placebo-subtracted adjusted mean change from baseline value [SE] ranged from 0.

Glucose-to-creatinine ratios were higher with dapagliflozin than with placebo Table 2. Higher values with the evening dose presumably reflect the pharmacokinetic half-life of dapagliflozin.

Adverse events are summarized in Table 3. There was one death due to a motor vehicle accident in the 10 mg dapagliflozin group. There were no major episodes of hypoglycemia in this study, and none of the patients discontinued the study medication due to hypoglycemia.

An increased incidence in signs and symptoms and other reports suggestive of UTIs and genital infections was noted with dapagliflozin treatment.

Safety data in the exploratory evening dose cohort were similar to those in the morning dose cohort. There were no other notable differences in the number or type of adverse events reported with the evening dose.

Administration of dapagliflozin as monotherapy to treatment-naive patients with type 2 diabetes resulted in clinically meaningful decreases in A1C and FPG, along with favorable effects on weight, blood pressure, and other metabolic parameters.

Although the decrease in body weight in our study did not reach statistical significance compared with placebo, dapagliflozin treatment did lead to increased renal glucose excretion.

It should also be noted that the progressive decrease in weight over time had not reached a plateau by the end of study; thus, long-term studies are needed to more precisely gauge the effect of dapagliflozin on weight in the monotherapy setting.

Furthermore, in exploratory analysis of pooled data greater increments in fractional renal glucose excretion were associated with greater decrements in body weight, suggesting a link between the mechanism of action of dapagliflozin and clinical outcome.

Data from the high-A1C cohort are of particular relevance given the mechanism of action of dapagliflozin as an SGLT2 inhibitor. Patients with high A1C at enrollment are likely already to present with glycosuria as their filtered glucose load may exceed the absorption capacity of the kidney.

However, dapagliflozin was able to elicit a considerable improvement in glycemia in the exploratory high-A1C cohort. There were no major episodes of hypoglycemia in this study.

After prospectively defined monitoring see research design and methods , signs and symptoms suggestive of UTIs and genital infections were more frequently reported in the dapagliflozin arms.

The decrease in mean systolic and diastolic blood pressure noted in this study is in keeping with the diuretic effect of dapagliflozin.

Also consistent with this effect is the increase in hematocrit levels noted in the dapagliflozin arms.

In addition to blood pressure, favorable, albeit small, effects were also noted in several other clinical parameters including HDL cholesterol, uric acid, and high-sensitivity C-reactive protein.

Although effects on weight, blood pressure, and other metabolic risk factors were small, they may have a cumulative benefit in the long term.

Most notably, lowering of plasma glucose with dapagliflozin is accompanied by a urinary loss of calories, suggesting a shift toward negative net energy balance.

This effect of dapagliflozin is unlike that of other antidiabetic agents, which often cause weight gain as they lower plasma glucose concentrations.

Given its effect on net energy balance and its insulin-independent mechanism, dapagliflozin is likely to have beneficial effects in a wide spectrum of patients with diabetes 17 , No other potential conflicts of interest relevant to this article were reported.

We thank the investigators and contributors from each of the study sites. We also thank Sudha Vemuri, Ph. The costs of publication of this article were defrayed in part by the payment of page charges.

Section solely to indicate this fact. National Center for Biotechnology Information , U. Journal List Diabetes Care v. Published online Jun Find articles by Weihua Tang.

Author information Article notes Copyright and License information Disclaimer. Received Mar 30; Accepted Jun Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

This article has been cited by other articles in PMC. Abstract OBJECTIVE Dapagliflozin, a highly selective inhibitor of the renal sodium-glucose cotransporter-2, increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner.

End points and assessments The primary efficacy end point was change from baseline in A1C at week 24 in the main patient cohort. Optical coherence tomography is one of a class of optical tomographic techniques.

A relatively recent implementation of optical coherence tomography, frequency-domain optical coherence tomography, provides advantages in signal-to-noise ratio , permitting faster signal acquisition.

Commercially available optical coherence tomography systems are employed in diverse applications, including art conservation and diagnostic medicine, notably in ophthalmology and optometry where it can be used to obtain detailed images from within the retina.

Recently, it has also begun to be used in interventional cardiology to help diagnose coronary artery disease.

Starting from white-light interferometry for in vivo ocular eye measurements [3] [4] imaging of biological tissue, especially of the human eye, was investigated by multiple groups worldwide.

A first two-dimensional in vivo depiction of a human eye fundus along a horizontal meridian based on white light interferometric depth scans was presented at the ICO SAT conference in James Fujimoto laboratory at Massachusetts Institute of Technology , [8] optical coherence tomography OCT with micrometer resolution and cross-sectional imaging capabilities has become a prominent biomedical tissue-imaging technique; it is particularly suited to ophthalmic applications and other tissue imaging requiring micrometer resolution and millimeter penetration depth.

OCT has interesting advantages over other medical imaging systems. Medical ultrasonography , magnetic resonance imaging MRI , confocal microscopy, and OCT are differently suited to morphological tissue imaging: OCT is based on low-coherence interferometry.

In OCT, this interference is shortened to a distance of micrometers, owing to the use of broad-bandwidth light sources i.

Light with broad bandwidths can be generated by using superluminescent diodes or lasers with extremely short pulses femtosecond lasers. White light is an example of a broadband source with lower power.

Light in an OCT system is broken into two arms—a sample arm containing the item of interest and a reference arm usually a mirror. The combination of reflected light from the sample arm and reference light from the reference arm gives rise to an interference pattern, but only if light from both arms have traveled the "same" optical distance "same" meaning a difference of less than a coherence length.

By scanning the mirror in the reference arm, a reflectivity profile of the sample can be obtained this is time domain OCT.

Areas of the sample that reflect back a lot of light will create greater interference than areas that don't. Any light that is outside the short coherence length will not interfere.

A cross-sectional tomograph B-scan may be achieved by laterally combining a series of these axial depth scans A-scan.

A face imaging at an acquired depth is possible depending on the imaging engine used. OCT delivers high resolution because it is based on light, rather than sound or radio frequency.

An optical beam is directed at the tissue, and a small portion of this light that reflects from sub-surface features is collected.

Note that most light is not reflected but, rather, scatters off at large angles. In conventional imaging, this diffusely scattered light contributes background that obscures an image.

However, in OCT, a technique called interferometry is used to record the optical path length of received photons allowing rejection of most photons that scatter multiple times before detection.

Thus OCT can build up clear 3D images of thick samples by rejecting background signal while collecting light directly reflected from surfaces of interest.

Within the range of noninvasive three-dimensional imaging techniques that have been introduced to the medical research community, OCT as an echo technique is similar to ultrasound imaging.

Other medical imaging techniques such as computerized axial tomography, magnetic resonance imaging, or positron emission tomography do not use the echo-location principle.

It is also important to note that the laser output from the instruments is low — eye-safe near-infrared light is used — and no damage to the sample is therefore likely.

The principle of OCT is white light, or low coherence, interferometry. The optical setup typically consists of an interferometer Fig.

Light is split into and recombined from reference and sample arm, respectively. In time domain OCT the pathlength of the reference arm is varied in time the reference mirror is translated longitudinally.

A property of low coherence interferometry is that interference, i. This interference is called auto correlation in a symmetric interferometer both arms have the same reflectivity , or cross-correlation in the common case.

The envelope of this modulation changes as pathlength difference is varied, where the peak of the envelope corresponds to pathlength matching. Due to the coherence gating effect of OCT the complex degree of coherence is represented as a Gaussian function expressed as [4].

In equation 2 , the Gaussian envelope is amplitude modulated by an optical carrier. The peak of this envelope represents the location of the microstructure of the sample under test, with an amplitude dependent on the reflectivity of the surface.

The optical carrier is due to the Doppler effect resulting from scanning one arm of the interferometer, and the frequency of this modulation is controlled by the speed of scanning.

Therefore, translating one arm of the interferometer has two functions; depth scanning and a Doppler-shifted optical carrier are accomplished by pathlength variation.

In OCT, the Doppler-shifted optical carrier has a frequency expressed as. The axial and lateral resolutions of OCT are decoupled from one another; the former being an equivalent to the coherence length of the light source and the latter being a function of the optics.

The axial resolution of OCT is defined as. In frequency domain OCT FD-OCT the broadband interference is acquired with spectrally separated detectors either by encoding the optical frequency in time with a spectrally scanning source or with a dispersive detector, like a grating and a linear detector array.

Due to the Fourier relation Wiener-Khintchine theorem between the auto correlation and the spectral power density the depth scan can be immediately calculated by a Fourier-transform from the acquired spectra, without movement of the reference arm.

The parallel detection at multiple wavelength ranges limits the scanning range, while the full spectral bandwidth sets the axial resolution.

Thereby the information of the full depth scan can be acquired within a single exposure. The drawbacks of this technology are found in a strong fall-off of the SNR, which is proportional to the distance from the zero delay and a sinc-type reduction of the depth dependent sensitivity because of limited detection linewidth.

One pixel detects a quasi-rectangular portion of an optical frequency range instead of a single frequency, the Fourier-transform leads to the sinc z behavior.

Additionally the dispersive elements in the spectroscopic detector usually do not distribute the light equally spaced in frequency on the detector, but mostly have an inverse dependence.

Therefore, the signal has to be resampled before processing, which can not take care of the difference in local pixelwise bandwidth, which results in further reduction of the signal quality.

However, the fall-off is not a serious problem with the development of new generation CCD or photodiode array with a larger number of pixels.

Synthetic array heterodyne detection offers another approach to this problem without the need for high dispersion.

Here the spectral components are not encoded by spatial separation, but they are encoded in time. The spectrum is either filtered or generated in single successive frequency steps and reconstructed before Fourier-transformation.

By accommodation of a frequency scanning light source i. Drawbacks are the nonlinearities in the wavelength especially at high scanning frequencies , the broadening of the linewidth at high frequencies and a high sensitivity to movements of the scanning geometry or the sample below the range of nanometers within successive frequency steps.

An imaging approach to temporal OCT was developed by Claude Boccara's team in , [23] with an acquisition of the images without beam scanning.

More precisely, interferometric images are created by a Michelson interferometer where the path length difference is varied by a fast electric component usually a piezo mirror in the reference arm.

These images acquired by a CCD camera are combined in post-treatment or on-line by the phase shift interferometry method, where usually 2 or 4 images per modulation period are acquired, depending on the algorithm used.

The "en-face" tomographic images are thus produced by a wide-field illumination, ensured by the Linnik configuration of the Michelson interferometer where a microscope objective is used in both arms.

Furthermore, while the temporal coherence of the source must remain low as in classical OCT i. Focusing the light beam to a point on the surface of the sample under test, and recombining the reflected light with the reference will yield an interferogram with sample information corresponding to a single A-scan Z axis only.

Scanning of the sample can be accomplished by either scanning the light on the sample, or by moving the sample under test.

A linear scan will yield a two-dimensional data set corresponding to a cross-sectional image X-Z axes scan , whereas an area scan achieves a three-dimensional data set corresponding to a volumetric image X-Y-Z axes scan.

Any light that is outside the short coherence length will not interfere. In the main cohort, mean A1C reductions were dose ordered and apparent by week 4 and la liga pokal thereafter Fig. Cochrane Database Syst Rev. Retrieved December 15, Support Center Support Center. A face imaging at an acquired depth is possible depending on the imaging engine used. In von Bally, G. No other potential conflicts of interest relevant to this article were reported. Refrigerated specimens should be cultured within 24 h. In OCT, the Doppler-shifted optical carrier has a frequency Beste Spielothek in Bergheide finden as. Current Opinion in Ophthalmology. Beste Spielothek in Hofbau finden is used for medical imaging and industrial nondestructive testing NDT.

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