IMPORTANCE Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis.OBJECTIVE To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). DESIGN, SETTING, AND PARTICIPANTSMulticenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020.INTERVENTIONS Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. MAIN OUTCOMES AND MEASURESThe primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 ×10 3 /μL). All outcomes were blindly adjudicated. RESULTS Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, −6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P = .70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, −ϱ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P = .01).CONCLUSIONS AND RELEVANCE Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days...
Background: Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods: This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). Conclusion: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.
A critical point for better management of COVID-19 is: knowing more about exact pathomechanisms of events in different organs during disease course and COVID-related histopathological events like tissue sampling, either biopsy or necropsy/autopsy of died people, collecting from different populations. →What this article adds:In lung necropsy of 15 Iranian patients, we found similar presentation of histopathologic events compared with previous similar studiers: A high percentage of anthracosis and viral cytopathic effects, and a lower percentage of microthrombotic vascular lung injuries, suggesting some probable differences in pathologic events among different populations.
We have assessed the value of single fiber reflectance (SFR) spectroscopy in prediction of cervical squamous intraepithelial lesions (SIL). SFR was used to measure reflected light from 32 patients undergoing standard colposcopy. Seven parameters extracted from the spectra in addition to two biographic parameters were compared in biopsy-confirmed SIL versus nonSIL. The significant parameters in the model were determined using stepwise logistic regression. The classification performance was evaluated by a leave-one-out cross-validation method and reported by receiver operating characteristic (ROC) curves. Light absorption properties and biographic characteristics of the patient contributed significantly to the accuracy of the model. Combining important parameters, the best retrospective sensitivity, specificity and area under the ROC curve for SIL sites versus nonSIL were 89%, 80% and 0.89%, respectively. SFR spectroscopy shows promise as a noninvasive, real-time method to guide the clinician in reducing the number of unnecessary biopsies. Discrimination of SIL from other abnormalities compares favorably with that obtained by fluorescence alone and by fluorescence combined with reflectance spectroscopy while the simplicity and low cost of the presented system are dominant.
BACKGROUND Irritable bowel syndrome (IBS) is the most common chronic gastrointestinal (GI) disorder. Patients with IBS usually suffer from anxiety and depression. A combination of psychological approaches and pharmacological treatments can be a significantly effective treatment for IBS. The main objective of the present study was to provide a therapeutic plan based on laughter yoga and anti-anxiety medication, employed for the very first time, and to determine the effectiveness of these treatments on the anxiety and GI symptoms of patients with IBS. METHODS In this randomized, controlled, clinical trial, the participants were 60 patients selected from those who referred to the GI clinic of Vali-asr Hospital (Birjand, Iran) during the study period (April 2017 to March 2017) and were diagnosed as having IBS based on ROME III criteria. The participants were randomly assigned to either the laughter yoga group, the anti-anxiety medication group, or the symptomatic treatment (control) group. Severity levels of anxiety and GI symptoms before and after intervention were determined and compared among these three groups according to approved protocols. RESULTS The severity of IBS symptoms after the interventions was more greatly reduced in the laughter yoga group than in the anti-anxiety medication and control groups (p = 0.006). The severity of anxiety after interventions decreased in all three groups, especially in the yoga treatment group, but the difference was not statistically significant (p = 0.1). CONCLUSION Laughter yoga is more effective than anti-anxiety medication in reducing the GI symptoms of patients with IBS. Therefore, applying laughter yoga along with common pharmacological therapies for patients with IBS might be strongly advised.
Purpose This work was set out to investigate the feasibility of dose reduction in SPECT myocardial perfusion imaging (MPI) without sacrificing diagnostic accuracy. A deep learning approach was proposed to synthesize full-dose images from the corresponding low-dose images at different dose reduction levels in the projection space. Methods Clinical SPECT-MPI images of 345 patients acquired on a dedicated cardiac SPECT camera in list-mode format were retrospectively employed to predict standard-dose from low-dose images at half-, quarter-, and one-eighth-dose levels. To simulate realistic low-dose projections, 50%, 25%, and 12.5% of the events were randomly selected from the list-mode data through applying binomial subsampling. A generative adversarial network was implemented to predict non-gated standard-dose SPECT images in the projection space at the different dose reduction levels. Well-established metrics, including peak signal-to-noise ratio (PSNR), root mean square error (RMSE), and structural similarity index metrics (SSIM) in addition to Pearson correlation coefficient analysis and clinical parameters derived from Cedars-Sinai software were used to quantitatively assess the predicted standard-dose images. For clinical evaluation, the quality of the predicted standard-dose images was evaluated by a nuclear medicine specialist using a seven-point (− 3 to + 3) grading scheme. Results The highest PSNR (42.49 ± 2.37) and SSIM (0.99 ± 0.01) and the lowest RMSE (1.99 ± 0.63) were achieved at a half-dose level. Pearson correlation coefficients were 0.997 ± 0.001, 0.994 ± 0.003, and 0.987 ± 0.004 for the predicted standard-dose images at half-, quarter-, and one-eighth-dose levels, respectively. Using the standard-dose images as reference, the Bland–Altman plots sketched for the Cedars-Sinai selected parameters exhibited remarkably less bias and variance in the predicted standard-dose images compared with the low-dose images at all reduced dose levels. Overall, considering the clinical assessment performed by a nuclear medicine specialist, 100%, 80%, and 11% of the predicted standard-dose images were clinically acceptable at half-, quarter-, and one-eighth-dose levels, respectively. Conclusion The noise was effectively suppressed by the proposed network, and the predicted standard-dose images were comparable to reference standard-dose images at half- and quarter-dose levels. However, recovery of the underlying signals/information in low-dose images beyond a quarter of the standard dose would not be feasible (due to very poor signal-to-noise ratio) which will adversely affect the clinical interpretation of the resulting images.
In order to investigate the effectiveness of optical spectroscopy for in vivo diagnosis of cervical pre-cancerous conditions, a series of published studies are surveyed. The six optical technologies investigated include fluorescence spectroscopy, reflectance spectroscopy, and their combination using point probe or multispectral imaging approaches. Searching in the well-known databases, the most recent published works were sought out. Various aspects of the studies were evaluated including the details of the technology used, the pathologic threshold for tissue classification and the gold standard, the study population and prevalence of disease in this population, the method of measurement, the number of clinicians involved in the study, the classification and validation algorithms, and the performance in terms of sensitivity, specificity and, when available, the area under the receiver operating characteristic curve. Forty-four studies conducted from 1994 to 2012 were evaluated. The data are gathered in two comprehensive tables, and five illustrations are provided to simplify a comparison between studies from different points of view. There is a broad band of studies from small pilot studies through phase III clinical trials. Among the reviewed articles, only three factors were found to influence the performance of the optical spectroscopy studies. Multispectral approaches show higher specificity than the point probe approaches (p = 0.001). The use of acetic acid before measurement and prevalence of disease among the studied population, also, have an impact on the sensitivity and specificity of the studies (p< 0.05), respectively.
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