Ajanta pharma kamagra oral jelly
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Patients Figure 1 ajanta pharma kamagra oral jelly. Figure 1. Enrollment and Randomization ajanta pharma kamagra oral jelly. Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir ajanta pharma kamagra oral jelly group and 522 to the placebo group (Figure 1).
Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 ajanta pharma kamagra oral jelly because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned. Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, ajanta pharma kamagra oral jelly a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died.
Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were ajanta pharma kamagra oral jelly 132 patients in the remdesivir group and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit. The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available ajanta pharma kamagra oral jelly at the time of the database freeze. Table 1.
Table 1 ajanta pharma kamagra oral jelly. Demographic and Clinical Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1). On the ajanta pharma kamagra oral jelly basis of the evolving epidemiology of erectile dysfunction treatment during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported.
249 (23.4%) were Hispanic ajanta pharma kamagra oral jelly or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was ajanta pharma kamagra oral jelly 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix. 272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category ajanta pharma kamagra oral jelly 6, 421 (39.6%) category 5, and 127 (11.9%) category 4.
There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome ajanta pharma kamagra oral jelly Figure 2. Figure 2. KaplanâMeier Estimates of Cumulative Recoveries ajanta pharma kamagra oral jelly.
Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 ajanta pharma kamagra oral jelly (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation. Panel D), and in those with a baseline score of ajanta pharma kamagra oral jelly 7 (receiving mechanical ventilation or ECMO. Panel E).
Table 2. Table 2 ajanta pharma kamagra oral jelly. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3 ajanta pharma kamagra oral jelly. Figure 3.
Time to Recovery According to ajanta pharma kamagra oral jelly Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ajanta pharma kamagra oral jelly ethnic group were reported by the patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32.
95% confidence interval ajanta pharma kamagra oral jelly [CI], 1.12 to 1.55. P<0.001. 1059 patients ajanta pharma kamagra oral jelly (Figure 2 and Table 2). Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 ajanta pharma kamagra oral jelly patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively.
For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), ajanta pharma kamagra oral jelly the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ajanta pharma kamagra oral jelly ratio for recovery, 1.31.
95% CI, 1.12 to 1.54. 1017 patients) ajanta pharma kamagra oral jelly. Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57 ajanta pharma kamagra oral jelly. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.
380 patients) (Figure 3) ajanta pharma kamagra oral jelly. Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91. P=0.001. 844 patients) (Table 2 and Fig.
S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04. 1059 patients). The KaplanâMeier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2).
The KaplanâMeier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10). Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients).
Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4). The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]).
Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Population Table 1. Table 1.
Characteristics of the Participants in the mRNA-1273 Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected erectile dysfunction treatment while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits.
The demographic characteristics of participants at enrollment are provided in Table 1. treatment Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.
Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination.
After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3).
erectile dysfunction Binding Antibody Responses Table 2. Table 2. Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2.
erectile dysfunction Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live kamagra PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively. Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants.
Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay.
The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A).
Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domainâspecific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens. The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). erectile dysfunction Neutralization Responses No participant had detectable PsVNA responses before vaccination.
After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50]. Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80]. Fig.
S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens.
Before vaccination, no participant had detectable 80% live-kamagra neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type kamagraâneutralizing activity capable of reducing erectile dysfunction infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay. Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273.
erectile dysfunction T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig.
S11).Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with erectile dysfunction treatment at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network. (Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavirâritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed erectile dysfunction and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020.
Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net.
The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment.
Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial. For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments.
Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first. Information was recorded regarding the patientsâ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.
Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the erectile dysfunction treatment kamagra. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients.
For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio. Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. KaplanâMeier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization.
For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1. Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1).
To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and â¥80 years). This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk.
(One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest. Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle. The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.Trial Design and Oversight We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to erectile dysfunction treatment.12 We randomly assigned participants in a 1:1 ratio to receive either hydroxychloroquine or placebo.
Participants had known exposure (by participant report) to a person with laboratory-confirmed erectile dysfunction treatment, whether as a household contact, a health care worker, or a person with other occupational exposures. Trial enrollment began on March 17, 2020, with an eligibility threshold to enroll within 3 days after exposure. The objective was to intervene before the median incubation period of 5 to 6 days. Because of limited access to prompt testing, health care workers could initially be enrolled on the basis of presumptive high-risk exposure to patients with pending tests. However, on March 23, eligibility was changed to exposure to a person with a positive polymerase-chain-reaction (PCR) assay for erectile dysfunction, with the eligibility window extended to within 4 days after exposure.
This trial was approved by the institutional review board at the University of Minnesota and conducted under a Food and Drug Administration Investigational New Drug application. In Canada, the trial was approved by Health Canada. Ethics approvals were obtained from the Research Institute of the McGill University Health Centre, the University of Manitoba, and the University of Alberta. Participants We included participants who had household or occupational exposure to a person with confirmed erectile dysfunction treatment at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Participants were excluded if they were younger than 18 years of age, were hospitalized, or met other exclusion criteria (see the Supplementary Appendix, available with the full text of this article at NEJM.org).
Persons with symptoms of erectile dysfunction treatment or with PCR-proven erectile dysfunction were excluded from this prevention trial but were separately enrolled in a companion clinical trial to treat early . Setting Recruitment was performed primarily with the use of social media outreach as well as traditional media platforms. Participants were enrolled nationwide in the United States and in the Canadian provinces of Quebec, Manitoba, and Alberta. Participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.13 After participants read the consent form, their comprehension of its contents was assessed. Participants provided a digitally captured signature to indicate informed consent.
We sent follow-up e-mail surveys on days 1, 5, 10, and 14. A survey at 4 to 6 weeks asked about any follow-up testing, illness, or hospitalizations. Participants who did not respond to follow-up surveys received text messages, e-mails, telephone calls, or a combination of these to ascertain their outcomes. When these methods were unsuccessful, the emergency contact provided by the enrollee was contacted to determine the participantâs illness and vital status. When all communication methods were exhausted, Internet searches for obituaries were performed to ascertain vital status.
Interventions Randomization occurred at research pharmacies in Minneapolis and Montreal. The trial statisticians generated a permuted-block randomization sequence using variably sized blocks of 2, 4, or 8, with stratification according to country. A research pharmacist sequentially assigned participants. The assignments were concealed from investigators and participants. Only pharmacies had access to the randomization sequence.
Hydroxychloroquine sulfate or placebo was dispensed and shipped overnight to participants by commercial courier. The dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total). If participants had gastrointestinal upset, they were advised to divide the daily dose into two or three doses. We chose this hydroxychloroquine dosing regimen on the basis of pharmacokinetic simulations to achieve plasma concentrations above the erectile dysfunction in vitro half maximal effective concentration for 14 days.14 Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group. Rising Pharmaceuticals provided a donation of hydroxychloroquine, and some hydroxychloroquine was purchased.
Outcomes The primary outcome was prespecified as symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, erectile dysfunction treatmentârelated symptoms. We assumed that health care workers would have access to erectile dysfunction treatment testing if symptomatic. However, access to testing was limited throughout the trial period. erectile dysfunction treatmentârelated symptoms were based on U.S. Council for State and Territorial Epidemiologists criteria for confirmed cases (positivity for erectile dysfunction on PCR assay), probable cases (the presence of cough, shortness of breath, or difficulty breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).15 All the participants had epidemiologic linkage,15 per trial eligibility criteria.
Four infectious disease physicians who were unaware of the trial-group assignments reviewed symptomatic participants to generate a consensus with respect to whether their condition met the case definition.15 Secondary outcomes included the incidence of hospitalization for erectile dysfunction treatment or death, the incidence of PCR-confirmed erectile dysfunction , the incidence of erectile dysfunction treatment symptoms, the incidence of discontinuation of the trial intervention owing to any cause, and the severity of symptoms (if any) at days 5 and 14 according to a visual analogue scale (scores ranged from 0 [no symptoms] to 10 [severe symptoms]). Data on adverse events were also collected with directed questioning for common side effects along with open-ended free text. Outcome data were measured within 14 days after trial enrollment. Outcome data including PCR testing results, possible erectile dysfunction treatmentârelated symptoms, adherence to the trial intervention, side effects, and hospitalizations were all collected through participant report. Details of trial conduct are provided in the protocol and statistical analysis plan, available at NEJM.org.
Sample Size We anticipated that illness compatible with erectile dysfunction treatment would develop in 10% of close contacts exposed to erectile dysfunction treatment.9 Using Fisherâs exact method with a 50% relative effect size to reduce new symptomatic s, a two-sided alpha of 0.05, and 90% power, we estimated that 621 persons would need to be enrolled in each group. With a pragmatic, Internet-based, self-referral recruitment strategy, we planned for a 20% incidence of attrition by increasing the sample size to 750 participants per group. We specified a priori that participants who were already symptomatic on day 1 before receiving hydroxychloroquine or placebo would be excluded from the prophylaxis trial and would instead be separately enrolled in the companion symptomatic treatment trial. Because the estimates for both incident symptomatic erectile dysfunction treatment after an exposure and loss to follow-up were relatively unknown in early March 2020,9 the protocol prespecified a sample-size reestimation at the second interim analysis. This reestimation, which used the incidence of new s in the placebo group and the observed percentage of participants lost to follow-up, was aimed at maintaining the ability to detect an effect size of a 50% relative reduction in new symptomatic s.
Interim Analyses An independent data and safety monitoring board externally reviewed the data after 25% and 50% of the participants had completed 14 days of follow-up. Stopping guidelines were provided to the data and safety monitoring board with the use of a LanâDeMets spending function analogue of the OâBrienâFleming boundaries for the primary outcome. A conditional power analysis was performed at the second and third interim analysis with the option of early stopping for futility. At the second interim analysis on April 22, 2020, the sample size was reduced to 956 participants who could be evaluated with 90% power on the basis of the higher-than-expected event rate of s in the control group. At the third interim analysis on May 6, the trial was halted on the basis of a conditional power of less than 1%, since it was deemed futile to continue.
Statistical Analysis We assessed the incidence of erectile dysfunction treatment disease by day 14 with Fisherâs exact test. Secondary outcomes with respect to percentage of patients were also compared with Fisherâs exact test. Among participants in whom incident illness compatible with erectile dysfunction treatment developed, we summarized the symptom severity score at day 14 with the median and interquartile range and assessed the distributions with a KruskalâWallis test. We conducted all analyses with SAS software, version 9.4 (SAS Institute), according to the intention-to-treat principle, with two-sided type I error with an alpha of 0.05. For participants with missing outcome data, we conducted a sensitivity analysis with their outcomes excluded or included as an event.
Subgroups that were specified a priori included type of contact (household vs. Health care), days from exposure to enrollment, age, and sex.Announced on May 15, Operation Warp Speed (OWS) â a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector â aims to accelerate control of the erectile dysfunction treatment kamagra by advancing development, manufacturing, and distribution of treatments, therapeutics, and diagnostics. OWS is providing support to promising candidates and enabling the expeditious, parallel execution of the necessary steps toward approval or authorization of safe products by the Food and Drug Administration (FDA).The partnership grew out of an acknowledged need to fundamentally restructure the way the U.S. Government typically supports product development and treatment distribution. The initiative was premised on setting a âstretch goalâ â one that initially seemed impossible but that is becoming increasingly achievable.The concept of an integrated structure for erectile dysfunction treatment countermeasure research and development across the U.S.
Government was based on experience with Zika and the Zika Leadership Group led by the National Institutes of Health (NIH) and the assistant secretary for preparedness and response (ASPR). One of us (M.S.) serves as OWS chief advisor. We are drawing on expertise from the NIH, ASPR, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), and the DOD, including the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Advanced Research Projects Agency. OWS has engaged experts in all critical aspects of medical countermeasure research, development, manufacturing, and distribution to work in close coordination.The initiative set ambitious objectives. To deliver tens of millions of doses of a erectile dysfunction treatment â with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S.
Population â beginning at the end of 2020 and to have as many as 300 million doses of such treatments available and deployed by mid-2021. The pace and scope of such a treatment effort are unprecedented. The 2014 West African Ebola kamagra epidemic spurred rapid treatment development, but though preclinical data existed before the outbreak, a period of 12 months was required to progress from phase 1 first-in-human trials to phase 3 efficacy trials. OWS aims to compress this time frame even further. erectile dysfunction treatment development began in January, phase 1 clinical studies in March, and the first phase 3 trials in July.
Our objectives are based on advances in treatment platform technology, improved understanding of safe and efficacious treatment design, and similarities between the SARS-CoV-1 and erectile dysfunction disease mechanisms.OWSâs role is to enable, accelerate, harmonize, and advise the companies developing the selected treatments. The companies will execute the clinical or process development and manufacturing plans, while OWS leverages the full capacity of the U.S. Government to ensure that no technical, logistic, or financial hurdles hinder treatment development or deployment.OWS selected treatment candidates on the basis of four criteria. We required candidates to have robust preclinical data or early-stage clinical trial data supporting their potential for clinical safety and efficacy. Candidates had to have the potential, with our acceleration support, to enter large phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the kamagra, to deliver efficacy outcomes by the end of 2020 or the first half of 2021.
Candidates had to be based on treatment-platform technologies permitting fast and effective manufacturing, and their developers had to demonstrate the industrial process scalability, yields, and consistency necessary to reliably produce more than 100 million doses by mid-2021. Finally, candidates had to use one of four treatment-platform technologies that we believe are the most likely to yield a safe and effective treatment against erectile dysfunction treatment. The mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform.OWSâs strategy relies on a few key principles. First, we sought to build a diverse project portfolio that includes two treatment candidates based on each of the four platform technologies. Such diversification mitigates the risk of failure due to safety, efficacy, industrial manufacturability, or scheduling factors and may permit selection of the best treatment platform for each subpopulation at risk for contracting or transmitting erectile dysfunction treatment, including older adults, frontline and essential workers, young adults, and pediatric populations.
In addition, advancing eight treatments in parallel will increase the chances of delivering 300 million doses in the first half of 2021.Second, we must accelerate treatment program development without compromising safety, efficacy, or product quality. Clinical development, process development, and manufacturing scale-up can be substantially accelerated by running all streams, fully resourced, in parallel. Doing so requires taking on substantial financial risk, as compared with the conventional sequential development approach. OWS will maximize the size of phase 3 trials (30,000 to 50,000 participants each) and optimize trial-site location by consulting daily epidemiologic and disease-forecasting models to ensure the fastest path to an efficacy readout. Such large trials also increase the safety data set for each candidate treatment.With heavy up-front investment, companies can conduct clinical operations and site preparation for these phase 3 efficacy trials even as they file their Investigational New Drug application (IND) for their phase 1 studies, thereby ensuring immediate initiation of phase 3 when they get a green light from the FDA.
To permit appropriate comparisons among the treatment candidates and to optimize treatment utilization after approval by the FDA, the phase 3 trial end points and assay readouts have been harmonized through a collaborative effort involving the National Institute of Allergy and Infectious Diseases (NIAID), the erectile dysfunction Prevention Network, OWS, and the sponsor companies.Finally, OWS is supporting the companies financially and technically to commence process development and scale up manufacturing while their treatments are in preclinical or very early clinical stages. To ensure that industrial processes are set, running, and validated for FDA inspection when phase 3 trials end, OWS is also supporting facility building or refurbishing, equipment fitting, staff hiring and training, raw-material sourcing, technology transfer and validation, bulk product processing into vials, and acquisition of ample vials, syringes, and needles for each treatment candidate. We aim to have stockpiled, at OWSâs expense, a few tens of millions of treatment doses that could be swiftly deployed once FDA approval is obtained.This strategy aims to accelerate treatment development without curtailing the critical steps required by sound science and regulatory standards. The FDA recently reissued guidance and standards that will be used to assess each treatment for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit treatment administration before all BLA procedures are completed.Of the eight treatments in OWSâs portfolio, six have been announced and partnerships executed with the companies.
Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein). These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.Moderna developed its RNA treatment in collaboration with the NIAID, began its phase 1 trial in March, recently published encouraging safety and immunogenicity data,1 and entered phase 3 on July 27. Pfizer and BioNTechâs RNA treatment also produced encouraging phase 1 results2 and started its phase 3 trial on July 27. The ChAdOx replication-defective live-vector treatment developed by AstraZeneca and Oxford University is in phase 3 trials in the United Kingdom, Brazil, and South Africa, and it should enter U.S.
Phase 3 trials in August.3 The Janssen Ad26 erectile dysfunction treatment replication-defective live-vector treatment has demonstrated excellent protection in nonhuman primate models and began its U.S. Phase 1 trial on July 27. It should be in phase 3 trials in mid-September. Novavax completed a phase 1 trial of its recombinant-subunit-adjuvanted protein treatment in Australia and should enter phase 3 trials in the United States by the end of September.4 Sanofi/GSK is completing preclinical development steps and plans to commence a phase 1 trial in early September and to be well into phase 3 by yearâs end.5On the process-development front, the RNA treatments are already being manufactured at scale. The other candidates are well advanced in their scale-up development, and manufacturing sites are being refurbished.While development and manufacturing proceed, the HHSâDOD partnership is laying the groundwork for treatment distribution, subpopulation prioritization, financing, and logistic support.
We are working with bioethicists and experts from the NIH, the CDC, BARDA, and the Centers for Medicare and Medicaid Services to address these critical issues. We will receive recommendations from the CDC Advisory Committee on Immunization Practices, and we are working to ensure that the most vulnerable and at-risk persons will receive treatment doses once they are ready. Prioritization will also depend on the relative performance of each treatment and its suitability for particular populations. Because some technologies have limited previous data on safety in humans, the long-term safety of these treatments will be carefully assessed using pharmacovigilance surveillance strategies.No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices weâve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor..
Patients Figure 1 kamagra oral jelly online shop. Figure 1. Enrollment and kamagra oral jelly online shop Randomization. Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir group and 522 kamagra oral jelly online shop to the placebo group (Figure 1).
Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew kamagra oral jelly online shop consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned. Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, a total of 391 patients in the remdesivir group and kamagra oral jelly online shop 340 in the placebo group had completed the trial through day 29, recovered, or died.
Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and kamagra oral jelly online shop 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit. The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were kamagra oral jelly online shop available at the time of the database freeze. Table 1.
Table 1 kamagra oral jelly online shop. Demographic and Clinical Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1). On the basis of the evolving kamagra oral jelly online shop epidemiology of erectile dysfunction treatment during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported.
249 (23.4%) kamagra oral jelly online shop were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, kamagra oral jelly online shop 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix. 272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, kamagra oral jelly online shop 421 (39.6%) category 5, and 127 (11.9%) category 4.
There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure kamagra oral jelly online shop 2. Figure 2. KaplanâMeier Estimates kamagra oral jelly online shop of Cumulative Recoveries.
Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in kamagra oral jelly online shop those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation. Panel D), and in those kamagra oral jelly online shop with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E).
Table 2. Table 2 kamagra oral jelly online shop. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3 kamagra oral jelly online shop. Figure 3.
Time to kamagra oral jelly online shop Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the kamagra oral jelly online shop patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32.
95% confidence interval kamagra oral jelly online shop [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table kamagra oral jelly online shop 2). Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 kamagra oral jelly online shop (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively.
For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), kamagra oral jelly online shop the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate kamagra oral jelly online shop ratio for recovery, 1.31.
95% CI, 1.12 to 1.54. 1017 patients) kamagra oral jelly online shop. Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days kamagra oral jelly online shop after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.
380 patients) kamagra oral jelly online shop (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91. P=0.001. 844 patients) (Table 2 and Fig.
S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04. 1059 patients). The KaplanâMeier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2).
The KaplanâMeier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10). Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients).
Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4). The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]).
Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Population Table 1. Table 1.
Characteristics of the Participants in the mRNA-1273 Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected erectile dysfunction treatment while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits.
The demographic characteristics of participants at enrollment are provided in Table 1. treatment Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.
Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination.
After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3).
erectile dysfunction Binding Antibody Responses Table 2. Table 2. Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2.
erectile dysfunction Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live kamagra PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively. Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants.
Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay.
The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A).
Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domainâspecific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens. The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). erectile dysfunction Neutralization Responses No participant had detectable PsVNA responses before vaccination.
After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50]. Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80]. Fig.
S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens.
Before vaccination, no participant had detectable 80% live-kamagra neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type kamagraâneutralizing activity capable of reducing erectile dysfunction infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay. Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273.
erectile dysfunction T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig.
S11).Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with erectile dysfunction treatment at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network. (Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavirâritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed erectile dysfunction and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020.
Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net.
The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment.
Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial. For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments.
Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first. Information was recorded regarding the patientsâ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.
Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the erectile dysfunction treatment kamagra. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients.
For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio. Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. KaplanâMeier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization.
For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1. Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1).
To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and â¥80 years). This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk.
(One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest. Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle. The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.Trial Design and Oversight We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to erectile dysfunction treatment.12 We randomly assigned participants in a 1:1 ratio to receive either hydroxychloroquine or placebo.
Participants had known exposure (by participant report) to a person with laboratory-confirmed erectile dysfunction treatment, whether as a household contact, a health care worker, or a person with other occupational exposures. Trial enrollment began on March 17, 2020, with an eligibility threshold to enroll within 3 days after exposure. The objective was to intervene before the median incubation period of 5 to 6 days. Because of limited access to prompt testing, health care workers could initially be enrolled on the basis of presumptive high-risk exposure to patients with pending tests. However, on March 23, eligibility was changed to exposure to a person with a positive polymerase-chain-reaction (PCR) assay for erectile dysfunction, with the eligibility window extended to within 4 days after exposure.
This trial was approved by the institutional review board at the University of Minnesota and conducted under a Food and Drug Administration Investigational New Drug application. In Canada, the trial was approved by Health Canada. Ethics approvals were obtained from the Research Institute of the McGill University Health Centre, the University of Manitoba, and the University of Alberta. Participants We included participants who had household or occupational exposure to a person with confirmed erectile dysfunction treatment at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Participants were excluded if they were younger than 18 years of age, were hospitalized, or met other exclusion criteria (see the Supplementary Appendix, available with the full text of this article at NEJM.org).
Persons with symptoms of erectile dysfunction treatment or with PCR-proven erectile dysfunction were excluded from this prevention trial but were separately enrolled in a companion clinical trial to treat early . Setting Recruitment was performed primarily with the use of social media outreach as well as traditional media platforms. Participants were enrolled nationwide in the United States and in the Canadian provinces of Quebec, Manitoba, and Alberta. Participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.13 After participants read the consent form, their comprehension of its contents was assessed. Participants provided a digitally captured signature to indicate informed consent.
We sent follow-up e-mail surveys on days 1, 5, 10, and 14. A survey at 4 to 6 weeks asked about any follow-up testing, illness, or hospitalizations. Participants who did not respond to follow-up surveys received text messages, e-mails, telephone calls, or a combination of these to ascertain their outcomes. When these methods were unsuccessful, the emergency contact provided by the enrollee was contacted to determine the participantâs illness and vital status. When all communication methods were exhausted, Internet searches for obituaries were performed to ascertain vital status.
Interventions Randomization occurred at research pharmacies in Minneapolis and Montreal. The trial statisticians generated a permuted-block randomization sequence using variably sized blocks of 2, 4, or 8, with stratification according to country. A research pharmacist sequentially assigned participants. The assignments were concealed from investigators and participants. Only pharmacies had access to the randomization sequence.
Hydroxychloroquine sulfate or placebo was dispensed and shipped overnight to participants by commercial courier. The dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total). If participants had gastrointestinal upset, they were advised to divide the daily dose into two or three doses. We chose this hydroxychloroquine dosing regimen on the basis of pharmacokinetic simulations to achieve plasma concentrations above the erectile dysfunction in vitro half maximal effective concentration for 14 days.14 Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group. Rising Pharmaceuticals provided a donation of hydroxychloroquine, and some hydroxychloroquine was purchased.
Outcomes The primary outcome was prespecified as symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, erectile dysfunction treatmentârelated symptoms. We assumed that health care workers would have access to erectile dysfunction treatment testing if symptomatic. However, access to testing was limited throughout the trial period. erectile dysfunction treatmentârelated symptoms were based on U.S. Council for State and Territorial Epidemiologists criteria for confirmed cases (positivity for erectile dysfunction on PCR assay), probable cases (the presence of cough, shortness of breath, or difficulty breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).15 All the participants had epidemiologic linkage,15 per trial eligibility criteria.
Four infectious disease physicians who were unaware of the trial-group assignments reviewed symptomatic participants to generate a consensus with respect to whether their condition met the case definition.15 Secondary outcomes included the incidence of hospitalization for erectile dysfunction treatment or death, the incidence of PCR-confirmed erectile dysfunction , the incidence of erectile dysfunction treatment symptoms, the incidence of discontinuation of the trial intervention owing to any cause, and the severity of symptoms (if any) at days 5 and 14 according to a visual analogue scale (scores ranged from 0 [no symptoms] to 10 [severe symptoms]). Data on adverse events were also collected with directed questioning for common side effects along with open-ended free text. Outcome data were measured within 14 days after trial enrollment. Outcome data including PCR testing results, possible erectile dysfunction treatmentârelated symptoms, adherence to the trial intervention, side effects, and hospitalizations were all collected through participant report. Details of trial conduct are provided in the protocol and statistical analysis plan, available at NEJM.org.
Sample Size We anticipated that illness compatible with erectile dysfunction treatment would develop in 10% of close contacts exposed to erectile dysfunction treatment.9 Using Fisherâs exact method with a 50% relative effect size to reduce new symptomatic s, a two-sided alpha of 0.05, and 90% power, we estimated that 621 persons would need to be enrolled in each group. With a pragmatic, Internet-based, self-referral recruitment strategy, we planned for a 20% incidence of attrition by increasing the sample size to 750 participants per group. We specified a priori that participants who were already symptomatic on day 1 before receiving hydroxychloroquine or placebo would be excluded from the prophylaxis trial and would instead be separately enrolled in the companion symptomatic treatment trial. Because the estimates for both incident symptomatic erectile dysfunction treatment after an exposure and loss to follow-up were relatively unknown in early March 2020,9 the protocol prespecified a sample-size reestimation at the second interim analysis. This reestimation, which used the incidence of new s in the placebo group and the observed percentage of participants lost to follow-up, was aimed at maintaining the ability to detect an effect size of a 50% relative reduction in new symptomatic s.
Interim Analyses An independent data and safety monitoring board externally reviewed the data after 25% and 50% of the participants had completed 14 days of follow-up. Stopping guidelines were provided to the data and safety monitoring board with the use of a LanâDeMets spending function analogue of the OâBrienâFleming boundaries for the primary outcome. A conditional power analysis was performed at the second and third interim analysis with the option of early stopping for futility. At the second interim analysis on April 22, 2020, the sample size was reduced to 956 participants who could be evaluated with 90% power on the basis of the higher-than-expected event rate of s in the control group. At the third interim analysis on May 6, the trial was halted on the basis of a conditional power of less than 1%, since it was deemed futile to continue.
Statistical Analysis We assessed the incidence of erectile dysfunction treatment disease by day 14 with Fisherâs exact test. Secondary outcomes with respect to percentage of patients were also compared with Fisherâs exact test. Among participants in whom incident illness compatible with erectile dysfunction treatment developed, we summarized the symptom severity score at day 14 with the median and interquartile range and assessed the distributions with a KruskalâWallis test. We conducted all analyses with SAS software, version 9.4 (SAS Institute), according to the intention-to-treat principle, with two-sided type I error with an alpha of 0.05. For participants with missing outcome data, we conducted a sensitivity analysis with their outcomes excluded or included as an event.
Subgroups that were specified a priori included type of contact (household vs. Health care), days from exposure to enrollment, age, and sex.Announced on May 15, Operation Warp Speed (OWS) â a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector â aims to accelerate control of the erectile dysfunction treatment kamagra by advancing development, manufacturing, and distribution of treatments, therapeutics, and diagnostics. OWS is providing support to promising candidates and enabling the expeditious, parallel execution of the necessary steps toward approval or authorization of safe products by the Food and Drug Administration (FDA).The partnership grew out of an acknowledged need to fundamentally restructure the way the U.S. Government typically supports product development and treatment distribution. The initiative was premised on setting a âstretch goalâ â one that initially seemed impossible but that is becoming increasingly achievable.The concept of an integrated structure for erectile dysfunction treatment countermeasure research and development across the U.S.
Government was based on experience with Zika and the Zika Leadership Group led by the National Institutes of Health (NIH) and the assistant secretary for preparedness and response (ASPR). One of us (M.S.) serves as OWS chief advisor. We are drawing on expertise from the NIH, ASPR, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), and the DOD, including the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Advanced Research Projects Agency. OWS has engaged experts in all critical aspects of medical countermeasure research, development, manufacturing, and distribution to work in close coordination.The initiative set ambitious objectives. To deliver tens of millions of doses of a erectile dysfunction treatment â with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S.
Population â beginning at the end of 2020 and to have as many as 300 million doses of such treatments available and deployed by mid-2021. The pace and scope of such a treatment effort are unprecedented. The 2014 West African Ebola kamagra epidemic spurred rapid treatment development, but though preclinical data existed before the outbreak, a period of 12 months was required to progress from phase 1 first-in-human trials to phase 3 efficacy trials. OWS aims to compress this time frame even further. erectile dysfunction treatment development began in January, phase 1 clinical studies in March, and the first phase 3 trials in July.
Our objectives are based on advances in treatment platform technology, improved understanding of safe and efficacious treatment design, and similarities between the SARS-CoV-1 and erectile dysfunction disease mechanisms.OWSâs role is to enable, accelerate, harmonize, and advise the companies developing the selected treatments. The companies will execute the clinical or process development and manufacturing plans, while OWS leverages the full capacity of the U.S. Government to ensure that no technical, logistic, or financial hurdles hinder treatment development or deployment.OWS selected treatment candidates on the basis of four criteria. We required candidates to have robust preclinical data or early-stage clinical trial data supporting their potential for clinical safety and efficacy. Candidates had to have the potential, with our acceleration support, to enter large phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the kamagra, to deliver efficacy outcomes by the end of 2020 or the first half of 2021.
Candidates had to be based on treatment-platform technologies permitting fast and effective manufacturing, and their developers had to demonstrate the industrial process scalability, yields, and consistency necessary to reliably produce more than 100 million doses by mid-2021. Finally, candidates had to use one of four treatment-platform technologies that we believe are the most likely to yield a safe and effective treatment against erectile dysfunction treatment. The mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform.OWSâs strategy relies on a few key principles. First, we sought to build a diverse project portfolio that includes two treatment candidates based on each of the four platform technologies. Such diversification mitigates the risk of failure due to safety, efficacy, industrial manufacturability, or scheduling factors and may permit selection of the best treatment platform for each subpopulation at risk for contracting or transmitting erectile dysfunction treatment, including older adults, frontline and essential workers, young adults, and pediatric populations.
In addition, advancing eight treatments in parallel will increase the chances of delivering 300 million doses in the first half of 2021.Second, we must accelerate treatment program development without compromising safety, efficacy, or product quality. Clinical development, process development, and manufacturing scale-up can be substantially accelerated by running all streams, fully resourced, in parallel. Doing so requires taking on substantial financial risk, as compared with the conventional sequential development approach. OWS will maximize the size of phase 3 trials (30,000 to 50,000 participants each) and optimize trial-site location by consulting daily epidemiologic and disease-forecasting models to ensure the fastest path to an efficacy readout. Such large trials also increase the safety data set for each candidate treatment.With heavy up-front investment, companies can conduct clinical operations and site preparation for these phase 3 efficacy trials even as they file their Investigational New Drug application (IND) for their phase 1 studies, thereby ensuring immediate initiation of phase 3 when they get a green light from the FDA.
To permit appropriate comparisons among the treatment candidates and to optimize treatment utilization after approval by the FDA, the phase 3 trial end points and assay readouts have been harmonized through a collaborative effort involving the National Institute of Allergy and Infectious Diseases (NIAID), the erectile dysfunction Prevention Network, OWS, and the sponsor companies.Finally, OWS is supporting the companies financially and technically to commence process development and scale up manufacturing while their treatments are in preclinical or very early clinical stages. To ensure that industrial processes are set, running, and validated for FDA inspection when phase 3 trials end, OWS is also supporting facility building or refurbishing, equipment fitting, staff hiring and training, raw-material sourcing, technology transfer and validation, bulk product processing into vials, and acquisition of ample vials, syringes, and needles for each treatment candidate. We aim to have stockpiled, at OWSâs expense, a few tens of millions of treatment doses that could be swiftly deployed once FDA approval is obtained.This strategy aims to accelerate treatment development without curtailing the critical steps required by sound science and regulatory standards. The FDA recently reissued guidance and standards that will be used to assess each treatment for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit treatment administration before all BLA procedures are completed.Of the eight treatments in OWSâs portfolio, six have been announced and partnerships executed with the companies.
Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein). These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.Moderna developed its RNA treatment in collaboration with the NIAID, began its phase 1 trial in March, recently published encouraging safety and immunogenicity data,1 and entered phase 3 on July 27. Pfizer and BioNTechâs RNA treatment also produced encouraging phase 1 results2 and started its phase 3 trial on July 27. The ChAdOx replication-defective live-vector treatment developed by AstraZeneca and Oxford University is in phase 3 trials in the United Kingdom, Brazil, and South Africa, and it should enter U.S.
Phase 3 trials in August.3 The Janssen Ad26 erectile dysfunction treatment replication-defective live-vector treatment has demonstrated excellent protection in nonhuman primate models and began its U.S. Phase 1 trial on July 27. It should be in phase 3 trials in mid-September. Novavax completed a phase 1 trial of its recombinant-subunit-adjuvanted protein treatment in Australia and should enter phase 3 trials in the United States by the end of September.4 Sanofi/GSK is completing preclinical development steps and plans to commence a phase 1 trial in early September and to be well into phase 3 by yearâs end.5On the process-development front, the RNA treatments are already being manufactured at scale. The other candidates are well advanced in their scale-up development, and manufacturing sites are being refurbished.While development and manufacturing proceed, the HHSâDOD partnership is laying the groundwork for treatment distribution, subpopulation prioritization, financing, and logistic support.
We are working with bioethicists and experts from the NIH, the CDC, BARDA, and the Centers for Medicare and Medicaid Services to address these critical issues. We will receive recommendations from the CDC Advisory Committee on Immunization Practices, and we are working to ensure that the most vulnerable and at-risk persons will receive treatment doses once they are ready. Prioritization will also depend on the relative performance of each treatment and its suitability for particular populations. Because some technologies have limited previous data on safety in humans, the long-term safety of these treatments will be carefully assessed using pharmacovigilance surveillance strategies.No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices weâve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor..
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IntroductionLa Peste (Camus 1947) has served as a buy kamagra oral jelly wholesale basis for several critical works, including some in the field of medical purchase kamagra humanities (Bozzaro 2018. Deudon 1988. Tuffuor and Payne purchase kamagra 2017). Frequently interpreted as an allegory of Nazism (with the plague as a symbol of the German occupation of France) (Finel-Honigman 1978. Haroutunian 1964), it has also received philosophical readings beyond the sociopolitical context in which it was written (Lengers 1994).
Other scholars, on the other hand, have centred their analyses on its purchase kamagra literary aspects (Steel 2016).The erectile dysfunction treatment kamagra has increased general interest about historical and fictional epidemics. La Peste, as one of the most famous literary works about this topic, has been revisited by many readers during recent months, leading to an unexpected growth in sales in certain countries (Wilsher 2020. Zaretsky 2020). Apart from that, commentaries about the novel, especially among health sciences scholars, have emerged with a purchase kamagra renewed interest (Banerjee et al. 2020.
Bate 2020. Vandekerckhove 2020 purchase kamagra. Wigand, Becker, and Steger 2020). This sudden curiosity is easy to understand if we consider both La Pesteâs literary value, and peopleâs desire to discover real or fictional situations similar to theirs. Indeed, Oran inhabitantsâ experiences are not quite far from our own, even if geographical, chronological and, specially, scientific factors (two different diseases occurring at two different stages in the history of medical development) prevent us from establishing too close resemblances between both situations.Furthermore, it purchase kamagra will not be strange if erectile dysfunction treatment serves as a frame for fictional works in the near future.
Other narrative plays were based on historical epidemics, such as Daniel Defoeâs A Journal of the Plague Year or Giovanni Boccaccioâs Decameron (Wigand, Becker, and Steger 2020. Withington 2020). The biggest kamagra in the last century, the so-called âSpanish Influenzaâ, has been purchase kamagra described as not very fruitful in this sense, even if it produced famous novels such as Katherine A Porterâs Pale Horse, Pale Rider or John OâHaraâs The Doctor Son (Honigsbaum 2018. Hovanec 2011). The overlapping with another disaster like World War I has been argued as one of the reasons explaining this scarce production of fictional works (Honigsbaum 2018).
By contrast, we may think that erectile dysfunction treatment is having a global impact hardly overshadowed by other events, and that it will leave a significant mark on the collective memory.Drawing on the reading of La Peste, we point out in this essay different aspects of living under an epidemic that can be identified both in Camusâs work and in our current situation purchase kamagra. We propose a trip throughout the novel, from its early beginning in Part I, when the Oranians are not aware of the threat to come, to its end in Part V, when they are relieved of the epidemic after several months of ravaging disasters.We think this journey along La Peste may be interesting both to health professionals and to the lay person, since all of them will be able to see themselves reflected in the characters from the novel. We do not skip critique of some aspects related to the authoritiesâ management of erectile dysfunction treatment, as Camus does concerning Oranâs rulers. However, what we want to foreground is La Pesteâs intrinsic value, its suitability to be read now and after erectile dysfunction treatment has passed, when purchase kamagra Camusâs novel endures as a solid art work and erectile dysfunction treatment remains only as a defeated plight.MethodsWe confronted our own experiences about erectile dysfunction treatment with a conventional reading of La Peste. A first reading of the novel was used to establish associations between those aspects which more saliently reminded us of erectile dysfunction treatment.
In a second reading, we searched for some examples to illustrate those aspects and tried to detect new associations. Subsequent readings of certain parts were done to integrate purchase kamagra the information collected. Neither specific methods of literary analysis, nor systematic searches in the novel were applied. Selected paragraphs and ideas from Part I to Part V were prepared in a draft copy, and this manuscript was written afterwards.Part ISome phrases in the novel could be transposed word by word to our situation. This one pertaining to its purchase kamagra start, for instance, may make us remember the first months of 2020:By now, it will be easy to accept that nothing could lead the people of our town to expect the events that took place in the spring of that year and which, as we later understood, were like the forerunners of the series of grave happenings that this history intends to describe.
(Camus 2002, Part I)By referring from the beginning to âthe people of our townâ, Camus is already suggesting an idea which is repeated all along the novel, and which may be well understood by us as erectile dysfunction treatmentâs witnesses. Epidemics affect the community as a whole, they are present in everybodyâs mind and their joys and sorrows are not individual, but collective. For example (and we are anticipating Part II), the narrator says:But, once the gates were closed, they all noticed that they were in the same boat, including purchase kamagra the narrator himself, and that they had to adjust to the fact. (Camus 2002, Part II)Later, he will insist in this opposition between the concepts of âindividualâ, which used to prevail before the epidemic, and âcollectiveâ:One might say that the first effect of this sudden and brutal attack of the disease was to force the citizens of our town to act as though they had no individual feelings. (Camus 2002, Part II)There were no longer any individual destinies, but a collective history that was the plague, and feelings shared by all.
(Camus 2002, Part III)This distinction is not trivial, since the story will display a strong confrontation between those who get involved and help their neighbours and those who remain behaving purchase kamagra selfishly. Related to this, Claudia Bozzaro has pointed out that the main topic in La Peste is solidarity and auistic love (Bozzaro 2018). We may add that the disease is so attached to peopleâs lives that the epidemic becomes the new everyday life:In the morning, they would return to the pestilence, that is to say, to routine. (Camus 2002, Part III)Being collective issues does not mean that epidemics always enhance auism and solidarity purchase kamagra. As said by Wigand et al, they frequently produce ambivalent reactions, and one of them is the opposition between auism and maximised profit (Wigand, Becker, and Steger 2020).
Therefore, the dichotomy between individualism and collectivism, a central point in the characterisation of national cultures (Hofstede 2015), could play a role in epidemics. In fact, concerning erectile dysfunction treatment, some authors have described a greater impact of the kamagra purchase kamagra in those countries with higher levels of individualism (Maaravi et al. 2021. Ozkan et al. 2021).
However, this finding should be complemented with other national culturesâ aspects before concluding that collectivism itself exerts a protective role against epidemics. Concerning this, it has been shown how âpower distanceâ frequently intersects with collectivism, being only a few countries in which the last one coexists with a small distance to power, namely with a capacity to disobey the power authority (Gupta, Shoja, and Mikalef 2021). Moreover, those countries classically classified as âcollectivistâ (China, Japan, South Korea, India, Vietnam, etc.) are also characterised by high levels of power distance, and their citizens have been quite often forced to adhere to erectile dysfunction treatment restrictions and punished if not (Gupta, Shoja, and Mikalef 2021). Thus, it is important to consider that individualism is not always opposed to âlook after each otherâ (Ozkan et al. 2021, 9).
For instance, the European region, seen as a whole as highly âindividualisticâ, holds some of the most advanced welfare protection systems worldwide. It is worth considering too that collectivism may hide sometimes a hard institutional authority or a lack in civil freedoms.Coming back to La Peste, we may think that Camusâs Oranians are not particularly âcollectivistâ. Their initial description highlights that they are mainly interested in their own businesses and affairs:Our fellow-citizens work a good deal, but always in order to make money. They are especially interested in trade and first of all, as they say, they are engaged in doing business. (Camus 2002, Part I)And later, we see some of them trying selfishly to leave the city by illegal methods.
By contrast, we observe in the novel some examples of more âcollectivisticâ attitudes, such as the discipline of those quarantined at the football pitch, and, over all, the main charactersâ behaviour, which is generally driven by auism and common goals.Turning to another topic, the plague in Oran and erectile dysfunction treatment are similar regarding their animal origin. This is not rare since many infectious diseases pass to humans through contact with animal vectors, being rodents, especially rats (through rat fleas), the most common carriers of plague bacteria (CDC. N.d.a, ECDC. N.d, Pollitzer 1954). Concerning erectile dysfunction, even if further research about its origin is needed, the most recent investigations conducted in China by the WHO establish a zoonotic transmission as the most probable pathway (Joint WHO-China Study Team 2021).
In Camusâs novel, the animalâs link to the epidemic seemed very clear since the beginning:Things got to the point where Infodoc (the agency for information and documentation, â all you need to know on any subjectâ) announced in its free radio news programme that 6,231 rats had been collected and burned in a single day, the 25th. This figure, which gave a clear meaning to the daily spectacle that everyone in town had in front of their eyes, disconcerted them even more. (Camus 2002, Part I)This accuracy in figures is familiar to us. People nowadays have become very used to the statistical aspects of the kamagra, due to the continuous updates in epidemiological parameters launched by the media and the authorities. Camus was aware about the relevance of figures in epidemics, which always entail:â¦required registration and statistical tasks.
(Camus 2002, Part II)Because of this, the novel is scattered with numbers, most of them concerning the daily death toll, but others mentioning the number of rats picked up, as we have seen, or combining the number of deaths with the time passed since the start of the epidemic:â Will there be an autumn of plague?. Professor B answers. Â Noâ â, â One hundred and twenty-four dead. The total for the ninety-fourth day of the plague.â (Camus 2002, Part II)We permit ourselves to introduce here a list of recurring topics in La Peste, since the salience of statistical information is one of them. These topics, some of which will be treated later, appear several times in the novel, in various contexts and stages in the evolution of the epidemic.
We synthesise them in Table 1, coupled with a erectile dysfunction treatment parallel example extracted from online press. This ease to find a current example for each topic suggests that they are not exclusive of plague or of Camusâs mindset, but shared by most epidemics.View this table:Table 1 Recurring topics in La Peste. Each topic is accompanied by two examples from the novel and one concerning erectile dysfunction treatment, extracted from online press.Talking about journalism and the media (one of the topics above), we might say that erectile dysfunction treatmentâs coverage is frequently too optimistic when managing good news and too alarming when approaching the bad. Mediaâs âexaggeratedâ approach to health issues is not new. It was already a concern for medical journalsâ editors a century ago (Reiling 2013) and it continues to be it for these professionals in recent times (Barbour et al.
2008). It is well known that media tries to attract spectatorsâ attention by making the news more appealing. However, they deal with the risk of expanding unreliable information, which may be pernicious for the public opinion. Related to the intention of âgarnishingâ the news, Aslam et al. (2020) have described that 82% of more than 100â000 pieces of information about erectile dysfunction treatment appearing in media from different countries carried an emotional, either negative (52%) or positive (30%) component, with only 18% of them considered as âneutralâ (Aslam et al.
2020). Some evidence about this tendency to make news more emotional was described in former epidemics. For instance, a study conducted in Singapore in 2009 during the H1N1 crisis showed how press releases by the Ministry of Health were substantially transformed when passed to the media, by increasing their emotional appeal and by changing their dominant frame or their tone (Lee and Basnyat 2013). In La Peste, this superficial way of managing information by the media is also observed:The newspapers followed the order that they had been given, to be optimistic at any cost. (Camus 2002, Part IV)At the first stages of the epidemic in Oran, journalists proclaim the end of the dead ratsâ invasion as something to be celebrated.
Dr Rieux, the character through which Camus symbolises caution (and comparable nowadays to trustful scientists, well-informed journalists or sensible authorities), exposes then his own angle, quite far from suggesting optimism:The vendors of the evening papers were shouting that the invasion of rats had ended. But Rieux found his patient lying half out of bed, one hand on his belly and the other around his neck, convulsively vomiting reddish bile into a rubbish bin. (Camus 2002, Part I)Camus, who worked as a journalist for many years, insists afterwards on this cursory interest that some media devote to the epidemic, more eager to grab the noise than the relevant issues beneath it:The press, which had had so much to say about the business of the rats, fell silent. This is because rats die in the street and people in their bedrooms. And newspapers are only concerned with the street.
(Camus 2002, Part I)By then, Oranians continue rejecting the epidemic as an actual threat, completely immersed in that phase that dominates the beginning of all epidemics and is characterised by âdenial and disbeliefâ (Wigand, Becker, and Steger 2020, 443):A pestilence does not have human dimensions, so people tell themselves that it is unreal, that it is a bad dream which will end. [â¦] The people of our town were no more guilty than anyone else, they merely forgot to be modest and thought that everything was still possible for them, which implied that pestilence was impossible. They continued with business, with making arrangements for travel and holding opinions. Why should they have thought about the plague, which negates the future, negates journeys and debate?. They considered themselves free and no one will ever be free as long as there is plague, pestilence and famine.
(Camus 2002, Part I)Probably to avoid citizens' disapproval, among other reasons, the Oranian Prefecture (health authority in Camus' novel) does not want to go too far when judging the relevance of the epidemic. While not directly exposed, we can guess in this fragment the tone of the Prefectâs message, his intention to convey confidence despite his own doubts:These cases were not specific enough to be really disturbing and there was no doubt that the population would remain calm. None the less, for reasons of caution which everyone could understand, the Prefect was taking some preventive measures. If they were interpreted and applied in the proper way, these measures were such that they would put a definite stop to any threat of epidemic. As a result, the Prefect did not for a moment doubt that the citizens under his charge would co-operate in the most zealous manner with what he was doing.
(Camus 2002, Part I)The relevant role acquired by health authorities during epidemics is another topic listed in our table. Language use, on the other hand, is an issue linkable both with the media topic and with this one. As in La Peste, during erectile dysfunction treatment we have seen some public figures using words not always truthfully, carrying out a careful selection of words that serves to the goal of conveying certain interests in each moment. Dr Rieux refers in Part I to this language manipulation by the authorities:The measures that had been taken were insufficient, that was quite clear. As for the â specially equipped wardsâ, he knew what they were.
Two outbuildings hastily cleared of other patients, their windows sealed up and the whole surrounded by a cordon sanitaire. (Camus 2002, Part I)He illustrates the need of frankness, the preference for clarity in language, which is often the clarity in thinking:No. I phoned Richard to say we needed comprehensive measures, not fine words, and that either we must set up a real barrier to the epidemic, or nothing at all. (Camus 2002, Part I)At the end of this part, his fears about the inadequacy of not taking strict measures are confirmed. Oranian hospitals become overwhelmed, as they are now in many places worldwide due to erectile dysfunction treatment.Part IILeft behind the phases of âdenial and disbeliefâ and of âfear and panicâ, it appears among the Oranians the âacceptance paired with resignationâ (Wigand, Becker, and Steger 2020, 443):Then we knew that our separation was going to last, and that we ought to try to come to terms with time.
[â¦] In particular, all of the people in our town very soon gave up, even in public, whatever habit they may have acquired of estimating the length of their separation. (Camus 2002, Part II)In erectile dysfunction treatment as well, even if border closure has not been so immovable as in Oran, many people have seen themselves separated from their loved ones and some of them have not yet had the possibility of reunion. This is why, in the actual kamagra, the idea of temporal horizons has emerged like it appeared in Camusâs epidemic. In Spain, the general lockdown in March and April 2020 made people establish the summer as their temporal horizon, a time in which they could resume their former habits and see their relatives again. This became partially true, and people were allowed in summer to travel inside the country and to some other countries nearby.
However, there existed some reluctance to visit ill or aged relatives, due to the fear of infecting them, and some families living in distant countries were not able to get together. Moreover, autumn brought an increase in the number of cases (âthe second waveâ) and countries returned to limit their internal and external movements.Bringing all this together, many people nowadays have opted to discard temporal horizons. As Oranians, they have noted that the epidemic follows its own rhythm and it is useless to fight against it. Nonetheless, it is in human nature not to resign, so abandoning temporal horizons does not mean to give up longing for the recovery of normal life. This vision, neither maintaining vain hopes nor resigning, is in line with Camusâs philosophy, an author who wrote that âhope, contrary to what it is usually thought, is the same to resignation.â (Camus 1939, 83.
Cited by Haroutunian 1964, 312 (translation is ours)), and that âthere is not love to human life but with despair about human life.â (Camus 1958, 112â5. Cited by Haroutunian 1964, 312â3 (translation is ours)).People nowadays deal with resignation relying on daily life pleasures (being not allowed to make further plans or trips) and in company from the nearest ones (as they cannot gather with relatives living far away). Second, they observe the beginning of vaccination campaigns as a first step of the final stage, and summer 2021, reflecting what happened with summer 2020, has been fixed as a temporal horizon. This preference for summers has an unavoidable metaphorical nuance, and their linking to joy, long trips and life in the streets may be the reason for which we choose them to be opposed to the lockdown and restrictions of the kamagra.We alluded previously to the manipulation of language, and figures, as relevant as they are, they are not free from manipulation either. Tarrou, a close friend to Dr Rieux, points out in this part of the novel how this occurred:Once more, Tarrou was the person who gave the most accurate picture of our life as it was then.
Naturally he was following the course of the plague in general, accurately observing that a turning point in the epidemic was marked by the radio no longer announcing some hundreds of deaths per week, but 92, 107 and 120 deaths a day. ÂThe newspapers and the authorities are engaged in a battle of wits with the plague. They think that they are scoring points against it, because 130 is a lower figure than 910.â (Camus 2002, Part II)Tarrou collaborates with the health teams formed to tackle the plague. Regarding these volunteers and workers, Camus refuses to consider them as heroes, as many essential workers during erectile dysfunction treatment have rejected to be named as that. The writer thinks their actions are the natural behaviour of good people, not heroism but âa logical consequenceâ:The whole question was to prevent the largest possible number of people from dying and suffering a definitive separation.
There was only one way to do this, which was to fight the plague. There was nothing admirable about this truth, it simply followed as a logical consequence. (Camus 2002, Part II)We consider suitable to talk here about two issues which represent, nowadays, a great part of erectile dysfunction treatment fears and hopes, respectively. New genetic variants and treatments. Medical achievements are another recurrent issue included in table 1, and we write about them here because it is in Part II where Camus writes for the first time about treatments, and where it insists on an idea aforementioned in Part I.
That the plague bacillus affecting Oran is different from previous variants:â¦the microbe differed very slightly from the bacillus of plague as traditionally defined. (Camus 2002, Part II)Related to erectile dysfunction treatment new variants, they represent a challenge because of two main reasons. Their higher transmissibility and/or severity and their higher propensity to skip the effect of natural or treatment-induced immunity. Public health professionals are determining which is the actual threat of all the new variants discovered, such as those first characterised in the UK (Public Health England 2020), South Africa (Tegally et al. 2021) or Brazil (Fujino et al.
2021). In La Peste, Dr Rieux is always suspecting that the current bacteria they are dealing with is different from the one in previous epidemics of plague. Since several genetic variations for the bacillus Yersinia pestis have been characterised (Cui et al. 2012), it could be possible that the epidemic in Oran originated from a new one. However, we should not forget that we are analysing a literary work, and that scientific accuracy is not a necessary goal in it.
In fact, Rieuxâs reluctances have to do more with clinical aspects than with microbiological ones. He doubts since the beginning, relying exclusively on the symptoms observed, and continues doing it after the laboratory analysis:I was able to have an analysis made in which the laboratory thinks it can detect the plague bacillus. However, to be precise, we must say that certain specific modifications of the microbe do not coincide with the classic description of plague. (Camus 2002, Part II)Camus is consistent with this idea and many times he mentions the bacillus to highlight its oddity. Insisting on the literary condition of the work, and among other possible explanations, he is maybe declaring that that in the novel is not a common (biological, natural) bacteria, but the Nazism bacteria.Turning to treatments, they constitute the principal resource that the global community has to defeat the erectile dysfunction treatment kamagra.
Vaccination campaigns have started all over the world, and three types of erectile dysfunction treatments are being applied in the European Union, after their respective statements of efficacy and security (Baden et al. 2021 http://brew17.com/?page_id=2. Polack et al. 2020. Voysey et al.
2021), while a fourth treatment has just recently been approved (EMA 2021a). Although some concerns regarding the safety of two of these treatments have been raised recently (EMA 2021b. EMA 2021c), vaccination plans are going ahead, being adapted according to the state of knowledge at each moment. Some of these treatments are mRNA-based (Baden et al. 2021.
Polack et al. 2020), while others use a viral vector (Bos et al. 2020. Voysey et al. 2021).
They are mainly two-shot treatments, with one exception (Bos et al. 2020), and complete immunity is thought to be acquired 2âweeks after the last shot (CDC. N.d.b, Voysey et al. 2021). Other countries such as China or Russia, on the other hand, were extremely early in starting their vaccination campaigns, and are distributing among their citizens different treatments than the aforementioned (Logunov et al.
2021. Zhang et al. 2021).Even if at least three types of plague treatments had been created by the time the novel takes place (Sun 2016), treatments do not play an important role in La Peste, in which therapeutic measures (the serum) are more important than prophylactic ones. Few times in the novel the narrator refers to prophylactic inoculations:There was still no possibility of vaccinating with preventive serum except in families already affected by the disease. (Camus 2002, Part II)Deudon has pointed out that Camus mixes up therapeutic serum and treatment (Deudon 1988), and in fact there exists a certain amount of confusion.
All along the novel, the narrator focuses on the prophylactic goals of the serum, which is applied to people already infected (Othonâs son, Tarrou, Grandâ¦). However, both in the example above (which can be understood as vaccinating household contacts or already affected individuals) and in others, the differences between treating and vaccinating are not clear:After the morning admissions which he was in charge of himself, the patients were vaccinated and the swellings lanced. (Camus 2002, Part II)In any case, this is another situation in which Camus stands aside from scientific matters, which are to him less relevant in his novel than philosophical or literary ones. The distance existing between the relevance of treatments in erectile dysfunction treatment and the superficial manner with which Camus treats the topic in La Peste exemplifies this.Part IIIIn part III, the plagueâs ravages become tougher. The narrator turns his focus to burials and their disturbance, a frequent topic in epidemicsâ narrative (table 1).
Camus knew how acutely increasing demands and hygienic requirements affect funeral habits during epidemics:Everything really happened with the greatest speed and the minimum of risk. (Camus 2002, Part III)Like many other processes during epidemics, the burial process becomes a protocol. When protocolised, everything seems to work well and rapidly. But this perfect mechanism is the Prefectureâs goal, not Rieuxâs. He reveals in this moment an aspect in his character barely shown before.
Irony.The whole thing was well organized and the Prefect expressed his satisfaction. He even told Rieux that, when all was said and done, this was preferable to hearses driven by black slaves which one read about in the chronicles of earlier plagues. Â Yes,â Rieux said. Â The burial is the same, but we keep a card index. No one can deny that we have made progress.â (Camus 2002, Part III)Even if this characteristic may seem new in Dr Rieux, we must bear in mind that he is the story narrator, and the narration is ironic from time to time.
For instance, speaking precisely about the burials:The relatives were invited to sign a register âwhich just showed the difference that there may be between men and, for example, dogs. You can keep check of human beings-. (Camus 2002, Part III)In Camusâs philosophy, the absurd is a core issue. According to Lengers, Rieux is ironic because he is a kind of Sisyphus who has understood the absurdity of plague (Lengers 1994). The response to the absurd is to rebel (Camus 2013), and Rieux does it by helping his fellow humans without questioning anything.
He does not pursue any other goal than doing his duty, thus humour (as a response to dire situations) stands out from him when he observes others celebrating irrelevant achievements, such as the Prefect with his burial protocol. In the field of medical ethics, Lengers has highlighted the importance of Camusâs perspective when considering âthe immediacy of life rather than abstract valuesâ (Lengers 1994, 250). Rieux himself is quite sure that his solid commitment is not âabstractâ, and, even if he falls into abstraction, the importance relies on protecting human lives and not in the name given to that task:Was it truly an abstraction, spending his days in the hospital where the plague was working overtime, bringing the number of victims up to five hundred on average per week?. Yes, there was an element of abstraction and unreality in misfortune. But when an abstraction starts to kill you, you have to get to work on it.
(Camus 2002, Part II)Farewells during erectile dysfunction treatment may have not been particularly pleasant for some families. Neither those dying at nursing homes nor in hospitals could be accompanied by their families as previously, due to corpses management protocols, restrictions of external visitors and hygienic measures in general. However, as weeks passed by, certain efforts were made to ease this issue, allowing people to visit their dying beloved sticking to strict preventive measures. On the other hand, the number of people attending funeral masses and cemeteries was also limited, which affected the conventional development of ceremonies as well. Hospitals had to deal with daily tolls of deaths never seen before, and the overcrowding of mortuaries made us see rows of coffins placed in unusual spaces, such as ice rinks (transformation of facilities is another topic in table 1).We turn now to two other points which erectile dysfunction treatment has not evaded.
s among essential workers and epidemicsâ economic consequences. The author links burials with s among essential workers because gravediggers constitute one of the most affected professions, and connects this fact with the economic recession because unemployment is behind the large availability of workers to replace the dead gravediggers:Many of the male nurses and the gravediggers, who were at first official, then casual, died of the plague. [â¦] The most surprising thing was that there was never a shortage of men to do the job, for as long as the epidemic lasted. [â¦] When the plague really took hold of the town, its very immoderation had one quite convenient outcome, because it disrupted the whole of economic life and so created quite a large number of unemployed. [â¦] Poverty always triumphed over fear, to the extent that work was always paid according to the risk involved.
(Camus 2002, Part III)The effects of the plague over the economic system are one of our recurrent topics (table 1). The plague in Oran, as it forces to close the city, impacts all trading exchanges. In addition, it forbids travellers from arriving to the city, with the economic influence that that entails:This plague was the ruination of tourism. (Camus 2002, Part II)Oranians, who, as we saw, were very worried about making money, are especially affected by an event which jeopardises it. In erectile dysfunction treatment, for one reason or for another, most of the countries are suffering economic consequences, since the impact on normal life from the epidemic (another recurrent topic) means also an impact on the normal development of trading activities.Part IVIn Part IV we witness the first signals of a stabilisation of the epidemic:It seemed that the plague had settled comfortably into its peak and was carrying out its daily murders with the precision and regularity of a good civil servant.
In theory, in the opinion of experts, this was a good sign. The graph of the progress of the plague, starting with its constant rise, followed by this long plateau, seemed quite reassuring. (Camus 2002, Part IV)At this time, we consider interesting to expand the topic about the transformation of facilities. We mentioned the case of ice rinks during erectile dysfunction treatment, and we bring up now the use of a football pitch as a quarantine camp in Camusâs novel, a scene which has reminded some scholars of the metaphor of Nazism and concentration camps (Finel-Honigman 1978). In Spain, among other measures, a fairground was enabled as a field hospital during the first wave, and it is plausible that many devices created with other purposes were used in tasks attached to healthcare provision during those weeks, as occurred in Oranâs pitch with the loudspeakers:Then the loudspeakers, which in better times had served to introduce the teams or to declare the results of games, announced in a tinny voice that the internees should go back to their tents so that the evening meal could be distributed.
(Camus 2002, Part IV)Related to this episode, we can also highlight the opposition between science and humanism that Camus does. The author alerts us about the dangers of a dehumanised science, of choosing procedures perfectly efficient regardless of their lack in human dignity:The men held out their hands, two ladles were plunged into two of the pots and emerged to unload their contents onto two tin plates. The car drove on and the process was repeated at the next tent.â Itâs scientific,â Tarrou told the administrator.â Yes,â he replied with satisfaction, as they shook hands. Â Itâs scientific.â (Camus 2002, Part IV)Several cases with favourable outcomes mark Part IV final moments and prepare the reader for the end of the epidemic. To describe these signs of recovering, the narrator turns back to two elements with a main role in the novel.
Rats and figures. In this moment, the first ones reappear and the second ones seem to be declining:He had seen two live rats come into his house through the street door. Neighbours had informed him that the creatures were also reappearing in their houses. Behind the walls of other houses there was a hustle and bustle that had not been heard for months. Rieux waited for the general statistics to be published, as they were at the start of each week.
They showed a decline in the disease. (Camus 2002, Part IV)Part VGiven that we continue facing erectile dysfunction treatment, and that forecasts about its end are not easy, we cannot compare ourselves with the Oranians once they have reached the end of the epidemic, what occurs in this part. However, we can analyse our current situation, characterised by a widespread, though cautious, confidence motivated by the beginning of vaccination campaigns, referring it to the events narrated in Part V.Even more than the Oranians, since we feel further than them from the end of the problem, we are cautious about not to anticipate celebrations. From time to time, however, we lend ourselves to dream relying on what the narrator calls âa great, unadmitted hopeâ. erectile dysfunction treatment took us by surprise and everyone wants to âreorganiseâ their life, as Oranians do, but patience is an indispensable component to succeed, as fictional and historical epidemics show us.Although this sudden decline in the disease was unexpected, the towns-people were in no hurry to celebrate.
The preceding months, though they had increased the desire for liberation, had also taught them prudence and accustomed them to count less and less on a rapid end to the epidemic. However, this new development was the subject of every conversation and, in the depths of peopleâs hearts, there was a great, unadmitted hope. [â¦] One of the signs that a return to a time of good health was secretly expected (though no one admitted the fact) was that from this moment on people readily spoke, with apparent indifference, about how life would be reorganized after the plague. (Camus 2002, Part V)We put our hope on vaccination. Social distancing and other hygienic measures have proved to be effective, but treatments would bring us a more durable solution without compromising so hardly many economic activities and social habits.
As we said, a more important role of scientific aspects is observed in erectile dysfunction treatment if compared with La Peste (an expected fact if considered that Camusâs story is an artistic work, that he skips sometimes the most complex scientific issues of the plague and that health sciences have evolved substantially during last decades). Oranians, in fact, achieve the end of the epidemic not through clearly identified scientific responses but with certain randomness:All one could do was to observe that the sickness seemed to be going as it had arrived. The strategy being used against it had not changed. It had been ineffective yesterday, and now it was apparently successful. One merely had the feeling that the disease had exhausted itself, or perhaps that it was retiring after achieving all its objectives.
In a sense, its role was completed. (Camus 2002, Part V)They receive the announcement made by the Prefecture of reopening the townâs gates in 2âweeks time with enthusiasm. Dealing with concrete dates gives them certainty, helps them fix the temporal horizons we wrote about. This is also the case when they are told that preventive measures would be lifted in 1âmonth. Camus shows us then how the main characters are touched as well by this positive atmosphere:That evening Tarrou and Rieux, Rambert and the rest, walked in the midst of the crowd, and they too felt they were treading on air.
Long after leaving the boulevards Tarrou and Rieux could still hear the sounds of happiness following them⦠(Camus 2002, Part V)Then, Tarrou points out a sign of recovery coming from the animal world. In a direct zoological chain, infected fleas have vanished from rats, which have been able again to multiply across the city, making the cats abandon their hiding places and to go hunting after them again. At the final step of this chain, Tarrou sees the human being. He remembers the old man who used to spit to the cats beneath his window:At a time when the noise grew louder and more joyful, Tarrou stopped. A shape was running lightly across the dark street.
It was a cat, the first that had been seen since the spring. It stopped for a moment in the middle of the road, hesitated, licked its paw, quickly passed it across its right ear, then carried on its silent way and vanished into the night. Tarrou smiled. The little old man, too, would be happy. (Camus 2002, Part V)Unpleasant things as a town with rats running across its streets, or a man spending his time spitting on a group of cats, constitute normality as much as the reopening of gates or the reboot of commerce.
However, when Camus speaks directly about normality, he highlights more appealing habits. He proposes common leisure activities (restaurants, theatres) as symbols of human life, since he opposes them to Cottardâs life, which has become that of a âwild animalâ:At least in appearance he [ Cottard ] retired from the world and from one day to the next started to live like a wild animal. He no longer appeared in restaurants, at the theatre or in his favourite cafés. (Camus 2002, Part V)We do not disclose why Cottardâs reaction to the end of the epidemic is different from most of the Oraniansâ. In any case, the narrator insists later on the assimilation between common pleasures and normality:â Perhaps,â Cottard said, â Perhaps so.
But what do you call a return to normal life?. Â â New films in the cinema,â said Tarrou with a smile. (Camus 2002, Part V)Cinema, as well as theatre, live music and many other cultural events have been cancelled or obliged to modify their activities due to erectile dysfunction treatment. Several bars and restaurants have closed, and spending time in those who remain open has become an activity which many people tend to avoid, fearing contagion. Thus, normality in our understanding is linked as well to these simple and pleasant habits, and the complete achievement of them will probably signify for us the desired defeat of the kamagra.In La Peste, love is also seen as a simple good to be fully recovered after the plague.
While Rieux goes through the ârebornâ Oran, it is loversâ gatherings what he highlights. Unlike them, everyone who, during the epidemic, sought for goals different from love (such as faith or money, for instance) remain lost when the epidemic has ended:For all the people who, on the contrary, had looked beyond man to something that they could not even imagine, there had been no reply. (Camus 2002, Part V)And this is because lovers, as the narrator says:If they had found that they wanted, it was because they had asked for the only thing that depended on them. (Camus 2002, Part V)We have spoken before about language manipulation, hypocrisy and public figuresâ roles during epidemics. Camus, during Dr Rieuxâs last visit to the old asthmatic man, makes this frank and humble character criticise, with a point of irony, the authoritiesâ attitude concerning tributes to the dead:â Tell me, doctor, is it true that theyâre going to put up a monument to the victims of the plague?.
Ââ So the papers say. A pillar or a plaque.ââ I knew it!. And thereâll be speeches.âThe old man gave a strangled laugh.â I can hear them already.  Our deadâ¦â Then theyâll go and have dinner.â (Camus 2002, Part V)The old man illustrates wisely the authoritiesâ propensity for making speeches. He knows that most of them usually prefer grandiloquence rather than common words, and seizes perfectly their tone when he imitates them (âOur deadâ¦â).
We have also got used, during erectile dysfunction treatment, to these types of messages. We have also heard about âour old peopleâ, âour youthâ, âour essential workersâ and even âour deadâ. Behind this tone, however, there could be an intention to hide errors, or to falsely convey carefulness. Honest rulers do not usually need nice words. They just want them to be accurate.We have seen as well some tributes to the victims during erectile dysfunction treatment, some of which we can doubt whether they serve to victimsâ relief or to authoritiesâ promotion.
We want rulers to be less aware of their own image and to stress truthfulness as a goal, even if this is a hard requirement not only for them, but for every single person. Language is essential in this issue, we think, since it is prone to be twisted and to become untrue. The old asthmatic man illustrates it with his âThereâll be speechesâ and his âOur deadâ¦â, but this is not the only time in the novel in which Camus brings out the topic. For instance, he does so when he equates silence (nothing can be thought as further from wordiness) with truth:It is at the moment of misfortune that one becomes accustomed to truth, that is to say to silence. (Camus 2002, Part II)or when he makes a solid statement against false words:â¦I understood that all the misfortunes of mankind came from not stating things in clear terms.
(Camus 2002, Part IV)The old asthmatic, in fact, while praising the deceased Tarrou, remarks that he used to admire him because âhe didnât talk just for the sake of it.â (Camus 2002, Part V).Related to this topic, what the old asthmatic says about political authorities may be transposed in our case to other public figures, such as scholars and researchers, media leaders, businessmen and women, health professionals⦠and, if we extend the scope, to every single citizen. Because hypocrisy, language manipulation and the fact of putting individual interests ahead of collective welfare fit badly with collective issues such as epidemics. Hopefully, also examples to the contrary have been observed during erectile dysfunction treatment.The story ends with the fireworks in Oran and the depiction of Dr Rieuxâs last feelings. While he is satisfied because of his medical performance and his activity as a witness of the plague, he is concerned about future disasters to come. When erectile dysfunction treatment will have passed, it will be time for us as well to review our life during these months.
For now, we are just looking forward to achieving our particular âpart Vâ.AbstractThis study addresses the existing gap in literature that ethnographically examines the experiences of Spanish-speaking patients with limited English proficiency in clinical spaces. All of the participants in this study presented to the emergency department (ED) for evaluation of non-urgent health conditions. Patient shadowing was employed to explore the challenges that this population face in unique clinical settings like the ED. This relatively new methodology facilitates obtaining nuanced understandings of clinical contexts under study in ways that quantitative approaches and survey research do not. Drawing from the field of medical anthropology and approach of narrative medicine, the collected data are presented through the use of clinical ethnographic vignettes and thick description.
The conceptual framework of health-related deservingness guided the analysis undertaken in this study. Structural stigma was used as a complementary framework in analysing the emergent themes in the data collected. The results and analysis from this study were used to develop an argument for the consideration of language as a distinct social determinant of health.emergency medicinemedical anthropologymedical humanitiesData availability statementData sharing not applicable as no datasets were generated and/or analysed for this study..
IntroductionLa Peste kamagra oral jelly online shop (Camus 1947) has served as a basis for several https://ilysesimonrd.com/nf_sub/377/ critical works, including some in the field of medical humanities (Bozzaro 2018. Deudon 1988. Tuffuor and kamagra oral jelly online shop Payne 2017). Frequently interpreted as an allegory of Nazism (with the plague as a symbol of the German occupation of France) (Finel-Honigman 1978. Haroutunian 1964), it has also received philosophical readings beyond the sociopolitical context in which it was written (Lengers 1994).
Other scholars, on the other hand, have kamagra oral jelly online shop centred their analyses on its literary aspects (Steel 2016).The erectile dysfunction treatment kamagra has increased general interest about historical and fictional epidemics. La Peste, as one of the most famous literary works about this topic, has been revisited by many readers during recent months, leading to an unexpected growth in sales in certain countries (Wilsher 2020. Zaretsky 2020). Apart from that, commentaries about the novel, especially among health sciences scholars, have emerged with kamagra oral jelly online shop a renewed interest (Banerjee et al. 2020.
Bate 2020. Vandekerckhove 2020 kamagra oral jelly online shop. Wigand, Becker, and Steger 2020). This sudden curiosity is easy to understand if we consider both La Pesteâs literary value, and peopleâs desire to discover real or fictional situations similar to theirs. Indeed, Oran inhabitantsâ experiences are not quite far from our own, even if geographical, chronological and, specially, scientific factors (two different diseases occurring at two different stages in the history of medical development) prevent us from establishing kamagra oral jelly online shop too close resemblances between both situations.Furthermore, it will not be strange if erectile dysfunction treatment serves as a frame for fictional works in the near future.
Other narrative plays were based on historical epidemics, such as Daniel Defoeâs A Journal of the Plague Year or Giovanni Boccaccioâs Decameron (Wigand, Becker, and Steger 2020. Withington 2020). The biggest kamagra in the last century, the so-called âSpanish Influenzaâ, has been described as not very fruitful in this sense, even if it produced famous novels such as Katherine A Porterâs Pale Horse, Pale Rider or John OâHaraâs kamagra oral jelly online shop The Doctor Son (Honigsbaum 2018. Hovanec 2011). The overlapping with another disaster like World War I has been argued as one of the reasons explaining this scarce production of fictional works (Honigsbaum 2018).
By contrast, we may think that erectile dysfunction treatment is having a global impact hardly overshadowed by other events, and that it will leave a significant mark on kamagra oral jelly online shop the collective memory.Drawing on the reading of La Peste, we point out in this essay different aspects of living under an epidemic that can be identified both in Camusâs work and in our current situation. We propose a trip throughout the novel, from its early beginning in Part I, when the Oranians are not aware of the threat to come, to its end in Part V, when they are relieved of the epidemic after several months of ravaging disasters.We think this journey along La Peste may be interesting both to health professionals and to the lay person, since all of them will be able to see themselves reflected in the characters from the novel. We do not skip critique of some aspects related to the authoritiesâ management of erectile dysfunction treatment, as Camus does concerning Oranâs rulers. However, what we want to foreground is La Pesteâs intrinsic value, its suitability to be read now and after erectile dysfunction treatment has passed, when Camusâs novel endures as a solid art work and erectile dysfunction treatment remains only as a defeated kamagra oral jelly online shop plight.MethodsWe confronted our own experiences about erectile dysfunction treatment with a conventional reading of La Peste. A first reading of the novel was used to establish associations between those aspects which more saliently reminded us of erectile dysfunction treatment.
In a second reading, we searched for some examples to illustrate those aspects and tried to detect new associations. Subsequent readings of certain parts were done kamagra oral jelly online shop to integrate the information collected. Neither specific methods of literary analysis, nor systematic searches in the novel were applied. Selected paragraphs and ideas from Part I to Part V were prepared in a draft copy, and this manuscript was written afterwards.Part ISome phrases in the novel could be transposed word by word to our situation. This one pertaining to its start, for instance, may make us remember the first months of 2020:By now, it will be easy to accept that nothing could lead the people of our town to expect the events that took place in the spring of that year and which, as we later understood, were like the kamagra oral jelly online shop forerunners of the series of grave happenings that this history intends to describe.
(Camus 2002, Part I)By referring from the beginning to âthe people of our townâ, Camus is already suggesting an idea which is repeated all along the novel, and which may be well understood by us as erectile dysfunction treatmentâs witnesses. Epidemics affect the community as a whole, they are present in everybodyâs mind and their joys and sorrows are not individual, but collective. For example (and we are anticipating Part II), the narrator says:But, once the gates were closed, they all noticed that they were in the same boat, including the narrator himself, kamagra oral jelly online shop and that they had to adjust to the fact. (Camus 2002, Part II)Later, he will insist in this opposition between the concepts of âindividualâ, which used to prevail before the epidemic, and âcollectiveâ:One might say that the first effect of this sudden and brutal attack of the disease was to force the citizens of our town to act as though they had no individual feelings. (Camus 2002, Part II)There were no longer any individual destinies, but a collective history that was the plague, and feelings shared by all.
(Camus 2002, Part III)This distinction is not trivial, since the story will display a strong confrontation between those who get involved and help their kamagra oral jelly online shop neighbours and those who remain behaving selfishly. Related to this, Claudia Bozzaro has pointed out that the main topic in La Peste is solidarity and auistic love (Bozzaro 2018). We may add that the disease is so attached to peopleâs lives that the epidemic becomes the new everyday life:In the morning, they would return to the pestilence, that is to say, to routine. (Camus 2002, Part III)Being collective kamagra oral jelly online shop issues does not mean that epidemics always enhance auism and solidarity. As said by Wigand et al, they frequently produce ambivalent reactions, and one of them is the opposition between auism and maximised profit (Wigand, Becker, and Steger 2020).
Therefore, the dichotomy between individualism and collectivism, a central point in the characterisation of national cultures (Hofstede 2015), could play a role in epidemics. In fact, concerning erectile dysfunction treatment, some authors have kamagra oral jelly online shop described a greater impact of the kamagra in those countries with higher levels of individualism (Maaravi et al. 2021. Ozkan et al. 2021).
However, this finding should be complemented with other national culturesâ aspects before concluding that collectivism itself exerts a protective role against epidemics. Concerning this, it has been shown how âpower distanceâ frequently intersects with collectivism, being only a few countries in which the last one coexists with a small distance to power, namely with a capacity to disobey the power authority (Gupta, Shoja, and Mikalef 2021). Moreover, those countries classically classified as âcollectivistâ (China, Japan, South Korea, India, Vietnam, etc.) are also characterised by high levels of power distance, and their citizens have been quite often forced to adhere to erectile dysfunction treatment restrictions and punished if not (Gupta, Shoja, and Mikalef 2021). Thus, it is important to consider that individualism is not always opposed to âlook after each otherâ (Ozkan et al. 2021, 9).
For instance, the European region, seen as a whole as highly âindividualisticâ, holds some of the most advanced welfare protection systems worldwide. It is worth considering too that collectivism may hide sometimes a hard institutional authority or a lack in civil freedoms.Coming back to La Peste, we may think that Camusâs Oranians are not particularly âcollectivistâ. Their initial description highlights that they are mainly interested in their own businesses and affairs:Our fellow-citizens work a good deal, but always in order to make money. They are especially interested in trade and first of all, as they say, they are engaged in doing business. (Camus 2002, Part I)And later, we see some of them trying selfishly to leave the city by illegal methods.
By contrast, we observe in the novel some examples of more âcollectivisticâ attitudes, such as the discipline of those quarantined at the football pitch, and, over all, the main charactersâ behaviour, which is generally driven by auism and common goals.Turning to another topic, the plague in Oran and erectile dysfunction treatment are similar regarding their animal origin. This is not rare since many infectious diseases pass to humans through contact with animal vectors, being rodents, especially rats (through rat fleas), the most common carriers of plague bacteria (CDC. N.d.a, ECDC. N.d, Pollitzer 1954). Concerning erectile dysfunction, even if further research about its origin is needed, the most recent investigations conducted in China by the WHO establish a zoonotic transmission as the most probable pathway (Joint WHO-China Study Team 2021).
In Camusâs novel, the animalâs link to the epidemic seemed very clear since the beginning:Things got to the point where Infodoc (the agency for information and documentation, â all you need to know on any subjectâ) announced in its free radio news programme that 6,231 rats had been collected and burned in a single day, the 25th. This figure, which gave a clear meaning to the daily spectacle that everyone in town had in front of their eyes, disconcerted them even more. (Camus 2002, Part I)This accuracy in figures is familiar to us. People nowadays have become very used to the statistical aspects of the kamagra, due to the continuous updates in epidemiological parameters launched by the media and the authorities. Camus was aware about the relevance of figures in epidemics, which always entail:â¦required registration and statistical tasks.
(Camus 2002, Part II)Because of this, the novel is scattered with numbers, most of them concerning the daily death toll, but others mentioning the number of rats picked up, as we have seen, or combining the number of deaths with the time passed since the start of the epidemic:â Will there be an autumn of plague?. Professor B answers. Â Noâ â, â One hundred and twenty-four dead. The total for the ninety-fourth day of the plague.â (Camus 2002, Part II)We permit ourselves to introduce here a list of recurring topics in La Peste, since the salience of statistical information is one of them. These topics, some of which will be treated later, appear several times in the novel, in various contexts and stages in the evolution of the epidemic.
We synthesise them in Table 1, coupled with a erectile dysfunction treatment parallel example extracted from online press. This ease to find a current example for each topic suggests that they are not exclusive of plague or of Camusâs mindset, but shared by most epidemics.View this table:Table 1 Recurring topics in La Peste. Each topic is accompanied by two examples from the novel and one concerning erectile dysfunction treatment, extracted from online press.Talking about journalism and the media (one of the topics above), we might say that erectile dysfunction treatmentâs coverage is frequently too optimistic when managing good news and too alarming when approaching the bad. Mediaâs âexaggeratedâ approach to health issues is not new. It was already a concern for medical journalsâ editors a century ago (Reiling 2013) and it continues to be it for these professionals in recent times (Barbour et al.
2008). It is well known that media tries to attract spectatorsâ attention by making the news more appealing. However, they deal with the risk of expanding unreliable information, which may be pernicious for the public opinion. Related to the intention of âgarnishingâ the news, Aslam et al. (2020) have described that 82% of more than 100â000 pieces of information about erectile dysfunction treatment appearing in media from different countries carried an emotional, either negative (52%) or positive (30%) component, with only 18% of them considered as âneutralâ (Aslam et al.
2020). Some evidence about this tendency to make news more emotional was described in former epidemics. For instance, a study conducted in Singapore in 2009 during the H1N1 crisis showed how press releases by the Ministry of Health were substantially transformed when passed to the media, by increasing their emotional appeal and by changing their dominant frame or their tone (Lee and Basnyat 2013). In La Peste, this superficial way of managing information by the media is also observed:The newspapers followed the order that they had been given, to be optimistic at any cost. (Camus 2002, Part IV)At the first stages of the epidemic in Oran, journalists proclaim the end of the dead ratsâ invasion as something to be celebrated.
Dr Rieux, the character through which Camus symbolises caution (and comparable nowadays to trustful scientists, well-informed journalists or sensible authorities), exposes then his own angle, quite far from suggesting optimism:The vendors of the evening papers were shouting that the invasion of rats had ended. But Rieux found his patient lying half out of bed, one hand on his belly and the other around his neck, convulsively vomiting reddish bile into a rubbish bin. (Camus 2002, Part I)Camus, who worked as a journalist for many years, insists afterwards on this cursory interest that some media devote to the epidemic, more eager to grab the noise than the relevant issues beneath it:The press, which had had so much to say about the business of the rats, fell silent. This is because rats die in the street and people in their bedrooms. And newspapers are only concerned with the street.
(Camus 2002, Part I)By then, Oranians continue rejecting the epidemic as an actual threat, completely immersed in that phase that dominates the beginning of all epidemics and is characterised by âdenial and disbeliefâ (Wigand, Becker, and Steger 2020, 443):A pestilence does not have human dimensions, so people tell themselves that it is unreal, that it is a bad dream which will end. [â¦] The people of our town were no more guilty than anyone else, they merely forgot to be modest and thought that everything was still possible for them, which implied that pestilence was impossible. They continued with business, with making arrangements for travel and holding opinions. Why should they have thought about the plague, which negates the future, negates journeys and debate?. They considered themselves free and no one will ever be free as long as there is plague, pestilence and famine.
(Camus 2002, Part I)Probably to avoid citizens' disapproval, among other reasons, the Oranian Prefecture (health authority in Camus' novel) does not want to go too far when judging the relevance of the epidemic. While not directly exposed, we can guess in this fragment the tone of the Prefectâs message, his intention to convey confidence despite his own doubts:These cases were not specific enough to be really disturbing and there was no doubt that the population would remain calm. None the less, for reasons of caution which everyone could understand, the Prefect was taking some preventive measures. If they were interpreted and applied in the proper way, these measures were such that they would put a definite stop to any threat of epidemic. As a result, the Prefect did not for a moment doubt that the citizens under his charge would co-operate in the most zealous manner with what he was doing.
(Camus 2002, Part I)The relevant role acquired by health authorities during epidemics is another topic listed in our table. Language use, on the other hand, is an issue linkable both with the media topic and with this one. As in La Peste, during erectile dysfunction treatment we have seen some public figures using words not always truthfully, carrying out a careful selection of words that serves to the goal of conveying certain interests in each moment. Dr Rieux refers in Part I to this language manipulation by the authorities:The measures that had been taken were insufficient, that was quite clear. As for the â specially equipped wardsâ, he knew what they were.
Two outbuildings hastily cleared of other patients, their windows sealed up and the whole surrounded by a cordon sanitaire. (Camus 2002, Part I)He illustrates the need of frankness, the preference for clarity in language, which is often the clarity in thinking:No. I phoned Richard to say we needed comprehensive measures, not fine words, and that either we must set up a real barrier to the epidemic, or nothing at all. (Camus 2002, Part I)At the end of this part, his fears about the inadequacy of not taking strict measures are confirmed. Oranian hospitals become overwhelmed, as they are now in many places worldwide due to erectile dysfunction treatment.Part IILeft behind the phases of âdenial and disbeliefâ and of âfear and panicâ, it appears among the Oranians the âacceptance paired with resignationâ (Wigand, Becker, and Steger 2020, 443):Then we knew that our separation was going to last, and that we ought to try to come to terms with time.
[â¦] In particular, all of the people in our town very soon gave up, even in public, whatever habit they may have acquired of estimating the length of their separation. (Camus 2002, Part II)In erectile dysfunction treatment as well, even if border closure has not been so immovable as in Oran, many people have seen themselves separated from their loved ones and some of them have not yet had the possibility of reunion. This is why, in the actual kamagra, the idea of temporal horizons has emerged like it appeared in Camusâs epidemic. In Spain, the general lockdown in March and April 2020 made people establish the summer as their temporal horizon, a time in which they could resume their former habits and see their relatives again. This became partially true, and people were allowed in summer to travel inside the country and to some other countries nearby.
However, there existed some reluctance to visit ill or aged relatives, due to the fear of infecting them, and some families living in distant countries were not able to get together. Moreover, autumn brought an increase in the number of cases (âthe second waveâ) and countries returned to limit their internal and external movements.Bringing all this together, many people nowadays have opted to discard temporal horizons. As Oranians, they have noted that the epidemic follows its own rhythm and it is useless to fight against it. Nonetheless, it is in human nature not to resign, so abandoning temporal horizons does not mean to give up longing for the recovery of normal life. This vision, neither maintaining vain hopes nor resigning, is in line with Camusâs philosophy, an author who wrote that âhope, contrary to what it is usually thought, is the same to resignation.â (Camus 1939, 83.
Cited by Haroutunian 1964, 312 (translation is ours)), and that âthere is not love to human life but with despair about human life.â (Camus 1958, 112â5. Cited by Haroutunian 1964, 312â3 (translation is ours)).People nowadays deal with resignation relying on daily life pleasures (being not allowed to make further plans or trips) and in company from the nearest ones (as they cannot gather with relatives living far away). Second, they observe the beginning of vaccination campaigns as a first step of the final stage, and summer 2021, reflecting what happened with summer 2020, has been fixed as a temporal horizon. This preference for summers has an unavoidable metaphorical nuance, and their linking to joy, long trips and life in the streets may be the reason for which we choose them to be opposed to the lockdown and restrictions of the kamagra.We alluded previously to the manipulation of language, and figures, as relevant as they are, they are not free from manipulation either. Tarrou, a close friend to Dr Rieux, points out in this part of the novel how this occurred:Once more, Tarrou was the person who gave the most accurate picture of our life as it was then.
Naturally he was following the course of the plague in general, accurately observing that a turning point in the epidemic was marked by the radio no longer announcing some hundreds of deaths per week, but 92, 107 and 120 deaths a day. ÂThe newspapers and the authorities are engaged in a battle of wits with the plague. They think that they are scoring points against it, because 130 is a lower figure than 910.â (Camus 2002, Part II)Tarrou collaborates with the health teams formed to tackle the plague. Regarding these volunteers and workers, Camus refuses to consider them as heroes, as many essential workers during erectile dysfunction treatment have rejected to be named as that. The writer thinks their actions are the natural behaviour of good people, not heroism but âa logical consequenceâ:The whole question was to prevent the largest possible number of people from dying and suffering a definitive separation.
There was only one way to do this, which was to fight the plague. There was nothing admirable about this truth, it simply followed as a logical consequence. (Camus 2002, Part II)We consider suitable to talk here about two issues which represent, nowadays, a great part of erectile dysfunction treatment fears and hopes, respectively. New genetic variants and treatments. Medical achievements are another recurrent issue included in table 1, and we write about them here because it is in Part II where Camus writes for the first time about treatments, and where it insists on an idea aforementioned in Part I.
That the plague bacillus affecting Oran is different from previous variants:â¦the microbe differed very slightly from the bacillus of plague as traditionally defined. (Camus 2002, Part II)Related to erectile dysfunction treatment new variants, they represent a challenge because of two main reasons. Their higher transmissibility and/or severity and their higher propensity to skip the effect of natural or treatment-induced immunity. Public health professionals are determining which is the actual threat of all the new variants discovered, such as those first characterised in the UK (Public Health England 2020), South Africa (Tegally et al. 2021) or Brazil (Fujino et al.
2021). In La Peste, Dr Rieux is always suspecting that the current bacteria they are dealing with is different from the one in previous epidemics of plague. Since several genetic variations for the bacillus Yersinia pestis have been characterised (Cui et al. 2012), it could be possible that the epidemic in Oran originated from a new one. However, we should not forget that we are analysing a literary work, and that scientific accuracy is not a necessary goal in it.
In fact, Rieuxâs reluctances have to do more with clinical aspects than with microbiological ones. He doubts since the beginning, relying exclusively on the symptoms observed, and continues doing it after the laboratory analysis:I was able to have an analysis made in which the laboratory thinks it can detect the plague bacillus. However, to be precise, we must say that certain specific modifications of the microbe do not coincide with the classic description of plague. (Camus 2002, Part II)Camus is consistent with this idea and many times he mentions the bacillus to highlight its oddity. Insisting on the literary condition of the work, and among other possible explanations, he is maybe declaring that that in the novel is not a common (biological, natural) bacteria, but the Nazism bacteria.Turning to treatments, they constitute the principal resource that the global community has to defeat the erectile dysfunction treatment kamagra.
Vaccination campaigns have started all over the world, and three types of erectile dysfunction treatments are being applied in the European Union, after their respective statements of efficacy and security (Baden et al. 2021 cheap kamagra pills. Polack et al. 2020. Voysey et al.
2021), while a fourth treatment has just recently been approved (EMA 2021a). Although some concerns regarding the safety of two of these treatments have been raised recently (EMA 2021b. EMA 2021c), vaccination plans are going ahead, being adapted according to the state of knowledge at each moment. Some of these treatments are mRNA-based (Baden et al. 2021.
Polack et al. 2020), while others use a viral vector (Bos et al. 2020. Voysey et al. 2021).
They are mainly two-shot treatments, with one exception (Bos et al. 2020), and complete immunity is thought to be acquired 2âweeks after the last shot (CDC. N.d.b, Voysey et al. 2021). Other countries such as China or Russia, on the other hand, were extremely early in starting their vaccination campaigns, and are distributing among their citizens different treatments than the aforementioned (Logunov et al.
2021. Zhang et al. 2021).Even if at least three types of plague treatments had been created by the time the novel takes place (Sun 2016), treatments do not play an important role in La Peste, in which therapeutic measures (the serum) are more important than prophylactic ones. Few times in the novel the narrator refers to prophylactic inoculations:There was still no possibility of vaccinating with preventive serum except in families already affected by the disease. (Camus 2002, Part II)Deudon has pointed out that Camus mixes up therapeutic serum and treatment (Deudon 1988), and in fact there exists a certain amount of confusion.
All along the novel, the narrator focuses on the prophylactic goals of the serum, which is applied to people already infected (Othonâs son, Tarrou, Grandâ¦). However, both in the example above (which can be understood as vaccinating household contacts or already affected individuals) and in others, the differences between treating and vaccinating are not clear:After the morning admissions which he was in charge of himself, the patients were vaccinated and the swellings lanced. (Camus 2002, Part II)In any case, this is another situation in which Camus stands aside from scientific matters, which are to him less relevant in his novel than philosophical or literary ones. The distance existing between the relevance of treatments in erectile dysfunction treatment and the superficial manner with which Camus treats the topic in La Peste exemplifies this.Part IIIIn part III, the plagueâs ravages become tougher. The narrator turns his focus to burials and their disturbance, a frequent topic in epidemicsâ narrative (table 1).
Camus knew how acutely increasing demands and hygienic requirements affect funeral habits during epidemics:Everything really happened with the greatest speed and the minimum of risk. (Camus 2002, Part III)Like many other processes during epidemics, the burial process becomes a protocol. When protocolised, everything seems to work well and rapidly. But this perfect mechanism is the Prefectureâs goal, not Rieuxâs. He reveals in this moment an aspect in his character barely shown before.
Irony.The whole thing was well organized and the Prefect expressed his satisfaction. He even told Rieux that, when all was said and done, this was preferable to hearses driven by black slaves which one read about in the chronicles of earlier plagues. Â Yes,â Rieux said. Â The burial is the same, but we keep a card index. No one can deny that we have made progress.â (Camus 2002, Part III)Even if this characteristic may seem new in Dr Rieux, we must bear in mind that he is the story narrator, and the narration is ironic from time to time.
For instance, speaking precisely about the burials:The relatives were invited to sign a register âwhich just showed the difference that there may be between men and, for example, dogs. You can keep check of human beings-. (Camus 2002, Part III)In Camusâs philosophy, the absurd is a core issue. According to Lengers, Rieux is ironic because he is a kind of Sisyphus who has understood the absurdity of plague (Lengers 1994). The response to the absurd is to rebel (Camus 2013), and Rieux does it by helping his fellow humans without questioning anything.
He does not pursue any other goal than doing his duty, thus humour (as a response to dire situations) stands out from him when he observes others celebrating irrelevant achievements, such as the Prefect with his burial protocol. In the field of medical ethics, Lengers has highlighted the importance of Camusâs perspective when considering âthe immediacy of life rather than abstract valuesâ (Lengers 1994, 250). Rieux himself is quite sure that his solid commitment is not âabstractâ, and, even if he falls into abstraction, the importance relies on protecting human lives and not in the name given to that task:Was it truly an abstraction, spending his days in the hospital where the plague was working overtime, bringing the number of victims up to five hundred on average per week?. Yes, there was an element of abstraction and unreality in misfortune. But when an abstraction starts to kill you, you have to get to work on it.
(Camus 2002, Part II)Farewells during erectile dysfunction treatment may have not been particularly pleasant for some families. Neither those dying at nursing homes nor in hospitals could be accompanied by their families as previously, due to corpses management protocols, restrictions of external visitors and hygienic measures in general. However, as weeks passed by, certain efforts were made to ease this issue, allowing people to visit their dying beloved sticking to strict preventive measures. On the other hand, the number of people attending funeral masses and cemeteries was also limited, which affected the conventional development of ceremonies as well. Hospitals had to deal with daily tolls of deaths never seen before, and the overcrowding of mortuaries made us see rows of coffins placed in unusual spaces, such as ice rinks (transformation of facilities is another topic in table 1).We turn now to two other points which erectile dysfunction treatment has not evaded.
s among essential workers and epidemicsâ economic consequences. The author links burials with s among essential workers because gravediggers constitute one of the most affected professions, and connects this fact with the economic recession because unemployment is behind the large availability of workers to replace the dead gravediggers:Many of the male nurses and the gravediggers, who were at first official, then casual, died of the plague. [â¦] The most surprising thing was that there was never a shortage of men to do the job, for as long as the epidemic lasted. [â¦] When the plague really took hold of the town, its very immoderation had one quite convenient outcome, because it disrupted the whole of economic life and so created quite a large number of unemployed. [â¦] Poverty always triumphed over fear, to the extent that work was always paid according to the risk involved.
(Camus 2002, Part III)The effects of the plague over the economic system are one of our recurrent topics (table 1). The plague in Oran, as it forces to close the city, impacts all trading exchanges. In addition, it forbids travellers from arriving to the city, with the economic influence that that entails:This plague was the ruination of tourism. (Camus 2002, Part II)Oranians, who, as we saw, were very worried about making money, are especially affected by an event which jeopardises it. In erectile dysfunction treatment, for one reason or for another, most of the countries are suffering economic consequences, since the impact on normal life from the epidemic (another recurrent topic) means also an impact on the normal development of trading activities.Part IVIn Part IV we witness the first signals of a stabilisation of the epidemic:It seemed that the plague had settled comfortably into its peak and was carrying out its daily murders with the precision and regularity of a good civil servant.
In theory, in the opinion of experts, this was a good sign. The graph of the progress of the plague, starting with its constant rise, followed by this long plateau, seemed quite reassuring. (Camus 2002, Part IV)At this time, we consider interesting to expand the topic about the transformation of facilities. We mentioned the case of ice rinks during erectile dysfunction treatment, and we bring up now the use of a football pitch as a quarantine camp in Camusâs novel, a scene which has reminded some scholars of the metaphor of Nazism and concentration camps (Finel-Honigman 1978). In Spain, among other measures, a fairground was enabled as a field hospital during the first wave, and it is plausible that many devices created with other purposes were used in tasks attached to healthcare provision during those weeks, as occurred in Oranâs pitch with the loudspeakers:Then the loudspeakers, which in better times had served to introduce the teams or to declare the results of games, announced in a tinny voice that the internees should go back to their tents so that the evening meal could be distributed.
(Camus 2002, Part IV)Related to this episode, we can also highlight the opposition between science and humanism that Camus does. The author alerts us about the dangers of a dehumanised science, of choosing procedures perfectly efficient regardless of their lack in human dignity:The men held out their hands, two ladles were plunged into two of the pots and emerged to unload their contents onto two tin plates. The car drove on and the process was repeated at the next tent.â Itâs scientific,â Tarrou told the administrator.â Yes,â he replied with satisfaction, as they shook hands. Â Itâs scientific.â (Camus 2002, Part IV)Several cases with favourable outcomes mark Part IV final moments and prepare the reader for the end of the epidemic. To describe these signs of recovering, the narrator turns back to two elements with a main role in the novel.
Rats and figures. In this moment, the first ones reappear and the second ones seem to be declining:He had seen two live rats come into his house through the street door. Neighbours had informed him that the creatures were also reappearing in their houses. Behind the walls of other houses there was a hustle and bustle that had not been heard for months. Rieux waited for the general statistics to be published, as they were at the start of each week.
They showed a decline in the disease. (Camus 2002, Part IV)Part VGiven that we continue facing erectile dysfunction treatment, and that forecasts about its end are not easy, we cannot compare ourselves with the Oranians once they have reached the end of the epidemic, what occurs in this part. However, we can analyse our current situation, characterised by a widespread, though cautious, confidence motivated by the beginning of vaccination campaigns, referring it to the events narrated in Part V.Even more than the Oranians, since we feel further than them from the end of the problem, we are cautious about not to anticipate celebrations. From time to time, however, we lend ourselves to dream relying on what the narrator calls âa great, unadmitted hopeâ. erectile dysfunction treatment took us by surprise and everyone wants to âreorganiseâ their life, as Oranians do, but patience is an indispensable component to succeed, as fictional and historical epidemics show us.Although this sudden decline in the disease was unexpected, the towns-people were in no hurry to celebrate.
The preceding months, though they had increased the desire for liberation, had also taught them prudence and accustomed them to count less and less on a rapid end to the epidemic. However, this new development was the subject of every conversation and, in the depths of peopleâs hearts, there was a great, unadmitted hope. [â¦] One of the signs that a return to a time of good health was secretly expected (though no one admitted the fact) was that from this moment on people readily spoke, with apparent indifference, about how life would be reorganized after the plague. (Camus 2002, Part V)We put our hope on vaccination. Social distancing and other hygienic measures have proved to be effective, but treatments would bring us a more durable solution without compromising so hardly many economic activities and social habits.
As we said, a more important role of scientific aspects is observed in erectile dysfunction treatment if compared with La Peste (an expected fact if considered that Camusâs story is an artistic work, that he skips sometimes the most complex scientific issues of the plague and that health sciences have evolved substantially during last decades). Oranians, in fact, achieve the end of the epidemic not through clearly identified scientific responses but with certain randomness:All one could do was to observe that the sickness seemed to be going as it had arrived. The strategy being used against it had not changed. It had been ineffective yesterday, and now it was apparently successful. One merely had the feeling that the disease had exhausted itself, or perhaps that it was retiring after achieving all its objectives.
In a sense, its role was completed. (Camus 2002, Part V)They receive the announcement made by the Prefecture of reopening the townâs gates in 2âweeks time with enthusiasm. Dealing with concrete dates gives them certainty, helps them fix the temporal horizons we wrote about. This is also the case when they are told that preventive measures would be lifted in 1âmonth. Camus shows us then how the main characters are touched as well by this positive atmosphere:That evening Tarrou and Rieux, Rambert and the rest, walked in the midst of the crowd, and they too felt they were treading on air.
Long after leaving the boulevards Tarrou and Rieux could still hear the sounds of happiness following them⦠(Camus 2002, Part V)Then, Tarrou points out a sign of recovery coming from the animal world. In a direct zoological chain, infected fleas have vanished from rats, which have been able again to multiply across the city, making the cats abandon their hiding places and to go hunting after them again. At the final step of this chain, Tarrou sees the human being. He remembers the old man who used to spit to the cats beneath his window:At a time when the noise grew louder and more joyful, Tarrou stopped. A shape was running lightly across the dark street.
It was a cat, the first that had been seen since the spring. It stopped for a moment in the middle of the road, hesitated, licked its paw, quickly passed it across its right ear, then carried on its silent way and vanished into the night. Tarrou smiled. The little old man, too, would be happy. (Camus 2002, Part V)Unpleasant things as a town with rats running across its streets, or a man spending his time spitting on a group of cats, constitute normality as much as the reopening of gates or the reboot of commerce.
However, when Camus speaks directly about normality, he highlights more appealing habits. He proposes common leisure activities (restaurants, theatres) as symbols of human life, since he opposes them to Cottardâs life, which has become that of a âwild animalâ:At least in appearance he [ Cottard ] retired from the world and from one day to the next started to live like a wild animal. He no longer appeared in restaurants, at the theatre or in his favourite cafés. (Camus 2002, Part V)We do not disclose why Cottardâs reaction to the end of the epidemic is different from most of the Oraniansâ. In any case, the narrator insists later on the assimilation between common pleasures and normality:â Perhaps,â Cottard said, â Perhaps so.
But what do you call a return to normal life?. Â â New films in the cinema,â said Tarrou with a smile. (Camus 2002, Part V)Cinema, as well as theatre, live music and many other cultural events have been cancelled or obliged to modify their activities due to erectile dysfunction treatment. Several bars and restaurants have closed, and spending time in those who remain open has become an activity which many people tend to avoid, fearing contagion. Thus, normality in our understanding is linked as well to these simple and pleasant habits, and the complete achievement of them will probably signify for us the desired defeat of the kamagra.In La Peste, love is also seen as a simple good to be fully recovered after the plague.
While Rieux goes through the ârebornâ Oran, it is loversâ gatherings what he highlights. Unlike them, everyone who, during the epidemic, sought for goals different from love (such as faith or money, for instance) remain lost when the epidemic has ended:For all the people who, on the contrary, had looked beyond man to something that they could not even imagine, there had been no reply. (Camus 2002, Part V)And this is because lovers, as the narrator says:If they had found that they wanted, it was because they had asked for the only thing that depended on them. (Camus 2002, Part V)We have spoken before about language manipulation, hypocrisy and public figuresâ roles during epidemics. Camus, during Dr Rieuxâs last visit to the old asthmatic man, makes this frank and humble character criticise, with a point of irony, the authoritiesâ attitude concerning tributes to the dead:â Tell me, doctor, is it true that theyâre going to put up a monument to the victims of the plague?.
Ââ So the papers say. A pillar or a plaque.ââ I knew it!. And thereâll be speeches.âThe old man gave a strangled laugh.â I can hear them already.  Our deadâ¦â Then theyâll go and have dinner.â (Camus 2002, Part V)The old man illustrates wisely the authoritiesâ propensity for making speeches. He knows that most of them usually prefer grandiloquence rather than common words, and seizes perfectly their tone when he imitates them (âOur deadâ¦â).
We have also got used, during erectile dysfunction treatment, to these types of messages. We have also heard about âour old peopleâ, âour youthâ, âour essential workersâ and even âour deadâ. Behind this tone, however, there could be an intention to hide errors, or to falsely convey carefulness. Honest rulers do not usually need nice words. They just want them to be accurate.We have seen as well some tributes to the victims during erectile dysfunction treatment, some of which we can doubt whether they serve to victimsâ relief or to authoritiesâ promotion.
We want rulers to be less aware of their own image and to stress truthfulness as a goal, even if this is a hard requirement not only for them, but for every single person. Language is essential in this issue, we think, since it is prone to be twisted and to become untrue. The old asthmatic man illustrates it with his âThereâll be speechesâ and his âOur deadâ¦â, but this is not the only time in the novel in which Camus brings out the topic. For instance, he does so when he equates silence (nothing can be thought as further from wordiness) with truth:It is at the moment of misfortune that one becomes accustomed to truth, that is to say to silence. (Camus 2002, Part II)or when he makes a solid statement against false words:â¦I understood that all the misfortunes of mankind came from not stating things in clear terms.
(Camus 2002, Part IV)The old asthmatic, in fact, while praising the deceased Tarrou, remarks that he used to admire him because âhe didnât talk just for the sake of it.â (Camus 2002, Part V).Related to this topic, what the old asthmatic says about political authorities may be transposed in our case to other public figures, such as scholars and researchers, media leaders, businessmen and women, health professionals⦠and, if we extend the scope, to every single citizen. Because hypocrisy, language manipulation and the fact of putting individual interests ahead of collective welfare fit badly with collective issues such as epidemics. Hopefully, also examples to the contrary have been observed during erectile dysfunction treatment.The story ends with the fireworks in Oran and the depiction of Dr Rieuxâs last feelings. While he is satisfied because of his medical performance and his activity as a witness of the plague, he is concerned about future disasters to come. When erectile dysfunction treatment will have passed, it will be time for us as well to review our life during these months.
For now, we are just looking forward to achieving our particular âpart Vâ.AbstractThis study addresses the existing gap in literature that ethnographically examines the experiences of Spanish-speaking patients with limited English proficiency in clinical spaces. All of the participants in this study presented to the emergency department (ED) for evaluation of non-urgent health conditions. Patient shadowing was employed to explore the challenges that this population face in unique clinical settings like the ED. This relatively new methodology facilitates obtaining nuanced understandings of clinical contexts under study in ways that quantitative approaches and survey research do not. Drawing from the field of medical anthropology and approach of narrative medicine, the collected data are presented through the use of clinical ethnographic vignettes and thick description.
The conceptual framework of health-related deservingness guided the analysis undertaken in this study. Structural stigma was used as a complementary framework in analysing the emergent themes in the data collected. The results and analysis from this study were used to develop an argument for the consideration of language as a distinct social determinant of health.emergency medicinemedical anthropologymedical humanitiesData availability statementData sharing not applicable as no datasets were generated and/or analysed for this study..
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So you think your online kamagra prescription blood pressure http://margaretarts.com/sample-page-2/ is normal?. Think again.The latest iteration of an âidealâ blood pressure â a level of 120 millimeters of mercury for systolic pressure, the top number â that Americans are urged to achieve and maintain has been called into question by a long-term multiethnic study of otherwise healthy adults.The study, published in June in JAMA Cardiology, found that as systolic blood pressure rose above 90 mm, online kamagra prescription the risk of damage to coronary arteries rose along with it. Systolic blood pressure represents the pressure within arteries when the heart pumps (as opposed to diastolic blood pressure, the lower smaller number, when the heart rests).The new findings suggest a need to look more carefully at why, despite considerable overall improvements in risk factors for heart disease in recent decades, it remains the nationâs leading killer.Starting in the 1940s, cardiovascular researchers have unveiled evidence that Americans live in a society that all but guarantees a disproportionately high risk of developing and dying of heart disease.
Since my first weeks writing for this newspaper in the early 1960s, Iâve publicized their advice urging people to curb preventable risks to their hearts and blood vessels.Although significant progress has been made along several fronts, especially online kamagra prescription drastic cuts in cigarette smoking and lowered levels of artery-damaging cholesterol, atherosclerotic heart disease still kills far too many people in this country long before they reach their potential life span. If not for a plethora of therapeutic advances, like antihypertensive drugs, cholesterol-lowering statins and open-heart surgery to bypass clogged arteries, life expectancy would be online kamagra prescription a lot worse for many people.But the overall picture suggests weâve still got a long way to go. For example, as Americans get fatter and fatter, two major risk factors for heart disease â Type 2 diabetes and high blood pressure â rise along with readings on bathroom scales.Yes, there are medications to treat both conditions.
But why resort to pills, including drugs with unwanted side effects, to online kamagra prescription modify risks that are within the personal control of most people?. And as shown in the study, even levels of blood pressure that are generally considered ânormalâ may indeed be high enough to foster the development of atherosclerotic heart disease by more than fourfold above the risk faced by people with systolic blood pressures that are physiologically ideal.Heart experts have long known that people in traditional nonindustrial societies typically maintain online kamagra prescription systolic blood pressures in the low 90s throughout life. Unlike typical Americans, their blood pressure does not rise with age.
Rather, it seems, the increase in blood pressure most common among Americans as online kamagra prescription they age into mid- and late adulthood is an artifact of our sedentary lifestyles and diets too rich in calories and high in sodium, all of which result in stiff, narrowed arteries that result in high blood pressure.The study, directed by Dr. Seamus P online kamagra prescription. Whelton, cardiologist and epidemiologist at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease in Baltimore, followed a cohort of 1,457 middle-aged men and women initially free of atherosclerotic vascular disease and known risk factors for 14.5 years.
As the participants aged, their risk factors for heart disease increased, along with calcium deposits in their coronary arteries and cardiovascular events like heart attacks and strokes.The research team focused on increases in systolic blood pressure with online kamagra prescription age, adjusting the data for changes in other heart risks. They found that for every 10 mm increase in systolic blood pressure, the risk of online kamagra prescription calcium deposits and cardiovascular events rose accordingly. Compared with people with systolic pressures of 90 to 99 mm, those with pressures of 120 to 129 mm were 4.58 times more likely to have experienced a cardiovascular event.Still, Dr.
Whelton said in an interview that it online kamagra prescription would be wrong to focus preventive strategies on blood pressure alone. People with online kamagra prescription high blood pressure, he said, âare also more likely to have higher cholesterol and blood glucose levels. The ideal strategy would focus on all risk factors â blood cholesterol, blood sugar and blood pressure.
Maintaining a healthful diet, exercising, not smoking and consuming alcohol only in moderation would improve all the risk factors for cardiovascular disease.âLevels of what doctors consider a healthy systolic online kamagra prescription blood pressure have been falling for about half a century. In August 1950, a report in JAMA suggested that labeling systolic blood pressures of 140, 150 or 160 mm as abnormally high is âarbitrary, particularly when age is concerned.â The authors suggested that raising acceptable blood pressure levels for people over 40 âwould result in a decrease in the reported incidence of hypertension and thus allay some of the widespread and unnecessary fear regarding high blood pressure.âThe latest blood pressure advisory, issued in 2017 by the American Heart Association and American College of Cardiology, considers a systolic blood pressure of 120 mm the upper limit of normal, and defines 130 mm and above as high blood pressure that warrants treatment with lifestyle measures or medication.In an editorial accompanying the new study, Dr. Daniel W online kamagra prescription.
Jones, hypertension specialist at the University of Mississippi Medical Center who helped formulate the current blood pressure guidelines, wrote, âthe risk imposed online kamagra prescription by a blood pressure level below the currently defined hypertensive level is continuous beginning with a systolic blood pressure as low as 90 mm mercury.âDr. Jones said in an interview, âNormal blood pressure can be in the 90s, which is what it is in young healthy women, before the vascular system is damaged by elevated blood pressure over the years. Prevention should start with children, with a healthy diet low in salt and regular exercise, and adults should avoid gaining weight with age, which I realize is very difficult to do in our toxic food online kamagra prescription society.âIn praising me for maintaining a systolic blood pressure of 100 to 110 throughout my adult life, he said, âItâs rare for Americans to reach your age of 79 and not have hypertension.âWhen I asked why doctors donât put more emphasis on maintaining youthful levels of blood pressure, Dr.
Jones said that in the 1960s medical schools taught that blood pressure should rise with age to assure an adequate blood supply to the brain.âOnly in recent decades has it been accepted that itâs actually better for the brain, kidneys and heart to keep blood pressure down as people age,â he said.People who have never tried intense interval training might be surprised to find that the workouts can be more appealing than they anticipate, according to an interesting new study of peopleâs emotional reactions online kamagra prescription to different types of workouts.The study, which involved inactive adults sampling intervals and other types of exercise, often for the first time, found that some â although not all â of them preferred the intense efforts to gentler workouts. The findings challenge common assumptions about the disagreeableness of high-intensity exercise and also suggest that the best way to decide which workout might entice you is to play the exercise field.Almost anyone with a passing interest in fitness is familiar, by now, with the concept of high-intensity interval training. Consisting of brief, online kamagra prescription repeated bursts of strenuous exercise interspersed with periods of rest, H.I.I.T.
Has become online kamagra prescription a trendy if controversial way to work out.Past studies show that even a few minutes of interval training improve fitness and health as much as hours of milder exercise. But in some cautionary psychological studies, novice exercisers report disliking such intense training, which would seem to limit the workoutsâ long-term allure.Few of these past studies have directly compared peopleâs feelings about intense and moderate exercise in head-to-head, in-depth exercise matchups, however. So, for the online kamagra prescription new study, which was published in August in Psychology of Sport &.
Exercise, researchers at the University of British Columbia, online kamagra prescription in Kelowna, recruited 30 sedentary but otherwise healthy young men and women who said that they had not tried intense interval training before. (The new study expands on preliminary findings first published in 2018.)The researchers invited the men and women to the lab and talked to them there, at some length, about what they had heard about interval training and more-traditional exercise, including whether they thought they would be able to complete such workouts and enjoy them, or not.In general, the volunteers expressed knowledge of but also trepidation about interval training. Most worried that such workouts would be beyond them, physically, and would feel awful.Then the researchers asked the volunteers online kamagra prescription to exercise.
On one visit to the lab, each completed a standard, moderate workout, riding a stationary bicycle for 45 minutes at a sustainable pace. During another visit, they all tried online kamagra prescription H.I.I.T. For the first time, online kamagra prescription pedaling strenuously for one minute, resting for a minute, and repeating the sequence 10 times.
During a third session, they were introduced to super-short intervals, consisting of three repetitions of 20-second, all-out pedaling spurts, with two minutes of rest between each interval.During and after each workout, the researchers asked the volunteers how they felt. In general, most gasped that they online kamagra prescription were not having fun during the interval sessions. But afterward, reflecting on the experience, many told the researchers that maybe those workouts had been tolerable, after all online kamagra prescription.
Surprised and pleased they had gotten through the intervals, a majority of the volunteers reported, in fact, that they now considered the longer H.I.I.T. Session to online kamagra prescription have been the most pleasant of all of the workouts.Supervised lab sessions are not a good reflection of real-life exercise, however. So, as a final step in the study, the researchers asked the volunteers to go home and work out on their own for a month, keeping exercise logs, then return to the lab to talk at length with the online kamagra prescription researchers again.This month of do-it-yourself workouts proved to be revealing.
Almost everyone remained active, with most completing frequent, moderate exercise sessions, like the 45-minute bike rides at the lab. But many also threaded some sort of interval training into their weekly workouts, although few of these sessions replicated the structured online kamagra prescription intervals from the lab. Instead, people tended to sprint up and down stairs or grunted through some quick burpees and other body weight exercises.Most interesting, during their subsequent, prolonged interviews with online kamagra prescription the researchers, the volunteers who interval trained on their own said they felt more engaged and motivated during those workouts than in the longer, continuous-intensity sessions, even when the intervals were physically draining.The upshot of the study data would seem to be that many of us might want to consider H.I.I.T., if we have not already, says Matthew Stork, a postdoctoral fellow at the University of British Columbia, who led the new study.
We might surprise ourselves by liking the workouts.But, he points out, some volunteers continued to prefer the familiar, less-intense exercise, and almost everyone completed more of those sessions than of intervals.âWhat the data really show is that there is no one-size-fits-all way to work out,â Dr. Stork says online kamagra prescription. The best exercise will be the online kamagra prescription one each of us ultimately relishes most, he says.
It may require some experimentation, though, for us to settle on our particular, preferred workouts.Of course, this study involved healthy young adults and followed them for a month. Whether people who are older or have health concerns will respond similarly to intervals and whether anyone will stick to their chosen workouts for more than online kamagra prescription four weeks remain uncertain. Also, people who have not exercised in some time should generally consult a physician before tackling a new exercise routine..
So you think your kamagra oral jelly online shop blood pressure is normal? buy kamagra online uk paypal. Think again.The latest iteration of an âidealâ blood pressure â a level of 120 millimeters of kamagra oral jelly online shop mercury for systolic pressure, the top number â that Americans are urged to achieve and maintain has been called into question by a long-term multiethnic study of otherwise healthy adults.The study, published in June in JAMA Cardiology, found that as systolic blood pressure rose above 90 mm, the risk of damage to coronary arteries rose along with it. Systolic blood pressure represents the pressure within arteries when the heart pumps (as opposed to diastolic blood pressure, the lower smaller number, when the heart rests).The new findings suggest a need to look more carefully at why, despite considerable overall improvements in risk factors for heart disease in recent decades, it remains the nationâs leading killer.Starting in the 1940s, cardiovascular researchers have unveiled evidence that Americans live in a society that all but guarantees a disproportionately high risk of developing and dying of heart disease.
Since my first weeks writing for this newspaper in the early 1960s, Iâve publicized their advice urging people to curb preventable risks to their hearts and blood vessels.Although significant progress has been made along several fronts, especially drastic cuts in cigarette smoking and lowered levels of artery-damaging cholesterol, atherosclerotic heart kamagra oral jelly online shop disease still kills far too many people in this country long before they reach their potential life span. If not for a plethora of therapeutic advances, like antihypertensive drugs, cholesterol-lowering statins and open-heart surgery to bypass clogged arteries, life expectancy would be a lot worse for many people.But the overall picture suggests weâve still got a long way to go kamagra oral jelly online shop. For example, as Americans get fatter and fatter, two major risk factors for heart disease â Type 2 diabetes and high blood pressure â rise along with readings on bathroom scales.Yes, there are medications to treat both conditions.
But why resort to pills, including drugs with unwanted kamagra oral jelly online shop side effects, to modify risks that are within the personal control of most people?. And as shown in the study, even levels of blood pressure that are generally considered ânormalâ may indeed be high enough to foster the kamagra oral jelly online shop development of atherosclerotic heart disease by more than fourfold above the risk faced by people with systolic blood pressures that are physiologically ideal.Heart experts have long known that people in traditional nonindustrial societies typically maintain systolic blood pressures in the low 90s throughout life. Unlike typical Americans, their blood pressure does not rise with age.
Rather, it seems, the kamagra oral jelly online shop increase in blood pressure most common among Americans as they age into mid- and late adulthood is an artifact of our sedentary lifestyles and diets too rich in calories and high in sodium, all of which result in stiff, narrowed arteries that result in high blood pressure.The study, directed by Dr. Seamus P kamagra oral jelly online shop. Whelton, cardiologist and epidemiologist at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease in Baltimore, followed a cohort of 1,457 middle-aged men and women initially free of atherosclerotic vascular disease and known risk factors for 14.5 years.
As the participants aged, their risk factors for heart disease increased, along with calcium deposits in their coronary arteries and cardiovascular kamagra oral jelly online shop events like heart attacks and strokes.The research team focused on increases in systolic blood pressure with age, adjusting the data for changes in other heart risks. They found that for every 10 mm increase in systolic blood kamagra oral jelly online shop pressure, the risk of calcium deposits and cardiovascular events rose accordingly. Compared with people with systolic pressures of 90 to 99 mm, those with pressures of 120 to 129 mm were 4.58 times more likely to have experienced a cardiovascular event.Still, Dr.
Whelton said in kamagra oral jelly online shop an interview that it would be wrong to focus preventive strategies on blood pressure alone. People with high blood pressure, he said, kamagra oral jelly online shop âare also more likely to have higher cholesterol and blood glucose levels. The ideal strategy would focus on all risk factors â blood cholesterol, blood sugar and blood pressure.
Maintaining a healthful diet, exercising, not smoking and consuming alcohol only in moderation would improve all the risk factors for kamagra oral jelly online shop cardiovascular disease.âLevels of what doctors consider a healthy systolic blood pressure have been falling for about half a century. In August 1950, a report in JAMA suggested that labeling systolic blood pressures of 140, 150 or 160 mm as abnormally high is âarbitrary, particularly when age is concerned.â The authors suggested that raising acceptable blood pressure levels for people over 40 âwould result in a decrease in the reported incidence of hypertension and thus allay some of the widespread and unnecessary fear regarding high blood pressure.âThe latest blood pressure advisory, issued in 2017 by the American Heart Association and American College of Cardiology, considers a systolic blood pressure of 120 mm the upper limit of normal, and defines 130 mm and above as high blood pressure that warrants treatment with lifestyle measures or medication.In an editorial accompanying the new study, Dr. Daniel W kamagra oral jelly online shop.
Jones, hypertension specialist at the University of Mississippi Medical Center who helped formulate the current blood pressure guidelines, wrote, âthe risk imposed by a blood pressure level below the currently defined hypertensive level is continuous beginning with kamagra oral jelly online shop a systolic blood pressure as low as 90 mm mercury.âDr. Jones said in an interview, âNormal blood pressure can be in the 90s, which is what it is in young healthy women, before the vascular system is damaged by elevated blood pressure over the years. Prevention should start with children, with a healthy diet low in salt and regular exercise, and adults should avoid gaining weight with age, which I realize is very difficult to do in our toxic kamagra oral jelly online shop food society.âIn praising me for maintaining a systolic blood pressure of 100 to 110 throughout my adult life, he said, âItâs rare for Americans to reach your age of 79 and not have hypertension.âWhen I asked why doctors donât put more emphasis on maintaining youthful levels of blood pressure, Dr.
Jones said that in the 1960s medical schools taught that blood pressure should rise with age to assure an adequate blood supply to the brain.âOnly in recent decades has it been accepted that itâs actually better for the brain, kidneys and heart to keep blood pressure down as people age,â he said.People who have never tried intense interval training might be surprised to find that the workouts can be more appealing than they anticipate, kamagra oral jelly online shop according to an interesting new study of peopleâs emotional reactions to different types of workouts.The study, which involved inactive adults sampling intervals and other types of exercise, often for the first time, found that some â although not all â of them preferred the intense efforts to gentler workouts. The findings challenge common assumptions about the disagreeableness of high-intensity exercise and also suggest that the best way to decide which workout might entice you is to play the exercise field.Almost anyone with a passing interest in fitness is familiar, by now, with the concept of can u buy kamagra over the counter high-intensity interval training. Consisting of brief, kamagra oral jelly online shop repeated bursts of strenuous exercise interspersed with periods of rest, H.I.I.T.
Has become a trendy if controversial way to work out.Past studies show that even a few kamagra oral jelly online shop minutes of interval training improve fitness and health as much as hours of milder exercise. But in some cautionary psychological studies, novice exercisers report disliking such intense training, which would seem to limit the workoutsâ long-term allure.Few of these past studies have directly compared peopleâs feelings about intense and moderate exercise in head-to-head, in-depth exercise matchups, however. So, for the new study, kamagra oral jelly online shop which was published in August in Psychology of Sport &.
Exercise, researchers at the University of British Columbia, in Kelowna, recruited 30 sedentary but otherwise healthy young men kamagra oral jelly online shop and women who said that they had not tried intense interval training before. (The new study expands on preliminary findings first published in 2018.)The researchers invited the men and women to the lab and talked to them there, at some length, about what they had heard about interval training and more-traditional exercise, including whether they thought they would be able to complete such workouts and enjoy them, or not.In general, the volunteers expressed knowledge of but also trepidation about interval training. Most worried that such workouts would be beyond them, physically, and would feel awful.Then the researchers asked kamagra oral jelly online shop the volunteers to exercise.
On one visit to the lab, each completed a standard, moderate workout, riding a stationary bicycle for 45 minutes at a sustainable pace. During another kamagra oral jelly online shop visit, they all tried H.I.I.T. For the first time, pedaling strenuously for one minute, resting for a minute, and repeating the kamagra oral jelly online shop sequence 10 times.
During a third session, they were introduced to super-short intervals, consisting of three repetitions of 20-second, all-out pedaling spurts, with two minutes of rest between each interval.During and after each workout, the researchers asked the volunteers how they felt. In general, most gasped that they were not having fun kamagra oral jelly online shop during the interval sessions. But afterward, reflecting on the experience, many told the researchers that kamagra oral jelly online shop maybe those workouts had been tolerable, after all.
Surprised and pleased they had gotten through the intervals, a majority of the volunteers reported, in fact, that they now considered the longer H.I.I.T. Session to kamagra oral jelly online shop have been the most pleasant of all of the workouts.Supervised lab sessions are not a good reflection of real-life exercise, however. So, as a final step in the study, the researchers asked kamagra oral jelly online shop the volunteers to go home and work out on their own for a month, keeping exercise logs, then return to the lab to talk at length with the researchers again.This month of do-it-yourself workouts proved to be revealing.
Almost everyone remained active, with most completing frequent, moderate exercise sessions, like the 45-minute bike rides at the lab. But many also threaded some sort of interval training into their weekly workouts, although few of these sessions kamagra oral jelly online shop replicated the structured intervals from the lab. Instead, people tended to sprint up and down stairs or grunted through some quick burpees and other body weight exercises.Most interesting, during their subsequent, prolonged interviews with the researchers, the volunteers who interval trained on their own said they felt more engaged and motivated during those workouts than in the longer, continuous-intensity sessions, even when the intervals were physically draining.The upshot of the study data would seem to be that many of us might want to consider H.I.I.T., if kamagra oral jelly online shop we have not already, says Matthew Stork, a postdoctoral fellow at the University of British Columbia, who led the new study.
We might surprise ourselves by liking the workouts.But, he points out, some volunteers continued to prefer the familiar, less-intense exercise, and almost everyone completed more of those sessions than of intervals.âWhat the data really show is that there is no one-size-fits-all way to work out,â Dr. Stork says kamagra oral jelly online shop. The best exercise will kamagra oral jelly online shop be the one each of us ultimately relishes most, he says.
It may require some experimentation, though, for us to settle on our particular, preferred workouts.Of course, this study involved healthy young adults and followed them for a month. Whether people who are older or have health concerns will respond similarly to intervals and whether anyone will stick to their chosen workouts for kamagra oral jelly online shop more than four weeks remain uncertain. Also, people who have not exercised in some time should generally consult a physician before tackling a new exercise routine..
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The former issue can be addressed by adopting as eligible admissions see this site the 10 conditions CMS has deemed kamagra erection preventable hospitalizations in oncology. Safety in patient selection can be ensured by starting conservatively and having oncologists or oncologic nurse practitioners filling the role of admitting provider.ConclusionA payment model for oncology HaH is not only possible but necessary as the limitations of the OCM become evident. Spurred by the kamagra, both providers and CMS have shown willingness to engage in innovative models, as evidenced by the waivers for HaH.
Ideally, this program will allow hospitals to gain experience providing acute care at home and generate more evidence in support of kamagra erection the model. However, if the waivers are not replaced by a sustainable economic incentive once they expire, hospitals are unlikely to enter into this arena, and any momentum built during the kamagra toward developing HaH may stall. Implementing a payment structure for oncology HaH must be prioritized to accelerate the adoption of patient-centered, high-value cancer care.Authorsâ NoteThis work was supported by the Penn Center for Cancer Care Innovation at the University of Pennsylvania.
Dr. Bekelman reported receiving grants from Pfizer, UnitedHealth Group, Blue Cross Blue Shield of North Carolina, and Embedded Healthcare and personal fees from CVS Health and UnitedHealthcare and honorarium from Optum and the National Comprehensive Cancer Network, outside the submitted work.Start Preamble Centers for Medicare &. Medicaid Services, Health and Human Services (HHS).
Notice. The Centers for Medicare &. Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public.
Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Comments must be received by January 19, 2021.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways. 1.
Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for âComment or Submissionâ or âMore Search Optionsâ to find the information collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following address.
CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number __, Room C4-26-05, Start Printed Page 737217500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following.
1. Access CMS' website address at https://www.cms.gov/âRegulations-and-Guidance/âLegislation/âPaperworkReductionActof1995/âPRA-Listing.html. 2.
Call the Reports Clearance Office at (410) 786-1326. Start Further Info William N. Parham at (410) 786-4669.
End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10764âEvaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions CMS-10454âDisclosure of State Rating Requirements CMS-R-71âQuality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations CMS-370/CMS-377âASC Forms for Medicare Program Certification CMS-1572âHome Health Agency Survey and Deficiencies Report CMS-10332âDisclosure Requirement for the In-Office Ancillary Services Exception Under the PRA (44 U.S.C.
3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term âcollection of informationâ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1.
Type of Information Collection Request. New collection (Request for a new OMB control number). Title of Information Collection.
Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions. Use. CMS recognizes that the success of accurately identifying risk-adjustment payments and payment errors is dependent upon the data submitted by Medicare Advantage Organizations (MAOs), and is strongly committed to providing appropriate education and technical outreach to MAOs and third-party administrators (TPAs).
In addition, CMS is strongly committed to providing appropriate education and technical outreach to States, issuers, self-insured group health plans and TPAs participating in the Marketplace and/or market stabilization programs mandated by the Affordable Care Act (ACA). CMS will strengthen outreach and engagement with MAOs and stakeholders in the Marketplace through satisfaction surveys following contract-level (CON) RADV audit and Health Insurance Exchange training events. The survey results will help to determine stakeholders' level of satisfaction with trainings, identify any issues with training and technical assistance delivery, clarify stakeholders' needs and preferences, and define best practices for training and technical assistance.
Form Number. CMS-10764 (OMB control number. 0938-NEW).
Private Sector. Number of Respondents. 4,270.
Total Annual Responses. 4,270. Total Annual Hours.
1,068. (For questions regarding this collection contact Melissa Barkai at 410-786-4305.) 2. Type of Information Collection Request.
Extension of a currently approved collection. Title of information Collection. Disclosure of State Rating Requirements.
Use. The final rule âPatient Protection and Affordable Care Act. Health Insurance Market Rules.
Rate Reviewâ implements sections 2701, 2702, and 2703 of the Public Health Service Act (PHS Act), as added and amended by the Affordable Care Act, and sections 1302(e) and 1312(c) of the Affordable Care Act. The rule directs that states submit to CMS certain information about state rating and risk pooling requirements for their individual, small group, and large group markets, as applicable. Specifically, states will inform CMS of age rating ratios that are narrower than 3:1 for adults.
Tobacco use rating ratios that are narrower than 1.5:1. A state-established uniform age curve. Geographic rating areas.
Whether premiums in the small and large group market are required to be based on average enrollee amounts (also known as composite premiums). And, in states that do not permit any rating variation based on age or tobacco use, uniform family tier structures and corresponding multipliers. In addition, states that elect to merge their individual and small group market risk pools into a combined pool will notify CMS of such election.
This information will allow CMS to determine whether state-specific rules apply or Federal default rules apply. It will also support the accuracy of the federal risk adjustment methodology. Form Number.
CMS-10454 (OMB control number 0938-1258). Frequency. Occasionally.
Affected Public. State, Local, or Tribal Governments. Number of Respondents.
Total Annual Hours. 17. (For policy questions regarding this collection contact Russell Tipps at 301-869-3502.) 3.
Type of Information Collection Request. Extension of a currently approved collection. Title of Information Collection.
Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations. Use. The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities.
The term PRO has been renamed Quality Improvement Organization (QIO). This information collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers.
Form Number. CMS-R-71 (OMB control number. 0938-0445).
Business or other for-profit and Not-for-profit institutions. Number of Respondents. 6,939.
Total Annual Responses. 972,478. Total Annual Hours.
1,034,655. (For policy questions regarding this collection contact Kimberly Harris at 401-837-1118.) 4. Type of Information Collection Request.
Extension of a currently approved collection. Titles of Information Collection. ASC Forms for Medicare Program Certification.
Use. The form CMS-370 titled âHealth Insurance Benefits Agreementâ is used for the purpose of establishing an ASC's eligibility for payment under Title XVIII of the Social Security Act (the âActâ). This agreement, upon acceptance by the Secretary of Health &.
Human Services, shall be binding on the ASC and the Secretary. The agreement may be Start Printed Page 73722terminated by either party in accordance with regulations. In the event of termination of this agreement, payment will not be available for the ASC's services furnished to Medicare beneficiaries on or after the effective date of termination.
The CMS-377 form is used by ASCs to initiate both the initial and renewal survey by the State Survey Agency, which provides the certification required for an ASC to participate in the Medicare program. An ASC must complete the CMS-377 form and send it to the appropriate State Survey Agency prior to their scheduled accreditation renewal date. The CMS-377 form provides the State Survey Agency with information about the ASC facility's characteristics, such as, determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC.
Form Numbers. CMS-370 and CMS-377 (OMB control number. 0938-0266).
Private SectorâBusiness or other for-profit and Not-for-profit institutions. Number of Respondents. 1,567.
Total Annual Responses. 1,567. Total Annual Hours.
1,012. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 5. Type of Information Collection Request.
Revision of a currently approved collection. Title of Information Collection. Home Health Agency Survey and Deficiencies Report.
Use. In order to participate in the Medicare Program as a Home Health Agency (HHA) provider, the HHA must meet federal standards. This form is used to record information and patients' health and provider compliance with requirements and to report the information to the federal government.
Form Number. CMS-1572 (OMB control number. 0938-0355).
State, Local or Tribal Government. Number of Respondents. 3,833.
Total Annual Responses. 3,833. Total Annual Hours.
1,917. (For policy questions regarding this collection contact Tara Lemons at 410-786-3030.) 6.
Providers would be responsible for containing costs under this rate, including reducing or kamagra oral jelly online shop eliminating readmissions for related symptoms in the postacute click to investigate period.Such a model, applied to the oncology population, could drive significant cost savings by decreasing readmissions and increasing care coordination. This model is also fairly straightforward, as the patient population is well-defined. Patients are enrolled when they present needing acute care.
However, such a model may not fully maximize cost savings as it does not preempt initial ED presentations, and for patients with recurrent symptoms, an episodic approach may not be optimal.In Medicare, CMS could consider incorporating HaH as a kamagra oral jelly online shop component of the forthcoming Oncology Care First (OCF) model, which will replace the OCM. As proposed, the OCF bundles payment for evaluation and management visits with drug administration fees for each Medicare beneficiary undergoing active cancer treatment, over a six-month period. This model represents a departure from the OCM, which pays for these services under the typical fee-for-service model.
While the OCF has not been finalized, it may also be a step toward a capitated model in cancer care, with CMS kamagra oral jelly online shop signaling that more components (radiology, labs) could be added in the future. HaH could be incorporated modularly into the OCF bundle, with an additional monthly population payment covering the remote care coordination for HaH program administration. The core home services, including home nursing, could be reimbursed on a fee-for-service or bundled basis as discrete episodes.
Allowing for acute care at home under the OCF would help practices contain costs and succeed in the shared-savings component of the model.Finally, in a more progressive approach, payers could allocate a global payment for all acute care, per kamagra oral jelly online shop beneficiary undergoing cancer treatment, over a given period of time. In this fully capitated model, providers would bear a great amount of risk but would have flexibility in determining which site of care is most appropriate. Patients who have recurring symptoms could easily be re-enrolled in the program or de-escalated to remote monitoring as necessary, without triggering a new episode.
Moreover, such a model may achieve greater cost savings by preemptively enrolling patients kamagra oral jelly online shop before they require acute care. However, many providers may not have an appetite for a fully capitated modelâonly large centers with sufficient patient volume would likely be able to bear this risk.Challenges And AlternativesWhile HaH has the potential to become a new paradigm in cancer care, it is a complex model that also brings challenges. It may be less feasible for smaller practices, as it requires coordinating with home health nursing, home infusion services, and durable medical equipment providers.
However, if a payment model offers kamagra oral jelly online shop sufficient reimbursement and the opportunity for shared savings, this scalability challenge could be overcome. Testing the applicability of the model to rural settings is also key to ensure timely urgent care response across a wide geographic area. Huntsman at Home is addressing this question by planning an expansion to three rural counties starting later this year.
Lastly, patient selection presents a challenge, as HaH patients should be ill enough to require hospitalization but not so clinically kamagra oral jelly online shop unstable that they cannot be managed at home. The former issue can be addressed by adopting as eligible admissions the 10 conditions CMS has deemed preventable hospitalizations in oncology. Safety in patient selection can be ensured by starting conservatively and having oncologists or oncologic nurse practitioners filling the role of admitting provider.ConclusionA payment model for oncology HaH is not only possible but necessary as the limitations of the OCM become evident.
Spurred by the kamagra, kamagra oral jelly online shop both providers and CMS have shown willingness to engage in innovative models, as evidenced by the waivers for HaH. Ideally, this program will allow hospitals to gain experience providing acute care at home and generate more evidence in support of the model. However, if the waivers are not replaced by a sustainable economic incentive once they expire, hospitals are unlikely to enter into this arena, and any momentum built during the kamagra toward developing HaH may stall.
Implementing a payment structure for oncology HaH kamagra oral jelly online shop must be prioritized to accelerate the adoption of patient-centered, high-value cancer care.Authorsâ NoteThis work was supported by the Penn Center for Cancer Care Innovation at the University of Pennsylvania. Dr. Bekelman reported receiving grants from Pfizer, UnitedHealth Group, Blue Cross Blue Shield of North Carolina, and Embedded Healthcare and personal fees from CVS Health and UnitedHealthcare and honorarium from Optum and the National Comprehensive Cancer Network, outside the submitted work.Start Preamble Centers for Medicare &.
Medicaid Services, Health and Human kamagra oral jelly online shop Services (HHS). Notice. The Centers for Medicare &.
Medicaid Services kamagra oral jelly online shop (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Comments must kamagra oral jelly online shop be received by January 19, 2021. When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways.
1. Electronically. You may send your comments electronically to http://www.regulations.gov.
Follow the instructions for âComment or Submissionâ or âMore Search Optionsâ to find the information collection document(s) that are accepting comments. 2. By regular mail.
You may mail written comments to the following address. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention. Document Identifier/OMB Control Number __, Room C4-26-05, Start Printed Page 737217500 Security Boulevard, Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following. 1. Access CMS' website address at https://www.cms.gov/âRegulations-and-Guidance/âLegislation/âPaperworkReductionActof1995/âPRA-Listing.html.
2. Call the Reports Clearance Office at (410) 786-1326. Start Further Info William N.
Parham at (410) 786-4669. End Further Info End Preamble Start Supplemental Information Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).
CMS-10764âEvaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions CMS-10454âDisclosure of State Rating Requirements CMS-R-71âQuality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations CMS-370/CMS-377âASC Forms for Medicare Program Certification CMS-1572âHome Health Agency Survey and Deficiencies Report CMS-10332âDisclosure Requirement for the In-Office Ancillary Services Exception Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term âcollection of informationâ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.
Information Collection 1. Type of Information Collection Request. New collection (Request for a new OMB control number).
Title of Information Collection. Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions. Use.
CMS recognizes that the success of accurately identifying risk-adjustment payments and payment errors is dependent upon the data submitted by Medicare Advantage Organizations (MAOs), and is strongly committed to providing appropriate education and technical outreach to MAOs and third-party administrators (TPAs). In addition, CMS is strongly committed to providing appropriate education and technical outreach to States, issuers, self-insured group health plans and TPAs participating in the Marketplace and/or market stabilization programs mandated by the Affordable Care Act (ACA). CMS will strengthen outreach and engagement with MAOs and stakeholders in the Marketplace through satisfaction surveys following contract-level (CON) RADV audit and Health Insurance Exchange training events.
The survey results will help to determine stakeholders' level of satisfaction with trainings, identify any issues with training and technical assistance delivery, clarify stakeholders' needs and preferences, and define best practices for training and technical assistance. Form Number. CMS-10764 (OMB control number.
Affected Public. Private Sector. Number of Respondents.
Total Annual Hours. 1,068. (For questions regarding this collection contact Melissa Barkai at 410-786-4305.) 2.
Type of Information Collection Request. Extension of a currently approved collection. Title of information Collection.
Disclosure of State Rating Requirements. Use. The final rule âPatient Protection and Affordable Care Act.
Health Insurance Market Rules. Rate Reviewâ implements sections 2701, 2702, and 2703 of the Public Health Service Act (PHS Act), as added and amended by the Affordable Care Act, and sections 1302(e) and 1312(c) of the Affordable Care Act. The rule directs that states submit to CMS certain information about state rating and risk pooling requirements for their individual, small group, and large group markets, as applicable.
Specifically, states will inform CMS of age rating ratios that are narrower than 3:1 for adults. Tobacco use rating ratios that are narrower than 1.5:1. A state-established uniform age curve.
Geographic rating areas. Whether premiums in the small and large group market are required to be based on average enrollee amounts (also known as composite premiums). And, in states that do not permit any rating variation based on age or tobacco use, uniform family tier structures and corresponding multipliers.
In addition, states that elect to merge their individual and small group market risk pools into a combined pool will notify CMS of such election. This information will allow CMS to determine whether state-specific rules apply or Federal default rules apply. It will also support the accuracy of the federal risk adjustment methodology.
Form Number. CMS-10454 (OMB control number 0938-1258). Frequency.
Occasionally. Affected Public. State, Local, or Tribal Governments.
Number of Respondents. 3. Total Annual Responses.
(For policy questions regarding this collection contact Russell Tipps at 301-869-3502.) 3. Type of Information Collection Request. Extension of a currently approved collection.
Title of Information Collection. Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations. Use.
The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities. The term PRO has been renamed Quality Improvement Organization (QIO). This information collection describes the review functions to be performed by the QIO.
It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers. Form Number. CMS-R-71 (OMB control number.
Affected Public. Business or other for-profit and Not-for-profit institutions. Number of Respondents.
Total Annual Hours. 1,034,655. (For policy questions regarding this collection contact Kimberly Harris at 401-837-1118.) 4.
Type of Information Collection Request. Extension of a currently approved collection. Titles of Information Collection.
ASC Forms for Medicare Program Certification. Use. The form CMS-370 titled âHealth Insurance Benefits Agreementâ is used for the purpose of establishing an ASC's eligibility for payment under Title XVIII of the Social Security Act (the âActâ).
This agreement, upon acceptance by the Secretary of Health &. Human Services, shall be binding on the ASC and the Secretary. The agreement may be Start Printed Page 73722terminated by either party in accordance with regulations.
In the event of termination of this agreement, payment will not be available for the ASC's services furnished to Medicare beneficiaries on or after the effective date of termination. The CMS-377 form is used by ASCs to initiate both the initial and renewal survey by the State Survey Agency, which provides the certification required for an ASC to participate in the Medicare program. An ASC must complete the CMS-377 form and send it to the appropriate State Survey Agency prior to their scheduled accreditation renewal date.
The CMS-377 form provides the State Survey Agency with information about the ASC facility's characteristics, such as, determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC. Form Numbers. CMS-370 and CMS-377 (OMB control number.
Affected Public. Private SectorâBusiness or other for-profit and Not-for-profit institutions. Number of Respondents.
Total Annual Hours. 1,012. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 5.
Type of Information Collection Request. Revision of a currently approved collection.
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