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Daniel James George, MD

Professor of Medicine
Professor in Surgery
Member of the Duke Cancer Institute

https://medicine.duke.edu/faculty/daniel-james-george-md

The small sample sizes and the lack of head to head studies precludes any firm conclusions impotence juice recipe buy generic cialis with dapoxetine 20/60 mg line, but this warrants further study erectile dysfunction doctor in pune buy cialis with dapoxetine 40/60 mg lowest price. The risk is likely to be quite low erectile dysfunction medications discount cialis with dapoxetine online, but is an important long-term concern for further study experimental erectile dysfunction drugs purchase cialis with dapoxetine discount. Given the possibility of selection bias in these trials erectile dysfunction treatment new york purchase cialis with dapoxetine 40/60 mg online, it is impossible to compare outcomes from these trials to those of other trials without considerable uncertainty erectile dysfunction acupuncture discount cialis with dapoxetine 20/60 mg with amex. In the intermediate term, there is insufficient data to estimate how many patients will continue to have clinically important hypogammaglobulinemia from B-cell aplasia. Finally, there may be unanticipated harms that arise as larger numbers of patients are followed for several years. Improvements in the manufacturing process with experience may lead to fewer manufacturing failures and shorter times from leukapheresis to infusion. All of the uncertainties highlighted above make our comparative efficacy analyses versus standard therapy controversial. There are no head to head trials of axicabtagene ciloleucel and tisagenlecleucel for patients with relapsed/refractory B-cell lymphomas. Mortality after five years was based on the general population ageand gender-adjusted all-cause risks of mortality with modifications for excess disease-related mortality experienced by long-term survivors of each B-cell malignancy. Five years was chosen as a transition time between the partitioned survival model and the Markov model because those who were alive and responding to treatment at that time were assumed to be long-term survivors and considered to be effectively cured, though this assumption was also tested in a scenario analysis. An impact inventory detailing what cost components were included in the analysis is provided in Appendix Table D1. A detailed description of the model and survival curve extrapolation can be found in Appendix D. Probabilities, costs, and other inputs differed between treatments to reflect varying effectiveness across interventions. Model Parameters the base-case analysis took a third-party payer perspective and focused on direct medical care costs only. A modified societal perspective including productivity losses to the patient and caregiver was evaluated in a scenario analysis. Outcomes were estimated over a lifetime time horizon using a monthly cycle to capture the potential lifetime impacts of short-term and ongoing morbidity and mortality. For tisagenlecleucel, the payment strategy used in the base-case analysis was payment only for responders at one month, consistent with public statements the manufacturer has made. B-cell Lymphoma Cohort Characteristics B-cell Lymphoma Value Primary Source Median Age 58. Comparators Comparator selection was informed by stakeholders and clinical experts and was based on the next best available therapy as well as the availability of evidence from patients with similar characteristics. After year five, survivors experienced a mortality At year five, those who were alive were assumed to be risk profile consistent with that of a long-term effectively cured. All patients who transitioned to the alive and not the intervention and comparator therapies are responding to treatment health state received considered end-of-line treatments. Model Inputs Model inputs were estimated from the clinical review as well as from published literature and information provided by stakeholders. Clinical Inputs Response to Treatment Treatment response rates were obtained from published literature and information provided from manufacturers. Appendix Table D4 details the evidence used to calculate transition probabilities. Appendix Table D5 includes the survival curve fit, shape, and scale parameters for each curve used in the model and Appendix Table D6 includes the proportion of the cohort in each health state (alive and responding to treatment, alive and not responding to treatment, and dead) at one year, two years, and five years after assessment of treatment response. Utilities To adjust for quality of life, utilities were applied for each model health state. Health state utilities were derived from publicly available literature and applied to the disease states. The utility for a longterm survivor was assumed to equal the utility of the alive and responding to treatment health state. Appendix Table D9 details the disutilities and duration of reduction in quality of life applied for each treatment. Our approach for hospital mark-up that incorporated this feedback is provided below. We assumed each cohort represented a 50:50 split of publicly and privately insured patients. Both tisagenlecleucel and clofarabine were assumed to be administered as inpatient treatments. For the adult B-cell lymphoma comparator chemotherapy arm, the hospital mark-up was price+48%. Health Care Utilization-Related Costs Costs associated with other healthcare utilization that resulted from administration and monitoring were included in the model. Appendix Table D10 details the healthcare utilization unit costs used in the model. Unit costs for healthcare utilization were the same across different treatments within a cohort. Appendix Table D11 includes the schedule of healthcare utilization modeled for a lifetime time horizon. Hospitalizations might in the future be paid through a bundled payment mechanism. The average monthly healthcare costs by age band were assigned to patients for the remainder of their lifetime if they were alive and responding to treatment after five years. Sensitivity Analyses One-way sensitivity analyses were conducted to identify the key drivers of model outcomes, using available measures of parameter uncertainty. Probabilistic sensitivity analyses were performed by jointly varying model parameters with uncertainty able to be quantified over 5,000 simulations, then calculating 95% credible range estimates for each model outcome based on the results. Sensitivity around survival curve parameters was not modeled; however, uncertainty around long-term survival was explored through variation in the discount rate used in the sensitivity analysis. Thus, the resulting one-way and probabilistic sensitivity analysis findings were not fully able to quantify the uncertainty within this appraisal. Scenario analyses described below further attempt to capture the uncertainty in long-term survival evidence. Second, an approach of no antileukemic/antilymphomic therapy was modeled as a comparator instead of an active chemotherapy regimen. We assumed the hospital mark-up was not included as part of the outcomes-based contract between the manufacturer and the payer, and thus that payment from the payer to the hospital for the mark-up occurred regardless of response status. This scenario analysis provides decision makers with the ability to make judgements around the duration and forecasting of the cure-related benefits observed in the single-arm trials. Sixth, to account for uncertainty in survival following the trial time horizon, a scenario analysis was conducted under different parametric assumptions. In the base-case analysis, a knot was added when the slope of the Kaplan-Meier curve was zero. In this scenario analysis, the knot was removed which made the parametric curve extend out through five years. Seventh, because the costs and outcomes in the base-case results are weighted and should be interpreted as the average costs and outcomes for a patient initiating treatment, we present different total cost estimates in this scenario analysis for the certain pathways a patient could follow. The price needed to reach these thresholds included both the manufacturer price of the product and the hospital mark-up. Base-case payment for axicabtagene ciloleucel assumes payment at infusion *For inpatient administered therapies, costs associated with adverse events only included costs associated with adverse events that were expected to increase the length of stay (cytokine release syndrome) or extend beyond discharge (B cell aplasia). Across broad ranges in model inputs with quantifiable uncertainty, the incremental cost-effectiveness ratio remained within acceptable cost-effectiveness thresholds. In this case, when model inputs were varied within plausible ranges one by one, cost-effectiveness estimates frequently did extend above commonly cited costeffectiveness thresholds, highlighting the uncertainty in some of the parameter values. The incremental cost-effectiveness ratio assuming no hospital mark-up for axicabtagene ciloleucel was approximately $109,000. A scatterplot of the 5,000 iterations for each comparison can be found in Appendix Figures D1 and D2. To account for lost productivity during inpatient administered treatments, we assumed the amount of time missed from work was equal to the total number of days in which care was provided. For chemotherapy in B-cell lymphoma, the days missed from work equated to the number of days an intravenous administration was received. For B-cell Lymphoma, lost productivity was the result of the patient having to miss work to receive the treatment. For clofarabine, because administration does not have to be at a specialized site, transportation costs were not included in this restricted societal perspective. Discounted societal costs for the tisagenlecleucel arm were nearly $12,000, whereas discounted societal costs for clofarabine were less than $5,000. Discounted societal costs for the axicabtagene ciloleucel arm were approximately $7,500, whereas discounted societal costs for chemotherapy were less than $2,500. Note that a time horizon, such as 24 years, does not assume that everyone in the model lives for 24 years (in fact, at a median age of 58 for B-cell lymphoma, few patients will live this long), but for those within the treated cohort that do live this long, their costs and outcomes are tracked and contribute proportionally toward the average findings that are aggregated across time. Figures showing the cost-effectiveness over all time horizons (from one year to lifetime) are provided in Appendix Figures D3 through D6. In B-cell lymphoma, the incremental costeffectiveness ratio for axicabtagene ciloleucel versus chemotherapy increased to $140,443. We acknowledge that, in the real world, these late-relapse patients may relapse at time points after five years and that this scenario could underestimate life years gained by assuming all relapses and deaths occur at five years. It is also conceivable that rates of late relapse may increase over historical estimates given a potentially larger pool of patients responding to treatment of refractory disease. Alternative Survival Assumption In the base-case analysis, we introduced a knot in the survival curve fit once the curve flattened (slope equaled zero). For certain subsets of the cohort, total costs and outcomes may be lower and, for others, total costs and outcomes may be higher than the base-case results. First, we presented preliminary methods and results to manufacturers, patient groups, and clinical experts, and based on feedback from these groups, refined data inputs used in the model as needed. Second, we varied model input parameters to evaluate face validity of changes in results. Finally, we compared results to other cost-effectiveness models in this therapy area. Their analysis explored different levels of assumed evidence availability (using imputed data sets), alternative evaluation frameworks. These differences in estimates between the two models are likely due to the use of two different approaches to curve extrapolation. The results were robust through one-way and probabilistic sensitivity analyses given the parameter uncertainty quantified. The payment strategy used in the base case for tisagenlecleucel assumed payment for responders at one month; however, even with different payment strategies, including payment at infusion, costeffectiveness estimates for tisagenlecleucel remained below commonly cited cost-effectiveness thresholds. The base-case findings used a lifetime time horizon, while cost-effectiveness estimates for tisagenlecleucel at other time horizons were presented in a scenario analysis. This translated into cost-effectiveness estimates that met commonly cited cost-effectiveness thresholds in the adult relapsed/refractory B-cell lymphoma cohort under current assumptions used in this analysis. The payment strategy used in the base-case for axicabtagene ciloleucel assumed payment at infusion. The base-case findings took a lifetime time horizon, and cost-effectiveness estimates for axicabtagene ciloleucel at other time horizons were presented in a scenario analysis. This analysis was limited primarily by the lack of comparative evidence available for these therapies. Evidence was abstracted from singlearm trials, which resulted in challenges in selecting the most appropriate comparator therapies. We believe we chose the most appropriate comparators based on cohort similarities between trials; however, a different comparator could produce different results. Thus, the uncertainty produced from this analysis likely underestimates the total uncertainty. Because of this, evidence on long-term effectiveness is still unknown, which resulted in assumptions being made related to trial survival curve extrapolation and the time point at which long-term survivors would be considered effectively cured. Uncertainty in inputs and long-term survival were partially quantified in sensitivity and scenario analyses that evaluated different curative assumptions and model time horizons. Also, one uniform source for cost was not available, which could lead to variation between sources in cost calculations. These uncertainties were partially addressed through adding wide variation around cost inputs in sensitivity analyses and through the presentation of cost-effectiveness estimates for three different payment strategies. Survival curve fitting relies on assumptions that may differ substantially between different parametric models. However, our model structure in combination with no comparative clinical evidence. Last, we acknowledge the importance of including a societal perspective, but we were only able to model a restricted societal perspective based on evidence available at this time. Our restricted societal perspective focused on productivity losses and patient-level costs. The societal perspective results should thus be viewed as a limited societal perspective. With the evidence available at this time, these therapies seem to be priced in alignment with clinical benefits over a lifetime time horizon.

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Optimal approach for prostate cancer detection as initial biopsy: prospective randomized study comparing transperineal versus transrectal systematic 12-core biopsy jacksonville impotence treatment center buy cialis with dapoxetine 20/60mg line. The Comparison between Transperineal and Transrectal Ultrasound-Guided Prostate Needle Biopsy erectile dysfunction see urologist cialis with dapoxetine 20/60mg for sale. Antibiotic prophylaxis for transrectal needle biopsy of the prostate: A randomized controlled study erectile dysfunction treatment methods discount 40/60 mg cialis with dapoxetine visa. Antibiotic prophylaxis for transrectal biopsy of the prostate: A prospective randomized study of the prophylactic use of single dose oral fluoroquinolone versus trimethoprimsulfamethoxazole protein shakes erectile dysfunction cheap 20/60 mg cialis with dapoxetine. Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy erectile dysfunction brands buy cialis with dapoxetine 40/60mg fast delivery. Transrectal prostatic biopsy: the incidence of fever and sepsis after treatment with antibiotics impotence in young males order discount cialis with dapoxetine online. The problem of infection after prostatic biopsy: the case for the transperineal approach. A double-blind study of trimethoprim-sulfamethoxazole prophylaxis in patients having transrectal needle biopsy of the prostate. Efficacy and safety of fosfomycin-trometamol in the prophylaxis for transrectal prostate biopsy. Antimicrobial prophylaxis for transrectal ultrasound guided biopsy of prostate: A comparative study between single dose of Gentamicin vs. Antibiotic prophylaxis for transrectal prostate biopsy: A prospective randomized study of tosufloxacin versus levofloxacin. Antimicrobial prophylaxis for transrectal prostatic biopsy: A prospective study of ciprofloxacin vs piperacillin/tazobactam. Prospective assessment of the efficacy of single dose versus traditional 3-day antimicrobial prophylaxis in 12-core transrectal prostate biopsy. Reducing Infectious Complications Following Transrectal Ultrasound-guided Prostate Biopsy: A Systematic Review. Only the alphaand betacoronavirus genera include strains pathogenic to humans (Paules, C. The first human coronavirus was isolated from the nasal cavity and propagated on human ciliated embryonic trachea cells in vitro by Tyrrell and Bynoe in 1965. The first four are endemic locally; they have been associated mainly with mild, selflimiting disease, whereas the latter two can cause severe illness (Zumla, A. The virus, provisionally designated 2019-nCoV, was isolated and the viral genome sequenced. The S glycoprotein is a major antigen responsible for both receptor binding and cell fusion (Song, Z. Coronaviruses are capable of adapting quickly to new hosts through the processes of genetic recombination and mutation in vivo. The intrinsic error rate of RdRp is approximately 1,000,000 mutation/site/replication, resulting in continuous point mutations. Point mutations alone are not sufficient to create a new virus, however; this can only occur when the same host is simultaneously infected with two coronavirus strains, enabling recombination. Coronaviruses can also cause gastroenteritis in humans as well as a plethora of diseases in other animals (To, K. In a comprehensive epidemiology study conducted over a nine-year period in Sao Paulo, Brazil, human coronaviruses were detected in 7. An analysis of 686 adult patients presenting with acute respiratory infections in Mallorca, Spain (January 2013-February 2014) showed that 7% overall were caused by coronavirus, including 21. The virus, provisionally known as 2019-nCoV, was first detected in the urban center of Wuhan. The polymerase gene is closely related to the bovine and murine coronaviruses in group 2, but also has some characteristics of avian coronaviruses in group 3. Both appear to be distributed worldwide, and at least the former has been circulating in human populations for centuries (Perlman, S. Sequence analysis of isolates from Singapore, Canada, Hong Kong, Hanoi, Guangzhou annd Beijing revealed two distinct strains that were related to the geographic origin of the virus (Ruan, Y. However sequence studies of the entire genome did not reveal a bovine-murine origin. The presence of the virus was confirmed in the Himalayan palm civet (Paguma larvata) and was found in a raccoon dog (Nytereutes procyonoides) (Chan, P. There appear to be at least three phases by which the virus adapted to the human host on a population basis. Second, high urban population densities, especially on the Asian continent, make person-to-person contact frequent (Arita, I. Practices such as use of ventilators and nebulized bronchodilators may cause aerosols and spread of droplets containing virus. The risk of spreading the virus may also be increased by cardiopulmonary resuscitation, bronchoscopy, endotracheal intubation, airway and sputum suction (Loeb, M. Nocosomial spread was reduced through use of surgical masks, gloves and gowns (Seto, W. Other superspreading events were reported in the Hotel Metropole in Hong Kong, among passengers on Air China flight 112 from Hong Kong to Beijing, and in an acute care hospital in Toronto, Canada (Braden, C. Giant-cell infiltration, hemophagocytosis and cytomegalic alveolar pneumocytes were also observed in some cases (Nicholls, J. In the first week after infection, symptoms usually consisted of fever and myalgia. A third phase occured in 20% of infected patients and was characterized clinically by disease progression that could not be explained by uncontrolled viral replication. The changes in lung tissue pointed to damage inflicted by cytokines and chemokines (Gralinski, L. During the outbreak, about 40% of infected patients developed respiratory failure requiring assisted ventilation, however 90% of patients recovered within a week after the first appearance of symptoms. Smokers required mechanical ventilation more frequently than nonsmokers (Poutanen, S. Host genetic variants may have also influenced variations in disease response (Schafer, A. The highest rates of infection occurred in people of 20-39 years of age, whereas only 1% of cases occurred in children under age 10 years (Liang, W. High rates among young adults may reflect cases among healthcare workers, while similar high rates in older people may be the consequence of nosocomial infections. Symptoms included chronic widespread musculoskeletal pain, fatigue, depression and disordered sleep (Moldofsky, H. China was hardest hit, with at least 5,327 cases and 349 deaths (66% and 45% of the total, respectively) (Zhang, Y. The 6% annual economic growth of East Asia in 2003 was reduced to 5% during the epidemic (Kondro, W. The protease furin activates the S protein on the viral envelope, mediating membrane fusion and enabling virus entry into the host cell (Banik, G. Although it is primarily a zoonotic virus, nonsustained human-to-human transmission has been confirmed in 53-60% of all cases, albeit predominantly in health care settings and family clusters (Zumla, A. Symptoms and Disease the incubation period is approximately 5 days (range 2-15 days), with 94% of patients showing signs of disease by day 12 (Chan, J. Typical presenting symptoms are nonspecific and include fever, chills, nonproductive cough, dyspnea, rigor, headache, myalgia and malaise. Some patients present with gastrointestinal symptoms, including diarrhea, nausea and vomiting, and abdominal pain. Symptoms and manifestations of Middle East respiratory syndrome range from mild or asymptomatic infection to severe pneumonia, acute respiratory distress, septic shock and multiorgan failure resulting in death (Zumla, A. While the early case-fatality rate was close to 60%, this has decreased with improved awareness and surveillance; however, mortality remains above 35% (Al-Tawfiq, J. The probability of a fatal outcome is much greater among patients aged 50 years and older as compared to younger patients (77% vs. Mortality is also higher in men and in patients with multiple comorbidities (Banik, G. Several cases later occurred in clusters, including a hospital outbreak in Saudia Arabia, and confirmed that the virus can be transmitted between humans during close contact (Assiri, A. However, a study of the general population of Saudi Arabia suggests that the rate of asymptomatic disease is much higher. The index patient had recently traveled to four countries in the Middle East, and returned to Korea while still asymptomatic. Nonethless, experts advise increased surveillance and active contact tracing as well as thorough investigation into potential animal hosts and routes of zoonotic reinfection, which appears to be perpetuating the outbreak (Breban, R. The as-yet-unidentified animal host of 2019-nCoV is presumed to be a bat; an intermediate host may also have been involved (Perlman, S. Although the initial cases were traced to zoonotic transmission, human-to-human transmission was soon documented, both in healthcare settings and in familial clusters. In an early description of 41 clinical cases, patients had serious, sometimes fatal, pneumonia. Isolated and travel-related cases were reported in several countries including Thailand, Japan, the Republic of Korea, the U. Although the early case-fatality rate appeared to be low, the rapid spread and ease of transmission of the virus, even by asymptomatic individuals, is causing global alarm: experts point out that although a virus may pose a low health threat at the individual level, if easily transmissible it can nonetheless pose a significant risk at the population level. Diagnosis may be confirmed by chest radiography if there is evidence of infiltration consistent with pneumonia or respiratory distress syndrome. Neither virus isolation in cell cultures nor electron microscopy are sensitive enough for general diagnostic use and both methods are inconvenient. The virus remains detectable in respiratory secretions for more than one month in some patients, but after three weeks cannot be recovered for culture. However as the procedure for collecting these specimens is invasive, upper respiratory specimens are sometimes used instead (Chan, J. Other febrile viral diseases that should also be included in the differential diagnosis include seasonal and avian Influenza, Respiratory Syncytial Virus, Varicella Zoster Virus, human metapneumovirus and hantavirus. When appropriate, other epidemic or population-wide diseases may also need to be taken into consideration. Hygienic measures are recommended to prevent the spread of disease in situations where individuals are in contact with patients or contaminated fomites. Initial efforts to treat the disease with broad-spectrum antibodies from human immune serum globulins were unsuccessful. Some nonspecific immunosuppressive treatments or broadspectrum antiviral agents, such as ribavirin, were of limited success (Lee, N. In the case of ribavirin, 26 trials were inconclusive and four suggested potential harm. In the case of steroids, 25 studies were inconclusive and four indicated possible harm. They emphasized that clinical trials should be designed to validate a standard treatment protocol for possible future outbreaks, in order to standardize doses and timing of treatment and to facilitate data accrual and the monitoring of specific adverse effects and potential benefits of specific therapies (Stockman, L. Ribavirin and interferon were the most widely used combination in observational studies, and may warrant further investigation (Momattin, H. The optimum dose was determined to be 1-3 mg/kg (or 160-240 mg/day) for a total accumulated dose of 1000-2000 mg. Based on this experience, routine use of corticosteroids is not recommended in patients with 2019-nCoV (Huang, C. Adverse events, including dose-dependent anemia, arrhythmia, chest pain and dizziness, are a significant concern with ribavirin (Cleri, D. The development of broad-range agents requires a better understanding of pivotal virus-host interactions and the identification of targetable host cell proteins involved. Nucleoside inhibitors might specifically inhibit viral replication without causing damage to the host cell. Following successful preclinical evaluation of lopinavir/ritonavir plus interferon-beta1b, in which significant reductions in mortality were obtained in a marmoset model, clinical evaluation of the combination was recommended (Chan, J. Elements of the viral replication process have also been identified as potential therapeutic targets, including viral helicase, features of which are highly conserved among different coronaviruses (Adedeji, A. Nine patients were given the combination therapy, while 13 patients were treated with corticosteroids alone. However, the incidence of transfers to the intensive care unit and need for intubation and mechanical ventilation were lower in the interferon/corticosteroid combination group (33. Because ribavirin decreases the release of proinflammatory cytokines in mice infected with the mouse hepatitis coronaviruses, it may also act as an immunomodulator (Peiris, J. A systematic review and meta-analysis of healthcare databases and so-called grey literature describing the use of convalescent plasma, serum or hyperimmune immunoglobulin derived from convalescent plasma to treat severe acute respiratory infections of viral origin has concluded that this approach is safe and may decrease the risk of mortality 22 (Mair-Jenkins, J. However, Saudi Arabian scientists reported that clinical trials evaluating this therapy would be challenging due to the limited availability of suitable donors, i. Neutralization of Middle East respiratory syndrome coronavirus has also been achieved using monoclonal antibodies. For an overview of validated therapeutic targets for this indication, consult the targetscape below. Purple and pink text boxes indicate extracellular and intracellular effects, respectively. For in-depth information on a specific target or mechanism of action, see the corresponding section in this report. Eligible participants were enrolled sequentially using a dose-escalation protocol to receive 0. At the time of data cutoff, 25 subjects were enrolled in each of the 3 dose cohorts. Unsolicited symptoms were reported for 56 of the 75 participants (75%) and were deemed treatment-related for 26 participants (35%). Laboratory abnormalities were generally uncommon, except for 15 increases in creatine phosphokinase, reported in 14 participants. T-cell responses were detected in 47 of 66 participants (71%) after two vaccinations and in 44 of 58 participants (76%) after three vaccinations.

Among gram-positive organisms that are catalase negative and display chains by Gram stain erectile dysfunction numbness buy generic cialis with dapoxetine line, the genera associated most often with human disease are Streptococcus and Enterococcus erectile dysfunction with age buy cialis with dapoxetine discount. Members of the Streptococcus genus that are beta-hemolytic on blood agar plates include Streptococcus pyogenes (see Group A Streptococcal Infections erectile dysfunction blood pressure medications side effects order cialis with dapoxetine uk, p 668) erectile dysfunction treatment houston tx generic cialis with dapoxetine 40/60mg on-line, Streptococcus agalactiae (see Group B Streptococcal Infections erectile dysfunction treatment history purchase 40/60mg cialis with dapoxetine free shipping, p 680) and groups C and G streptococci erectile dysfunction drugs cost order cialis with dapoxetine without prescription. S agalactiae subspecies equisimilis is the group C species most often associated with human infections. The anginosus group (S anginosus, Streptococcus constellatus, and Streptococcus intermedius) can have variable hemolysis, and approximately one third possess group A, C, F, or G antigens. Nutritionally variant streptococci, once thought to be viridans streptococci, now are classifed in the genera Abiotrophia and Granulicatella. The genus Enterococcus (previously included with Lancefeld group D streptococci) contains at least 18 species, with Enterococcus faecalis and Enterococcus faecium accounting for most human enterococcal infections. Outbreaks and nosocomial spread in association with Enterococcus gallinarum also have occurred occasionally. Nonenterococcal group D streptococci include Streptococcus bovis and Streptococcus equinus, both members of the bovis group. Typical human habitats of different species of viridans streptococci are the oropharynx, epithelial surfaces of the oral cavity, teeth, skin, and gastrointestinal and genitourinary tracts. Intrapartum transmission is responsible for most cases of early-onset neonatal infection caused by nongroup A and B streptococci and enterococci. Groups C and G streptococci have been known to cause foodborne outbreaks of pharyngitis. Antimicrobial susceptibility testing of isolates from usually sterile sites should be performed to guide treatment of infections caused by viridans streptococci or enterococci. The proportion of vancomycin-resistant enterococci among hospitalized patients can be as high as 30%. Other agents with good activity include ampicillin, cefotaxime, vancomycin, and linezolid. The combination of gentamicin with a beta-lactam antimicrobial agent (eg, penicillin or ampicillin) or vancomycin may enhance bactericidal activity needed for treatment of life-threatening infections (eg, endocarditis or meningitis). Nonpenicillin antimicrobial agents with good activity against viridans streptococci include cephalosporins (especially ceftriaxone), vancomycin, linezolid, daptomycin, and tigecycline, although experience with daptomycin and tigecycline is limited, and these are not approved for use in children. Abiotrophia and Granulicatella organisms can exhibit relative or high-level resistance to penicillin. The combination of high-dose penicillin or vancomycin and an aminoglycoside can enhance bactericidal activity. Enterococci exhibit uniform resistance to cephalosporins and isolates resistant to vancomycin, especially E faecium, are increasing in prevalence. In general, children with a central line-associated bloodstream infection caused by enterococci should have the device removed promptly. Invasive enterococcal infections, such as endocarditis or meningitis, should be treated with ampicillin if the isolate is susceptible or vancomycin in combination with an aminoglycoside. Gentamicin should be discontinued if in vitro susceptibility testing demonstrates highlevel resistance, in which case synergy cannot be achieved. The role of combination therapy for treating central line-associated bloodstream infections is uncertain. Linezolid is approved for use in children, including neonates, only for treatment of infections caused by vancomycin-resistant E faecium. Although most vancomycin-resistant isolates of E faecalis and E faecium are daptomycin susceptible, daptomycin is approved for use only in adults for treatment of infections attributable to vancomycinresistant E faecalis. Limited data suggest that clearance rates of daptomycin are more rapid in young children compared with adolescents and adults. Microbiologic and clinical cure has been reported in children infected with vancomycin-resistant E faecium who were treated with quinupristin-dalfopristin. Tigecycline is approved for use in adults with infections caused by vancomycin-susceptible E faecalis. Tigecycline has good activity in vitro against both vancomycin-resistant E faecalis and vancomycin-resistant E faecium, but experience in children is limited. Guidelines for antimicrobial therapy in adults have been formulated by the American Heart Association and should be consulted for regimens that are appropriate for children and adolescents. Common practice is to maintain precautions until the patient no longer harbors the organism or is discharged from the health care facility. For these patients, early instruction in proper diet; oral health, including use of dental sealants and adequate fuoride intake; and prevention or cessation of smoking will aid in prevention of dental carries and potentially lower their risk of recurrent endocarditis. Hospitals should develop institutionspecifc guidelines for the proper use of vancomycin. A guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. When symptoms occur, they are most often related to larval skin invasion, tissue migration, and/or the presence of adult worms in the intestine. Infective (flariform) l arvae are acquired from skin contact with contaminated soil, producing transient pruritic papules at the site of penetration. Larvae migrate to the lungs and can cause a transient pneumonitis or Loeffer-like syndrome. After ascending the tracheobronchial tree, larvae are swallowed and mature into adults within the gastrointestinal tract. Symptoms of intestinal infection include nonspecifc abdominal pain, malabsorption, vomiting, and diarrhea. This condition, which frequently is fatal, is characterized by fever, abdominal pain, diffuse pulmonary infltrates, and septicemia or meningitis caused by enteric gram-negative bacilli. Humans are the principal hosts, but dogs, cats, and other animals can serve as reservoirs. Transmission involves penetration of skin by infective (flariform) larvae from contact with infected soil. Infections rarely can be acquired from intimate skin contact or from inadvertent coprophagy, such as from ingestion of contaminated food or within institutional settings. Adult females release eggs in the small intestine, where they hatch as frst-stage (rhabditiform) larvae that are excreted in feces. A small percentage of larvae molt to the infective (flariform) stage during intestinal transit, at which point they can penetrate the bowel mucosa or perianal skin, thus maintaining the life cycle within a single person (autoinfection). Because of this capacity for autoinfection, people can remain infected for decades after leaving a geographic area with endemic infection. At least 3 consecutive stool specimens should be examined microscopically for characteristic larvae (not eggs), but stool concentration techniques may be required to establish the diagnosis. The use of agar plate culture methods may have greater sensitivity than fecal microscopy, and examination of duodenal contents obtained using the string test (EnteroTest), or a direct aspirate through a fexible endoscope also may demonstrate larvae. Eosinophilia (blood eosinophil count greater than 500/fiL) is common in chronic infection but may be absent in hyperinfection syndrome. Serodiagnosis is sensitive and should be considered in all people with unexplained eosinophilia. Gram-negative bacillary meningitis is a common associated fnding in disseminated disease and carries a high mortality rate. Alternative agents include thiabendazole and albendazole, although both drugs are associated with lower cure rates (see Drugs for Parasitic Infections, p 848). Prolonged or repeated treatment may be necessary in people with hyperinfection and disseminated strongyloidiasis, and relapse can occur. Examination of stool for larvae and serum for antibodies to S stercoralis is recommended in patients with unexplained eosinophilia, especially for those who are immunosuppressed or for whom administration of glucocorticoids is planned. If possible, patients should be treated for strongyloidiasis prior to initiation of immunosuppressive therapy. Intrauterine infection with Treponema pallidum can result in stillbirth, hydrops fetalis, or preterm birth or may be asymptomatic at birth. Infected infants can have hepatosplenomegaly, snuffes (copious nasal secretions), lymphadenopathy, mucocutaneous lesions, pneumonia, osteochondritis and pseudoparalysis, edema, rash, hemolytic anemia, or thrombocytopenia at birth or within the frst 4 to 8 weeks of age. Skin lesions or moist nasal secretions of congenital syphilis are highly infectious. However, organisms rarely are found in lesions more than 24 hours after treatment has begun. The primary stage appears as one or more painless indurated ulcers (chancres) of the skin or mucous membranes at the site of inoculation. Lesions most commonly appear on the genitalia but may appear elsewhere, depending on the sexual contact responsible for transmission (ie, oral). The secondary stage, beginning 1 to 2 months later, is characterized by rash, mucocutaneous lesions, and lymphadenopathy. The polymorphic maculopapular rash is generalized and typically includes the palms and soles. This stage also resolves spontaneously without treatment in approximately 3 to 12 weeks, leaving the infected person completely asymptomatic. A variable latent period follows but sometimes is interrupted during the frst few years by recurrences of symptoms of secondary syphilis. Latent syphilis is defned as the period after infection when patients are seroreactive but demonstrate no clinical manifestations of disease. The tertiary stage of infection occurs 15 to 30 years after the initial infection and can include gumma formation, cardiovascular involvement, or neurosyphilis. The incidence of acquired and congenital syphilis increased dramatically in the United States during the late 1980s and early 1990s but decreased subsequently, and in 2000, the incidence was the lowest since reporting began in 1941. Since 2001, however, the rate of primary and secondary syphilis has increased, primarily among men who have sex with men. Among women, the rate of primary and secondary syphilis has increased since 2005, with a concomitant increase in cases of congenital syphilis. Rates of infection remain disproportionately high in large urban areas and in the southern United States. Primary and secondary rates of syphilis are highest in black, non-Hispanic people and in males compared with females. Congenital syphilis is contracted from an infected mother via transplacental transmission of T pallidum at any time during pregnancy or possibly at birth from contact with maternal lesions. Among women with untreated early syphilis, as many as 40% of pregnancies result in spontaneous abortion, stillbirth, or perinatal death. The rate of transmission is 60% to 100% during primary and secondary syphilis and slowly decreases with later stages of maternal infection (approximately 40% with early latent infection and 8% with late latent infection). The World Health Organization estimates that 1 million pregnancies are affected by syphilis worldwide. Of these, 460 000 will result in stillbirth, hydrops fetalis, abortion, or perinatal death; 270 000 will result in an infant born preterm or with low birth weight; and 270 000 will result in an infant with stigmata of congenital syphilis. Acquired syphilis almost always is contracted through direct sexual contact with ulcerative lesions of the skin or mucous membranes of infected people. Relapses of secondary syphilis with infectious mucocutaneous lesions can occur up to 4 years after primary infection. In most cases, identifcation of acquired syphilis in children must be reported to state child protective services agencies. The incubation period for acquired primary syphilis typically is 3 weeks but ranges from 10 to 90 days. Specimens should be scraped from moist mucocutaneous lesions or aspirated from a regional lymph node. Although such testing can provide defnitive diagnosis, in most instances, serologic testing is necessary. Polymerase chain reaction tests and immunoglobulin (Ig) M immunoblotting have been developed but are not yet available commercially. Presumptive diagnosis is possible using nontreponemal and treponemal serologic tests. Use of only 1 type of test is insuffcient for diagnosis, because false-positive nontreponemal test results occur with various medical conditions, and treponemal test results remain positive long after syphilis has been treated adequately and can be falsely positive with other spirochetal diseases. These tests measure antibody directed against lipoidal antigen from T pallidum, antibody interaction with host tissues, or both. These tests are inexpensive and performed rapidly and provide semiquantitative results. Occasionally, a nontreponemal test performed on serum samples containing high concentrations of antibody against T pallidum will be weakly reactive or falsely negative, a reaction termed the prozone phenomenon. A reactive nontreponemal test result from a patient with typical lesions indicates a presumptive diagnosis of syphilis and the need for treatment. However, any reactive nontreponemal test result must be confrmed by one of the specifc treponemal tests to exclude a false-positive test result. False-positive results can be caused by certain viral infections (eg, Epstein Barr virus infection, hepatitis, varicella, and measles), lymphoma, tuberculosis, malaria, endocarditis, connective tissue disease, pregnancy, abuse of injection drugs, laboratory or technical error, or Wharton jelly contamination when umbilical cord blood specimens are used. Treatment should not be delayed while awaiting the results of the treponemal test results if the patient is symptomatic or at high risk of infection.

Diseases

Heart aneurysm
Rasmussen subacute encephalitis
Cone dystrophy
Cataract microcornea syndrome
Meningomyelocele
Cantu Sanchez Corona Hernandes syndrome

Late withdrawal of the rains will lessen Storability of food grains and crops pose challenges in the tropthe turnaround time erectile dysfunction and proton pump inhibitors cialis with dapoxetine 20/60 mg free shipping. The Honey Bee databaseiii has sevwomen to harvest the paddy crop before full ripening erectile dysfunction age generic cialis with dapoxetine 20/60mg with mastercard, drying them eral practices provided by women natural erectile dysfunction pills reviews purchase cialis with dapoxetine now, which they use to make crops in the sun for threshing and sowing of the next crop impotence grounds for annulment philippines cialis with dapoxetine 40/60mg sale. Gupta (1987a) erectile dysfunction doctor in bhopal order cialis with dapoxetine from india, Gupta (1987b erectile dysfunction drugs covered by insurance buy cialis with dapoxetine 20/60mg without a prescription, Gupta (1987c, Gupta amount of rainfall received is negatively correlated to the maxi(2007a, Gupta (2007b) reported that women in Bangladesh not only mum temperature in the previous season i. In most rural areas, women fetch water for drinking Bangladesh cut some of the rootlets from the nodes of sweet potato and other household chores, often from long distances. This helped in the development of rainfall received per number of rainy days, is inversely correof rounder tuber with a thicker skin. Consumers in the market prelated to the maximum temperature in the summer/zaid season, ferred rounder tubers and the thick skin increased the shelf life suggesting the chances of fiood or cloudbursts. He also reported that a woman farmer in Bangladesh problems for the women: (1) restricts their mobility and increase followed the practice of planting one banana plant among four areca their dependence on stored resources (Ahmed, 2004), (2) increases trees (see Sheshagiri, Narayanaswamy, & Shivanna, 2010). This becomes an important coping strategy to ing and lateral diffusion of knowledge. Many of these plants, as said earlier, at the age of 14, dedicated a chapter in her book Hunnar Mahasagar have been used in the traditional medicine systems for their ther(1898), to examples of ecological and climatic indicators. Modern scientific tools and techniques have valialso contains information on over two thousand eighty practices/ dated some of the properties. It was a great hit among the plants shared in food recipe competitions held during Shodhyatras readers. However, in spite of such outare uncultivated or rarely cultivated plants or involve their rarely standing examples of contribution to science and society, the eaten part. A compilation of the uses of weeds that are found and knowledge of women has remained under represented, especially used in Isoulibhari, Kharella, and Shivnathpur in Faizabad district, in decisionmaking and policy discourses. Munni Devi and other women of her village Isoulibhari harkodo millet growing on the bunds and the leafy weeds and make vest the weeds and segregate them for consumption by human a meal). It not only informs us about palatability (due to high fiber content)vi of kodo millet, which one may otherwise throw away as a and/or cattle while the non-edible ones are either composted or thrown away. It husbandry, while men take decisions on breeding and sale of dairy also asks people to look for other weeds that are eaten as leafy vegproducts. One of the interpretaadult women and children besides being a good source of iron, mantions told to us by Susheela meant that if the family could get ganese, potassium (Umar, Hassan, Dangoggo, & Ladan, 2007). Its enough millet to eat, that would have sufficed for their needs in nutritional properties particularly with regard to antioxidants and the tough times. Such folksongs were probably the cues society essential amino acids have been confirmed (Doka, Tigani, & Yagi, has used, to survive in difficult times when the crops failed. It gives 2014 and other scientific studies) (Prasad, Shivamurthy, & a clear indication of the nutritional superiority of the millets and Aradhya, 2008). This knowledge has stayed with the society for are put into the ears in the case of earache. Another widely adapted long but only recently formal institutions have recognized some of weed mostly growing in waste lands/field bunds, locally called lehthe components of Indigenous/local knowledge and innovation syssua (false amaranthus, Digeramuricata (L. Shodhyatras twice a year in the hinterland of India to learn from the local Such resources need to be popularized after verifying and testing communities and share available information, honor local innovators and traditional knowledge holders at their door step. Not all of this local knowledge might be true to its claim but it must be Women in this region consume only uncultivated plants as food blended with formal scientific knowledge systems for societal while celebrating the festival of teej. Of these plants, Oryza ru empowering local communities and the dichotomy between sopogon Griff. They believe that called indigenous and formal knowledge systems must be overcome the fast will be incomplete without eating this rice. There is an urgent need to document, tions have evolved in society probably for conservation of these validate, value add, and disseminate it for a more climate resilient otherwise less appreciated crops and varieties. Interestingly, future (Gupta, 1987a, 1987b, 1987c, 1988, 1989, 2007a, 2017b; scientists have characterized the wild rice variety for many Hiwasaki, Luna, & Shaw, 2014). Botanical name Use(s) Traditional uses Pharmacology reported in field 1 Ecilpta alba/ Indigestion, Acidity, Asthma, Constipation, Diarrhea and dysentery, Fever, Anti-hepatotoxic property (Kim et al. Om Prakash Pandey, Kasari village, Faizabad District insisted on planting With climate change and destruction of forests, women have to samai (Echinochloacolona (L. She got walk up to greater distances to collect fuel wood (Oxfam, 2006; the seeds from her brother who lives in Isoulibhari. The sama grown in the kharif season ties, learn to be frugal and efficient in resource utilization. For called Bhadelasamai is considered very auspicious for offering to example, in tribal areas of Manipur, Meghalaya, Andhra Pradesh the deities during funeral. Echinochloacolona, a weed in rice fields, women use shelves at multiple levels above the cooking stove to is reported as an alternate host for several paddy pests and cure wood, dry fuel wood, dry different vegetables, cheese, and pathogens (Bharati, Om, & Kushwaha, 1990; Tanwar et al. In this way, It shows resistance to feeding activity of brown planthopper due they are able to harvest the waste heat through a heat gradient to its anti-feedant property (Kim et al. In the is at par with the cereals and more in terms of Iron and Zinc (Salih, 21st Shodhyatra in the Arku valley of Andhra Pradesh, Jyoti Nour, & Harper, 1992). It has higher Ca than its domesticated informed that she kept the paddy panicles on the shelf so that pancounterpart (Mandelbaum, Barbeau, & Hilu, 1995). This makes the husk and the seed adaptive, growing in a wide change of climatic and ecological expand at different rates and makes threshing easier thus reducing conditions and more so in drought conditions (Padulosi et al. Some of the cultural institutions had taken care of practices have been developed after generations of experimentasustainability through such institutions and knowledge systems tion and testing while some have been developed recently. Most of the collective understanding needs negotiations, but (g) Small savings, sharing, and reciprocity public extension functionaries are seldom trained in institution building or induced autopoiesis (Dey et al. CommunityWomen sustain themselves through small savings in the rainy managed portfolios of resource management choices such as days. Another interesting practice in these villages is that rather than formal or legal contracts plays a crucial role in they prefer to share the surplus production from the homestead survival through such institutions. The informal exchanges of gardens with other women rather than selling it in the market. They can share their emotions and knowledge with other Sometimes government provides subsidies or relief on individual women much more freely and hence they can serve as an imporbasis and not group basis, thereby possibly weakening the tant link in participatory research and execution of adaptation collective institutions. Part 3: Policy recommendations and conclusion tors in these informal institutions. There are some institutions where community representatives could censure the undesirable (a) Recommendations behavior. Moreover, it is evident that women are part of many social groups or networks simultaneously. Women need platforms where their can share their knowledge, ficult to accept the idea of mediating support through any one get feedback and rewards. They have dealt with restrictions and stringent social We discussed a few cases from the Honey Bee Network institusanctions for generations. This knowledge solutions better and prevent rapid obsolescence of emergent needs to be disseminated at a large scale in multi-media and solutions. Weather information needs to be provided according to local diversity of India and disparity in literacy levels. If we can develop easily manageable and comprehenlarly among women is vital for maintaining sustainability quest sible expert systems, then women can feed their local field of vulnerable communities. Gender-specific policies need to build upon their strength mented, or embedded in induced institutional innovations. Hence, this knowledge becomes a community or public To illustrate, a woman farm laborer who does weeding might domain knowledge owing to the culture of open sharing. She ever, in the absence of low transaction cost platform of lateral can be hired to make a database and herbarium of such learning, the adequate churning of their knowledge system useful/harmful weeds and paid wages for that instead of may not take place contributing sufficiently to climate change being asked to break stones or dig earth under employment resilience. The informal networks of women can be the channels for tarTheir expertise and knowledge about non-agricultural food geting climate adaptation policies dealing with horizontal sources help in dealing with food and nutrition availability for knowledge management systems. Many of them were either In the study area, we could see that there is a culture of open weeds or wild perennial plants used round the year. This open sharing helps weeds had therapeutic and nutritional properties identified by the knowledge system become more robust. If women groups become the loci of the knowledge and resource dissemination at least in the cases of a disaster like viii Small informal groups who carry out certain activities together like singing vii. Women who have some autonomy or a say in household decision-making processes are able to cope better as they can share resources with others. The access to informal institutions acts as safety nets in times of need and they rely heavily on them. The assurance that knowledge and resources will be shared, infiuences the attitude toward even consumable goods like the homestead gardens. When women do not have autonomy, they try to utilize endogenous resources sub-optimally or may succumb to malnutrition due to prolonged episodes of self-sacrifice. We have argued that women would need both, the autonomy and agency to allow them to exchange of knowledge, and other resources including labor and Figure 1. These exchanges take into account the asymmetry in knowledge systems because of the expertise developed by some women over time. These exchanges may be reciprocal but at times these lead to creation to public goods because of the communal ethics. Hence, policies for women should be Although mostly non-monetary, importance of these exchanges based upon the strength of theirs rather than their obvious may not always be obvious to outsiders. This knowledge remains like number of households involved in these transactions, one can distributed islands generally untapped in the formal knowledge appreciate their contribution better. The knowledge and ideas of one place may lead mal channels of dissemination of the knowledge are often not to many other derivative innovations locally or elsewhere. Even the discourse However, it is also important that knowledge can fiow among on traditional knowledge does not seem to represent as much of the knowledge holders and the users so that the users provide the knowledge of women traditional knowledge holders, mida feedback, strengthening thereby the knowledge and innovawives, or female herbal healers as may be needed (Reyes-Garcia, tion system as a whole (see Figure 1). Some funds have also been invested to build social have tried to overcome these through their ethos and social netbusinesses through these innovations or knowledge. These enterprises are different from a process making the Indigenous knowledge system more robust. Ethics shapes the type of netrather than catering to the products whose market already work created by women for sharing risk, resource, and skills. These enterprises will become very important resources conservation ethics (the fourth E) through biodiversity conservain the wake of extreme climatic events and consequent food tion and optimal utilization of energy resources could be seen in insecurity. Hence, it pays off to build and maintain them the case of wild rice and the multi-tier heat-harvesting systems. This fund will the conservation ethics manifests through enhanced environmenenable communities or women groups to build enterprises tal consciousness. This reinforces the coping strategies community to overcome food and nutrition insecurity (see through 4Es in a dynamic manner. Although quantum of exchange and time of assurances both play (b) Exchange, expertise, ethics, and environmental consciousness an important role, criticality of time often supersedes the rest in the case of uncertainty. We notice that way they try to cope with seasonal irregularities in food and lateral learning is an important strategy and platforms where animal feed supply. We can perhaps better understand these coping strategies through the 4E model ure A2) i. Given enormous socio-economic and wellbeing despite climatic fiuctuation-induced stresses. We need to create platforms, which enable women farm workers and farmers to learn from Acknowledgment other farm workers. The women groups to late Parshottam Patel who helped us in conducting the field or individual knowledge providers in turn become foci of new work. Focus on the economically poor but nutritionally healthy families can bring out many frugal practices of weedand minor Correlation table of Max and Min. Middle-East Journal of Scientific Research, 14(5), Ethnobotanical Assessment of Moringa oleifera Lam.

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