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Latest version submitted Male escort aalborg city 10, on ClinicalTrials. A study version is represented by a row in the table. Select two study versions to compare. One each from columns A and B. Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed.
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Latest version submitted Russiam 10, on ClinicalTrials. A study version is represented by a row in the table. Select two study versions to compare. One each from columns A and B.
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Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Houxton format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and free escorts in davis the differences. Select a version's Submitted Date link to see a rendering of the study for that version. A yellow table row indicates the study version currently being viewed. Hover over the " Recruitment Status russiwn to see how the study's recruitment status changed.
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Study edits or deletions are displayed in red. Study additions are displayed in green. Scroll up to access the controls. Oversight U. Study Description Brief Summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care SOC treatment compared to placebo in combination with SOC treatment.
The study will be conducted in 3 phases: screening phase, double-blind treatment period 5 daysa post treatment follow-up period 23 days. The duration of participation in the study for each participant is 28 days. Conditions Conditions: Sabrina indian escort A Keywords:. The choice desi escorts grenaa use influenza antivirals as part of the SOC should be made before randomization.
The influenza antiviral should be started no later than Day 2 morning up to noon.
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An influenza antiviral as part of the SOC cannot be changed for example, switching one influenza antiviral for another during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event AE. Participants rusxian receive pimodivir mg, orally, twice daily, for 5 days on Days 1 through 5; for participants who will receive only 1 seeking men in el ktaoua of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6.
Participants may receive SOC treatment as a part of background therapy.
Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6 along with SOC treatment. An influenza antiviral as part of the SOC cannot be changed for example, switching one influenza antiviral for another during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Participants will receive placebo matching to pimodivir, orally twice daily for 5 days on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6. Escorts tbilisi Measures Primary Outcome Measures: 1.
The resolution of influenza-related symptoms is defined as the beginning of the hour period that 7 influenza symptoms cough, sore throat, headache, nasal congestion, feeling feverish, free amateur girl sex personals irvine uk aches and pains, fatigue are at most mild or at least back to level of symptom severity in case the participant reported the symptom as pre-existing.
of Participants With Adverse Events as chat blogspot Measure of Safety and Tolerability An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability Blood samples for hematology, serum chemistry, and urinalysis will be collected at predefined time escort evansville indiana for clinical laboratory testing. of Participants With Vital abnormalities as a Measure of Safety and Tolerability of participants with vital temperature, pulse rate, respiratory rate and blood pressure abnormalities will be reported.
Percentage of Participants Hospitalized Percentage of participants hospitalized 28 days after treatment initiation will be reported. Percentage of Participants with Complications Associated with Influenza After the Start of Study Treatment Percentage of participants with complications associated with influenza after the start of study will be reported. Complications include pulmonary complications such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma and extrapulmonary complications such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of ly controlled diabetes mellitus, other infections [for example, sinusitis and otitis].
Time to Return to Daily Activities Time to return to daily activities will be assessed by means of the participant's rusisan to the escors 'Over the markham private asian escorts 24 hours, how much has influenza interfered with your ability to carry out your daily activities'. Participants will respond to the above question through an electronic Patient-reported Outcome ePRO device by means of the following response scale: Not at all; A little bit; Somewhat; Quite a bit; Very much.
of Participants with All-cause Mortality The of participants who died escofts to any cause will be assessed. Maximum Plasma Concentration Cmax of pimodivir Russoan Cmax is the maximum plasma concentration after a dose of pimodivir. Russiann Plasma Concentration Ctrough of Pimodivir The Ctrough is the plasma concentration just prior to escort service boca raton me beginning or at the end of a dosing interval.
Time to Reach Maximum Plasma Concentration tmax of Pimodivir The tmax is defined as time to reach maximum perth cruz escort plasma concentration. Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste Questionnaire Acceptability of the pimodivir formulation in adolescents will be measured by a taste questionnaire.
For overall taste, questions will be answered on a following response scale: No taste, Weak taste, Moderate taste, and Strong taste. Escrots of the Pimodivir Formulation in Adolescents as Measured by a Swallowability Questionnaire Acceptability of the pimodivir formulation in adolescents will be measured by a swallowability questionnaire. Swallowability questions will be answered on a response scale of 1 to 7: 1.
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Moderately difficult; 3. Slightly difficult; 4. Neither difficult or easy; 5.
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Slightly easy; 6. Moderately easy; and 7. Very easy. Time to Influenza Viral Negativity Time to influenza escort victoria list negativity will be determined by quantitative real time - polymerase chain reaction qRT-PCR and viral culture from nasal midturbinate MT swabs.
Time to Resolution of Each of the 10 Individual Influenza-Related Symptoms as Assessed by the PRO Measure Flu-iiQ The resolution of each influenza-related symptom is defined as the beginning of the hour period when the influenza symptom score is at most mild or at least back to escort couple new kitchener of symptom severity in case the participant reported the symptom as pre-existing.
Eligibility Minimum Age: 13 Years Uouston Age: 85 Years Sex: All Gender Based: Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 houstkn symptom and at least 1 systemic symptom, both scored as at least houdton if the symptom did not pre-exist before influenza onset, or scored worse than usual if east city of milford female escorts symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device.
Symptoms must include the following by category: a Respiratory symptoms: cough, sore throat, nasal congestion b Systemic state college personals headache, body aches or pain, feverishness, fatigue Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test RIDT escofts, if available, a polymerase chain reaction PCR -based or other rapid molecular diagnostic assay Not be in need of secorts medical care at screening.
CT sylogent. Simon, M. Lewis research Inc. Lewis Research Inc.
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Bati, a. Juan I. Kukuru Michalovce, a. Svobodu Svidnik, eescorts. Clinico Univ. Scroll up to access the controls Scroll to the Study top. December 18, None earliest Version on record 2. February 28, March 27, April 24, May 3, May 22, June 19, July 17, December knoxville tn escorts, January 29, March 21, March 26, April 3, May 6, May 14, Ruesian 26, August 6, September 3, October 1, October 29, November 26, December 24, January 21, February 18, March 17, May 11, June 9, July 7, September 1, November 10, Study Best website to find escorts Record Verification:.
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