valdoxan
... In clinical studies, VALDOXAN had no affect on QT interval and no clinically-significant affect on heart rate, blood pressure and ECG tracings Body weight VALDOXAN (agomelatine) had no affect on body weight in clinical and non-clinical studies. Withdrawal / Discontinuation The abrupt discontinuation ...
... In clinical studies, VALDOXAN had no affect on QT interval and no clinically-significant affect on heart rate, blood pressure and ECG tracings Body weight VALDOXAN (agomelatine) had no affect on body weight in clinical and non-clinical studies. Withdrawal / Discontinuation The abrupt discontinuation ...
Nedocromil sodium versus sodium cromoglycate in treatment of
... ABSTRACT: The objective of this review was to compare the effects of prophylactic doses of nedocromil sodium (NCS) and sodium cromoglycate (SCG) on postexercise lung function, in persons diagnosed with exercise-induced bronchoconstriction. Randomized controlled trials were identi®ed from the Cochran ...
... ABSTRACT: The objective of this review was to compare the effects of prophylactic doses of nedocromil sodium (NCS) and sodium cromoglycate (SCG) on postexercise lung function, in persons diagnosed with exercise-induced bronchoconstriction. Randomized controlled trials were identi®ed from the Cochran ...
ritalin®10 / ritalin®la
... The aetiology of this syndrome is unknown and there is no single diagnostic test. Adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility ...
... The aetiology of this syndrome is unknown and there is no single diagnostic test. Adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility ...
RITALIN 10 / RITALIN LA
... The aetiology of this syndrome is unknown and there is no single diagnostic test. Adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility ...
... The aetiology of this syndrome is unknown and there is no single diagnostic test. Adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility ...
CLINICAL STUDY PROTOCOL - Annals of the Rheumatic Diseases
... Patients must meet all of the following randomization criteria to be eligible for randomization into the double-blind treatment period at the randomization visit: Symptomatic status required for randomization: o Duration of morning stiffness of 45 minutes or more (on at least 4 days within the last ...
... Patients must meet all of the following randomization criteria to be eligible for randomization into the double-blind treatment period at the randomization visit: Symptomatic status required for randomization: o Duration of morning stiffness of 45 minutes or more (on at least 4 days within the last ...
Adenosine as an Adjunct to Thrombolytic Therapy for Acute
... pressure ⬍100 mm Hg, cardiogenic shock (systolic blood pressure ⬍90 mm Hg with rales or cardiac index ⬍2.2 L/min/m2), underlying condition in which hypotension may be poorly tolerated (such as severe aortic stenosis or cerebrovascular disease), history or clinical evidence of bronchospastic lung dis ...
... pressure ⬍100 mm Hg, cardiogenic shock (systolic blood pressure ⬍90 mm Hg with rales or cardiac index ⬍2.2 L/min/m2), underlying condition in which hypotension may be poorly tolerated (such as severe aortic stenosis or cerebrovascular disease), history or clinical evidence of bronchospastic lung dis ...
NIHR HTA Programme 16 November 2012
... of daily living such as mobility and the number of times they use the bathroom during the night. Additionally, other health-related factors such as heart function, mood and memory will be assessed. This information will be compared to that collected in another group of older patients in whom OSAHS w ...
... of daily living such as mobility and the number of times they use the bathroom during the night. Additionally, other health-related factors such as heart function, mood and memory will be assessed. This information will be compared to that collected in another group of older patients in whom OSAHS w ...
Induction of remission is usually a symptomatic endpoint although
... • CRP: Only biological parameter, identified as predictor of a more severe clinical course of CD • Norwegian population-based study: 176 CD – CRP levels measured at diagnosis, after 1 and 5 yrs ...
... • CRP: Only biological parameter, identified as predictor of a more severe clinical course of CD • Norwegian population-based study: 176 CD – CRP levels measured at diagnosis, after 1 and 5 yrs ...
Pharmacological interventions for preventing post
... of medication treatment for PTSD indicates that medication may be effective in preventing PTSD; the most evidence of efficacy currently existing for the selective serotonin reuptake inhibitors (SSRIs), with promising initial findings for the selective noradrenergic reuptake inhibitor venlafaxine and ...
... of medication treatment for PTSD indicates that medication may be effective in preventing PTSD; the most evidence of efficacy currently existing for the selective serotonin reuptake inhibitors (SSRIs), with promising initial findings for the selective noradrenergic reuptake inhibitor venlafaxine and ...
Clinical Practice Guideline for the Management of Headache
... guideline is not intended to include all possible methods of care for headaches presenting to a chiropractor or all clinically relevant criteria for choosing to use a specific treatment. Limitations exist in the published evidence.2 If a treatment modality is not mentioned in this guideline, it is b ...
... guideline is not intended to include all possible methods of care for headaches presenting to a chiropractor or all clinically relevant criteria for choosing to use a specific treatment. Limitations exist in the published evidence.2 If a treatment modality is not mentioned in this guideline, it is b ...
Advances in Environmental Biology
... example, some suggest that small volume fluids in short intervals or cold fluids be used and some others prescribe a single dose of ondansetron. As vomiting is a fundamental component of viral gastroenteritis in children, its association with diarrhea causes dehydration-associated complications; the ...
... example, some suggest that small volume fluids in short intervals or cold fluids be used and some others prescribe a single dose of ondansetron. As vomiting is a fundamental component of viral gastroenteritis in children, its association with diarrhea causes dehydration-associated complications; the ...
Mevacor - Merck.com
... The effect of lovastatin on the progression of atherosclerosis in the coronary arteries has been corroborated by similar findings in another vasculature. In the Asymptomatic Carotid Artery Progression Study (ACAPS), the effect of therapy with lovastatin on carotid atherosclerosis was assessed by B-m ...
... The effect of lovastatin on the progression of atherosclerosis in the coronary arteries has been corroborated by similar findings in another vasculature. In the Asymptomatic Carotid Artery Progression Study (ACAPS), the effect of therapy with lovastatin on carotid atherosclerosis was assessed by B-m ...
(Estradiol Transdermal System, USP)
... estrone and its conjugates, giving rise to higher circulating levels of estrone than estradiol. Therefore, transdermal administration produces therapeutic plasma levels of estradiol with lower levels of estrone and estrone conjugates and requires smaller total ...
... estrone and its conjugates, giving rise to higher circulating levels of estrone than estradiol. Therefore, transdermal administration produces therapeutic plasma levels of estradiol with lower levels of estrone and estrone conjugates and requires smaller total ...
Design and Conduct of Clinical Trials
... for generalization of the study findings, but treatment effects may be obscured by heterogeneity of disease status. C. Outcome Measures The outcome measure used to compare treatments may be either a clinical event or a surrogate outcome measure. The primary outcome measure should be selected prior t ...
... for generalization of the study findings, but treatment effects may be obscured by heterogeneity of disease status. C. Outcome Measures The outcome measure used to compare treatments may be either a clinical event or a surrogate outcome measure. The primary outcome measure should be selected prior t ...
Wheezing in the young : How to approach and treat ? ั
... ith viral i l respiratory i t infection-induced lower airway disease: a randomized placebo randomized, placebo-controlled controlled trial The results of this study were similar to those two previous studies of dexamethasone that • systemic corticosteroid did not demonstrate its usefulness in admiss ...
... ith viral i l respiratory i t infection-induced lower airway disease: a randomized placebo randomized, placebo-controlled controlled trial The results of this study were similar to those two previous studies of dexamethasone that • systemic corticosteroid did not demonstrate its usefulness in admiss ...
Dictionary of Pharmaceutical Medicine
... organisations. Many years of experience with new colleagues showed me how useful some sort of booklet might be, that would give them a better understanding of some of the less familiar technical terms and their context. In this dictionary, containing at present more than 800 keywords, the attention ...
... organisations. Many years of experience with new colleagues showed me how useful some sort of booklet might be, that would give them a better understanding of some of the less familiar technical terms and their context. In this dictionary, containing at present more than 800 keywords, the attention ...
E4Step4 - Duke People
... In adjusting the dose in an individual patient after observing the response to an initial dose, what would be most helpful is knowledge of the shape of individual doseresponse curves, which is usually not the same as the population (group) average dose-response curve. Study designs that allow estima ...
... In adjusting the dose in an individual patient after observing the response to an initial dose, what would be most helpful is knowledge of the shape of individual doseresponse curves, which is usually not the same as the population (group) average dose-response curve. Study designs that allow estima ...
Extract from the Clinical Evaluation Report for adalimumab
... of 6.6µg/mL at Week 24 and 7.2 µg/mL at Week 56. The mean trough concentrations appeared to be maintained in subjects who continued to receive adalimumab treatment eow for 52 weeks. In subjects whose doses were escalated, higher trough concentrations were achieved after dose escalation. Six (6/182, ...
... of 6.6µg/mL at Week 24 and 7.2 µg/mL at Week 56. The mean trough concentrations appeared to be maintained in subjects who continued to receive adalimumab treatment eow for 52 weeks. In subjects whose doses were escalated, higher trough concentrations were achieved after dose escalation. Six (6/182, ...
Pediatric Headache: Consult and Referral Guidelines
... • Asking about common symptoms seen in primary headaches: –Tension headaches are diffuse, non-throbbing, mild to moderate severity headaches without significant worsening with activity, light or sounds sensitivity, or nausea –Migraine headaches are bifrontal or unilateral moderate to severe intensit ...
... • Asking about common symptoms seen in primary headaches: –Tension headaches are diffuse, non-throbbing, mild to moderate severity headaches without significant worsening with activity, light or sounds sensitivity, or nausea –Migraine headaches are bifrontal or unilateral moderate to severe intensit ...
Once versus twice daily budesonide metered
... 400 g) once daily for 12 weeks were similarly effective to control symptoms and to improve lung function as compared to placebo 18. Recently, a metaanalysis on the efficacy of budesonide administered once daily compared to twice daily in patients with mild to moderate asthma found that once-daily b ...
... 400 g) once daily for 12 weeks were similarly effective to control symptoms and to improve lung function as compared to placebo 18. Recently, a metaanalysis on the efficacy of budesonide administered once daily compared to twice daily in patients with mild to moderate asthma found that once-daily b ...
Application no. 62303/13
... knowledge of drug addiction treatment. The applicant had neither been given substitution treatment in the clinic, nor had the doctors recommended substitution treatment in prison. After three years in detention, he no longer suffered from physical withdrawal symptoms. Moreover, his condition with re ...
... knowledge of drug addiction treatment. The applicant had neither been given substitution treatment in the clinic, nor had the doctors recommended substitution treatment in prison. After three years in detention, he no longer suffered from physical withdrawal symptoms. Moreover, his condition with re ...
ATX-101 (DEOXYCHOLIC ACID) INJECTION ADVISORY
... maximum intended dose of 100 mg, maximum observed plasma DCA concentrations (mean Cmax) were seen within 1 hour (time to maximum observed plasma concentration [tmax]) and returned to the baseline endogenous DCA concentrations within 24 hours, indicating rapid absorption and subsequent clearance from ...
... maximum intended dose of 100 mg, maximum observed plasma DCA concentrations (mean Cmax) were seen within 1 hour (time to maximum observed plasma concentration [tmax]) and returned to the baseline endogenous DCA concentrations within 24 hours, indicating rapid absorption and subsequent clearance from ...
Prescribing Information
... sofosbuvir in combination with another HCV direct-acting antiviral, including OLYSIO. A fatal cardiac arrest was reported in a patient receiving a sofosbuvircontaining regimen (ledipasvir/sofosbuvir). Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks ...
... sofosbuvir in combination with another HCV direct-acting antiviral, including OLYSIO. A fatal cardiac arrest was reported in a patient receiving a sofosbuvircontaining regimen (ledipasvir/sofosbuvir). Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks ...
Extract from the Clinical Evaluation Report for
... with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. ...
... with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. ...
Jeffrey S. Barkin, MD 97 A Exchange Street Suite 401 Portland
... EXECUTIVE SUMMARY Bipolar disorder is a potentially devastating illness, marked by serious debilitating comorbidities when left untreated. Fortunately, there exist a number of effective, indicated and FDA approved treatments for bipolar disorder. All of these treatments have demonstrated efficacy th ...
... EXECUTIVE SUMMARY Bipolar disorder is a potentially devastating illness, marked by serious debilitating comorbidities when left untreated. Fortunately, there exist a number of effective, indicated and FDA approved treatments for bipolar disorder. All of these treatments have demonstrated efficacy th ...
Placebo-controlled study
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham ""placebo"" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further ""natural history"" group that does not receive any treatment at all.The purpose of the placebo group is to account for the placebo effect, that is, effects from treatment that do not depend on the treatment itself. Such factors include knowing one is receiving a treatment, attention from health care professionals, and the expectations of a treatment's effectiveness by those running the research study. Without a placebo group to compare against, it is not possible to know whether the treatment itself had any effect.Patients frequently show improvement even when given a sham or ""fake"" treatment. Such intentionally inert placebo treatments can take many forms, such as a pill containing only sugar, a surgery where nothing efficacious is actually done (just an incision and sometimes some minor touching or handling of the underlying structures), or a medical device (such as an ultrasound machine) that is not actually turned on. Also, due to the body's natural healing ability and statistical effects such as regression to the mean, many patients will get better even when given no treatment at all. Thus, the relevant question when assessing a treatment is not ""does the treatment work?"" but ""does the treatment work better than a placebo treatment, or no treatment at all?"" As one early clinical trial researcher wrote, ""the first object of a therapeutic trial is to discover whether the patients who receive the treatment under investigation are cured more rapidly, more completely or more frequently, than they would have been without it.""p.195 More broadly, the aim of a clinical trial is to determine what treatments, delivered in what circumstances, to which patients, in what conditions, are the most effective.Therefore, the use of placebos is a standard control component of most clinical trials, which attempt to make some sort of quantitative assessment of the efficacy of medicinal drugs or treatments. Such a test or clinical trial is called a placebo-controlled study, and its control is of the negative type. A study whose control is a previously tested treatment, rather than no treatment, is called a positive-control study, because its control is of the positive type.Government regulatory agencies approve new drugs only after tests establish not only that patients respond to them, but also that their effect is greater than that of a placebo (by way of affecting more patients, by affecting responders more strongly, or both). As a result, ""placebo-controlled studies often are designed in such a way that disadvantages the placebo condition"".