Intravenous Magnesium as an Adjuvant in Acute Bronchospasm: A
... acute bronchospasm, its effectiveness for this indication remains unclear, prompting this meta-analysis. Methods: All randomized controlled trials of adjuvant bolus intravenous magnesium sulfate for acute bronchospasm in the emergency department were eligible. Trials were identified using MEDLINE, E ...
... acute bronchospasm, its effectiveness for this indication remains unclear, prompting this meta-analysis. Methods: All randomized controlled trials of adjuvant bolus intravenous magnesium sulfate for acute bronchospasm in the emergency department were eligible. Trials were identified using MEDLINE, E ...
Hemorrhoids and Varicose Veins
... modalities aim to affect sclerosis of the vascular root and to fix the mucosa to the underlying submucosa and muscle.18 There have been several studies showing the efficacy of these treatments as comparable to the semiinvasive therapeutic modalities. A study of 758 patients with symptomatic hemorrho ...
... modalities aim to affect sclerosis of the vascular root and to fix the mucosa to the underlying submucosa and muscle.18 There have been several studies showing the efficacy of these treatments as comparable to the semiinvasive therapeutic modalities. A study of 758 patients with symptomatic hemorrho ...
Merck`s policy on posting of redacted study protocols on journal
... Initiation of Part 2 will be contingent on the availability of a final report from the 3-month nonhuman primate (NHP) toxicology study, with an acceptable safety profile, which will include a 6-month postdose observation period. Moreover, initiation of Cohort 5 (3 mg/kg) in Part 2 of the study will ...
... Initiation of Part 2 will be contingent on the availability of a final report from the 3-month nonhuman primate (NHP) toxicology study, with an acceptable safety profile, which will include a 6-month postdose observation period. Moreover, initiation of Cohort 5 (3 mg/kg) in Part 2 of the study will ...
AusPAR: Selexipag - Therapeutic Goods Administration
... Uptravi is effective in combination with an endothelin receptor antagonist (ERA) or a phosphodiesterase-5 (PDE-5) inhibitor, or in triple combination with an ERA and a PDE5 inhibitor, or as monotherapy.1 Selexipag is an oral, selective, prostacyclin receptor (IP receptor) agonist, and is structurall ...
... Uptravi is effective in combination with an endothelin receptor antagonist (ERA) or a phosphodiesterase-5 (PDE-5) inhibitor, or in triple combination with an ERA and a PDE5 inhibitor, or as monotherapy.1 Selexipag is an oral, selective, prostacyclin receptor (IP receptor) agonist, and is structurall ...
Intravitreal bevacizumab injection alone or combined with macular
... due to satisfying results or no further improvement, the next step of treatment, laser photocoagulation using the focal/grid method on 53 eyes, was performed after 4 to 6 weeks. The effect of combined therapy was evaluated after 6 weeks. The mean reduction in CMT for the eyes (n = 31) treated with b ...
... due to satisfying results or no further improvement, the next step of treatment, laser photocoagulation using the focal/grid method on 53 eyes, was performed after 4 to 6 weeks. The effect of combined therapy was evaluated after 6 weeks. The mean reduction in CMT for the eyes (n = 31) treated with b ...
Appendix 7 Analysis of 220 papers/letters that cite the Keller paper
... adolescents (27,28). Available studies show similar rates of clinical response to either psychotherapy or medication (27,31). Either approach would therefore be empirically justified, with the choice based on the patient’s and clinician’s inclination. Table 1 quotes ‘responders’ as 63% for paroxetin ...
... adolescents (27,28). Available studies show similar rates of clinical response to either psychotherapy or medication (27,31). Either approach would therefore be empirically justified, with the choice based on the patient’s and clinician’s inclination. Table 1 quotes ‘responders’ as 63% for paroxetin ...
... Double-blind randomized placebo-controlled trials assessing lung function changes under repeated use of antihistamine in adult asthma were selected, and the quality of studies was scored. Morning peak expiratory flow rate (PEFR) was the primary outcome: an effect size was computed for each study, wi ...
Comparative Efficacy, Speed, and Adverse Effects of Three PTSD
... PTSD such as numbing symptoms. Moreover, exposure might not be beneficial for all patients. Tarrier et al. (1999) reported that 31% of patients treated with imaginal exposure experienced a worsening of PTSD symptoms from pre- to posttreatment. The validity of this claim has been debated (Devilly & F ...
... PTSD such as numbing symptoms. Moreover, exposure might not be beneficial for all patients. Tarrier et al. (1999) reported that 31% of patients treated with imaginal exposure experienced a worsening of PTSD symptoms from pre- to posttreatment. The validity of this claim has been debated (Devilly & F ...
Day Hospital and Residential Addiction Treatment
... programs that adhere to traditional social model ideals (i.e., emphasis on maintaining an environment conducive to recovery; Institute of Medicine, 1990) have reported that the hallmark of this setting is the opportunity for social interactions about recoveryrelated issues among peers in a homelike ...
... programs that adhere to traditional social model ideals (i.e., emphasis on maintaining an environment conducive to recovery; Institute of Medicine, 1990) have reported that the hallmark of this setting is the opportunity for social interactions about recoveryrelated issues among peers in a homelike ...
Remestemcel-L, ex vivo adult human mesenchymal stem cells
... submission (Clinical Overview and Clinical Summary of Efficacy), and in the sponsor’s letter of application to register Prochymal for the proposed indication. The main features of the submitted clinical rationale are outlined below. Acute graft versus host disease (GVHD) is an iatrogenic, progressiv ...
... submission (Clinical Overview and Clinical Summary of Efficacy), and in the sponsor’s letter of application to register Prochymal for the proposed indication. The main features of the submitted clinical rationale are outlined below. Acute graft versus host disease (GVHD) is an iatrogenic, progressiv ...
Alternative Headache Treatments: Nutraceuticals, Behavioral and
... through its role in aerobic cellular respiration. Because of its activity in mitochondrial function and as an antioxidant, it has been hypothesized to be useful in migraine prevention. Two small studies thus far have shown some benefit of CoQ10 in migraine treatment. In the first, an open-label stud ...
... through its role in aerobic cellular respiration. Because of its activity in mitochondrial function and as an antioxidant, it has been hypothesized to be useful in migraine prevention. Two small studies thus far have shown some benefit of CoQ10 in migraine treatment. In the first, an open-label stud ...
Viread - activatethecard.com
... for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with VIREAD should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steat ...
... for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with VIREAD should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steat ...
Recent Advances in the Management of Hereditary Angioedema
... portant to reduce the burden of care. Quality assurance ...
... portant to reduce the burden of care. Quality assurance ...
Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing
... is intended (e.g., venous stasis ulcer, diabetic foot ulcer, pressure ulcer, burn sites, and donor sites) as well as the product’s benefits, risks, and limitations. Because wounds differ in their pathophysiology, it is difficult to generalize results obtained from a trial conducted in subjects with ...
... is intended (e.g., venous stasis ulcer, diabetic foot ulcer, pressure ulcer, burn sites, and donor sites) as well as the product’s benefits, risks, and limitations. Because wounds differ in their pathophysiology, it is difficult to generalize results obtained from a trial conducted in subjects with ...
PROZAC
... Age--The disposition of single doses of fluoxetine in healthy elderly subjects (greater than 65 years of age) did not differ significantly from that in younger normal subjects. However, given the long half-life and nonlinear disposition of the drug, a single-dose study is not adequate to rule out th ...
... Age--The disposition of single doses of fluoxetine in healthy elderly subjects (greater than 65 years of age) did not differ significantly from that in younger normal subjects. However, given the long half-life and nonlinear disposition of the drug, a single-dose study is not adequate to rule out th ...
MulitFlex+ brochure
... stored credits are low, further credits can be purchased to top up the account. It is only necessary to return applicators in the rare event these need physical refurbishment. And when this happens standard refurbishment is free of charge. Fast treatment The ergonomic I2PL applicators offer fast and ...
... stored credits are low, further credits can be purchased to top up the account. It is only necessary to return applicators in the rare event these need physical refurbishment. And when this happens standard refurbishment is free of charge. Fast treatment The ergonomic I2PL applicators offer fast and ...
s for disease control i Socio-cultural determinants of timely and delayed
... (EMIC) was administered to 178 BU-affected persons. Based on research evidence, respondents were classified as timely treatment (use of medical treatment 3 months from awareness of disease) and delayed treatment (medical treatment 3 months after onset of disease and failure to use medical treatment) ...
... (EMIC) was administered to 178 BU-affected persons. Based on research evidence, respondents were classified as timely treatment (use of medical treatment 3 months from awareness of disease) and delayed treatment (medical treatment 3 months after onset of disease and failure to use medical treatment) ...
As a PDF file
... prohibit long-term use (Woods et al., 1992). Case reports have shown that some anxietydisordered patients have required long-term BZ treatment with higher than normal doses to make gains from any treatment, even if they were physiologically dependent on them (Huttunen, 2002). Furthermore, while subj ...
... prohibit long-term use (Woods et al., 1992). Case reports have shown that some anxietydisordered patients have required long-term BZ treatment with higher than normal doses to make gains from any treatment, even if they were physiologically dependent on them (Huttunen, 2002). Furthermore, while subj ...
(PSD) July 2015 PBAC Meeting
... The sponsor requested a hearing for this item. The clinician presented clinical case studies and discussed how strontium ranelate is currently used in practice. The clinician stated that strontium ranelate has a unique mode of action and maintains an important place in clinical therapy for those pat ...
... The sponsor requested a hearing for this item. The clinician presented clinical case studies and discussed how strontium ranelate is currently used in practice. The clinician stated that strontium ranelate has a unique mode of action and maintains an important place in clinical therapy for those pat ...
Protocol Template - UCSF HUB - University of California, San
... State the secondary OBJECTIVE. The secondary is usually one of the other items listed above or may be research related, etc. ...
... State the secondary OBJECTIVE. The secondary is usually one of the other items listed above or may be research related, etc. ...
WHO GCP 1995
... A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the prod ...
... A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the prod ...
Effect of once daily and twice daily sustained release
... broken in half. A matching placebo was also used to allow the study to be blind. The study began with a theophylline dosage titration period. While taking their pretrial slow release theophylline twice a day each patient had his/her dosage adjusted, if necessary, to produce morning theophylline conc ...
... broken in half. A matching placebo was also used to allow the study to be blind. The study began with a theophylline dosage titration period. While taking their pretrial slow release theophylline twice a day each patient had his/her dosage adjusted, if necessary, to produce morning theophylline conc ...
GAMMAGARD LIQUID
... and/or symptoms of some viral infections. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxalta Canada Corporation, 1-800-387-8399. GAMMAGARD LIQUID should only be administered intravenously ...
... and/or symptoms of some viral infections. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxalta Canada Corporation, 1-800-387-8399. GAMMAGARD LIQUID should only be administered intravenously ...
Product Monograph - Novo Nordisk Canada
... In clinical trials of VICTOZA®, subjects with clinically significant heart disease, acute myocardial infarction within 6 months, unstable angina pectoris and congestive heart failure (NYHA, class III to IV) were not studied. Therefore, VICTOZA® should be used with caution in ...
... In clinical trials of VICTOZA®, subjects with clinically significant heart disease, acute myocardial infarction within 6 months, unstable angina pectoris and congestive heart failure (NYHA, class III to IV) were not studied. Therefore, VICTOZA® should be used with caution in ...
PDF
... Statistical Methodology The purpose of this pilot study was to assess the safety and outcome of combined IV and IA therapy to determine if it is futile to proceed to a larger randomized trial. For the sample size estimation, we used the proportions of successful outcomes obtained from subsets of pla ...
... Statistical Methodology The purpose of this pilot study was to assess the safety and outcome of combined IV and IA therapy to determine if it is futile to proceed to a larger randomized trial. For the sample size estimation, we used the proportions of successful outcomes obtained from subsets of pla ...
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"".