5.11 pasireotide
... pasireotide LAR arms of the trial demonstrated a >25% reduction in tumour volume by week 24 compared to the active control arm. However, there was no significant difference between pasireotide LAR at either dose and active control therapy in the reduction of most signs and symptoms of acromegaly (fa ...
... pasireotide LAR arms of the trial demonstrated a >25% reduction in tumour volume by week 24 compared to the active control arm. However, there was no significant difference between pasireotide LAR at either dose and active control therapy in the reduction of most signs and symptoms of acromegaly (fa ...
ZEMPLAR® (paricalcitol) Injection Fliptop Vial
... during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Nursing Mothers Studies in rats have shown that paricalcitol is present in the milk. It is not known whether paricalcitol is excreted in human milk. In the nursing patient, a decision should be ma ...
... during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Nursing Mothers Studies in rats have shown that paricalcitol is present in the milk. It is not known whether paricalcitol is excreted in human milk. In the nursing patient, a decision should be ma ...
1596-6743-1-SP - Iranian Journal of Kidney Diseases
... The average age of the participants of both groups was calculated at 5.8±2.2. This figure was 6.1±2.48 and 5.5±2.01 for intervention and control groups, respectively (p=0.14). The frequencies of the clinical symptoms of intervention and control group members are presented in table 1. Research result ...
... The average age of the participants of both groups was calculated at 5.8±2.2. This figure was 6.1±2.48 and 5.5±2.01 for intervention and control groups, respectively (p=0.14). The frequencies of the clinical symptoms of intervention and control group members are presented in table 1. Research result ...
TB_7-1 - I-Tech
... Combination Tabs (2) • Fixed Dose Combination pills include two, three or even four drugs in one pill • Advantages of FDCs ...
... Combination Tabs (2) • Fixed Dose Combination pills include two, three or even four drugs in one pill • Advantages of FDCs ...
Z:ResProt.prn.pdf - University of Rochester
... [Remove section if not applicable] If genetic and/or genomic research activities are proposed as either the main objective of the study, or as an ancillary activity within the protocol, the following information should be described here: a general description of the test and the purpose for conducti ...
... [Remove section if not applicable] If genetic and/or genomic research activities are proposed as either the main objective of the study, or as an ancillary activity within the protocol, the following information should be described here: a general description of the test and the purpose for conducti ...
Expanded Access - Treatment Use of Drug or Biologic
... (a) Drug not being developed. The drug is not being developed, for example, because the disease or condition is so rare that the sponsor is unable to recruit patients for a clinical trial. (b) Drug being developed. The drug is being studied in a clinical trial, but patients requesting the drug for e ...
... (a) Drug not being developed. The drug is not being developed, for example, because the disease or condition is so rare that the sponsor is unable to recruit patients for a clinical trial. (b) Drug being developed. The drug is being studied in a clinical trial, but patients requesting the drug for e ...
Effect of Sodium Zirconium Cyclosilicate on Potassium Lowering for
... the normal range in 84% of patients (95% CI, 79% to 88%) by 24 hours and in 98% (95% CI, 96% to 99%) by 48 hours. Mean serum potassium during days 8-29 was significantly reduced in all zirconium cyclosilicate groups vs placebo, with numerically lower potassium achieved with higher doses (4.8 mEq/L [ ...
... the normal range in 84% of patients (95% CI, 79% to 88%) by 24 hours and in 98% (95% CI, 96% to 99%) by 48 hours. Mean serum potassium during days 8-29 was significantly reduced in all zirconium cyclosilicate groups vs placebo, with numerically lower potassium achieved with higher doses (4.8 mEq/L [ ...
A Lot More than Patient Data
... In clinical trials, it’s not just the patient’s data that SAS programmers deal with. There are several other associated data/ information that are being used to analyze the clinical trial data. Patient’s data are basically obtained from CRFs (Case Report Forms) which are processed and reported in a ...
... In clinical trials, it’s not just the patient’s data that SAS programmers deal with. There are several other associated data/ information that are being used to analyze the clinical trial data. Patient’s data are basically obtained from CRFs (Case Report Forms) which are processed and reported in a ...
PAPER Short-term effects of sibutramine (Reductil ) on
... SUBJECTS: A total of 36 obese (nine men/27women) with a body mass index of 39.374.3 (mean7s.d.) (range 30.2 – 45.2) kg/ m2 and age 44.4712.1 y. PROCEDURE AND METHODS: First phaseFshort-term effects: At baseline, the subjects were treated for 14 days with 15 mg sibutramine/placebo (period 1) followed ...
... SUBJECTS: A total of 36 obese (nine men/27women) with a body mass index of 39.374.3 (mean7s.d.) (range 30.2 – 45.2) kg/ m2 and age 44.4712.1 y. PROCEDURE AND METHODS: First phaseFshort-term effects: At baseline, the subjects were treated for 14 days with 15 mg sibutramine/placebo (period 1) followed ...
Full Prescribing Information
... pressure and heart rate have also been observed. The majority were mild to moderate in severity as assessed by the investigator. Experience with other biologic medications suggests that hypersensitivity reactions and anaphylaxis to ENTYVIO may vary in their time of onset from during infusion or imme ...
... pressure and heart rate have also been observed. The majority were mild to moderate in severity as assessed by the investigator. Experience with other biologic medications suggests that hypersensitivity reactions and anaphylaxis to ENTYVIO may vary in their time of onset from during infusion or imme ...
787_2006_Article_0549-web 1..20 - ADHS
... signs of liver damage, or heart irregularities in monitoring patients. These recommendations are the same as those for immediate-release drugs, and do not differ for different stimulants or preparations. Routine blood tests are not recommended by us (though they are by the companies); blood dyscrasi ...
... signs of liver damage, or heart irregularities in monitoring patients. These recommendations are the same as those for immediate-release drugs, and do not differ for different stimulants or preparations. Routine blood tests are not recommended by us (though they are by the companies); blood dyscrasi ...
Extract from the Clinical Evaluation
... Multiple sclerosis (MS) is a relatively common neurological condition in young adults, in which plaques of demyelination develop in the central nervous system (CNS): the brain, spinal cord or optic nerve. Demyelination of the peripheral nervous system (PNS) does not occur in MS, and Rebif is not ind ...
... Multiple sclerosis (MS) is a relatively common neurological condition in young adults, in which plaques of demyelination develop in the central nervous system (CNS): the brain, spinal cord or optic nerve. Demyelination of the peripheral nervous system (PNS) does not occur in MS, and Rebif is not ind ...
Efficacy of Scalene Muscle Botulinum Toxin Injection for the
... thoracic outlet syndrome who were being treated with botulinum toxin injections alone, studies in English, dates from 2000-2012. Studies excluded if patients had previous surgical intervention for TOS and evaluated using the GRADE system. Results: Three studies met inclusion criteria. A double-blind ...
... thoracic outlet syndrome who were being treated with botulinum toxin injections alone, studies in English, dates from 2000-2012. Studies excluded if patients had previous surgical intervention for TOS and evaluated using the GRADE system. Results: Three studies met inclusion criteria. A double-blind ...
Efficacy of Tart Cherry Juice to Reduce
... The sample size for this study was based on the difference in symptoms of the serum inflammation biomarker C-Reactive Protein (CRP). Based on the expected change (SD of the difference) in CRP, it was estimated that, with a sample of 20 subjects, a 14% difference in CRP could be detected between the ...
... The sample size for this study was based on the difference in symptoms of the serum inflammation biomarker C-Reactive Protein (CRP). Based on the expected change (SD of the difference) in CRP, it was estimated that, with a sample of 20 subjects, a 14% difference in CRP could be detected between the ...
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf. Accessed January 24, 2013.
... hypoglycemia compared with 39 of 263 (14.8%) patients administered placebo in combination with metformin and a sulfonylurea. Adverse reactions of hypoglycemia were based on all reports of hypoglycemia. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is ...
... hypoglycemia compared with 39 of 263 (14.8%) patients administered placebo in combination with metformin and a sulfonylurea. Adverse reactions of hypoglycemia were based on all reports of hypoglycemia. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is ...
PDF - Asian Journal of Andrology
... (IELT)-the time from vaginal penetration to the start of intravaginal ejaculation-as an objective outcome measure. The IELT is positively skewed with a median of 5.4 min. The 0.5 percentile equates to an IELT of 0.9 min and the 2.5 percentile an IELT of 1.3 min [5]. It is generally accepted but not ...
... (IELT)-the time from vaginal penetration to the start of intravaginal ejaculation-as an objective outcome measure. The IELT is positively skewed with a median of 5.4 min. The 0.5 percentile equates to an IELT of 0.9 min and the 2.5 percentile an IELT of 1.3 min [5]. It is generally accepted but not ...
Public Summary Document (Word 458 KB)
... disorders and thrombocytopenia were higher in the radium-223 group compared with best supportive care due to its myelosuppressive nature. The results of the indirect comparison between radium-223 and strontium-89 showed no statistically significant differences in AEs. Radium-223 also appeared to be ...
... disorders and thrombocytopenia were higher in the radium-223 group compared with best supportive care due to its myelosuppressive nature. The results of the indirect comparison between radium-223 and strontium-89 showed no statistically significant differences in AEs. Radium-223 also appeared to be ...
Effect of Tribulus terrestris treatment on impotence and
... To test the effectiveness of Tribulus terrestris in treating impotence and male libido disorders, we enrolled 11 subjects, composed of 4 men diagnosed with lowered or nonexistent libido and 7 impotent men. To these two groups, 3 x 1 Libilov tablets were administered per day for 2 weeks, without any ...
... To test the effectiveness of Tribulus terrestris in treating impotence and male libido disorders, we enrolled 11 subjects, composed of 4 men diagnosed with lowered or nonexistent libido and 7 impotent men. To these two groups, 3 x 1 Libilov tablets were administered per day for 2 weeks, without any ...
SUGI 24: Cross Crossover Studies Off Your List
... often. Moreover, each treatment follows directly each other treatment equally often. This is a very efficient design for looking at treatment effects since the period effect can be separated from the treatment effect due to the orthogonal design. Balanced designs such as this will require as many pe ...
... often. Moreover, each treatment follows directly each other treatment equally often. This is a very efficient design for looking at treatment effects since the period effect can be separated from the treatment effect due to the orthogonal design. Balanced designs such as this will require as many pe ...
The effect of montelukast on respiratory infants
... recommends that a physician should consider daily controller medication trial for children who consistently require symptomatic treatment .2 days per week for .4 weeks [1]. According to the National Asthma Education and Prevention Program, the ranking of evidence of the expert panel was D, i.e. pane ...
... recommends that a physician should consider daily controller medication trial for children who consistently require symptomatic treatment .2 days per week for .4 weeks [1]. According to the National Asthma Education and Prevention Program, the ranking of evidence of the expert panel was D, i.e. pane ...
A dose-response study with formoterol Turbuhaler maintenance therapy in asthmatic patients
... power, 50 patients per group (200 in total) were required to detect a true mean difference in change in morning PEF of about 28 L· min-1 in a pairwise comparison using a two-tailed t-test at 5% significance level, given a standard deviation in morning PEF change of about 50 L· min-1. In addition to ...
... power, 50 patients per group (200 in total) were required to detect a true mean difference in change in morning PEF of about 28 L· min-1 in a pairwise comparison using a two-tailed t-test at 5% significance level, given a standard deviation in morning PEF change of about 50 L· min-1. In addition to ...
19-51028-000-TMS-Therapy-Level-II-and-External
... 3. The technology must improve the net health outcome. The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes. Two Level 1 sham-controlled randomized studies provide consistent data documenting that TMS Therapy using a specific NeuroStar treatm ...
... 3. The technology must improve the net health outcome. The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes. Two Level 1 sham-controlled randomized studies provide consistent data documenting that TMS Therapy using a specific NeuroStar treatm ...
Brief Treatment for Elementary School Children with Disaster
... total CRI, total CDI, and total RCMAS (adjusted p of .017). No significant differences were found between those with follow-up CRI scores above 11 and those scoring less than 12 on the follow-up CRI. Visits to the School Health Nurse There was a significant reduction in the number of health care vis ...
... total CRI, total CDI, and total RCMAS (adjusted p of .017). No significant differences were found between those with follow-up CRI scores above 11 and those scoring less than 12 on the follow-up CRI. Visits to the School Health Nurse There was a significant reduction in the number of health care vis ...
clinical-therapeutic assessment of the use of lysine clonixinate in the
... production of prostaglandins, such as PGE2, which are involved ...
... production of prostaglandins, such as PGE2, which are involved ...
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"".