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An Evidence-based Dietary Fiber Enrichment
An Evidence-based Dietary Fiber Enrichment

... treatment, involving bulk-forming laxatives, stool softeners, osmotic laxatives, stimulants and suppositories. It is suggested that serving laxatives as first line treatment or long-term therapy for constipation is widely not advocated because of heavy economic burden and multiple adverse effects li ...
Document
Document

...  Assessed safety and efficacy of cangrelor as an adjunct to tpa in 92 patients with AMI  All patients were treated with aspirin and heparin  Randomized to cangrelor alone (280micro g/min), full-dose tpa alone, or cangrelor 35, 140, or 280micro g/min in conjunction with half-dose tpa  Combination ...
NEWER ANTIPLATELETS
NEWER ANTIPLATELETS

...  Assessed safety and efficacy of cangrelor as an adjunct to tpa in 92 patients with AMI  All patients were treated with aspirin and heparin  Randomized to cangrelor alone (280micro g/min), full-dose tpa alone, or cangrelor 35, 140, or 280micro g/min in conjunction with half-dose tpa  Combination ...
Clinical Study Protocol
Clinical Study Protocol

... dry powder), but its bioavailability, pharmacokinetics, possible accumulation and effect during chronic use of the plant has not yet been established. Similarly, this type of information is also not available for the other possible active constituents of this plant medicine. To our knowledge no clin ...
An introduction to Phase 1 dual
An introduction to Phase 1 dual

... If a prior ordering of the dose combinations can be assumed then a 1-dimensional CRM can be applied. 2 Alternatively, the likelihood of each possible ordering can be assessed after each patient is recruited. 3 Can become problematic if many dose levels are used (many possible orderings). ...
Edoxaban versus Warfarin in Patients with Atrial Fibrillation
Edoxaban versus Warfarin in Patients with Atrial Fibrillation

... came first), with interval censoring of events during study-drug interruptions that lasted more than 3 days. To satisfy noninferiority, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio of the primary efficacy end point comparing edoxaban with warfarin could not exce ...
Transcranial magnetic stimulation: a historical evaluation and future
Transcranial magnetic stimulation: a historical evaluation and future

... neurobiological effects can be leveraged for therapeutic applications in neurology, psychiatry and rehabilitation. Historically, the ethical considerations guiding the therapeutic practice of TMS were largely concerned with aspects of subject safety in clinical trials. While safety remains of paramo ...
Alzheimer`s disease –mechansims-cause-factors-prevalence
Alzheimer`s disease –mechansims-cause-factors-prevalence

... is usually less than three years from when symptoms first appear [11]. Jean-Martin Charcot, employing the clinicoanatomic method that he devised, described the clinical and pathological features of ALS during a series of lectures in the 1860s and 1870s [12]. The methodology available to Charcot was ...
Clinical exam
Clinical exam

... formulated that has become the standard formulation used today. Approximately 80 million doses of IPV are used each year, primarily in industrialized countries. The safety profile of IPV is wellcharacterized, and no serious adverse events have been associated with IPV use. Similarly, the immunogenic ...
The efficacy and toxicity of Methotrexate (MTX) monotherapy vs
The efficacy and toxicity of Methotrexate (MTX) monotherapy vs

... WMD -0.28 (95% CI -0.36 to -0.21) respectively]. However, significant difference was not found for ESR[5-7] [WMD -0.53 (95% CI-11.47 to 10.41)]. The radiographic outcome from one study[8] showed significantly less progression in the combination of MTX+ Zolendronic acid [WMD of Modified Sharp’s score ...
vitae pharmaceuticals, inc. - corporate
vitae pharmaceuticals, inc. - corporate

... amended, including statements regarding the clinical development of VTP-34072. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design ...
Vitae Pharmaceuticals, Inc
Vitae Pharmaceuticals, Inc

... including statements regarding the clinical development of VTP-34072. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estim ...
Journal Of Manged Care Pharmacy
Journal Of Manged Care Pharmacy

... in 1993 for the adjunctive therapy of partial seizures with or without secondary generalization. Despite being indicated only for the adjunctive treatment of seizures, utilization of gabapentin has increased markedly since its introduction. The National Institute for Health Care Management reported ...
Adalimumab Humira® – Abbott Laboratories Limited
Adalimumab Humira® – Abbott Laboratories Limited

... corticosteroids (budesonide); second-line therapy consists of corticosteroids (prednisone); thirdline therapy consists of immunosuppressants (azathioprine, 6-mercaptopurine, or methotrexate); and anti-tumour necrosis factor (TNF) biologic agents (infliximab or adalimumab) for patients who have faile ...
IIH:WT Trial Protocol - University of Birmingham
IIH:WT Trial Protocol - University of Birmingham

... For University of Birmingham sponsored trials, the sponsor will confirm approval of the protocol by signing the IRAS form and therefore a signature on the protocol is not required. ...
IS an OCCURENCE of NAbs the PERMANENT MARKER of the
IS an OCCURENCE of NAbs the PERMANENT MARKER of the

... by Oger and Cantillon (2007). The median NAb titer peaked at months 18. The highest median titer was 48, which is not considered as high ...
AusPAR: Zonisamide
AusPAR: Zonisamide

... comparing the same dose level, subjects of higher total body weight appear to have lower steady-state serum concentrations, but this effect appears to be relatively modest. Age (≥ 12 years) and gender, after adjustment for body weight effects, have no apparent effect on zonisamide exposure in epilep ...
Efficacy of a New Hypotonic Oral Rehydration Solution
Efficacy of a New Hypotonic Oral Rehydration Solution

... The positive clinical effect exerted by this new ORS on diarrhea could be related to a synergistic effect between prebiotics and zinc. Prebiotics have been proposed for the prevention and treatment of acute diarrhea, but efficacy data of FOS and xilooligosaccharides in the treatment of acute diarrhe ...
Bisphosphonates for treatment of osteoporosis
Bisphosphonates for treatment of osteoporosis

... (2.6 million patients) between 2007 and 2009 (approximately 15 000 femur fractures). Bisphosphonates were taken by 97 of the 102 AFF patients for an average of 5.5 years. The risk of an AFF increased with duration of bisphosphonate use from 2 cases per 100 000 patientyears for 2 years of treatment t ...
Carglumic acid - Therapeutic Goods Administration
Carglumic acid - Therapeutic Goods Administration

... The breadth of studies in the submitted dossier was generally smaller than would be expected for a new chemical entity submission as minimal pharmacology studies were submitted to support efficacy, no secondary pharmacology studies, a basic set of pharmacokinetic studies, repeat dose studies were co ...
An examination of the observed placebo effect associated with the
An examination of the observed placebo effect associated with the

... the review was threefold – to first determine whether one treatment results in a more profound change after a sham intervention than another; second, to determine whether any of those observed effects are large enough to be considered clinically meaningful; and finally, to assess whether studies des ...
Hanmi Pharm (128940 KS)
Hanmi Pharm (128940 KS)

... (HbA1C) by about 1.0%. (Medical professionals measure HbA1C to get an overall picture of average blood sugar levels over a period of weeks/months). They are injectable drugs and normally prescribed for patients who have not been able to control their conditions with tablet medicine. They preserve an ...
Prescribing Information
Prescribing Information

... tachycardia, no consistent changes in ECG tracings were observed during reboxetine treatment in adult patients. In studies of longer than 8 weeks, newly emergent adverse events were reported in approximately 30% of the reboxetine-treated patients and approximately 25% of the placebo-treated patients ...
Efficacy of Paroxetine in the Treatment of Adolescent Major
Efficacy of Paroxetine in the Treatment of Adolescent Major

... treatment with paroxetine, imipramine, or placebo in a 1:1:1 ratio. Tablets were overencapsulated in matching Supro B locking capsules to preserve medication blinding. Subjects assigned to paroxetine treatment received 20 mg/day in the morning for weeks 1 through 4. Optional dosage increases to 30 m ...
Extract from Clinical Evaluation Report: Fentanyl citrate
Extract from Clinical Evaluation Report: Fentanyl citrate

... 14 pharmacokinetic studies (7 in opioid naïve healthy subjects, 1 in opioid tolerant patients with cancer pain); ...
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Clinical trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Trials can be quite costly, depending on a number of factors. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.Only 10% of all drugs started in human clinical trials become an approved drug.
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