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K2 Biomedical
K2 Biomedical

... diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia ...
2015 Poster Submissions - New England Nursing Informatics
2015 Poster Submissions - New England Nursing Informatics

... Introduction/Background: Medications errors (wrong drug, dose, route, concentration, and/or rate) are the largest source of errors within the hospital. The administration of certain high-risk medications requires an independent double check for verification. According to Bataille et al, (2015), high ...
NOVEMBER 2016 PBAC MEETING – DEFERRALS DRUG
NOVEMBER 2016 PBAC MEETING – DEFERRALS DRUG

... submission, the PBAC reaffirmed that the claim of superior effectiveness and inferior safety, compared with placebo, was reasonable. A resubmission for nintedanib for the treatment of IPF was also considered by the PBAC at the November 2016 meeting. The PBAC noted the challenges of making comparison ...
Strategies for Companion Diagnostic Development in a
Strategies for Companion Diagnostic Development in a

... A biomarker that is measured in an analytical test system with well‐ established  performance characteristics and for which there is widespread agreement in the  medical or scientific community about the physiologic, toxicologic pharmacologic or  clinical significance of the results  Diagnostics A t ...
AshwAgAndhA - Gaia Herbs
AshwAgAndhA - Gaia Herbs

... and  VO2  max.21  Study  participants’  measures  of  balance  and  diastolic  blood  pressure   ...
Prescribing Information
Prescribing Information

... RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days. Limitations of Use: • Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infecti ...
Findings on “Right to Try” Laws and Pre
Findings on “Right to Try” Laws and Pre

... Medical Products The number of requests submitted to the FDA has increased over the last several years; in 2014, requests rose by 92%. The number of Change.org online petitions in support of individual requests has increased over the last several years. Many companies developing investigational medi ...
Study Organization and Administration (Section 1
Study Organization and Administration (Section 1

... Data Management System (DMS) is required to ensure the accuracy and integrity of the collaborative database. At the central training, the Study Coordinator must demonstrate proficiency in the use of the study’s laptop computer system to be certified for data entry and participant randomization on th ...
A Phase IB Pilot Trial of Herpesvirus Treatment in Idiopathic
A Phase IB Pilot Trial of Herpesvirus Treatment in Idiopathic

... increased risk for IPF with odds ratio from case-control studies ranging from 1.11-3.23. In addition to inhaled irritants, several viruses including adenovirus and herpesviruses have been associated with IPF(2, 3, 25, 26). A common feature of all these environmental factors is the ability to injure ...
The Pharmacogenetics Clinical Decision Support System is a
The Pharmacogenetics Clinical Decision Support System is a

... lack any formal training in the field, and most do not know how to incorporate this information into their practices to improve safety and outcomes for patients (Baars, 2005). It would be impossible for providers to memorize all of this information as more and more clinically relevant information an ...
document
document

... • G. Sledge (JCO, 2005): ‘‘A targeted therapy should attack a biologically important process (usually, though not necessarily, a single molecule), preferably one central to a hallmark of cancer. The target should be measurable in the clinic, and measurement of the target (in either quantitative or q ...
Marketing Authorisations under Exceptional Circumstances for
Marketing Authorisations under Exceptional Circumstances for

... Since the founding of the European Medicines Agency (EMA) in 1995, over fifty novel oncologic drugs have reached the European market. Despite advances in the development of cancer drugs in the last decades, there is still a high medical need for curative therapies. To accelerate patient access to ne ...
Lobeline for smoking cessation
Lobeline for smoking cessation

... Lobeline is an alkaloid derived from the leaves of an Indian tobacco plant (Lobelia inflata). It was synthesised in the early 1900s and classified as a partial nicotinic agonist. The first reported use in aiding smoking cessation was in the 1930s (Dorsey 1936), Since then it has been tested in a var ...
5 Intranasal Ciclesonide for Treatment of Allergic Rhinitis in Children
5 Intranasal Ciclesonide for Treatment of Allergic Rhinitis in Children

... discharge, itching, and congestion. These scores are often defined as reflective, representing the patient’s assessment of symptoms over the previous 12 hours, or instantaneous, representing symptoms present at the time of documentation. In a premarketing seasonal allergic rhinitis trial conducted i ...
n/2
n/2

... Determine the dose for the first patient as the dose level which produces the prior probability of dose-limiting clinical toxicity closest to p. ...
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1 - UAMS Translational Research Institute

... and safety. This is particularly important for investigational agents, and may not be necessary for commercially available drugs, and/or drugs with sufficient clinical data.  A summary from relevant clinical studies, with focus on those that provide background for your study. Please include importa ...
Intravenous Droperidol or Olanzapine as an
Intravenous Droperidol or Olanzapine as an

... Intravenous Droperidol or Olanzapine as an Adjunct to Midazolam for the Acutely Agitated Patient: A Multicentre, Randomized, Double-Blind, PlaceboControlled Clinical Trail ...
Which should be the first-line drug for newly diagnosed epilepsy
Which should be the first-line drug for newly diagnosed epilepsy

... This year saw the publication of the SANAD study, published as 2 papers in the Lancet by Marson et al. [1,2]. The SANAD study consisted of 2 arms. In arm A1, the effectiveness of carbamazepine, taken as the standard treatment for partial onset seizures, was compared to that of 4 other anti-epileptic ...
AMRIXAL extended-release capsules
AMRIXAL extended-release capsules

... contraindication-4). AMRIXAL may enhance the effects of alcohol, barbiturates, and other CNS depressants, and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Some of the more serious central nervous syst ...
Memorandum
Memorandum

... greater than the therapeutic dose during 26 weeks of treatment with Diosmin Complex.’ Tests on bacteria, human lymphocytes, mouse bone marrow and DNA in HeLa cells revealed no mutagenic effects, and the embryology, peri- and post- natal development of rat offspring bone to treated parents were not a ...
CNS newsletter - School of Nursing
CNS newsletter - School of Nursing

... Nashville, TN March 29th – April 1st. The Excellence She accomplished this all while working full time as a in Advanced Practice Nursing Award is awarded to a clinical nurse specialist caring for oncology patients neuroscience nurse in an advanced practice role who and was recognized by receiving th ...
AusPAR: Triptorelin acetate
AusPAR: Triptorelin acetate

... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
role of phenobarbitone as an antiepileptic drug in 21st century
role of phenobarbitone as an antiepileptic drug in 21st century

... the phenytoin group, with only 11% of patients being lost to follow-up. This study however did not compare the efficacy of treatment on seizure control between the two groups.13 An open-labeled, multicentric, non-comparative study to analyse the risk-benefits of treatment with phenobarbitone in adul ...
Zofran Subcutaneous Pump in the Treatment of Hyperemesis
Zofran Subcutaneous Pump in the Treatment of Hyperemesis

... effectiveness cannot be substantiated with the available data. CONCLUSION: Randomized, controlled trials of sufficient power are necessary before long-term continuous subcutaneous metoclopramide or ondansetron can be used on a widespread basis to treat nausea and vomiting during pregnancy. Cost appr ...
Product Monograph - AstraZeneca Canada
Product Monograph - AstraZeneca Canada

... Due to lack of relevant experience, treatment with DAXAS should not be initiated or existing treatment with DAXAS should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy) or patients bei ...
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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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