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Z:ResProt.prn.pdf - University of Rochester
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 ...
Comparative effectiveness of a complex Ayurvedic treatment and conventional standard
Comparative effectiveness of a complex Ayurvedic treatment and conventional standard

... Background: Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however ...
Full Prescribing Information
Full Prescribing Information

... leukoencephalopathy (PML), a rare and often fatal opportunistic infection of the central nervous system (CNS). PML is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised. In ENTYVIO clinical trials, patients were actively monitored for PML with fr ...
this presentation as a tool to present at your town library
this presentation as a tool to present at your town library

... A Relative Risk, RR, is how many more times SUICIDE and its precursors THINKING OF SUICIDE AND SUICIDAL ATTEMPTS occur in SSRI-TREATED PATIENTS over and above those treated with a Tricyclic ...
1 - BMJ Open
1 - BMJ Open

... and household roles, and participation in society20 21 Melbourne, Australia: Alfred Hospital, 2014); notably, as we are unable to measure prefracture disability prospectively in this population, we will rely on patient recall of prefracture self-performance in WHODAS V.2.0 domains; (2) cognitive sta ...
Protocol S1.
Protocol S1.

... consumption in patients after revision knee arthroplasty. Total knee arthroplasty is associated with intense postoperative pain and revision arthroplasty is assumed to be even more painful. The patient population consists primarily of elderly people with high co-morbidity. It is therefore essential ...
Orally Effective Drugs for Kala-azar
Orally Effective Drugs for Kala-azar

... than that seen with some parenteral therapies, GI symptoms could be of more consequence in severely ill patients, such as those who are malnourished or dehydrated than they were in patients included in the clinical trials. As miltefosine has been shown to be teratogenic in animals, it should not be ...
Developing evidence-based clinical indicators: a
Developing evidence-based clinical indicators: a

... Although the presented indicators for lung cancer are associated with B- and C-evidence, they might be regarded as important by a measurement team when evaluating the treatment for lung cancer, because it is important from a clinical perspective to evaluate this clinical practice even though no rand ...
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION
1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION

... Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials in HIV-asso ...
Generic IRB Application for Research
Generic IRB Application for Research

... board committees for clinical studies since 1983 (Appendix A). A bibliography of recent publications is available from the internet (Appendix B). The same device can be used to measure a patient’s Pain Tolerance Threshold (PTT). A PTT is the maximum amount of the atraumatic neuroselective electrical ...
Herb-drug interactions
Herb-drug interactions

... Know the main reasons for caution with herbs and surgery or dental procedures, i.e., herbal anticoagulants (cause bleeding), sedative or stimulant herbs (modify anesthesia). Know principles for clinical coping with herb-drug ...
Elinogrel, an orally and intravenously available ADP
Elinogrel, an orally and intravenously available ADP

... Elinogrel, a quinazoline-2,4-dione, is a potent, reversible, ADP receptor antagonist that is available in an oral and intravenous formulation (4). Elinogrel has a plasma half-life of approximately 12 hours. Its direct mode of action does not require metabolic activation or conversion into an active ...
Therapy Biomedical - International Academy of Homotoxicology
Therapy Biomedical - International Academy of Homotoxicology

... display screen equipment are frequently exposed to lack of space, noise, poor lighting, and poor ergonomics.20 From 2009 to 2010, an estimated 21,000 individuals in Great Britain who worked in the past 12 months were experiencing hearing problems that they believed to be work related.6 Symptoms of s ...
Clinical audit tool
Clinical audit tool

... inflammatory exacerbation of Crohn’s disease in a 12month period are offered monotherapy with a conventional glucocorticosteroid (prednisolone, methylprednisolone or intravenous hydrocortisone) to induce remission. [See data collection form, questions 1 and 3] 2. In all people with 1 or more of: ...
Biochemical Markers as Tools to Increase Efficiency in Drug
Biochemical Markers as Tools to Increase Efficiency in Drug

... Burden of disease markers assess the severity or extent of disease, typically at a single point in time, among individuals with OA. An investigative marker is one for which there is insufficient information to allow inclusion into one of the existing categories. This includes markers whose relations ...
(PSD) March 2015 PBAC meeting
(PSD) March 2015 PBAC meeting

... PBAC Comment: ‘…PBAC observed that both vedolizumab and infliximab showed statistically significant better response rates and remission rates at week 6-8 and 52 compared to placebo. The indirect comparison of infliximab and vedolizumab demonstrated a similar response rate for the two drugs. Noting t ...
Treatment of Cough
Treatment of Cough

... Treatment of Cough 1. Antitussive a. Opioid i. Codeine (methylmorphine) b. Non – opioid i. Dextromethorphan 2. Expectorant a. Guaifenesin 3. Mucolytics a. N – actylcysteine b. Bromhexine c. Ambroxol (active metabolite of Bromhexine) ...
News Release Puma Biotechnology Reports Fourth Quarter and Full
News Release Puma Biotechnology Reports Fourth Quarter and Full

... This press release contains forward-looking statements, including statements regarding anticipated timing for the commencement and completion of various clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks ...
Trillium Therapeutics Inc. (Form: 6-K, Received: 02
Trillium Therapeutics Inc. (Form: 6-K, Received: 02

... addition of other cohorts to this trial. The TTI-621-02 solid tumor trial has enrolled its first patient and we expect this study to provide key scientific data for charting the course of our clinical development program, especially as it relates to combination therapies,” said Dr. Niclas Stiernholm ...
research newsletter - VCU
research newsletter - VCU

... chemicals) upon activation by pollen particles or other allergens, leading to the itching and sneezing that is all-too-familiar for many. However, MCs are also immune cells and participate in a variety of complex immune reactions. For example, we know that MCs are found at increased numbers in the s ...
NH3 N]ammonia
NH3 N]ammonia

... minutes). In the myocardium, its biologic half-life has been estimated to be less than 2 minutes (effective half-life less than 1.67 minutes). In the brain its biologic half-life is less than 3 seconds. The mass of 13N-ammonia injected for imaging is very small compared to the normal range of ammoni ...
united states securities and exchange commission - corporate
united states securities and exchange commission - corporate

... potential benefits of product candidates, the expected timing of data from clinical trials, technology enhancements and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor’s management but are subject to significant risks and unce ...
View press release  doc - 79 KB
View press release doc - 79 KB

... jointly with the Geneva-based MMV. RBx 11160 is entering into Phase IIb dose range studies in India, Thailand and Africa very soon after the successful completion of a Phase IIa Proof of Concept study in October 2005. RBx 11160 is the first synthetic peroxide antimalarial, and one that could be prod ...
Notification on Practical Operations of Electronic Study Data
Notification on Practical Operations of Electronic Study Data

... established for dosage and administration based on the study results (5) Bioequivalence studies that provide a major evidence for efficacy, safety, and dosage and administration. For example, bioequivalence studies of both drug products, where the formulation used in pivotal study is different from ...
CDISC Clinical Research Glossary
CDISC Clinical Research Glossary

... channels have a bandwidth. baseline assessment. Assessment of subjects as they enter a trial and before they receive any treatment. baseline characteristics. Demographic, clinical, and other data collected for each participant at the beginning of the trial before the intervention is administered. NO ...
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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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