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... period, including symptoms that are present on awaking. Patients were instructed to consider the awakenings that occurred either during sleep or on awaking, and the number of times they used an inhaled β-agonist from bedtime to the time of awakening (defined as prior to arising from bed) when comple ...
Specific Immunotherapy—Indications and Mode of Action
Specific Immunotherapy—Indications and Mode of Action

... The clinical effect of SIT is evaluated by a comparison of the symptom and medication scores (SMS) during the allergy season of patients receiving either the active substance or placebo. The results obtained in different trials cannot be direcly compared for a number of reasons, but mainly because n ...
Draft Guidance for Industry and FDA Staff
Draft Guidance for Industry and FDA Staff

... indicated on the cover of this document. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutor ...
Trends in Diabetes - 2004
Trends in Diabetes - 2004

... half of Type II diabetes patients not responding to oral medications will want to use Exenatide to prevent progression of their diabetic condition. Bottom Line: As Diabetes cases continue to rise, these survey results show promise for several new types of therapies and technologies. First, “Increase ...
Transparency and Registration in Clinical Research in the Nordic
Transparency and Registration in Clinical Research in the Nordic

... Patients and societies depend on physicians and other health-care professionals regarding health and disease. Physicians and other health-care professionals depend on results of clinical research described in guidelines, systematic reviews, overviews, and study reports on randomised clinical trials, ...
Helsingborg Declaration 2006 on European Stroke
Helsingborg Declaration 2006 on European Stroke

... The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are disti ...
2016 annual report - Ophthalmology and Visual Sciences
2016 annual report - Ophthalmology and Visual Sciences

... Dr. Lucarelli is the Director of the Oculoplastics Service in the UW Department of Ophthalmology and Visual Sciences. He has authored 111 peer-reviewed journal articles, several textbooks, 39 book chapters and 6 digital publications. He is also a leader nationally in ASOPRS, and has received many aw ...
4 MBKelley_Branch_Recruitment and Adherence
4 MBKelley_Branch_Recruitment and Adherence

... 4. Complaints about office visits 5. Impatience during clinic visit 6. Length of time (mandatory) at each visit 7. “Distance” during interview 8. Length of time since participation in study was discussed between physician and participant 9. Humor dealing with negative aspects of trial medication ...
Protocol S1.
Protocol S1.

... (ACTUs) or [email protected] for sites outside the U.S. (ICTUs)] to have the relevant personnel at the site added to the actg.protA5164 e-mail group as soon as possible. Inclusion in the protocol e-mail group will ensure that sites receive important information about the study during its imple ...
Good practice guide for clinical radiologists Second edition
Good practice guide for clinical radiologists Second edition

... The accountability of doctors and standards of healthcare provision remain in the spotlight of public, media and political concerns. Careerlong maintenance of clinical standards of practice is required for all doctors rather than the reliance of standards determined at the time of entry into practic ...
IMP management at site
IMP management at site

... Directive • (b) dispensed to a subject in accordance with a prescription given by a health care professional, and • (c) labelled in accordance with the requirements of Schedule 5 to the Medicines for Human Use (Marketing Authorisation etc) Regulation 1994 that apply in relation to dispensed relevant ...
NIAID Protocol Template Extramural Guidance, V. 2.0 (Extra), July
NIAID Protocol Template Extramural Guidance, V. 2.0 (Extra), July

... their plan for all aspects of the study. It provides a guide for the research team to reference and follow over time and ensures that the IRB approved version of the study is implemented. When the study is complete, the protocol will aid in writing-up the study to publish. This template provides a f ...
BACKGROUND PAPER Complementary Medicine: ethics
BACKGROUND PAPER Complementary Medicine: ethics

... CAM arouses considerable controversy in the UK and there is entrenched disagreement over whether and how it may exert any effects on those who use it. CAM therapies have not been tested to the same extent as licensed drugs or approved treatments in conventional medicine and there is dispute over whe ...
First Visit - Townsend Chiropractic
First Visit - Townsend Chiropractic

... United States. Sometimes these infections are due to bacteria and sometimes these are due to a virus. The most common medical care for this situation has been antibiotics, even though antibiotics have no effect on viruses. While the article mentions that the antibiotic may be effective in an acute b ...
HMRI Governance - Hunter Medical Research Institute
HMRI Governance - Hunter Medical Research Institute

... and established a satellite foundation in Singleton, to develop and lead fundraising and awareness for HMRI in the Upper Hunter region. The HMRI Board appointed two new directors, and the HMRI Foundation also appointed three new members, providing HMRI with a diverse range of experienced professiona ...
Guidelines on Common Technical Document (CTD)
Guidelines on Common Technical Document (CTD)

... registration of pharmaceutical products for human use. The same is already in use for biological products since 2009 and now this guidance document describes the format for preparation of CTD for marketing approval of pharmaceuticals for human use other than biological products (vaccines, biotechnol ...
Chapter_003_LO
Chapter_003_LO

... • Fairness, equity, appropriateness of treatment • Recognition that goods and services are limited • Decisions about who will receive limited resources are based on various philosophies and might use the criteria of equal distribution; individual need, merit, social contribution, rights, or effort; ...
Testing Treatments interactive
Testing Treatments interactive

... presentation of facts and figures, telling only part of the story, glossing over flaws, and ‘cherry picking’ the scientific evidence which shows one treatment in a particular light. But in popular culture, there can be more interesting processes at play. We have an understandable desire for miracle ...
NIAID Protocol Template Extramural Guidance, V. 2.0
NIAID Protocol Template Extramural Guidance, V. 2.0

... SJMHS Clinical Trial Protocol Template Adapted from: National Institute of Allergy and Infectious Disease Protocol Template ...
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Supplementary Material (doc 858K)

... baseline and post-fMRI (in conjunction with the first and fourth heart rate measurements). Subjects also completed the Profile of Mood States, for which they provided self-report ratings (0-10, “How do you feel right now?”) for the dimensions of “high” and “methylphenidate desire.” These self-report ...
Pleurodesis Final Ratified April 2015 Review April 2020 LB 1 Title of
Pleurodesis Final Ratified April 2015 Review April 2020 LB 1 Title of

... Small bore intercostal drains should be the initial choice for effusion drainage and pleurodesis (Antunes et al 2003). There is no evidence that large bore tubes (20-24F) are any better than small tubes in the management of pnuemothoraces (Henry et al 2003). Prior to this procedure a chest x-ray mus ...
If the study includes genetic analyses of blood or tissue, or if
If the study includes genetic analyses of blood or tissue, or if

... Before you begin the study: You will have the following exams, tests or procedures to find out if you can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the study. If you have had some of them recently, they may not need to b ...
Guideline: Peripheral intravenous catheter (PIVC)
Guideline: Peripheral intravenous catheter (PIVC)

... o degree of cardiovascular stability o medical or surgical interventions.(8) • Clinicians should use the smallest gauge and shortest length PIVC that will accommodate the prescribed therapy to reduce the risk of phlebitis.(8, 17) • It is recommended that the size of the target vein is also considere ...
Practice Guideline: Performance of Thyroid Scintigraphy and Uptake
Practice Guideline: Performance of Thyroid Scintigraphy and Uptake

... practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, the American College of Radiology cautions against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into q ...
Agonists for Sedation in Pediatric Critical Care: A Systematic Review
Agonists for Sedation in Pediatric Critical Care: A Systematic Review

... of its marked sedative properties in PICUs (6). Yet, opioids are well known to produce tolerance, dependence, and a number of unwanted side effects. Midazolam has also been established as an effective sedative agent in the PICU environment (7). However, it shares the potential side effects of tolera ...
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Declaration of Helsinki

The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations. Its role was described by a Brazilian forum in 2000 in these words ""Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity"".
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