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Opinions of the Ethics Committee The Principles of Medical Ethics
Opinions of the Ethics Committee The Principles of Medical Ethics

... -- like trust, beneficence, empathy, and confidentiality – cannot genuinely exist in these two examples. It would be necessary to assign other staff members to work therapeutically with this patient preferably assigning the patient to a separate unit with no contact to the staff member pressing cri ...
AusPAR: Aflibercept (rch) - Therapeutic Goods Administration
AusPAR: Aflibercept (rch) - Therapeutic Goods Administration

... This AusPAR describes the application by Sanofi-Aventis Australia Pty Ltd (the sponsor) to register the product for the indication: “aflibercept in combination with irinotecanfluoropyrimidine-based chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) previously treated with a ...
Quality Improvement Guidelines for the Performance of Inferior Vena
Quality Improvement Guidelines for the Performance of Inferior Vena

... performing vena cavograms and filter placement. In planning facilities for IVC placement, equipment and facilities more advanced than those outlined here may be desired to produce higher-quality studies with reduced risk and time of study. The facility should include, at a minimum: 1. A high-resolut ...
QIs excluded from application to patients with advanced dementia
QIs excluded from application to patients with advanced dementia

... target behavioral disturbance or safety issue justifying use of restraints must be identified to the consenting person (patient or legal guardian) and documented in the chart. IF a NH Resident has MDS documentation of or presents with new onset of one of the following symptoms: sad mood, feeling dow ...
Developing Effective Drills in Preparation for a Malignant
Developing Effective Drills in Preparation for a Malignant

... with a mutation in the RYR1 gene, such as central core disease or multi-minicore disease, are also considered at risk for MH.8 Importantly, a history of previous uneventful general anesthesia does not rule out the possibility that a patient may be MH susceptible. The risk for MH is less clear in pat ...
1999 - World Health Organization
1999 - World Health Organization

... or region-specific guidelines for matters which lie within the legal jurisdiction of that country or region, i.e. International Air Transport Association (IATA) regulations for transportation of hazardous goods, or bio-safety containment levels for laboratories. Readers should be familiar with such ...
THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL
THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL

... study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements. The clinical study report described in this guideline is ...
National Institute for Health and Clinical Excellence
National Institute for Health and Clinical Excellence

... In fact the “evidence” for the true efficacy of CBT in a clinical setting is being further discredited by research papers - even during the consultation period! The Guideline Development Group should take note of: recent research evidence on CBT which found that it offered no significant overall ben ...
2010 Annual Research Report, Princess Alexandra Hospital
2010 Annual Research Report, Princess Alexandra Hospital

... T1 – Translation to first in humans: Findings from basic research are tested for clinical effect and/or applicability. T1 research yields knowledge about human physiology and the potential for intervention. ...
Circulating Matters Progress Report 2010>2012
Circulating Matters Progress Report 2010>2012

... Leader, one has to have experience in science (at least PhD), be able to obtain grants, and supervise cardiovascular research projects within the ICaR-VU. The Directorate decides on the appointment of new Project Leaders. ...
SAMPLE I-SEARCH PAPER
SAMPLE I-SEARCH PAPER

... organized, easy to understand, and it provided answers to all three aspects of my research question. A Whois search of lungusa.org confirmed that the web site was registered to the American Lung Association. It gave me a street address at which I could contact the American Lung Association, as well ...
Department of Dermatology, Zurich University Hospital
Department of Dermatology, Zurich University Hospital

... the best standards of diagnosis and care, a multi-disciplinary approach with tumor boards where required, and a broad variety of treatments including: ...
Ethical Strategies that Make `Good` Business Sense
Ethical Strategies that Make `Good` Business Sense

... advertisements further contend that because the ads present such convincing arguments, many patients are convinced that they have an illness, sometimes causing them to get second and even third opinions when their family doctor will not prescribe the marketed medication (“Impact of Direct”). Not on ...
Department of Dermatology, Zurich University Hospital
Department of Dermatology, Zurich University Hospital

... the best standards of diagnosis and care, a multi-disciplinary approach with tumor boards where required, and a broad variety of treatments including: ...
Are Cannabinoids an Effective and Safe Treatment Option in the
Are Cannabinoids an Effective and Safe Treatment Option in the

... States, it is not licensed for use in the United Kingdom. The evidence used in the public debate about the analgesic efficacy of cannabinoids in humans has been gathered in a less than systematic manner and has often been taken from low quality study designs, such as anecdotal reports, questionnaire ...
Extract from the Clinical Evaluation Report for Diemthyl Fumarate
Extract from the Clinical Evaluation Report for Diemthyl Fumarate

... The sponsor also sought guidance through from scientific-advice meetings in Europe and the US. The main issue addressed was the ethics of performing a placebo-controlled study in MS, when several active agents are known to be effective. [information redacted]. The main recommendations that were inco ...
Australian Public Assessment Report (AUSPAR) for Romiplostim
Australian Public Assessment Report (AUSPAR) for Romiplostim

... Absorption of romiplostim into the systemic circulation after SC administration was slow in all species studied, with peak serum concentrations typically reached 12 h post-dose in rats and rabbits, 4–8 h post-dose in monkeys and 24 h post-dose in humans. Terminal elimination following SC administrat ...
Guideline on the investigation of subgroups in - EMA
Guideline on the investigation of subgroups in - EMA

... sponsors and to assessors engaged in providing Scientific Advice. This guidance document describes principles and does not dictate any particular practical solutions in respect of statistical methodology for estimating or testing the treatment effect in subgroups of the trial population. ...
Research today, Hope for tomorrow.
Research today, Hope for tomorrow.

... response for patients with genotype 1. Although this was exciting news for doctors and their patients who had been waiting for treatment alternatives, there were still many hurdles to overcome before they would be accessible to all who needed them. As part of Health Canada’s review of the two drug t ...
Emerging Infectious Diseases Journal - Editorial Style Guide
Emerging Infectious Diseases Journal - Editorial Style Guide

... conclusions, and a brief biographical sketch of first author or of both authors if only 2 authors. Report laboratory and epidemiologic results within a public health perspective. Explain the value of the research in public health terms and place the findings in a larger perspective (i.e., “Here is w ...
Pediatric Acute Respiratory Distress Syndrome
Pediatric Acute Respiratory Distress Syndrome

... of calculation, a strong agreement corresponded to a percentage of agreement more than 95% (no more than one expert rated below 7 on the RAND/UCLA scale). The third and final meeting took place on October 9, 2013, in Paris, France. Each group presented their final recommendations, and a third round ...
The Ethics of Pharmaceutical Industry Influence in Medicine (English)
The Ethics of Pharmaceutical Industry Influence in Medicine (English)

... meaningfully ethical in one time or context may be unethical in another time or context. We hope readers across all levels of professional experience and ethical sophistication will be reminded of some of these vignettes in the course of their everyday practice, when it comes time to ask first, “Is ...
Respiratory care : the official journal of the American Association for
Respiratory care : the official journal of the American Association for

... Comparison of Gentle-Haler Actuator and Aerocliamber Spacer tor MeDose Inhaler (MDI) Use by Asthmatics b\ Bradley E Chipps. Peter F Naunuinn. and Gordon A W'ong Sacramento, California, and Otto G Raahe Davis. California ...
Experimental treatments for spinal cord injury
Experimental treatments for spinal cord injury

... To truly understand whether there is a causal relationship between a therapeutic intervention and any subsequent improvement, we need to compare outcomes of a group of patients who received the treatment to those in a control group who did not. While not always feasible, a placebo or “sham” treatmen ...
Experimental treatments for spinal cord injury
Experimental treatments for spinal cord injury

... there are beneficial effects of the therapy. In fact, without some type of control group during the later stages (Phase 2 or 3) of a clinical trial program, the research study will not be able to provide valid evidence of the therapeutic effects - good or bad. In a trial, randomly selected control p ...
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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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