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SCIENTIFIC DISCUSSION 1. Introduction
SCIENTIFIC DISCUSSION 1. Introduction

... clearly more effective than another and no single medication results in remission for all patients. In many occasions the choice of the medication is made looking at the side effect profile. The cyclic antidepressants are less commonly used as first-line antidepressants with the development of the S ...
Traumatic Brain Injury: Therapeutic and Diagnostic Pipeline Assessment and Commercial Prospects Brochure
Traumatic Brain Injury: Therapeutic and Diagnostic Pipeline Assessment and Commercial Prospects Brochure

... young adults following an injury. With around 10 million new cases diagnosed and 1.5 million deaths occurring per annum globally; this ‘silent’ epidemic accounts for more fatalities than diabetes or lung cancer. Despite three decades of intensive research and development effort, translating benchsid ...
PDF - Undiagnosed Diseases Network International
PDF - Undiagnosed Diseases Network International

... program are to: 1) improve the level of diagnosis and care for patients with undiagnosed diseases through the development of common protocols designed by a community of investigators; 2) facilitate research into the etiology of undiagnosed diseases, by collecting and sharing standardized, high-quali ...
AHA/ACC Guideline for Management of Patients
AHA/ACC Guideline for Management of Patients

... Intended Use—CPGs provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but CPGs developed in collaboration with other organizations may have a broader target. Although CPGs may be used to inform re ...
Australian public assessment report for Dolutegravir (as sodium)
Australian public assessment report for Dolutegravir (as sodium)

... 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. ...
VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol
VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol

... rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflects exposure to VENTOLIN HFA in 248 subjects treated with VENTOLIN HFA in 3 placebo-c ...
Clinical overview - WHO archives
Clinical overview - WHO archives

... developed by Mepha Ltd. and successfully tested.18,19 Three different solid oral dosage strengths of Artequin (600/1500, 600/750 and 300/750, the numbers indicating the total artesunate/mefloquine dosage per therapy) have been investigated in two randomized, double blind, parallel group, comparative ...
HIGHLIGHTS OF PRESCRIBING INFORMATION more days. (2.3)
HIGHLIGHTS OF PRESCRIBING INFORMATION more days. (2.3)

... Long-Term (12 Month) Safety Trial: In the 12 month, open-label, active-controlled, long-term safety trial, 862 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with ASTEPRO Nasal Spray 0.1% two sprays per nostril twice daily or Astelin Nasal Spray t ...
european organisation for research and treatment of cancer
european organisation for research and treatment of cancer

... Treatment of Cancer (EORTC) are to conduct, develop, coordinate, and stimulate laboratory and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patients’ quality of life. Extensive and comprehensive research in this wide field is oft ...
The management of pressure ulcers in primary and secondary care
The management of pressure ulcers in primary and secondary care

... opposed to paid carers such as care workers. ...
ACCF/SCAI/SVMB/SIR/ASITN 2007 Clinical Expert Consensus
ACCF/SCAI/SVMB/SIR/ASITN 2007 Clinical Expert Consensus

... bruits, diagnostic tests for carotid disease should only be performed in those patients who are also considered good candidates for carotid revascularization. Imaging Noninvasive imaging is useful to assess carotid stenosis severity and guide treatment. Carotid duplex is the most widely available an ...
PUBLIC ASSESSMENT REPORT Decentralised Procedure
PUBLIC ASSESSMENT REPORT Decentralised Procedure

... μg/ml and 25 μg/ml is highly bound (>90%) to plasma proteins.). Elimination: Clopidogrel is excreted via the urine and the faeces. While unchanged drug has not been detected in urine, the main identified compounds were SR26334 and glucuronidated metabolites. Renal excretion amounted to 48% and faeca ...
Word - corporate
Word - corporate

... hypoxia, leading to anemia, stroke, multi-organ failure, severe pain crises, and shortened patient life span. GBT440 inhibits abnormal hemoglobin polymerization, the underlying mechanism of RBC sickling. In our clinical trials of GBT440 in SCD subjects, we observed reduced markers of red blood cell ...
Untitled - DONA™, The Original Glucosamine Sulfate
Untitled - DONA™, The Original Glucosamine Sulfate

... the preferred long-term symptomatic agent 15,16,17. Nevertheless, this pure analgesic is less effective than NSAIDs in short-term pain relief 18. On the other hand, recent meta-analyses suggest that NSAIDs are not greatly effective for osteoarthritis and, above all, that their long-term use is not s ...
Module 2.5 Clinical Overview
Module 2.5 Clinical Overview

... insertion of the viral genome into the deoxyribonucleic acid (DNA) of the host cell. Since genome integration is a vital step in retroviral replication, it is an attractive target for HIV therapy. Dolutegravir (DTG, GSK1349572) is an INI owned by ViiV Healthcare, which is working with GlaxoSmithKlin ...
- City Research Online
- City Research Online

... the issuing of CBRN-PPE, plus decontamination equipment across the NHS represented an attempt to improve capacity to respond to a chemical incident.2 8 At that time, there were increasing concerns regarding potential CBRN terrorism9, which was heightened further by the 2005 announcement that the 201 ...
Motor Neurone Disease: full guideline
Motor Neurone Disease: full guideline

... 11.1 Introduction ...................................................................................................................... 148 11.2 Review question: What are the social care support needs of people with MND and their families and carers? ................................................ ...
Monitoring Consciousness Using the Bispectral Index
Monitoring Consciousness Using the Bispectral Index

... combined via an algorithm to optimize the correlation between the EEG and the clinical effects of anesthesia, and quantified using the BIS Index range. In 1996, the U.S. Food and Drug Administration cleared the BIS Index as an aid in monitoring the effects of certain anesthetic agents. In 2003, the ...
Evidence-based clinical guidelines
Evidence-based clinical guidelines

... An estimated 50-80% of people with shoulder pain don’t seek medical attention for it. Despite this, shoulder pain is the third most common musculoskeletal reason for people to visit their GPs, and around 15% of these people are referred for physiotherapy in the three years following their initial co ...
HIGHLIGHTS OF PRESCRIBING INFORMATION ADCIRCA
HIGHLIGHTS OF PRESCRIBING INFORMATION ADCIRCA

... Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their un ...
Monitoring Consciousness Using the Bispectral Index™ (BIS
Monitoring Consciousness Using the Bispectral Index™ (BIS

... anesthetic agents and adjuvants—which can all lead to elevated BIS values. Serious clinical conditions—which may require prompt response—have been associated with the sudden appearance of low BIS™ values. • Clinical Impact of BIS™ Monitoring (See Page 24) – A substantial number of randomized contr ...
Australian Public Assessment Report for Rosuvastatin Proprietary Product Name: Crestor/Visacor
Australian Public Assessment Report for Rosuvastatin Proprietary Product Name: Crestor/Visacor

... Atherosclerosis Prevention Study (AFCAPS/TexCAPS). In order to detect a 25% reduction from the placebo event rate with 90% power, the study needed to observe 514 events (rounded up to 520 events), based on a two-sided alpha of 0.05, an accrual period of 1 year and the mean follow-up of 3.5 years, 12 ...
1 ——— CONTRAINDICATIONS ——— Hypersensitivity to the
1 ——— CONTRAINDICATIONS ——— Hypersensitivity to the

... 11 times the expected human dose), one of the twelve monkeys died 4 hours after treatment due to thrombosis. Procoagulant risk factors, including 6 indwelling catheters per monkey and the induction of anesthesia, may have complicated the study results. It is unclear whether the mortality was related ...
EPAR - Assessment Report - Variation - EMA
EPAR - Assessment Report - Variation - EMA

... During the registration procedure questions were raised about the selection of the dose of RPV, which appeared to be motivated not by the most optimal efficacy but by fears of QT prolongation. The selected dose was sensitive to disruptions by non-adherence, concomitant use of PPIs and lack of concom ...
Evidence-based clinical guidelines for the diagnosis, assessment
Evidence-based clinical guidelines for the diagnosis, assessment

... An estimated 50–80% of people with shoulder pain don’t seek medical attention for it. Despite this, shoulder pain is the third most common musculoskeletal reason for people to visit their GPs, and around 15% of these people are referred for physiotherapy in the three years following their initial co ...
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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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