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NOACs versus warfarin for stroke prevention in patients with AF: a
NOACs versus warfarin for stroke prevention in patients with AF: a

... of 77 011. A further eight supplementary publications providing further insight into the methodology and outcomes were also used to augment the accuracy of this meta-analysis. All studies included were well conducted randomised controlled trials. Four were double blind trials with a method for doubl ...
Cutaneous B-Cell Lymphoma - Lymphoma Research Foundation
Cutaneous B-Cell Lymphoma - Lymphoma Research Foundation

... Treatment selection for CBCL depends on the type of CBCL, the patient’s symptoms and overall health, and the stage of the disease. Depending on the number of lesions present, primary cutaneous follicle center lymphoma and cutaneous marginal zone B-cell lymphoma may be observed (a method known as “wa ...
imitrex tablets
imitrex tablets

... Precautions (5.1)] • Arrhythmias [see Warnings and Precautions (5.2)] • Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] • Cerebrovascular events [see Warnings and Precautions (5.4)] • Other vasospasm reactions [see Warnings and Precautions (5.5)] • Medica ...
November 2014 PBAC Meeting
November 2014 PBAC Meeting

... Patient must not show continuing progression of disability while on treatment with this drug AND ...
The Journal of Rheumatology Antirheumatic Drug Strategies in
The Journal of Rheumatology Antirheumatic Drug Strategies in

... 2 or more strategies, providing direct evidence of the relative treatment effect, no single trial exists that has made comparisons between all strategies of interest. To account for the range of direct and indirect evidence, a mixed treatment comparison method was adopted28,29 (also known as a netwo ...
introduction
introduction

... integrity by prolonged contact with feces and urine. It is a condition that still occurs regularly in young children, and is best managed by prevention. In this update, we will consider the reasons that irritant napkin dermatitis develops, and the simple methods that parents can adopt to avert it. T ...
ICH E10 - Duke People
ICH E10 - Duke People

... profile of the product can change over time through expanded use in terms of patient characteristics and the number of patients exposed. In particular, during the early postmarketing period the product might be used in settings different from clinical trials and a much larger population might be exp ...
Trial Protocol (Amendment).
Trial Protocol (Amendment).

... Study title: Randomized, double-blind, 7-day study of the efficacy and safety of rofecoxib vs. placebo and diclofenac in patients with acute painful Rotator Cuff Syndrome. Primary criterion: Comparing the short-term symptomatic efficacy (pain NRS) of rofecoxib (50 mg q.d.) versus placebo on mean cha ...
MOUNTAIN STATES HEALTH ALLIANCE RESEARCH DEPARTMENT PROCEDURAL MANUAL
MOUNTAIN STATES HEALTH ALLIANCE RESEARCH DEPARTMENT PROCEDURAL MANUAL

... informed consent process. The PSC or PI will present informed consent at the first clinic visit. Copy of Informed Consent Form must be filed in patient’s medical record. The PSC is responsible for scheduling and conducting study visits per protocol, for arranging dispensing of study medication throu ...
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
UNITED STATES SECURITIES AND EXCHANGE COMMISSION

... Continued dosing hemophilia patients in ongoing Phase 1/2 OLE study, with patients currently having received up to 13 months of dosing. The Company also updated its guidance for Phase 3 initiation, and now plans to start studies in early 2017. Reported initial clinical results in patients with parox ...
AdreView Product Monograph
AdreView Product Monograph

... Pediatrics: The safety and effectiveness of AdreView have been established in the age groups 1 month to 16 years in patients with known or suspected neuroblastoma (see Clinical Trials). Safety and effectiveness in pediatric patients below the age of 1 month or in any pediatric patient with congesti ...
Effects of Computerized Physician Order Entry and Clinical
Effects of Computerized Physician Order Entry and Clinical

... followed by an “A” (eg, a systematic review that included 1 randomized controlled trial and several observational studies with controls was designated “Level 1A-3A”). ...
Guideline on the development of new medicinal products for
Guideline on the development of new medicinal products for

... be highlighted using 'track changes') ...
Luke Lin, MD
Luke Lin, MD

... GIOTRIF® and in the U.S. under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in othe ...
UAB Comprehensive Cancer Center Clinical Trials Audit Manual
UAB Comprehensive Cancer Center Clinical Trials Audit Manual

... Version 10/7/09 ...
AusPAR: Fidaxomicin
AusPAR: Fidaxomicin

... (CDI), and for reducing the risk of recurrence when used for treatment of CDI. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dificid and other antibacterial drugs, Dificid should be used only to treat infections that are diagnosed to be caused by Clostridium ...
assert
assert

... Control forms and evaluation system are carried out in accordance with the requirements of the program of discipline and Instruction about the system of evaluation of educational activity of students at credit-module to the system of organization of educational process, Ukraine ratified by MH (2005) ...
Chapter 15: Semantic Text Parsing for Patient Records
Chapter 15: Semantic Text Parsing for Patient Records

... means it must be mapped to a controlled vocabulary and to a standard representation for the domain. Although different clinical vocabularies exist (i.e. UMLS, ICD-9, SNOMED-CT), none are complete and there is no single standard. An equally serious problem is that although there are standard controll ...
Understanding FDA Regulatory Requirements for Investigational
Understanding FDA Regulatory Requirements for Investigational

... involves the use of a drug.8 Hence, to authorize a drug study in humans, the FDA requires sufficient information to assess the safety of the intended research study. The IND is the mechanism by which by the investigator or sponsor provides the requisite information to obtain authorization to adminis ...
Drugs 2011
Drugs 2011

... the purview of the Dietary Supplement and Health Education Act of 1994. No efficacy or safety has to be proven to sell these agents. In addition, there are no official standards governing the production of alternative therapies in the US, and the potency and purity of these products are subject to s ...
MFA - asdera
MFA - asdera

... Most bioinformatics tools in genetics are based on the statistical methods that were feasible in the 20th century, where memory was scarce. Hence, most GWAS are analyzed one SNP at a time and, thus, can detect only recent (de novo) mutations (‘letters’), but not the common cis-epistatic risk factors ...
Development and Initial Evaluation of a Software
Development and Initial Evaluation of a Software

... ocumentation of clinical activities in patients’ medical records is an essential practice standard for pharmacists.1 This practice facilitates communication and assessment of interventions by health care peers and helps to ensure optimal patient care. In addition, this information can be used to hel ...
LOCAL DRUG DELIVERY SYSTEMS IN THE TREATMENT OF PERIODONTITIS –...  Review Article DR ARVIND VENKATESH
LOCAL DRUG DELIVERY SYSTEMS IN THE TREATMENT OF PERIODONTITIS –... Review Article DR ARVIND VENKATESH

... root planing (SRP), or access flap (AF) were assigned according to probing pocket depth (PPD). PPD and vertical relative attachment level (RAL-V) were obtained initially, 3 and 6 months after therapy. Baseline data were compared according to therapy, jaw, tooth type, and site. Factors influencing cl ...
AusPAR Lenvatinib mesilate - Therapeutic Goods Administration
AusPAR Lenvatinib mesilate - Therapeutic Goods Administration

... it is important to limit the use of systemic treatments to patients at significant risk for morbidity or mortality due to progressive metastatic disease.4 DTC can occur in children, and radiation exposure is a risk factor, but incidence is low and prognosis is better than in adults.5 The submission ...
Single dose oral dexamethasone versus multi
Single dose oral dexamethasone versus multi

... not usually diagnosed before the age of two years because of the prevalence of bronchiolitis in this age group. Ideally all trials included would have studied a homogeneous age group, and included patients up to the age of 16 years. All but one of these studies used a five-day course of prednisolone ...
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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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