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Six minute corridor walk test as an outcome measure for the
Six minute corridor walk test as an outcome measure for the

... literature review, the utility of the 6MWT as a measure of the effectiveness of treatment in randomized controlled trials of heart failure. Methods and results A literature search was performed using Medline, EMBASE, CINAHL, and Biological abstracts for randomized controlled trials that measured 6MW ...
ZYRTEC® (cetirizine hydrochloride) Tablets and
ZYRTEC® (cetirizine hydrochloride) Tablets and

... Pharmacodynamics: Studies in 69 adult normal volunteers (aged 20 to 61 years) showed that ZYRTEC at doses of 5 and 10 mg strongly inhibited the skin wheal and flare caused by the intradermal injection of histamine. The onset of this activity after a single 10-mg dose occurred within 20 minutes in 50 ...
Measuring Depth of Anesthesia
Measuring Depth of Anesthesia

... monitoringcould improve the outcome of an anesthetic regimen. 7. Simple hardware and sensors were developed and are commercially available to facilitate highquality signal capture despite the noisy electrical environment of the operating room. ...
Condrosulf®: Structural Characterization, Pharmacological Activities
Condrosulf®: Structural Characterization, Pharmacological Activities

... evaluated the effect of 800 mg/die of CS/naproxen combination versus naproxen alone over a 2 years period. This study confirmed the capacity of oral CS to improve some features of erosive OA (Table 1). A randomized, double-blind, placebo-controlled trial was conducted in 2005 [40]. 300 patients affe ...
"Accounting for Behavior in Treatment Effects: New Applications for Blind Trials"
"Accounting for Behavior in Treatment Effects: New Applications for Blind Trials"

... The expectation of treatment can change the unconscious and conscious behavior of experimental participants [1, 2, 3], and may therefore affect measured treatment effects [4]. For example, a participant who believes he or she is receiving treatment may decide to engage in a number of lifestyle chang ...
2002 ACC/AHA Guidelines. CRUSADE Quality Improvement
2002 ACC/AHA Guidelines. CRUSADE Quality Improvement

... patients (NSTEMI) are a heterogeneous group, frequently elderly patients who tend to rule in with positive troponin levels. It is now well recognized that this group of patients with troponin elevations have a substantial 30-day as well as 1-year and 3-year increase in mortality compared to traditio ...
Comparing HMG-CoA reductase inhibitors
Comparing HMG-CoA reductase inhibitors

... The Heart Protection Study has added weight to the intriguing theory that the antiatherogenic effects of statin therapy extend beyond lipid lowering—that they are, in fact, pleiotropic. Basic research suggests that the statins may exert such nonlipid effects as modifying endothelial function, mediat ...
Estimating the “First in human” dose – a revisit with particular
Estimating the “First in human” dose – a revisit with particular

... Step 1: NOAEL determination This is the first step in the process, which involves the evaluation of the available animal data to determine the NOAELs from toxicology studies. Here, the NOAEL refers to the highest dose level that does not produce significant adverse effects compared with the control ...
Slides - The Section on Evidence Based Health Care of The New
Slides - The Section on Evidence Based Health Care of The New

... activity after surgery, hemorrhage, dehydration, injury, and anesthetic complications; direct nonsurgical costs (antibiotics, clinician visit) and indirect costs (caregiver time, time missed from school).  Benefits-harm assessment: Balance of benefit to harm  Value judgments: Importance of balanci ...
Raltegravir - Therapeutic Goods Administration (TGA)
Raltegravir - Therapeutic Goods Administration (TGA)

... 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. ...
- The University of Liverpool Repository
- The University of Liverpool Repository

... agents may be associated with benefit, a question currently being addressed in randomised controlled trials. Genetic variants associated with metabolic traits and multiple disease outcomes can be used to validate therapeutic targets at an early stage in the drug development process. ...
NRDD_Surrogate_correspondence_final
NRDD_Surrogate_correspondence_final

... innovative treatments for patients in the past two decades has led to the introduction of various regulatory initiatives intended to facilitate this1. Consequently, regulatory authorities and payers often have to base their decisions about the use of a technology on surrogate outcomes, which allow t ...
Protocol - NIHR Evaluation, Trials and Studies
Protocol - NIHR Evaluation, Trials and Studies

... Clinical queries should be addressed to Mr Marcus Drake. This protocol describes the UPSTREAM study and provides information about procedures for entering participants. Every care was taken in its drafting, but corrections or amendments may be necessary. These will be circulated to investigators in ...
DNDi @ WorldLeish 6
DNDi @ WorldLeish 6

... Journalists, Germany) ...
Research Focus - MOTP Atlantic Canada
Research Focus - MOTP Atlantic Canada

... The tragic fact that hundreds of people die each year waiting for a transplant is compounded by another tragic fact: as many as 20 per cent of potential graft organs must be discarded, instead of transplanted, because they are not healthy enough to withstand the procedure or function well enough aft ...
Buprenorphine in Opiate Dependence
Buprenorphine in Opiate Dependence

... High dose sublingual buprenorphine (Subutex) tablets are available in the following strengths – 0.4 mg, 2 mg, and 8 mg. Suboxone tablets, a combination of buprenorphine and naloxone, are available in preparations containing buprenorphine and naloxone in the following ratios; 2mg:0.5mg and 8mg:2mg. S ...
Designing Clinical Trials to Evaluate Mucus
Designing Clinical Trials to Evaluate Mucus

... sex, and even by cultural differences (eg, the social acceptability of sputum expectoration). Thus, it is important to define a disease as unambiguously as possible. One of the more difficult questions to answer is whether testing should be done while the patient is clinically stable, during an exac ...
عناوين الكتب الاجنبيه ت عنوان الكتاب 1 Parameters hand book of
عناوين الكتب الاجنبيه ت عنوان الكتاب 1 Parameters hand book of

... Grabs encyclopedia of flaps GABA in the nervous system the vewat fifty years Spinal instrumentation Medical genetics Microsuegery of the cervical spine Physical pharmacy(As per B.pharmsyllabus) Study guide to accompany materntywommens health care Study guide to accompany pschology Instructions for o ...
American Heart Association meeting, Fall 2007
American Heart Association meeting, Fall 2007

... Brand Y ...
Information on Clinical Investigation Plan (CIP) Template
Information on Clinical Investigation Plan (CIP) Template

... should all be deleted before finalising the document. All sample text is in ‘basic text’ style. This text of course will be altered or deleted as required while you produce the draft. Repetition of information throughout the CIP is not necessary; it may be useful to cross-reference other sections of ...
The following protocol information is provided solely to describe how... research underlying the published report associated with the following article:
The following protocol information is provided solely to describe how... research underlying the published report associated with the following article:

... (http://jco.ascopubs.org/site/ifc/protocol.xhtml) only specific elements of the most recent version of the protocol are requested by JCO. The protocol information is not intended to replace good clinical judgment in selecting appropriate therapy and in determining drug doses, schedules, and dose mod ...
`A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic
`A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic

... occurred over the past two decades is attributable to type 2 diabetes and diabetic nephropathy (3). Diabetes is now the leading cause of end-stage renal disease (ESRD), with more than 40% of all new cases of ESRD occurring in patients with diabetes (3). The pathophysiology of diabetic nephropathy an ...
Background - Specialist Pharmacy Service
Background - Specialist Pharmacy Service

... Intravenous (IV) paracetamol is licensed for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when administration by intravenous route is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of ...
A software tool for pure-tone audiometry - HODOKORT
A software tool for pure-tone audiometry - HODOKORT

... “inclusion parameters” table. The “minimum severity of hearing loss” is defined as the minimum hearing level (4PTA; 0.5, 1, 2, 4 kHz) of the acute audiogram needed for inclusion into the study. The “minimum hearing level” difference is calculated as the maximum difference between the mean hearing thres ...
Methylphenidate for attention deficit hyperactivity disorder and drug relapse in
Methylphenidate for attention deficit hyperactivity disorder and drug relapse in

... method. Fisher’s exact test was calculated for the categorical variables. Retention in the trial, calculated up through the last visit at the clinic (or if the patient did not visit the clinic after the release, the day of release), was analysed using the Kaplan–Meier survival analysis. All statisti ...
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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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