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A randomized controlled clinical trial evaluating the
A randomized controlled clinical trial evaluating the

... reduction in the anticipation that these methods would be effective in preventing transmission of known pathogens and provide protection against emerging or mutant strains or viruses and bacteria. Methods of pathogen reduction for red blood cells (RBCs), platelets (PLTs), and plasma are currently in ...
Probiotics, with special emphasis on their role in the management of
Probiotics, with special emphasis on their role in the management of

... for the use of probiotics in various clinical settings are unclear. According to some, caution must be exercised when prescribing probiotics in newborns, immune compromised patients, patients with pancreatitis, those with short-bowel syndrome, with a CVC in situ, and those with severe underlying ill ...
Invega PI
Invega PI

... caused a slight increase in the free fraction of paliperidone at 50 ng/mL. These changes are not expected to be of clinical significance. Metabolism and Elimination: One week following administration of a single oral dose of 1 mg immediate-release 14C-paliperidone, 59% (range 51% - 67%) of the dose ...
American Society of Clinical Oncology Statement: A Conceptual
American Society of Clinical Oncology Statement: A Conceptual

... Working from these principles, ASCO presents herein a proposed framework for assessing the value of treatment options. The framework is designed to eventually assist in facilitating shared decision making with patients about clinical benefits and costs. The framework has benefitted from input from r ...
Herb-Drug Interactions: What Clinicians Need to Know.
Herb-Drug Interactions: What Clinicians Need to Know.

... The majority of data on herb-drug interactions are theoretical and based on case reports, in vitro assays, animal studies, and/or speculation.6 Case reports are frequently cited as unequivocal evidence of dangerous interactions, despite the fact that “published case reports are often incomplete” and ...
Anatomy of an In-Custody Death—Medical Causation Issues
Anatomy of an In-Custody Death—Medical Causation Issues

... such that individual practitioners are unlikely to encounter large numbers of cases, the decision to identify ExDS as a syndrome instead of a unique disease has been delayed, somewhat similar to the decades-long controversy over Sudden Infant Death Syndrome. The problem is that a small percentage of ...
and Paul J. Seligman, MD, MPH
and Paul J. Seligman, MD, MPH

... event curves in a Kaplan-Meier plot did not appear to begin to separate until after approximately 18 months of treatment. In contrast to the results seen in APPROVe, two long-term placebo-controlled trials in patients with early Alzheimer’s disease, including up to four years of treatment in a small ...
View the powerpoint presentation - stop
View the powerpoint presentation - stop

...  The pooled odds ratio after 3-8 weeks in the 3 placebocontrolled trials (two were doubled-blind and one was randomized) was 1.93 (95% CI: 1.21 to 3.06).  For the 2 placebo-controlled, double-blind trials with longer follow-up, the pooled odds ratio after 3-6 months was 1.83 (1.12 to 2.99).  One ...
clinical mycology - NHS Greater Glasgow and Clyde
clinical mycology - NHS Greater Glasgow and Clyde

... Yorkhill porters or taken by secretarial staff to the mail room where they are distributed to hospital wards and clinics or via the Royal Mail. Urgent interim results may be requested by telephone. Authorised results may also be viewed through the SCI store system. ...
Slides - Clinical Trial Results
Slides - Clinical Trial Results

... • Recommended by key guidelines (ESC, ACCF / AHA) • Bivalirudin + selective (7% - 15%) use of GPI • Established anti-thrombotic treatment option ...
evidence based pharmaco- clinical studies on ashwagandha
evidence based pharmaco- clinical studies on ashwagandha

... Professor & HOD Department of Dravyaguna, IPGT & RA, Jamnagar, India. ...
Electrophysiological Effects of Corticosteroids on the
Electrophysiological Effects of Corticosteroids on the

... probable that RPE dysfunction is equally associated, thus leading to localized breakdown of the outer blood–retinal barrier. Currently, there is some evidence for pathophysiological links between corticosteroid treatment and the incidence of central serous chorioretinopathy.3– 6 The existence of thi ...
Prescribing Information
Prescribing Information

... Pediatric Use ELOCON Ointment may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Since safety and efficacy of ELOCON Ointment have not been established in pediatric patients below 2 y ...
Loteprednol etabonate - Therapeutic Goods Administration
Loteprednol etabonate - Therapeutic Goods Administration

... 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. ...
Impact of cardiovascular magnetic resonance on management and
Impact of cardiovascular magnetic resonance on management and

... which were most predictive of significant clinical impact using multivariable modeling. Another difference between the two registries was that the EuroCMR study included patients undergoing stress testing (in 20.9% of cases). We did not include stress CMR in this study because it is currently signif ...
Australian Public Assessment Report for loteprednol etabonate Proprietary Product Name: Lotemax
Australian Public Assessment Report for loteprednol etabonate Proprietary Product Name: Lotemax

... 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. ...
Pediatric ABC`s - Calgary Emergency Medicine
Pediatric ABC`s - Calgary Emergency Medicine

... The effectiveness of inhaled corticosteroids in the emergency department treatment of acute asthma: a meta-analysis Edmonds, 2002 • 6 trials ( 4 adult, 2 pediatric) – 2 compared inhaled steroids in addition to systemic steroids, 4 comparison to placebo • 352 pts • Less likely to be admitted (OR 0.3 ...
KIPRES® Chewable Tablets 5mg
KIPRES® Chewable Tablets 5mg

... should be taken continuously not only during periods of worsening asthma, but also while asthma is controlled. 2) Because KIPRES differs from bronchial dilators, steroids, etc., it is not a drug to relieve existing asthma attacks. This fact must be fully explained to pediatric patients and their gua ...
Cost-effectiveness of initial stress cardiovascular MR
Cost-effectiveness of initial stress cardiovascular MR

... CABG and PCI were included in the regression analyses as time-varying covariates, taking a value 0 up to the time of intervention and 1 thereafter, to ensure that any differences between the groups was not due to differences in treatment. Inclusion of treatment (CABG/PCI) did not affect comparison o ...
Semprex®-D Capsules(acrivastine and pseudoephedrine
Semprex®-D Capsules(acrivastine and pseudoephedrine

... study in 7 healthy volunteers showed that acrivastine is primarily eliminated by the kidneys. Over a 72-hour collection period, about 84% of the administered total radioactivity was recovered in urine and about 13% in feces, for a combined recovery of about 97%. Further, 67% of the administered radi ...
Interoperability in eHealth Systems
Interoperability in eHealth Systems

... Patients with Cardiac Implants and Diabetes patients ...
Merck`s policy on posting of redacted study protocols on journal
Merck`s policy on posting of redacted study protocols on journal

... Initiation of Part 2 will be contingent on the availability of a final report from the 3-month nonhuman primate (NHP) toxicology study, with an acceptable safety profile, which will include a 6-month postdose observation period. Moreover, initiation of Cohort 5 (3 mg/kg) in Part 2 of the study will ...
Ophthalmic drug discovery: novel targets and
Ophthalmic drug discovery: novel targets and

... mice. Genetically modified mice are the only animal models developed to date that recapitulate the features of both dry and wet AMD35–40. Ranibizumab (Lucentis; Genentech/Roche), bevacizumab (Avastin; Genentech/Roche) and aflibercept (Eylea; Regeneron Pharmaceuticals) — all anti-VEGF agents — are cu ...
3.1. Initial Contact, Recruitment, Pre
3.1. Initial Contact, Recruitment, Pre

... All potential participants will receive informed consent material as approved by the Institutional Review Board at each center. Trained study personnel will perform the formal process of obtaining consent for screening and enrollment into the study. Sites may choose to obtain consent separately for ...
BRIDION - Merck.com
BRIDION - Merck.com

... Recurrence of neuromuscular blockade may occur due to displacement of rocuronium or vecuronium from BRIDION by other drugs [see Drug Interactions (7.2)]. In this situation the patient may require mechanical ventilation. Administration of the drug which caused displacement should be stopped in case o ...
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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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