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Prolonged Seizures
Prolonged Seizures

... * AED levels taken at about the time of prolonged convulsive epileptic seizures are useful in that if the plasma or serum concentration is high (at or above the top of the target range), that AED may need to be changed. If the plasma or serum concentration is mid range or low then it may be worth ex ...
Rivey MP, Allington DR, Reinivaara
Rivey MP, Allington DR, Reinivaara

... clinical program development, drug utilization review including antibiotic review, pharmacokinetic service, drug therapy monitoring service and drug information. Residency Program Director since 2001. Member of P&T, Infection Control, Physician QI, and Diabetes Task Force Committees. Assistant Clini ...
Prescribing Information
Prescribing Information

... C. difficile produces toxins A and B which contribute to the development of CDAD. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of ...
Intra-patient Dose Escalation
Intra-patient Dose Escalation

... • Should be based on a toxicity/efficacy trade off? • Possibility to adjust the dose of the launched agent? ...
Prescribing Information for SPIRIVA HandiHaler
Prescribing Information for SPIRIVA HandiHaler

... trials, two 1-year active-controlled trials, and two 6-month placebo-controlled trials in patients with COPD. In these trials, 1308 patients were treated with SPIRIVA HANDIHALER at the recommended dose of 18 mcg once a day. The population had an age ranging from 39 to 87 years with 65% to 85% males, ...
Cassiopea SpA (SKIN) - 04/07/2015
Cassiopea SpA (SKIN) - 04/07/2015

... regulatory pathways, including product candidates that we believe have demonstrated attractive profiles in early clinical testing and that we can advance into late-stage development, as well as earlier-stage product candidates targeting substantial commercial opportunities that we can quickly and ef ...
Renaissance of antibiotics against difficult infections: Focus on
Renaissance of antibiotics against difficult infections: Focus on

... a spectrum of activity limited to Gram-positive bacteria, because its large size prevents it from crossing the outer membrane of Gram-negative bacteria. Two resistance mechanisms have emerged over the years (4, and references cited herein). The first one, mainly found in enterococci, consists in the ...
Effect of Oral Pseudoephedrine on Blood Pressure and Heart Rate
Effect of Oral Pseudoephedrine on Blood Pressure and Heart Rate

... formed to determine whether results differed between high- and low-quality (Jadad score ⬍6) studies and studies that specifically included baseline BP readings immediately before administration of the treatment or placebo medication. Several measures of the sensitivity of the meta-analysis results ...
Pharmaceutical Sciences - King`s Health Partners
Pharmaceutical Sciences - King`s Health Partners

... and that governance processes, in terms of both clinical safety and cost, are in place for the safe and effective use of medicines. Each department employs a number of highly-specialist pharmacists, essential as medicines and prescribing becomes more complex. ...
Percutaneous left atrial appendage (LAA) occlusion
Percutaneous left atrial appendage (LAA) occlusion

... and safety of a technology. In the US, WATCHMAN patients are being monitored in the Continued Access PROTECT-AF (CAP) and Aspirin-Plavix (ASAP) registries. Clinical trials are still underway in the US that will inform these registries so final approval for commercial use is pending. The WATCHMAN dev ...
l[SCHEDULE Y (See rules l22A, l22B, 122D, 122DA, 122DAA and
l[SCHEDULE Y (See rules l22A, l22B, 122D, 122DA, 122DAA and

... 1. Application for permission> (1) Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44 accompanied with following data in accordance with the appendices, namely:(i) chemical and pharmaceutical information as prescribed in it ...
Lansoprazole/C02-039 A Phase 2, Open-Label Multicenter
Lansoprazole/C02-039 A Phase 2, Open-Label Multicenter

... Some clinical studies may include information not contained in the approved package insert. Please refer to the full prescribing information for additional information. Because the status of studies often changes, TAP makes no warranties or representations of any kind as to the current status or co ...
Incidental Extra-cardiac Findings on Clinical CMR
Incidental Extra-cardiac Findings on Clinical CMR

... correlation. Both Fellows closely collaborated and assured that they applied identical criteria for classification/categorisation of IEF in line with the following definition. Definition: We prospectively decided to classify IEF in minor and major findings whereby minor findings were considered beni ...
Selection and interpretation of clinical pathology indicators of
Selection and interpretation of clinical pathology indicators of

... Indicators of hepatocellular injury: ALT and AST The aminotransferase enzymes, ALT and AST, also termed transaminases, are recommended for the assessment of hepatocellular injury in rats, dogs, and NHPs in preclinical studies. ALT is considered a more specific and sensitive indicator of hepatocellul ...
revised consent - Dartmouth College
revised consent - Dartmouth College

... received by a health care provider or insurance plan. If you have questions about whether the information collected for the study constitutes PHI, please consult the CPHS Office staff. The information collected for this study will be used only for the purposes of research as stated earlier in this f ...
10.1 Case Report Forms
10.1 Case Report Forms

... Alternatives to medical treatment exist in the form of nerve blockade, lithotripsy and surgical treatment. However, results from studies of non-medical treatment modalities are equivocal and medical analgesic therapy must still be considered as the first choice in the management of painful chronic p ...
Product Monograph
Product Monograph

... Directions for Use SURVANTA® should be inspected visually for discolouration prior to administration. The colour of SURVANTA® is off-white to light brown. If settling occurs during storage, swirl the vial gently (do not shake) to redisperse. Some foaming at the surface may occur during handling and ...
Major Extremity Trauma Research Consortium
Major Extremity Trauma Research Consortium

... the presence of clinically significant deep SSI in the first 24 weeks after surgery, as determined by CDC guidelines for determining surgical site infection 24,34,51. These guidelines were developed to provide clear, objective criteria for evaluating surgical wounds and determining the presence or a ...
Focus on Lisdexamfetamine: A Review of its use in Child and
Focus on Lisdexamfetamine: A Review of its use in Child and

... duration of up to 13 hours. Administration of lisdexamfetamine via nasal or intravenous routes did not result in significant elevation of drug liking scores in known stimulant abusers, suggesting low potential for abuse. Lisdexamfetamine has been available in the United States since 2007, but was on ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These
HIGHLIGHTS OF PRESCRIBING INFORMATION These

... and hamster proteins ≤1.5 ng/IU ADVATE. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment. 5.2 Neutralizing Antibodies Neutralizing antibodies (in ...
Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial
Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial

... These complications include cardiac failure, MI, respiratory failure, arrhythmias, stroke, renal failure, wound infection, thromboembolism, and a need for surgical re-exploration (1-6). Each has an incidence of 0.5-5%. A common underlying mechanism is poor myocardial function secondary to myocardial ...
Study protocol: a phase III randomised, double-blind
Study protocol: a phase III randomised, double-blind

... ▪ This study builds on the experience of several double-blind randomised controlled trials in therapeutic interventions for breathlessness. ▪ This is a relatively long study for participants from palliative care which may potentially influence completion rates independently of the intervention. ▪ Th ...
Publicly funded Practice-oriented Clinical Trials
Publicly funded Practice-oriented Clinical Trials

... The external experts were consulted about a (preliminary) version of the scientific report. Their comments were discussed during meetings. They did not co-author the scientific report and did not necessarily agree with its content. Subsequently, a (final) version was submitted to the validators. The ...
Results of clinical trials with diuretics in heart failure - Heart
Results of clinical trials with diuretics in heart failure - Heart

... and the clinical syndrome of overt heart failure therefore involve a very different physiological state even though there is obviously a considerable overlap between the two conditions. There is no reason to suppose that both can be improved by the same drugs. Studies of the neuroendocrine system in ...
Comparison of Hypertonic Saline to Epinephrine in
Comparison of Hypertonic Saline to Epinephrine in

... children are too breathless to feed and some require oxygen supplementation to maintain blood oxygen levels. These children may require hospitalization. Treatment is mostly supportive using fluids and oxygen therapy. Nebulised bronchodilators like Salbutamol, Ipravent and Epinephrine have been used ...
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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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