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THIRTY -SEVENTH  ANNUAL  REPORT RESEARCH  ADVISORY  PANEL 2007
THIRTY -SEVENTH ANNUAL REPORT RESEARCH ADVISORY PANEL 2007

... has been shown to attenuate the neurotoxic effects of MPTP and to ameliorate symptoms in Parkinson's disease. We conducted an inpatient, double-blind, placebo-controlled, parallel design evaluation of potential interactions between oral perindopril and methamphetamine (MA). Non-treatment-seeking, MA ...
New Tuberculosis Therapeutics: A Growing
New Tuberculosis Therapeutics: A Growing

... ∼80% noted with standard therapy [7]. Perhaps more impressive were the reported relapse rates. Patients assigned to receive daily therapy with isoniazid, rifampin, pyrazinamide, and ofloxacin for 3 months, followed by twice-weekly therapy with isoniazid and rifampin for 1 month, experienced a 4% rel ...
2014 AHA/ACC/HRS Guideline for the Management of
2014 AHA/ACC/HRS Guideline for the Management of

... inhibitor dabigatran and the factor Xa inhibitor rivaroxaban are not recommended in patients with AF and end-stage CKD or on dialysis because of the lack of evidence from clinical trials regarding the balance of risks and benefits.” The sentence previously read, “The direct thrombin inhibitor dabigat ...
DOES NEW MEAN BETTER
DOES NEW MEAN BETTER

... Back pain has been reported with tadalafil, possibly related to inhibition of PDE11. The clinical significance of PDE11 inhibition on other tissues remains to be seen. More study is required to better assess the adverse effect profile of the newer agents particularly in long-term use and the high-ri ...
Pulmozyme - Genentech
Pulmozyme - Genentech

... The most common adverse reaction (risk difference ≥5%) was voice alteration. The proportion of most adverse events was similar for patients on PULMOZYME and on placebo, probably reflecting the sequelae of the underlying lung disease. In most cases reactions that were increased were mild, transient i ...
Nature Made TripleFlex
Nature Made TripleFlex

... •Four clinical trials on white willow bark with a standardized 15% salicin content found both 240 and 120 mg doses salicin/day effective for joint discomfort relief.[6][7][8][9] Dosage: The Nature Made recommended daily dose of TripleFlex is two tablets daily with a meal. The tablets can be taken to ...
here - Michael Rogawski
here - Michael Rogawski

... observed in juvenile dogs at a 10-fold lower dose associated with lower exposures. The results in animals indicate that caution is warranted in the use of perampanel in children and young adults. As discussed later in this chapter, there is evidence from clinical studies that juveniles may be at gre ...
Rozerem - Takeda
Rozerem - Takeda

... Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of ...
Phase I Clinical Trials
Phase I Clinical Trials

... • A formal application to study an intervention in patients that can be sponsored (submitted) by: • Commercial-sponsor usually a pharmaceutical company ...
clinical site information form (csif)
clinical site information form (csif)

... Other: Please list CPR must be American Heart Association for Health Care Providers. HIPAA training onsite. TB test must be current (within 1 year) during length of the affiliation. ...
Impact of a pharmacist-led medication review on
Impact of a pharmacist-led medication review on

... Methods/design: The study is a randomized controlled clinical trial. A total of 1400 hospitalized patients will be randomized in two groups: (1) the experimental group (group receiving a pharmacist-led medication review) and (2) the control group (group receiving usual care). The pharmacist-led medi ...
A	Literature	Review	Examining	the	Use	of	Combina9on	Inhaler	Tiotropium/Olodaterol	in	COPD
A Literature Review Examining the Use of Combina9on Inhaler Tiotropium/Olodaterol in COPD

... analyses, and ongoing trials were found using PubMed, Clinical Key, ClinicalTrials.gov, and Potropium/olodaterol's website. Clinical trials comparing Potropium/olodaterol to other medicaPons in similar drug classes and monitoring the inhaler for safety were included. Opinion arPcles were exclude ...
The value of computer-administered self
The value of computer-administered self

... Subjective investigator ratings have formed the basis of primary efficacy endpoints in clinical drug trials in depression, anxiety, schizophrenia and many other CNS disorders. Assessments are made following semi-structured interviews, and clinicians rate the severity of symptoms exhibited by patient ...
Critical Care Nursing 4333.D10
Critical Care Nursing 4333.D10

... clinical experience, the student will:  Notify the agency before scheduled time to report on duty  Notify the clinical instructor a minimum of one hour before scheduled time to report on duty  Failure to call in will result in an unsatisfactory for that clinical day o Students will be prepared fo ...
RADIATION THERAPY ONCOLOGY GROUP CONCEPT
RADIATION THERAPY ONCOLOGY GROUP CONCEPT

... 1. Give dose and schedule for intervention together with justification (or potential doses/schedules of agent[s]) ...
Moving from Animal Models to the Clinic
Moving from Animal Models to the Clinic

... physiological or other biological similarities to humans that are specific to the drug (e.g., the presence of relevant receptors, ADME parameters, the nature of the dose-limiting toxicity).149 The agency recommends that researchers first use the NOAEL of the most appropriate species and determine th ...
otezla - Celgene
otezla - Celgene

... In the period of exposure to OTEZLA® in the pivotal psoriasis trials, the most common serious adverse event for patients exposed to OTEZLA® was nephrolithiasis (0.3%). The most common adverse reactions leading to discontinuation for patients taking OTEZLA® were nausea, diarrhea, psoriasis, headache, ...
Outcome Tools for Alcohol Treatment
Outcome Tools for Alcohol Treatment

... 6. TOP data that has been collected so far will be analysed nationally to inform current thinking, but will not be made available at local level. 7. Alcohol treatment is often short in duration, compared to drug treatment and therefore may not lend itself to these formal outcome measures. Other meas ...
Nelotanserin
Nelotanserin

... subject to risks and uncertainties that could cause actual results and the timing of certain events to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the succ ...
Review the published MAY03-1-BIO manuscript.
Review the published MAY03-1-BIO manuscript.

... AUC0-24 h for sulindac and each metabolite are provided in Table 2 for both formulations. Plasma concentrationtime curves are illustrated in Fig. 1. Following a short delay of 0.46 h, a mean peak plasma concentration of 3.34Ag/mL for sulindac sulfoxide was achieved 1.90 h after administration of the ...
Swine: Baytril® 100 is indicated for the treatment and control of
Swine: Baytril® 100 is indicated for the treatment and control of

... 14 post-treatment. Treatment success in the Baytril® 100 group (497/573, 87.83%) was significantly higher (P = 0.0013) than success in the saline control group (455/571, 80.92%). In addition, there were more treatment successes (n = 13) than failures (n = 3) in the group of animals positive for M. b ...
openEHR
openEHR

... • Deliver evidence-based health care • Improve safety ...
Objectives - IndPharNet
Objectives - IndPharNet

... ---- GCP guidelines ...
OXISTAT®(oxiconazole nitrate cream) Cream, 1%* OXISTAT
OXISTAT®(oxiconazole nitrate cream) Cream, 1%* OXISTAT

... microbiologically established tinea pedis. Of these evaluable patients, 64% were diagnosed with hyperkeratotic plantar tinea pedis and 28% with interdigital tinea pedis. Seventy-seven percent (77%) had disease secondary to infection with Trichophyton rubrum, 18% had disease secondary to infection wi ...
A PLACEBO-CONTROLLED, MULTICENTER, DOUBLE
A PLACEBO-CONTROLLED, MULTICENTER, DOUBLE

... Literature reports suggest increasing levels of cCK18/M30 were associated with increasing hepatic disease severity and that the higher the cCK18/M30 level, the worse the patient outcome. This study confirmed that ACLF patients had elevated levels of all 3 biomarkers (cCK18/M30, flCK18/M65, Caspase 3 ...
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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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