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Omnibus Codes - Oxford Health Plans
Omnibus Codes - Oxford Health Plans

... This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for information ...
Simeprevir - Therapeutic Goods Administration (TGA)
Simeprevir - Therapeutic Goods Administration (TGA)

... Simeprevir (also referred to as TMC 435) is a nonstructural protein 3 (NS3)/4A protease inhibitor. Protease inhibitors prevent viral replication by selectively binding to viral proteases such as NS3/4A and blocking proteolytic cleavage of protein precursors that are necessary for the production of i ...
Product Monograph
Product Monograph

... should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The overall safety profile of RiaSTAP was derived from the standardized collection of ...
SEREVENT DISKUS
SEREVENT DISKUS

... SEREVENT DISKUS is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients aged 4 years and older with reversible obstructive airway disease, including patients ...
Sucroferric oxyhydroxide - Therapeutic Goods Administration
Sucroferric oxyhydroxide - Therapeutic Goods Administration

... Tentori F, et al. Mortality risk for dialysis patients with different levels of serum phosphorus, and PTH. The Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2008;52(3):519-530. 3 Kestenbaum B, et al. Serum phosphate levels and mortality risk among people with chronic kidney ...
Moderate Hypothermia in Neonatal Encephalopathy: Safety Outcomes
Moderate Hypothermia in Neonatal Encephalopathy: Safety Outcomes

... We used chi-square or Fisher exact tests for categorical variables, the pooled t test for continuous variables that were normally distributed, and Satterthwaite t test for continuous variables when unequally distributed. Laboratory values are reported as means if normally distributed, specifically l ...
ankle fractures
ankle fractures

... 7. Seek independent advice (i) The Guidelines are intended to aid Permitted Users in the management of their patients but do not provide explanations as to the conditions or treatments outlined. There may be clinical or other reasons for using different therapy. In all cases, users should understand ...
Clinical Investigation of Medicinal Products in the Pediatric
Clinical Investigation of Medicinal Products in the Pediatric

... When a medicinal product is to be used in younger pediatric patients for the same indication(s) as those studied in older pediatric patients, the disease process is similar, and the outcome of therapy is likely to be comparable, extrapolation of efficacy from older to younger pediatric patients may ...
Niroshan Siriwardena and Philip M. Bath Sandeep Ankolekar
Niroshan Siriwardena and Philip M. Bath Sandeep Ankolekar

... Where patients died prior to an assessment, a value different from any living value was imputed into those functional measures that do not include death (death is already included in mRS, Barthel Index, and EQ5D): Mini Mental State Examination=−1, Zung Depression Scale=102.5, EQ-VAS=−1, Scandinavian ...
[Product Monograph Template - Schedule D]
[Product Monograph Template - Schedule D]

... of ZOSTAVAX® 42 days following the initial dose; the vaccine was generally well tolerated. The frequency of vaccine-related adverse experiences after the second dose of ZOSTAVAX® was generally similar to that seen with the first dose. Safety in subjects on chronic/maintenance systemic corticosteroid ...
Clinical Incident Management
Clinical Incident Management

... With regard to clinical incidents involving mental health patients, the focus should be on how did health care delivery or the lack of health care delivery contribute to the clinical incident occurring. High risk mental health patients include those detained under the Mental Health Act (1996 or 2014 ...
(PSD) July 2015 PBAC Meeting
(PSD) July 2015 PBAC Meeting

... approximately 300 patients per month, including around 100 who had received a previous treatment for osteoporosis. For these patients, strontium addresses an otherwise unmet clinical need’.  ‘In the case of the larger population of approximately 10,000 existing patients who are currently receiving ...
Australian public assessment report for Axitinib
Australian public assessment report for Axitinib

... interval adjusted for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death. Sponsor comment: “Pfizer agreed to the changes to the tablet assay in the Company Response dated 17 July 2012. The revised tablet assay was submitted to the TGA on 14 August ...
Relative potency of proton-pump inhibitors-comparison of
Relative potency of proton-pump inhibitors-comparison of

... in healthy volunteers with intragastric 24-h pH monitoring were included. We restricted the patient studies to those with GERD because very few studies with 24-h pH assessment were available for other diseases such as peptic ulcer or Zollinger-Elison syndrome. Studies performed exclusively in Hp-pos ...
Nitrofurantoin revisited: a systematic review and meta
Nitrofurantoin revisited: a systematic review and meta

... Downloaded from http://jac.oxfordjournals.org/ at University of Athens on April 6, 2016 ...
Balsalazide disodium for the treatment of ulcerative colitis Drug Profile
Balsalazide disodium for the treatment of ulcerative colitis Drug Profile

... effective method of delivering 5-ASA to the colon while minimizing systemic absorption [10]. Several trials have been conducted to examine the efficacy of balsalazide in inducing remission in active ulcerative colitis. Induction of response in active disease ...
effects of antihypertensive drugs on carotid intima
effects of antihypertensive drugs on carotid intima

... In the ELSA study, including 2,334 patients with uncomplicated hypertension, death, MI, major and all CV events had an increased incidence in the highest carotid IMT quintile and in groups with the greatest number of plaques at baseline.26 The risk increase compared to the lowest quintile was about ...
Concomitant Administration of Clopidogrel With Statins or Calcium
Concomitant Administration of Clopidogrel With Statins or Calcium

... and prior MI or coronary artery bypass graft surgery, but were less likely to have a reduced creatinine clearance (Table 1). Patients treated with a CCB were more likely to be older, female, and have additional risk factors including hypertension, hyperlipidemia, diabetes, prior MI, family history o ...
Aprepitant Emend™ — Merck Frosst Canada Ltd.
Aprepitant Emend™ — Merck Frosst Canada Ltd.

... Chemotherapy-induced Nausea and Vomiting: Overview of CDR Clinical and Pharmacoeconomic Reports [May 2008]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2008. This Overview is a synopsis of the evidence-based reviews prepared by the Common Drug Review (CDR) Directorate at the Canadi ...
12.4 Risk Reduction Counseling
12.4 Risk Reduction Counseling

... INTRODUCTION........................................................................................................ 9 Background .................................................................................................................. 9 ...
NYMALIZE PRODUCT FACT SHEET
NYMALIZE PRODUCT FACT SHEET

... Nimodipine plasma concentration and efficacy may be significantly reduced when concomitantly administered with strong CYP3A4 inducers. Therefore, concomitant use of NYMALIZE with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s Wort) should generally be avo ...
Pharmacokinetic interaction studies of atosiban with labetalol
Pharmacokinetic interaction studies of atosiban with labetalol

... with the Declaration of Helsinki (last amended at Somerset West in October 1996). Participants were informed of the purpose of the studies and had to give their voluntary signed informed consent before being enrolled. For both studies, healthy female volunteers, either nonsmokers or smokers (<10 cig ...
inspiolto - Boehringer Ingelheim (Canada)
inspiolto - Boehringer Ingelheim (Canada)

... of lactating rats, but it is not known whether tiotropium and/or olodaterol passes into human breast milk. Therefore, the use of INSPIOLTO RESPIMAT by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Fertility: Clini ...
arnuity ellipta
arnuity ellipta

... corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of mon ...
The Placebo Effect: is achieving trial success all in our minds?
The Placebo Effect: is achieving trial success all in our minds?

... Over the last decade we have observed a great in- improve the chances of achieving adequate sepacrease in the amount of dedicated experimental ration between treatment groups. work performed on these processes4,5 , and ultimately we have arrived at a consensus that they constitute real psychobiologi ...
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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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