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Clinical Guidelines for Chronic Conditions in the
Clinical Guidelines for Chronic Conditions in the

... endorsed or recommended by the European Observatory on Health Systems and Policies in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been t ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These
HIGHLIGHTS OF PRESCRIBING INFORMATION These

... one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. While using TRUVADA for PrEP - HIV-1 screening tests should be repeated at least every 3 months. (5.9) ...
AVAGE ® (tazarotene) Cream 0.1%
AVAGE ® (tazarotene) Cream 0.1%

... occur, discontinue the medication until the integrity of the skin is restored, or reduce the dosing to an interval the patient can tolerate. However, efficacy at reduced frequency of application has not been established. Closely monitor the frequency of application by carefully observing the therape ...
Breo Ellipta
Breo Ellipta

... from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to patients’ usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on sal ...
Lamictal - GSK Source
Lamictal - GSK Source

... the maintenance dose will in most cases need to be increased by as much as 2-fold to maintain a consistent lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/ ...
Assessment Report - Word 512 KB
Assessment Report - Word 512 KB

... Enquiries about the content of the report should be directed to the above address. This report is a contracted technical report for use by the Medical Services Advisory Committee (MSAC) to inform its deliberations. MSAC is an independent committee which has been established to provide advice to the ...
Australian public assessment for Crizotinib
Australian public assessment for Crizotinib

... (Xalkori), as an oral treatment for patients with anaplastic lymphoma kinase (ALK)positive advanced non-small cell lung cancer (NSCLC); “The treatment of patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC)”. The proposal is for first (or subsequent) l ...
Sub-Lingual Immunotherapy - World Allergy Organization
Sub-Lingual Immunotherapy - World Allergy Organization

... Increased availability of authorized allergen products with proven quality, safety and efficacy will lead to an improved benefit for allergic patients and may also improve the general acceptance of SIT as an established treatment by regulatory agencies. Sublingual vaccines seem to have heralded a ne ...
Neuropathic pain The pharmacological management
Neuropathic pain The pharmacological management

... disadvantages, as well as potential benefits. A further issue is that a number of commonly used treatments (such as amitriptyline) are unlicensed for treatment of neuropathic pain, which may limit their use by practitioners. There is also uncertainty about which drugs should be used initially (first ...
Asthma Control and Exacerbations
Asthma Control and Exacerbations

... environmental factors, and comorbidities (6). There is clinical utility in distinguishing patients with ‘‘difficult-to-treat’’ or severe asthma from those who have ‘‘easy-to-treat’’ or mild asthma. This represents a change from previously published definitions of asthma severity (8, 9), which was pr ...
Prescribing Information Only Fluticasone Propionate Nasal Spray
Prescribing Information Only Fluticasone Propionate Nasal Spray

... A total of 13 randomized, double-blind, parallel-group, multicenter, vehicle placebo-controlled clinical trials were conducted in the United States in adults and pediatric patients (4 years of age and older) to investigate regular use of fluticasone propionate nasal spray in patients with seasonal o ...
Otezla - Celgene
Otezla - Celgene

... to ensure disease control (Gladman, 2001; Mease, 2005a). Current therapies do not always adequately control the disease in all patients. Ultimately, most therapies fail to maintain clinical disease control over time. An unmet medical need for new treatments remains high, especially for therapies tha ...
Preotact, INN-parathyroid hormone (rdna)
Preotact, INN-parathyroid hormone (rdna)

... produced in E. coli that is identical to the endogenous human PTH. RhPTH is manufactured by fermentation at an 1100 L scale, followed by a 2-step recovery and a 5-step purification process and terminated by filtration and filling. The intended therapeutic indication of PTH is the treatment of osteop ...
SCIENTIFIC DISCUSSION
SCIENTIFIC DISCUSSION

... the recent introduction of several new AEDs has considerably increased the number of possible combinations. The rational basis for combining AEDs is largely based upon their modes of action, although these mechanisms are not fully understood for some drugs. The efficacy of the newer AEDs in adjuncti ...
Truvada - Gilead Sciences, Inc.
Truvada - Gilead Sciences, Inc.

... least one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. o While using TRUVADA for PrEP − HIV-1 screening tests should be repeated at least every 3 months. (5.8) ------------------ ...
Elkins
Elkins

... Hypnosis has found a broad range of clinical applications. It has been used for general pain management (Brown, 2007; Hawkins, 2001; Montgomery, DuHamel & Redd, 2000) as well as to reduce pain-related negative affect, degree of pain, amount of pain medication used, physiological aspects of pain, rec ...
PrDALACIN* C FLAVOURED GRANULES
PrDALACIN* C FLAVOURED GRANULES

... Geriatrics (> 65 years of age): Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. Pediatrics (over one month of age): It is not known if use of clindamycin in the pediatric population i ...
Clinical Manual Part 2 Drug Infusion Guidelines
Clinical Manual Part 2 Drug Infusion Guidelines

... The guidelines which follow cover the common drugs used by the Service in patient transport. The guidelines are standardised to assist staff from widely differing clinical backgrounds. Use of standard guidelines assists in preventing drug administration errors and aids in the handover of patients. T ...
Control: full guideline
Control: full guideline

... the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page. The use of ...
1.3.1 LEVITRA-Annotated PM dated 06-Mar-2015
1.3.1 LEVITRA-Annotated PM dated 06-Mar-2015

... There are no controlled clinical data on the efficacy and safety of LEVITRA in known hereditary degenerative retinal disorders such as retinitis pigmentosa; its use is therefore not recommended until further information is available. Otologic Sudden decrease or loss of hearing has been reported in a ...
Prescribing Information
Prescribing Information

... compared to subjects never exposed to ACTOS (HR 1.2 [95% CI 0.9 −1.5]). Compared to never exposure, a duration of ACTOS therapy longer than 12 months was associated with an increase in risk (HR 1.4 [95% CI 0.9 −2.1]), which reached statistical significance after more than 24 months of ACTOS use (HR ...
Evaluation of Pharmacokinetic Interaction between PA
Evaluation of Pharmacokinetic Interaction between PA

... Study design. A phase I study was conducted to evaluate the effects of the multiple-dose administration of PA-824 on the PK of orally administered midazolam and to evaluate the safety and tolerability of PA-824 when coadministered with midazolam. The study was an open-label, multidose, fixed-sequenc ...
Sumatriptan Succinate Injection - Pack Insert
Sumatriptan Succinate Injection - Pack Insert

... Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency ...
Safety and Efficacy of Ranibizumab and Bevacizumab for the
Safety and Efficacy of Ranibizumab and Bevacizumab for the

... CNV with or without classic CNV secondary to AMD. It also examined dosing regimen to determine whether ranibizumab can be given less frequently (i.e. at three-month intervals) compared with monthly intervals. VA improved significantly at one year versus the sham group. The two-year results demonstra ...
Spinal injury assessment
Spinal injury assessment

... What is the diagnostic accuracy of i) X-ray, ii) dynamic fluoroscopy, iii) CT and iv) MRI, for people with isolated spinal column injury?................................................................. 109 ...
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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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