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Herbs for the Treatment of the Symptoms of Menopause
Herbs for the Treatment of the Symptoms of Menopause

... controlled trials assessing the efficacy of Black Cohosh among breast cancer survivors, patients or women with a perceived increased risk of breast cancer. The herb significantly reduced hot flushes (1 trial, 12 months), had no effect (1 trial, 4 weeks) and had no significant improvement in menopaus ...
What data can a 14C clinical study deliver?
What data can a 14C clinical study deliver?

... nausea and vomiting, CINV, is described as acute, when it ...
View - IPAC-RS
View - IPAC-RS

... • Quantitative (Q2) consideration – Same inactive ingredient(s) but may differ in concentration • Cannot exceed the levels used in other FDA approved products administered by the same route of administration (i.e., inhalation) • Effect of Q2 difference on bioequivalence assessed by in vitro and in v ...
Protocol S1.
Protocol S1.

... haematological changes were seen up to 4 weeks after a total dose of 30 mg/kg was administered i. v. over 18 hours (Burrows 1984). From this study it was concluded that the dosage of i. v. MB may safely be increased up to at least 15 mg/kg in the therapy of severe methaemoglobinaemia in humans. Howe ...
Instructions for use `Template Research Protocol`
Instructions for use `Template Research Protocol`

... determination in blood as standard of care. The impact that so-called serum concentration guided dosing of voriconazole will have on treatment success can only be evaluated through a prospective randomized clinical trial. Objective: The objective of this study proposal is to determine whether pharma ...
lothian university nhs trust
lothian university nhs trust

... British Association of Prosthetists and Orthotists - BAPO) and HPC Council. The post holder is expected to use his/her own training and education, work experience, peer support, the clinical supervision framework and to research the evidence base before deciding how to proceed with a particular clin ...
Desvenlafaxine succinate
Desvenlafaxine succinate

... indicated for individual patients, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. Vasomotor Symptoms (VMS) associated with Menopause The recommended dose for Desvenlafaxine is 100 mg once daily, with or without food. It is recomme ...
N-Acetylcysteine and Acute Kidney Injury
N-Acetylcysteine and Acute Kidney Injury

... – ? reduce Dexmedetomidine infusion by 0.2 mcg/kg/hr. Please note the long offset time for bradycardia. Maintain RASS target as per protocol. – You may increase dobutamine / adrenaline to the desired effect. ...
Study Manual
Study Manual

... The visit schedule is presented in appendix 1. The enrolment/screening visit will occur one week prior to the first injection. Randomisation will occur at this screening visit. On the day of the first injection the vision and fundus will be checked again. If there is a significant change in acuity ( ...
ORDER SET DEVELOPMENT AND APPROVAL PROCESS
ORDER SET DEVELOPMENT AND APPROVAL PROCESS

... Primary Authors lead the order set development and may include more than one health professional. Ideally the primary authors would include a physician, nurse and clinical pharmacist from the specialty area. This is particularly relevant with the creation of a new order set. For small and minor chan ...
Microsoft Word - CLoK - University of Central Lancashire
Microsoft Word - CLoK - University of Central Lancashire

... clozapine-induced hypersalivation. We aim to recruit 42 patients who have been prescribed clozapine and are experiencing hypersalivation, and randomise them to one of three study arms (either hyoscine, glycopyrrolate or placebo). The primary outcome measures will be the participant recruitment and a ...
Implantation and explantation of an active epiretinal visual
Implantation and explantation of an active epiretinal visual

... Implantation surgery was performed under general anaesthesia. Phacoemulsification of the lens was followed by a complete 20-gauge vitrectomy via the pars plana. Using the vitrectome, an excentric posterior capsulotomy was created. The receiver unit was inserted into the capsular bag through an 11-mm ...
A1984SU44500001
A1984SU44500001

... been cited frequently over the years is because this study with ketamine was the first of its kind. Those early events in my research career have caused me to return again and again to study ketamine and other arylcyclohexylamines.1,2 Since ketamine has some actions clearly related to phencyclidine, ...
How we help our customers
How we help our customers

... metadata-driven approach addresses non-standardized data and exceptions in data range and type. This enables robust data validation and quality assurance, while reducing overall programming and on-boarding efforts. By adopting the offering, enterprises can: ...
ELESTAT® Prescribing Information
ELESTAT® Prescribing Information

... fornix; and (2) environmental field studies where patients were dosed and evaluated during allergy season in their natural habitat. Results demonstrated a rapid onset of action for epinastine HCl 0.05% within 3 to 5 minutes after conjunctival antigen challenge. Duration of effect was shown to be 8 h ...
Overview of clinical research design
Overview of clinical research design

... against, and may have increased, the risk of heart disease. The health-user bias is based on the premise that, in observational studies, subjects are not randomized to treatment groups and are, in a sense, self-selected; therefore, important differences in comorbidity and lifestyle may also be selec ...
Kaposi Sarcoma
Kaposi Sarcoma

... Ethnicity - people of Jewish or Mediterranean descent, as well as equatorial Africans, have a higher risk of developing KS o Gender – men, generally, have a higher risk of developing Kaposi sarcoma than women o Human herpes virus 8 (HHV-8) - this virus may be the cause for Kaposi sarcoma to develop. ...
Draft Paediatric Addendum on treatment of acute heart failure
Draft Paediatric Addendum on treatment of acute heart failure

... referral for transplantation using objective and pre-specified criteria could be a useful indicator of Draft Paediatric Addendum on the CHMP Guideline on clinical investigation of medicinal products for the treatment of acute heart failure ...
Hot Flashes: Evidence-Based Review of Alternative Therapies
Hot Flashes: Evidence-Based Review of Alternative Therapies

... present evidence-based literature for use of ...
Drugs Used in Coagulation Disorders
Drugs Used in Coagulation Disorders

... – ↓ reduced form of vitamin K → ↓ factors II, VII, IX, X, protein C and S ...
Ruxolitinib for the treatment of myelofibrosis: its clinical potential Alen Ostojic
Ruxolitinib for the treatment of myelofibrosis: its clinical potential Alen Ostojic

... volume ­reduction of $35% from baseline at week 24, compared with placebo in one study (41.9% versus 0.7%; P , 0.0001) and with best available therapy in the other (31.9% versus 0%; P  ,  0.0001). Alleviation of MF symptoms and improvements in quality of life were also significantly greater in ruxol ...
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)

... When endpoints listed above are not specified as primary they may be chosen as secondary endpoints. In addition, a number of secondary endpoints may provide useful information. These measure different aspects of the condition and they should be justified by referencing published data that support th ...
Full Prescribing Information for NATRECOR® (nesiritide)
Full Prescribing Information for NATRECOR® (nesiritide)

... subjects requiring either hemofiltration or dialysis. In the PRECEDENT trial, the incidence of elevations in serum creatinine to >0.5 mg/dL above baseline through Day 14 was higher in the NATRECOR® 0.015 mcg/kg/min group (17%) and the NATRECOR® 0.03 mcg/kg/min group (19%) than with standard therapy ...
Automated discovery of drug treatment patterns for endocrine
Automated discovery of drug treatment patterns for endocrine

... Enterprise Data Trust (EDT)8 and Informatics for Integrating Biology and the Bedside (i2b2) datamarts.9 In an August, 2011 JAMA editorial, Jha10 discusses the promises of the EMR, emphasizing the importance of NLP as an enabling tool for accessing the vast information residing in the EMR, and stated ...
Pneumonia clinical protocol MMC.docx
Pneumonia clinical protocol MMC.docx

... All medications will be stored, labelled and dispensed in accordance with hospital policy and relevant legislation ...
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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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