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Product Information for Triptorelin Acetate
Product Information for Triptorelin Acetate

... drugs affecting pituitary secretion of gonadotrophins caution should be exercised and it is recommended that the patient’s hormonal status should be supervised. Mood changes Mood changes, including depression have been reported during long term use. Patients with known depression should be monitored ...
Latest data on management of bleeding in patients taking DOACs
Latest data on management of bleeding in patients taking DOACs

... which is also in development. ...
News Release Puma Biotechnology Reports First Quarter 2017
News Release Puma Biotechnology Reports First Quarter 2017

... Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. ...
Preclinical Toxicology of Anticancer Agents
Preclinical Toxicology of Anticancer Agents

... initiated at a dose one-third that of the animal MTD. The mouse was as useful as any other species in this regard. Homan (8) applied regression analysis to the MTO's of 25 anticancer drugs for dog and monkey. It was estimated that one-tenth of the dog MTO in mg/sq m carried a 1.3% risk of exceeding ...
nuvo research sells pennsaid 2% us rights for us$45 million to
nuvo research sells pennsaid 2% us rights for us$45 million to

... “This sale was made possible by our recent litigation settlement with our former U.S. marketing licensee that returned the U.S. PENNSAID and PENNSAID 2% rights to Nuvo,” said John London, Nuvo’s President and Co-CEO. “This transaction, together with the US$10 million litigation settlement payment, h ...
PLATO Trial - Delfini.org
PLATO Trial - Delfini.org

... the primary outcome but increased risk of bleeding compared to clopidogrel. However, since the NNT is small (good) and the NNH is larger in comparison (good), the net benefit appears to favor ticagrelor. -Major bleeding between the two groups did not show statistical significance. However, further s ...
November - December 2016 Monitoring International Trends
November - December 2016 Monitoring International Trends

... an immune response to its gene therapy, SPK-9001. The responses lowered both patients’ levels of replacement Factor IX, but so far those levels have not dropped low enough to cause bleeds or require other treatments. Spark is optimistic that temporary treatment with tapering doses of steroids will h ...
Systematic Review of Clinical Trials Assessing Pharmacological
Systematic Review of Clinical Trials Assessing Pharmacological

... Subjects (Oral Administration) In one article, results of two placebo-controlled, double-blind, balanced, crossover clinical trials (Trials 1 and 2) have been reported. The trial was performed by multidose, multiple-testing time regimes. In Trial 1, twenty mainly female healthy young subjects (mean ...
[et al.]….
[et al.]….

... 1. Addressing missing participant outcome data in dental clinical trials / By L.M. Spineli, P.S. Fleming, N. Pandis………………………………………………………….605 2. Association between developmental defects of enamel and dental caries: A systematic review and meta-analysis / By F. Vargas-Ferreira, [et al.]………………619 3. ...
IOSR Journal of Research & Method in Education (IOSR-JRME)
IOSR Journal of Research & Method in Education (IOSR-JRME)

... are commonly injured in knee trauma especially in road traffic accidents and amongst young males in the sports field [2]. Medial Meniscus is more commonly injured than lateral Meniscus [3]. Individuals who experience a meniscus tear usually complain of pain and swelling as their primary symptoms. It ...
VIdeo assisted thoracoscopic lobectomy versus conventional Open
VIdeo assisted thoracoscopic lobectomy versus conventional Open

... Case report form Computerised Tomography Common Terminology Criteria for Adverse Events Clinical Trials and Evaluation Unit Disease free survival Data monitoring and safety committee High dependency unit Health Technologies Assessment International Association of the Study of Lung Cancer Internation ...
OHRP: Institutional Review Board Guidelines
OHRP: Institutional Review Board Guidelines

... The IRB should be aware of other risks associated with vaccine trials, including the possibility that vaccines produced synthetically or using recombinant DNA techniques may present risks as yet unknown, that groups often most likely to benefit from receiving a vaccine are often the most vulnerable ...
2012 פברואר ה
2012 פברואר ה

... The concurrent use of latex condoms or diaphragms with vaginal antiinfective preparations may decrease the effectiveness of latex contraceptive agents. Therefore, GYNO-DAKTARIN products should not be used concurrently with a latex condom or latex diaphragm. ...
InsTITuTe FoR ClInICal and TRanslaTIonal ReseaRCH
InsTITuTe FoR ClInICal and TRanslaTIonal ReseaRCH

... informatics, biostatistics, research design or clinical trials support. Research training and career development are also part of our mission, as we cross boundaries from pediatric to adult patients, from laboratory sciences to community-based research, and act as partners with Einstein and Montefio ...
concept sheet template
concept sheet template

... load in this setting is a subject of debate; in particular, it remains uncertain whether the limited resources for care are best spent on viral load monitoring or on the purchase of therapy for more patients. Central to these discussions are the yet unknown long-term benefits and costeffectiveness o ...
Evaluation of WOMAC 20, 50, 70 Response Criteria in Patients
Evaluation of WOMAC 20, 50, 70 Response Criteria in Patients

... (OA), and rheumatoid arthritis (RA) clinical trials, have followed similar but not identical pathways. While measures of pain, function and patient global assessment have been selected as core set measures for both OA and RA clinical trials, the Outcome Measures in Arthritis Clinical Trials–American ...
BioMarin Provides Program Update on Vosoritide in Achondroplasia
BioMarin Provides Program Update on Vosoritide in Achondroplasia

... achondroplasia is about one in 25,000 live births, per the World FactBook 2014 edition which translates into approximately 96,000 potential patients. Vosoritide is being tested in children whose growth plates are still "open," typically those under 18 years of age. This is approximately 25 percent o ...
Missing Data For Repeated Measures: Single Imputation VS Multiple Imputation
Missing Data For Repeated Measures: Single Imputation VS Multiple Imputation

... with incomplete data. Siddiqui and Ali (1998) compare direct-likelihood and LOCF methods. Molenberghs, Thijs, Jansen, Beunckens et al (2004) compare the effects of different methods on three different clinical trials. This paper will focus on a case study where repeated measures are used to evaluate ...
New Oncology Drugs 2004: A Year in Review
New Oncology Drugs 2004: A Year in Review

... Rounds Series, November 29, 2004 ...
Novel treatments for idiopathic pulmonary fibrosis
Novel treatments for idiopathic pulmonary fibrosis

... start, a careful discussion with each patient should involve dosing, potential side effects and expected outcomes of therapy. The most common side effects of pirfenidone are skin rash, nausea and dyspepsia, but they were not a common cause of drug discontinuation in clinical trials.6,8 Similarly, wh ...
Clinical audit tool: initiating drug treatment
Clinical audit tool: initiating drug treatment

... example; cancer, heart failure and chronic illnesses such as kidney, liver and respiratory disease) starting treatment with strong opioids for pain control. Strong opioids are morphine-like drugs e.g. diamorphine, fentanyl, oxycodone and buprenorphine. In secondary care the controlled drug book coul ...
Working with a CRO / TPO Using SDD to Implement an Adaptive Design Clinical Trial Monitored by a DMC
Working with a CRO / TPO Using SDD to Implement an Adaptive Design Clinical Trial Monitored by a DMC

... normally achieved through separate trials in Phase 2 and 3 to be addressed in a single trial. Specifically, the adaptive dose-finding design should lead to a dose selection decision of the type normally associated with Phase 2. With this seamless adaptive design framework, it is then best advised to ...
cdec final recommendation
cdec final recommendation

... devastating. Fractures can result in a loss of independence, decreased mobility, isolation, depression and, in some cases, death. In addition to the impact on patients, fractures can have a significant emotional and financial impact on caregivers.  Bisphosphonates have been the most commonly prescr ...
clinical simulation laboratory orientation manual
clinical simulation laboratory orientation manual

... The simulation lab is designed to present health care professionals/ students with clinical scenarios in a controlled setting to enable the student/professional to process and analyze clinical decision-making. The simulation lab enables students/professionals to make errors in a controlled setting, ...
Appendix - LWW.com
Appendix - LWW.com

... Study design issues involve concerns about the use of biomarkers as the primary endpoints for determining successful outcome of treatment. Proximal rather than distal endpoints are emphasized in many endpoint measurements. Typically, pharmaceutical trials have tended to restrict endpoints to sympto ...
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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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