Clinical trial

reaction that occurs after immunization.2 Acetaminophen has been used for decades in various settings for its antipyretic effects, however the efficacy and safety of using this agent when immunizing infants is investigated. 3 The clinical trial, “A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination…

Technology is changing the way our society accesses information and communicates; no doubt the future of clinical research will be shaped by these changes. One such example is the need for source data verification (SDV). The process of SDV begins with the patient and the information captured by the clinician into a document (mostly on paper) which someone manually transcribes into a computer database to send to the sponsor. The CRA reads this source, usually in person, and verifies the data…

be employed to detect the OC recurrence according to the standard operational process. Based on the Response Evaluation Criteria In Solid Tumors (RECIST) standard, the frequency of tumor re-evaluation is recommended as 6-8 weeks for a phase II clinical trial where the beneficial effect of therapy is not known, specifically when PFS is taken as the primary outcome(49). However, as the OC patients in our study may not stand the high frequency of CT scans as shown in previous study(40), 6 months…

importance of choosing drugs that do not increase cardiovascular risk and reduce the risk of cardiovascular events. The US FDA and has recommended its Guidance for Industry for drug developers in 2008 that new drugs for type 2 diabetes undergo clinical trials should fulfill cardiovascular safety in addition to glycemic benefit and rule out potentially harmful drug interactions. The European Medicines Agency recommended same. Cautious selection of the drug therapy, specifically cardiovascular…

resources and technology available. For a new drug to reach the market, it takes more than a decade and several tests and trials that the FDA needs to clear. The information for the pre-clinical testing and the new molecular entity (NME) is submitted by a New Investigational Drug (IND) document to the FDA and if approved, it moves to the clinical phases. There are 4 clinical phases that need to be cleared and if the tests are positive with an acceptable toxicity and safety profile of the…

usually effects the hip, knee and thumb joints. Osteoarthritis is one of the most common diseases in the world and the most affected by the knee joint. According to a randomized placebo controlled clinical trial using a pulsed shortwave treatment in women with knee osteoarthritis, the purpose of the trial is to evaluate the effect of pulsed shortwave therapy treatment in different doses and to compare low-dose and high-dose pulsed shortwave therapy groups with controlled and placebo groups”.…

Pharmacogenomics is the study of how genes affect a person’s response to drug. A new emerging field which hold the combinational knowledge of pharmacology and genomics in order to provide not only safe and effective medication but also have the high degree of acceptance with the genetic make up of the patients. Current status of dose regimen followed ”one size fits all”. But is very tiresome job to predict these therapeutic responses in all the patient. Some times dominating negative side…

have held various clinical and research positions in leading academic institutions. I gained substantial clinical competencies in hematology-oncology combined with robust knowledge of basic Immunology and Cancer Immunotherapy. Thanks to my broad expertise, I can easily comprehend scientific information and effectively provide guidance to both clinical and scientific partners. I have extensive knowledge of scientific, statistical, policy, and ethical aspects of clinical trials…

To move forward research in the area of detection and treatment of cancer, using EHRs is vital because randomized controlled trials represent only 3% of patients, and most diagnosis and treatment activities take place within the healthcare system, making EHRs the primary repositories for data that have the potential to improve and personalize cancer care. EHR data differ fundamentally…

1.1 Background Atrial fibrillation (AF) is responsible for significantly increased morbidity and mortality, worsened New York Heart Association (NYHA) functional class, and impaired quality of life in the general population [1]. For instance, data from the longitudinal population-based Framingham Heart Study suggest that AF is solely associated with a threefold to fivefold increased risk of stroke [2] and with an approximately twofold increased risk for mortality [3]. The ischemic strokes due to…