Efficacy research studies

The decision to use these agents should be made with considerable caution, and only after possible underlying causes of the patient s symptoms have been explored and treated appropriately. Although surveys indicate that BZDs are frequently prescribed for elderly patients, the NIH Consensus Development Conference stated that the efficacy and safety of sedatives and hypnotics have not been established for older people, nor has the extent to which they contribute to or alleviate sleep problems (302, 305, 306). Saizman (307) has pointed out that relatively few research studies, most of which are seriously flawed, have examined the therapeutic effect of these agents in elderly patients. Thus, recommendations for the use of BZDs in elderly patients are derived almost exclusively from studies of young adult patients, studies of pharmacokinetics and toxicity in elderly patients, and clinical and anecdotal experience. 

Sound too good to be true More than twelve hundred research studies, conducted at top medical centers around the world and published in the most prestigious medical journals, document both the safety and efficacy of phytosterols in cholesterol control. They are completely safe not only because they are naturally found in plants but also because they never enter the bloodstream. After blocking the receptor micelles for probably one to two hours, they are rejected, owing to the slight difference in molecular structure, and are eliminated by the body. Even children and pregnant women can take them without fear. 

A growing body of well-controlled research studies (double-blind, randomized, placebo controlled) lend convincing support to the efficacy of psychotropic drugs. 

In addition, NCCAM plans to support a contract for the development and production of research grade cranberry (Vaccinium macrocarpon) products and placebos for use in clinical studies. There is evidence from small clinical trials suggesting that cranberry may relieve symptoms of urinary tract infection (UTI) and may reduce the need for antibiotics in treating such infections (23). The products developed under the contract will be evaluated in basic and clinical research studies on the role of cranberry in the prevention and treatment of UTIs and other conditions for which there is credible evidence of efficacy. 

Clinical trials are formal research studies investigating the efficacy of a particular drug or other type of modality on a selected disease or condition. There are different types of trials. For example, there are treatment, prevention, and screening trials in the case of cancer. Clinical trials are classified into three phases. A phase-I trial investigates a product s safety on a small study population. Phase-II tests the efficacy over a longer period of time. Phase-III studies are usually randomized and controlled, involving a large study population, and may last several years. These trials compare the protocol under study to the current standard. 

Whenever a new antidepressant drug is being tested for efficacy, researchers must also give half the test subjects a pill that does not have any drug in it. Patients participating in the experiment are told they may be treated with an active drug or just a sugar pill, but they will not be told until after the study which one they received. 

When objective measurement of performance capacities has been incorporated into many clinical trials, concepts and tools from human performance engineering can facilitate the selection of variables and shed some Hght on issues noted above. In either safety- or efficacy-oriented studies, study variable selection can be characterized as a two-step process (1) identification of the factors in question (Table 82.1) and (2) selection of the relevant performance capacities to be measured and associated measurement instruments. This Hnk between these two steps often represents a challenge to researchers for a number of reasons. First, duality in terminology must be overcome. Concerns about an intervention are typically initially identified with negative terms such as dizziness and not in terms of performance capacities such as postural stability. Human performance models based on systems engineering concepts [Kondraske, 1995] can be used to facilitate the translation of both formal and lay terms used to identify adverse effects to relevant performance capacities to be measured, as shown in Table 82.1. 

In a research study conducted by van Vlerken et al, pH responsiveness was utilized for targeting breast cancer with the use of a polymer-blend nanoparticle system of 30% by weight pH-responsive polymer poly(beta-amino ester) and 70% by weight poly(D,L-lactide-co-glycolide) to administer paclitaxel and Cg-ceramide, an apoptotic signaling molecule, respectively [39]. The polymer blend allowed for a delay in the release of Cg-ceramide, which based on preliminary results improved therapeutic efficacy in this specific combination therapy scheme for multidrug-resistant breast and ovarian cancer. Expected conclusions were generated for the accumulation of particles based on the enhanced... 

Cheung provides an extensive review of the literature on chemistry self-efficacy, reports recent research studies about self-efficacy conducted in Hong Kong secondary schools, and offers some directions for future research on chemistry self-efficacy. 

Research studies conducted on chitosan for its antiulcer potential have shown its efficacy in ulcer healing and regenerating of gastric mucosa. It acts as a gastric cytoprotec-tive by accelerating the formation of gastric mucus [54,55]. 

Studying the behavior and impact of biopesticides in different environmental compartments is one of the main objectives for which validation of analytic methods is carried out. The control of residue levels in the matrices of interest is also important to evaluate the efficacy of different treatments used. However, monitoring data for biopesticides and their transformation products in field are generally poor and there are still scarce full research studies. 

Several other antigens with good immunocontraceptive potential have been identified and investigated in laboratory animals. In most studies, the rate and duration of the immunocontraceptive effect are less than acceptable. A potential problem in immunological approaches to antifertUity research is the need for a safe, effective adjuvant and suitable animal models for evaluating the efficacy and safety of methods (111). Newer and more effective adjuvants are required for contraceptive vaccines and vaccines in general. 

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