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A clinical trial evaluates the effect of a new drug or device or procedure ; on human volunteers. These trials can be used to evaluate the safety of a new drug in healthy human volunteers, or to assess treatment benefits in patients with a specific disease. Clinical trials can compare a new drug against existing drugs or against dummy medications placebo ; or they may not have a comparison arm see Chapter 2 ; . A large proportion of clinical trials are sponsored by pharmaceutical or biotechnology companies who are developing the new drug, but some studies using older drugs in new disease areas are funded by healthrelated government agencies, or through charitable grants. In a randomized clinical trial, patients and trial personnel are deliberately kept unaware of which patient is on the new drug. This minimizes bias in the later evaluation so that the initial blind random allocation of patients to one or other treatment group is preserved throughout the trial. Clinical trials must be designed in an ethical manner so that patients are not denied the benefit of usual treatments. Patients must give their voluntary consent that they appreciate the purpose of the trial. Several key guidelines regarding the ethics, conduct, and reporting of clinical trials have been constructed to ensure that a patient's rights and safety are not compromised by participating in clinical trials [13] and vasotec.
Hypothesis-driven analyses Caudate FDOPA uptake was related to cognition. These relationships were expected, based on a. previous PD literature on caudate dopaminergic function and cognition, b. 18 findings in other patient groups such as patients with Huntington's disease and cau19 20 date hemorrhage , and c. findings in healthy subjects . In PD, caudate dopaminergic 8; 15; 17 fun-ction has been linked to tests measuring executive function and memory . In particular the interference effect on the Stroop test has been associated with caudate 15-17 dopaminergic function in addition to measurement of cognitive switching that 8 included reward for the right response . However, measurements of cognitive switching that did not include reward i.e. WCST ; have not revealed significant relation14; 15 ships with caudate FDOPA uptake in PD . Similarly, memory has not been consis14; 15 tently related to caudate FDOPA uptake or may only show this relationship in more 16 advanced patients . Rinne et al. reported memory to be related to frontal FDOPA 17 uptake but not to caudate FDOPA uptake . Fluency performance was studied in two larger FDOPA-PET studies with interesting results: Broussolle et al. concluded that fluency is independent from striatal FDOPA uptake, and Rinne et al. found fluency to 14; 17 be related to frontal but not to striatal uptake . Our main finding compared to previous studies is the association found between putamen FDOPA-uptake and executive functioning. This is a surprising finding, since previous reports and neuroanatomical findings suggest that the putamen is involved in motor functioning but not in cognition. However, other authors have also suggested 21; 22 an association between FDOPA uptake in the putamen and cognitive processing 123 using comparable paradigms FDG-PET and [ I]b-CIT SPECT, respectively ; , in addi23; 24 tion to findings with other paradigms . In our patients, putamen FDOPA uptake was related to executive functioning and fluency, but not to memory. It should be noted that, as addressed in the introduction, the measures for memory and fluency also concern executive functioning since they reflect cognitive searching strategies and organization of verbal material. However, different aspects of executive functioning can be distinguished from each other; our variable "executive functioning" concerned mostly mental flexibility, while the others concerned the organization of behavior. Putamen FDOPA uptake was related to the "flexibility" factor in executive functioning. Monchi et al offer a possible explanation for this finding with their activation study in which they investigated brain activation patterns 25 during neuropsychological testing instead of relying on correlational analyses . They concluded that the putamen was activated during actions that followed a cognitive switch, i.e. actions according to specific behavioural rules. The mental components of this cognitive switch were unrelated to putamen activity. Since most neuropsychological tests require such a motor response after mental switching, it may be this motor component of test performance that is related to putamen FDOPA uptake. Indeed, our 21 tests e.g. Trail Making Test and OMO Test ; and those of Lozza et al required motor actions after cognitive switching while some of the studies that did not find a relation!

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Serious or Life-Threatening Diseases and Conditions, " Food and Drug Administration, U.S. Department of Health and Human Services; National Institutes of Health; Pharmaceutical Research and Manufacturers of America; "Is This Clinical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors, " International Committee of Medical Journal Editors; Department of Legislative Services Fiscal Note History: nas jr First Reader - January 30, 2006 and vicoprofen.

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