The Maintenance of Koasati

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

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Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264618804962 ◽

2018 ◽

Vol 13 (5) ◽

pp. 494-510 ◽

Cited By ~ 5

Author(s):

Jill A. Fisher ◽

Lisa McManus ◽

Megan M. Wood ◽

Marci D. Cottingham ◽

Julianne M. Kalbaugh ◽

...

Keyword(s):

Clinical Trials ◽

Phase I ◽

Healthy Volunteers ◽

Employment Status ◽

Qualitative Interviews ◽

Trial Participation ◽

Phase I Trials ◽

Phase I Clinical Trials ◽

Financial Compensation ◽

Trial History

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants’ sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants’ perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

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Modulation of additive and interactive effects in lexical decision by trial history.

Journal of Experimental Psychology Learning Memory and Cognition ◽

10.1037/a0029180 ◽

2013 ◽

Vol 39 (3) ◽

pp. 898-914 ◽

Cited By ~ 10

Author(s):

Michael E. J. Masson ◽

Reinhold Kliegl

Keyword(s):

Lexical Decision ◽

Interactive Effects ◽

Trial History

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Modulating the influence of recent trial history on attentional capture via transcranial magnetic stimulation (TMS) of right TPJ

Cortex ◽

10.1016/j.cortex.2020.09.009 ◽

2020 ◽

Vol 133 ◽

pp. 149-160

Author(s):

Carlotta Lega ◽

Elisa Santandrea ◽

Oscar Ferrante ◽

Rossana Serpe ◽

Carola Dolci ◽

...

Keyword(s):

Transcranial Magnetic Stimulation ◽

Attentional Capture ◽

Magnetic Stimulation ◽

Recent Trial ◽

Trial History

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Corticoinsular circuits encode subjective value expectation and violation for effortful goal-directed behavior

Proceedings of the National Academy of Sciences ◽

10.1073/pnas.1800444115 ◽

2018 ◽

Vol 115 (22) ◽

pp. E5233-E5242 ◽

Cited By ~ 22

Author(s):

Amanda R. Arulpragasam ◽

Jessica A. Cooper ◽

Makiah R. Nuutinen ◽

Michael T. Treadway

Keyword(s):

Decision Making ◽

Relevant Information ◽

Neural Mechanisms ◽

Anterior Cingulate ◽

Error Signal ◽

Value Prediction ◽

Subjective Value ◽

Effort Discounting ◽

Trial History ◽

Goal Directed Behavior

We are presented with choices each day about how to invest our effort to achieve our goals. Critically, these decisions must frequently be made under conditions of incomplete information, where either the effort required or possible reward to be gained is uncertain. Such choices therefore require the development of potential value estimates to guide effortful goal-directed behavior. To date, however, the neural mechanisms for this expectation process are unknown. Here, we used computational fMRI during an effort-based decision-making task where trial-wise information about effort costs and reward magnitudes was presented separately over time, thereby allowing us to model distinct effort/reward computations as choice-relevant information unfolded. We found that ventromedial prefrontal cortex (vmPFC) encoded expected subjective value. Further, activity in dorsal anterior cingulate (dACC) and anterior insula (aI) reflected both effort discounting as well as a subjective value prediction error signal derived from trial history. While prior studies have identified these regions as being involved in effort-based decision making, these data demonstrate their specific role in the formation and maintenance of subjective value estimates as relevant information becomes available.

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EEG Signal Decomposition Evidence for a Role of Perceptual Processes during Conflict-related Behavioral Adjustments in Middle Frontal Regions

Journal of Cognitive Neuroscience ◽

10.1162/jocn_a_01558 ◽

2020 ◽

Vol 32 (7) ◽

pp. 1381-1393

Author(s):

Nico Adelhöfer ◽

Christian Beste

Keyword(s):

Time Window ◽

Flanker Task ◽

Decomposition Methods ◽

Signal Decomposition ◽

Conflict Monitoring ◽

Stimulus Response ◽

Eeg Data ◽

Congruency Sequence Effect ◽

Trial History

Conflict monitoring processes are central to cope with fluctuating environmental demands. However, the efficacy of these processes depends on previous trial history/experience, which is reflected in the “congruency sequence effect” (CSE). Several theoretical accounts have been put forward to explain this effect. Some accounts stress the role of perceptual processes in the emergence of the CSE. As yet, it is elusive how these perceptual processes are implemented on a neural level. We examined this question using a newly developed moving dots flanker task. We combine decomposition methods of EEG data and source localization. We show that perceptual processes modulate the CSE and can be isolated in neurophysiological signals, especially in the N2 ERP time window. However, mechanisms relating perception to action are also coded and modulated in this time window. We show that middle frontal regions (BA 6) are associated with processes dealing with purely perceptual processes. Inferior frontal regions (BA 45) are associated with processes dealing with stimulus–response transition processes. Likely, the neurophysiological modulations reflect unbinding processes at the perceptual level, and stimulus–response translation level needed to respond correctly on the presented (changed) stimulus–response relationships. The data establish a direct relationship between psychological concepts focusing on perceptual processes during conflict monitoring and neurophysiological processes using signal decomposition.

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