The Potential of Brain-Specific Blood Biomarkers for TBI Patient Management, Diagnosis, and Clinical Research

Neurotrauma ◽  
2018 ◽  
pp. 189-210
Author(s):  
Olena Y. Glushakova ◽  
Alex B. Valadka ◽  
Ronald L. Hayes ◽  
Alexander V. Glushakov
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Patient Management ◽  
Therapeutic Interventions ◽  
Disease Monitoring ◽  
Management Tools ◽  
Secondary Insults ◽  
Short And Long Term ◽  
Type Of Injury

Rapid and continuous monitoring and analysis of biomarkers present in blood after TBI could serve as a reliable and useful tool to distinguish type of injury, predict secondary insults, and evaluate the efficacy of therapeutic interventions. The use of biomarkers in combination with current disease monitoring and management tools could improve management of TBI patients and improve clinical trials for TBI drug development. In this chapter, the authors discuss current clinical studies on brain-specific neuronal and glial biomarkers of TBI and their association with short- and long-term TBI outcome and secondary insults, as well the ability of biomarkers to distinguish type of injury and correlation with treatment.

1 Final Report on the Safety Assessment of Isostearyl Neopentanoate

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Short And Long Term ◽  
Cosmetic Formulation

Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.

scholarly journals Recent advances in understanding and treating vasculitis

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 1436 ◽  
Author(s):  
Matthew J. Koster ◽  
Kenneth J. Warrington
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Long Term Effects ◽  
Dose Frequency ◽  
Treatment Regimens ◽  
Recent Advances ◽  
Short And Long Term ◽  
Anti Cd20 ◽  
Long Term Adverse Effects

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAVs) are near universally fatal conditions if untreated. Although effective therapeutic options are available for these diseases, treatment regimens are associated with both short- and long-term adverse effects. The recent identification of effective B-cell-targeted therapy with an anti-CD20 monoclonal antibody has transformed the treatment landscape of AAV. Questions, nevertheless, remain regarding the appropriate timing, dose, frequency, duration, and long-term effects of treatment. The aim of this article is to provide an overview of the current information, recent advances, ongoing clinical trials, and future treatment possibilities in AAV.

Digitalis: new actions for an old drug

2005 ◽  
Vol 289 (5) ◽  
pp. H1781-H1793 ◽  
Author(s):  
J. Andrew Wasserstrom ◽  
Gary L. Aistrup
Keyword(s):  
Cell Function ◽  
Cardiovascular Effects ◽  
Therapeutic Interventions ◽  
Current Status ◽  
Cardiac Cell ◽  
Nuclear Signaling ◽  
New Information ◽  
Short And Long Term ◽  
Intracellular Ions

The mechanisms by which digitalis causes its therapeutic and toxic actions have been studied for nearly a half century, revealing a great deal about cardiac cell regulation of intracellular ions via the Na-K-ATPase (NKA) and how it is altered by cardiac glycosides. However, recent observations suggest that digitalis may have additional effects on cardiac cell function in both the short and long term that include intracellular effects, interactions with specific NKA isoforms in different cellular locations, effects on intracellular (including nuclear) signaling, and long-term regulation of intracellular ionic balances through circulating ouabain-like compounds. The purpose of this review is to examine the current status of a number of the newest and most interesting developments in the study of digitalis with a particular focus on cardiac function, although we will also discuss some of the new advances in other relevant cardiovascular effects. This new information has important implications for both our understanding of ionic regulation in normal and diseased hearts as well as for potential avenues for the development of future therapeutic interventions for the treatment of heart failure.

Role and Relevance of Neurocognitive Assessment in Clinical Trials of Patients With CNS Tumors

2006 ◽  
Vol 24 (8) ◽  
pp. 1305-1309 ◽  
Author(s):  
Christina A. Meyers ◽  
Paul D. Brown
Keyword(s):  
Clinical Trials ◽  
Cns Tumors ◽  
Tumor Control ◽  
End Points ◽  
Treatment Regimens ◽  
Neurocognitive Assessment ◽  
Short And Long Term ◽  
Effect Of Treatment ◽  
Cognitive Problems

The inclusion of neurocognitive end points in clinical trials of patients with CNS tumors is increasing. Neurocognitive end points are used to understand what cognitive problems exist before treatment to establish a baseline by which the effect of treatment is judged, and to determine whether different treatment regimens improve neurocognitive function due to better tumor control, slow expected neurocognitive deterioration due to the tumor, or have more or less short- and long-term neurotoxicity. However, the use of neurocognitive end points in clinical trials for patients with CNS tumors is in its infancy, so that long-term outcomes are difficult to predict and the ability to determine the effects of different agents and treatment approaches is scant. Including this aspect of patient evaluation in addition to survival and time to tumor progression will yield better risk-versus-benefit assessments as well as provide a basis for improving interventions.

scholarly journals A Computational Solution to Bolster Epigenetic Clock Reliability for Clinical Trials and Longitudinal Tracking

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 5-5
Author(s):  
Albert Higgins-Chen ◽  
Kyra Thrush ◽  
Tina Hu-Seliger ◽  
Yunzhang Wang ◽  
Sara Hagg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Reliability ◽  
Principal Component ◽  
Epigenetic Clock ◽  
Age Related ◽  
Longitudinal Tracking ◽  
Short And Long Term ◽  
Epigenetic Biomarker ◽  
Computational Solution

Abstract Epigenetic clocks are widely used aging biomarkers, but they are calculated from methylation data for individual CpGs that can be surprisingly unreliable. We report that technical noise causes six major epigenetic clocks to deviate by 3 to 9 years between replicates. We present a novel computational solution: we perform principal component analysis followed by biological age prediction using principal components, extracting shared age-related changes across CpGs while ignoring noise from individual CpGs. Our novel principal-component versions of six clocks show agreement between most technical replicates within 1 year, and increased stability in short- and long-term longitudinal studies. This requires only one additional step compared to traditional clocks, does not require prior knowledge of CpG reliabilities, and can improve the reliability of any existing or future epigenetic biomarker. The extremely high reliability of principal component epigenetic clocks makes them particularly useful for personalized medicine and clinical trials evaluating novel aging interventions.

scholarly journals Therapeutic Interventions for Scapular Kinematics and Disability in Patients With Subacromial Impingement: A Systematic Review

2019 ◽  
Vol 54 (3) ◽  
pp. 283-295 ◽  
Author(s):  
Katsumi Takeno ◽  
Neal R. Glaviano ◽  
Grant E. Norte ◽  
Christopher D. Ingersoll
Keyword(s):  
Patient Reported Outcomes ◽  
Mean Difference ◽  
Therapeutic Interventions ◽  
Subacromial Impingement ◽  
Scapular Kinematics ◽  
Patient Reported ◽  
Posterior Tilt ◽  
Short And Long Term ◽  
Scapular Plane

Context Impaired scapular kinematics are commonly reported in patients with subacromial impingement syndrome (SIS). Various therapeutic interventions designed to improve scapular kinematics and minimize pain and disability have been described in the literature. However, the short- and long-term benefits of these interventions are unclear. Objective To determine the effects of specific short- and long-term therapeutic interventions on scapular kinematics and disability in patients with SIS. Data Sources We searched PubMed, CINAHL, and SPORTDiscus databases from their origins to January 2018 using a combination of the key words scapular kinematics AND (shoulder dysfunction OR subacromial impingement) and conducted a manual search by reviewing the references of the identified papers. Study Selection Studies were included if (1) preintervention and postintervention measures were available; (2) patient-reported outcomes were reported; (3) scapular kinematics measures at 90° of ascending limb elevation in the scapular plane were included; (4) SIS was diagnosed in participants or participants self-reported symptoms of SIS; (5) they were original clinical studies published in English; and (6) the sample sizes, means, and measure of variability for each group were reported. Data Extraction Seven studies were found. Sample sizes, means, and standard deviations of scapular upward rotation, posterior tilt, and internal rotation at 90° of ascending limb elevation on the scapular plane and the Disabilities of the Arm, Shoulder and Hand scores were extracted. Data Synthesis Standardized mean differences between preintervention and postintervention measures with 95% confidence intervals (CIs) were calculated. We observed that the Disabilities of the Arm, Shoulder and Hand scores improved (mean difference = 0.85; 95% CI = 0.54, 1.16) but did not observe changes in scapular upward rotation (mean difference = −0.04; 95% CI = −0.31, 0.22), posterior tilt (mean difference = −0.09; 95% CI = −0.32, 0.15), or internal rotation (mean difference = 0.06; 95% CI = −0.19, 0.31). Conclusions The short- and long-term therapeutic interventions for SIS improved patient-reported outcomes but not scapular kinematics. The identified improvements in shoulder pain and function were not likely explained by changes in scapular kinematics.

A World of Research Subjects: Informed Consent and Benefit Sharing*

2010 ◽  
Vol 9 (4) ◽  
pp. 208-213
Author(s):  
George J. Annas ◽  
Michael A. Grodin
Keyword(s):  
At Risk ◽  
Clinical Trials ◽  
Informed Consent ◽  
Medical Research ◽  
Benefit Sharing ◽  
Research Subjects ◽  
Short And Long Term ◽  
Ethical Norms ◽  
Term Benefit

The most important question for any research project is whether the research should be done at all. Only after this is answered do issues of how and where to do the research become relevant. When doing research in another country, however, the whether and where questions become intertwined. This is because the recent globalization of clinical trials is itself suspect. What is the motivation for the sudden upsurge in clinical trials in other countries? Who benefits from the globalization of research, and who is put at risk? Some advantages have been suggested, including reduced regulation, less oversight, decreased costs, and more rapid results, but none of these alone (or together) is sufficient to justify the expansion of medical research to an underserved, disenfranchised, and exploitable population. The only justification is that the proposed research addresses a question that can only be answered by this unique population and the results must bring short- and long-term benefit. The research remains suspect until ethical norms are met. The subjects must never be worse off from participating in the trials than if they had never participated.

Efektivitas Dan Keamanan Vaksin Covid-19 : Studi Refrensi

2021 ◽  
Vol 9 (2) ◽  
pp. 61-107
Author(s):  
Setiyo Adi Nugroho ◽  
Indra Nur Hidayat
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Public Confidence ◽  
Study Approach ◽  
A Value ◽  
Study Results ◽  
Approach Method ◽  
Short And Long Term ◽  
Protective Effectiveness

Various strategies and development of the Covid-19 vaccine have been carried out for the control of the Covid-19 pandemic. Various vaccines have undergone clinical trials with promising results in various countries. The effectiveness and safety and short- and long-term side effects of vaccines are a major concern in clinical trials in these strategies and developments. Purpose: The purpose of this study is to find out the effectiveness and safety of the Covid-19 vaccine so that it can inform and increase public confidence in the Covid-19 vaccine through a reference study approach. Method: The research method we use here is a reference study using electronic databases through journals from international and national. Google Scholar, science direx, elsiver, Pubmed are used as the main Journal database for this reference study. Results: From the results of reference studies found that all vaccines in clinical trials have promising effectiveness and safety. The Pfizer-BiONTech vaccine is a vaccine that has a good level of effectiveness and safety with a value of 94.6% and does not cause serious side effects. Double-dose vaccination further improves the immune response in younger and older adults. Conclusion: The Covid-19 vaccine in clinical trials all demonstrates promising immunogenicity with varying levels of protective effectiveness and an acceptable safety profile.

scholarly journals Regenerative Role of Stem Cell-Derived Extracellular Vesicles in Acute Kidney Injury

Nephron ◽  
2020 ◽  
Vol 144 (12) ◽  
pp. 638-643
Author(s):  
Davide Medica ◽  
Sergio Dellepiane ◽  
Vincenzo Cantaluppi
Keyword(s):  
Acute Kidney Injury ◽  
Clinical Trials ◽  
Extracellular Vesicles ◽  
Therapeutic Option ◽  
Kidney Injury ◽  
Glomerular Injury ◽  
Paracrine Factors ◽  
Short And Long Term

Acute kidney injury (AKI) is a frequent complication of hospital admission and worsens short- and long-term patients’ prognosis. Currently, AKI treatment remains supportive and no therapy has proven significant benefit in clinical trials. Stem cells (SCs) are a promising therapeutic option, but their translation to the clinical setting is limited by the risk of rejection or aberrant differentiation. Numerous studies have shown how SC effects are mediated by paracrine factors such as extracellular vesicles (EVs). In this review, we describe the preclinical evidence about EV efficacy in acute tubular and glomerular injury and the recently generated clinical data.

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