scholarly journals Endoscopic adrenalectomy

1998 ◽  
Vol 44 (3) ◽  
pp. 49-53 ◽  
Author(s):  
P. S. Vetshev ◽  
L. I. Ippolitov ◽  
D. I. Gabaidze
Keyword(s):  
Clinical Trials ◽  
Endoscopic Surgery ◽  
Technological Progress ◽  
The Past ◽  
Endoscopic Adrenalectomy ◽  
Endoscopic Video ◽  
Number Of Patients

The widespread use of endoscopic surgery over the past 10 years is primarily associated with scientific and technological progress, the improvement of endoscopic video equipment, special tools necessary for ultra-precise operating techniques. Some laparoscopic surgeries have already been recognized by experts and are the method of choice in the treatment of a large number of patients, others are still at the stage of clinical trials and a set of sufficient observations to generalize [2, 10, 47].

The Past, Present, and Future of Pancreatic Cancer Clinical Trials

2016 ◽  
pp. e205-e215 ◽  
Author(s):  
Lynn M. Matrisian ◽  
Jordan D. Berlin
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trials ◽  
The United States ◽  
Phase Iii ◽  
Gastrointestinal Malignancies ◽  
The Past ◽  
Phase Iii Clinical Trials ◽  
Number Of Patients ◽  
Liver Cancers ◽  
Upper Gastrointestinal

Upper gastrointestinal malignancies comprise half of the deadliest cancers as defined by those with a 5-year survival rate less than 50%. Using pancreatic adenocarcinoma (PAC) as an example, we retrospectively evaluated the success of phase III clinical trials, examined the current landscape of clinical trials, and identified emerging areas that foretell the future for this disease. Pancreatic and liver cancers are on the rise and will be the second and third leading causes of cancer deaths in 2030. A total of 35 different agents or combinations have been tested in randomized phase III clinical trials for patients with advanced PAC over the past 25 years, but only 11% have been incorporated into clinical practice. There has been a 37% increase in the number of PAC trials open in the United States between 2011 to 2012 and 2014 to 2015. Enrollment has also increased slightly, from 3.85% of the newly diagnosed cases in 2011 to 4.15% in 2014. However, the demand for patients far exceeds the number of patients available for these trials. On the horizon is the realization that stratification of patients with PAC using biomarkers that predict a high probability of a response could reallocate patients to faster, smaller trials with a greater chance of a survival benefit. The current landscape of PAC clinical trials and the launch of the Pancreatic Cancer Action Network’s Know Your Tumor initiative indicate this shift is starting to occur, with particular emphasis on targeted therapies, immunotherapies, and agents that disrupt the stroma.

scholarly journals ANCA Status or Clinical Phenotype — What Counts More?

2021 ◽  
Vol 23 (6) ◽  
Author(s):  
Martin Windpessl ◽  
Erica L. Bettac ◽  
Philipp Gauckler ◽  
Jae Il Shin ◽  
Duvuru Geetha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Granulomatosis With Polyangiitis ◽  
Clinical Phenotype ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Cardiovascular Death ◽  
Genetic Associations ◽  
Ongoing Debate ◽  
The Past ◽  
Anca Associated Vasculitis

Abstract Purpose of Review There is ongoing debate concerning the classification of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. That is, whether classification should be based on the serotype (proteinase 3 (PR3)- or myeloperoxidase (MPO)-ANCA) or on the clinical phenotype (granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)). To add clarity, this review focused on integration of the most recent literature. Recent Findings Large clinical trials have provided evidence that a serology-based risk assessment for relapses is more predictive than distinction based on the phenotype. Research conducted in the past decade indicated that a serology-based approach more closely resembles the genetic associations, the clinical presentation (i.e., lung involvement), biomarker biology, treatment response, and is also predicting comorbidities (such as cardiovascular death). Summary Our review highlights that a serology-based approach could replace a phenotype-based approach to classify ANCA-associated vasculitides. In future, clinical trials and observational studies will presumably focus on this distinction and, as such, translate into a “personalized medicine.”

scholarly journals Bayesian adaptive design of early-phase clinical trials for precision medicine based on cancer biomarkers

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Shinjo Yada
Keyword(s):  
Neural Network ◽  
Clinical Trials ◽  
Precision Medicine ◽  
Early Phase ◽  
Patient Specific ◽  
Specific Gene ◽  
Cancer Type ◽  
Background Characteristics ◽  
Number Of Patients ◽  
Early Phase Clinical Trials

Abstract Cancer tissue samples obtained via biopsy or surgery were examined for specific gene mutations by genetic testing to inform treatment. Precision medicine, which considers not only the cancer type and location, but also the genetic information, environment, and lifestyle of each patient, can be applied for disease prevention and treatment in individual patients. The number of patient-specific characteristics, including biomarkers, has been increasing with time; these characteristics are highly correlated with outcomes. The number of patients at the beginning of early-phase clinical trials is often limited. Moreover, it is challenging to estimate parameters of models that include baseline characteristics as covariates such as biomarkers. To overcome these issues and promote personalized medicine, we propose a dose-finding method that considers patient background characteristics, including biomarkers, using a model for phase I/II oncology trials. We built a Bayesian neural network with input variables of dose, biomarkers, and interactions between dose and biomarkers and output variables of efficacy outcomes for each patient. We trained the neural network to select the optimal dose based on all background characteristics of a patient. Simulation analysis showed that the probability of selecting the desirable dose was higher using the proposed method than that using the naïve method.

scholarly journals Mesenchymal stem cells and oncolytic viruses: joining forces against cancer

2021 ◽  
Vol 9 (2) ◽  
pp. e001684
Author(s):  
Rafael Moreno
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Mesenchymal Stem Cells ◽  
Immune System ◽  
Oncolytic Viruses ◽  
Immunogenic Cell Death ◽  
The Past ◽  
Physical Barriers ◽  
Immunogenic Properties ◽  
New Strategies

The development of oncolytic viruses (OVs) has increased significantly in the past 20 years, with many candidates entering clinical trials and three of them receiving approval for some indications. Recently, OVs have also gathered interest as candidates to use in combination with immunotherapies for cancer due to their immunogenic properties, which include immunogenic cell death and the possibility to carry therapeutic transgenes in their genomes. OVs transform non-immunogenic ‘cold’ tumors into inflamed immunogenic ‘hot’ tumors, where immunotherapies show the highest efficacy. However, in monotherapy or in combination with immunotherapy, OVs face numerous challenges that limit their successful application, in particular upon systemic administration, such as liver sequestration, neutralizing interactions in blood, physical barriers to infection, and fast clearance by the immune system. In this regard, the use of mesenchymal stem cells (MSCs) as cells carrier for OV delivery addresses many of these obstacles acting as virus carriers and factories, expressing additional transgenes, and modulating the immune system. Here, I review the current progress of OVs-loaded MSCs in cancer, focusing on their interaction with the immune system, and discuss new strategies to improve their therapeutic efficacy.

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

scholarly journals How I treat pediatric venous thromboembolism

Blood ◽  
2017 ◽  
Vol 130 (12) ◽  
pp. 1402-1408 ◽  
Author(s):  
Guy Young
Keyword(s):  
Clinical Trials ◽  
Venous Thromboembolism ◽  
Large Scale ◽  
Central Venous Catheters ◽  
Rare Disorder ◽  
Central Venous ◽  
Management Decisions ◽  
Logical Approach ◽  
The Past ◽  
Medical Disorders

Abstract The incidence of pediatric venous thromboembolism (VTE) has been increasing significantly over the past decade in part as a result of increased recognition of this serious disorder but more so because of the increased use of central venous catheters and other technological advancements involved in the care of ill children. Management of pediatric VTE is a complex undertaking, considering that the vast majority of children who develop this complication have serious underlying medical disorders. Although the incidence is rising, in comparison with adults, this remains a relatively rare disorder, and as such, large-scale clinical trials have not been completed, rendering management decisions to be based on extrapolation from adult data and the experience of the treating physician. Clearly, both are fraught with problems. Thus, day-to-day management remains more art than science until such time that the results from clinical trials (many of which are under way) become available. This edition of “How I Treat” describes the author’s experience in managing 3 common scenarios that one may encounter in pediatric thrombosis and suggests a logical approach to such situations. Furthermore, the author provides 3 algorithms to help guide management decisions.

scholarly journals Virus Eradication and Synthetic Biology: Changes with SARS-CoV-2?

Viruses ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 569
Author(s):  
Jean-Nicolas Tournier ◽  
Joseph Kononchik
Keyword(s):  
Clinical Trials ◽  
Synthetic Biology ◽  
Viral Disease ◽  
Virus Eradication ◽  
Disease Eradication ◽  
The Public ◽  
The Past ◽  
The World ◽  
Significant Effort

The eradication of infectious diseases has been achieved only once in history, in 1980, with smallpox. Since 1988, significant effort has been made to eliminate poliomyelitis viruses, but eradication is still just out of reach. As the goal of viral disease eradication approaches, the ability to recreate historically eradicated viruses using synthetic biology has the potential to jeopardize the long-term sustainability of eradication. However, the emergence of the severe acute respiratory syndrome-coronavirus (SARS-CoV)-2 pandemic has highlighted our ability to swiftly and resolutely respond to a potential outbreak. This virus has been synthetized faster than any other in the past and is resulting in vaccines before most attenuated candidates reach clinical trials. Here, synthetic biology has the opportunity to demonstrate its truest potential to the public and solidify a footing in the world of vaccines.

ASPECTS REGARDING THE USE OF ARTIFICIAL INTELLIGENCE IN IMPROVING DEFENSE RESOURCE MANAGEMENT

2021 ◽  
Vol 17 (1) ◽  
pp. 323-330
Author(s):  
Gabriela-Florina NICOARĂ ◽  
Gergonia-Cristiana BOGĂȚEANU
Keyword(s):  
Artificial Intelligence ◽  
Resource Management ◽  
Technological Progress ◽  
Digital Systems ◽  
Constructive Approach ◽  
The Past ◽  
A Priority ◽  
High Level

Abstract: Regarding the society evolution dominated by a high-level technology, we consider this article a constructive approach. The aim of the paper is to highlight a few activities/places/spots in which competences of humans/soldiers interfere with different elements of the artificial intelligence. We deem that the technological progress in the past few years has been impressive. Nowadays, thousands of activities that were mostly or exclusively executed by people can be done faster and often with greater precision using digital systems. In this instance and considering the achievement of functional compatibility between Romanian Army and forces from NATO as being a priority, the development of the technology based on artificial intelligence is vital within the defense resource management.

Skin as a Source of Nosocomial Infection: Directions for Future Research

1986 ◽  
Vol 7 (S2) ◽  
pp. 113-117 ◽  
Author(s):  
Dennis G. Maki
Keyword(s):  
Clinical Trials ◽  
Nosocomial Infection ◽  
Scientific Data ◽  
Control Measures ◽  
Future Research ◽  
Controlled Clinical Trials ◽  
Nosocomial Pathogens ◽  
The Past ◽  
Infection Control Measures ◽  
Per Se

Whereas infections of the skin per se comprise only a fraction of all institutionally-acquired infections, the skin has become one of the most important reservoirs of nosocomial pathogens in the hospital. Professor Noble has provided a scholarly review of the increasing importance of the major constituents of the cutaneous microflora as nosocomial pathogens and what we know of their epidemiology. Unfortunately, the empiricism and limited scientific data which underlie essential infection control measures in this area, particularly in regard to cutaneous antisepsis and handwashing, is almost incongruous in an era in which controlled clinical trials have dominated most other areas of medicine. The numerous outbreaks traced to contaminated antiseptics and disinfectants over the past two decades, stand as mute testimony to the inadequate investigative attention this area has received.

Sign in / Sign up

Export Citation Format

Share Document