Randomized single institute pilot study of vaccinia-CEA(6D)-tricom and fowlpox-CEA (6D)-tricom with GM-CSF (V) in combination with docetaxel (D) in patients with colorectal cancer (CC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13538-13538
Author(s):  
A. R. He ◽  
J. Hwang ◽  
S. Malik ◽  
S. Park ◽  
J. Schlom ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Pilot Study ◽  
Stable Disease ◽  
Clinical Benefit ◽  
Tumor Vaccine ◽  
Negative Impact ◽  
Safety Data ◽  
Liver Function Tests ◽  
Gm Csf ◽  
The Impact

13538 Background: Our previous study demonstrated 40% patients with CC achieved stable disease at 4 months with V (JCO, 23(4):720–31, 2005.). Preclinical studies showed taxene enhanced tumor vaccine in delaying tumor growth and increasing the antigen-specific T cells. We report the results of a Randomized phase II pilot study of V in combination with docetaxel (D) in CC patients. Methods: 27 patients with metastatic CC were randomly assigned to 3 arms, stratified for HLA-A2. All patients received a ‘prime’ dose of vaccinia-Tricom on Day 0, followed by ‘boost’ doses of fowlpox-Tricom on Days 21 and q 21 days for 4 months; all vaccinations were followed by local GM-CSF (100 μg) for 4 days. Arm 1 received V; Arm II and III received V and D on D1, D8 during each fowlpox vaccination at 10mg/m2 and 30mg/m2, respectively. Patients with stable disease continued vaccinations monthly after study completed. Safety data was evaluated. Primary endpoints included the impact of varying doses of D on CEA-specific T cell immune responses (CTL) using the ELISPOT assay, the recommended dose for further study as defined by the best immune response with acceptable toxicity, and objective clinical response. Results: The most common AE related to the vaccines was grade (g) 1 injection site reactions. Other common AEs were g1 fatigue, nausea, vomiting, fever, headache, and myalgia. There were 1 g3 fever and 1 g3 abdominal pain. The AE from the combination arm were contributed by D as expected, included g3: hyperglycemia (1), fatigue (1), elevation of liver function tests (2), pulmonary infection (1), abdominal pain (1), vomiting (1) or diarrhea (1). 6/ 27 patients have died 17 months after starting V. Patients received 2 to 12 cycles of therapy before disease progression. Observed clinical benefit was significantly lower than the 40% previously documented with V alone. The immune data is to be presented. Conclusions: Inferior clinical benefit as compared to our previous experiment could be explained by more heavily pretreated patients in this trial or negative impact of D on V. CTL data should explain this observation. No significant financial relationships to disclose.

scholarly journals Impact of COVID-19 related lockdown on cognition and emotion: A pilot study

2020 ◽  
Author(s):  
Durjoy Lahiri ◽  
Souvik Dubey ◽  
Alfredo Ardila
Keyword(s):  
Pilot Study ◽  
Negative Impact ◽  
Emotional Symptom ◽  
Emotional Symptoms ◽  
Cognitive Changes ◽  
Symptom Index ◽  
Cognition And Emotion ◽  
The World ◽  
Lower Education ◽  
The Impact

AbstractCOVID-19 pandemic has posed an unprecedented challenge in front of the world contributed mostly by social distancing and lockdown. Among several other effects this pandemic has wreaked havoc on the psychology and cognition of people across the globe. In this paper we attempted to find out the impact of lockdown and social isolation on the cognition and emotion of young healthy adults with high education (n=43) by means of a questionnaire sent through email. We found that more than 50% of the participants had some kind of emotional or cognitive (dysexecutive) symptoms, as calculated through emotional symptom index (ESI) and cognitive symptom index (CSI). The correlation between cognitive and emotional symptoms was also found to be moderately strong (0.59). Although it is a pilot study and larger samples are required to draw firm conclusion, the results argue in favor of a negative impact on the cognition and emotion of healthy educated young people caused by the COVID-19 related lockdown. It can be conjectured that, if taking an older sample with a lower education, emotional and cognitive changes would be more evident.

The performance of Dutch train drivers based on the impact of the presence of a second person in the cab

2017 ◽  
Vol 231 (10) ◽  
pp. 1130-1140
Author(s):  
Vera JMP Verstappen
Keyword(s):  
Pilot Study ◽  
Negative Impact ◽  
Driving Performance ◽  
Attention Allocation ◽  
Second Person ◽  
Performance Tasks ◽  
Driving Task ◽  
Train Drivers ◽  
The Impact ◽  
And Task

Insufficient attention allocation of train drivers towards the driving task impairs the driving performance and increases the risk of signals passed at danger. This pilot study explores the performance and attention allocation of train drivers based on the impact of the behaviour of another person present in the driver’s cab. A method that uses a train simulator has been developed to assess the attention allocation and task performance for routes with different complexity levels and for conditions when train drivers were driving alone, with a person present who was considerate of the driving task or with a person who was not. The presence of a non-considerate person in the cabin has a negative impact on the driving performance; tasks were completed successfully more often when driving alone. Train drivers interrupted conversations more often to focus on driving on routes with high complexity, which indicates that conversations increased the workload. An increase in the conversation frequency had a negative impact on the accuracy of speed monitoring. Participants indicated that the driving performance improved as a result of participating in the experiment on the awareness of the impact of another person’s presence in the cab. It is anticipated that the findings of this pilot study and further works will provide more understanding about the factors that are important to the performance of train drivers and the improvement of railway safety.

scholarly journals The Effect of Vaping and Nicotine-containing Liquids to Suppress the Immune System: A Pilot Study

2021 ◽  
pp. 284-291
Author(s):  
Sanjana Anand ◽  
Madeline Wilkerson ◽  
Robert Malkin
Keyword(s):  
Immune System ◽  
Pilot Study ◽  
Negative Impact ◽  
Electronic Cigarettes ◽  
Statistical Significance ◽  
Large Population ◽  
Entire Population ◽  
Negative Effects ◽  
History Of ◽  
The Impact

Aims: We present a pilot study to illustrate how the impact of vaping can be quickly and conclusively documented in a large population and appropriate subpopulations. Methods: It has been predicted that with longer duration and higher frequency of vaping, there would be a higher frequency of, a longer duration of, and more severe flu and cold symptoms — indicating a negative impact on the immune system. Studies have linked electronic cigarettes and vaping to respiratory and cardiovascular issues, drastic changes in blood pressure, and the reduced function of tissues and cells in the lungs, but only in small populations, making generalization to the entire population less convincing. A sample of 120, 18–22-year-olds in northern California were asked to complete a 14-question, two-minute, anonymous survey. Those with pre-existing respiratory ailments or a family history of respiratory ailments were excluded from the study along with those who smoke cigarettes or have smoked cigarettes in the past. The survey collected the frequency and time spent vaping and the severity, frequency, and longevity of the flu and cold symptoms. Responses were converted into numerical values and analyzed. Results: Those who vaped more often had more severe flu and cold symptoms (p<0.005). However, no strong trends were present as can be expected from a pilot study. A power analysis based on this pilot data suggests that only 667 subjects would be required to answer the short survey to reach statistical significance. Conclusion: A quick survey was created to show the negative effects of vaping on a general population. Showing effects generalizable to the entire population would require a very reasonably sized sample and could easily allow analysis of subpopulations.

The prognostic impact of KRAS, TP53, STK11 and KEAP1 mutations and the influence of the NLR in NSCLC patients treated with immunotherapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21010-e21010
Author(s):  
Francis Proulx-Rocray ◽  
Bertrand Routy ◽  
Rami Mohamad Nassabein ◽  
Omar El Ouarzadi ◽  
Wiam Belkaid ◽  
...  
Keyword(s):  
Negative Impact ◽  
Nsclc Patient ◽  
Safety Data ◽  
Resistance Mechanism ◽  
Response To Therapy ◽  
Prognostic Impact ◽  
Wild Type ◽  
Kras Mutations ◽  
Impact On Survival ◽  
The Impact

e21010 Background: ICIs changed the way NSCLC is treated, but not all patients benefit from it. PD-L1 level is used to predict response to therapy, but its performance is sub-optimal. KRAS is important in NSCLC tumorigenesis, but the impact of its mutations in patients treated with ICIs is unclear. Similarly, studies evaluating co-mutations in TP53, STK11 and KEAP1 as well as the NLR showed that they may predict the benefit of ICIs. Methods: We conducted a retrospective study including all consenting patients with NSCLC treated with ICIs at the CHUM between July 2015 and June 2020. OS and PFS were compared in co-mutation subgroups using Kaplan-Meier and logrank methods. Co-mutations in TP53, STK11 and KEAP1 as well as the NLR were accounted for. Overall response rate (ORR) and safety data was also compared in subgroups and will be detailed at the meeting. Results: We included 100 patients with known KRAS status. From these, 50 were wild-type ( KRASWT) and 50 were mutated ( KRASMut). The most frequent mutation was G12C (54%). Co-mutation status for TP53, STK11 and KEAP1 were known for, respectively, 40, 39 and 38 patients. Co-mutations for these genes were present in respectively 19 (47.5%), 8 (20.5%) and 4 (10.5%). Data comparing KRASMut and KRASWT showed non-significant differences in survival (median OS of respectively 21.1 vs. 17.7 months, p = 0.27). The presence of STK11 and/or KEAP1 mutations was associated with a negative impact on survival when compared with wild-type (median OS 7.4 vs 20.4 months, p = 0.001). When the presence of a KRAS mutation was compounded with STK11 and KEAP1, KRASMut (vs KRASWT) trended to a better prognosis in STK11+KEAP1WT tumors (median OS of 21.1 for KRASMut vs 15.8 for KRASWT, p = 0.15), but not in STK11+/-KEAP1Mut tumors (7.4 for KRASMut vs 7.0 for KRASWT). No influence on survival was seen in relationship to the TP53 co-mutation. Interestingly, the NLR was significantly higher with STK11 mutations (6.66Mut vs 3.59WT, p = 00012), slightly lower with TP53 mutations (3.23Mut vs 4.82WT, p = 0.047) but not impacted by KEAP1 (3.72Mut vs 4.20WT, p = 0.72) or KRAS mutations (4.32Mut vs 5.21WT, p = 0.34). Conclusions: The STK11 and KEAP1 mutations are significant adverse predictors of ICI therapy benefit. The NLR is strongly impacted by STK11 mutations but not by KEAP1 mutations suggesting marked differences in the resistance mechanism for both mutations. In STK11-KEAP1WT tumors, KRAS mutations seems to be associated with improved survival in NSCLC patient treated with ICIs.

scholarly journals A qualitative investigation of eating difficulties in adolescents with chronic fatigue syndrome/myalgic encephalomyelitis

2016 ◽  
Vol 22 (1) ◽  
pp. 128-139 ◽  
Author(s):  
Sarah Harris ◽  
Matthew Gilbert ◽  
Lucy Beasant ◽  
Catherine Linney ◽  
Jessica Broughton ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Chronic Fatigue Syndrome ◽  
Negative Impact ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Specialist Service ◽  
Low Mood ◽  
Fatigue Syndrome ◽  
Abdominal Symptoms ◽  
The Impact

Background: An estimated 10% of children and adolescents with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) experience eating difficulties; however, little is known about why these difficulties develop, what the impact is or how to manage them. Methods: Semi-structured interviews were conducted with adolescents (aged 12–17 years) attending a specialist service who have a primary diagnosis of CFS/ME and experience nausea, abdominal pain and/or eating difficulties. A total of 11 adolescents were interviewed (eight female, mean age: 15 years). Transcripts were analysed thematically using techniques of constant comparison which commenced soon after data collection and informed further interview protocols. Results: Adolescents perceived their eating difficulties were caused by abdominal symptoms, being too fatigued to eat and changes to their senses of taste and smell. Some of the adolescents recognised how their eating difficulties were exacerbated and maintained by psychological factors of low mood and anxiety. The adolescents eating difficulties had a negative impact on their weight, fatigue, socialising and family life. They perceived helpful interventions to include modifying their diets, families adjusting and also medical interventions (e.g. medication). Adolescents identified that early education and support about diet and eating habits would have been helpful. Conclusions: If adolescents diagnosed with CFS/ME develop eating difficulties, this has a significant impact on their quality of life, illness and on their families. Not eating increases fatigue, low mood and anxiety which further exacerbates the eating difficulties. Clinicians should screen for eating difficulties in those with symptoms of nausea and abdominal pain, warn adolescents and their families of the risk of developing eating difficulties and provide interventions and support as early as possible.

Pilot Study: The Impact of Yoga on Health

2007 ◽  
Author(s):  
Danielle V. Shelov ◽  
Sonia Suchday ◽  
Jennifer P. Friedberg
Keyword(s):  
Pilot Study ◽  
The Impact

Urbanization of fauna on the example of marsh frog (Pelophylax ridibundus)

2015 ◽  
Vol 26 (3-4) ◽  
pp. 116-123
Author(s):  
A. P. Korzh ◽  
T. V. Zahovalko
Keyword(s):  
Urban Areas ◽  
Cognitive Modeling ◽  
Negative Impact ◽  
Natural Populations ◽  
Cellular Level ◽  
Anthropogenic Factors ◽  
Migration Routes ◽  
Corrective Effect ◽  
The Impact ◽  
The City

Recently, the number of published works devoted to the processes of synanthropization of fauna, is growing like an avalanche, which indicates the extreme urgency of this theme. In our view, the process of forming devices to coexist with human and the results of his life reflects the general tandency of the modern nature evolution. Urbanization is characteristic for such a specific group of animals like amphibians, the evidence of which are numerous literature data. Many researchers use this group to assess the bioindicative quality of the environment. For this aim a variety of indicators are used: from the cellular level of life of organization up to the species composition of the group in different territories. At the same time, the interpretation of the results is not always comparable for different areas and often have significantly different interpretations by experts. Urban environment, primarily due to the contamination is extremely aggressive to amphibians. As a consequence, the urban populations of amphibians may be a change in the demographic structure, affecting the reproductive ability of the population, the disappearance of the most sensitive species or individuals, resizing animals, the appearance of abnormalities in the development, etc. At the same time play an important amphibians in the ecosystems of cities, and some species in these conditions even feel relatively comfortable. Therefore, it is interesting to understand the mechanisms of self-sustaining populations of amphibians in urban environments. To assess the impact of natural and anthropogenic factors on the development of amphibian populations were used cognitive modeling using the program Vensim PLE. Cognitive map of the model for urban and suburban habitat conditions were the same. The differences concerned the strength of connections between individual factors (migration, fertility, pollution) and their orientation. In general, factors like pollution, parasites, predators had negative impact on the population, reducing its number. The birth rate, food and migration contributed to raising number of individuals. Some of the factors affected on the strength to of each other as well: the majority of the factors affected the structure of the population, had an influence on the fertility. Thanks to it the model reflects the additive effect of complex of factors on the subsequent status of the population. Proposed and analyzed four scenarios differing strength and duration of exposure. In the first scenario, a one-time contamination occurs and not subsequently repeated. The second and third scenario assumes half board contamination, 1 year (2 scenario) and two years (scenario 3). In the fourth scenario, the pollution affected the population of amphibians constantly. In accordance with the results of simulation, much weaker than the natural populations respond to pollution - have them as an intensive population growth and its disappearance at constant pollution is slow. Changes to other parameters of the model showed that this pollution is the decisive factor -only the constant action leads to a lethal outcome for the populations. All other components of the model have a corrective effect on the population dynamics, without changing its underlying trand. In urban areas due to the heavy impact of pollution maintaining the population is only possible thanks to the migration process – the constant replenishment of diminishing micropopulations of natural reserves. This confirms the assumption that the form of existence metapopulations lake frog in the city. In order to maintain the number of amphibians in urban areas at a high level it is necessary to maintain existing migration routes and the creation of new ones. Insular nature of the placement of suitable habitats in urban areas causes the metapopulation structure of the types of urbanists. Therefore, the process of urbanization is much easier for those species whicht are capable of migration in conditions of city. In the initial stages of settling the city micropopulationis formed by selective mortality of the most susceptible individuals to adverse effects. In future, maintaining the categories of individuals is provided mainly due to migration processes metapopulisation form of the species of existence is supported). It should be noted that the changes in the previous levels are always saved in future. In the case of reorganizations of individuals we of morphology can assume the existence of extremely adverse environmental conditions that threaten the extinction of the micropopulations. 

Modernisation of Higher Education – Willful Action or Wishful Thinking? The Case of Bulgaria

2020 ◽  
Vol 8 (3) ◽  
pp. 3-17
Author(s):  
Elena Blagoeva
Keyword(s):  
Higher Education ◽  
Economic Crisis ◽  
Negative Impact ◽  
National Level ◽  
Sustainable Growth ◽  
Research Approach ◽  
Case Study Methodology ◽  
The Impact ◽  
The Eu

The impact of the last global economic crisis (2008) on the European economy put a strain on higher education (HE), yet it also pushed the sector towards intensive reforms and improvements. This paper focuses on the “Strategy for the Development of Higher Education in the Republic of Bulgaria 2014-2020”. With a case study methodology, we explore the strategic endeavours of the Bulgarian government to comply with the European directions and to secure sustainable growth for the HE sector. Our research question is ‘How capable is the Bulgarian HE Strategy to overcome the economic and systemic restraints of Bulgarian higher education?’. Because the development of strategies for HE within the EU is highly contextual, a single qualitative case study was chosen as the research approach. HE institutions are not ivory towers, but subjects to a variety of external and internal forces. Within the EU, this is obviated by the fact that Universities obtain their funds from institutions such as governments, students and their families, donors, as well as EU-level programmes. Therefore, to explore how these pressures interact to affect strategic action on national level, the case method is well suited as it enabled us to study the phenomena thoroughly and deeply. The paper suggests the actions proposed within the Strategy have the potential to overcome the delay, the regional isolation and the negative impact of the economic crisis on the country. Nevertheless, the key elements on which the success or failure of this Strategy hinges are the control mechanisms and the approach to implementation. Shortcomings in these two aspects of strategic actions in HE seem to mark the difference between gaining long-term benefits and merely saving face in front of international institutions.

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