Prospective analysis of the early modulation of plasma amphiregulin (AR) during treatment with cetuximab and irinotecan in irinotecan-refractory metastatic colorectal cancer (mCRC) patients (pts).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3602-3602 ◽  
Author(s):  
Chiara Cremolini ◽  
Fotios Loupakis ◽  
Carlotta Antoniotti ◽  
Anna Fioravanti ◽  
Paola Orlandi ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Rank Test ◽  
Clinical Experiences ◽  
Egfr Ligands ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Low Levels ◽  
Clinical Trial Information

3602 Background: The potential role of AR tissue levels in the prediction of benefit from anti-EGFRs in mCRC pts was suggested by retrospective series. Preclinical and preliminary clinical experiences showed a modulation of plasma EGFR ligands during the treatment with cetuximab. Previous data by our group evidenced that a significant increase of plasma AR occurred one hour after the administration of cetuximab and higher increases were associated with worse clinical outcome in KRAS and BRAFwt irinotecan-refractory mCRC pts receiving cetuximab and irinotecan. Methods: We designed a prospective confirmatory study in the same setting of mCRC pts. To detect a HR for PFS of 2.3 for pts with high AR levels one hour after the administration of cetuximab (1hr-AR) compared to those with low levels, with two-sided a=0.05 and b=0.2, 45 events were required. The median value was adopted as cut-off. Plasma AR levels were assessed by means of validated ELISA kits. Results: Forty-nine KRAS and BRAFwt pts were included. A significant early increase of AR levels was observed (median increase +24.7%; median levels of baseline AR and 1hr-AR: 18.06 and 24.06 pg/mL, respectively; Wilcoxon signed rank test, p<0.0001). At a median follow-up of 20.4 mos, median PFS and OS were 4.6 and 12.1 mos, respectively. No differences in PFS or OS were observed according to 1hr-AR levels (median PFS 5.5 vs 4.6 mos, HR: 0.76 [95%CI:0.40-1.32], p=0.322; median OS: 15.6 vs 13.4 mos, HR:0.77 [95%CI:0.36-1.62], p=0.485). Conclusions: This prospective experience confirms that AR early increases one hour after the administration of cetuximab. Underlying biological mechanisms should be investigated. Nevertheless, this modulation of AR does not predict clinical outcome. Our work underlines the need to prospectively validate retrospective findings in independent series, to assess their reliability. Clinical trial information: 2008-003160-19.

Polyvalent vaccine-KLH conjugate and OPT-821 with bevacizumab (BEV) in patients with ovarian cancer in second or greater remission.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5550-5550
Author(s):  
Roisin Eilish O'Cearbhaill ◽  
Alexia Iasonos ◽  
Qin Zhou ◽  
Robert Durany ◽  
Carol Aghajanian ◽  
...  
Keyword(s):  
Phase I ◽  
Tumor Vaccine ◽  
Rank Test ◽  
Polyvalent Vaccine ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Baseline Values ◽  
Therapy Clinical Trial ◽  
Clinical Trial Information

5550 Background: We previously completed a phase I study of a polyvalent vaccine containing GM2, Globo-H, LeY, Tn-MUC1, Tn(c), STn(c) and TF(c) antigens (AGs) individually conjugated to KLH and mixed with adjuvant OPT-821. We showed safe induction of antibody (ab) responses to 5 of the 7 vaccine AGs. Data has shown that tumor vaccine efficacy may be enhanced through disruption of angiogenesis thus providing a rationale for combining BEV with the polyvalent vaccine. We conducted an IRB-approved pilot study to evaluate the safety and immunogenicity of the poly-KLH-vaccine when given with BEV in OC in remission. Methods: Pts with recurrent OC in ≥2nd complete or partial remission were enrolled from 12/2010-03/2012. Pts received 6 vaccines and BEV over 17 weeks. BEV was continued beyond the vaccination phase. Treatment was continued until disease progression or toxicity. Serologic IgM and IgG responses were measured by ELISA against each AG. Wilcoxon signed rank test was used to test changes in cytokines (CKs): FGFβ, IL-8, PDGF, VEGF measured by angio multiplex assay. Results: n=21 Median age 56yrs (51-70). 2, 8, 8, 3 pts were in 2nd, 3rd, 4th, 5th remission, respectively. 1 DLT (gr 4 fever post vaccine #2). Immune Results: n=19 IgG +/or IgM: ≥3 AGs in 17pts. IgM: ≥1 AG in 19pts, ≥3 AGs in 15pts. IgG: ≥1 AG in 17pts, ≥3 AGs in 3pts. CK Results: In 10 pts who completed 6 vaccines there was a mean (median) decrease in VEGF of 144 (111) pg/ml at the 17-week timepoint compared to baseline (p=0.05). For 8 pts who did not complete all 6 vaccines there was a mean (median) increase of 76 (69) pg/ml compared to baseline at the off-study visit (p=0.16). There was no statistically significant change in the other CKs compared to baseline values. At last follow-up, 18 pts had recurred and 3 pts had died. The median PFS was 5.6mths. Conclusions: 89% of pts responded to ≥3 AGs comparable to the 89% response in our prior phase I trial without BEV. BEV and polyvalent-KLH vaccine can be safely administered together with retention of the vaccine’s immunogenicity. Serum VEGF levels decreased in patients on continued BEV therapy. Clinical trial information: NCT01223235. [Table: see text]

scholarly journals Clinical and doppler monitoring of patients with Takayasu arteritis with ITAS 2010 and CDUS-K score respectively following medical intervention: a 12 months follow-up study

2018 ◽  
Vol 6 (11) ◽  
pp. 3602
Author(s):  
Debanjali Sinha ◽  
Sumantro Mondal ◽  
Arijit Nag ◽  
Debasish Lahiri ◽  
Alakendu Ghosh
Keyword(s):  
Disease Activity ◽  
Disease Progression ◽  
Takayasu Arteritis ◽  
Medical Intervention ◽  
Matched Pair ◽  
Rank Test ◽  
Colour Doppler ◽  
Signed Rank ◽  
Signed Rank Test

Background: The objective of the present study was to monitor the disease activity of Takayasu arteritis clinically by the Indian Takayasu Activity Score 2010 (ITAS) and ultra sonographically by Colour Doppler Ultrasound-Kolkata (CDUS-K) Score after 12months of treatment with methotrexate and steroid, and to find the correlation between these two scores.Methods: Around 25 Angiographically proven Takayasu arteritis patients were treated with Methotrexate (15mg weekly) and Steroids (1mg/kg/day for 6weeks and then tapered) for 12months. Wilcoxon matched pair signed rank test was done to assess the change in ITAS 2010 with treatment. A correlation study was done between ITAS 2010 and change in CDUS-K scores at the end of 12months.Results: By Wilcoxon’s matched pair signed rank test, a non-significant change of ITAS 2010 (p=0.066) was observed at the end of 12months, which means that the treatment helps to control the disease progression by preventing a significant increase in ITAS 2010. Strong correlation (correlation coefficient of 0.878, 95% CI = 0.602 to 1.000) was found between the ITAS 2010 and change in CDUS-K scores at 12months follow up.Conclusions: The combination of Methotrexate and steroids helps to control the disease progression in Takayasu arteritis. Colour doppler ultrasonography may serve as a reliable and safe surrogate disease activity measure at follow up, as it avoids the radioactivity exposure and invasiveness of angiography.

Using distributional semantics in loanword research: A concept-based approach to quantifying semantic specificity of Anglicisms in Spanish

2016 ◽  
Vol 21 (5) ◽  
pp. 521-540 ◽  
Author(s):  
Jacqueline Serigos
Keyword(s):  
Semantic Space ◽  
Rank Test ◽  
Entropy Measure ◽  
New Concepts ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Lower Entropy ◽  
Three Stages ◽  
High Degree

Aims and objectives: This study aims to redress the paucity of research on the semantics of loanwords, by extending and empirically testing Backus’s ((2001). The role of semantic specificity in insertional codeswitching: Evidence from Dutch-Turkish. Jacobson, Rodolfo (Hg): Codeswitching Worldwide. Bd, 2, 125–154) Specificity Hypothesis – ‘Embedded language elements in code-switching have a high degree of semantic specificity’ (p. 128). Approach: Adopting a concept-based approach to examine loanwords in a large, reliable corpus, the study pursues the following question: Do loanwords have a high degree of semantic specificity relative to their receiving-language equivalents? Specificity is operationalized as an entropy measure of the target word’s environment, the assumption being that more specific words have less variety in their surrounding context. Data and analysis: To test this hypothesis, Anglicisms in a 24-million-word newspaper corpus of Argentine Spanish were processed in three stages: detecting loanwords, selecting semantic equivalents, and measuring specificity. Findings/conclusions: A Wilcoxon Signed-Rank Test revealed that loanwords receive significantly lower entropy scores, that is, they are more specific than their Spanish equivalents. The results suggest a possible motive for adopting loanwords when terms already exist in the source language, namely, to utilize words that provide more nuanced meaning. Originality: Methodologically, this study offers innovative applications of computational methods to loanword research, employing a distributional model to measure entropy. Theoretically, it addresses an underrepresented aspect of loanword adoption, semantics, by extending Backus’s hypothesis to loanwords and increasing its scope to data often viewed as ‘monolingual’. Significance/implications: The conclusions offer novel perspectives on loanwords with existing semantic equivalents, often viewed as ‘unnecessary’ when compared to loanwords that introduce new concepts into the recipient language (e.g. blog). With the notion of specificity, we may understand these loanwords as disruptors to the semantic system of the recipient language, dividing up the semantic space formerly occupied solely by the native equivalent, thus increasing the level of nuance expressed in the original concept.

scholarly journals Change in cigarette dependence among a cohort of smokers following COVID-19 diagnosis in Kashmir valley: An observational follow-up study

2021 ◽  
Vol 12 (11) ◽  
pp. 22-28
Author(s):  
Asif Jeelani ◽  
Shafat Sideeq Lone ◽  
Hilal Rather
Keyword(s):  
Univariate Analysis ◽  
Supplemental Oxygen ◽  
Rank Test ◽  
Newly Diagnosed ◽  
Health Providers ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Older Subjects ◽  
Cigarette Dependence

Background: COVID-19 diagnosis should serve as an impetus for smokers to discontinue its use. The study was conducted to estimate the change in cigarette dependence among newly diagnosed COVID-19 cases. Aims and Objectives: COVID-19 diagnosis should serve as an impetus for smokers to discontinue its use. The study was conducted to estimate change in cigarette dependence among newly diagnosed COVID-19 cases. Materials and Methods: Study was conducted between October and December 2020 and newly diagnosed male COVID-19 patients who were current smokers at diagnosis were recruited from two hospitals involved in testing and treatment of COVID-19. Baseline socioclinical information was recorded at diagnosis in addition to the estimation of cigarette dependence using Fagerstrom Test for Nicotine Dependence (FTND) and health status using Post-COVID-19 Functional Scale (PCFS). Follow-up was done at 2 weeks after recovery using both FTND and PCFS scales. Wilcoxon signed-rank test, paired t-test, and ANOVA were used for univariate analysis and multivariate regression was done. Results: A total of 171 subjects with mean age of 43.79 years were included in the study. FTND scores decreased significantly from the day of diagnosis to follow-up visit with 79% of subjects reporting a decrease. On univariate analysis, decrease in FTND had a significant association with presence of comorbidity, any symptoms, presence of respiratory symptoms, and if supplemental oxygen was administered. On multivariate analysis, symptomatic COVID-19 disease, higher age, PCFS at baseline, and PCFS at follow-up had a significant association with decreased PCFS values at follow-up. Conclusion: COVID-19 diagnosis was followed by significant decrease in FTND score, particularly for symptomatic and older subjects. Post-COVID follow-up visits should be used asan opportunity by health providers to ensure its sustainability and for achieving cessation.

scholarly journals The effectiveness of the Montessori training programme for mothers

2020 ◽  
Vol 10 (4) ◽  
pp. 166-156
Author(s):  
Fatma Ülkü Yıldız ◽  
Aysel Cagdas ◽  
Gokhan Kayili
Keyword(s):  
Daily Living ◽  
Training Programme ◽  
Daily Living Skills ◽  
Rank Test ◽  
Montessori Education ◽  
School Year ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Living Skills

It was the aim of this study to follow-up for 2 years the mathematics and daily living skills of children whose mothers participated in the Montessori training programme for mothers (MTPM) and to determine whether the children still maintained these skills 2 years after the intervention. In 2016–2017, the MTPM was administered to the mothers of 4–5-year-old children who received Montessori education at preschool. The first follow-up was carried out 6 months after the training programme was completed; the second follow-up took place 6 months after the first follow-up and the third one was carried out12 months after the second follow-up. Eleven children included in the study group in the 2016–2017 school year were all reached. ‘Basic School Skills Inventory 3 – Mathematics and Daily Living Skills subtests – Age 4–8 years’ were used for data collection. The data were provided by the teachers. Statistical analysis of the data was carried out using Wilcoxon’s signed-rank test and Statistical Package for the Social Sciences 20.0 data analysis package programme. The results showed that the MTPM maintained its effect on mathematics and daily living skills of the experimental group children 24 months after the implementation of the programme.   Keywords: Montessori training programme for mothers, mathematics, daily living skills.

scholarly journals Efficacy of Microneedling with Dermaroller Alternating with CROSS Peeling with 30% TCA in Management of Acne Induced Scarring

2019 ◽  
Vol 7 (4) ◽  
pp. 299-303
Author(s):  
Nadia Waqas ◽  
Muhammad Amer Saleem
Keyword(s):  
Rank Test ◽  
Acne Scar ◽  
Signed Rank ◽  
Wilcoxon Signed Rank Test ◽  
Signed Rank Test ◽  
Acne Scarring ◽  
Grade Ii ◽  
Skin Scar ◽  
Grade Iii

Objective: To study the effect of combination of two therapies i.e. Microneedling with Dermaroller alternating with Chemical Reconstruction Skin Scar (CROSS) peeling with 30% TCA in management of acne induced scarring.Patients and Methods: This experimental study was conducted in the department of Dermatology, Benazir Bhutto Hospital, Rawalpindi from March 2017 to December 2017. A total of 20 patients underwent microneedling with dermaroller at week=0 (baseline) and were subjected to CROSS peeling with 30% TCA on follow up after 2 weeks. Four sessions of each procedure were repeated at 2 weeks’ interval. Photographs were taken at baseline and 4 weeks after the end of therapy (week=18). The baseline and final photographs were assessed for acne scar grading as per Goodman and Baron qualitative scale by two dermatologists who were blinded to the whole study.Results: Out of 20 patients, 16 (80%) of the patients had grade IV acne scarring and 4 (20%) had grade III scarring at baseline (week=0). On assessment at 4 weeks after the end of therapy (week=18), 16 patients who were having grade IV acne 6 (37.5%) improved to grade III, and 10 (62.5%) improved to grade II. Out of 4 patients who were initially having grade III at week=0, all 4 (100%) improved to grade II by week=18. A Wilcoxon signed rank test showed highly significant improvement in the grading of scarring (z=-3.92, p=0.00008).Conclusion: The combination therapy of microneedling with dermaroller, alternating with CROSS peeling with 30% TCA was highly effective in treating all types of atrophic acne scarring.

scholarly journals Follow-up study on serum cholesterol profiles in recovered COVID-19 patients

2020 ◽  
Author(s):  
Wenbin Tan ◽  
Guiling Li ◽  
Li Du ◽  
Xiuqi Wei ◽  
Xiaoling Cao ◽  
...  
Keyword(s):  
White Blood Cells ◽  
Recovery Process ◽  
Serum Levels ◽  
Rank Test ◽  
Reactive Protein ◽  
Follow Up Study ◽  
Laboratory Values ◽  
Signed Rank ◽  
Signed Rank Test

Abstract Background: COVID-19 patients develop hypolipidemia. However, it is unknown whether lipid levels have improved in recovered patients.Objective: In this follow-up study, we evaluated serum lipidemia and other physiopathological laboratory values in recovered patients.Methods: A 3–6 month follow-up study was performed between June 15 and September 3, 2020, to examine serum levels of laboratory values in 107 discharged COVID-19 patients (mild = 59; severe/critical = 48; diagnoses on admission). 61 patients had a revisit chest CT scan. A Wilcoxon signed-rank test was used to analyze changes in laboratory values at admission and follow-up.Results: LDL-c and HDL-c levels were significantly higher at follow-up than at admission in severe/critical cases (p < 0.05). LDL-c levels were significantly higher at follow-up than at admission in mild cases (p < 0.05). With adjustment of the factor of traditional Chinese medicine, LDL-c and HDL-c levels were significantly improved at follow-up than at admission in severe/critical cases (p < 0.05). Coagulation and liver laboratory values were significantly lower at follow-up than at admission for patients (p < 0.05). Increases in HDL-c significantly correlated with increases in numbers of white blood cells (p<0.001) and decreases in levels of C-reactive protein (p < 0.05) during patients’ recovery. Residue lesions were observed in CT images in 69% (42 of 61) of follow-up patients.Conclusions: Improvements of LDL-c, HDL-c and incomplete absorption of lung lesions were observed at 3–6 month follow-up for recovered patients, indicating that a long-term recovery process could be required.

scholarly journals Daily Application of a Toothpaste with Biomimetic Hydroxyapatite and Its Subjective Impact on Dentin Hypersensitivity, Tooth Smoothness, Tooth Whitening, Gum Bleeding, and Feeling of Freshness

Biomimetics ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. 17 ◽  
Author(s):  
Sonja Steinert ◽  
Kai Zwanzig ◽  
Helga Doenges ◽  
Joern Kuchenbecker ◽  
Frederic Meyer ◽  
...  
Keyword(s):  
Tooth Surface ◽  
Rank Test ◽  
Dentin Hypersensitivity ◽  
Tooth Color ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Dental Practices ◽  
Biomimetic Hydroxyapatite ◽  
Analogue Scales

The aim of this observational study was to analyze the effect of a toothpaste with biomimetic zinc hydroxyapatite (HAP) on subjective parameters after a four-week home use. Patients with subjective dentin hypersensitivity were recruited at three dental practices in Germany and received a questionnaire with visual analogue scales and Likert scales both at baseline and follow-up. The questionnaire was specifically developed for this study and focused on questions about subjective parameters like dentin hypersensitivity, tooth surface texture, tooth color, and freshness after toothbrushing. Patients answered the questionnaire both at baseline and after a four-week home use (follow-up) of the HAP toothpaste. Data of 46 patients were analyzed by paired t-test and non-parametric Wilcoxon signed-rank test, respectively. Subjective parameters on dentin hypersensitivity were reduced after the four-week use of the HAP toothpaste (p < 0.001). Additionally, patients assessed their tooth surface as smoother (p < 0.001), tooth color as whiter (p = 0.003), and reported a stronger feeling of freshness after toothbrushing (p = 0.014) after four-week use of the HAP toothpaste compared to the previously used toothpaste. In conclusion, the tested toothpaste with biomimetic HAP is well-suited for individuals suffering from dentin hypersensitivity, because subjective symptoms on dentin hypersensitivity were reduced. Additionally, patients reported smoother and whiter teeth after using the HAP toothpaste.

3p and 10q deletions detected by fluorescence in situ hybridization (FISH): A potential new tool for early detection of non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7606-7606
Author(s):  
S. Yendamuri ◽  
A. A. Vaporciyan ◽  
T. Zaidi ◽  
R. Fernandez ◽  
D. C. Rice ◽  
...  
Keyword(s):  
Lung Parenchyma ◽  
Normal Lung ◽  
Rank Test ◽  
Fish Analysis ◽  
Mainstem Bronchus ◽  
Deletion Rate ◽  
Chromosomal Deletions ◽  
Signed Rank ◽  
Signed Rank Test

7606 Objectives: To study the feasibility of detecting chromosomal deletions at the 3p and 10q regions in bronchoscopic brush biopsies and touch preparations by FISH and to study their distribution in different areas of the airway in patients with NSCLC. Methods: Bronchoscopic brush biopsies from the mainstem bronchus on the normal side contralateral to the tumor (NBB) and normal mainstem bronchus on the tumor side (TBB) were obtained from 120 patients who underwent surgical resection. Touch preparations from the tumor (TTP) and normal lung parenchyma from the involved lung (NTP) and from bronchi adjacent to the tumor (TAB) were also obtained. Two FISH assays using probes complementary to 3p22.1 and 10q22.3 were used for evaluation of chromosomal deletions at each site. The ratios of the percentage of deletions detected at different anatomical sites were compared using the Wilcoxon signed rank test. Correlations between deletions at TTP and other sites were estimated with a Spearman coefficient. Results: Contralateral normal bronchial tissue (NBB) showed a relatively low deletion rate of 3p and 10q compared to TTP (p<0.0001). FISH on brush biopsies at TBB showed a significantly higher rate of deletions compared to NBB (p<0.05) for both 3p and 10q. A significantly higher deletion rate was seen at TTP compared to NTP at both the 3p (p<0.0001) and 10 q regions (p<0.0001). Significant correlations were seen between the rate of deletions between TTP and TBB at 3p (ρ=0.61, p<0.0001) and between TTP and TAB at 10q (ρ=0.64, p<0.0001). Conclusions: Chromosomal deletions of the 3p and 10q regions can be reliably detected by FISH in bronchoscopic biopsies and touch preparations. As one progresses from the contralateral normal bronchus to the bronchus on the side of tumor and the tumor itself, the percentage of chromosomal deletions increases in a statistically significant fashion,supporting an etiological role of these changes. Deletions at the bronchoscopically normal main and adjacent bronchus on the side of the tumor correlate with an increased deletion rate in the tumor itself. This suggests that FISH analysis of bronchoscopic brushes may be useful for identifying patients at high risk for developing NSCLC. No significant financial relationships to disclose.

Effectiveness of High-intensity Focused Ultrasound (HIFU) Therapy of Solid and Complex Benign Thyroid Nodules – A Long-term Follow up Two-center Study

2022 ◽  
Author(s):  
Anne Fischer ◽  
Christian Vorländer ◽  
Hüdayi Korkusuz
Keyword(s):  
Thyroid Nodules ◽  
High Intensity Focused Ultrasound ◽  
Rank Test ◽  
Signed Rank ◽  
Wilcoxon Signed Rank Test ◽  
Signed Rank Test ◽  
Benign Thyroid Nodules ◽  
Benign Thyroid

Abstract Purpose To investigate the effectiveness of high-intensity focused ultrasound (HIFU) of solid and complex benign thyroid nodules. Methods Fifty-eight patients with benign thyroid nodules were treated with HIFU at two centers from 2014–2019. The device, EchoPulse (Teraclion, Malakoff, France), heats the nodes to 80–90 °C. Nodal volumes were measured by ultrasound at regular intervals before and up to 12 months after therapy. In a retrospective long-term two-center study, average volume reductions in relation to baseline volume were statistically analyzed by the Wilcoxon signed-rank test. Side effects were documented. Results In solid nodules, the average percent volume reductions at the 3, 6, 9, and 12-months follow-up were 49.98%, 46.40%, 65.77%, and 63.88%, respectively. The results were significant with p<0.05 in the Wilcoxon signed-rank test at the 3, 6, and 9-months follow-up. In complex nodules, the average percent volume reduction was 35.2% at 3 months, 36.89% at 6 months, and 63.64% at twelve months follow up. The results were significant with p<0.05 in the Wilcoxon signed-rank test at the 3- and 6-months follow-up. The complication rate was 5.2%. All complications occurred in patients with solid nodules. Conclusion The study showed that HIFU is an effective treatment method for both solid and complex nodules. The complication rate is relatively high at 5.2%. No long-term complications occurred. The solid nodules responded better to HIFU than complex nodules.

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