Randomized study of darbepoetin alfa as modifier of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC): Final outcome of the DAHANCA 10 trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6007-6007 ◽  
Author(s):  
J. Overgaard ◽  
C. M. Hoff ◽  
H. S. Hansen ◽  
L. Specht ◽  
M. Overgaard ◽  
...  
Keyword(s):  
Interim Analysis ◽  
Randomized Study ◽  
Disease Free Survival ◽  
Experimental Treatment ◽  
Control Group ◽  
Tumor Control ◽  
Tumor Site ◽  
Significant Difference ◽  
The Difference ◽  
N Staging

6007 Background: The study aimed to evaluate if correction of low hemoglobin (Hb) levels by means of the erythropoietin stimulating agent: darbepoetin alpha (Aranesp) during radiotherapy (RT) improves outcome in patients with HNSCC. Following a planned interim analysis which showed inferiority of the experimental treatment, the trial was stopped in November 2006. Methods: Pts with HNSCC eligible for primary RT alone and with Hb values below 14.0 g/dl were randomized to receive Aranesp together with accelerated fractionated RT. Pts. were stratified according to gender, T and N staging, tumor site, and institution. Aranesp was given subcutaneously in a dose of 150 micrograms weekly during RT, or stopped earlier if the Hb exceeded 15.5 g/dl. Results: In total, 522 patients (of a planned intake of 600) were included at the time of the interim analysis. Of these 514 pts were eligible for analysis (255 pts treated with Aranesp and 259 pts in the control group) with a median follow up of 49 months. Among these, 201 developed a loco-regional failure (primary endpoint). There have been 238 deaths of which 176 are due to HNSCC. The patients were evenly distributed according to the stratification parameters (gender, T and N staging, tumor site, institution).Aranesp resulted in the expected increase in Hb in more than 81% of the patients. The compliance to Aranesp was good with no significant difference in serious (cardiovascular) adverse events (3% vs. 1%). Overall, the results showed a poorer outcome in 5-year loco-regional control (59% vs. 68% (p = 0.04, RR: 1.47 [1.14–1.94]) for the Aranesp vs. control arm. This was also seen for the endpoint of disease-free survival (37% vs. 47%, p = 0.02, RR: 1.32 [1.04–1.68]), whereas there was no significant difference in overall survival (40% vs. 51%, p = 0.16, RR: 1.20 [0.93–1.55]). There were no differences in radiation related morbidity. All univariate analyses were confirmed in a multivariate setting. Conclusions: Correction of the Hb level with Aranesp in patients with HNSCC resulted in a significantly poorer tumor control after radiotherapy. The treatment principle was abandoned and the difference in outcome is being subjected to further examination. No significant financial relationships to disclose.

Pseudonormokalemia in Patients with Thrombocytosis.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3964-3964
Author(s):  
Amir S. Steinberg ◽  
Raimonda Goldman ◽  
Randy L. Levine ◽  
Georgia Panagopoulos ◽  
Marvin C. Cooper
Keyword(s):  
Platelet Count ◽  
Serum Potassium ◽  
Interim Analysis ◽  
Plasma Potassium ◽  
Normal Serum ◽  
Control Group ◽  
P Value ◽  
Significant Difference ◽  
The Mean ◽  
The Difference

Abstract Introduction: Pseudohyperkalemia represents an artificial elevation in serum potassium concentration. It is well described that patients with thrombocytosis may have elevated serum but normal plasma potassium. The difference between serum and plasma potassium is felt to be due to potassium release from platelets during clotting. We propose to prove that a similar mechanism will lead to a "pseudonormokalemia," where serum potassium appears to be in the normal range (3.5–5.0 MEq/L) despite below-normal levels in the plasma(<3.5 MEq/L). Method: This is an interim analysis of a prospective, IRB-approved planned comparison of 146 patients. We compared 36 thrombocytosis patients (platelets>500,000/uL) to 36 control patients (platelets<500,000/uL). Patients were identified from a list of lab results generated by a computer search and serum and plasma potassium and CBC were then drawn concomitantly. The two groups were compared using either the t-test or the Mann-Whitney U test depending on the distribution of the variables. A p <.05 was considered a priori to indicate statistical significance. Results: There was no statistically significant difference in sex distribution or age between the two groups. The average platelet count was 643,190/uL in the thrombocytosis group (SD 134,426 uL) and 280,220/uL (SD 106,217 uL) in the control group with a p value <0.001. While the serum potassium was noted to be significantly different between the two groups, the plasma potassium was not (see table). This was reflected in the difference between the serum and plasma potassium in the two groups. The thrombocytosis group was noted to have a difference between serum and plasma potassium of .52 MEq/L (SD .32 MEq/L) while the control group had a difference of .18 MEq/L (SD .23 MEq/L). The thrombocytosis group had 14 cases in which the difference between serum and plasma potassium was over 0.5 MEq/L whereas the control group had none. Conclusion: In this study, patients with thrombocytosis had higher mean serum potassium levels than the control group but similar mean plasma potassium levels. The mean difference between serum and plasma potassium (Delta) exceeded 0.5 MEq/L in the thrombocytosis arm and there was a statistically significant difference in the Delta values between the two groups. The mean platelet volume (MPV) of the thrombocytosis group was smaller than that of the control group. This indicates that the elevation in serum potassium in the thrombocytosis group cannot be attributed to the actual size of the platelets but rather to the number of platelets involved. Patients with thrombocytosis and normal serum potassium may actually be hypokalemic as this study demonstrates. As we continue to evaluate patients, we believe this difference will become more demonstratable. On interim analysis, our study suggests that in patients with thrombocytosis and normal serum potassium, plasma potassium should be considered along with routine labs. Group Comparison Values (N=36) Thrombocytosis Group-Platelets>500,000/uL Control Group-Platelets<500,000/uL p value Age 60.33 yrs 57.53 yrs p =.50 Serum K+ 4.43 MEq/L 4.15 MEq/L <.001 Plasma K+ 3.91 MEq/L 3.97 MEq/L p =.54 Mean Delta between Serum and Plasma K+ .52 MEq/L (SD .32) .18 MEq/L (SD .23) <0.001 Platelet Count 643.19 X103/uL 280.22X103/uL <0.001 MPV 7.27 fl 8.24 fl <0.001 WBC 12.05 mm3 9.98 mm3 p =.16

scholarly journals A study of weekly paclitaxel vs weekly cisplatin with concomitant chemoradiation in locally advanced head and neck cancer

2017 ◽  
Vol 5 (11) ◽  
pp. 4895 ◽  
Author(s):  
Himadri Kumar Daru ◽  
Yumkhaibam Sobita Devi ◽  
Yumkhaibam Sobita Devi ◽  
Jaichand Singh ◽  
Jaichand Singh
Keyword(s):  
Head And Neck ◽  
Locally Advanced ◽  
Haematological Toxicity ◽  
Disease Free Survival ◽  
Control Group ◽  
Advanced Head ◽  
Skin Reactions ◽  
Significant Difference ◽  
Concomitant Chemoradiation ◽  
The Difference

Background: The purpose of this study was to compare the role of concomitant chemoradiation using paclitaxel versus cisplatin in locally advanced head and neck cancers.Methods: 52 patients were randomly assigned to one of the two concomitant chemoradiation arms: arm I (n=26) and arm II (n= 26) who received injection of paclitaxel 40 mg/m2 I/V 1-hour infusion before radiation, repeated weekly for 6 cycles, and cisplatin 30 mg/m2 I/V 1-hour infusion before radiation, repeated weekly for 6 cycles, respectively. The planned radiotherapy dose was 66-70 Gy, 2 Gy/day, 5#/Week in 6-7 weeks.Results: Response rates were 69.2% and 57.7% in arm I and arm II, respectively. There was no statistically significant difference observed between the study group and the control group (P = 0.85) On median follow up of 7-15 months, Disease free survival was (83.3%) in arm I compared with (73.3%) in arm II but the difference was statistically insignificant. Local toxicities including mucositis, dysphasia and skin reactions were more in the study the haematological toxicity was generally mild. On the contrary, non-hematologic toxicities were severe. Grade IV mucositis occurred in 26.9% in arm I and in 3.8% in arm II (P = 0.003). Moreover, grade IV dermatitis were encountered in 23.1% in arm I (P = 0.00).Conclusions: Both concomitant chemoradiotherapy regimens were easily given in the outpatient clinic. The regimen based on paclitaxel was more effective; however, the difference was insignificant. 

Comparative study of inj. Rocuronium with priming dose and inj. Rocuronium without priming with respect to onset, time of intubation and intubating conditions in patients undergoing general anaesthesia

2021 ◽  
Vol 19 (2) ◽  
pp. 39-43
Author(s):  
Sachin Swami ◽  
Keyword(s):  
General Anaesthesia ◽  
Randomized Study ◽  
Age Groups ◽  
Onset Time ◽  
Control Group ◽  
P Value ◽  
Priming Dose ◽  
Intubating Conditions ◽  
Significant Difference ◽  
The Difference

Background: Rocuronium is fastest among non-depolarizing muscle relaxants ,but still it produces appropriate intubating conditions comparable to succinylcholine, in >90 seconds on administering 2 × ED95 dose as a bolus dose. In present study we compared the effect of inj. Rocuronium with priming dose and inj. Rocuronium without priming on intubating conditions and onset time of intubation with respect to rocuronium as bolus. Material and Methods: Present study was single-center, prospective, randomized study, conducted in patients of age groups from 18-60 years of either sex , 40-60 kgs weight, ASA grades I and II, undergoing surgeries under general anaesthesia and given valid written consent for participation. The patients were randomly allocated into 2 groups of 30 patients each as Group C (control group) and Group P (priming group). Results: Overall, 60 patients were studied in age group of 18 to 60 years, 30 patients in each group C and group P. we compared mean age, weight, gender and ASA grade between group C and group P and difference was statistically not significant (p value >0.05). We compared mean HR, mean MAP and mean SPO2 preoperatively baseline, at induction, at intubation, mean HR at 1 minute after intubation and mean HR at 5 minute after intubation between group C and group P, the difference between two groups was statistically insignificant. (P value >.05) In group C, out of 30 patients ,17 patients were having score 9 while 12 patients were having score 8, while 1 patient had score 7 which was comparable with the group P in which out of 30 patients ,18 were having score 9,while 11 patients were having score 8 and 1 patient was of score 7,so in both groups most of the patients (96.67% in each group) had excellent intubating condition, and the groups were comparable as statistically no significant difference was noted. In group C mean Onset Time of Intubation was 92.33± 6.26 seconds, while in group P it was 56± 6.75 seconds, so the difference between the groups on the basis of OTI was statistically highly significant. (P value 0.0001) Conclusion: Rocuronium with priming would be an excellent alternative to succinylcholine, whenever fast induction will be needed. Intubating conditions were good to excellent and comparable in both rocuronium with priming and without priming. NMT monitoring is a useful tool for indicating the clinically acceptable paralysis.

Effect of Protracted High-Dose l-Asparaginase Given as a Second Exposure in a Berlin-Frankfurt-Münster–Based Treatment: Results of the Randomized 9102 Intermediate-Risk Childhood Acute Lymphoblastic Leukemia Study—A Report From the Associazione Italiana Ematologia Oncologia Pediatrica

2001 ◽  
Vol 19 (5) ◽  
pp. 1297-1303 ◽  
Author(s):  
C. Rizzari ◽  
M.G. Valsecchi ◽  
M. Aricò ◽  
V. Conter ◽  
A. Testi ◽  
...  
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Lymphoblastic Leukemia ◽  
Randomized Study ◽  
Disease Free Survival ◽  
Experimental Treatment ◽  
Childhood Acute Lymphoblastic Leukemia ◽  
High Dose ◽  
Intermediate Risk ◽  
Free Survival ◽  
Significant Difference

PURPOSE: To assess in a randomized study the therapeutic effect of the addition of high-dose l-asparaginase (HD ASP) in the context of a Berlin-Frankfurt-Münster (BFM)–based chemotherapy regimen for intermediate risk (IR) childhood acute lymphoblastic leukemia (ALL). PATIENTS AND METHODS: From March 1991 to April 1995, a total of 705 patients, with 59% of the cohort of patients fewer than 15 years old, with newly diagnosed non-B ALL, enrolled onto the Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) ALL-91 study, were assigned to the IR group. Patients in remission at the beginning of the reinduction phase were randomized either to the standard treatment (SD ASP arm) or the experimental treatment (HD ASP arm; weekly intramuscular administration of HD ASP 25,000 IU/m2 repeated for a total of 20 weeks). Most of the patients (90%) were treated with Erwinia chrysanthemi l-asparaginase product. RESULTS: Among the 610 patients randomized to the SD ASP arm (n = 322) or to the HD ASP arm (n = 288), relapse occurred at a median time of 24 months after randomization in 76 (24%) and in 64 children (22%), respectively. Most of the relapses occurred in the marrow (100 isolated, 21 combined). There was no significant difference between the disease-free survival in the two treatment arms (P = .64), with estimated values at 7 years from randomization of 72.4% (SE 3.1) v 75.7% (SE 2.6) in the SD ASP and HD ASP arms, respectively. CONCLUSION: No advantage was observed for IR ALL children treated with BFM-based intensive chemotherapy who received protracted E chrysanthemi HD ASP during reinduction and the early continuation phase.

scholarly journals QOLP-17. GROUP MEDICAL PLAY EFFECTIVELY IMPROVES HOSPITALIZATIONADAPTABILITY OF PEDIATRIC PATIENTS WITH NEUROTUMOR

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii178-ii178
Author(s):  
Xing Zhang ◽  
Fuqiang Zhang ◽  
Mingyao Lai ◽  
Juan Li ◽  
Yangqiong Zhang ◽  
...  
Keyword(s):  
Social Status ◽  
Pediatric Patients ◽  
Picture Book ◽  
Family Satisfaction ◽  
Control Group ◽  
Play Intervention ◽  
Significant Difference ◽  
The Difference ◽  
Therapeutic Play ◽  
Experimental Group

Abstract OBJECTIVE To explore the effect of group medical games on the hospitalization adaptability of pediatric patients with neuro tumor. METHODS pediatric patients with neuro tumor (age:6 to 13 years) who were treated in hospital from June to December 2019 and were hospitalized for 1 month to 2 months. 29 pediatric patients(mean age:9y) were selected as the control group and treated as usual; 26 pediatric patients(meanage:8y) were selected as the experimental group for group therapeutic play intervention. Interventions last Monday, Wednesday and Friday of each week, with an average duration of one hour. Group medical play include: medical picture book education, medical preview game, emotional games, social table games. Two groups completed self-made questionnaires at the time of admission and two weeks after admission, including: diet, sleep, compliance, and social status, hospital adaptation and other related issues, two groups completed a satisfaction questionnaire after two weeks of admission, recorded analysis and compared the difference of questionnaire data and satisfaction of the two groups of pediatric patients. RESULTS There was no statistical difference in age and sex between the two groups, and there was no significant difference in baseline RESULTS: The re-test results showed that the experimental group was significantly better than the control group in terms of social status, hospital adaptation, compliance and family satisfaction(p＜0.05). CONCLUSION Group medical games can effectively improve the adaptability, compliance and family satisfaction of pediatric with neuro tumor.

A prospective randomized study to assess the efficacy of post-operative nasal medication after endonasal surgery

1995 ◽  
Vol 109 (7) ◽  
pp. 618-621 ◽  
Author(s):  
Paul D. R. Spraggs ◽  
Marcelle Macnamara ◽  
Theo Joseph
Keyword(s):  
Randomized Study ◽  
Correlation Coefficients ◽  
Control Group ◽  
Time Intervals ◽  
Treatment Groups ◽  
Ephedrine Hydrochloride ◽  
Patent Airway ◽  
Significant Difference ◽  
Blood Clots ◽  
Betamethasone Sodium Phosphate

AbstractPost-operative nasal medications are commonly used following routine septal or turbinate surgery but their efficacy in removing blood clots, improving the sensation of a patent airway and promoting healing are unknown. This prospective randomized trial of patients undergoing septal and/or turbinate surgery assessed the efficacy of three commonly used nasal medicines, 0.5 per cent ephedrine hydrochloride nasal drops, betamethasone sodium phosphate (Betnosol®) nose drops and alkaline nasal douches, in producing the sensation of a patent airway in the 14 days following surgery. Ninety-seven patients were randomized into the three treatment groups and a control group who received no nasal medication. Patients assessed their nasal patency by means of a visual analogue scale (VAS) and any complications of treatment were recorded. Statistical analysis of the 76 complete sets of results using the Mann-Whitney U-test showed that there was a significant difference in the distribution of all of the treatments for each of the time intervals (p<0.05). Glass rank biserial correlation coefficients were all small (rg<0.085) but the most significant differences were between ephedrine and the control group at two hours, two, seven and 10 days (0.02, 0.054, 0.057, 0.085 respectively), alkaline nasal douches being most significant at four and 14 days (0.06 and 0.0722 respectively).

Mainstream and Remedial School Attention Deficit Hyperactivity Disorder Boys: More Alike than Different

2005 ◽  
Vol 35 (1) ◽  
pp. 73-88
Author(s):  
J. B. Savitz ◽  
P. Jansen
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Control Group ◽  
Adhd Group ◽  
Hyperactivity Disorder ◽  
Significant Difference ◽  
Executive Deficits ◽  
Mainstream School ◽  
The Difference ◽  
Neuropsychological Tasks

The literature on the neuropsychology of Attention Deficit Hyperactivity Disorder (ADHD) is plagued by inconsistent findings, which are usually attributed to a variety of extraneous variables. One of the most inadequately explored of these variables is the difference between ADHD children attending remedial and mainstream schools. This study aimed to investigate whether the performance of remedial and mainstream school ADHD boys differs on relevant neuropsychological tasks. The sample consisted of three groups of 8- to 12-year-old boys. Two of these groups consisted of children with ADHD: one from remedial schools and one from mainstream schools. The third group was made up of participants without ADHD, who attended mainstream schools. The performance of the remedial school learners on the Stroop, Lurian and cancellation tasks was investigated and compared to a mainstream school ADHD sample. The performance of the ADHD group as a whole was compared with that of a control group. No significant difference in performance was found between the two ADHD groups, except for the length of time taken to read words in the control condition of the Stroop. The control group out-performed the ADHD samples on the Stroop, Lurian and cancellation tasks. The findings suggest that mainstream and remedial ADHD boys do not differ in the severity of their executive deficits, but that boys with ADHD attending remedial schools may be more likely to have another learning disorder than their counterparts at mainstream schools.

scholarly journals The Effectiveness of the Use of Animation in Arabic Language Learning

2017 ◽  
Vol 13 (10) ◽  
pp. 124 ◽  
Author(s):  
Norhayati Che Hat ◽  
Mohd Fauzi Abdul Hamid ◽  
Shaferul Hafes Sha'ari ◽  
Safawati Basirah Zaid
Keyword(s):  
Student Achievement ◽  
Language Learning ◽  
Language Teaching ◽  
Arabic Language ◽  
Control Group ◽  
Teaching Aid ◽  
Significant Difference ◽  
Post Test ◽  
The Difference ◽  
Experimental Group

Implementation of animation as an Arabic language teaching aid is an innovation in creating an atmosphere that can influence student achievement. This study aimed to identify the effectiveness of the use of animation in Arabic language teaching and learning among diploma students at Universiti Sultan Zainal Abidin (UniSZA), Terengganu, Malaysia. A total of 66 diploma students were randomly selected and divided into experimental group (n = 33) and control group (n = 33). The results obtained from the data collected from pre-and post-test for each group were analyzed using t-test in SPSS version 17.0. The results showed a significant difference of (t = 8789, df = 64, p <0.05) between the achievement of the experimental group and the control group in the post test. The difference in mean score of the experimental group and the control group was 33.03. This shows that there is significant improvement in Arabic language according to the groups. The difference prove that the use of animation in learning sessions contribute to the achievement of students in the Arabic language. This study advocate the idea that animation applications can be integrated as part of language teaching aid to positively improve student achievement, classroom learning environment and student motivation. 

scholarly journals Effects of Negative Emotions on Cognitive Schemas

2020 ◽  
Vol 11 (1) ◽  
pp. 65-69
Author(s):  
Marius-Gabriel Amzulescu ◽  
Andreea-Ionela Chiscop ◽  
Diana-Nicol Marin ◽  
Cristina Lare ◽  
Andra-Maria Popescu
Keyword(s):  
Negative Emotions ◽  
T Test ◽  
Control Group ◽  
Core Beliefs ◽  
Cognitive Schemas ◽  
Main Research ◽  
Significant Difference ◽  
Independent Variable ◽  
The Difference ◽  
The University

The present study investigates the effect of negative emotions (focusing on disappointment, sadness and regret) on cognitive schemas. The sample consist in students from the University of Bucharest (convenience groups). A univariate unifactorial experimental design was used, as the current study had one independent variable, negative emotions, and a dependent variable, cognitive schemas, which was measured with the Core Beliefs Questionnaire instrument. We applied T test for independent samples, using SPSS. The t test was statistically significant, t (45) = 2.57, p <0.05. The confidence interval (95%) for the difference between the averages is between 2.95 and 24.35. After applying the intervention, the evaluated sample (M = 43.17, SD = 29,074) showed a statistically significant difference compared to the control group (M = 29.52, SD = 11.257). The data collected support the main research hypothesis of the study, negative emotions can bring about changes in certain cognitive schemas by modifying, altering or disrupting them.

scholarly journals The difference in saliva pH before and after brushing with fluoride containing toothpaste and without toothpaste

2008 ◽  
Vol 20 (3) ◽  
Author(s):  
Samuel Setiawan ◽  
Edeh Rolleta Haroen ◽  
Dede Hadidjah
Keyword(s):  
Drinking Water ◽  
Research Method ◽  
Control Group ◽  
Research Subjects ◽  
Male And Female ◽  
Significant Difference ◽  
Salivary Ph ◽  
Before And After ◽  
Quasi Experimental ◽  
The Difference

In administering fluoride through drinking water there is the risk of overdose, higher cost and inadequate availability of drinking water containing fluoride in developing countries like Indonesia. A safe fluoride source is contained in toothpaste. The purpose of this research was to obtain data concerning difference in saliva pH before and after brushing with toothpaste containing fluoride and without toothpaste. The research method used was the quasi-experimental method. Samples were collected by the way of purposive sampling, conducted on 43 male and female research subjects. The data were analyzed by statistical analysis using the t test at 95% confidence level. In this research a control group consisting of 43 people was used. Research results indicated that the average saliva pH before brushing was 7.174; after brushing with fluoride containing toothpaste salivary pH was 7.593. Result research of brushing without toothpaste showed an average saliva of 7.163 before brushing and 7.379 after brushing without toothpaste. The average changes in saliva pH before and after brushing using fluoride containing toothpaste was 0.216. The conclusion of this research was that there was significant difference in saliva pH before and after brushing with toothpaste containing fluoride; there was significant difference in saliva pH before and after brushing without toothpaste, and there was significant difference in saliva pH before and after brushing with toothpaste containing fluoride and without toothpaste.

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