scholarly journals Tank vapor sampling and analysis data package for tank 241-C-106 waste retrieval sluicing system process test phase III

1999 ◽  
Author(s):  
L.L. LOCKREM
Keyword(s):  
Analysis Data ◽  
Test Phase ◽  
Phase Iii ◽  
System Process ◽  
Vapor Sampling

Regional deposition of 3.6-micron particles and lung function in asthmatic subjects

1991 ◽  
Vol 71 (6) ◽  
pp. 2238-2243 ◽  
Author(s):  
M. Svartengren ◽  
M. Anderson ◽  
G. Bylin ◽  
K. Philipson ◽  
P. Camner
Keyword(s):  
Airway Resistance ◽  
Regression Line ◽  
Test Phase ◽  
Phase Iii ◽  
Poor Correlation ◽  
Small Airways ◽  
Single Breath ◽  
Regional Deposition ◽  
Severe Asthmatic ◽  
Highly Correlated

In a group of moderately severe asthmatic subjects, regional deposition of 3.6-microns (aerodynamic diameter) monodispersed Teflon particles labeled with 111In was studied twice. The particles were inhaled with maximally deep inhalation at 0.5 l/s. Lung retention was measured at 0, 6, 24, and 48 h by use of a profile scanner equipped with two 13 x 5-cm NaI crystals. The retentions at 24 (Ret24) and 48 h were highly correlated (r = 0.96 with a slope of the regression line close to 1). There was a poor correlation between retention at 6 h and Ret24 (r = 0.54). The Ret24 values at the two exposures were well correlated (r = 0.86). There were significant correlations between airway resistance as well as single-breath nitrogen test phase III and Ret24 (r = 0.70 and 0.67, respectively). The correlation between single-breath nitrogen test phase III and Ret24 persisted also when only subjects within a narrow interval of airway resistance were included. The study indicates that regional deposition can be studied by measurements of Ret24 in subjects with moderately severe asthma and that it is dependent on changes in both large and small airways.

The Influences of Step Aerobics Routines on Exercise Capacity Among Middle-Aged Women

2019 ◽  
pp. 75-80
Author(s):  
Anca -Raluca Tanasă ◽  
Iulian-Marius Dumitru ◽  
Cristina-Elena Moraru ◽  
Florin Nichifor
Keyword(s):  
Quality Of Life ◽  
Body Mass Index ◽  
Test Phase ◽  
Phase Iii ◽  
Middle Aged ◽  
Negative Effects ◽  
Beneficial Effects ◽  
Independent Variable ◽  
Research Plan

Step aerobics is a form of practicing of aerobic fitness representing an efficient and pleasant alternative in the process of obtaining optimal physical condition. The purpose of this study is the confirm the hypothesis according to which the practiceof step aerobics routines middle-aged women has an important role in improving the quality of life. The research was carried out throughout the year 2018, on a sample of 20 female adults attending Clubul D inIaşi, who were divided into two groups: experimental and witness and it was carried out throughout three phases: phase I: selecting and studying bibliography, developing the research plan and determining the sample; phase II: applying the initial tests: Body mass index-BMIand Ruffier Test; phase III: applying the final tests, comparatively analysing the results and the progress obtained, to point out the conclusions. In order to analyse the results we used the ANOVA statistical analysis test. The resultsindicate that the independent variable that we applied does not influence the results of the IMC (p= 0,2805), but the Ruffier index presents statistically significant changes (p=˂0,0001). As a general conclusion, we want to emphasize that the sport for heath, more exactly the step-aerobic programs, improves the negative effects of some diseases, the physical deficiencies, functional or trauma to which the human body may be subjected, and thus contributing to its recovery. The beneficial effects of the step-aerobic programs can contribute in a good measure to improve the quality of life.

Durvalumab ± tremelimumab + platinum-etoposide in first-line extensive-stage SCLC (ES-SCLC): Updated results from the phase III CASPIAN study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Luis G. Paz-Ares ◽  
Mikhail Dvorkin ◽  
Yuanbin Chen ◽  
Niels Reinmuth ◽  
Katsuyuki Hotta ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Standard Of Care ◽  
Analysis Data ◽  
Phase Iii ◽  
Open Label ◽  
Primary Endpoints ◽  
Open Label Phase ◽  
First Results ◽  
Treatment Naïve ◽  
Grade 3

9002 Background: CASPIAN is an open-label, Phase 3 study of durvalumab (D) ± tremelimumab (T) + etoposide and either cisplatin or carboplatin (EP) for pts with 1L ES-SCLC. At the planned interim analysis (data cutoff Mar 11, 2019; 63% maturity), D + EP demonstrated a statistically significant improvement in OS compared with EP alone (HR 0.73 [95% CI 0.59–0.91]; p=0.0047). Here we present a planned updated analysis of OS for D + EP vs EP and the first results for D + T + EP vs EP. Methods: Treatment-naïve pts with ES-SCLC (WHO PS 0/1) were randomized 1:1:1 to D 1500 mg + EP q3w, D 1500 mg + T 75 mg + EP q3w, or EP q3w. In the IO arms, pts received 4 cycles of EP + D ± T, followed by maintenance D 1500 mg q4w until disease progression. Pts received one additional dose of T 75 mg post EP in the D + T + EP arm. In the EP arm, pts received up to 6 cycles of EP and optional PCI (investigator’s discretion). The two primary endpoints were OS for D + EP vs EP and for D + T + EP vs EP. Results: 268, 268 and 269 pts were randomized to D + EP, D + T + EP and EP, respectively; baseline characteristics were generally well balanced across arms. As of Jan 27, 2020, the median follow-up was 25.1 mo, 82% maturity. D + EP continued to demonstrate improvement in OS vs EP, with a HR of 0.75 (95% CI 0.62–0.91; nominal p=0.0032); median OS 12.9 vs 10.5 mo, respectively. 22.2% of pts were alive at 2 y with D + EP vs 14.4% of pts with EP. D + T + EP numerically improved OS vs EP, however this did not reach statistical significance per the prespecified statistical plan: HR 0.82 (95% CI 0.68–1.00; p=0.0451 [p≤0.0418 required for stat sig]); the median OS was 10.4 mo and 23.4% of pts were alive at 2 y. Secondary endpoints of PFS and ORR remained improved with D + EP vs EP and will be presented. Confirmed investigator-assessed ORR was similar for D + T + EP vs EP (58.4% vs 58.0%). Median PFS was similar for D + T + EP vs EP (4.9 mo vs 5.4 mo), but the 12-mo PFS rate was numerically higher (16.9% vs 5.3%); PFS HR 0.84 (95% CI 0.70–1.01). In the D + EP, D + T + EP and EP arms, respectively, incidences of all-cause AEs of Grade 3/4 were 62.3%, 70.3% and 62.8%; AEs leading to discontinuation 10.2%, 21.4% and 9.4%; and AEs leading to death 4.9%, 10.2% and 5.6%. Conclusions: The addition of durvalumab to EP continued to demonstrate improvement in OS compared with a robust control arm, further supporting this regimen as a new standard of care for 1L ES-SCLC offering the flexibility of platinum choice. No additional benefit was observed when T was combined with D + EP in this pt population. Safety findings in all arms remained consistent with the known safety profiles of all agents. Clinical trial information: NCT03043872.

Correlation of hand-foot skin reaction (HFS) with treatment efficacy in pancreatic cancer (PC) patients (pts) treated with gemcitabine/capecitabine plus erlotinib: A subgroup analysis from the AIO-PK0104 randomized, cross-over phase III trial in advanced PC.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4023-4023
Author(s):  
Michael Haas ◽  
Stefan Hubert Boeck ◽  
Ruediger Paul Laubender ◽  
Dominik Paul Modest ◽  
Ursula Vehling-Kaiser ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Subgroup Analysis ◽  
Locally Advanced ◽  
Skin Toxicity ◽  
Analysis Data ◽  
Phase Iii ◽  
Study Endpoint ◽  
Primary Study ◽  
Line Treatment ◽  
Phase Iii Trial

4023 Background: AIO-PK 0104 investigated the efficacy and safety of gemcitabine/erlotinib (G/E) followed by capecitabine (C) vs. C/E followed by G. The present subgroup analysis evaluated the correlation between C-associated skin toxicity and outcome parameters in PC. Methods: Within this multicenter phase III trial, pts with confirmed advanced PC were randomly assigned to 1st-line treatment with either C (2,000 mg/m2/d, d1-14 q d21) plus E (150 mg/d, arm A) or G (1,000 mg/m2 over 30 min weekly x 7, then d1, 8, 15 q d28) plus E (150 mg/d, arm B). A cross-over to either G (arm A) or C (arm B) was performed after treatment failure (e. g. disease progression or unacceptable toxicity). Time to treatment failure after 1st- and 2nd-line therapy (TTF2) was the primary study endpoint. Treatment-related skin toxicity was evaluated separately for each treatment arm/each regimen based on NCI-CTCv2. Results: Of 279 eligible pts, 47 had locally advanced, 232 had metastatic disease and 141 pts received second-line chemotherapy. For the present subgroup analysis data on skin toxicity were available from 255 pts. For the 73 pts (29%) with a HFS (any grade documented at any time during the treatment strategy), TTF2 and OS both were significantly prolonged compared to pts without HFS (7.4 vs 4.0 months, p<0.001 and 9.7 vs 5.5 months, p=0.002, respectively). Considering HFS during 1st-line treatment in 123 pts within the CE arm, these results could be confirmed for the 47 pts (38%) with a documented HFS of any grade (TTF2: 7.6 vs. 3.2 months, p<0.001; OS: 10.2 vs. 4.4 months, p=0.001). In pts receiving 1st-line treatment with G/E (n=132) no difference in outcome was observed for pts with (n=13) or without (n=119) HFS of any grade (TTF2: 5.7 vs. 4.2 months, p=0.375; OS: 8.4 vs. 6.6 months, p=0.505). Conclusions: The current subgroup analysis of AIO-PK0104 supports the assumption of a correlation between HFS in PC pts treated with capecitabine or capecitabine/erlotinib and efficacy endpoints like TTF2 and OS. A capecitabin-associated HFS thus might be predictive for efficacy in patients with advanced PC.

The CFTA evaluation of alternatives program: An evaluation of in vitro alternatives to the draize primary eye irritation test. (Phase III) surfactant-based formulations

1996 ◽  
Vol 34 (1) ◽  
pp. 79-117 ◽  
Author(s):  
S.D. Gettings ◽  
R.A. Lordo ◽  
K.L. Hintze ◽  
D.M. Bagley ◽  
P.L. Casterton ◽  
...  
Keyword(s):  
Test Phase ◽  
Phase Iii ◽  
Eye Irritation ◽  
Irritation Test
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