Steroid Use in Rhinoplasty: An Objective Assessment of Postoperative Edema

1998 ◽  
Vol 77 (1) ◽  
pp. 40-43 ◽  
Author(s):  
Todd H. Berinstein ◽  
Steven M. Bane ◽  
Craig L. Cupp ◽  
J. Kevin DeMarco ◽  
Darrell H. Hunsaker
Keyword(s):  
Objective Assessment ◽  
Double Blind Study ◽  
Resonance Imaging ◽  
Tissue Thickness ◽  
Tertiary Referral ◽  
Double Blind ◽  
Tertiary Referral Center ◽  
Soft Tissue Thickness ◽  
Preoperative Magnetic Resonance ◽  
The Difference

The objective of this study was to measure the effect of a single, preoperative 10 mg dose of dexamethasone on postoperative edema associated with rhinoplasty. This was a randomized, double-blind prospective study conducted in a military academic tertiary referral center. Twenty men, aged 18 to 45 years, were enrolled in the study over 28 months. All 20 men underwent rhinoplasty with osteotomy. Preoperative magnetic resonance imaging scans were obtained on the morning of surgery and postoperative scans were obtained within 48 hours. Postoperative edema was quantified as the difference in soft tissue thickness (mm) between the pre- and postoperative scans. Contrary to our expectations, the rhinoplasty patients who received dexamethasone had increased postoperative edema (p<0.02) when compared to patients not receiving dexamethasone. This is the first objective, double-blind study that shows an increase in postoperative edema after rhinoplasty with a single preoperative dose of dexamethasone.

scholarly journals A Phase 3, Randomized, Double-Blind Study Comparing Tedizolid Phosphate and Linezolid for Treatment of Ventilated Gram-Positive Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

2021 ◽  
Author(s):  
Richard G Wunderink ◽  
Antoine Roquilly ◽  
Martin Croce ◽  
Daniel Rodriguez Gonzalez ◽  
Satoshi Fujimi ◽  
...  
Keyword(s):  
Clinical Response ◽  
Bacterial Pneumonia ◽  
Double Blind Study ◽  
Phase 3 ◽  
Gram Positive ◽  
Double Blind ◽  
Intention To Treat ◽  
The Difference ◽  
Hospital Acquired ◽  
Noninferiority Margin

Abstract Background Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are associated with high mortality rates. We evaluated the efficacy and safety of tedizolid (administered as tedizolid phosphate) for treatment of gram-positive ventilated HABP/VABP. Methods In this randomized, noninferiority, double-blind, double-dummy, global phase 3 trial, patients were randomized 1:1 to receive intravenous tedizolid phosphate 200 mg once daily for 7 days or intravenous linezolid 600 mg every 12 hours for 10 days. Treatment was 14 days in patients with concurrent gram-positive bacteremia. The primary efficacy end points were day 28 all-cause mortality (ACM; noninferiority margin, 10%) and investigator-assessed clinical response at test of cure (TOC; noninferiority margin, 12.5%) in the intention-to-treat population. Results Overall, 726 patients were randomized (tedizolid, n = 366; linezolid, n = 360). Baseline characteristics, including incidence of methicillin-resistant Staphylococcus aureus (31.3% overall), were well balanced. Tedizolid was noninferior to linezolid for day 28 ACM rate: 28.1% and 26.4%, respectively (difference, –1.8%; 95% confidence interval [CI]: –8.2 to 4.7). Noninferiority of tedizolid was not demonstrated for investigator-assessed clinical cure at TOC (tedizolid, 56.3% vs linezolid, 63.9%; difference, –7.6%; 97.5% CI: –15.7 to 0.5). In post hoc analyses, no single factor accounted for the difference in clinical response between treatment groups. Drug-related adverse events occurred in 8.1% and 11.9% of patients who received tedizolid and linezolid, respectively. Conclusions Tedizolid was noninferior to linezolid for day 28 ACM in the treatment of gram-positive ventilated HABP/VABP. Noninferiority of tedizolid for investigator-assessed clinical response at TOC was not demonstrated. Both drugs were well tolerated. Clinical Trials Registration NCT02019420.

Pharmacological Modulation of Cutaneous Reactivity to Histamine: A Double-Blind Acute Comparative Study between Cetirizine, Terfenadine and Astemizole

1989 ◽  
Vol 17 (1) ◽  
pp. 24-27 ◽  
Author(s):  
L. Ghys ◽  
J.-P. Rihoux
Keyword(s):  
Comparative Study ◽  
Healthy Volunteers ◽  
Inhibitory Effect ◽  
Blind Study ◽  
Double Blind Study ◽  
Single Administration ◽  
Double Blind ◽  
Pharmacological Modulation ◽  
The Difference ◽  
Cutaneous Reactivity

In a double-blind study performed in 81 healthy volunteers, 10 mg cetirizine and 60 mg terfenadine given orally in a single administration significantly inhibited skin reactivity to histamine. Astemizole (10 mg) was completely ineffective. The inhibitory effect of cetirizine was potent and regular whereas 6/28 (21%) volunteers did not respond to terfenadine. The difference observed beween cetirizine and terfenadine might be due to differences in the metabolism of the two drugs after administration: terfenadine is rapidly and extensively metabolized whereas cetirizine is directly active without the need for biotransformation and, indeed is poorly metabolized.

Efficacy and tolerability of bevacizumab (BEV) plus capecitabine and cisplatin (XP) in Chinese patients (pts) with locally advanced or metastatic gastric/gastroesophageal junction cancer (AGC): Results from the AVATAR study.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 73-73 ◽  
Author(s):  
Lin Shen ◽  
Jin Li ◽  
Jian-Ming Xu ◽  
Hong-Ming Pan ◽  
Guanghai Dai ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Chinese Patients ◽  
Double Blind Study ◽  
Double Blind ◽  
Gastroesophageal Junction Cancer ◽  
The Difference ◽  
Grade 3

73 Background: In the AVAGAST study, chemotherapy (fluoropyrimidine and cisplatin) + BEV did not significantly improve overall survival (OS) vs. chemotherapy + placebo. Geographic differences in efficacy were observed, but only 12 Chinese pts were included. AVATAR, a study similar in design to AVAGAST, is a randomized double-blind study conducted exclusively in China in pts with AGC. Methods: Pts aged >18 years with gastric adenocarcinoma were randomized 1:1 to XP + BEV 7.5 mg/kg or placebo + XP. The primary objective was OS; secondary objectives included progression-free survival (PFS) and safety. Results: Baseline characteristics of the 202 pts were well balanced. The primary efficacy endpoint of improved OS in the BEV arm was not met (HR 1.11, 95% CI 0.79–1.56; p=0.5567; see table ). BEV + XP was well tolerated. Grade 3–5 adverse events (AEs) and serious AEs were 60% and 19% for BEV and 68% vs. 21% for placebo, respectively. Grade 3–5 AEs of special interest with BEV occurred in 8% of BEV pts and 15% of placebo pts; the difference was mainly due to grade 3–5 haemorrhage (BEV 4%, placebo 12%). Conclusions: Addition of BEV to XP in Chinese pts with AGC did not significantly improve outcomes in AVATAR. The results from AVATAR are consistent with the findings seen in the Asian sub-population of the previous AVAGAST study. [Table: see text]

Tu1250 What Is the Difference Between Crohn's Disease Admissions to a Tertiary Referral Center and a Community Hospital?

2015 ◽  
Vol 148 (4) ◽  
pp. S-836
Author(s):  
Anwar Dudekula ◽  
Benjamin H. Click ◽  
Claudia Ramos Rivers ◽  
Jana G. Hashash ◽  
Michael A. Dunn ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Community Hospital ◽  
Tertiary Referral ◽  
Tertiary Referral Center ◽  
Referral Center ◽  
The Difference

scholarly journals Evaluation of Fetal Mid-Thigh Soft Tissue Thickness and Femur Length for Estimation of Fetal Birth Weight

2020 ◽  
Vol 3 (2) ◽  
pp. 01-10
Author(s):  
Nareman Elhamamy
Keyword(s):  
Birth Weight ◽  
Soft Tissue ◽  
Fetal Weight ◽  
Tissue Thickness ◽  
Femur Length ◽  
Soft Tissue Thickness ◽  
Percent Difference ◽  
Fetal Birth Weight ◽  
Kappa Value ◽  
The Difference

Accurate calculation of fetal weight relies on two equally important factors: the use of a formula with strong intrinsic properties, and the use of sonographic biometric parameters that are not susceptible to errors in measurement. From a statistical perspective, the inclusion of multiple variables in a model improves multicollinearity chances and decreases each measurement's internal error. Precisely predicting estimated fetal weight during childbirth may have a significant impact on successful obstetric management, especially in the case of suspected macrosomia or low birth weight. Macrosomic fetuses can cause maternal and neonatal complications during childbirth, and low-born fetuses are at increased risk for perinatal morbidity and mortality. The main aim of the study was to assess the accuracy of measurement of mid-thigh soft tissue thickness and femur length, in estimation of expected fetal birth weight The study was conducted during the period January 2017 to August 2019, at Tanta University hospitals, Obstetrics & Gynecology department. 65 pregnant ladies at term (between 37-40weeks) were included in the study. Results: Mean difference between fetal weight by Hadlock formulae and actual fetal weight is -10.88g; percent difference is (0.32%). The difference statistically insignificant p>0.05. Mean difference between fetal weight by Scioscia’s formulae and Actual fetal weight is 2.83; the percent difference is (0.08%). The difference statistically insignificant p>0.05. Good agreement between Hadlock formulae and Actual Fetal Weight Kappa value (0.73).Also shows moderate agreement between Scioscia’s formulae and Actual Fetal Weight Kappa value (0.52). area under curve Hadlock formulae (0.79), Scioscia’s formulae (0.78) for detecting fetal weight ≥3500gm among pregnant women at 39-40 weeks of gestation. Conclusion: The mid-thigh soft tissue thickness and femur length can be used in estimation of expected fetal birth weight like as other sonographic parameters. The validity of Scioscia's formulae is not better than Hadlock formulae in detection of fetal weight less than 3500 gm. The validity of both formulae Scioscia's and Hadlock in detection of fetal weight more than 3500 gm. Reduced and cannot be dependable in extremes of weight.

Evening Primrose Oil (Efamol) in the Treatment of Raynaud’s Phenomenon: A Double Blind Study

1985 ◽  
Vol 54 (02) ◽  
pp. 490-494 ◽  
Author(s):  
J J F Belch ◽  
B Shaw ◽  
A O’Dowd ◽  
A Saniabadi ◽  
P Leiberman ◽  
...  
Keyword(s):  
Raynaud’S Phenomenon ◽  
Objective Assessment ◽  
Raynaud's Phenomenon ◽  
Double Blind Study ◽  
Evening Primrose Oil ◽  
Double Blind ◽  
Evening Primrose ◽  
Alternative Approach ◽  
Cold Challenge ◽  
Analogue Scales

SummaryProstaglandin E1 (PGE1) and prostacyclin have been used in Raynaud’s phenomenon (RP) but are unstable and require intravenous administration. An alternative approach is to stimulate the body’s own PGE1 production via administration of the precursor essential fatty acid. We studied the effect of 12 capsules/day of evening primrose oil (EPO) on the manifestations of RP. 21 patients received a two week course of placebo, thereafter 11 received EPO for 8 weeks and 10 patients received placebo. As the weather worsened the placebo group experienced significantly more attacks than the EPO group. Visual analogue scales assessing the severity of attacks and coldness of hands improved in the EPO group. No changes were seen in either group in hand temperatures and cold challenge plethysmography. Blood tests showed some antiplatelet effects of the drug. In conclusion patients receiving EPO benefited symptomatically. This was not matched however by any change in objective assessment of blood flow, although changes in platelet behaviour and blood prostanoids were observed.

Withdrawal of Neuroleptic Medications from Institutionalized Dementia Patients: Results of a Double-Blind, Baseline-Treatment—Controlled Pilot Study

1997 ◽  
Vol 10 (3) ◽  
pp. 119-126 ◽  
Author(s):  
Sarah Bridges-Parlet ◽  
David Knopman ◽  
Susan Steffes
Keyword(s):  
Aggressive Behavior ◽  
Objective Assessment ◽  
Extended Period ◽  
Good Clinical Practice ◽  
Chi Square ◽  
Double Blind ◽  
Term Care ◽  
Dementia Patients ◽  
Significant Difference ◽  
The Difference

Among dementia patients in long-term care facilities, neuroleptics (NL) are frequently prescribed for the treatment of agitation. Although good clinical practice and federal law mandate attempts at withdrawal of these medications, empiric data regarding the cessation of NL treatment are limited in this population. The objective of the present study was to assess through direct observation the effects of short-term NL withdrawal on physically aggressive behavior and other aspects of agitation. We carried out a randomized, double-blind, baseline NL-controlled 4-week trial of the effects of NL withdrawal in 36 institutionalized patients with possible or probable Alzheimer's disease. Patients were directly observed for four 2-hour sessions during baseline, a prerandomization week, and during weeks 1, 2, and 4 of the double-blind portion of the study. Completion of the 4 weeks of double-blind medication and number of observed episodes of physically aggressive behavior (PAB) were the two primary outcome measures. Of the 22 patients who were withdrawn from NL, 20 (91%) completed the 4-week double-blinded withdrawal. Two patients were discontinued from the study due to unacceptable levels of agitation at the request of their nursing staff. Of the 14 patients not withdrawn, all completed the 4-week trial. The chi-square test for the difference between groups was not significant ( P > .05). Based on the observed instances of PAB, there was no significant difference ( P > .05) between withdrawn and not-withdrawn subjects. Half of the withdrawn patients remained off NLs for an extended period of time after the end of the study, even after the blind was broken. Withdrawing institutionalized dementia patients from NLs was successful in most but not all study patients. Generalization of these results is limited by the highly selected nature of the participants. Unmasking of unmanageable agitation and physical aggressiveness in a small minority must be weighed against the benefits of removing unnecessary medication in the majority of dementia patients in whom NL withdrawal is attempted. PAB itself should not drive continuing NL use without regard to objective assessment of efficacy of the NL treatment.

scholarly journals Randomized, Double-Blind, Multicenter Safety and Efficacy Study of Rifalazil Compared with Azithromycin for Treatment of Uncomplicated Genital Chlamydia trachomatis Infection in Women

2014 ◽  
Vol 58 (7) ◽  
pp. 4014-4019 ◽  
Author(s):  
William M. Geisler ◽  
Maria Luz G. Pascual ◽  
Judy Mathew ◽  
William D. Koltun ◽  
Franklin Morgan ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Lower Limit ◽  
Double Blind Study ◽  
Cure Rate ◽  
Double Blind ◽  
Content Type ◽  
Chlamydia Trachomatis Infection ◽  
The Difference ◽  
Number Of Treatment ◽  
Treatment Emergent Adverse Event

ABSTRACTA randomized, double-blind study comparing single-dose chlamydia therapies of oral rifalazil (25 mg) and azithromycin (1 g) was conducted in 82 women with uncomplicated genitalChlamydia trachomatisinfection. The microbiologic cure rate ofC. trachomatiswith rifalazil (n= 33) was 84.8% at the visit on day 22 to 26 (test-of-cure visit), versus 92.1% with azithromycin (n= 38), and the number of treatment failures in each group was 5 and 3, respectively. The difference in cure rate was −7.3%, with a lower limit of the 95% confidence interval (95% CI) of −22.5, and thus, noninferiority was not established at the prespecified margin (lower limit of CI of −15%). The overall treatment-emergent adverse event (TEAE) and treatment-related TEAE rates were lower in the rifalazil group (68% and 55%) than in the azithromycin group (71% and 62%), respectively. Subjects classified as treatment failures at day 22 to 26 had a lower mean plasma concentration of rifalazil at the visit on day 8 to 12 than those classified as treatment cures, but this difference was not significant; however, the levels were similar for both groups at the visit on day 22 to 26. A single 25-mg dose of rifalazil was well tolerated and eradicatedC. trachomatisin most of these women with uncomplicated genitalC. trachomatisinfection. (The study was registered at clinicaltrials.gov under registration no. NCT01631201).

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