scholarly journals Semmes-Weinstein monofilament: A tool to quantify skin sensation in macular lesions for leprosy diagnosis

2021 ◽  
Vol 0 ◽  
pp. 1-9
Author(s):  
Marco Andrey Cipriani Frade ◽  
Dario Júnior de Freitas Rosa ◽  
Fred Bernardes Filho ◽  
John Stewart Spencer ◽  
Norma T. Foss
Keyword(s):  
Clinical Diagnosis ◽  
Operating Characteristic ◽  
Low Cost ◽  
Characteristic Curve ◽  
Sensory Loss ◽  
Double Blind Study ◽  
Double Blind ◽  
Touch Sensitivity ◽  
The Difference ◽  
Altered Sensitivity

Introduction: Hypochromatic macules with altered sensitivity are the first manifestations of skin leprosy. Validation of this sensory loss assists in the confirmation of the clinical diagnosis. Aims: The aim of the study was to quantify the loss of sensation in leprosy lesions using the Semmes-Weinstein monofilament to strengthen the clinical diagnosis mainly of macular forms. Methods: Seventy-four hypochromatic macules in the macular leprosy subgroup, 27 typical borderline leprosy subgroup lesions and 49 macules of other macular dermatoses (non-leprosy group) were evaluated using the 0.05 g force Semmes-Weinstein monofilament to quantify the alteration of sensitivity within and outside of the lesions. The esthesiometric change index was established as the total number of points with altered sensation divided by the total number of tested points within the lesions to calculate the internal esthesiometric change index and outside the lesions to calculate the peripheral esthesiometric change index; these indexes were calculated for all groups. The difference (Δ) between the esthesiometric change indices of the lesional area and the adjacent skin was calculated for the leprosy and nonleprosy groups. Results: The percentage of points with touch sensitivity alterations within the macular and typical borderline leprosy lesions was higher in leprosy than in the non-leprosy group. The borderline and macular leprosy presented higher esthesiometric change index within injured areas than outside injured areas or in the nonleprosy group (P < 0.005). When internal esthesiometric change index values in the macular and borderline leprosy groups were higher than 0.53 and 0.5, respectively, the receiver operating characteristic curve showed 98% sensitivity and approximately 99% specificity for both groups (P < 0.0001). Regarding the difference between indices, borderline and macular leprosy had values that were higher and closer to one than in the nonleprosy group (P < 0.0001), with 100% sensitivity and 96.5% specificity for leprosy diagnosis when ΔLG was higher than 0.34. A limitation was the inability to perform a double-blind study. Conclusion: Semmes-Weinstein esthesiometry is a simple, useful and low-cost tool to quantify the focal alteration of cutaneous sensitivity to improve clinical leprosy diagnosis, especially for macular lesions.

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.

scholarly journals Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025649 ◽  
Author(s):  
Elisabeth Pasquier ◽  
Luc de Saint-Martin ◽  
Gisèle Marhic ◽  
Celine Chauleur ◽  
Caroline Bohec ◽  
...  
Keyword(s):  
Recurrent Miscarriage ◽  
Low Cost ◽  
Controlled Trial ◽  
Oral Treatment ◽  
Safety Data ◽  
Live Birth Rate ◽  
First Trimester ◽  
Double Blind Study ◽  
Double Blind ◽  
Underlying Mechanisms

IntroductionRecurrent miscarriage (RM), defined by three or more consecutive losses during the first trimester of pregnancy, affects 1%–2% of fertile couples. Standard investigations fail to reveal any apparent cause in ~50% of couples. However, on the basis of animal models and clinical studies, several hypotheses have been put forward concerning underlying mechanisms of RM: altered ovarian reserve, progesterone defect, thrombotic and/or endothelial dysfunction and immunological disturbances. Nonetheless, no study has yet reached conclusive beneficial clinical evidence for a potential treatment in unexplained RM. Hydroxychloroquine (HCQ) is a molecule with extensive safety data during pregnancy. The pharmacological properties of HCQ (eg, antithrombotic, vascular protective, immunomodulatory, improved glucose tolerance, lipidlowering and anti-infectious) could be effective against some mechanisms of unexplained RM. Furthermore, eventhough clinical benefit of HCQ is suggested in prevention of thrombotic and late obstetric events in antiphospholipid (APL) syndrome, there are no data suggesting the benefit of HCQ in RM in the presence of APL antibodies.Methods and analysisTaken all together and given the low cost of HCQ, the aim of this multicentre, randomised, placebo-controlled, double-blind study is to investigate whether HCQ would improve the live birth rate in women with RM, irrespective of maternal thrombophilic status: (1) no known thrombophilia, (2) inherited thrombophilia or (3) APL antibodies. The primary end point is a live and viable birth. After confirming eligibility and obtaining consent, 300 non-pregnant women will be randomised into two parallel groups for a daily oral treatment (HCQ 400 mg or placebo), initiated before conception and stopped at 10 weeks’ gestation. If pregnancy does not occur after 1 year, the treatment will be stopped.Ethics and disseminationAgreement from the French National Public Health and Drug Security Agency (160765A-22) and ethical approval from the Committee for the Protection of Persons of NORD-OUEST I (2016-001330-97) have been obtained.Trial registration numbersNCT0316513; Pre-results.

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]

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).

The treatment of depression in general practice: a comparison of L-tryptophan, amitriptyline, and a combination of L-tryptophan and amitriptyline with placebo

1982 ◽  
Vol 12 (4) ◽  
pp. 741-751 ◽  
Author(s):  
Joan Thomson ◽  
H. Rankin ◽  
G. W. Ashcroft ◽  
Celia M. Yates ◽  
Judith K. McQueen ◽  
...  
Keyword(s):  
Depression Scale ◽  
Double Blind Study ◽  
Global Rating ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Groups ◽  
Plasma Tryptophan ◽  
Treatment Of Depression ◽  
Biochemical Profiles ◽  
The Difference

SynopsisOne hundred and fifteen patients from 5 general practices participated in a 12-week, double-blind study comparing L-tryptophan, amitriptyline, L-tryptophan–amitriptyline combination and placebo in the treatment of depression. Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo. Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups. Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active tratment groups, but this difference was not significant. Plasma amitriptyline and nortriptyline levels were similar in the difference was not significant. Plasma amitriptyline and nortriptyline and biochemical profiles did not alter significantly in any group, but mean heart rate was significantly increased in patients receiving amitriptyline. There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms.

scholarly journals Intraoperative pH Is a Reliable Prognostic Factor for Patients With Periampullary Carcinoma Undergoing Pancreaticoduodenectomy

2021 ◽  
Vol 11 ◽  
Author(s):  
Chao Dang ◽  
Min Wang ◽  
Tingmei Wang ◽  
Renyi Qin
Keyword(s):  
Prognostic Factor ◽  
Operating Characteristic ◽  
Ph Value ◽  
Characteristic Curve ◽  
Low Ph ◽  
Periampullary Carcinoma ◽  
Short Term ◽  
The Difference ◽  
Long Term Prognosis

A reliable prognostic factor for periampullary carcinoma is critical to improve surgical outcomes. Intraoperative acidosis reflects the incidence of intraoperative adverse events and impact the prognosis. In this study, 612 patients with periampullary carcinoma who underwent pancreaticoduodenectomy (PD) were divided into high- and low-pH groups according to the cut-off value of receiver operating characteristic curve (7.34). Through statistical analysis of the difference between the high- and low-pH group, it was found that the low-pH group had worse short-term prognosis than the high pH group, and intraoperative pH was an independent prognostic factor for patients with periampullary carcinoma undergoing PD. In addition, patients who underwent laparoscopic pancreaticoduodenectomy had a more alkaline pH after surgery. This is of great help for early judgment of short-term and even long-term prognosis of patients with pancreatic cancer after surgery, and can even guide clinicians to improve prognosis by early adjustment of pH value.

Evaluation of daily breakthrough chemotherapy-induced nausea and vomiting (CINV) rates in a phase III study of NEPA versus an aprepitant (APR)/granisetron (GRAN) regimen.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 120-120 ◽  
Author(s):  
Eric Roeland ◽  
Gary Binder ◽  
Joseph Ma ◽  
Corinna Lanzarotti ◽  
Li Zhang
Keyword(s):  
Statistical Significance ◽  
Secondary Analysis ◽  
Complete Response ◽  
Phase Iii ◽  
Double Blind Study ◽  
Close Monitoring ◽  
Double Blind ◽  
Treatment Groups ◽  
The Difference ◽  
Delayed Phase

120 Background: Antiemetic trials typically evaluate CINV control during acute (Day 1), delayed (Days 2-5), and overall (Days 1-5) phases post-chemotherapy; the daily course of events is often unstudied in the delayed phase. In a head-to-head study evaluating NK1RA-containing regimens, a single dose of NEPA, an oral fixed combination of the NK1RA netupitant and 5-HT3RA palonosetron, was non-inferior to a 3-day regimen of APR and GRAN for overall complete response (no emesis/no rescue use) rates (74% NEPA vs 72% APR/GRAN) in 828 patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). This secondary analysis explores daily rates of breakthrough CINV in this study. Methods: This was a double-blind study in chemotherapy-naïve patients with solid tumors. Daily rates of breakthrough CINV, defined as the % of patients with emesis and/or rescue use were calculated with differences between treatment groups evaluated by the Cochran-Mantel-Haenszel method stratified by sex. Results: While daily rates of patients with breakthrough CINV remained stable between 13%-15.1% for APR/GRAN, they declined from 15.5% to 8% over the 5 days for NEPA, with the difference between groups reaching statistical significance on Day 5 (Table). Percent of total patient days with CINV events were 11.7% [NEPA] and 14.0% [APR/GRAN]. The % of patients with ≥ 3 days of breakthrough CINV were 8.5% and 12.3%, respectively. Conclusions: In this study evaluating guideline-recommended antiemetic regimens for HEC, CINV was prevented in most patients during the overall phase yet breakthrough CINV on individual days differed between treatment groups. APR/GRAN showed a relatively constant rate over time, while NEPA rates decreased and patients had fewer total days with breakthrough. This suggests the need for close monitoring of CINV events during the delayed phase. [Table: see text]

scholarly journals Comparison between low cost USB nailfold capillaroscopy and videocapillaroscopy: a pilot study

Rheumatology ◽  
2020 ◽  
Author(s):  
Michael Berks ◽  
Graham Dinsdale ◽  
Elizabeth Marjanovic ◽  
Andrea Murray ◽  
Chris Taylor ◽  
...  
Keyword(s):  
Pilot Study ◽  
Receiver Operating Characteristic Curve ◽  
Receiver Operating Characteristic ◽  
Standard Error ◽  
Operating Characteristic ◽  
Low Cost ◽  
Characteristic Curve ◽  
Microscope Images ◽  
Operating Characteristic Curve ◽  
Receiver Operating

Abstract Objectives Universal serial bus (USB) microscopy (capillaroscopy) could provide all rheumatologists with an easy-to-use, low-cost tool to examine the nailfold capillaries to facilitate early diagnosis of SSc. The objectives of this pilot study were to examine the feasibility of acquiring and analysing images using USB microscopy and to compare results to videocapillaroscopy. Methods Videocapillaroscopy and USB microscope images were obtained from the right and left ring fingers of 20 patients with SSc and 20 healthy control subjects. In addition to generating panoramic capillary mosaics from across the whole nailbed, custom software made fully automated measurements of vessel structure including capillary width and density. The area under the receiver operating characteristic curve (AZ) was used to measure separation between the SSc and healthy control groups. Results High quality images could be generated from the USB microscope, with reconstructed USB images comparing very favourably with those obtained using videocapillaroscopy. Using USB microscope images, the receiver operating characteristic curve AZ for group separation based on mean width was 0.81 (standard error 0.120) compared with 0.81 (standard error 0.095) for the (gold standard) videocapillaroscopy. The receiver operating characteristic curve AZ for group separation using capillary density was 0.48 (standard error 0.16) for USB microscope images, compared with 0.70 (standard error 0.10) for videocapillaroscopy. Conclusion In this pilot study, USB capillaroscopy was able to discriminate between patients with SSc and controls as well as videocapillaroscopy on the basis of capillary width. This finding, together with the high-quality images obtained, highlights the potential of USB capillaroscopy as a low-cost, easily accessible clinical and research tool.

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.

Sign in / Sign up

Export Citation Format

Share Document