scholarly journals A Randomized Open Labeled Parallel Group Study to Compare the Efficacy and Safety of Topical Terbinafine and Miconazole in Patients with Tinea Corporis

2021 ◽  
Vol 14 (02) ◽  
pp. 1077-1086
Author(s):  
Prince Ekisha Gideon ◽  
Alphienes Stanley Xavier ◽  
Punnagai Kumaravelu ◽  
Darling Chellathai David
Keyword(s):  
Global Assessment ◽  
Statistical Significance ◽  
Tinea Corporis ◽  
Composite Score ◽  
Successful Outcome ◽  
P Value ◽  
Physician Global Assessment ◽  
Efficacy And Safety ◽  
Mycological Cure

Topical preparations of allylamines and imidazoles are the commonly used medications for the treatment of tinea corporis, having extended efficacy and good safety profile. In our study, we have compared topical terbinafine, an allylamine and topical miconazole, which is an imidazole to assess their efficacy and safety in tinea corporis infection. Hundred patients with tinea corporis infection were equally randomized to receive either terbinafine (1%) or miconazole (2%) for 4 weeks. The reduction in clinical symptoms (pruritus, erythema, vesicle, and desquamation), attaining mycological cure, reduction in composite score, as well as physician global assessment were evaluated from baseline to the end of intervention, and at follow up visit, and compared between the groups. Incidence of adverse drug reactions was also noted for safety analysis. Baseline demographic characteristics of terbinafine and miconazole groups were similar. The study demonstrated statistical significance reduction in clinical symptom scores, attaining Mycological cure, composite score and Physician Global Assessment from baseline to 4th week and follow up week between both groups with a p value <0.05. Compared to terbinafine group, patients received miconazole as intervention had significant successful outcome at the end of treatment (4 weeks) and during the follow-up visit at 5 weeks. Topical miconazole is found to be better and an ideal drug in patients with tinea corporis for the improvement in clinical cure and successful treatment outcome compared to topical terbinafine. Both the drugs are well tolerated drug with the incidence of side effects like itching, irritation, dryness which are comparatively lesser in miconazole group.

scholarly journals Comparable Efficacy of Terbinafine and Itraconazole in the Treatment of Tinea Pedis

2013 ◽  
Vol 21 (2) ◽  
pp. 74-79
Author(s):  
Md Abdul Wahab ◽  
Mohammad Jamal Uddin ◽  
Biswas Shahen Hassan ◽  
Md Zafrul Islam ◽  
Ishrat Bhuiyan ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Tinea Pedis ◽  
Comparable Efficacy ◽  
P Value ◽  
Mycological Cure ◽  
Efficacy Analysis ◽  
Group A ◽  
Group B

Background: Tinea pedis (athlet’s foot) is the most common fungal infection. Relapse is common in tinea pedis and may be result of recurrence following inadequate treatment or reinfection. Objective: To evaluate the comparable efficacy of terbinafine and itraconazole in the treatment of tinea pedis. Methods: 120 patients of tinea pedis confirmed by KOH microscopy were included in the study. The study was carried out in three different Hospitals and Private Chambers for a period of 3 years from July 2006 to June 2009. Mean age of the patients was 40.28±10.23. The patients were devided into 2 equal group:A & B. Group- A was given terbinafine 250 mg/day and group-B was given intraconazole 200 mg/day for 2 weeks. Results: Follow up 2 weeks after cessation of therapy revealed clinical and mycological cure of 93.3% in terbinafine group and 86.6% in itraconazole group. Conclusion: Efficacy analysis revealed that terbinafine is superior than itraconazole in the treatment of tinea pedis (P value 0.224). DOI: http://dx.doi.org/10.3329/bjmed.v21i2.13615 Bangladesh J Medicine 2010; 21: 74-79

Role of ctDNA to predict risk of recurrence following potentially curative resection of biliary tract and pancreatic malignancies.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 336-336
Author(s):  
Angela Lamarca ◽  
Mairead Geraldine McNamara ◽  
Richard Hubner ◽  
Juan W. Valle
Keyword(s):  
Relapse Rate ◽  
Curative Resection ◽  
Cox Regression ◽  
Statistical Significance ◽  
Molecular Profiling ◽  
P Value ◽  
Relapse Risk ◽  
Baseline Characteristics

336 Background: The potential role of ctDNA to identify residual disease after potentially curative resection has been suggested in some malignancies; its role in resected pancreatico(P)-biliary(B) malignancies is unknown. Methods: Patients diagnosed with PB malignancies underwent molecular profiling (ctDNA) using FoundationMedicine Liquid (72 cancer-related genes) following potentially curative resection. Baseline patient characteristics and molecular profiling outcomes, including mutant allele frequency (MAF) for pathological alterations were extracted. Primary objective: prevalence of ctDNA identification and its correlation with recurrence (relapse-free survival (RFS) and relapse rate). Results: Total of 11 individuals had ctDNA analysed following potentially curative resection for PB malignancies: 8 B (4 extra-hepatic cholangiocarcinoma (eCCA), 2 ampulla, 1 intrahepatic cholangiocarcinoma (iCCA), 1 gallbladder cancer (GBC)) and 3 P. Baseline characteristics: 6 female (54.55%), median age 71.59 years (range 39.98-81.19). Most were pT2 (45.45%), pN0 (54.55%) and R0 (63.64%). Following surgery, 6 patients were started on adjuvant chemotherapy; at the end of follow-up (data cut-off 25/6/2020; median follow-up 11.15 months (range 5.45-13.52); 5 relapsed (45.45%) and 2 died (18.18%). Estimated median RFS was 11.43 months (95% CI 2.28-not reached); median overall survival was not reached. No sample failed ctDNA analysis; presence of ctDNA was identified in 3/11 (27.27%) of the samples; 2 and 1 samples had 2 and 1 pathological alterations identified, respectively: ALK fusion (1 sample; GBC), TP53 mutation (2 samples; eCCA and GBC), CHEK2 mutation (1 sample; pancreas), IDH2 mutation (1 sample; eCCA). Mean maximum MAF was 1.47 (2 in biliary; 0.43 in pancreas). Variants of unknown significance were identified in 72.73% of the samples (87.5% in B; 33.33% in P; p-value 0.152). None of the baseline characteristics explored correlated with presence of ctDNA. There was a trend towards increased relapse risk in the patients with ctDNA present following potentially curative surgery; Cox regression for RFS [HR 2.64 (95% CI 0.36-19.31); median RFS 11.44 months (95% CI 2.28-not reached) vs 10.87 (95% CI 2.21-not reached)]; relapse rate 37.5% (ctDNA absent) vs 66.67% (ctDNA present); statistical significance was not reached (p-value 0.340 and p-value 0.545, respectively). Conclusions: This pilot study demonstrates the feasibility of testing for ctDNA following potentially curative resection in PB malignancies. Presence of ctDNA may be associated with increased relapse risk; further studies are required to increase sample size and assess clinical implications.

scholarly journals Long-Term Postoperative Total Knee Arthroplasty Flexion Scores in Relation to Body Mass Index

2020 ◽  
Author(s):  
Matthew A. Siegel ◽  
Michael J. Patetta ◽  
Angie M. Fuentes ◽  
Armaan S. Haleem ◽  
Craig W. Forsthoefel ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Total Knee Arthroplasty ◽  
Body Mass ◽  
Knee Arthroplasty ◽  
Statistical Significance ◽  
P Value ◽  
Preoperative Body Mass Index ◽  
Total Knee

AbstractKnee range of motion (ROM) is an important postoperative measure of total knee arthroplasty (TKA). There is conflicting literature whether patients who are obese have worse absolute ROM outcomes than patients who are not obese. This study analyzed whether preoperative body mass index (BMI) influences knee ROM after patients' primary TKA. A retrospective investigation was performed on patients, who underwent primary TKA at an academic institution, by one of three fellowship-trained adult reconstruction surgeons. Patients were stratified according to their preoperative BMI into nonobese (BMI < 30.0 kg/m2) and obese (BMI ≥ 30.0 kg/m2) classifications. Passive ROM was assessed preoperatively as well as postoperatively at patients' most recent follow-up visit that was greater than 2 years. Mann–Whitney U tests were performed to determine statistical significance at p-value <0.05 for ROM outcomes. No statistically significant differences were observed when ROM in the nonobese group was compared with ROM in the obese group both preoperatively (105.73 ± 11.58 vs. 104.14 ± 13.58 degrees, p-value = 0.417) and postoperatively (105.83 ± 14.19 vs. 104.49 ± 13.52 degrees, p-value = 0.777). Mean follow-up time for all patients was 4.49 ± 1.92 years. In conclusion, long-term postoperative ROM outcomes were similar between patients who were nonobese and patients who were obese.

Combination anti-PD-1 and ipilimumab (ipi) therapy in patients with advanced melanoma and pre-existing autoimmune disorders (AD).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10026-10026
Author(s):  
Lauren Julia Brown ◽  
Alison Weppler ◽  
Prachi Bhave ◽  
Clara Allayous ◽  
James Randall Patrinely ◽  
...  
Keyword(s):  
Single Agent ◽  
Advanced Melanoma ◽  
Duodenal Perforation ◽  
P Value ◽  
Efficacy And Safety ◽  
Safety And Efficacy ◽  
Toxicity Risk ◽  
Substantial Risk ◽  
Inflammatory Bowel

10026 Background: Clinical trials of immunotherapy exclude patients (pts) with pre-existing AD. While retrospective data exist regarding the efficacy and safety of single agent ipi and anti-PD1 antibodies (PD1) in pts with AD, no data are available regarding the safety and efficacy of combination therapy in pts with AD, which has a higher toxicity risk. Methods: Pts with melanoma and pre-existing AD treated with combination ipi/PD1 were retrospectively identified from 10 international centres. Data regarding AD, treatment, toxicity and outcomes were examined. Results: Fifty-five pts were included, 46 were treated with ipi/nivolumab and 9 with ipi/pembrolizumab. 40 had an ipi dose of 3mg/kg while 15 had a lower dose regimen. 9 pts received prior PD1 therapy; 3 suffered moderate immune-related adverse events (irAE) with no flares of AD on single agent PD1. Pre-existing AD included inflammatory bowel disease (IBD), thyroiditis, rheumatoid arthritis (RA), multiple sclerosis and psoriasis. 10 pts had active symptoms of AD and 13 were immunosuppressed at commencement of ipi/PD1. Eighteen pts (33%) experienced a flare of their AD including 4/7 with RA, 3/6 with psoriasis, 5/9 with IBD, 3/18 with thyroiditis, 1/1 with Sjogren’s syndrome, 1/1 with polymyalgia, 1/1 with Behcet’s syndrome. Median time to flare was 19 days (range 4 – 167). 13 pts were managed with steroids, 5 required additional immunosuppressants. 7 pts were hospitalised for management of flare (5 with IBD, 2 with RA). 2 pts required intensive care and vasopressors for severe IBD flare, quiescent prior to ipi/PD1. One for diarrhoea and shock and one for duodenal perforation. 8 pts ceased treatment due to flare (3 with IBD, 2 with RA, 1 with Behcet’s, 1 with Sjogren’s). Thirty-seven pts (67%), experienced an irAE unrelated to their AD, 38% G3 or G4. The most frequent irAEs were colitis (n = 16), hepatitis (n = 12), endocrinopathies (n = 12), with 13 pts experiencing an irAE in ≥ 2 organs. 9 pts experienced both AD flare and an irAE. 20 pts (36%) ceased immunotherapy due to irAEs. ORR was 55% (54% in PD1 naive pts), at a median follow up of 14 months, 77% of responses ongoing. ORR in pts who had a flare of their AD was 44% and in pts on immunosuppression was 46%. Median PFS was shorter in pts who had a flare of AD compared with those who did not (2.6 vs 9 months; P-value 0.047). Conclusions: Combination ipi/PD1 shows efficacy comparable to clinical trial populations in pts with pre-existing AD and advanced melanoma. Whilst there was a substantial risk of flare of AD, no increased frequency of irAE’s was observed.

scholarly journals Primary intra-articular osteotomy for varus malunion of the medial condyle of the tibial plateau

2020 ◽  
Vol 6 (2) ◽  
pp. 360
Author(s):  
Jeremy Bliss ◽  
Dan Barnabas Inja ◽  
Manasseh Nithyananth ◽  
Vinoo Mathew Cherian
Keyword(s):  
Functional Outcome ◽  
Tibial Plateau ◽  
Statistical Significance ◽  
P Value ◽  
Medial Condyle ◽  
Medial Condyle Fracture ◽  
Excellent Functional Outcome ◽  
Male Patients ◽  
Condyle Fracture

<p class="abstract"><strong>Background:</strong> Reconstructive operative procedures for post-traumatic deformities of the tibial plateau have been described in literature, though rarely. We report short term follow-up of eleven such cases of primary intra-articular osteotomy.</p><p class="abstract"><strong>Methods:</strong> From 2005 through 2011, a primary intra-articular osteotomy for varus malunion of the medial condyle of the tibial plateau was performed in eleven consecutive cases. The patients were assessed clinically and radiologically at a minimum of 28 months post-operatively. The functional outcome was assessed using Rasmussen score.  Paired ‘t’ test was used to determine the statistical significance.<strong></strong></p><p class="abstract"><strong>Results:</strong> There were eleven male patients. Average follow up was 59 months (range 28 to 159). Articular congruity was restored to acceptable in all patients and varus malalignment was corrected from a mean of 1.5 degrees varus to 5.7 degrees of valgus (statistically significant, two-tailed P value of 0.0056) to an extent comparable to the normal side (mean 5.8 degrees). There were no infections. All patients had good to excellent functional outcome.</p><p class="abstract"><strong>Conclusions:</strong> A primary intra-articular osteotomy and osteosynthesis for malunited medial condyle fracture of the tibial plateau would help to restore mechanical alignment and improve functional outcome.</p>

P543Cardiac resynchronization therapy in left ventricular non-compaction: long-term results in a series of 40 patients

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
D A Radu ◽  
C N Iorgulescu ◽  
S N Bogdan ◽  
A I Deaconu ◽  
A Badiul ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Systolic Dysfunction ◽  
Serum Levels ◽  
Left Ventricular ◽  
Long Term Results ◽  
P Value ◽  
P Values ◽  
Mean Differences

Abstract Background Left ventricular non-compaction (LVNC) is a structural cardiomyopathy (SC) with a high probability of LV systolic dysfunction. Left bundle branch block (LBBB) frequently occurs in SCs. Purpose We sought to analyse the evolution of LVNC-CRT (LC) patients in general and compare it with the non-LVNC-CRT group (nLC). Methods We analysed 40 patients with contrast-MRI documented LVNC (concomitant positive Petersen and Jacquier criteria) implanted with CRT devices in CEHB. The follow-up included 7 hospital visits for each patient (between baseline and 3 years). Demographics, risk factors, usual serum levels, pre-procedural planning factors, clinical, ECG, TTE and biochemical markers were recorded. Statistical analysis was performed using software. Notable differences were reported as either p-values from crosstabs (discrete) or mean differences, p-values and confidence intervals from t-tests (continuous). A p-value of .05 was chosen for statistical significance (SS). Results Subjects in LC were younger (-7.52 ys; &lt;.000; (-3.617;-11.440)), with no sex predominance, more obese (45.9 vs. 28.3%; &lt;0.24) and had less ischaemic disease (17.9 vs. 39.7%; &lt;.007). LC implants were usually CRT-Ds (91 vs. 49.5%; &lt;.000) and more frequently MPP-ready (35.8 vs. 8.4%; &lt;.000). At baseline, sinus rhythm was predominant in LC (97.4 vs. 79.8%; &lt;.007) and permitted frequent use of optimal fusion CRT (75.5 vs. 46.6%; &lt;.002). Although initial LVEFs were similar, LCs had much larger EDVs (+48.91 ml; &lt;.020; (+7.705;+90.124)) and ESVs (+34.91; &lt;.05; (+1.657;+71.478)). After an initial encouraging ⁓ 1 year evolution the LC-CRT group crashed its performance in terms of both LVEF and volumes. Thus, at 1 year follow-up, when compared to nLCs, LVEFs were far lower (-22.02%; &lt;.000; (-32.29;-11.76)) while EDVs and ESVs much higher – (+70.8 ml; &lt;.037; (+49.27;+ 189.65)) and (+100.13; &lt;.039; (+5.25;+195)) respectively – in LCs in spite of similarly corrected dyssynchrony. The mean mitral regurgitation (MR) degree at 1 year was much higher in LCs (+1.8 classes; &lt;.002; (+0.69;+2.97)) certainly contributing to the poor results. The cumulated super-responder/responder (SR/R) rates were constantly lower and decreasing at both 1 year (37.5 vs. 72.4; &lt;.040) and 2 years of follow-up (10.1 vs. 80%; NS). Conclusions CRT candidates with LVNC are significantly more severe at the time of implant. After an initial short-term improvement (probably due to acute correction of dyssynchrony) most patients fail to respond in the long term. Severe dilation with important secondary MR probably plays an important role.

The Fragility of Statistical Significance in Patellofemoral Instability Research: A Systematic Review

2021 ◽  
pp. 036354652110392
Author(s):  
Michael Constant ◽  
David P. Trofa ◽  
Bryan M. Saltzman ◽  
Christopher S. Ahmad ◽  
Xinning Li ◽  
...  
Keyword(s):  
Systematic Review ◽  
Statistical Significance ◽  
Patellofemoral Instability ◽  
Fragility Analysis ◽  
P Value ◽  
Level Of Evidence ◽  
Pubmed Database ◽  
Orthopaedic Literature ◽  
Comparative Trials

Background: Fragility analysis is increasingly utilized to evaluate the robustness of results within the orthopaedic literature and has frequently revealed instability of reported outcomes. Purpose/Hypothesis: The purpose of this investigation was to utilize a fragility analysis to evaluate the stability of reported results in the patellofemoral instability (PFI) literature. We hypothesized the demonstration of significant fragility in patellofemoral research to be similar to that identified throughout other areas of the orthopaedic literature. Study Design: Systematic review; Level of evidence, 4. Methods: The PubMed database was queried from January 1, 2000, to October 10, 2020 for comparative trials in 10 prominent orthopaedic journals that reported dichotomous outcomes related to the management of PFI. The fragility index (FI) and the fragility quotient (FQ) were calculated for each individual outcome event, and the overall FI and FQ were determined for all included studies. Results: A total of 22 comparative studies comprising 11 randomized controlled trials and 11 nonrandomized trials were included for the analysis. A total of 75 outcome events underwent a fragility analysis and revealed a median FI and FQ of 3 (interquartile range [IQR], 1-5) and 0.043 (IQR, 0.018-0.081), respectively. Also 27% of included studies reported loss to follow-up greater than the overall FI, therefore suggesting the maintenance of the follow-up may have resulted in the reversal of significance. Conclusion: The result of the comprehensive fragility analysis demonstrated a lack of robustness in PFI research with the alteration of only a few outcome events required to reverse statistical significance. We therefore recommend the triple reporting of the P value, the FI, and the FQ to aid in the interpretation of the statistical integrity of future comparative trials in the PFI literature.

Analysis of robustness of the landmark Cardiovascular outcome trials of antidiabetic drugs – A systematic review

2021 ◽  
Vol 17 ◽  
Author(s):  
Debdipta Bose ◽  
Mahanjit Konwar
Keyword(s):  
Statistical Significance ◽  
Rank Correlation ◽  
Primary Objective ◽  
Antidiabetic Drugs ◽  
Cardiovascular Outcome ◽  
P Value ◽  
Fragility Index ◽  
Cardiovascular Outcome Trials ◽  
Lost To Follow Up

Background: It is essential for Randomized controlled trials [RCTs] to report its results in a comprehensive manner. Hence, it is necessary to assess the robustness of the trials with statistically significant and as well as non-significant results. Robustness can be evaluated using fragility index (FI) and reverse fragility index [RFI] is for trials with statistically significant and as well as non-significant results. The primary aim of this study was to calculate FI and RFI for cardiovascular outcome trials [CVOT]. Materials & Methods: PubMed/MEDLINE was searched to identify all RCTs of antidiabetic drugs where the primary objective was to evaluate the cardiovascular outcomes. We recorded the trial characteristics of each CVOT trial. The FI, RFI, Fragility quotient [FQ] and reverse fragility quotient [FQ] was calculated to evaluate the robustness of the trials. Spearman rank correlation test was used for correlation. Findings: A total of 889 studies were identified and 24 RCTs was included. Among the 24 trials, 12 [50%] trials achieved statistical significance. The median FI and RFI were 29 [4-12] and 22.5 [1-37] for trials with statistically significant and non-significant results. The median FQ and RFQ were 0.0075 [0.002-0.013] and 0.0003 [0.0001-0.004] for trials with statistically significant and non-significant results. The hazard ratio, p value and NNT-B had strong negative relation with FI. Interpretation: Our study showed that half of the trials showing superiority of cardioprotective benefits have favourable FI. The trials failed to show superiority also have a reasonable RFI indicating the robustness of these trials. But the results pf the trials where patients lost to follow-up exceed the FI of that trial demands caution during interpretation.

scholarly journals Efficacy and safety of adalimumab by intra-articular injection for moderate to severe knee osteoarthritis: An open-label randomized controlled trial

2017 ◽  
Vol 46 (1) ◽  
pp. 326-334 ◽  
Author(s):  
Jianping Wang
Keyword(s):  
Knee Osteoarthritis ◽  
Global Assessment ◽  
Controlled Trial ◽  
Womac Pain ◽  
Physician Global Assessment ◽  
Efficacy And Safety ◽  
Open Label ◽  
Womac Pain Score ◽  
Physical Function Score ◽  
Pain Visual Analog Scale

Objective To evaluate the efficacy and safety of adalimumab (ADA) versus hyaluronic acid (HA) by intra-articular injection for moderate to severe knee osteoarthritis. Methods Fifty-six consecutive patients with moderate to severe knee osteoarthritis were randomly allocated to either the ADA group or HA group. On day 0, patients in the ADA group received 10 mg of ADA by intra-articular injection, while those in the HA group received 25 mg of HA. All patients received celecoxib at 200 mg/day for 4 weeks. The pain visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Patient Global Assessment (PGA), and Physician Global Assessment (PhGA) scores were assessed. Results At baseline, the pain VAS, WOMAC, PGA, and PhGA scores were similar between the two groups. The decrease in the pain VAS score, WOMAC pain score, WOMAC physical function score, and WOMAC total score from baseline to week 4 were greater in the ADA than HA group. A greater decrease in the PGA and PhGA scores from baseline to week 4 was noted in the ADA than HA group. No difference in adverse events was observed between the two groups. Conclusion ADA by intra-articular injection was effective and tolerated for moderate to severe knee osteoarthritis.

scholarly journals Long-term results of endonasal dacryocystorhinostomy with and without stenting

2013 ◽  
Vol 95 (3) ◽  
pp. 196-199 ◽  
Author(s):  
SH Mohamad ◽  
I Khan ◽  
M Shakeel ◽  
V Nandapalan
Keyword(s):  
Success Rate ◽  
Statistical Significance ◽  
Case Series ◽  
Senior Author ◽  
Long Term Results ◽  
P Value ◽  
Stent Group ◽  
Chi Squared

Introduction This study aimed to evaluate the short and long-term results of endoscopic dacryocystorhinostomy (DCR) with and without silicone stenting in chronic dacrocystorhinitis due to postsaccal blockage. Methods The study involved a case series of consecutive 89 patients (128 eyes) who underwent endoscopic DCR. All patients were operated on by the senior author. The stent group comprised 63 eyes (44 patients), for which the DCR was performed between September 2002 and September 2005. The non-stent group with 65 eyes (45 patients) underwent the DCR between October 2005 and December 2006. The follow-up duration was up to 33 months after surgery. The statistical significance (p-value) was calculated using the chi-squared test. Results The short-term success rate at six months’ follow-up was 70% in the stent group and 97% in the non-stent group (p=0.0005) while the long-term success rate at 33 months was only 57% in stent group compared with 89% in the non-stent group (p=0.0003). Conclusions In this study, the non-stent group showed a higher success rate than the stent group on both short and longterm follow-up. Our study suggests that postoperative stents are not necessary for primary DCR and may be associated with a worse outcome.

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