Efficacy of imiquimod in the management of lentigo maligna.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10074-10074
Author(s):  
Brigitte Dréno ◽  
Monica Dinulescu ◽  
Jean-Michel NGuyen ◽  
Hevé Maillard ◽  
Florence Le Duff ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Surgical Excision ◽  
Phase Iii ◽  
P Value ◽  
Lentigo Maligna ◽  
International Consensus ◽  
Main Challenge ◽  
Significant Difference ◽  
The Face ◽  
Beta Risk

10074 Background: Lentigo maligna (LM), a melanocytic proliferation occurring on photoexposed skin, might progress to LM melanoma. Surgery is recommended as first-line treatment. However, the main challenge is the size of the excision inducing often-aesthetic injuries on the face and thus often refused by patients. The excision margins of 5 to 10 mm remain without international consensus. Several studies have shown that imiquimod induced LM regression, acting by enhancing IFN-γ production and effector function of T cells. The main goal of this study is to investigate the effect of imiquimod versus placebo in neoadjuvant setting to decrease the excision size as from the first surgical procedure. Methods: We performed a prospective, randomized, open, multicenter, phase III clinical study (NCT01720407). The health authority and ethics committee approvals were obtained and all subjects signed an informed consent. The primary endpoint was to demonstrate that in neoadjuvant situation, imiquimod could reduce the surgical excision size of LM with a healthy tissue margin of 5 mm. The main inclusion criteria were: Patients > 18 years fit for surgery. LM of the head histologically confirmed and not previously treated. Surface lesion ≥ to 1cm² and ≤ to 20cm². The two treatment arms were imiquimod or placebo followed by LM excision. Imiquimod or placebo were applied once daily, 5 days/week for 4 weeks followed by 5 mm margin surgery performed four weeks after the last treatment application. For sample size, 268 patients were expected to demonstrate a difference of 15% between the two arms in a bilateral situation with an alpha risk of 5% and a beta risk of 20%. Results: The trial involved 273 patients, 238 (105 men (44%) and 133 women (56%), mean age of 71 ± 10.2 years, were analyzed in modified ITT. Statistical analysis was performed on 122 patients in the imiquimod arm and 116 patients in the placebo arm. For the primary endpoint, the first extralesionnal excision has been achieved for 112 (91.8%) patients in the imiquimod arm and for 98 (84.5%) placebo patients group. There was no significant difference (p value = 0.1067) between the two arms. However, regarding the surface of LM, imiquimod allowed a highly significant reduction (4.2 cm² ± 4.6 to 2.3 cm² ± 3.3) compared to LM treated by placebo (4.0 cm² ± 3.5 to 4.0 cm² ±3.3; p < 0.0001). Conclusions: This randomized prospective study shows that imiquimod reduces the LM area (-50%) after one month of treatment. Reducing the surface of LM with imiquimod is not associated with a higher risk of intralesional excision (marge 5mm), with a significant esthetic result (less excised surface). Clinical trial information: NCT01720407.

Q-TWiST analysis of tivozanib (T) versus sorafenib (S) in patients with advanced renal cell carcinoma (RCC) in the TIVO-3 study.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 298-298
Author(s):  
Michael Szarek ◽  
Michael N. Needle ◽  
Brian I. Rini ◽  
Sumanta K. Pal ◽  
David F. McDermott ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Phase Iii ◽  
P Value ◽  
Patient Centered ◽  
Health States ◽  
Significant Difference ◽  
Phase Iii Study ◽  
The Difference ◽  
Similar Survival ◽  
Mean Differences

298 Background: In the randomized phase III study TIVO-3, the VEGFR-TKI tivozanib (TIVO) increased progression-free survival with better tolerability but no difference in overall survival (OS) relative to sorafenib (SORA) as third- or fourth-line therapy in patients with metastatic RCC. These results provide motivation to apply quality-adjusted time without symptoms of disease and toxicity (Q-TWiST) methods to quantify the net health benefits of TIVO, in the presence of similar survival, when compared to SORA. Methods: In application of Q-TWiST, patient-level OS was subdivided into three mutually exclusive states: time with toxicity (TOX), time without symptoms and toxicity (TWiST), and time after progression/relapse (REL). Mean Q-TWiST was calculated by applying utility coefficients of 0.5, 1.0, and 0.5 to the restricted mean (max 36 months follow-up) health states of TOX, TWiST, and REL, respectively; 95% CIs for the means and mean differences were estimated by bootstrap distributions. Relative Q-TWiST gain was defined as the mean absolute Q-TWiST difference divided by the SORA mean OS. Results: Mean TWiST was significantly longer for TIVO than for SORA (10.30 months v.5.35 months; Table). Mean REL time was significantly shorter for TIVO, with no difference in mean TOX time. Mean Q-TWiST was 15.04 and 12.78 months for TIVO and SORA, respectively, a statistically significant difference (p=0.0493). The relative gain for TIVO was 11.2%. Clinical trial information: NCT02627963 . Values in table are mean (95% CI) in months or p-value for difference in treatment group means. Conclusions: The difference in Q-TWiST in TIVO-3 was primarily driven by benefits of TIVO in TWiST, partially offset by superiority of SORA in REL time. As a third- or fourth-line treatment for RCC, TIVO significantly increased Q-TWiST relative to SORA, primarily through an increase in TWiST, which is generally considered to be the state with highest utility to patients. Consequently, Q-TWiST may be considered an alternative patient-centered measure of benefit of TIVO in these settings. [Table: see text]

Automatic Item Generation for Elementary Logic Quizzes via Markov Logic Networks

2016 ◽  
pp. 177-186
Author(s):  
Davor Lauc ◽  
Nina Grgić Hlača ◽  
Sandro Skansi
Keyword(s):  
Expert Assessment ◽  
P Value ◽  
Markov Logic ◽  
Exam Preparation ◽  
Main Challenge ◽  
Initial Learning ◽  
Significant Difference ◽  
Automatic Item Generation ◽  
Markov Logic Network ◽  
Learning Data

The aim of this chapter is to present an exam preparation system designed to generate exams for propositional logic. The main challenge was to determine a filter to single out relevant problems. An expert assessment was used to generate initial learning data for Markov Logic Network and then the result was analyzed in terms of evaluation conducted on students. The results point out that there is no significant difference (p-value of 0.2708) between problems prepared by a human examiner and problems generated.

A prospective randomized phase III trial of adjuvant chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with stage II colon cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4052-4052
Author(s):  
W. Schippinger ◽  
H. Samonigg ◽  
R. Greil ◽  
J. Tschmelitsch ◽  
G. Steger ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Lower Risk ◽  
Stage Ii ◽  
Phase Iii ◽  
Disease Relapse ◽  
Chi Square ◽  
Significant Difference ◽  
Stage Ii Colon Cancer

4052 Background: Whereas several studies showed adjuvant chemotherapy to improve survival of patients with stage III colon cancer, survival benefit from adjuvant treatment in patients with stage II disease is a matter of controversy. Methods: Patients with curatively resected stage II colon cancer (T3–4, N0, M0) according to UICC were randomized to either adjuvant chemotherapy with 5-FU/LV (100 mg/m2 LV + 450 mg/m2 5-FU weekly, w 1–6, in 8 w cycles x 7) or surveillance only. Primary endpoint was overall survival (OS) with 636 patients originally planned to demonstrate a difference in OS of 10% with 85% power and alfa =0.05 in a final analysis 7 years after study initiation. After accrual of 535 patients between 11/1993 and 6/2003, recruitment was stopped ahead of schedule for low accrual rates. Results: 505 patients were eligible and evaluable for analyses. After a median follow-up of 96 months, 56 (21.8%) patients have died in the 5-FU/LV arm and 58 (23.4%) in the surveillance arm. There was no statistically significant difference in OS between the two treatment arms (HR 1.137, 95% CI 0.787–1.641, p=0.4947, chi square), thus the primary endpoint of the study was not met. Disease relapse was documented in 35 (13.6%) patients of the chemotherapy arm and in 48 (19.4%) patients of the control arm. The relative risk for disease relapse was higher for patients in the surveillance arm compared to patients in the 5-FU/LV arm, however, this difference was statistically not significant (HR 1.506, 95% CI 0.974–2.328, p=0.0657, chi square). Subgroup analysis including in the chemotherapy arm only patients who received at least one cycle of 5-FU/LV (n=250), showed a statistically significantly lower risk for relapse in patients treated with 5- FU/LV (HR 1.559, 95% CI 1.001–2.429, p=0.0477, chi square). Conclusions: Results of this trial demonstrate a trend to a lower risk for relapse in patients treated with adjuvant 5-FU/LV for stage II colon cancer. However, adjuvant chemotherapy did not significantly improve DFS and OS. No significant financial relationships to disclose.

Carboplatin (C) plus paclitaxel (P) versus carboplatin plus pegylated liposomal doxorubicin (PLD) in patients with advanced ovarian cancer (AOC): Final analysis of the MITO-2 randomized multicenter trial.

2010 ◽  
Vol 28 (18_suppl) ◽  
pp. LBA5033-LBA5033 ◽  
Author(s):  
S. Pignata ◽  
G. Scambia ◽  
A. Savarese ◽  
R. Sorio ◽  
E. Breda ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Response Rate ◽  
Multivariable Analysis ◽  
Advanced Ovarian Cancer ◽  
Final Analysis ◽  
Phase Iii ◽  
P Value ◽  
First Line ◽  
Significant Difference ◽  
Line Chemotherapy

LBA5033 Background: CP is standard first-line chemotherapy for AOC. MITO-2 (Multicentre Italian Trials in Ovarian Cancer) is an academic multicenter randomized phase III study, testing whether C-PLD is more effective than CP. Methods: AOC chemo-naïve patients (pts), stage IC-IV, aged≤75, ECOG PS≤2, were randomized to CP (C AUC5 + P 175 mg/m2,d1q3w) or to C-PLD (C AUC5 + PLD 30 mg/m2,d1q3w), both for 6 cycles. Primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), response rate, toxicity and quality of life (QoL). To have 80% power in detecting a 0.80 HR in PFS, with 2-sided α error 0.05, 632 events were needed and 820 pts were planned. Response rate and toxicity have been reported at ASCO 2009 (abs #LBA5508). All analyses are based on intention to treat. Results: From Jan ’03 to Nov ’07, 820 pts were randomized, 410 to each arm. Median age was 57 yrs (range 21-77). Stage III (60%) and IV (21%) were prevalent. A plateau in PFS events was reached before obtaining the planned number. Thus, following an IDMC recommendation, the final analysis was done with 556 events occurred as of December 31, 2009. This size is consistent with HR to be detected equal to 0.79, with 80% power. With a median follow-up of 40.2 months, median PFS was 19.0 and 16.8 months with C-PLD and CP, respectively (HR 0.95, 95%CI 0.81-1.13, log-rank p value=0.58). Lack of significant difference was confirmed (HR 0.96, 95%CI 0.81-1.14) at multivariable analysis adjusted by stage, PS, residual disease, age and size of the institution. There was no heterogeneity of treatment effect among major subgroups. With 313 deaths recorded, median OS was 61.6 and 53.2 months with C-PLD and CP, respectively (HR 0.89, 95%CI 0.72-1.12, log-rank p value=0.32). QoL data will be presented at the meeting. Conclusions: In the MITO-2 trial, C-PLD was not found to be superior to CP, which remains the standard first-line chemotherapy for AOC.However, given the observed confidence interval and the different toxicity profile, C-PLD could be considered an alternative to standard therapy. Study was partially supported by Schering-Plough. [Table: see text]

Randomized phase II study of pharmacodynamic separation (PDS) of pemetrexed (Pem) and erlotinib (Erl) versus pem alone in patients (pts) with advanced non-small cell lung cancer (NSCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8097-8097 ◽  
Author(s):  
Tianhong Li ◽  
Bilal Piperdi ◽  
William Vincent Walsh ◽  
Mimi Kim ◽  
Rasim Gucalp ◽  
...  
Keyword(s):  
Phase Ii ◽  
Primary Endpoint ◽  
Performance Status ◽  
Progression Free Survival ◽  
Dose Schedule ◽  
Phase Iii ◽  
Smoking History ◽  
Clinical Activity ◽  
P Value ◽  
Randomized Phase Ii

8097 Background: Preclinical and phase I studies showed that PDS optimizes cytotoxicity of concurrent EGFR inhibitors and chemotherapy. We conducted a randomized phase II trial to assess relative efficacy of Pem alone (Arm A) versus Pem +Erl on a PDS dose-schedule (Arm B) as 2nd-line therapy in pts with advanced NSCLC (NCT00950365). Methods: Eligible pts were randomized 2:1 (Arm B: A), stratified by sex, smoking history, and performance status (0/1 vs 2). Accrual was restricted to non-squamous histology in 2009. Treatment: Arm A – Pem 500 mg/m2IV on day 1; Arm B – Pem + Erl 150 mg po QD on days 2-17. 1 cycle = 3 weeks. Primary endpoint was progression-free survival (PFS). 50 pts in Arm B were needed to detect an increase in median PFS from ~3 to 4.5 months. Results: 83 pts were entered. Age: 63 yo. Female: 42 (53%). Smoking ≥15PY: 58 (72%). Nonsquamous: 78 (99%). The primary endpoint of the study was met: Efficacy results from 79 eligible pts showed 1.6-fold longer PFS in Arm B (4.6 m) compared to Arm A (2.8 m). Although the study was not designed to directly compare two arms, p value was 0.052. Toxicity: G3/4 Hem (A/B): 8(30%)/12(23%); Neutropenia with infection (A/B): 0/3(6%). G3/4 Non-Hem (A/B): skin rash: 0/3(6%); diarrhea: 0/2(4%); joint pain: 1(4%)/6(11.5%). Treatment related death (A/B): 0/1. Interstitial lung disease (A/B): 0/1. Conclusions: PDS of Pem and Erl is well tolerated and has promising clinical activity in 2nd-line non-squamous NSCLC. Ongoing correlative studies aim to identify a subgroup of patients who might benefit most from this treatment, which will guide the design of a confirmatory phase III study. (UL1 RR024146, P30CA093373, Lilly, Astellas) Clinical trial information: NCT00950365. [Table: see text]

Afatinib versus methotrexate as second-line treatment for patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) progressing on or after platinum-based therapy: LUX-Head & Neck 3 phase III trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6024-6024 ◽  
Author(s):  
Ye Guo ◽  
Myung-Ju Ahn ◽  
Anthony T. C. Chan ◽  
Cheng-Hsu Wang ◽  
Jin Hyoung Kang ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Safety Data ◽  
Feeding Tube ◽  
Phase Iii ◽  
Second Line ◽  
Duration Of Treatment ◽  
Phase Iii Trial ◽  
Significant Difference ◽  
Patient Reported ◽  
Grade 3

6024 Background: In a previous global phase III trial (LUX-Head & Neck 1), second-line (2L) afatinib significantly improved PFS vs methotrexate (MTX) in pts with R/M HNSCC. Here, we compared efficacy/safety of 2L afatinib vs MTX in Asian pts with R/M HNSCC. Methods: Pts progressing on/after platinum therapy were randomized (2:1) to 40 mg/day afatinib (feeding tube or oral) or 40 mg/m2/week iv MTX. Primary endpoint was PFS by independent review. Secondary endpoints were OS, ORR, and patient-reported outcomes. Results: 340 pts were randomized (afatinib 228, MTX 112). Median (range) duration of treatment (Tx) was 3.0 ( < 0.1–35.9) and 1.4 ( < 0.1–8.8) mos, respectively. Afatinib significantly decreased the risk of progression or death by 37% compared with MTX (HR 0.63; 95% CI: 0.48, 0.82 p = 0.0005, median PFS, 2.9 vs 2.6 mos; landmark analysis at 12 and 24 wks, 58 vs 41%, 21 vs 9%). There was no significant difference in OS (HR 0.88; 95% CI: 0.68, 1.13; median 6.9 vs 6.4 mos). ORR was 28% with afatinib and 13% with MTX (OR 2.8; 95% CI: 1.5, 5.2, p = 0.016). More pts had clinically relevant improvements in global health status/quality of life (GHS/QoL; 40 vs 23%, p < 0.01), swallowing (34 vs 18%, p = 0.01) and pain (34 vs 25%, p = 0.22) with afatinib vs MTX. Post-baseline change in GHS/QoL score was more favorable with afatinib (p < 0.001). Treatment-related adverse events (TRAEs; all/grade ≥3) were reported in 89/16% and 67/23% pts with afatinib and MTX. The most common grade ≥3 TRAEs were rash/acne (4%), diarrhea (4%), and stomatitis (3%) with afatinib, and anemia, leukopenia, and fatigue (all 5%) with MTX. Fatal AEs were reported in 23 and 11% pts with afatinib and MTX. Two ( hypoglycemia, pneumonitis/lung infiltration) and 4 pts had fatal AEs considered related to Tx with afatinib and MTX. 11% and 17% pts discontinued Tx due to TRAEs. Conclusions: LUX-Head & Neck 3 achieved its primary endpoint. Two randomized phase III trials have now demonstrated clinical benefit with 2L afatinib vs MTX. Safety data were consistent with the known tolerability profiles of afatinib and MTX. Clinical trial information: NCT01856478.

scholarly journals Dor no pós-operatório em crianças submetidas a procedimentos cirúrgicos

2019 ◽  
Vol 87 (25) ◽  
Author(s):  
Amanda Francielle Santos ◽  
Rafaela Ribeiro Machado ◽  
Caíque Jordan Nunes Ribeiro ◽  
José Marden Mendes Neto ◽  
Maria do Carmo de Oliveira Ribeiro ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Child Health ◽  
Pain Intensity ◽  
Exploratory Study ◽  
P Value ◽  
Health Profile ◽  
Chi Square ◽  
Post Surgery ◽  
Significant Difference ◽  
The Face

O objetivo deste estudo foi avaliar os fatores sociodemográficos, clínicos e cirúrgicos relacionados com a intensidade dador no pós-operatório de crianças. Estudo descritivo e exploratório com abordagem quantitativa, realizado com 31 crianças de cinco a 12 anos nas primeiras 72 horas de pós-operatório utilizou-se um questionário com perguntas clínicas, sociodemográficas e as escalas de faces e numérica de dor. Foram realizados os testes Qui-quadrado e Exato de Fisher paraa análise dos resultados. Evidenciou-se que o tipo de cirurgia realizada influencia significativamente (p-valor= 0,036) napresença de dor nas 24h, após a cirurgia. A intensidade da dor com o tipo de cirurgia nos dois primeiros dias de pós-operatório apresentou valor significativo (p-valor=0,044) no primeiro dia e (p-valor=0,021) no segundo. No 2º dia de internação,a variável sexo (feminino) mostrou diferença significativa com relação à média de intensidade de dor (p-valor=0,032) eno 3º dia, a característica clínica que se fez significativa foram os antecedentes patológicos (p-valor=0,031) quando relacionado à intensidade da dor. Conclui-se que as variáveis sociodemográficas, clínica e cirúrgica interferem na presença eintensidade de dor em crianças no pós-operatório, principalmente tipo de cirurgia, sexo e antecedentes patológicos.Palavras-chave: Criança; Dor; Dor pós-operatória; Perfil de saúde.ABSTRACTThe aim of this study is evaluating the socio-demographic, clinical and surgical factors related to the pain intensity inthe children´s post-surgery. Descriptive and exploratory study with a quantitative approach conducted with 31 five totwelve-year-old children in the first 72 hours of the post-surgery, where it was applied a questionnaire with clinical andsocio- demographic questions, and the face and numerical scales of pain. The Chi-square and the Fischer Exact tests wereused for the analysis of the results. It was observed that the kind of surgery performed influences significantly (p-value=0.036) in the presence of pain in the first 24 hours, after the surgery. The intensity of pain with the kind of surgery in thefirst two post-surgery days presented a significant value (p-value=0.044) in the first day and (p-value=0.021) in the secondday. In the 2nd day of admission the variable sex (female) showed a significant difference in relation to the intensity of painaverage (p-value=0.032), and in the 3rd day the significant characteristic was the pathological background (p-value=0.031)when related to the intensity of pain. It is concluded that socio-demographic, clinical and surgical variables interfere in thepresence and intensity of pain in children in post-surgery, especially kind of surgery and pathological background.Keywords: Child; Health profile; Pain; Postoperative pain.

The Impact of Facial Asymmetry on the Surgical Outcome of Crooked Nose: A Case Control Study

2020 ◽  
Author(s):  
Shayan Dasdar ◽  
Nika Kianfar ◽  
Mohammad Sadeghi ◽  
Babak Saedi
Keyword(s):  
Subjective Evaluation ◽  
Facial Asymmetry ◽  
Anthropometric Measurements ◽  
P Value ◽  
Facial Soft Tissue ◽  
Crooked Nose ◽  
Visual Presence ◽  
Significant Difference ◽  
The Face ◽  
The Impact

Abstract Background Facial asymmetry is considered as a reason for the patients’ dissatisfaction with the outcome of rhinoplasty. Objectives The aim of this study was to evaluate the impact of facial asymmetry on the patients’ post-operative satisfaction with crooked nose and to investigate the relationship between visual perception of asymmetry and anthropometric measurements. Methods In this retrospective study, 61 rhinoplasty patients with crooked noses were assessed. Using frontal view photos, pre- and post-operative nasal deviation angles were calculated. The patients were divided into two groups based on the visual presence of facial asymmetry. Moreover, anthropometric characteristics of the face were evaluated using facial soft tissue landmarks. The patients’ satisfaction with surgery outcomes, including both aesthetic and functional aspects, was assessed using the Persian version of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS). Results Based on the observations, 19 (30.2%) and 44 (69.8%) patients had I-type and C-type noses, respectively. In both groups, the deviation angle decreased significantly post-operatively (p-value&lt;0.001). Regarding the subjective evaluation of facial asymmetry, 22 (34.9%) and 41 (65.1%) cases had symmetric and asymmetric faces, respectively. The anthropometric measurements were also consistent with visual assessments of asymmetry. The satisfaction scores were significantly higher after surgery in all patients; however, there was no significant difference in the mean aesthetic improvement between symmetric (15.83 ± 2.68) and asymmetric faces (15.23 ± 4.46) (P-value: 0.531). The power of study was 97.8%. Conclusions Rhinoplasty in patients with deviated noses and asymmetric faces may have comparable results with symmetric ones.

scholarly journals Prospective, Randomized, Double Blind, Multicenter Study for an Autocrosslinked Polysaccharide Gel to Evaluate Antiadhesive Effect and Safety Compared to Poloxamer/Sodium Alginate After Thyroidectomy

2019 ◽  
Vol 103 (9) ◽  
pp. 452-460
Author(s):  
Woo Young Kim ◽  
Jae Bok Lee ◽  
Hoon Yub Kim ◽  
Pyoung Jae Park ◽  
Seung Pil Jung ◽  
...  
Keyword(s):  
Sodium Alginate ◽  
Primary Endpoint ◽  
Esophageal Motility ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Secondary Endpoints ◽  
Double Blinded ◽  
Voice Range

The aim of the study was to compare the efficacy and safety between an autocrosslinked polysaccharide (ACP) gel (Hyalobarrier) and a poloxamer/sodium alginate (P/SA: Guardix-SG) in preventing adhesions after thyroidectomy and demonstrate the noninferiority of ACP gel to P/SA. To identify differences of antiadhesive efficacy and safety between the ACP gel and P/SA, we investigated various variables such as the proportion of normal esophageal motility as assessed using marshmallow esophagography, swallowing impairment, adhesion severity and so on. This prospective, randomized, double-blinded, multicenter, phase III study investigated the antiadhesive efficacy and safety of ACP gel compared with those of P/SA for 12 weeks. Subjects were randomly assigned to receive either ACP gel (n = 97) or P/SA (n = 96). The primary endpoint was the proportion of normal esophageal motility as assessed using marshmallow esophagography, while the secondary endpoints included swallowing impairment, adhesion severity, laryngoscopic assessment of the vocal cords, and voice range profile. Safety endpoints included adverse events. There was no significant difference between the ACP gel and P/SA groups in the proportion of normal esophageal motility as the primary endpoint (P = 0.7428). In addition, there were no differences in the secondary or safety endpoints between the 2 groups. It was demonstrated that ACP gel was not inferior to P/SA. ACP gel appears both effective and safe for use in preventing adhesions after thyroidectomy.

scholarly journals Cephalometric Approach to Vertical Facial Height

2019 ◽  
Vol 9 (1) ◽  
pp. 54-58
Author(s):  
Suvit Maskey ◽  
Rosha Shrestha
Keyword(s):  
Class I ◽  
P Value ◽  
Cephalometric Analysis ◽  
Prosthetic Rehabilitation ◽  
Skeletal Class ◽  
Facial Height ◽  
Significant Difference ◽  
The Face ◽  
Edentulous Patients ◽  
Vertical Height

Introduction: The vertical heights and the proportions are very important for balance of the face and attractiveness along with the good smile. Harmonious vertical proportions and the Antero-posterior relations contribute to aesthetics. Therefore it is necessary to determine the vertical facial height and the ratios in treatment planning of the patients. The aims and objectives of this study are to compare the vertical facial heights of patients considering the Lower Anterior Facial Height (LAFH), the Upper Anterior Facial Height (UAFH), Total Anterior Facial Height (TAFH) and Posterior Facial Height (PFH) among the sexes in Class I skeletal group obtained from cephalometric analysis. Materials & Method: The study material comprised of 52 patients (24 males and 28 females) and lateral cephalometric radiographs were traced with Skeletal Class I relationship. Cephalometric analysis was performed by using hand tracing. Independent t tests were used for comparisons. Result: The total anterior facial height (TAFH), lower anterior facial height (LAFH), upper anterior facial height (UAFH), total posterior facial height (TPFH) measurements showed no significant differences between both sexes in Skeletal Class I group but statistically significant difference in ratios of posterior facial height and total anterior facial height and also there was statistically significant differences in the ratio between upper facial height and the total anterior facial height (p value <0.05). Conclusion: This cephalometric analysis can be applied to determine the vertical height of occlusion which can be helpful in prosthetic rehabilitation of edentulous patients.

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