scholarly journals Clinical trial for comparison of clinical performance of I-Gel with LMA-proseal in elective surgeries

2020 ◽  
Vol 11 (4) ◽  
pp. 5350-5356
Author(s):  
Amit B. Kadam ◽  
Jamale P B
Keyword(s):  
Clinical Trial ◽  
Postoperative Complications ◽  
Lower Incidence ◽  
Clinical Performance ◽  
Standard Technique ◽  
Lower Airway ◽  
Postoperative Sore Throat ◽  
Clinically Significant ◽  
Sealing Pressure ◽  
Pressure Changes

The I-gel is genuinely interesting second era aviation route gadget with delicate gel like non inflatable sleeve. The objective of this study was to evaluate and compare the ease of insertion and number of insertion attempts, airway sealing pressure, and evaluation of device position and occurrence of complication. Total70 adult patients were allocated to either i-gel group or P-LMA group with 35patients in each group. Both i-gel and P- LMA were introduced with standard technique. The outcomes measured ease of insertion, number of insertion attempts, airway sealing pressure, changes, evaluation of device position and complications. the i-gel group the success rate at ease of insertion was greater (97% vs72% respectively;P=0.012). Airway sealing pressure was lesser (24.72±1.37 cmH2Ovs 30.09±2.64 cmH2O respectively; P=0.0003). The incidence of postoperative sore throat was lower (2.8% vs 25.7% respectively;P=0.01). Changes in parameters were not clinically significant. The i-gel is easier to insert than P-LMA however with a lower airway sealing pressure. It has a lower incidence of postoperative complications.

scholarly journals Ginsenoside Absorption Rate and Extent Enhancement of Black Ginseng (CJ EnerG) over Red Ginseng in Healthy Adults

Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 487
Author(s):  
Saebyul Yoo ◽  
Bom-I Park ◽  
Do-hyun Kim ◽  
Sooyoung Lee ◽  
Seung-hoon Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Molecular Weight ◽  
Absorption Rate ◽  
Systemic Exposure ◽  
Red Ginseng ◽  
Double Blind ◽  
Time Curve ◽  
Concentration Time ◽  
Black Ginseng ◽  
Clinically Significant

Red ginseng (RG) and black ginseng (BG, CJ EnerG) were prepared from fresh ginseng using one and nine cycles of steaming and drying, respectively. This process reduces the molecular weight (MW) of ginsenoside-active compounds in ginseng by removing sugar moieties from their dammaranes. We compared the pharmacokinetic characteristics of ginsenosides between BG comprising mainly low-MW ginsenosides (Rg3, Rg5, Rk1, and Rh1) and RG that predominantly contains high-MW ginsenosides (Rb1, Rb2, Rc, Rd, Re, and Rg1). The safety profiles and tolerability were also studied using a randomized, double-blind, single-dose, crossover clinical trial. A combination of Rb1, Rg1, and Rg3, well-known representative and functional RG components, exhibited a 1-h faster absorption rate (Tmax) and 58% higher exposure (24-h area under the concentration–time curve, AUC24) in BG than in RG. Furthermore, the combination of Rg3, Rg5, and Rk1, the major and most efficient components in BG, displayed 824% higher absorption (AUC24) in BG than in RG. The total ginsenoside showed a 5-h rapid intestinal absorption (Tmax) and 79% greater systemic exposure (AUC24) in BG than in RG. No clinically significant findings were observed in terms of safety or tolerability. Thus, BG extract was more effective than RG extract.

‘Rollover’ abdominal paracentesis versus standard technique: protocol of a crossover randomized comparative trial

2021 ◽  
Author(s):  
Vishal Sharma ◽  
Daya Krishna Jha ◽  
Manish Rohilla ◽  
Chandan K Das ◽  
Harjeet Singh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Carcinomatosis ◽  
Comparative Trial ◽  
Standard Technique ◽  
Malignant Ascites ◽  
Primary Objective ◽  
Clinical Trial Registration ◽  
Patient Will ◽  
Abdominal Paracentesis ◽  
Randomized Crossover Study

The sensitivity of single abdominal paracentesis for diagnosis of peritoneal carcinomatosis in patients with malignant ascites is 40–70%. Tumor cells shed from the peritoneum settle preferentially in certain recesses of the peritoneum. We aim to compare the standard technique of abdominal paracentesis versus a rollover technique in a randomized crossover study to assess the cytological yield in patients suspected to have peritoneal carcinomatosis. Each patient will serve as their own control and the outcome assessor (cytopathologist) will be blinded to the method of paracentesis performed. The primary objective will be to compare the tumor cell positivity between the standard paracentesis group and the rollover group among enrolled patients. Clinical Trial registration: CTRI/2020/06/025887 and NCT04232384 .

Catechin-based Dentin Pretreatment and the Clinical Performance of a Universal Adhesive: A Two-year Randomized Clinical Trial

2020 ◽  
Vol 45 (5) ◽  
pp. 473-483 ◽  
Author(s):  
CAGA Costa ◽  
NLG Albuquerque ◽  
JS Mendonça ◽  
AD Loguercio ◽  
VPA Saboia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Clinical Performance ◽  
Resin Composite ◽  
Retention Rates ◽  
Marginal Adaptation ◽  
Single Bond ◽  
Etch And Rinse ◽  
Significant Difference ◽  
Self Etch

Clinical Relevance At 24 months, the dentin pretreatment with epigallocatechin-3-gallate did not impair the clinical performance of the adhesive Single Bond Universal regardless of the bonding strategy used. SUMMARY Purpose: To evaluate the two-year effect of dentin pretreatment with epigallocatechin-3-gallate (EGCG) on the clinical performance of restorations of noncarious cervical lesions (NCCLs) with Single Bond Universal, applied in two different modes (self-etch and etch-and-rinse). Methods and Materials: In this randomized clinical trial, 33 volunteers were selected, and 156 NCCLs were assigned to four groups: ER, etch-and-rinse; ER-EGCG, 0.1% EGCG dentin pretreatment + etch-and-rinse; SE, self-etch; and SE-EGCG, 0.1% EGCG dentin pretreatment + self-etch. The NCCLs were restored with a nanofilled resin composite and evaluated at baseline and at six, 12, 18, and 24 months using FDI criteria for retention, marginal staining, marginal adaptation, caries, and postoperative sensitivity. Two evaluators were blinded to the treatments performed, and impressions were taken for resin replicas to allow indirect observations. Statistical analyses were performed with Kruskal-Wallis and McNemar tests with a significance level of 5%. Results: Six restorations (one from ER, two from SE, one from ER-EGCG, and two from SEEGCG) were lost at 24 months with no significant differences (p>0.05). The retention rates were 97.0% (ER and ER-EGCG), 94.1% (SE), and 94.2% (SE-EGCG). For marginal adaptation, a significant difference was detected between the baseline and 24 months for the SE group (p=0.0313). There were no statistical differences among all other evaluated criteria at 24 months, neither for each group at baseline nor for 24-month comparisons (p>0.05). Conclusions: The pretreatment with EGCG provided no benefit in the clinical performance of the adhesive regardless of the bonding strategy used. In addition, it adds an additional required step to the restorative procedure.

Clinical performance and periodontal outcome of temporary crowns and fixed partial dentures: A randomized clinical trial

2000 ◽  
Vol 83 (1) ◽  
pp. 32-39 ◽  
Author(s):  
Ralph Gunnar Luthardt ◽  
Mandy Stößel ◽  
Monika Hinz ◽  
Rüdiger Vollandt
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Clinical Performance

Esthetic and Clinical Performance of Implant-Supported All-Ceramic Crowns Made with Prefabricated or CAD/CAM Zirconia Abutments: A Randomized, Multicenter Clinical Trial

2016 ◽  
Vol 96 (2) ◽  
pp. 163-170 ◽  
Author(s):  
J.G. Wittneben ◽  
J. Gavric ◽  
U.C. Belser ◽  
M.M. Bornstein ◽  
T. Joda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Performance ◽  
Multicenter Clinical Trial ◽  
Anterior Maxilla ◽  
Single Crown ◽  
Significant Difference ◽  
All Ceramic ◽  
Cad Cam ◽  
Group A ◽  
Group B

Patients’ esthetic expectations are increasing, and the options of the prosthetic pathways are currently evolving. The objective of this randomized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns (ICs) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with hand buildup technique. The null hypothesis was that there is no statistically significant difference between the 2 groups. Forty implants were inserted in sites 14 to 24 (FDI) in 40 patients in 2 centers, the Universities of Bern and Geneva, Switzerland. After final impression, 20 patients were randomized into group A, restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique, or group B using an individualized CAD/CAM zirconia abutment (CARES abutment; Institut Straumann AG) with a hand buildup technique. At baseline, 6 mo, and 1 y clinical, esthetic and radiographic parameters were assessed. Group A exhibited 1 dropout patient and 1 failure, resulting in a survival rate of 94.7% after 1 y, in comparison to 100% for group B. No other complications occurred. Clinical parameters presented stable and healthy peri-implant soft tissues. Overall, no or only minimal crestal bone changes were observed with a mean DIB (distance from the implant shoulder to the first bone-to-implant contact) of −0.15 mm (group A) and 0.12 mm (group B) at 1 y. There were no significant differences at baseline, 6 mo, and 1 y for DIB values between the 2 groups. Pink esthetic score (PES) and white esthetic score (WES) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes. Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla ( ClinicalTrials.gov NCT02905838).

High-Wattage E-Cigarettes Induce Tissue Hypoxia and Lower Airway Injury: A Randomized Clinical Trial

2018 ◽  
Vol 198 (1) ◽  
pp. 123-126 ◽  
Author(s):  
Martin Chaumont ◽  
Alfred Bernard ◽  
Stéphanie Pochet ◽  
Christian Mélot ◽  
Charaf El Khattabi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Tissue Hypoxia ◽  
Lower Airway ◽  
Airway Injury

scholarly journals Validating fPSA Glycoprofile as a Prostate Cancer Biomarker to Avoid Unnecessary Biopsies and Re-Biopsies

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2988
Author(s):  
Tomas Bertok ◽  
Eduard Jane ◽  
Aniko Bertokova ◽  
Lenka Lorencova ◽  
Peter Zvara ◽  
...  
Keyword(s):  
Clinical Performance ◽  
Receiver Operating Curve ◽  
Low Grade ◽  
Clinical Validation ◽  
Serum Samples ◽  
R Software ◽  
Software Packages ◽  
Auc Value ◽  
Clinically Significant ◽  
Receiver Operating

Background: To compare the clinical performance of a new PCa serum biomarker based on fPSA glycoprofiling to fPSA% and PHI. Methods: Serum samples from men who underwent prostate biopsy due to increased PSA were used. A comparison between two equal groups (with histologically confirmed PCa or benign, non-cancer condition) was used for the clinical validation of a new glycan-based PCa oncomarker. SPSS and R software packages were used for the multiparametric analyses of the receiver operating curve (ROC) and for genetic algorithm metaheuristics. Results: When comparing the non-cancer and PCa cohorts, the combination of four fPSA glycoforms with two clinical parameters (PGI, prostate glycan index (PGI)) showed an area under receiver operating curve (AUC) value of 0.821 (95% CI 0.754–0.890). AUC values were 0.517 for PSA, 0.683 for fPSA%, and 0.737 for PHI. A glycan analysis was also applied to discriminate low-grade tumors (GS = 6) from significant tumors (GS ≥ 7). Conclusions: Compared to PSA on its own, or fPSA% and the PHI, PGI showed improved discrimination between presence and absence of PCa and in predicting clinically significant PCa. In addition, the use of PGI would help practitioners avoid 63.5% of unnecessary biopsies, while the use of fPSA% and PHI would help avoid 17.5% and 33.3% of biopsies, respectively, while missing four significant tumors (9.5%).

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