scholarly journals Transnasal Humidified Rapid Insufflation Ventilatory Exchange With Nasopharyngeal Airway Facilitates Apneic Oxygenation: A Randomized Clinical Noninferiority Trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Lingke Chen ◽  
Liu Yang ◽  
Weitian Tian ◽  
Xiao Zhang ◽  
Yanhua Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lower Boundary ◽  
Clinical Trial Registration ◽  
Apneic Oxygenation ◽  
Nasopharyngeal Airway ◽  
Airway Opening ◽  
The Difference ◽  
To Receive ◽  
Noninferiority Margin ◽  
Upper Boundary

Background: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) was used to extend the safe apnea time. However, THRIVE is only effective in patients with airway opening. Nasopharyngeal airway (NPA) is a simple device that can help to keep airway opening. This study aimed to investigate the noninferiority of NPA to jaw thrust for airway opening during anesthesia-induced apnea.Methods: This was a prospective randomized single-blinded noninferiority clinical trial on the use of THRIVE in patients with anesthesia-induced apnea. The participants were randomly allocated to receive NPA or jaw thrust. The primary outcomes were PaO2 and PaCO2 at 20 min after apnea, with noninferiority margin criteria of −6.67 and 0.67 kPa, respectively.Results: A total of 123 patients completed the trial: 61 in the NPA group and 62 in the jaw thrust group. PaO2 at 20 min after apnea was 42.9 ± 14.0 kPa in the NPA group and 42.7 ± 13.6 kPa in the jaw thrust group. The difference between these two means was 0.25 kPa (95% CI, −3.87 to 4.37 kPa). Since the lower boundary of the 95% CI was > −6.67 kPa, noninferiority was established because higher PO2 is better. PaCO2 at 20 min after apnea was 10.74 ± 1.09 kPa in the NPA group and 10.54 ± 1.18 kPa in the jaw thrust group. The difference between the two means was 0.19 kPa (95% CI, −0.14 to 0.53 kPa). Since the upper boundary of the 95% CI was <0.67 kPa, noninferiority was established because lower PCO2 is better. No patient had a SpO2 < 90% during apnea.Conclusion: When THRIVE was applied during anesthesia-induced apnea, NPA placement kept airway opening and was noninferior to jaw thrust in terms of its effects on PaO2 and PaCO2 at 20 min after apnea.Clinical Trial Registration:ClinicalTrials.gov (NCT03741998).

The effects of thermal conditions on the cell sizes of two-dimensional convection

1994 ◽  
Vol 281 ◽  
pp. 33-50 ◽  
Author(s):  
Masaki Ishiwatari ◽  
Shin-Ichi Takehiro ◽  
Yoshi-Yuki Hayashi
Keyword(s):  
Heat Flux ◽  
Lower Boundary ◽  
Thermal Conditions ◽  
Heat Fluxes ◽  
Internal Cooling ◽  
Two Dimensional ◽  
Numerical Integrations ◽  
The Difference ◽  
Convective Cells ◽  
Upper Boundary

The effects of thermal conditions on the patterns of two-dimensional Boussinesq convection are studied by numerical integration. The adopted thermal conditions are (i) the heat fluxes through both upper and lower boundaries are fixed, (ii) the same as (i) but with internal cooling, (iii) the temperature on the lower boundary and the heat flux through the upper boundary are fixed, (iv) the same as (iii) but with internal cooling, and (v) the temperatures on both upper and lower boundaries are fixed. The numerical integrations are performed with Ra = 104 and Pr = 1 over the region whose horizontal and vertical lengths are 8 and 1, respectively.The results confirm that convective cells with the larger horizontal sizes tend to form under the conditions where the temperature is not fixed on any boundaries. Regardless of the existence of internal cooling, one pair of cells spreading all over the region forms in the equilibrium states. On the other hand, three pairs of cells form and remain when the temperature on at least one boundary is fixed. The formation of single pairs of cells appearing under the fixed heat flux conditions shows different features with and without internal cooling. The difference emerges as the appearance of a phase change, whose existence can be suggested by the weak nonlinear equation derived by Chapman & Proctor (1980).

scholarly journals Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-5
Author(s):  
Farhad Fazel ◽  
Hossein Nikpour ◽  
Mohsen Pourazizi
Keyword(s):  
Clinical Trial ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Intravitreal Bevacizumab ◽  
Combination Group ◽  
Treatment Naïve ◽  
Systemic Side Effects ◽  
The Difference ◽  
Topical Dorzolamide ◽  
To Receive

Purpose. To evaluate the efficacy of three intravitreal bevacizumab (IVB) injections versus the same combined with 2% of topical dorzolamide in the treatment of diabetic macular edema (DME). Methods. In this randomized double-masked clinical trial, 32 eyes of 16 treatment-naive patients with bilateral DME were enrolled. The eyes were randomly assigned to receive three monthly injections of IVB (1.25 mg) plus topical dorzolamide 2% twice daily or IVB (1.25 mg) plus topical artificial tear twice daily. Best-corrected visual acuity (BCVA) was the primary outcome of the study followed by the central macular thickness (CMT) and central macular volume (CMV) as the secondary outcomes. Results. Mean BCVA changes were insignificant in both groups. It changed from 0.21 ± 0.08 logMAR at baseline to 0.23 ± 0.09 (P=0.24) in the combination group and from 0.18 ± 0.09 logMAR to 0.21 ± 0.09 (P=0.11) in the IVB alone group, at 3 months, respectively. Changes in mean CMT and CMV were significant in both groups. However, the difference between the groups was not significant at all the visits. In the study, no major ocular complication or systemic side effects were noted regarding IVB or topical dorzolamide. Conclusion. This randomized contralateral clinical trial demonstrated that adjuvant topical dorzolamide with IVB injection had no additional effects on IVB in the treatment of DME over a three-month course. This trial is registered with the Iranian Registry of Clinical Trials under the registration code IRCT20131229015975N5.

scholarly journals A Single-Center Retrospective Study of the Impact of Thyroid Cancer on the Malignant Risk of Contralateral TI-RADS 3 and 4 Nodules

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li
Keyword(s):  
Clinical Trial ◽  
Thyroid Cancer ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Confounding Factors ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
The Difference ◽  
The Impact ◽  
Experimental Group

Background. The incidence of thyroid nodules increases in the general population. Similarly, we have also seen a dramatic increase in the number of thyroid surgeries. However, the mortality rate of thyroid cancer remained stable or even decreased. The purpose of our study was to investigate whether thyroid cancer affects the malignant risk of the contralateral TI-RADS 3 and 4 nodules. Methods. We conducted a retrospective cohort study in our institution for all thyroid procedures due to nodules from December 2018 to December 2019. All eligible patients were divided into the experimental group (bilateral nodules) and the control group (unilateral nodules) to assess whether the proportion of malignant nodules was different between the two groups. Multivariate logistic regression analysis was used to control potential confounding factors to investigate whether their differences were statistically significant. Results. A total of 330 patients underwent thyroid surgery, of whom 137 were eligible, including 84 in the experimental group and 53 in the control group. The proportion of malignant nodules was significantly different between the experimental group and the control group (29.8% versus 58.5%, unadjusted OR 0.30, 95% CI: 0.17–0.82, p = 0.001 ). However, after controlling for potential confounding factors, including age ( p = 0.004 ), gender ( p = 0.775 ), and TI-RADS classification ( p ≤ 0.001 ), we found that the difference was not significant (adjusted OR 1.08, 95% CI: 0.39–3.01, p = 0.886 ). Conclusion. There is no evidence that thyroid cancer affects the malignant risk of the contralateral TI-RADS 3 and 4 nodules. This study has been registered with the Chinese Clinical Trial Registry (clinical trial registration number: ChiCTR2000038611, registration time: September 26, 2020).

Patient Satisfaction With Oral vs Intravenous Sedation for Vitrectomy Surgery: A Randomized, Noninferiority Clinical Trial

2021 ◽  
pp. 247412642110278
Author(s):  
Nicole H. Siegel ◽  
Marissa G. Fiorello ◽  
Steven Ness ◽  
Jiwoo Kim ◽  
Viha Vig ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
Intraoperative Complications ◽  
A Priori ◽  
Intravenous Sedation ◽  
Patient Satisfaction Scores ◽  
Oral Sedation ◽  
To Receive ◽  
Vitrectomy Surgery ◽  
Noninferiority Margin

Purpose: This work aims to determine whether patient satisfaction with oral sedation is noninferior to intravenous (IV) sedation in vitrectomy surgery. Methods: This prospective, randomized, double-masked, noninferiority clinical trial measured patient satisfaction in 84 participants receiving oral or IV sedation during vitrectomy surgery under monitored anesthesia care. Patients were excluded if they were unable to receive benzodiazepines. Results: The primary outcome was patient satisfaction. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications. Among the 84 patients (46 [54.8%] men; mean [SD] age, 57.0 [12.7 years]), mean patient satisfaction scores were 5.22 ± 0.81 (range, 3.08-6; scale 1-6) with oral and 5.25 ± 0.63 (range, 3.83-6; scale 1-6) with IV sedation. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the groups of 0.03 (1-tailed 95% CI, infinity to 0.29), our results demonstrated the noninferiority of oral sedation ( P = .002). There were no significant differences in surgeon or anesthesia satisfaction or major intraoperative complications. Five patients receiving oral (11.9%) and 3 receiving IV (7.1%) sedation required supplemental IV sedation (difference, 4.8%; P = .46). Conclusions: Patient satisfaction for oral sedation was noninferior to IV sedation for vitrectomy surgery.

scholarly journals Cladribine tablets added to IFN-β in active relapsing MS

2018 ◽  
Vol 5 (5) ◽  
pp. e477 ◽  
Author(s):  
Xavier Montalban ◽  
Thomas P. Leist ◽  
Bruce A. Cohen ◽  
Harold Moses ◽  
Jackie Campbell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Lymphocyte Count ◽  
Phase Ii Study ◽  
Clinical Trial Registration ◽  
Safety And Efficacy ◽  
Treatment Groups ◽  
Grade 3 ◽  
To Receive

ObjectiveTo evaluate the safety and efficacy of cladribine tablets in patients still experiencing active relapsing MS despite interferon (IFN)-β treatment.MethodsA 96-week phase II study, randomizing patients treated with IFN-β to cladribine tablets 3.5 mg/kg/IFN-β or placebo/IFN-β. Patients were to receive cladribine tablets 3.5 mg/kg/IFN-β or placebo/IFN-β in a 2:1 ratio (n = 172) with safety and exploratory efficacy outcomes being assessed.ResultsAdverse events (AEs) and serious AEs were similar across treatment groups, except lymphopenia. Fifty of 124 (40.3%) cladribine/IFN-β recipients vs 0% of placebo/IFN-β recipients reported lymphopenia as an AE, with grade 3/4 lymphopenia (laboratory lymphocyte count < 500 cells/mm3) experienced by 79/124 (63.7%) vs 1 (2.1%), respectively. Patients treated with cladribine tablets 3.5 mg/kg/IFN-β were 63% less likely to have a qualifying relapse than placebo/IFN-β recipients, and cladribine tablets 3.5 mg/kg/IFN-β reduced most MRI measures of disease activity.ConclusionsIn patients with active relapsing MS despite IFN-β treatment, cladribine tablets 3.5 mg/kg/IFN-β reduced relapses and MRI lesion activity over 96 weeks compared with placebo/IFN-β but led to an increased incidence of lymphopenia.Classification of evidenceThis study provides Class I evidence that for patients with active relapsing MS despite IFN-β treatment, cladribine tablets added to IFN-β reduced relapses and MRI lesion activity over 96 weeks and increased the incidence of lymphopenia.Clinical trial registrationNCT00436826.

A randomized, multicenter clinical trial to determine the efficacy and safety of pegfilgrastim (GEMA BIOTECH) compared to pegfilgrastim (Roche) for prevention of chemotherapy induced neutropenia in patients with breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3113-3113
Author(s):  
Martin Eduardo Richardet ◽  
Ruben Dario Kowalyszyn ◽  
Mirta Susana Varela ◽  
Eduardo Ortiz ◽  
Cristian Micheri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Study Drug ◽  
Severe Neutropenia ◽  
Myelosuppressive Chemotherapy ◽  
Secondary Endpoints ◽  
Study Population ◽  
Efficacy Measures ◽  
The Difference ◽  
To Receive

3113 Background: Peg-Neutropine, GEMA BIOTECH SAU biosimilar Peg-Filgrastim, is the first Peg-Filgrastim approved in LATAM for prevention of febrile neutropenia in patients treated with myelosuppressive chemotherapy. Methods: Study population: women with stage 2, 3 or 4 of breast cancer scheduled to receive 4 or 6 cycles of chemotherapy (with Taxane) at 3 weeks interval. Stratification was based on breast cancer stage. Study drug was administered subcutaneously in a 6 mg dose. The study was blind to the assessors. The primary endpoint was Duration of Severe Neutropenia (DSN, Absolute Neutrophil Count-ANC < 500/mm3) in the first cycle of chemotherapy. Secondary endpoints were incidence of severe neutropenia (SN), other efficacy measures, and incidence of ADRs. The non-inferiority margin for DSN was estimated in less than 1 day. Results: A total of 120 subjects were randomized 1:1, 58 were treated with Peg-Neutropine and 62 with Peg-Filgrastim (Roche). Efficacy: SN was developed in 52/283 (18,4%) cycles with Peg-Neutropine in 27 patients and 48/297 (16,2%) cycles with Peg-Filgrastim (Roche) in 20 patients (p=0,4836). In the first cycle, 16 patients with Peg-Neutropine and 11 patients with Peg-Filgrastim (Roche) developed SN. In per protocol analysis mean DNS in the first cycle was 0,78 ± 1,53 days for Peg-Neutropine group and 0,53±1,25 for Peg-Filgrastim (Roche) group (95% IC for the difference -0,26; 0,76). Per ITT analysis the mean DSN was 0,90±1,79 for Peg- Neutropine group and 0,50±1,21 for Peg-Filgrastim (Roche) group , (95% IC for the difference -0,15; 0,95). For all the efficacy secondary endpoints the differences were not statistically significant. Safety: 7 ADRs were developed by 3 subjects with Peg-Neutropine and 31 ADRs were developed by 10 subjects with Peg-Filgrastim (Roche). The most common reaction was myalgia, and other ADRs were arthralgia, asthenia, bone pain and acid sensitive syndrome. Conclusions: Based on the non-inferiority margin established we conclude that Peg-Neutropine is biosimilar to Peg-Filgrastim (Roche). Clinical trial information: NCT03404752.

Abstract WMP24: Collateral Status Contributes to Differences Between Observed and Predicted 24-Hour Infarct Volumes in DEFUSE 3

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Vaishnavi Rao ◽  
Michael Mlynash ◽  
Søren Christensen ◽  
Amarnath Yennu ◽  
Stephanie Kemp ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cerebral Blood Volume ◽  
Ct Perfusion ◽  
Infarct Volume ◽  
Volume Index ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Volume Estimate ◽  
The Difference

Background and Purpose: We have previously shown that in the DEFUSE 3 trial, the infarct volume 24 hours after randomization was predicted by the union of the baseline core and the 24-hour Tmax>6s perfusion lesion. We determined if collateral robustness measured by the hypoperfusion intensity ratio (HIR) and cerebral blood volume index (CBV) accounts for the variance in infarct volume predictions. Methods: DEFUSE 3 patients underwent MRI with perfusion or CT perfusion at baseline and 24 hours after randomization. We used RAPID software to determine ischemic core and Tmax>6s lesion volumes as well as HIR and CBV Index at baseline and 24 hours. Patients were stratified by the difference between the predicted and the observed infarct volume at 24 hours. We compared baseline and follow-up HIR and CBV Index, as well as several other imaging and clinical outcomes in subgroups based on the accuracy of the infarct volume estimate. Results: Out of 123 eligible patients, 34 had 24-hour infarcts larger than predicted and these patients had less favorable collaterals (HIR 0.43 vs 0.32, p=0.006 and CBV Index 0.78 vs 0.85, p=0.001) at baseline, as well as at 24-hour follow-up (HIR 0.56 vs 0.07, p=0.004 and CBV Index 0.47 vs 0.73, p=0.006) compared to the 71 patients with more accurate infarct volume prediction. The remaining 18 patients had 24-hour infarct volumes smaller than predicted. These patients had similar baseline collateral scores but a more favorable CBV Index at 24 hours (0.81 vs 0.73, p=0.040) compared to patients with more accurate infarct prediction. Conclusions: Patients with 24-hour infarcts larger than predicted had evidence of less favorable baseline collaterals that fail within 24 hours, while patients with 24-hour infarcts smaller than predicted typically had favorable collaterals that persisted for at least 24 hours. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02586415

scholarly journals The effect of dietary intervention on inflammatory markers in patients with type 2 diabetes. An analysis of the Lifestyle Over and Above Drugs in Diabetes (LOADD) study

2018 ◽  
Author(s):  
Chris S Booker ◽  
Kirsten J Coppell ◽  
Ashley Duncan ◽  
Minako Kataoka ◽  
Sheila M Williams ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Drug Therapy ◽  
Inflammatory Markers ◽  
Dietary Intervention ◽  
Dietary Advice ◽  
Interleukin 18 ◽  
Clinical Trial Registration ◽  
To Receive

Ninety-three participants with poorly controlled type 2 diabetes despite optimized drug therapy were randomised to receive intensive dietary advice or usual care for six months. Following dietary intervention a significant reduction in interleukin-18 levels was observed, with a ratio of change (95% CI) of 0.90 (0.82-0.99); p = 0.033. Changes in IL-18 correlated with changes in neopterin, r = 0.299 (p = 0.009). Clinical Trial registration ID #NCT00124553.

The Effects of a Caffeine Placebo and Experimenter Expectation on Blood Pressure, Heart Rate, Well-Being, and Cognitive Performance

2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Task ◽  
Well Being ◽  
Control Group ◽  
Double Blind ◽  
Main Effect ◽  
The Difference ◽  
Being There ◽  
To Receive

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.

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