scholarly journals Comparative Efficacy and Safety of Anterograde vs. Retrograde Iodine Staining During Esophageal Chromoendoscopy: A Single-Center, Prospective, Parallel-Group, Randomized, Controlled, Single-Blind Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Xu Tian ◽  
Wei Yang ◽  
Wei-Qing Chen
Keyword(s):  
Precancerous Lesions ◽  
Iodine Solution ◽  
Health Risk Appraisal ◽  
Starting Position ◽  
Iodine Staining ◽  
Primary Endpoints ◽  
Parallel Group ◽  
Patient Reported ◽  
Secondary Endpoints ◽  
Esophageal Carcinomas

Background and Aim: Chromoendoscopy with iodine staining is an important diagnostic method for esophageal carcinomas or precancerous lesions. Unfortunately, iodine staining can be associated with numerous adverse events (AEs). We found that the starting position of spraying iodine solution is likely the main reason of causing AEs. We conducted this work to determine whether clinical outcomes from anterograde iodine staining were superior to those achieved after retrograde iodine staining.Methods: A total of 134 subjects with a health risk appraisal flushing (HRA-F) score of >6 for esophageal cancer were randomly assigned to receive anterograde or retrograde iodine staining in the esophagus. The primary endpoints were the pain and the amount of iodine solution consumption. The secondary endpoints were iodine-staining effect, detection yield, and response to starch indicator.Results: Nine patients suffered from pain and six patients revealed positive response to starch indicator in retrograde iodine-staining group; however, no patient reported pain (0/67) and all patients revealed a negative response to starch indicator in anterograde iodine-staining group. The amount of iodine solution consumption in anterograde iodine-staining group (4.97 mL) was significantly lower than that (6.23 mL) in retrograde iodine-staining group; however, the iodine-staining effect and detection yield were comparable between the two groups.Conclusions: Anterograde iodine staining during Lugol chromoendoscopy appears to be as effective, but significantly safer than retrograde iodine staining.

A randomized study evaluating tailoring of advanced/metastatic colorectal cancer (mCRC) therapy using circulating cell-free tumor DNA (ctDNA) (TACT-D).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS277-TPS277
Author(s):  
Kanwal Pratap Singh Raghav ◽  
Xin Shelley Wang ◽  
Lianchun Xiao ◽  
Arvind Dasari ◽  
Van K. Morris ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiographic Progression ◽  
Randomized Study ◽  
Standard Of Care ◽  
Cancer Center ◽  
Clinical Events ◽  
Primary Endpoints ◽  
Patient Reported ◽  
Secondary Endpoints ◽  
Md Anderson

TPS277 Background: Identifying non-responders to expensive salvage therapies with modest benefits and substantial treatment related adverse events (TRAEs) (e.g. regorafenib/TAS102 in mCRC) is necessary to maximize benefits and limit toxicities. Serial ctDNA sequencing is reliable for tracking tumor dynamics and appears to predict resistance to therapy earlier than radiographic progression. Methods: TACT-D is a randomized study (N = 100) to validate the ability of changes in ctDNA (ΔctDNA) to predict resistance early and in limiting toxicities. We hypothesize that increase in ctDNA (measured by variant allele fraction) at 2 weeks (wk) into treatment can predict resistance earlier than standard radiographic means [at 8-12 wk] and detecting resistance early can enable prompt change in therapy resulting in reduction of TRAEs. Pts with mCRC eligible for either regorafenib/TAS102 are randomized 2:1 to either standard of care (SOC) or ctDNA arm. On SOC arm, treatment is given as per current paradigm i.e. for 8 wk and then restaging. On ctDNA arm, decision to continue therapy is based on ctDNA change between baseline and 2 weeks [ΔctDNA = ctDNA (C1D15 – C1D1)]. Increase in ctDNA triggers early radiographic staging (4 wk). Treatment is continued for disease stability/regression and discontinued for progression. Study has 2 co-primary endpoints: 1) Association of Δ ctDNA and radiographic progression [62 pts on SOC arm, have 94% power (2-sided α 0.05) to detect difference of 95% vs. 58% in progressive disease between pts with increase vs decrease in ctDNA] and 2) Compare proportion of pts experiencing TRAEs within 4 months between study arms [67 in SOC arm and 33 in ctDNA arm have 82% power (2-sided α 0.05) to detect a 30% decrease in toxicity]. Key secondary endpoints include: patient-reported outcomes (MD Anderson Symptom Inventory and PRO-CTCAE), OS, clinical events of special interest (hospitalizations/ER visits/medical interventions such as blood transfusions/IV hydration), clinical trial referral and cost effectiveness. Study is now actively accruing pts (NCT03844620). Funding: MD Anderson Cancer Center, Houston, TX & Guardant Health Inc., Redwood City, CA. Clinical trial information: NCT03844620.

Patient-reported outcomes in subjects with plaque psoriasis treated with tapinarof cream: Results from a phase 2b, randomized parallel-group study

2018 ◽  
Vol 2 ◽  
pp. S85
Author(s):  
Neal Bhatia ◽  
David Rubenstein ◽  
Anna M Tallman ◽  
James Lee
Keyword(s):  
Plaque Psoriasis ◽  
Patient Reported Outcomes ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Patient Reported

Abstract not available. Disclosures: Study sponsored by Dermavant.Copyright 2018 SKIN

Daily consumption of fermented soymilk helps to improve facial wrinkles in healthy postmenopausal women in a randomized, parallel-group, open-label trial

2018 ◽  
Vol 8 (2) ◽  
pp. 107 ◽  
Author(s):  
Mitsuyoshi Kano ◽  
Kazuyoshi Haga ◽  
Kouji Miyazaki ◽  
Fumiyasu Ishikawa
Keyword(s):  
Postmenopausal Women ◽  
Maximum Depth ◽  
Liquid Chromatography Mass Spectrometry ◽  
Daily Consumption ◽  
Open Label ◽  
Facial Wrinkle ◽  
Crow’S Feet ◽  
Parallel Group ◽  
Secondary Endpoints ◽  
Open Label Trial

Background: Soymilk fermented by lactobacilli and/or bifidobacteria is attracting attention due to the excellent bioavailability of its isoflavones. We investigated the effects of fermented soymilk containing high amounts of isoflavone aglycones on facial wrinkles and urinary isoflavones in postmenopausal women in a randomized, parallel-group, open-label trial. Healthy Japanese women were randomly divided into active (n = 44, mean age 56.3 ± 0.5) or control (n = 44, mean age 56.1 ± 0.5) groups, who consumed or did not consume a bottle of soymilk fermented by Bifidobacterium breve strain Yakult and Lactobacillus mali for 8 weeks. Maximum depth of wrinkles around the crow’s feet area and other wrinkle parameters were evaluated as primary and secondary endpoints respectively at weeks 0, 4, and 8 during the consumption period. Urinary isoflavone levels were determined by liquid chromatography-mass spectrometry. Results: The active group demonstrated significant improvements in the maximum depth (p=0.015) and average depth (p=0.04) of wrinkles, and significantly elevated urinary isoflavones (daidzein, genistein, and glycitein; each p < 0.001) compared with the control during the consumption period. No serious adverse effects were recorded.Conclusion: These findings suggest that fermented soymilk taken daily may improve facial wrinkles and elevate urinary isoflavones in healthy postmenopausal women.Key words: postmenopausal women; isoflavone; fermented soymilk; phytoestrogen; facial wrinkle 

Activity Tracking After Surgery: Does It Correlate With Postoperative Complications?

2021 ◽  
pp. 000313482098881
Author(s):  
Yehonatan Nevo ◽  
Tali Shaltiel ◽  
Naama Constantini ◽  
Danny Rosin ◽  
Mordechai Gutman ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Enhanced Recovery ◽  
Length Of Hospital Stay ◽  
Inverse Correlation ◽  
Complication Rates ◽  
Activity Tracking ◽  
Primary Endpoints ◽  
Specific Complication ◽  
Secondary Endpoints ◽  
Enhanced Recovery Programs

Background Postoperative ambulation is an important tenet in enhanced recovery programs. We quantitatively assessed the correlation of decreased postoperative ambulation with postoperative complications and delays in gastrointestinal function. Methods Patients undergoing major abdominal surgery were fitted with digital ankle pedometers yielding continuous measurements of their ambulation. Primary endpoints were the overall and system-specific complication rates, with secondary endpoints being the time to first passage of flatus and stool, the length of hospital stay, and the rate of readmission. Results 100 patients were enrolled. We found a significant, independent inverse correlation between the number of steps on the first and second postoperative days (POD1/2) and the incidence of complications as well as the recovery of GI function and the likelihood of readmission ( P < .05). POD2 step count was an independent risk factor for severe complications ( P = .026). Discussion Digitally quantified ambulation data may be a prognostic biomarker for the likelihood of severe postoperative complications.

506 Samelisant: Baseline Characteristics from a Phase 2 Study Evaluating Efficacy and Safety in Patients with Narcolepsy

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A199-A199
Author(s):  
Ramakrishna Nirogi ◽  
Jyothsna Ravula ◽  
Pradeep Jayarajan ◽  
Satish Jetta ◽  
Gopinadh Bhyrapuneni ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Demographic Data ◽  
Fixed Ratio ◽  
Study Drug ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Healthy Humans ◽  
Parallel Group ◽  
Secondary Endpoints ◽  
Baseline Characteristics

Abstract Introduction histamine H3 receptor (H3R) antagonists/ inverse agonists increase histaminergic neurotransmission and offer a therapeutic option for the treatment of narcolepsy. Samelisant (SUVN-G3031) is a potent and selective H3R inverse agonist exhibited selectivity over 70 other targets. Samelisant showed wake-promoting and anticataplectic effects in orexin knockout mice suggesting its potential therapeutic utility in the treatment of EDS and cataplexy associated with narcolepsy. Safety and tolerability studies in animals and healthy humans suggested a favorable risk/benefit profile. Methods The current study is a 2 week treatment, multicenter, double-blind, placebo controlled, parallel-group study in patients with Narcolepsy with or without Cataplexy. Eligibility criteria include age between 18 to 50 years old, an ESS score of ≥ 12; and mean MWT time of &lt; 12 minutes and a confirm diagnosis of narcolepsy as per ICSD-3. Further, the randomization will be stratified according to type of narcolepsy (Type-1 or Type-2). Each subject will receive either placebo or study drug once daily for 2 weeks in a fixed ratio of 1:1:1. The primary efficacy endpoint is change in maintenance of wakefulness test (MWT) score from baseline to week 2. Key secondary endpoints include change from baseline to week 2 in ESS and an improvement in CGI-S scores. Safety will be monitored by medical monitor and by an independent data safety monitoring committee. Baseline clinical and demographic data for the currently enrolled study is summarized descriptively. Since the study is blinded, a breakdown of baseline characteristics by treatment group will not be available until after completion. Results As of data cutoff date of Dec 20, 2020, a total of 54 subjects were completed in the study. The median age of subjects was 30 years (range: 18 - 50 years) with mean BMI of 28.6 (range: 18.3 - 43.1 kg/m2). Overall, 74% of subjects were female and 83% were Caucasian. Mean (SD) baseline values of MWT and ESS are 5.65 (3.5) and 16.7 (2.5), respectively. Conclusion Baseline characteristics are consistent with the general narcolepsy population. The study is currently enrolling the subjects with Narcolepsy with or without Cataplexy, and the Data readout is expected in the second half of 2021. Support (if any):

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals SARS-COV-2 colonizes coronary thrombus and impairs heart microcirculation bed in asymptomatic SARS-CoV-2 positive subjects with acute myocardial infarction

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Raffaele Marfella ◽  
Pasquale Paolisso ◽  
Celestino Sardu ◽  
Luciana Palomba ◽  
Nunzia D’Onofrio ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Viral Load ◽  
Coronary Intervention ◽  
Cardiovascular Death ◽  
Left Ventricular ◽  
Major Adverse Cardiovascular Events ◽  
Grade 5 ◽  
Primary Endpoints ◽  
Load Effects ◽  
Secondary Endpoints

Abstract Background The viral load of asymptomatic SAR-COV-2 positive (ASAP) persons has been equal to that of symptomatic patients. On the other hand, there are no reports of ST-elevation myocardial infarction (STEMI) outcomes in ASAP patients. Therefore, we evaluated thrombus burden and thrombus viral load and their impact on microvascular bed perfusion in the infarct area (myocardial blush grade, MBG) in ASAP compared to SARS-COV-2 negative (SANE) STEMI patients. Methods This was an observational study of 46 ASAP, and 130 SANE patients admitted with confirmed STEMI treated with primary percutaneous coronary intervention and thrombus aspiration. The primary endpoints were thrombus dimension + thrombus viral load effects on MBG after PPCI. The secondary endpoints during hospitalization were major adverse cardiovascular events (MACEs). MACEs are defined as a composite of cardiovascular death, nonfatal acute AMI, and heart failure during hospitalization. Results In the study population, ASAP vs. SANE showed a significant greater use of GP IIb/IIIa inhibitors and of heparin (p < 0.05), and a higher thrombus grade 5 and thrombus dimensions (p < 0.05). Interestingly, ASAP vs. SANE patients had lower MBG and left ventricular function (p < 0.001), and 39 (84.9%) of ASAP patients had thrombus specimens positive for SARS-COV-2. After PPCI, a MBG 2–3 was present in only 26.1% of ASAP vs. 97.7% of SANE STEMI patients (p < 0.001). Notably, death and nonfatal AMI were higher in ASAP vs. SANE patients (p < 0.05). Finally, in ASAP STEMI patients the thrombus viral load was a significant determinant of thrombus dimension independently of risk factors (p < 0.005). Thus, multiple logistic regression analyses evidenced that thrombus SARS-CoV-2 infection and dimension were significant predictors of poorer MBG in STEMI patients. Intriguingly, in ASAP patients the female vs. male had higher thrombus viral load (15.53 ± 4.5 vs. 30.25 ± 5.51 CT; p < 0.001), and thrombus dimension (4.62 ± 0.44 vs 4.00 ± 1.28 mm2; p < 0.001). ASAP vs. SANE patients had a significantly lower in-hospital survival for MACE following PPCI (p < 0.001). Conclusions In ASAP patients presenting with STEMI, there is strong evidence towards higher thrombus viral load, dimension, and poorer MBG. These data support the need to reconsider ASAP status as a risk factor that may worsen STEMI outcomes.

Abstract 15116: The Prognostic Value of Left Ventricular Mechanical Dyssynchrony in Patients With Idiopathic Dilated Cardiomyopathy

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Yangjie Li ◽  
Yuanwei Xu ◽  
Siqi Tang ◽  
Xiaoyue Zhou ◽  
Yucheng Chen
Keyword(s):  
Dilated Cardiomyopathy ◽  
Primary Endpoint ◽  
Prognostic Value ◽  
Mechanical Dyssynchrony ◽  
Idiopathic Dilated Cardiomyopathy ◽  
Ratio Estimate ◽  
Apical Level ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Cmr Imaging

Backgrounds: The mechanical dyssynchrony has been commonly observed in idiopathic dilated cardiomyopathy (DCM) patients, and several cardiac magnetic resonance (CMR) imaging techniques were used to evaluate the mechanical dyssynchrony. Standard deviation of time-to-peak (T2Psd) and uniformity ratio estimate (URE) indices are two widely used parameters to reflect the incoordinate movement of the left ventricle. However, the prognostic value of mechanical dyssynchrony in DCM patients is not clear. Methods and Results: We prospectively enrolled 402 DCM patients undergoing CMR imaging between Jun 2012 to Sep 2018. Mechanical dyssynchrony was measured as T2Psd and URE indices by CMR deformable registration algorithm (DRA) analysis. The primary endpoint was defined as all-cause mortality and heart transplantation, and the secondary endpoint was a combination of primary endpoint, aborted sudden cardiac death, and heart failure readmission. Univariate and multivariate Cox regression analyses were performed to identify the association between variables and outcome. Survival curves were obtained by Kaplan-Meier survival analysis and compared by log-rank test. During a median follow-up of 25.1 months (IQR: 16.2-41.6), there were 57 patients reached primary endpoints, and secondary endpoints occurred in 132 patients. Circumferential uniformity ratio estimate (CURE) at basal, mid and apical level, radial uniformity ratio estimate (RURE)at mid and apical level and longitudinal uniformity ratio estimate (LURE) were significantly worse in patients with primary endpoint compared to patients without primary endpoint. While no significant differences were observed regarding the T2Psd value between patients with and without primary endpoints. In multivariate analysis, CURE at apical level was independently associated with primary endpoints (HR 0.214, P=0.005) and secondary endpoints (HR 0.402, P=0.018). Furthermore, among patients with LVEF <35% or presence of LGE, those with decreased CURE at apical level (<0.917) showed a significantly higher rate of adverse outcome. Conclusion: The CURE at apical level is an independent predictor of adverse cardiac events in DCM patients. Compared with T2Psd, URE index is a better predictor of adverse events.

Procalcitonin and Interleukin-6 Levels: Are They Useful Biomarkers in Cardiac Surgery Patients?

2017 ◽  
Vol 43 (4) ◽  
pp. 290-297 ◽  
Author(s):  
Anna Clementi ◽  
Alessandra Brocca ◽  
Grazia Maria Virzì ◽  
Massimo de Cal ◽  
Davide Giavarina ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Interleukin 6 ◽  
Independent Predictor ◽  
Chronic Renal Disease ◽  
Kidney Injury ◽  
Renal Outcome ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Overall Mortality

Background/Aim: Cardiac surgery-associated acute kidney injury is an independent predictor of chronic renal disease and mortality. The scope of this study was to determine the utility of procalcitonin (PCT) and plasma interleukin-6 (IL-6) levels in predicting renal outcome and mortality in these patients. Methods: PCT and plasma IL-6 levels of 122 cardiac surgery patients were measured at 48 h after the surgical procedure. Primary endpoints were adverse renal outcome and mortality. Secondary endpoints were length of stay, bleeding, and number of transfusions. Results: PCT was found to be a better predictor of adverse renal outcome than IL-6. IL-6 seemed to be a better predictor of both 30-day and overall mortality than PCT. Neither PCT nor IL-6 levels were found to be good predictors of intensive care unit stay and bleeding. Conclusion: PCT may be considered a good predictor of adverse renal outcome in cardiac surgery patients, whereas IL-6 seems to possess a good predictive value for mortality in this population of patients.

scholarly journals Biotic Supplements for Renal Patients: A Systematic Review and Meta-Analysis

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1224 ◽  
Author(s):  
Anna Pisano ◽  
Graziella D’Arrigo ◽  
Giuseppe Coppolino ◽  
Davide Bolignano
Keyword(s):  
Systematic Review ◽  
Large Scale ◽  
Meta Analysis ◽  
Outcome Data ◽  
Reactive Protein ◽  
Surrogate Outcomes ◽  
Ovid Medline ◽  
Primary Endpoints ◽  
Intestinal Dysbiosis ◽  
Secondary Endpoints

Intestinal dysbiosis is highly pervasive among chronic kidney disease (CKD) patients and may play a key role in disease progression and complications. We performed a systematic review and meta-analysis to evaluate effects of biotic supplements on a large series of outcomes in renal patients. Ovid-MEDLINE, PubMed and CENTRAL databases were searched for randomized controlled trials (RCTs) comparing any biotic (pre-, pro- or synbiotics) to standard therapy or placebo. Primary endpoints were change in renal function and cardiovascular events; secondary endpoints were change in proteinuria/albuminuria, inflammation, uremic toxins, quality of life and nutritional status. Seventeen eligible studies (701 participants) were reviewed. Biotics treatment did not modify estimated glomerular filtration rate (eGFR) (mean difference (MD) 0.34 mL/min/1.73 m2; 95% CI −0.19, 0.86), serum creatinine (MD −0.13 mg/dL; 95% confidence interval (CI) −0.32, 0.07), C-reactive protein (MD 0.75 mg/dL; 95% CI −1.54, 3.03) and urea (standardized MD (SMD) −0.02; 95% CI −0.25, 0.20) as compared to control. Outcome data on the other endpoints of interest were lacking, sparse or in an unsuitable format to be analyzed collectively. According to the currently available evidence, there is no conclusive rationale for recommending biotic supplements for improving outcomes in renal patients. Large-scale, well-designed and adequately powered studies focusing on hard rather than surrogate outcomes are still awaited.

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