scholarly journals The Impact of Formulation on Lutein, Zeaxanthin, and meso-Zeaxanthin Bioavailability: A Randomised Double-Blind Placebo-Controlled Study

Antioxidants ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 767
Author(s):  
Marina Green-Gomez ◽  
Alfonso Prado-Cabrero ◽  
Rachel Moran ◽  
Tommy Power ◽  
Laura G. Gómez-Mascaraque ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Serum Concentrations ◽  
Omega 3 ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Technology Advancement ◽  
Registration Number ◽  
Serum Carotenoids ◽  
The Impact

Lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ) have been the focus of research and commercial interest for their applications in human health. Research into formulations to enhance their bioavailability is merited. This 6 month randomised placebo-controlled trial involving 81 healthy volunteers compared the bioavailability of different formulations of free L, Z, and MZ in sunflower or omega-3 oil versus L, Z, and MZ diacetates (Ld, Zd, and MZd) in a micromicellar formulation. Fasting serum carotenoids, macular pigment, and skin carotenoid score were analysed at baseline and 6 months. Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo (p < 0.001 to p = 0.008). The diacetate micromicelle formulation exhibited a significantly higher mean response in serum concentrations of Z and MZ compared to the other active interventions (p = 0.002 to 0.019). A micromicellar formulation with solubilised Z and MZ diacetates is a promising technology advancement that enhances the bioavailability of these carotenoids when compared to traditional carotenoid formulations (ISRCTN clinical trial registration number: ISRCTN18206561).

Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽  
2017 ◽  
Vol 32 (7) ◽  
pp. 591-597 ◽  
Author(s):  
Geoff G. Lockwood ◽  
Leilani Cabreros ◽  
Dorota Banach ◽  
Prakash P. Punjabi
Keyword(s):  
Cardiac Surgery ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Subcutaneous Infusion ◽  
Randomised Controlled Study ◽  
Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

scholarly journals Probiotics with vitamin C for the prevention of upper respiratory tract symptoms in children aged 3-10 years: randomised controlled trial

2021 ◽  
pp. 1-10
Author(s):  
I. Garaiova ◽  
Z. Paduchová ◽  
Z. Nagyová ◽  
D. Wang ◽  
D.R. Michael ◽  
...  
Keyword(s):  
Vitamin C ◽  
Respiratory Tract ◽  
Controlled Trial ◽  
Bifidobacterium Bifidum ◽  
Active Group ◽  
Controlled Study ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Upper Respiratory ◽  
The Impact

In a double-blind, randomised, parallel-group, placebo-controlled study, healthy school children aged 3-10 years received a probiotic based supplement daily for 6 months to assess the impact on the incidence and duration of upper respiratory tract infection (URTI) symptoms. The intervention comprised Lab4 probiotic (Lactobacillus acidophilus CUL21 and CUL60, Bifidobacterium bifidum CUL20 and Bifidobacterium animalis subsp. lactis CUL34) at 12.5 billion cfu/day plus 50 mg vitamin C or a matching placebo. 171 children were included in the analysis (85 in placebo and 86 in active group). Incidence of coughing was 16% (P=0.0300) significantly lower in the children receiving the active intervention compared to the placebo. No significant differences in the incidence rate of other URTI symptoms were observed. There was significantly lower risk of experiencing five different URTI related symptoms in one day favouring the active group (Risk ratio: 0.31, 95% confidence interval: 0.12, 0.81, P=0.0163). Absenteeism from school and the use of antibiotics was also significantly reduced for those in the active group (-16%, P=0.0060 and -27%, P=0.0203, respectively). Our findings indicate that six months daily supplementation with the Lab4 probiotic and vitamin C combination reduces the incidence of coughing, absenteeism and antibiotic usage in 3 to 10 year old children.

A small dose of dexmedetomidine decreased the postoperative bleeding by reducing cough and emergence agitation after thyroidectomy – A randomized, double-blind, controlled study

2021 ◽  
Author(s):  
Sang Hun Kim ◽  
Yoo Seok Kim ◽  
Seongcheol Kim ◽  
Ki Tae Jung
Keyword(s):  
Controlled Trial ◽  
Postoperative Bleeding ◽  
Postoperative Hemorrhage ◽  
Controlled Study ◽  
Emergence Agitation ◽  
Double Blind ◽  
Extubation Time ◽  
Registration Number ◽  
Postanesthetic Care Unit ◽  
Group D

Abstract Background: Bleeding after a thyroidectomy occurs due to violent cough during the emergence. Dexmedetomidine is helpful for smooth emergence and suppressing the cough. The purpose of the present study was to compare the effect of dexmedetomidine on postoperative bleeding after thyroidectomy. Methods: Randomized, double-blind, controlled trial in female patients (ASA I–II, aged 20 to 60 years) were conducted. Patients were randomly allocated into two groups. About fifteen minutes before the end of the surgery, dexmedetomidine was administered (0.6 μg/kg/hr) without a loading dose in group D (n=69), and normal saline was administered in group S (n=70) at the same infusion rate. Hemodynamic data, coughing reflex, extubation time, Ramsay sedation scale (RSS), recovery time were assessed during the administration of study drugs and recovery from anesthesia. Amounts of postoperative hemorrhage were measured for 3 days. Results: A total of 139 patients were analyzed. The incidence of severe cough was significantly decreased in group D compared to group S (4.3% vs. 11.5%, P = 0.022). Emergence agitation in the postanesthetic care unit was significantly decreased in group D compared to group S (P = 0.01). Postoperative bleeding showed a significant decrease in group D compared to group S until the second postoperative day (P = 0.015). Conclusions: Dexmedetomidine can decrease postoperative bleeding by reducing coughing and emergence agitation after thyroidectomy. Trial registration: This study was registered at http://clinicaltrials.gov (registration number NCT02412150, 09/04/2015).

scholarly journals Atrial nitroso-redox balance and refractoriness following on-pump cardiac surgery: a randomized trial of atorvastatin

2020 ◽  
Author(s):  
Raja Jayaram ◽  
Michael Jones ◽  
Svetlana Reilly ◽  
Mark J Crabtree ◽  
Nikhil Pal ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Redox Balance ◽  
Superoxide Production ◽  
Right Atrial ◽  
Controlled Study ◽  
Lv Function ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Paired Samples ◽  
The Impact

Abstract Aims Systemic inflammation and increased activity of atrial NOX2-containing NADPH oxidases have been associated with the new onset of atrial fibrillation (AF) after cardiac surgery. In addition to lowering LDL-cholesterol, statins exert rapid anti-inflammatory and antioxidant effects, the clinical significance of which remains controversial. Methods and results We first assessed the impact of cardiac surgery and cardiopulmonary bypass (CPB) on atrial nitroso-redox balance by measuring NO synthase (NOS) and GTP cyclohydrolase-1 (GCH-1) activity, biopterin content, and superoxide production in paired samples of the right atrial appendage obtained before (PRE) and after CPB and reperfusion (POST) in 116 patients. The effect of perioperative treatment with atorvastatin (80 mg once daily) on these parameters, blood biomarkers, and the post-operative atrial effective refractory period (AERP) was then evaluated in a randomized, double-blind, placebo-controlled study in 80 patients undergoing cardiac surgery on CPB. CPB and reperfusion led to a significant increase in atrial superoxide production (74% CI 71–76%, n = 46 paired samples, P &lt; 0.0001) and a reduction in atrial tetrahydrobiopterin (BH4) (34% CI 33–35%, n = 36 paired samples, P &lt; 0.01), and in GCH-1 (56% CI 55–58%, n = 26 paired samples, P &lt; 0.001) and NOS activity (58% CI 52–67%, n = 20 paired samples, P &lt; 0.001). Perioperative atorvastatin treatment prevented the effect of CPB and reperfusion on all parameters but had no significant effect on the postoperative right AERP, troponin release, or NT-proBNP after cardiac surgery. Conclusion Perioperative statin therapy prevents post-reperfusion atrial nitroso-redox imbalance in patients undergoing on-pump cardiac surgery but has no significant impact on postoperative atrial refractoriness, perioperative myocardial injury, or markers of postoperative LV function. Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT01780740

scholarly journals Prolonged-Release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: A Pilot, Double-Blind, Randomized, Placebo-Controlled Study

2018 ◽  
Vol 4 (1) ◽  
pp. 205521731876116 ◽  
Author(s):  
François Jacques ◽  
Adrian Schembri ◽  
Avi Nativ ◽  
Chantal Paquette ◽  
Pawel Kalinowski
Keyword(s):  
Statistical Significance ◽  
Treated Group ◽  
Rehabilitation Program ◽  
Controlled Study ◽  
Motor Training ◽  
Prolonged Release ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Registration Number ◽  
Active Motor

Background Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients. Their combined effect is, however, understudied. Objective The objective of this paper is to determine if PRF augments the beneficial effect of EAMT in MS patients as opposed to placebo. Method This is a pilot, randomized, placebo-controlled, double-blind 14-week study. Participants were randomly assigned to receive PRF 10 mg BID ( n = 21) or placebo ( n = 20). All patients underwent EAMT during the first six weeks. Patients were assessed at –4, 0, 6 and 14 weeks. Results Both groups remained stable between –4 to 0 weeks and showed statistically significant improvements for the six-minute walk and the five-times-sit-to-stand test at weeks 6 and 14. The PRF-treated group achieved a greater mean percentage improvement and a higher incidence of responders in all three tasks at both time points. The study was, however, underpowered to reach statistical significance. Conclusion Our results confirm previous studies demonstrating that MS patients, despite significant disability, do benefit from a rehabilitation program. Our study is the first to show a trend suggesting that PRF in MS patients appears to enhance the benefit of EAMT. Further studies are required to confirm this. Clinical trial registration number with Clinicaltrial.gov: NCT02146534

scholarly journals 630. Emergence of Colistin Resistance in the OVERCOME Trial: Impact of Combination Therapy with Meropenem

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S418-S419
Author(s):  
Jason M Pogue ◽  
Michael J Rybak ◽  
Kyle Stamper ◽  
Dror Marchaim ◽  
Visanu Thamlikitkul ◽  
...  
Keyword(s):  
Infection Type ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Controlled Study ◽  
Independent Contractor ◽  
Double Blind ◽  
Resistance Development ◽  
Significant Difference ◽  
The Impact

Abstract Background Colistin (COL) remains an important therapeutic option for carbapenem-resistant (CR) Gram-negative bacilli (GNB). COL is often utilized in combination with meropenem (MEM), in part due to concerns regarding the development of COL resistance with monotherapy. We recently completed a randomized controlled trial comparing outcomes in patients receiving COL + placebo to those receiving COL + MEM; herein we present data on the emergence of COL resistance in this trial. Methods OVERCOME was an international, multicenter, randomized, double-blind, placebo-controlled study comparing COL and COL + MEM for the treatment of bloodstream infection and/or pneumonia due to CR GNB. Subjects were included in the modified intent to treat population (mITT) if their enrollment pathogen had a COL MIC ≤2 mg/L, as determined by broth microdilution (BMD). Daily blood and/or respiratory samples were obtained in patients per protocol until two consecutive negatives were obtained or the end of study treatment. All subsequent isolates were evaluated for COL resistance via BMD, defined as MIC ≥ 4 mg/L. Results Of the 425 patients in the mITT population, 380 (191 COL; 189 COL + MEM) were evaluable for the endpoint of COL resistance development. The median age of the cohort was 70, 38% were female, 47% were white, and 45% were Asian. 70% had an index infection of pneumonia, 68% were in the intensive care unit at the onset of their infection, and A. baumannii was the most common pathogen (78% of patients). Baseline characteristics, infection type, severity of illness, and index pathogen were similar amongst treatment arms. No significant difference in resistance development was seen between the COL and COL + MEM groups overall (12% vs. 8%; p = 0.31), or in any subgroup (Table). In patients with A. baumannii, there was a trend towards decreased resistance development with COL + MEM (13.3% vs 7.5%; p = 0.13). Conclusion We were unable to identify a significant difference in resistance emergence between treatment arms, but given the low incidence of this outcome, were underpowered to do so. The impact of COL + MEM on preventing emergence of COL resistance in A. baumannii warrants further clinical study. Disclosures Jason M Pogue, PharmD, BCPS, BCIDP, Merck (Consultant)QPex (Consultant)Shionogi (Consultant)Utility Therapeutics (Consultant)VenatoRX (Consultant) Michael J. Rybak, PharmD, MPH, PhD, Paratek Pharmaceuticals (Research Grant or Support) Emmanuel Roilides, MD, PhD, FIDSA, FAAM, FESCMID, Merck Sharp & Dohme Corp. (Consultant, Grant/Research Support) Matthew Sims, MD, PhD, Astra Zeneca (Independent Contractor)Diasorin Molecular (Independent Contractor)Epigenomics Inc (Independent Contractor)Finch (Independent Contractor)Genentech (Independent Contractor)Janssen Pharmaceuticals NV (Independent Contractor)Kinevant Sciences gmBH (Independent Contractor)Leonard-Meron Biosciences (Independent Contractor)Merck and Co (Independent Contractor)OpGen (Independent Contractor)Prenosis (Independent Contractor)Regeneron Pharmaceuticals Inc (Independent Contractor)Seres Therapeutics Inc (Independent Contractor)Shire (Independent Contractor)Summit Therapeutics (Independent Contractor)

scholarly journals Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis

2017 ◽  
Vol 77 (1) ◽  
pp. 78-84 ◽  
Author(s):  
Walter P Maksymowych ◽  
Stephanie Wichuk ◽  
Maxime Dougados ◽  
Heather E Jones ◽  
Ron Pedersen ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
P Value ◽  
Sacroiliac Joints ◽  
Double Blind ◽  
Registration Number ◽  
Mri Scans ◽  
The Impact ◽  
Change In Mean

ObjectiveTo evaluate the impact on structural lesions observed on MRI in the sacroiliac joints (SIJ) at 12 weeks in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving etanercept or placebo in EMBARK (Effect of Etanercept on Symptoms and Objective Inflammation in nr-axSpA, a 104 week study).MethodsPatients were randomised to double-blind etanercept 50 mg/week or placebo for 12 weeks. Structural lesions at baseline and 12 weeks were scored by two independent readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score (SSS) on T1-weighted MRI. Change in SPARCC SSS and correlation with improvement in clinical outcomes was evaluated.ResultsMRI scans from 185 patients (etanercept, n=88; placebo, n=97) were reviewed. At baseline, there were no significant differences in mean SPARCC SSS between etanercept and placebo. From baseline to 12 weeks, change in mean SPARCC SSS was significantly greater for etanercept than placebo for erosion (–0.57 vs –0.08, respectively, adjusted p value=0.017) and backfill (0.36 vs 0.06, adjusted p value=0.022). A treatment difference was also present for the subgroup of patients with SIJ inflammation on MRI (SPARCC bone marrow oedema ≥2): erosion: –0.81 versus –0.13 for etanercept versus placebo, respectively, p=0.007; backfill: 0.48 versus 0.08, respectively, p=0.032. Decrease in erosion and increase in backfill correlated with improvement in more clinical outcomes for etanercept than placebo.ConclusionTreatment with etanercept was associated with significantly greater reduction in erosions and increase in backfill at 12 weeks compared with placebo, consistent with a very early reparative response to antitumour necrosis factor therapy. The impact on disease progression in spondyloarthritis should be studied further.Trial registration numberNCT01258738; Post-results.

scholarly journals Effects of Short Term Omega-3 Supplementation on Body Composition, Food Intake, and Lipid Profile in Elite Athletes: A Double-Blind Randomized Controlled Trial.

2020 ◽  
pp. 1-15
Keyword(s):  
Physical Activity ◽  
Body Composition ◽  
Food Intake ◽  
Lipid Profile ◽  
Controlled Trial ◽  
Fat Free Mass ◽  
Omega 3 ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Global Physical Activity Questionnaire

Abstract Previous studies consistently showed a key role for omega-3 fatty acids in decreasing fat mass (FM) in animal models. Also, increased omega-3 stimulates fat loss in individuals who experience obesity, diabetes and metabolic syndrome. However, it is not known whether omega-3 supplementation make similar effects in healthy individuals with low FM. This study aimed to investigate the effects of omega-3 on changes in body composition, food intake, and lipid profile in healthy athletes. In this double-blind placebo-controlled RCT, 36 healthy athletes were allocated into omega-3 or placebo groups. Physical activity (global physical activity questionnaire), dietary intake (24-h food recall), anthropometric status, and lipid profile were measured at baseline and after 3-weeks. 35 volunteers completed the trial. The weight did not significantly change at the end of the study. Body fat% decreased significantly at the end of the study in the omega-3 group (p=0.003), but intergroup differences were not significant (p=0.77). FM decreased and fat free mass (FFM) increased in omega-3 groups (p<0.05). HDL-C increased (omega-3 group p=0.001; placebo group p=0.01; after adjustment for baseline values p=0.78). Also, in the omega-3 group, energy intake (p=0.0007) and protein intake (p=0.04) increased after intervention, but after baseline adjustments they were not significant. In conclusion, 3-week omega-3 supplementation seems to be not effective in decreased FM, increased HDL-C, and energy and protein intakes in athletes. Further studies are recommended to determine the effect of different doses of omega-3 on adipose tissue and blood lipids in athletes with low FM. Clinical Trial Registration The present study was prospectively registered at the Iranian Registry of Clinical Studies on December 19, 2019 (ID: 20190625044008N1).

scholarly journals Efficacy of PCV vaccine is primarily mediated by controlling pneumococcal colonisation density

2019 ◽  
Author(s):  
E.L. German ◽  
C. Solórzano ◽  
S. Sunny ◽  
F. Dunne ◽  
J.F. Gritzfeld ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Herd Effect ◽  
Vaccine Type ◽  
Pneumococcal Serotype ◽  
Classical Culture ◽  
Randomised Controlled ◽  
The Impact ◽  
Quantitative Pcr Assay

AbstractWidespread use of Pneumococcal Conjugate Vaccines (PCV) has resulted in a reduction in nasopharyngeal colonisation and invasive pneumococcal disease caused by vaccine-types. In a double-blind, randomised controlled trial using the Experimental Human Pneumococcal Challenge (EHPC) model, PCV-13 (Prevenar-13) conferred 78% protection against colonisation acquisition and a reduction in bacterial intensity (AUC) in experimentally colonised volunteers as measured by classical culture. In this study, we used a multiplex quantitative PCR assay targeting lytA and pneumococcal serotype 6A/B cpsA genes to re-assess the experimental colonisation status of the same trial volunteers. Increase in detection of low-density colonised volunteers by this molecular method led to a decrease of PCV efficacy against colonisation acquisition (29%), as compared to classical culture (83%). For subjects who were colonised following pneumococcal challenge, PCV had a pronounced effect on decreasing colonisation density. These results have implications for vaccine efficacy and surveillance studies as they indicate that the success of PCV vaccination could primarily be mediated by the control of vaccine-type colonisation density which results in decreased transmission and the reported herd effect of PCVs. Studies assessing the impact of PCV should account for density measurements in their design.Clinical trial registration with ISRCTN: 45340436

scholarly journals Reliable and rapid smooth extubation after Ketofol for induction of general anesthesia in Laparoscopic Drilling of polycystic ovary: A randomized controlled trial.

2020 ◽  
Author(s):  
Atef Mohamed Sayed Mahmoud ◽  
Safaa Gaber Ragab ◽  
Joseph Makram Botros
Keyword(s):  
General Anesthesia ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Airway Response ◽  
American Society ◽  
American Society Of Anesthesiologists ◽  
The Impact

Abstract Background: The impact of ketofol on the hemodynamics and the airway response during the induction of general anesthesia has been studied before. However, its effect on the smoothness of extubation has not been studied before. Thus, we aimed to assess the effect of ketofol on the smoothness of extubation and compare it with propofol for the induction of general anesthesia.Methods: This double-blind, randomized, and controlled study was conducted on 106 class I and II female patients with the “American Society of Anesthesiologists Physical Status (ASA PS),” aged 18–40 years and scheduled for laparoscopic drilling for polycystic ovary disease under general anesthesia. The patients were assigned to one of two groups of (53) patients each; group KP = ketofol and group P = propofol. Results: There was a good sedation score during suction and extubation in the ketofol group. Airway response and smoothness of extubation were better in the ketofol than in the propofol group.Conclusion: Ketofol as an induction anesthetic agent was effective in attenuating the airway response during extubation more than only propofol.Trial registration: This trial was retrospectively registered at the Clinical Trial.gov with the Identification Number: NCT04365686.

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