scholarly journals Oxygen saturation improved with nitrate-based nutritional formula in patients with COVID-19

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110123
Author(s):  
Sergej M. Ostojic ◽  
Aleksandra Milovancev ◽  
Patrik Drid ◽  
Alexandros Nikolaidis
Keyword(s):  
Oxygen Saturation ◽  
Patient Reported Outcomes ◽  
Case Series ◽  
Potassium Nitrate ◽  
Open Label ◽  
Patient Reported ◽  
Baseline Values ◽  
Study Participants ◽  
To Receive ◽  
Test Result

In this open-label case series trial, we evaluated the effects of a nitrate-based nutritional formula on oxygen saturation (SpO2) and patient-reported outcomes in individuals with coronavirus disease 2019 (COVID-19). Five adult patients (three men and two women, age 39.6 ± 6.9 years) with a positive COVID-19 test result, breathing difficulties, and SpO2 ≤95%, who were free from other pulmonary and cardiovascular conditions, were recruited for this study. Participants were assigned to receive a multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid) every 4 hours during the 48-hour monitoring period. In all participants, SpO2 improved immediately after administration of the nutritional formula, from 1 to 7 percentage points (mean increase 3.6 ± 2.7 points; 95% confidence interval 0.3 to 7.0). SpO2 remained above baseline values throughout the monitoring interval, with values persisting over threshold values (>92%) for all patients and at each time point during the 48 hours. No patients reported any side effects of the intervention. These promising and rather unexpected results call for immediate, well-sampled, mechanistic randomized controlled trials to validate our findings.

scholarly journals Systematic Review of Outcome Measures Used in Observational Studies of Adults with Eosinophilic Esophagitis

2021 ◽  
pp. 1-25
Author(s):  
Alain M. Schoepfer ◽  
Camilla Schürmann ◽  
Sven Trelle ◽  
Marcel Zwahlen ◽  
Christopher Ma ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Eosinophilic Esophagitis ◽  
Observational Studies ◽  
Patient Reported Outcomes ◽  
Case Series ◽  
Open Label ◽  
Topical Corticosteroids ◽  
Therapeutic Trials ◽  
Patient Reported

<b><i>Background:</i></b> Over the last 20 years, diverse outcome measures have been used to evaluate the effectiveness of therapies for eosinophilic esophagitis (EoE). This systematic review aims to identify the readouts used in observational studies of topical corticosteroids, diet, and dilation in adult EoE patients. <b><i>Methods:</i></b> We searched MEDLINE and Embase for prospective and retrospective studies (cohorts/case series, randomized open-label, and case-control) evaluating the use of diets, dilation, and topical corticosteroids in adults with EoE. Two authors independently assessed the articles and extracted information about histologic, endoscopic, and patient-reported outcomes and tools used to assess treatment effects. <b><i>Results:</i></b> We included 69 studies that met inclusion criteria. EoE-associated endoscopic findings (assessed either as absence/presence or using Endoscopic Reference Score) were evaluated in 24/35, 11/17, and 9/17 studies of topical corticosteroids, diet, and dilation, respectively. Esophageal eosinophil density was recorded in 32/35, 17/17, and 11/17 studies of topical corticosteroids, diet, and dilation, respectively. Patient-reported outcomes were not uniformly used (only in 14, 8, and 3 studies of topical corticosteroids, diet, and dilation, respectively), and most tools were not validated for use in adults with EoE. <b><i>Conclusions:</i></b> Despite the lack of an agreed set of core outcomes that should be recorded and reported in studies in adult EoE patients, endoscopic EoE-associated findings and esophageal eosinophil density are commonly used to assess disease activity in observational studies. Standardization of outcomes and data supporting the use of outcomes are needed to facilitate interpretation of evidence, its synthesis, and comparisons of interventions in meta-analyses of therapeutic trials in adults with EoE.

scholarly journals Efficacy and Safety of Adalimumab in Canadian Patients with Moderate to Severe Crohn’s Disease: Results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn’s DiseaSe (ACCESS) Trial

2011 ◽  
Vol 25 (8) ◽  
pp. 419-425 ◽  
Author(s):  
Remo Panaccione ◽  
Edward V Loftus ◽  
David Binion ◽  
Kevin McHugh ◽  
Shamsul Alam ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Work Productivity ◽  
Clinical Effectiveness ◽  
Open Label ◽  
Adalimumab Therapy ◽  
Patient Reported ◽  
Fistula Healing

OBJECTIVE: To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn’s disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy.METHODS: Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada.RESULTS: Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients.CONCLUSIONS: Adalimumab therapy induced and sustained steroid-free remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.

scholarly journals Two Year Follow-Up of Patient Reported Outcomes Following Third Generation Minimally Invasive Chevron Akin Osteotomies (MICA) in Hallux Valgus Surgery

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0005
Author(s):  
Thomas L. Lewis ◽  
Robbie Ray ◽  
David Gordon
Keyword(s):  
Minimally Invasive ◽  
Hallux Valgus ◽  
Patient Reported Outcomes ◽  
Statistical Significance ◽  
Case Series ◽  
Published Data ◽  
Third Generation ◽  
Specific Patient ◽  
Patient Reported

Category: Bunion Introduction/Purpose: The aim of this study was to explore the 2 year results of third generation (using screw fixation) Minimally Invasive Chevron and Akin osteotomies (MICA) for hallux valgus correction. There is a paucity of published data regarding the outcomes of this relatively new technique. We present the largest series in the literature, using three separate validated patient-reported outcome measures (EQ-5DL, VAS Pain and Manchester Oxford Foot Questionnaire (MOXFQ), for this time point. Methods: A single surgeon case series of patients with hallux valgus underwent primary third generation minimally invasive chevron and akin osteotomies for hallux valgus correction. Between August 2015 and January 2018, 290 MICAs were performed in 203 patients that were eligible for 2 year follow up. Baseline and 2 year post-operative patient reported outcomes were collected for 164 feet in 130 patients (124 females; 6 males). Paired t-tests were used to determine the statistical significance of the difference between pre- and post-operative scores. Results: The mean age was 56.6 (range 29.5-81.0, standard deviation (s.d.) 10.9). At two year follow up, mean MOXFQ scores improved for each domain: Pain; baseline 40.6 (range 0-100, s.d. 22.8), reduced to 11.3 (range 0-75, s.d. 16.0, p<0.001); Walking; 36.0 (range 0-100, s.d. 25.9) reduced to 8.2 (range 0-75.0, s.d. 16.0, p<0.001); Social interaction; 46.7 (range 0-100, s.d. 24.3), reduced to 7.7 (range 0-75.0, s.d. 13.9, p<0.001). Mean VAS Pain score improved from 30.4 (range 0.0-90.0, s.d. 23.6) to 9.4 (range 0.00-70.0, s.d. 15.6, p<0.001). Mean EQ-5D index score improved from 0.750 (range 0.066-1.000, s.d. 0.148) to 0.892 (range 0.410-1.000, s.d. 0.135, p<0.001). Mean EQ-5D VAS score did not significantly improve from 81.9 (range 0-100, s.d. 17.1) to 83.0 (range 0-100, s.d. 18.0, p=0.559). Conclusion: This is the largest prospective case series of short-term patient reported outcomes using a validated assessment method for hallux valgus, following third generation MICA to date. These data show that this technique is effective at improving foot and ankle specific patient reported outcomes at 2 years. This cohort is being followed over the longer term.

scholarly journals A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

2016 ◽  
Vol 2 (2) ◽  
pp. 00101-2015 ◽  
Author(s):  
Tara Rheault ◽  
Sanjeev Khindri ◽  
Mitra Vahdati-Bolouri ◽  
Alison Church ◽  
William A. Fahy
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Patient Reported Outcomes ◽  
Chronic Obstructive ◽  
Open Label ◽  
Obstructive Pulmonary Disease ◽  
Once Daily ◽  
Inferior Margin ◽  
Link Type ◽  
Patient Reported

This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease.This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed.A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL) to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%).Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.

scholarly journals Improvement in patient-reported outcomes after rituximab in rheumatoid arthritis patients: An open-label assessment of 175 patients

2015 ◽  
Vol 82 (6) ◽  
pp. 451-454 ◽  
Author(s):  
Laure Gossec ◽  
Agnès Danré ◽  
Bernard Combe ◽  
Xavier Le Loët ◽  
Jaques Tebib ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Open Label ◽  
Patient Reported
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