scholarly journals Effect of hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial, an update with an intention-to-treat analysis and clinical outcomes

2021 ◽  
Vol 57 (1) ◽  
pp. 106239
Author(s):  
Philippe Gautret ◽  
Van Thuan Hoang ◽  
Jean-Christophe Lagier ◽  
Didier Raoult
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Clinical Outcomes ◽  
Open Label ◽  
Intention To Treat ◽  
Treat Analysis

Effectiveness of a conversational chatbot in the smartphone to cease smoking in the adult population: pragmatic, controlled, randomized clinical trial in primary care (Dejal@). (Preprint)

2021 ◽  
Author(s):  
EDUARDO OLANO-ESPINOSA ◽  
Jose Francisco Avila-Tomas ◽  
Cesar Minue-Lorenzo ◽  
Blanca Matilla Pardo ◽  
Encarnación Serrano-Serrano ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Clinical Practice ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Evidence Based ◽  
Intention To Treat ◽  
Usual Clinical Practice ◽  
Treat Analysis

BACKGROUND The magnitude and severity of smoking, the benefits of quitting, and the existence of effective and efficient interventions make it a priority problem. Health professionals intervene less than they should, and the most effective interventions are more expensive, require specific training and more time, which is a disadvantage for the service provider and for the accessibility of the services. Information and communication technologies avoid these problems thanks to their accessibility, privacy, customization possibilities, access to social support, and scalability. OBJECTIVE To assess the effectiveness of an evidence-based intervention to cease smoking via a chatbot in the smartphone compared to usual clinical practice in primary care. METHODS Pragmatic randomized clinical trial in 34 primary healthcare centers within the Madrid Health Service (Spain). Smokers over 18 years of age who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group, CG) or an evidence-based chatbot intervention (intervention group, IG). The interventions in both arms were based on the 5A´s by the US clinical practice guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of subjects although participants were unblinded to group assignment. An intention-to-treat analysis, entering the basal observation carried forward in cases of missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. RESULTS The trial was conducted between October 1st of 2018 and March 31st of 2019. The sample comprised 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 years (SD 10.82) and gender ratio of 59.3% women and 40.7% men. Of them, 232 patients (45.2%) completed the follow-up, 104 (42.9%) in the IG and 128 (47.2%) in the CG. Main outcome: In the intention-to-treat analysis, the biochemically-validated abstinence rate at 6 months was higher in the IG with 26.03% (63/242) versus 18.82% (51/271) in the CG (odds ratio (OR)=1.52, 95% CI: 1.00–2.31, P=.05). After adjusting for basal CO-oxymetry and bupropion intake, no substantial changes were observed (OR=1.52, 95% CI 0.99–2.33 P= .053; pseudo R2=0.045). In the IG, 61.16% (148/242) of users accessed the chatbot, average bot-patient interaction time was 121 minutes (CI 95% 121.1–140.0), and average number of contacts was 45.56 (SD 36.32). CONCLUSIONS A treatment including a chatbot for helping in tobacco cessation was more effective than usual clinical practice in primary care. CLINICALTRIAL ClinicalTrials.gov, reference number NCT 03445507.

scholarly journals Randomized Clinical Trial Comparing Concomitant and Tailored Therapy for Eradication of Helicobacter pylori Infection

2021 ◽  
Vol 11 (6) ◽  
pp. 534
Author(s):  
Nikola Perkovic ◽  
Antonio Mestrovic ◽  
Josko Bozic ◽  
Mirela Pavicic Ivelja ◽  
Jonatan Vukovic ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Primary Objective ◽  
First Line ◽  
Tailored Therapy ◽  
Open Label ◽  
Intention To Treat ◽  
Clarithromycin Resistance ◽  
Reasonable Choice ◽  
H Pylori

As high clarithromycin resistance (>20%) in the Split-Dalmatia region of Croatia hinders the treatment of H. pylori infection, the primary objective of this study was to compare concomitant quadruple with the tailored, personalized therapy as first-line eradication treatment of H. pylori. In an open-label, randomized clinical trial, 80 patients with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 gr, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or tailored therapy in accordance with the results of the antimicrobial susceptibility testing. Eradication status was assessed 4 weeks after treatment. Eradication rates were significantly higher in tailored group than in concomitant group both in intention-to-treat (70 vs. 92.5%, p = 0.010) and per-protocol (87.5 vs. 100%, p = 0.030) analysis in the setting of increasing antibiotic resistance (clarithromycin 37.5%, metronidazole 17.5%, dual resistance 10%). Adverse effects were more frequent in the concomitant group (32.5 vs. 7.5%, p = 0.006). Tailored therapy achieves higher eradication with a lower adverse events rate. With the increasing resistance of H. pylori strains to antibiotic treatment, eradication regimes with such characteristics should be strongly considered as a reasonable choice for first-line treatment.

Clinical Outcomes, Structure, and Function Improve With Both Heavy and Moderate Loads in the Treatment of Patellar Tendinopathy: A Randomized Clinical Trial

2021 ◽  
Vol 49 (4) ◽  
pp. 982-993
Author(s):  
Anne-Sofie Agergaard ◽  
Rene B. Svensson ◽  
Nikolaj M. Malmgaard-Clausen ◽  
Christian Couppé ◽  
Mikkel H. Hjortshoej ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcome ◽  
Randomized Clinical Trial ◽  
Clinical Outcomes ◽  
Rating Scale ◽  
Power Doppler ◽  
Patellar Tendinopathy ◽  
Short Term ◽  
Level Of Evidence

Background: Loading interventions have become a predominant treatment strategy for tendinopathy, and positive clinical outcomes and tendon tissue responses may depend on the exercise dose and load magnitude. Purpose/Hypothesis: The purpose was to investigate if the load magnitude influenced the effect of a 12-week loading intervention for patellar tendinopathy in the short term (12 weeks) and long term (52 weeks). We hypothesized that a greater load magnitude of 90% of 1 repetition maximum (RM) would yield a more positive clinical outcome, tendon structure, and tendon function compared with a lower load magnitude of 55% of 1 RM when the total exercise volume was kept equal in both groups. Study Design: Randomized clinical trial; Level of evidence, 1. Methods: A total of 44 adult participants with chronic patellar tendinopathy were included and randomized to undergo moderate slow resistance (MSR group; 55% of 1 RM) or heavy slow resistance (HSR group; 90% of 1 RM). Function and symptoms (Victorian Institute of Sport Assessment–Patella questionnaire [VISA-P]), tendon pain during activity (numeric rating scale [NRS]), and ultrasound findings (tendon vascularization and swelling) were assessed before the intervention, at 6 and 12 weeks during the intervention, and at 52 weeks from baseline. Tendon function (functional tests) and tendon structure (ultrasound and magnetic resonance imaging) were investigated before and after the intervention period. Results: The HSR and MSR interventions both yielded significant clinical improvements in the VISA-P score (mean ± SEM) (HSR: 0 weeks, 58.8 ± 4.3; 12 weeks, 70.5 ± 4.4; 52 weeks, 79.7 ± 4.6) (MSR: 0 weeks, 59.9 ± 2.5; 12 weeks, 72.5 ± 2.9; 52 weeks, 82.6 ± 2.5), NRS score for running, NRS score for squats, NRS score for preferred sport, single-leg decline squat, and patient satisfaction after 12 weeks, and these were maintained after 52 weeks. HSR loading was not superior to MSR loading for any of the measured clinical outcomes. Similarly, there were no differences in functional (strength and jumping ability) or structural (tendon thickness, power Doppler area, and cross-sectional area) improvements between the groups undergoing HSR and MSR loading. Conclusion: There was no superior effect of exercising with a high load magnitude (HSR) compared with a moderate load magnitude (MSR) for the clinical outcome, tendon structure, or tendon function in the treatment of patellar tendinopathy in the short term. Both HSR and MSR showed equally good, continued improvements in outcomes in the long term but did not reach normal values for healthy tendons. Registration: NCT03096067 (ClinicalTrials.gov identifier)

Sign in / Sign up

Export Citation Format

Share Document