Use of balanced crytsalloid solutions in the early treatment of acute pancreatitis – protocol for a randomized controlled trial

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1009 ◽

2020 ◽

Cited By ~ 39

Author(s):

Oriol Mitjà ◽

Marc Corbacho-Monné ◽

Maria Ubals ◽

Cristian Tebé ◽

Judith Peñafiel ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Viral Load ◽

Adverse Events ◽

Usual Care ◽

Symptom Onset ◽

Early Treatment ◽

Complete Resolution ◽

Controlled Trial ◽

Randomized Controlled ◽

The Mean

Abstract Background No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19. Methods Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days. Results A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (−1.41 vs −1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (−3.37 vs −3.44). Treatment did not reduce risk of hospitalization (7.1% control vs 5.9% intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported. Conclusions In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.

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Early Treatment for Women with Alcohol Addiction (EWA) Reduces Mortality: A Randomized Controlled Trial with Long-Term Register Follow-up

Alcohol and Alcoholism ◽

10.1093/alcalc/agq097 ◽

2011 ◽

Vol 46 (2) ◽

pp. 170-176 ◽

Cited By ~ 4

Author(s):

R. Gjestad ◽

J. Franck ◽

S. Lindberg ◽

B. Haver

Keyword(s):

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Alcohol Addiction ◽

Randomized Controlled

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Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial

European Journal of Orthodontics ◽

10.1093/ejo/cjaa073 ◽

2020 ◽

Author(s):

Jenny Kallunki ◽

Lars Bondemark ◽

Liselotte Paulsson

Keyword(s):

Randomized Controlled Trial ◽

Early Treatment ◽

Untreated Control ◽

Controlled Trial ◽

Class Ii ◽

Control Group ◽

Class Ii Malocclusion ◽

Single Centre ◽

Intention To Treat ◽

Randomized Controlled

Summary Objectives To compare early headgear activator treatment of Class II malocclusion with excessive overjet with untreated control subjects in terms of the primary outcomes overjet and overbite as well as the effect regarding oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes. Trial design Two-arm parallel group single-centre randomized controlled trial. Material and methods A total of 60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited. The trial was designed as intention-to-treat and the participants randomized by an independent person not involved in the trial to either early treatment with headgear activator or to an untreated control group (UG). Dental and skeletal variables as well as registrations of OHRQoL, lip closure, and incidence of trauma were recorded. For the treatment group, data were registered at baseline before treatment and when treatment was finished, corresponding to approximately 2 years. For the UG, registrations were made at baseline and at 11 years of age. Observers were blinded to treatment allocation when assessing outcomes. Results Early treatment with headgear activator significantly decreased overjet and improved molar relationship when compared with untreated controls. The effects were primarily due to dentoalveolar changes. Early treatment had no evident effect regarding OHRQoL, lip closure, or incidence of trauma. Lack of cooperation resulted in unsuccessful treatments for 27% of the patients. Limitations The trial was a single-centre trial and can thus be less generalizable. Conclusions The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet. Trial registration NCT04508322.

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Fluid resuscitation with lactated Ringer’s solution vs normal saline in acute pancreatitis: A triple-blind, randomized, controlled trial

United European Gastroenterology Journal ◽

10.1177/2050640617707864 ◽

2017 ◽

Vol 6 (1) ◽

pp. 63-72 ◽

Cited By ~ 38

Author(s):

Enrique de-Madaria ◽

Iván Herrera-Marante ◽

Verónica González-Camacho ◽

Laia Bonjoch ◽

Noé Quesada-Vázquez ◽

...

Keyword(s):

Acute Pancreatitis ◽

Randomized Controlled Trial ◽

Inflammatory Response ◽

Controlled Trial ◽

Ringer’S Solution ◽

Randomized Controlled ◽

Lactated Ringer's Solution ◽

Sirs Criteria ◽

Inflammatory Effect

Background Little is known regarding the optimal type of fluid resuscitation in acute pancreatitis (AP). Objective The objective of this article was to compare the effect of lactated Ringer’s solution (LR) vs normal saline (NS) in the inflammatory response in AP. Methods We conducted a triple-blind, randomized, controlled trial. Patients ≥ 18 admitted with AP were eligible. Patients were randomized to receive LR or NS. Primary outcome variables were number of systemic inflammatory response syndrome (SIRS) criteria at 24 hours, 48 hours and 72 hours and blood C-reactive protein (CRP) levels at 48 hours and 72 hours. In vitro complementary experiments were performed to further explore the interaction between pH, lactate and inflammation. Results Nineteen patients receiving LR and 21 receiving NS were analyzed. The median (p25–p75) number of SIRS criteria at 48 hours were 1 (1–2) for NS vs 1 (0–1) for LR, p = 0.060. CRP levels (mg/l) were as follows: at 48 hours NS 166 (78–281) vs LR 28 (3–124), p = 0.037; at 72 hours NS 217 (59–323) vs LR 25 (3–169), p = 0.043. In vitro, LR inhibited the induction of inflammatory phenotype of macrophages and NF-κB activation. This effect was not observed when using Ringer’s solution without lactate, suggesting a direct anti-inflammatory effect of lactate. Conclusions Lactated Ringer’s is associated with an anti-inflammatory effect in patients with acute pancreatitis.

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