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Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10years in the CLARICOR randomised, blinded clinical trial.

https://arctichealth.org/en/permalink/ahliterature268775
Source
Int J Cardiol. 2015 Mar 1;182:459-65
Publication Type
Article
Date
Mar-1-2015
Author
Per Winkel
Jørgen Hilden
Jørgen Fischer Hansen
Jens Kastrup
Hans Jørn Kolmos
Erik Kjøller
Gorm Boje Jensen
Maria Skoog
Jane Lindschou
Christian Gluud
Source
Int J Cardiol. 2015 Mar 1;182:459-65
Date
Mar-1-2015
Language
English
Publication Type
Article
Keywords
Aged
Anti-Bacterial Agents - administration & dosage - adverse effects
Cause of Death - trends
Clarithromycin - administration & dosage - adverse effects
Coronary Artery Disease - drug therapy - mortality
Denmark - epidemiology
Female
Follow-Up Studies
Forecasting
Humans
Male
Morbidity - trends
Retrospective Studies
Single-Blind Method
Stroke - chemically induced - epidemiology
Abstract
The CLARICOR trial reported that clarithromycin compared with placebo increased all-cause mortality in patients with stable coronary heart disease. This study investigates the effects of clarithromycin versus placebo during 10years follow up.
The CLARICOR trial is a randomised, placebo-controlled trial including 4373 patients with stable coronary heart disease. The interventions were 2weeks of clarithromycin 500mg a day versus placebo. 10year follow up was performed through Danish public registers and analysed with Cox regression.
Clarithromycin increased all-cause mortality (hazard ratio (HR): 1.10, 95% confidence interval (CI): 1.00-1.21) and cerebrovascular disease during 10years (HR: 1.19, 95% CI: 1.02-1.38). The increased mortality and morbidity were restricted to patients not on statin at entry (HR: 1.16, 95% CI: 1.04-1.31, and HR: 1.25, 95% CI: 1.03-1.50). The assumption of constant HR during the 10years was violated for cardiovascular death (P=0.01) and cardiovascular death outside hospital (P
PubMed ID
25602299 View in PubMed
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Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol.

https://arctichealth.org/en/permalink/ahliterature137704
Source
Trials. 2011;12:18
Publication Type
Article
Date
2011
Author
Ole Jakob Storebø
Jesper Pedersen
Maria Skoog
Per Hove Thomsen
Per Winkel
Christian Gluud
Erik Simonsen
Author Affiliation
Child Psychiatric Daytime Clinic, Child and Adolescent Psychiatric Centre, Region Zealand, Holbaek, Denmark. ojst@regionsjaelland.dk
Source
Trials. 2011;12:18
Date
2011
Language
English
Publication Type
Article
Keywords
Attention Deficit Disorder with Hyperactivity - diagnosis - drug therapy - psychology - therapy
Child
Child Behavior
Cognition
Combined Modality Therapy
Denmark
Emotions
Female
Humans
Male
Parents - psychology
Psychiatric Status Rating Scales
Questionnaires
Research Design
Sample Size
Social Behavior
Time Factors
Treatment Outcome
Abstract
Children with attention deficit hyperactivity disorder (ADHD) are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions.
The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms.
We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone.
ClinicalTrials (NCT): NCT00937469.
Notes
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PubMed ID
21255399 View in PubMed
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