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The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature290098
Source
Trials. 2017 01 19; 18(1):30
Publication Type
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Date
01-19-2017
Author
Malene Nøhr Demant
Ramon Gordon Jensen
Janus Christian Jakobsen
Christian Gluud
Preben Homøe
Author Affiliation
Department of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Køge, Denmark. malenedemant@gmail.com.
Source
Trials. 2017 01 19; 18(1):30
Date
01-19-2017
Language
English
Publication Type
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Keywords
Acute Disease
Anti-Bacterial Agents - administration & dosage
Chest Tubes
Child, Preschool
Clinical Protocols
Double-Blind Method
Equipment Design
Female
Greenland
Health Services Accessibility
Humans
Infant
Male
Middle Ear Ventilation - adverse effects - instrumentation
Otitis Media - diagnosis - surgery
Otitis Media with Effusion - diagnosis - surgery
Quality of Life
Recurrence
Research Design
Respiration, Artificial - instrumentation
Rural Health Services
Time Factors
Treatment Outcome
Tympanic Membrane Perforation - etiology
Abstract
The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted.
The trial is an investigator-initiated, multicentre, randomized, blinded superiority trial of bilateral ventilation tube insertion versus treatment as usual (no tube) in Greenlandic children aged 9-36 months with chronic otitis media with effusion or recurrent acute otitis media. With randomization stratified by otitis media subtype and trial site, a type 1 error of 5% and a power of 80%, a total of 230 participants are needed to detect a decrease of two visits to a health clinic during 2 years, which is considered the minimal clinical relevant difference. The primary outcome measure will be assessed blindly by investigating medical records. Secondary outcome measures are number of episodes of acute otitis media, quality of life, number of episodes of antibiotics administration and proportion of children with tympanic membrane perforations.
This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging.
ClinicalTrials.gov, NCT02490332 . Registered on 14 February 2016.
Notes
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PubMed ID
28103950 View in PubMed
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Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2?×?2 factorial designed randomised NEO trial.

https://arctichealth.org/en/permalink/ahliterature260673
Source
Trials. 2014;15:135
Publication Type
Article
Date
2014
Author
Christian L Carranza
Martin Ballegaard
Mads U Werner
Philip Hasbak
Andreas Kjær
Klaus F Kofoed
Jane Lindschou
Janus Christian Jakobsen
Christian Gluud
Peter Skov Olsen
Daniel A Steinbrüchel
Source
Trials. 2014;15:135
Date
2014
Language
English
Publication Type
Article
Keywords
Aorta - physiopathology - surgery
Aortography - methods
Clinical Protocols
Coronary Artery Bypass - adverse effects - methods
Denmark
Endoscopy
Female
Graft Occlusion, Vascular - etiology - physiopathology
Hand Injuries - etiology - physiopathology
Humans
Male
Mammary Arteries - physiopathology - radiography - surgery
Multidetector Computed Tomography
Pain Measurement
Pain, Postoperative - etiology - physiopathology
Predictive value of tests
Questionnaires
Radial Artery - physiopathology - radiography - transplantation
Research Design
Risk factors
Time Factors
Tissue and Organ Harvesting - adverse effects - methods
Treatment Outcome
Vascular Patency
Abstract
Coronary artery bypass grafting using the radial artery has, since the 1990s, gone through a revival. Observational studies have indicated better long-term patency when using radial arteries. Therefore, radial artery might be preferred especially in younger patients where long time patency is important. During the last 10 years different endoscopic techniques to harvest the radial artery have evolved. Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest, which requires an incision from the elbow to the wrist. However, it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest. When the radial artery has been harvested, there are two ways to use the radial artery as a graft. One way is sewing it onto the aorta and another is sewing it onto the mammary artery. It is unknown which technique is the superior revascularisation technique.
The NEO Trial is a randomised clinical trial with a 2?×?2 factorial design. We plan to randomise 300 participants into four intervention groups: (1) mammario-radial endoscopic group; (2) aorto-radial endoscopic group; (3) mammario-radial open surgery group; and (4) aorto-radial open surgery group.The hand function will be assessed by a questionnaire, a clinical examination, the change in cutaneous sensibility, and the measurement of both sensory and motor nerve conduction velocity at 3 months postoperatively. All the postoperative complications will be registered, and we will evaluate muscular function, scar appearance, vascular supply to the hand, and the graft patency including the patency of the central radial artery anastomosis. A patency evaluation by multi-slice computer tomography will be done at one year postoperatively.We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery. The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory.
ClinicalTrials.gov identifier: NCT01848886.Danish Ethics committee number: H-3-2012-116.Danish Data Protection Agency: 2007-58-0015/jr.n:30-0838.
Notes
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PubMed ID
24754891 View in PubMed
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Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial.

https://arctichealth.org/en/permalink/ahliterature266353
Source
BMJ Open. 2014;4(8):e004903
Publication Type
Article
Date
2014
Author
Janus Christian Jakobsen
Christian Gluud
Mickey Kongerslev
Kirsten Aaskov Larsen
Per Sørensen
Per Winkel
Theis Lange
Ulf Søgaard
Erik Simonsen
Source
BMJ Open. 2014;4(8):e004903
Date
2014
Language
English
Publication Type
Article
Keywords
Adult
Cognitive Therapy - methods
Denmark
Depressive Disorder, Major - psychology - therapy
Female
Follow-Up Studies
Humans
Male
Psychiatric Status Rating Scales
Theory of Mind
Treatment Outcome
Abstract
To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants.
The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde, Denmark.
44 consecutive adult participants diagnosed with major depressive disorder.
18 weeks of third-wave cognitive therapy (n=22) versus 18 weeks of mentalisation-based treatment (n=22).
The primary outcome was the Hamilton Rating Scale for Depression (HDRS) at end of treatment (18 weeks). Secondary outcomes were: remission (HDRS
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PubMed ID
25138802 View in PubMed
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