Analysis and metabolic evaluation in a standard clinical setting of a group of patients 7 years after a clinical trial with sensor-augmented pump (SAP)

2016 ◽  
Author(s):  
Marta Dominguez-Lopez ◽  
Rdriguez Natalia Colomo ◽  
Ruiz de Adana Navas M Soledad
Keyword(s):  
Clinical Trial ◽  
Clinical Setting ◽  
Metabolic Evaluation

scholarly journals Standardized multimodal intervention for stress-induced exhaustion disorder: an open trial in a clinical setting

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jakob Clason van de Leur ◽  
Monica Buhrman ◽  
Fredrik Åhs ◽  
Alexander Rozental ◽  
Gunilla Brodda Jansen
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Sick Leave ◽  
Return To Work ◽  
Clinical Setting ◽  
Developed Countries ◽  
Working Time ◽  
Multimodal Intervention ◽  
Exhaustion Disorder

Abstract Background Long-term sick-leave due to stress-related ill-health is increasing in several economically developed countries. Even though different forms of interventions are administered in regular care for stress-related disorders, such as Stress-induced Exhaustion disorder (SED), the scientific evidence for the effectiveness of such treatments is sparse. The objective of this study was to explore changes in SED-symptoms and return-to-work-rates in a large group of SED-patients participating in a standardized Multimodal intervention (MMI) in a clinical setting. Method This open clinical trial tracked 390 patients who fulfilled the criteria for SED undergoing a 24-week MMI, including return-to-work-strategies. Before inclusion, all patients underwent a multi-professional assessment by a team of licensed physicians, licensed psychologists, and licensed physiotherapists. Self-rated questionnaires were administered before treatment, at treatment-start, mid-treatment, post-treatment, and at 12-month follow-up. Within-group change was evaluated over time with mixed-effects models. Beyond different symptoms, working time, sick-leave compensation, and adverse effects were also measured. Results There were significant improvements in symptoms of SED, burnout, anxiety, depression, and insomnia, with large within-group effect sizes (d = 0.91–1.76), improvements that were maintained at 12-month follow-up. Furthermore, there was a significant increase in quality of life and large improvements in average working time and sick-leave compensation. Some adverse effects were reported, mainly concerning an increase in stress, anxiety, and worry. Conclusion SED-patients participating in this standardized MMI reported large symptom alleviation, increased working time and reduced sick-leave compensation, indicating a beneficial treatment. There were some adverse effects, but no more so than other psychological treatments. This study confirms previous findings that high levels of depression and anxiety decrease to sub-clinical levels during treatment, while symptoms of SED also decline, yet still persists above sub-clinical levels at 12-month follow-up. On the whole, this open clinical trial suggests that a standardized MMI, administered in a clinical setting, improves symptoms and return-to-work rates in a clinically representative SED-population. Trial registration This study was registered on Clinicaltrials.gov 2017.12.02 (Identifier: NCT03360136).

The Application of Clinical Trial Methods in the Clinical Setting

1981 ◽  
Vol 58 (4) ◽  
pp. 296-301
Author(s):  
RICHARD J. BRAND ◽  
KENNETH A. POLSE
Keyword(s):  
Clinical Trial ◽  
Clinical Setting ◽  
Clinical Trial Methods

scholarly journals Motivational Interviewing in an ordinary clinical setting: A controlled clinical trial at the Swedish National Tobacco Quitline

2013 ◽  
Vol 38 (7) ◽  
pp. 2321-2324 ◽  
Author(s):  
Helena Lindqvist ◽  
Lars G. Forsberg ◽  
Lisa Forsberg ◽  
Ingvar Rosendahl ◽  
Pia Enebrink ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Motivational Interviewing ◽  
Clinical Setting ◽  
Controlled Clinical Trial

How to run a placebo study

2020 ◽  
pp. 478-496
Author(s):  
Fabrizio Benedetti
Keyword(s):  
Clinical Trial ◽  
Placebo Effect ◽  
Clinical Setting ◽  
Experimental Designs ◽  
Placebo Effects ◽  
Clinical Trial Setting ◽  
Agonist And Antagonist ◽  
Underlying Mechanisms ◽  
Trial Setting

This chapter is addressed to those who want to run a study aimed at identifying the underlying mechanisms of placebo effects. To study a placebo effect requires specific designs that cannot be performed in the classic clinical trial setting. Complex experimental designs are particularly necessary when one wants to investigate the neurobiological mechanisms, for example by means of agonist and antagonist drugs. Complex pharmacological designs have used up to twelve experimental arms (groups) in order to answer specific questions. To study the role of learning in placebo effects, for example conditioning, one needs to control the associations between conditioned and unconditioned stimuli both in the experimental and in the clinical setting. In addition, several approaches are possible for hiding a therapy from the subject’s view, so that he is totally unaware that a treatment is being performed, thus allowing the investigation of placebo effects without the administration of placebos.

Evaluation of Potential Antigenicity of Active-Site-Inhibited Recombinant Human FVIIa (FFR-rFVIIa) in an Immune-Tolerant Rat Model

2002 ◽  
Vol 87 (05) ◽  
pp. 836-839 ◽  
Author(s):  
Hanne Kristensen ◽  
Annemarie Kristensen ◽  
Ulla Hedner ◽  
Else Nicolaisen
Keyword(s):  
Clinical Trial ◽  
Intravenous Administration ◽  
Rat Model ◽  
Clinical Setting ◽  
Active Site ◽  
Intraperitoneal Injection ◽  
Parent Compound ◽  
Chemically Modified ◽  
Immune Tolerant ◽  
Induced Tolerance

SummaryRecombinant human FVIIa (rFVIIa) was inactivated by coupling Phe-Phe-Arg-CO- (FFR) covalently to the active site of the enzyme. To test the chemically-modified human protein for potential antigenicity prior to clinical trial an immune-tolerant rat model was established. Intraperitoneal injection of the parent compound, human rFVIIa, within 30 h after birth, followed by repeated subcutaneous challenge with rFVIIa in Freunds incomplete adjuvant resulted in 79% non-responding rats at day 32. Monthly subcutaneous challenge showed that the induced tolerance was stable over the 3 months study period in 80% of the rats. The clinically relevant route, intravenous administration, was used for evaluating the potential antigenicity of FFR-rFVIIa. Repeated intravenous administration of different dosages of FFR-rFVIIa did not break tolerance, indicating that FFR-rFVIIa might not be antigenic, for a limited number of intravenous administrations in a clinical setting.

Methisazone for prophylaxis against chickenpox; a small clinical trial

JAMA ◽  
1966 ◽  
Vol 195 (7) ◽  
pp. 586-588
Author(s):  
D. Reed
Keyword(s):  
Clinical Trial ◽  
Small Clinical Trial

Biracial Testing: The Question of Clinicians' Influence on Children’s Test Performance

1977 ◽  
Vol 8 (1) ◽  
pp. 5-14 ◽  
Author(s):  
David L. Ratusnik ◽  
Roy A. Koenigsknecht
Keyword(s):  
Clinical Setting ◽  
Test Performance ◽  
Test Scores ◽  
Preschool Age ◽  
Speech And Language ◽  
Black And White ◽  
Drawing Test ◽  
Lower Socioeconomic ◽  
Preschool Age Children

Six speech and language clinicians, three black and three white, administered the Goodenough Drawing Test (1926) to 144 preschoolers. The four groups, lower socioeconomic black and white and middle socioeconomic black and white, were divided equally by sex. The biracial clinical setting was shown to influence test scores in black preschool-age children.

Systems of Oppression in Geriatric Clinical Service Delivery

2021 ◽  
pp. 1-3
Author(s):  
Diane L. Kendall
Keyword(s):  
Higher Education ◽  
Service Delivery ◽  
Clinical Setting ◽  
Service Providers ◽  
Hard Work ◽  
Clinical Service ◽  
Meaningful Change ◽  
Important Work ◽  
Speech Language Pathologists ◽  
Medical Institutions

Purpose The purpose of this article was to extend the concepts of systems of oppression in higher education to the clinical setting where communication and swallowing services are delivered to geriatric persons, and to begin a conversation as to how clinicians can disrupt oppression in their workplace. Conclusions As clinical service providers to geriatric persons, it is imperative to understand systems of oppression to affect meaningful change. As trained speech-language pathologists and audiologists, we hold power and privilege in the medical institutions in which we work and are therefore obligated to do the hard work. Suggestions offered in this article are only the start of this important work.

Randomized clinical trial of LigasureTM versus open haemorrhoidectomy

2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial
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