How to promote ‘discipline without tough love’ during pregnancy: a randomized controlled trial

2019 ◽

Vol 8 ◽

pp. 1936

Author(s):

Shunji Suzuki

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trial ◽

Pregnant Women ◽

Corporal Punishment ◽

Controlled Trial ◽

Japanese Version ◽

Japanese Women ◽

Randomized Controlled ◽

Singleton Pregnancies ◽

Prospective Investigation

Background: In Japan, the effect of education using the leaflet ‘Discipline Without Tough Love’ on mothers during caring for their infants have been reported. We examined the effect of this education on pregnant Japanese women. Methods: The present study was a prospective investigation of all Japanese women with singleton pregnancies who visited our hospital for a perinatal visit at 20-23 weeks’ gestation between November 2017 and March 2018 and gave birth at ≥ 37 weeks’ gestation at our hospital. We examined the maternal feelings (bonding situation) to babies of women who received the leaflet in comparison with that in women who did not receive it during the health check-up performed routinely at one month after delivery using the Japanese version of the Mother-to-Infant Bonding Scale. Results: There were no significant differences in maternal feelings for their babies between the two groups of women. Conclusions: We did not identify any effect of health consultations cased on ‘Discipline Without Tough Love’ during pregnancy on maternal feelings toward babies at one month after delivery. A further study to enlighten pregnant women about parenting without corporal punishment will be needed in Japan. Registration: Japan Registry of Clinical Trials 1030190112; registered on 5 October 2019.

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351-OR: Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes: Cost-Effectiveness Analyses of the CONCEPTT Randomized Controlled Trial

Diabetes ◽

10.2337/db19-351-or ◽

2019 ◽

Vol 68 (Supplement 1) ◽

pp. 351-OR

Author(s):

HELEN R. MURPHY ◽

DENICE FEIG ◽

NASHITA PATEL

Keyword(s):

Randomized Controlled Trial ◽

Type 1 Diabetes ◽

Cost Effectiveness ◽

Pregnant Women ◽

Continuous Glucose Monitoring ◽

Controlled Trial ◽

Glucose Monitoring ◽

Randomized Controlled

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Faculty Opinions recommendation of Effect of lifestyle intervention on dietary habits, physical activity, and gestational weight gain in obese pregnant women: a randomized controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1280988.746106 ◽

2009 ◽

Author(s):

Marleen van Baak

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Weight Gain ◽

Pregnant Women ◽

Lifestyle Intervention ◽

Gestational Weight Gain ◽

Dietary Habits ◽

Controlled Trial ◽

Gestational Weight ◽

Randomized Controlled

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Faculty Opinions recommendation of United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717954585.793463271 ◽

2012 ◽

Author(s):

Yiqian Nancy You ◽

Brian Keith Bednarski

Keyword(s):

United States ◽

Colon Cancer ◽

Clinical Trials ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

United States Military ◽

Randomized Controlled ◽

Pathological Evaluation

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Mitochondrial Reprogramming—What Is the Benefit of Hypothermic Oxygenated Perfusion in Liver Transplantation?

Transplantology ◽

10.3390/transplantology2020015 ◽

2021 ◽

Vol 2 (2) ◽

pp. 149-161

Author(s):

Rebecca Panconesi ◽

Mauricio Flores Carvalho ◽

Matteo Mueller ◽

Philipp Dutkowski ◽

Paolo Muiesan ◽

...

Keyword(s):

Liver Transplantation ◽

Clinical Trials ◽

Randomized Controlled Trial ◽

Cohort Studies ◽

Controlled Trial ◽

Machine Perfusion ◽

Randomized Controlled ◽

Hypothermic Perfusion ◽

Underlying Mechanisms ◽

Circulatory Death

Although machine perfusion is a hot topic today, we are just at the beginning of understanding the underlying mechanisms of protection. Recently, the first randomized controlled trial reported a significant reduction of ischemic cholangiopathies after transplantation of livers donated after circulatory death, provided the grafts were treated with an endischemic hypothermic oxygenated perfusion (HOPE). This approach has been known for more than fifty years, and was initially mainly used to preserve kidneys before implantation. Today there is an increasing interest in this and other dynamic preservation technologies and various centers have tested different approaches in clinical trials and cohort studies. Based on this, there is a need for uniform perfusion settings (perfusion route and duration), and the development of general guidelines regarding the duration of cold storage in context of the overall donor risk is also required to better compare various trial results. This article will highlight how cold perfusion protects organs mechanistically, and target such technical challenges with the perfusion setting. Finally, the options for viability testing during hypothermic perfusion will be discussed.

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Testing Meldonium: Assessing Soviet pragmatic alternatives to the randomized controlled trial

Clinical Trials ◽

10.1177/17407745211008540 ◽

2021 ◽

pp. 174077452110085

Author(s):

Anastasiya Chirkova ◽

Alexander Petrenko ◽

Pavel Vasilyev

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trial ◽

Soviet Union ◽

Drug Testing ◽

Controlled Trial ◽

Randomized Controlled ◽

Experimental Drugs ◽

The Soviet Union ◽

Experimental Drug ◽

Second World

Background/aims Current research largely tends to ignore the drug-testing model that was developed in the “Second World” as an explicit alternative to the randomized controlled trial. This system can be described as “socialist pharmapolitics,” accounting for the specific features of state socialism that influenced the development and testing of experimental drugs. The clinical trials model employed in the “Second World” was heavily influenced by the Soviet Union, which was by far the most influential player in the socialist bloc during the Cold War. Based on extensive archival research, this article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It accounts for the divergences between the official model prescribed by the Soviet authorities and the messy realities of healthcare practice. It further outlines different factors that ultimately shaped how clinical trials were organized in Soviet institutions “on the ground.” Accordingly, this article presents a “real-life” history of “socialist pharmapolitics” and outlines the problems that this system faced in practice. Methods Archival research was conducted at the Russian State Archive of Scientific and Technical Documentation in Moscow. Archival files include scientific, technical, and registration documentation such as biochemical, pharmacological, and clinical descriptions of the experimental drug Meldonium, letters between various hospitals, research institutes and the Soviet regulatory body, as well as 26 reports of completed clinical trials. Manual content analysis was used for the interpretation of results. Results This article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It demonstrates some key differences from the randomized controlled trial model. This article also highlights some of the discrepancies between the model that was officially prescribed by the Soviet authorities and the realities of experimental drug testing in the Soviet Union in the late 1980s and early 1990s. In particular, it notes some elements of randomization, double-blinding, and the use of placebo that were present in Meldonium trials despite being formally denounced by Soviet bioethics. Conclusion The Soviet model for testing experimental drugs differed from the Western one substantially in a number of respects. This difference was not only proclaimed officially by the Soviet authorities, but was for the most part enforced in clinical trials in practice. At the same time, our research demonstrates that there were important differences between the official model and the clinical realities on the ground.

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