scholarly journals A randomised controlled trial comparing a dietary antiplatelet, the water-soluble tomato extract Fruitflow, with 75 mg aspirin in healthy subjects

2016 ◽  
Vol 71 (6) ◽  
pp. 723-730 ◽  
Author(s):  
N O'Kennedy ◽  
L Crosbie ◽  
H-J Song ◽  
X Zhang ◽  
G Horgan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Healthy Subjects ◽  
Controlled Trial ◽  
Water Soluble ◽  
Tomato Extract ◽  
Randomised Controlled

scholarly journals Effects of oil-soluble versus water-soluble contrast media at hysterosalpingography on pregnancy outcomes in women with a low risk of tubal disease: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039166
Author(s):  
Guiling Liang ◽  
Qian Zhu ◽  
Xiaoqing He ◽  
Xiaofeng Wang ◽  
Ling Jiang ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Contrast Media ◽  
Live Birth ◽  
Controlled Trial ◽  
Water Soluble ◽  
Low Risk ◽  
Ongoing Pregnancy ◽  
Water Soluble Contrast ◽  
Tubal Disease ◽  
Randomised Controlled

IntroductionIn recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age. Hysterosalpingography (HSG) is a common diagnostic procedure during fertility examinations. However, there is no consensus on the choice of contrast agents and their effects. As the largest multicentre, randomised controlled trial (H2Oil trial from the Netherlands) has shown that oil-soluble contrast at HSG can enhance fertility compared with water-soluble contrast, we propose this study to examine whether the use of oil-soluble contrast media results in increased rates of pregnancy in Chinese women undergoing HSG.Methods and analysisThis study is a single-centre, randomised, controlled, parallel-group, superiority trial. Patients with low risk of tubal disease will be randomised to undergo HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media). To evaluate the potential superiority of the OSCM group, with 1:1 allocation ratio, 90% statistical power and a two-sided significance level of 5%, we have calculated a sample of 520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation. The primary outcome is the rate of ongoing pregnancy during 6 months after randomisation. The secondary outcomes will consist of thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations of the OSCM group/WSCM group, and assisted reproductive technology treatments between the two groups.Ethics and disseminationThis protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 18 January 2020 (approval no GKLW2020-02). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.Trial registration numberChiCTR2000031612.

scholarly journals Wheat bran extract alters colonic fermentation and microbial composition, but does not affect faecal water toxicity: a randomised controlled trial in healthy subjects

2014 ◽  
Vol 113 (2) ◽  
pp. 225-238 ◽  
Author(s):  
Karen Windey ◽  
Vicky De Preter ◽  
Geert Huys ◽  
Willem F. Broekaert ◽  
Jan A. Delcour ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Wheat Bran ◽  
Healthy Subjects ◽  
Controlled Trial ◽  
Microbial Composition ◽  
Colonic Fermentation ◽  
Bifidobacterium Adolescentis ◽  
Wheat Bran Extract ◽  
Randomised Controlled ◽  
Stimulation Of

Wheat bran extract (WBE), containing arabinoxylan-oligosaccharides that are potential prebiotic substrates, has been shown to modify bacterial colonic fermentation in human subjects and to beneficially affect the development of colorectal cancer (CRC) in rats. However, it is unclear whether these changes in fermentation are able to reduce the risk of developing CRC in humans. The aim of the present study was to evaluate the effects of WBE on the markers of CRC risk in healthy volunteers, and to correlate these effects with colonic fermentation. A total of twenty healthy subjects were enrolled in a double-blind, cross-over, randomised, controlled trial in which the subjects ingested WBE (10 g/d) or placebo (maltodextrin, 10 g/d) for 3 weeks, separated by a 3-week washout period. At the end of each study period, colonic handling of NH3was evaluated using the biomarker lactose[15N,15N′]ureide, colonic fermentation was characterised through a metabolomics approach, and the predominant microbial composition was analysed using denaturing gradient gel electrophoresis. As markers of CRC risk, faecal water genotoxicity was determined using the comet assay and faecal water cytotoxicity using a colorimetric cell viability assay. Intake of WBE induced a shift from urinary to faecal15N excretion, indicating a stimulation of colonic bacterial activity and/or growth. Microbial analysis revealed a selective stimulation ofBifidobacterium adolescentis. In addition, WBE altered the colonic fermentation pattern and significantly reduced colonic protein fermentation compared with the run-in period. However, faecal water cytotoxicity and genotoxicity were not affected. Although intake of WBE clearly affected colonic fermentation and changed the composition of the microbiota, these changes were not associated with the changes in the markers of CRC risk.

scholarly journals Hypersensitivity incidence after sugammadex administration in healthy subjects: a randomised controlled trial

2018 ◽  
Vol 121 (4) ◽  
pp. 749-757 ◽  
Author(s):  
K.C. Min ◽  
P. Bondiskey ◽  
V. Schulz ◽  
T. Woo ◽  
C. Assaid ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Healthy Subjects ◽  
Controlled Trial ◽  
Randomised Controlled

Filmed versus Live Social Contact Interventions to Reduce Stigma: A Randomised Controlled Trial

2012 ◽  
Author(s):  
Sarah Clement ◽  
Adrienne van Nieuwenhuizen ◽  
Aliya Kassam ◽  
Ian Norman ◽  
Clare Flach ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Social Contact ◽  
Randomised Controlled
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