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Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Assessment of willingness and determinants to receive the COVID-19 vaccine among the general population of the Somali region, Eastern Ethiopia: a 2021 cross-sectional study

Por: Wolde · M. · Wasihun · Y. · Melesse · A. · Tadesse · T. · Sharma · R. · Mon · H. S. · Challa · A. · Simireta · T. · Addisu · H.
Objective

This research aimed to assess COVID-19 vaccine acceptance and the factors influencing it among the population of the Somali region in Ethiopia through a cross-sectional COVID-19 survey.

Design

Community-based cross-sectional study.

Setting

The survey was conducted in eight selected districts of the Somali region in Ethiopia from 20 October 2021 to 30 October 2021.

Participants

Participants were chosen using simple random sampling and data analysis used Stata V.14. Both bivariable and multivariable binary logistic regression methods were applied, with variables having a p value below 0.2 considered for inclusion in the final model, where statistically significant factors were identified at p

Primary outcome measure

Willingness to take the vaccine.

Results

A total of 1010 respondents participated in this study. The proportion of people’s willingness to take the vaccine was 65% (95% CI 62 to 68). When you believe moderately or highly that getting a COVID-19 vaccine will protect others (AOR=6.2, 95% CI 1.43 to 26.6) and (AOR=7.2, 95% CI 1.7 to 29.7), then you will protect others as well. Whereas, a desire to get vaccinated little, moderately and highly (AOR=4.3, 95% CI 1.77 to 10.4), (AOR=20, 95% CI 8.5 to 47) and (AOR=147, 95% CI 55 to 392), respectively, was significantly associated with willingness to take the vaccine. Moreover having close family and friends who want them to get a COVID-19 vaccine (AOR=2, 95% CI 1.2 to 3.57) and religious leaders or community leaders (AOR=1.8, 95% CI 1 to 3.1) were significant factors in the multivariable logistic regression model.

Conclusion

This study found that COVID-19 vaccine acceptance was low in the Somali region. Factors positively linked to one’s willingness to get vaccinated included the belief that it protects others, personal desire for vaccination and support from family, friends, community and religious leaders.

Does atrial fibrillation affect prognosis in hospitalised COVID-19 patients? A multicentre historical cohort study in the Netherlands

Por: Spruit · J. R. · Jansen · R. W. M. M. · de Groot · J. R. · de Vries · T. A. C. · Hemels · M. E. W. · Douma · R. A. · de Haan · L. R. · Brinkman · K. · Moeniralam · H. S. · de Kruif · M. · Dormans · T. · Appelman · B. · Reidinga · A. C. · Rusch · D. · Gritters van den Oever · N. C.
Objectives

The aim of this multicentre COVID-PREDICT study (a nationwide observational cohort study that aims to better understand clinical course of COVID-19 and to predict which COVID-19 patients should receive which treatment and which type of care) was to determine the association between atrial fibrillation (AF) and mortality, intensive care unit (ICU) admission, complications and discharge destination in hospitalised COVID-19 patients.

Setting

Data from a historical cohort study in eight hospitals (both academic and non-academic) in the Netherlands between January 2020 and July 2021 were used in this study.

Participants

3064 hospitalised COVID-19 patients >18 years old.

Primary and secondary outcome measures

The primary outcome was the incidence of new-onset AF during hospitalisation. Secondary outcomes were the association between new-onset AF (vs prevalent or non-AF) and mortality, ICU admissions, complications and discharge destination, performed by univariable and multivariable logistic regression analyses.

Results

Of the 3064 included patients (60.6% men, median age: 65 years, IQR 55–75 years), 72 (2.3%) patients had prevalent AF and 164 (5.4%) patients developed new-onset AF during hospitalisation. Compared with patients without AF, patients with new-onset AF had a higher incidence of death (adjusted OR (aOR) 1.71, 95% CI 1.17 to 2.59) an ICU admission (aOR 5.45, 95% CI 3.90 to 7.61). Mortality was non-significantly different between patients with prevalent AF and those with new-onset AF (aOR 0.97, 95% CI 0.53 to 1.76). However, new-onset AF was associated with a higher incidence of ICU admission and complications compared with prevalent AF (OR 6.34, 95% CI 2.95 to 13.63, OR 3.04, 95% CI 1.67 to 5.55, respectively).

Conclusion

New-onset AF was associated with an increased incidence of death, ICU admission, complications and a lower chance to be discharged home. These effects were far less pronounced in patients with prevalent AF. Therefore, new-onset AF seems to represent a marker of disease severity, rather than a cause of adverse outcomes.

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