Publications by authors named "Sonia Guleria"

Introduction: The Reporting Recommendation Intended for Pharmaceutical Risk Minimisation Evaluation Studies (RIMES) checklist is endorsed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and is tailored for studies assessing Risk Minimisation Measures and Risk Evaluation and Mitigation Strategy (RMM/REMS) effectiveness; however, its awareness and usage remain unknown. We evaluated the implementation of the RIMES checklist in RMM/REMS effectiveness studies registered in the EUPAS register during 01 December 2017- 01 January 2024. Furthermore, the awareness and utilization of the RIMES checklist among researchers conducting RMM/REMS effectiveness studies was assessed.

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Whether fertility treatment increases the risk of ovarian cancer has been a concern for many decades, but previous research has yielded conflicting findings. We therefore investigated this association within a large population-based cohort study of infertile women aged 20-45 years and living in Denmark between 1995 and 2017, as identified in the Danish Infertility Cohort (n = 146,110). The study cohort was linked to nationwide registers to obtain information on fertility drug use, cancer diagnoses, covariates, emigration, and vital status was.

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Article Synopsis
  • - The study examined country-specific regulatory guidance on assessing risk minimization measures (RMM) across five continents, comparing it to the RIMES checklist used for evaluating the effectiveness of pharmaceutical risk assessments.
  • - The findings indicated that European Medical Agency (EMA) and Food and Drug Administration (FDA) guidelines partially aligned with the RIMES checklist, particularly in terms of measures and results, but overall guidance varied greatly by country.
  • - A notable lack of harmonization in RMM guidance was found, with some countries recommending EMA or FDA guidelines, while others, like Brazil and China, had no specific recommendations at all.
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Purpose: There has been rapid growth in the variety and number of real-world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studies. This study aims to assess differences in RWD guidance and variability in current practice for identifying and assessing RWD for studies with regulatory purpose.

Methods: Key criteria for feasibility assessment were mapped against relevant regulatory guidance documents across US, EU, and Asia-Pacific regions.

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Article Synopsis
  • - The study compares cardiovascular risks in patients with type 2 diabetes who started either empagliflozin or dipeptidyl peptidase-4 inhibitors (DPP-4i) across Europe and Asia, focusing on those with and without prior cardiovascular disease (CVD) or heart failure (HF).
  • - Using data from over 85,000 matched patients and advanced statistical methods, the research found that empagliflozin users had a significantly lower risk of hospitalizations for heart failure, cardiovascular mortality, and strokes compared to DPP-4i users.
  • - Overall, the findings indicate that empagliflozin offers protective cardiovascular benefits in diverse populations, regardless of their history of heart disease or heart
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Fertility drugs have not definitively been linked to malignant melanoma. By the use of data from a large nationwide cohort of women aged 20.0-45.

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Purpose: Using data from a large population-based cohort of women with fertility problems in Denmark, we examined the association between use of fertility drugs and endometrial cancer incidence.

Methods: Women aged 20-45 years living in Denmark during 1 January 1995-31 December 2017 and diagnosed with fertility problems (i.e.

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Introduction: Emergency contraceptive pill (ECP) use is reported to have increased in several countries over time. In this multi-country population-based questionnaire study, we aimed to describe the patterns of ECP use and identify factors associated with its use.

Material And Methods: In 2011-2012, women aged 18-45 years were randomly selected from national registers in Denmark, Norway and Sweden and invited to respond to questions related to lifestyle and contraceptive use.

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Background: Studies have shown that fertility treatment in mothers is associated with neurological problems in children. However, knowledge about any association between maternal use of fertility treatment and febrile seizures in children is lacking.

Objective: To determine whether maternal use of fertility treatment is associated with febrile seizures in children.

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Objective: To study the association between extra vitamin D from a mandatory margarine fortification program and chance of live birth among infertile women.

Design: Nationwide cohort study.

Setting: Not applicable.

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Purpose: The importance of benign ovarian tumors as precursors or risk markers for ovarian cancer is not fully understood. Studies on the association between benign ovarian tumors and ovarian cancer have provided inconclusive results. We examined the overall and histological type-specific risk of ovarian cancer among 158,221 Danish women diagnosed with a benign ovarian tumor during 1978-2016.

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Background: Using a nationwide cohort of Danish women, we investigated the association between use of fertility drugs and risk of breast cancer.

Methods: The study cohort included women ages 20 to 44 years and living in Denmark between January 1, 1995 and December 31, 2011. Information on fertility status, use of fertility drugs, breast cancer, covariates, and vital status was obtained from the Danish Infertility Cohort and various Danish national registers.

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Purpose: To assess the association between benign ovarian tumors and subsequent risk of breast cancer, and to examine this association according to type of benign ovarian tumors.

Methods: This nationwide cohort study comprised all Danish women diagnosed with a benign ovarian tumor during 1978-2016 (n = 158,221) identified through the Danish National Patient Register. The cohort was linked to the Danish Cancer Registry to identify all cases of breast cancer, and standardized incidence ratios (SIR) and 95% confidence intervals (CI) were calculated.

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Objective: Women's contraceptive use at first sexual intercourse (FSI) may be associated with subsequent sexual behaviors. We examined associations between contraceptive methods used at FSI and subsequent number of lifetime partners, induced abortions and sexually transmitted infections (STIs).

Study Design: During 2011-2012, we collected questionnaire data from a random sample of women aged 18-45 years from Denmark, Norway and Sweden.

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It is valuable to establish a population-based prevaccination baseline distribution of human papillomavirus (HPV) types among women with high-grade cervical intraepithelial neoplasia (CIN) grade 2 or 3 and cervical cancer in order to assess the potential impact of HPV vaccination. In four countries (Denmark, Norway, Sweden, and Iceland), we collected consecutive series of cervical cancers (n = 639) and high-grade precancerous cervical lesions (n = 1240) during 2004-2006 before implementation of HPV vaccination and subjected the specimens to standardized HPV genotyping. The HPV prevalence was 82.

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Objective: This study examined the associations between current behaviours/characteristics and self-perceived risk for STIs, among randomly selected women aged 18-45 years from Denmark, Norway and Sweden.

Method: A population-based, cross-sectional, questionnaire study (paper based, web based and telephone based) was conducted during 2011-2012. We compared medium-high STI risk perception with no/low risk perception.

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Objective: A growing number of studies suggest that some ovarian cancers can arise from benign and borderline ovarian tumors. However, studies on the association between benign and borderline ovarian tumors are lacking. We studied the overall- and histotype-specific risk of borderline ovarian tumors among women with a benign ovarian tumor.

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Introduction: The aim of this study was to describe recent patterns of contraceptive use at first sexual intercourse and to examine whether selected factors are associated with non-use and emergency contraceptive pill use at first sexual intercourse, among 18- to 26-year-old women from Denmark, Norway and Sweden.

Material And Methods: This was a population-based, questionnaire study of randomly chosen 18- to 26-year-old Scandinavian women. The prevalence of contraception methods used at first sexual intercourse was calculated.

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Peritoneal angiosarcoma is an extremely rare sarcoma (0.01287% incidence per 100,000) with an aggressive clinical course and a poor prognosis. We herein report a case of a young man with diagnosis of angiosarcoma whose tumor adhering to the inferior wall of his bladder and omentum was initially thought to be rhabdomyosarcoma.

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