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Life
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Clinical Trials
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Clinical Trials

A topical collection in Life (ISSN 2075-1729). This collection belongs to the section "Medical Research".

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Editors

Prof. Dr. Pabulo H. Rampelotto

E-Mail Website
Collection Editor
Bioinformatics and Biostatistics Core Facility, Institute of Basic Health Sciences, Federal University of Rio Grande do Sul, Porto Alegre 91501-970, Brazil
Interests: microbiome; molecular microbiology; metagenomics; omics; next-generation sequencing; microbial ecology; bioinformatics; biotechnology; system biology; grand challenges
Special Issues, Collections and Topics in MDPI journals
Dr. Anca Oana Docea

E-Mail Website
Collection Editor
Department of Toxicology, University of Medicine and Pharmacy of Craiova, 200349 Craiova, Romania
Interests: risk-assessment; pesticides; metabolic disorders; neurotoxicology; mixtures; animal studies
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Katalin Prokai-Tatrai

E-Mail Website
Collection Editor
Department of Pharmacology and Neuroscience, University of North Texas Health Science Center, 3500 Camp Bowie Blvd, Fort Worth, TX 76107, USA
Interests: drug design of central nervous system agents; neuropeptides and peptidomimetics; prodrugs for CNS delivery; CNS-selective estrogen therapy; neuroprotection; proteomics
Special Issues, Collections and Topics in MDPI journals

Topical Collection Information

Dear Colleagues,

This Topical Collection covers all aspects of the performance and findings of randomized controlled trials in human health. We publish articles on general trial methodology, research into trial processes, study protocols, statistical analysis plans for randomized controlled trials and traditional result papers, regardless of the outcome or significance of the findings. We also welcome systematic reviews of randomized controlled clinical trials.

Our goal is to promote transparency in reporting randomized trials and build an evidence base to inform the design and reporting of future trials. We consider articles or study protocols assessing aspects of the design, conduct or reporting of trials, as well as assessment and evaluation of lessons learned from past trials, including those that were prematurely ended. We advocate for the collective success of trials and the importance of linking publications together.

To facilitate the complete and transparent reporting of research, this Collection does not impose strict word upper limits. We request that the authors provide the details required to make the research replicable. Authors are asked to communicate not only all outcome measures, varying analyses and interpretations, but also in-depth descriptions of what they did and what they learned. This sharing of direct experience is fundamental to improving the quality and conduct of trials worldwide.

Prof. Dr. Pabulo H. Rampelotto
Dr. Anca Oana Docea
Prof. Dr. Katalin Prokai-Tatrai
Collection Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the collection website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Life is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • adverse events
  • clinical research
  • drug
  • intervention
  • protocol
  • Randomized
  • therapy
  • treatment

Published Papers (1 paper)

2024

11 pages, 630 KiB  
Protocol
Comprehensive Evaluation of a Levonorgestrel Intrauterine Device (LNG-IUD), Metformin, and Liraglutide for Fertility Preservation in Endometrial Cancer: Protocol for a Randomized Clinical Trial
by Gergő Leipold, Richárd Tóth, Péter Hársfalvi, Lotti Lőczi, Marianna Török, Attila Keszthelyi, Nándor Ács, Balázs Lintner, Szabolcs Várbíró and Márton Keszthelyi
Life 2024, 14(7), 835; https://doi.org/10.3390/life14070835 - 29 Jun 2024
Viewed by 465
Abstract
Endometrial cancer is a leading gynecological malignancy, with obesity being a significant risk factor due to increased estrogen production in body fat. Current treatments often involve hysterectomy, which precludes fertility, thus highlighting the need for fertility-preserving options. This study aims to evaluate the [...] Read more.
Endometrial cancer is a leading gynecological malignancy, with obesity being a significant risk factor due to increased estrogen production in body fat. Current treatments often involve hysterectomy, which precludes fertility, thus highlighting the need for fertility-preserving options. This study aims to evaluate the combined efficacy of a levonorgestrel intrauterine device (LNG-IUD), metformin, and liraglutide for treating women with endometrial hyperplasia or early stage endometrial cancer while preserving fertility. The study will enroll 264 women aged 18–45 with a BMI > 30 who desire uterine preservation. Participants will be randomized into three groups: LNG-IUD alone, LNG-IUD plus metformin, and LNG-IUD plus metformin and liraglutide. Primary outcomes will include complete pathological remission, while secondary outcomes will assess histological changes, glucose, insulin levels, and weight changes over a 12-month period. This study protocol hypothesizes that LNG-IUD combined with metformin and liraglutide may potentially lead to higher regression rates of endometrial hyperplasia (EH) and early stage endometrial cancer (EC) compared to LNG-IUD alone. Furthermore, the protocol anticipates that these combination therapies will demonstrate good tolerability with minimal adverse effects, suggesting the potential benefit of integrating metabolic interventions with LNG-IUD to enhance treatment efficacy while preserving fertility in women with EH and EC. Full article
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