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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

Dr. Pabulo Rampelotto

E-Mail Website
Collection Editor
Clinical Hospital of Porto Alegre (HCPA), affiliated with the Federal University of Rio Grande do Sul, Porto Alegre 91501-970, Brazil
Interests: microbiome; molecular microbiology; metagenomics; omics; biostatistics; next-generation sequencing; clinical research; bioinformatics; biotechnology; system biology; grand challenges
Special Issues, Collections and Topics in MDPI journals
Dr. Anca Oana Docea

E-Mail
Collection Editor
Department of Toxicology, University of Medicine and Pharmacy of Craiova, 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, 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 (4 papers)

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2025

Jump to: 2024

11 pages, 827 KiB  
Protocol
The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery: Protocol of a Prospective Randomized Controlled Trial
by Jakub Szrama, Agata Gradys, Amadeusz Woźniak, Zuzanna Nowak, Tomasz Bartkowiak, Ashish Lohani, Krzysztof Zwoliński, Tomasz Koszel and Krzysztof Kusza
Life 2025, 15(3), 400; https://doi.org/10.3390/life15030400 - 4 Mar 2025
Viewed by 623
Abstract
Introduction: Microvascular free flap surgery is a treatment method for patients with head and neck cancer requiring reconstruction surgery. Patients undergoing this complex, long-lasting surgery are prone to prolonged episodes of intraoperative hypotension, which is associated with increased incidence of postoperative mortality, morbidity, [...] Read more.
Introduction: Microvascular free flap surgery is a treatment method for patients with head and neck cancer requiring reconstruction surgery. Patients undergoing this complex, long-lasting surgery are prone to prolonged episodes of intraoperative hypotension, which is associated with increased incidence of postoperative mortality, morbidity, and free flap failure. A new technology recently approved, named the Hypotension Prediction Index (HPI), allows precise hemodynamic monitoring of patients under general anesthesia, with a significant reduction of intraoperative hypotension events. This study aims to assess the impact of the Hypotension Prediction Index (HPI) on the incidence and severity of intraoperative hypotension in patients undergoing free flap surgery. Methods and analysis: Eligible patients will be randomly assigned to one of two groups: Group A, receiving invasive blood pressure monitoring with standard medical therapy, or Group B, undergoing hemodynamic monitoring using the Hypotension Prediction Index (HPI) software. The primary outcome is the time-weighted average (TWA) of mean arterial pressure (MAP) < 65 mmHg. Secondary outcomes include free flap viability and perioperative complications. Ethics and dissemination: Ethics approval was obtained from the Poznan University of Medical Sciences Ethics Committee (KB-560/22; date 1 July 2022). Results will be submitted for publication in a peer-reviewed journal. Trial registration number: NCT 05738603. Full article
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19 pages, 2409 KiB  
Article
Efficacy of Phlai (Zingiber montanum) Spray Cool Formula in Managing Upper Trapezius Myofascial Pain Syndrome: A Randomized Controlled Trial
by Prakairat Tunit, Nurmee Mahama, Nursawiyah Mina, Nasrin Chi, Suwanna Maenpuen, Pornchai Sawangwong, Waratta Hemtong, Phasit Sirited and Chuda Chittasupho
Life 2025, 15(3), 360; https://doi.org/10.3390/life15030360 - 25 Feb 2025
Viewed by 608
Abstract
Phlai (Zingiber montanum) has long been valued for its anti-inflammatory and analgesic properties in traditional medicine. This study aimed to develop and assess the physical stability, chemical composition, and clinical efficacy of a novel Phlai spray cool formula (PSCF) compared to [...] Read more.
Phlai (Zingiber montanum) has long been valued for its anti-inflammatory and analgesic properties in traditional medicine. This study aimed to develop and assess the physical stability, chemical composition, and clinical efficacy of a novel Phlai spray cool formula (PSCF) compared to a diclofenac spray (DS) in patients with chronic myofascial pain syndrome. The chemical analysis revealed curcumin (28.73 ± 5.73 mg/100 g), β-sitosterol (50.92 ± 1.27 mg/100 g), and lauric acid (38.86 ± 1.72 g/100 g) as key active compounds. PSCF demonstrated stable physicochemical properties, including pH and peroxide value across storage conditions. In a randomized controlled trial involving 66 participants, PSCF and DS groups exhibited comparable reductions in pain intensity, as measured by the Visual Analog Scale (VAS), from baseline to week 2. Both groups also showed significant improvements in neck disability index (NDI), pressure pain threshold (PPT), and cervical range of motion (CROM). By week 2, the increase in CROM for flexion and extension reached 23.54 ± 4.09° and 19.43 ± 3.20°, respectively, with no significant intergroup differences. The SF-36 health survey indicated notable improvements in overall health status and quality of life, particularly in physical and emotional domains. The analgesic effects of PSCF are attributed to the combined action of menthol, β-sitosterol, and curcumin. The study demonstrated that PSCF offers a therapeutic effect comparable to diclofenac spray without adverse reactions, highlighting its potential as an alternative topical analgesic for chronic myofascial pain management. Full article
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20 pages, 1398 KiB  
Article
Health Benefits of Montmorency Tart Cherry Juice Supplementation in Adults with Mild to Moderate Ulcerative Colitis; A Placebo Randomized Controlled Trial
by Jonathan Sinclair, Graham McLaughlin, Robert Allan, Johanne Brooks-Warburton, Charlotte Lawson, Shan Goh, Terun Desai and Lindsay Bottoms
Life 2025, 15(2), 306; https://doi.org/10.3390/life15020306 - 17 Feb 2025
Viewed by 1393
Abstract
Aims: Ulcerative colitis (UC) significantly impacts individuals’ self-perception, body image, and overall quality of life, while also imposing considerable economic costs. These challenges highlight the necessity for complementary therapeutic strategies with reduced adverse effects to support conventional pharmacological treatments. Among natural interventions, Montmorency [...] Read more.
Aims: Ulcerative colitis (UC) significantly impacts individuals’ self-perception, body image, and overall quality of life, while also imposing considerable economic costs. These challenges highlight the necessity for complementary therapeutic strategies with reduced adverse effects to support conventional pharmacological treatments. Among natural interventions, Montmorency tart cherries, noted for their high anthocyanin content have emerged as a natural anti-inflammatory agent for UC. The current trial aimed to investigate the effects of Montmorency tart cherries compared to placebo in patients with mild to moderate UC. Materials and methods: Thirty-five patients with UC were randomly assigned to receive either placebo or Montmorency tart cherry juice, of which they drank 60 mL per day for 6 weeks. The primary outcomes and health-related quality of life, measured via the Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ), and the secondary measures, including other health-related questionnaires, blood biomarkers, and faecal samples, were measured before and after the intervention. Linear mixed-effects models were adopted to contrast the changes from baseline to 6 weeks between trial arms. Effect sizes were calculated using Cohen’s d. Results: There were significantly greater improvements in the IBDQ (22.61 (95% CI = 5.24 to 39.99) d = 0.90) and simple clinical colitis activity index (−3.98 (95% CI = −6.69 to –1.28) d = −1.01) in the tart cherry trial arm compared to placebo. In addition, reductions in faecal calprotectin levels were significantly greater in the tart cherry trial arm compared to placebo (−136.17 µg/g (95% CI = −258.06 to –4.28) d = −1.14). Loss to follow-up (N = 1) and adverse events (N = 1) were low and compliance was very high in the tart cherry (95.8%) trial arm. Conclusions: Given the profoundly negative effects of UC on health-related quality of life and its fiscal implications for global healthcare systems, this trial indicates that twice-daily tart cherry supplementation can improve IBD-related quality of life as well as the severity of symptoms and therefore may be important in the management of UC. Full article
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2024

Jump to: 2025

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
Cited by 2 | Viewed by 1789
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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