Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial
DiscussionThe results of this study will inform alcohol prevention efforts for high-risk community dwelling emerging adults.Trial registrationClinicalTrials.gov Identifier: NCT04776278. (Source: Trials)
Source: Trials - March 9, 2024 Category: Research Source Type: clinical trials
IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS)
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severely debilitating condition which markedly restricts activity and function of affected people. Since the beginning of the COVID-19 pandemic ... (Source: Trials)
Source: Trials - March 7, 2024 Category: General Medicine Authors: Hannah Pre ßler, Marie-Luise Machule, Friederike Ufer, Isabel Bünger, Lucie Yuanting Li, Emilie Buchholz, Claudia Werner, Esther Beraha, Frank Wagner, Matthes Metz, Susen Burock, Lisa Bruckert, Christiana Franke, Nicola Wilck, Anne Krüger, Alexander Re Tags: Study protocol Source Type: research
IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS)
DiscussionAlthough ME/CFS including PACS-CFS causes an immense individual, social, and economic burden, we lack efficient therapeutic options. The present study aims to investigate the efficacy of immunoadsorption and to contribute to the etiological understanding and establishment of diagnostic tools for ME/CFS.Trial registrationRegistration Number:NCT05710770. Registered on 02 February 2023. (Source: Trials)
Source: Trials - March 7, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the PRO B study: open-label, superiority randomised controlled trial of alarm-based patient-reported outcome monitoring in patients with metastatic breast cancer
ConclusionThis detailed SAP defines the main components of the statistical analysis for the PRO B study to assist the statistician and prevent bias in selecting analysis and reporting findings. Version 1 of the SAP was finalised on January 18, 2024.Trial registrationDRKS (German Clinical Trials Register)DRKS00024015. Registered on February 15, 2021. (Source: Trials)
Source: Trials - March 7, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the PRO B study: open-label, superiority randomised controlled trial of alarm-based patient-reported outcome monitoring in patients with metastatic breast cancer
With an increasing collection of patient-reported outcomes (PROs) to measure health-related quality of life (HRQoL) in oncological patients, there is still a lack of standardised strategies on how to interpret... (Source: Trials)
Source: Trials - March 7, 2024 Category: General Medicine Authors: Pimrapat Gebert, Maria Margarete Karsten, Anna Maria Hage, Adam David Dordevic and Ulrike Grittner Tags: Update Source Type: research
The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT
DiscussionThe World Health Organization (WHO) added UNIMMAP-MMS to its essential medicine lists in 2021 but recommended rigorous study. Several factors in addition to inadequate intakes of iron and folic acid contribute to the high prevalence of anemia among WRA in the Somali region. The findings of this study will provide evidence on the effect of UNIMMAP-MMS and IFA on Hb concentrations and anemia prevalence among anemic WRA.Trial registrationClinicalTrials.gov NCT05682261. Registered on January 12, 2023. (Source: Trials)
Source: Trials - March 6, 2024 Category: Research Source Type: clinical trials
UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial
DiscussionBased on preclinical and early pilot clinical evidence, we want to test the novel concept of temporary (lymph)angioregressive pretreatment of high-risk eyes by CXL to promote subsequent corneal graft survival. So far, there is no evidence-based approach to reliably improve graft survival in the high-risk corneal transplantation setting available in clinical routine. If successful, this approach will be the first to promote graft survival in high-risk transplants. It will significantly improve vision and quality of life in patients suffering from corneal blindness.Trial registrationClinicalTrials.gov NCT05870566. ...
Source: Trials - March 6, 2024 Category: Research Source Type: clinical trials
UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial
Good vision highly depends on the transparency of the cornea, which is the “windscreen” of the eye. In fact, corneal blindness due to transparency loss is the second most common cause of blindness worldwide, a... (Source: Trials)
Source: Trials - March 6, 2024 Category: General Medicine Authors: Johanna Wiedemann, Deniz Hos, Endrik Limburg, Ulrike Zettelmeyer, Petra Schiller, Jeremy Franklin, Bj örn Bachmann, Daniel Böhringer, Tina Dietrich-Ntoukas, Thomas A. Fuchsluger, Gerd Geerling, Stefan J. Lang, Wolfgang Johann Mayer, Siegfried Priglinger Tags: Study protocol Source Type: research
The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT
Women of reproductive age (WRA) in developing countries are often at risk of micronutrient deficiencies due to inadequate intakes and excessive losses. (Source: Trials)
Source: Trials - March 6, 2024 Category: General Medicine Authors: Desalegn Kuche, Zeweter Abebe, Masresha Tessema, Meron Girma, Alemayehu Hussen, Kaleab Baye and Barbara J. Stoecker Tags: Study protocol Source Type: research
The effects of intermittent fasting diet on quality of life, clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis: study protocol of a randomized controlled trial
DiscussionStudies show fasting has beneficial effects on inflammatory markers and results in an improvement in the health of different populations. Literature review shows it seems there is no study in this field to evaluate the effects of IF on RA patients, and they are limited to other types of fasting. However, studies show IF can have many positive effects on chronic and autoimmune diseases. Therefore, IF may have positive effects on these patients.Trial registrationIRCT20230217057441N1. Registered on 14 February 2023.https://en.irct.ir/user/trial/68669. (Source: Trials)
Source: Trials - March 5, 2024 Category: Research Source Type: clinical trials
Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST)
This article describes the study protocol for the first randomized controlled trial (RCT) of fluoridated water that assesses its potential dental caries preventive efficacy when delivered in bottles.MethodswaterBEST is a phase 2b proof-of-concept, randomized, quadruple-masked, placebo-controlled, parallel-group trial designed to estimate the potential efficacy of fluoridated versus non-fluoridated bottled water to prevent dental caries incidence in the first 4 years of life. Two hundred children living in eastern North Carolina, USA, and aged 2 –6 months at screening are being allocated at random in a 1:1 ratio to receiv...
Source: Trials - March 5, 2024 Category: Research Source Type: clinical trials
The effects of intermittent fasting diet on quality of life, clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis: study protocol of a randomized controlled trial
Rheumatoid arthritis (RA) is known as a chronic systemic autoimmune disorder that primarily targets synovial joints, and may cause pain and functional limitations. Studies show diet can have beneficial effects... (Source: Trials)
Source: Trials - March 5, 2024 Category: General Medicine Authors: Mahsa Ranjbar, Sakineh Shab-Bidar, Abdolrahman Rostamian, Hamed Mohammadi and Kurosh Djafarian Tags: Study protocol Source Type: research
Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST)
Fluoridation of public water systems is known as a safe and effective strategy for preventing dental caries based on evidence from non-randomized studies. Yet 110 million Americans do not have access to a fluo... (Source: Trials)
Source: Trials - March 5, 2024 Category: General Medicine Authors: Anne E. Sanders, Kimon Divaris, Tewodros R. Godebo and Gary D. Slade Tags: Study protocol Source Type: research
Evaluation of a financial incentive intervention on malaria prevalence among the residents in Lake Victoria basin, Kenya: study protocol for a cluster-randomized controlled trial
In the Lake Victoria basin of western Kenya, malaria remains highly endemic despite high coverage of interventions such as mass distribution of long-lasting insecticidal nets (LLIN), indoor residual spraying (... (Source: Trials)
Source: Trials - March 4, 2024 Category: General Medicine Authors: Tomoya Matsumoto, Masaru Nagashima, Wataru Kagaya, James Kongere, Jesse Gitaka and Akira Kaneko Tags: Study protocol Source Type: research
Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial
Endovascular thrombectomy (EVT) is a standard treatment for acute ischemic stroke (AIS) with large vessel occlusion. Hypertension and increased blood pressure variability within the first 24 h after successful... (Source: Trials)
Source: Trials - March 4, 2024 Category: General Medicine Authors: Li-na Yang, Yi Sun, Yu-zhu Wang, Jing Wang, Yi-sha Qi, Shan-shan Mu, Yun-peng Liu, Zi-qing Zhang, Zi-mo Chen, Xiao-jie Wang, Wu-xiang Xie, Chang-wei Wei, Yang Wang and An-shi Wu Tags: Study protocol Source Type: research
