EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ( “EFFECT-BACK”): study protocol for a randomized controlled trial
Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfac... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Rabea Vogt, Julia Haas, Lukas Baumann, Anja Sander, Christina Klose, Jenny Riecke, Winfried Rief, Ulrike Bingel, Dustin Maser, Michael Witth öft, Jens Keßler, Marco Richard Zugaj, Beate Ditzen and Julia Anna Glombiewski Tags: Study protocol Source Type: research
Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial
Multimorbid and frail elderly patients often carry a high burden of treatment. Hospitalization due to the onset of an acute illness can disrupt the fragile balance, resulting in further readmissions after hosp... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Christoph Heinrich Lindemann, Volker Burst, Linus Alexander V ölker, Sebastian Brähler, Dusan Simic, Ingrid Becker, Martin Hellmich, Clarissa Kurscheid, Nadine Scholten, Ruben Krauspe, Kerstin Leibel, Stephanie Stock and Paul Thomas Brinkkoetter Tags: Study protocol Source Type: research
Correction: Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts
(Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Samyra R. Cox, Abhay Kadam, Sachin Atre, Akshay N. Gupte, Hojoon Sohn, Nikhil Gupte, Trupti Sawant, Vishal Mhadeshwar, Ryan Thompson, Emily Kendall, Christopher Hofmann, Nishi Suryavanshi, Deanna Kerrigan, Srikanth Tripathy, Arjunlal Kakrani, Madhusudan S Tags: Correction Source Type: research
Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial
This study adds to a very small number of clinical trials seeking to prevent lethal suicide among a very high-risk group by addressing suicidal ideation directly rather than underlying conditions. It is hypothesized that youth receiving CTSP + SAU will show greater reductions in suicidal ideation (primary outcome), substance use, and depressive symptoms (secondary outcomes) over time compared to SAU alone, as well as improved risk and protective factors.Trial registrationNCT05994612. Date of Registration: August 16, 2023. (Source: Trials)
Source: Trials - March 9, 2024 Category: Research Source Type: clinical trials
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
Emerging adults (EAs) who are not 4-year college students nor graduates are at elevated risk for lifetime alcohol use disorder, comorbid drug use, and mental health symptoms, compared to college graduates. The... (Source: Trials)
Source: Trials - March 9, 2024 Category: General Medicine Authors: James G. Murphy, Ashley A. Dennhardt, Jacob Tempchin, Hannah E. Colgonis, Meghan E. McDevitt-Murphy, Brian Borsari and Kristoffer S. Berlin Tags: Study protocol Source Type: research
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
