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Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children
DiscussionSPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste.Trial RegistrationThe development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35) and CONSORT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reportin...
Source: Trials - January 30, 2024 Category: Research Source Type: clinical trials

The use of healthcare systems data for RCTs
ConclusionsHSD is being used in around two thirds of the studies but cannot yet be used to support PRO data collection within the cohort we examined. Comparison with an earlier cohort demonstrates an increase in the number of RCTs planning to use HSD. (Source: Trials)
Source: Trials - January 29, 2024 Category: Research Source Type: clinical trials

The 1st Tumor CytokinoTherapy Database (TCTD-1)
Conditions: Oncology Interventions: Drug: Tumor necrosis factor alpha; Drug: Interferon gamma Sponsors: OncoCareClinic 308 Ltd Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 25, 2024 Category: Research Source Type: clinical trials

Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework
ConclusionsThe INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed. (Source: Trials)
Source: Trials - January 25, 2024 Category: Research Source Type: clinical trials

Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician ’s perspective
ConclusionThe statistical methodologies implemented in ComFluCOV helped to deliver the study in the timescale set. Working in a new clinical area to tight timescales was challenging. Having two statisticians working together on the study provided a quality assurance process that enabled analyses to be completed efficiently and ensured data were interpreted correctly. Processes developed could be applied to other studies to maximise quality, reduce the risk of errors, and overall provide enhanced validation methods.Trial registrationISRCTN14391248, registered on 30 March 2021 (Source: Trials)
Source: Trials - January 23, 2024 Category: Research Source Type: clinical trials

Construction of Gynecological Tumor Sample Library
Conditions: Gynecologic Cancer Sponsors: Peking Union Medical College Hospital Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 12, 2024 Category: Research Source Type: clinical trials

Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV)
ConclusionThe rapid delivery of ComFluCOV was resource intensive. It was made possible in part due to a unique set of circumstances created by the pandemic situation including measures put in place to support urgent public health research and public support for COVID-19 vaccine research. Elements of the trial could be adopted to increase efficiency in ‘non-pandemic’ situations including working with a clinical trials unit to enable immediate mobilisation of a team of experienced researchers, greater sharing of resources between clinical trials units, use of electronic trial systems and virtual meetings.Trial registrati...
Source: Trials - January 11, 2024 Category: Research Source Type: clinical trials

Development and Validation of a Deep Learning-Based Survival Prediction Model for Pediatric Glioma Patients: A Retrospective Study Using the SEER Database and Chinese Data
Conditions: Glioma Interventions: Other: Survival state Sponsors: Tang-Du Hospital Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 10, 2024 Category: Research Source Type: clinical trials

Multi-omics Database Construction of Healthy Korean Volunteers
Conditions: Healthy Sponsors: Kyunghee University Medical Center; Hanyang University Seoul Hospital Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 27, 2023 Category: Research Source Type: clinical trials

Incidence of Colorectal Cancer in Southwest China: Based on SCC Database
Conditions: Colorectal Cancer Interventions: Other: treatment Sponsors: West China Hospital Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 15, 2023 Category: Research Source Type: clinical trials

Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry
Conditions: Psoriatic Arthritis; Psoriasis Sponsors: Novartis Pharmaceuticals Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 15, 2023 Category: Research Source Type: clinical trials

A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
Conditions: Psychological Stress; Heart Rate Variability; Mental Health Services Sponsors: 40FY Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 15, 2023 Category: Research Source Type: clinical trials

To adopt or adapt an existing neonatal core outcome set in Kenya: a study protocol
ConclusionsA COS for use in neonatal care in Kenya will help enhance outcome measurements and reporting not just in research but also in routine practice. This will enhance the comparability of interventions in trials and routine settings leading to reduced research wastage and likely improved quality of care. Additionally, the methodology used for this work can be adopted in other settings as a means of adopting or adapting an existing COS. (Source: Trials)
Source: Trials - December 15, 2023 Category: Research Source Type: clinical trials

Map of Unwanted Loneliness
Conditions: Loneliness Interventions: Other: Exploration of a database Sponsors: Jos é Joaquín Mira Solves; Centro Internacional para la Investigación del Envejecimiento Enrolling by invitation (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 12, 2023 Category: Research Source Type: clinical trials

A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial
DiscussionThis paper provides a comprehensive description of the statistical analysis plan in order to ensure the reproducibility of the analysis and avoid selective reporting of outcomes and data-driven analysis. Sensitivity analyses have been included in the protocol to assess the impact of intercurrent events related to the coronavirus disease 2019. By focusing on clinically meaningful and robust outcomes, this trial aims to determine whether TUDCA can be effective in slowing the disease progression in patients with ALS.Trial registrationClinicalTrials.govNCT03800524. Registered on January 11, 2019. (Source: Trials)
Source: Trials - December 5, 2023 Category: Research Source Type: clinical trials