Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Conditions: Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Primary Mediastinal Large B-Cell Lymphoma; Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma Interventions: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Epcoritamab; Procedure: Magnetic Resonance Imaging; Other: Patient Observation; Procedure: Positron Emission Tomography Sponsors: Academic and Community Cancer Research United Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 2, 2024 Category: Research Source Type: clinical trials
HELP (HEalthy Lifestyles Project) for Youth With Mental Distress
Conditions: Mental Health Issue Interventions: Behavioral: Healthy Lifestyles Project e-intervention Sponsors: Children ' s Hospital of Eastern Ontario; Children ' s Hospital Academic Medical Organization (CHAMO); The Physicians ' Services Incorporated Foundation Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 31, 2024 Category: Research Source Type: clinical trials
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
Total Lifestyle Reconstruction for Body Weight Control and Maintenance
Conditions: Overweight and Obesity Interventions: Behavioral: Designed on-line course A with 3-month consultation with the dietitian; Behavioral: Designed on-line course B with 3-month consultation with the dietitian; Behavioral: Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians; Behavioral: Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians Sponsors: Academia Sinica, Taiwan; National Health Research Institutes, Taiwan Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 25, 2024 Category: Research Source Type: clinical trials
Mental Health Literacy and Academic Performance
Conditions: Mental Health Wellness 1 Interventions: Behavioral: Automated Intervention; Behavioral: Blended Intervention Sponsors: University of Bucharest Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 22, 2024 Category: Research Source Type: clinical trials
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
Conditions: Chronic Kidney Diseases; Renal Failure Interventions: Drug: Colchicine Sponsors: Hamilton Health Sciences Corporation; Hamilton Academic Health Sciences Organization; St. Joseph ' s Health Care London Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 12, 2024 Category: Research Source Type: clinical trials
Effectiveness of a blended school-based mindfulness program for the prevention of co-rumination and internalizing problems in Dutch secondary school girls: a cluster randomized controlled trial
This study will provide insights into the short-term and long-term effects of the HFPM program on girls ’ internalizing problems, wellbeing, and social-emotional behavior.Trial registrationInternational Standard Randomized Controlled Trials, identifier: ISRCTN54246670. Registered on 27 February 2023. (Source: Trials)
Source: Trials - January 12, 2024 Category: Research Source Type: clinical trials
Experiences and challenges with the new European Clinical Trials Regulation
ConclusionsCTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials
Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room
Conditions: Sepsis; Septic Shock; Sepsis, Severe; Infections; Infection Viral; Infection, Bacterial; Infections, Respiratory Interventions: Other: No intervention Sponsors: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC); Amsterdam UMC, location VUmc; Flevoziekenhuis Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 21, 2023 Category: Research Source Type: clinical trials
Cluster Randomised Trial Testing Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres
Conditions: Surgical Site Infection Interventions: Other: Intervention: Reusable drapes and gowns; Other: Comparator: Disposable (single-use) drapes and gowns Sponsors: University of Birmingham; Christian Medical College, Vellore, India; Kigali University Teaching Hospital; Lagos State University; Hospital Espa ñol de Mexico; Christian Medical College and Hospital, Ludhiana, India; Centre National Hospitalier Universitaire Hubert Koutoukou MAGA; University for Development Studies, Tamale, Ghana; Chris Hani Baragwanath Academic Hospital Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 11, 2023 Category: Research Source Type: clinical trials
Multicentre Non-inferiority Cluster Randomised Trial Testing Disposable Versus Reusable drApes and Gowns for Green OperatiNg Theatres
Conditions: Surgical Site Infection Interventions: Other: Intervention: Reusable drapes and gowns; Other: Comparator: Disposable (single-use) drapes and gowns Sponsors: University of Birmingham; Christian Medical College, Vellore, India; Kigali University Teaching Hospital; Lagos State University; Hospital Espa ñol de Mexico; Christian Medical College and Hospital, Ludhiana, India; Centre National Hospitalier Universitaire Hubert Koutoukou MAGA; University for Development Studies, Tamale, Ghana; Chris Hani Baragwanath Academic Hospital Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 11, 2023 Category: Research Source Type: clinical trials
Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses ’ experiences
ConclusionsIn conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred c...
Source: Trials - December 11, 2023 Category: Research Source Type: clinical trials
Retifanlimab With Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
Conditions: Recurrent Glioblastoma; Recurrent WHO Grade 4 Glioma Interventions: Biological: Bevacizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Radiation: Hypofractionated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Retifanlimab Sponsors: Academic and Community Cancer Research United; National Cancer Institute (NCI) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 7, 2023 Category: Research Source Type: clinical trials
Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder —study protocol for a randomized controlled trial
DiscussionTo our knowledge, the current study is the first to evaluate the effectiveness of a psychological intervention for students with adjustment disorder. Therefore, it may have important practical implications for students with this disorder. It can potentially guide the development of a scalable, validated treatment option.Trial registrationClinical Trials, NCT05768308, registered 14 March 2023,https://www.clinicaltrials.gov/ct2/show/NCT05768308 (Source: Trials)
Source: Trials - December 1, 2023 Category: Research Source Type: clinical trials
Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial
DiscussionThe ED-AWARENESS-2 Trial will be the first ED-based trial aimed at preventing AWP, a critical threat to patient safety. Results could shape clinical use of NMB in the ED and prevent more than 10,000 annual cases of AWP related to ED care.Trial registrationClinicalTrials.gov identifierNCT05534243. Registered 06, September 2022. (Source: Trials)
Source: Trials - November 25, 2023 Category: Research Source Type: clinical trials
