The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial
This study is a multi-centre randomized controlled trial. A total of 132 adolescents, presenting with either depression, anxiety, or both and significant BPD features will be randomized to either MBT-early or CBT. The severity of BPD, symptoms of depression and anxiety, personality, social and academic functioning, and quality of life will be assessed at baseline, end of treatment, and at 12-, 18-, and 24-month follow-up, along with medical costs and costs of productivity losses for cost-effectiveness analyses.DiscussionThis study will provide an empirical evaluation of the potential surplus value of early intervention in ...
Source: Trials - April 15, 2024 Category: Research Source Type: clinical trials
Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
Conditions: Insomnia; Sleep Initiation and Maintenance Disorders; Health Status; Wearable Electronic Devices; Sleep Interventions: Device: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires Sponsors: University of Sao Paulo General Hospital; Samsung Eletr ônica da Amazônia Ltda; Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 12, 2024 Category: Research Source Type: clinical trials
The Feasibility of Motivational Interviewing on Emotional Authenticity, Dispositional Optimism, And Academic Motivation Among Nursing Students: A Randomized Controlled Trial
Conditions: Nursing Students Interventions: Behavioral: Motivational Interviewing Sponsors: Alexandria University Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 11, 2024 Category: Research Source Type: clinical trials
Developing generic templates to shape the future for conducting integrated research platform trials
ConclusionsThis publication is intended to enhance the use, understanding, and dissemination of the EU-PEARL suite of templates for designing IRPs. The reference user manual and the associated website (http://www.eu-pearl) should facilitate the designing of IRP trials. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study)
This study aimed to develop an m-Health-assisted lifestyle intervention program targeting overweight/obese children and assess its effectiveness on indicators of adiposity and NAFLD.MethodsThis is a cluster-randomized controlled trial that conducted in children with overweight/obesity in Ningbo city, Zhejiang Province, China. Students in Grade 3 (8 –10 years old) were recruited from six primary schools, with three be randomized to intervention group and three to usual practice group. The intervention program will last for one academic year and consists of health education, dietary guidance, and physical activity reinfor...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Growth Process and Development of the Musculoskeletal System in Young Gymnasts
Conditions: Development, Adolescent Interventions: Diagnostic Test: examination Sponsors: University of Haifa; The Academic college Levinsky-Wingate at the Wingate Institute, Netanya, Israel Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 19, 2024 Category: Research Source Type: clinical trials
Promoting Teenage Sleep for Improved Mental Health and School Performance
Conditions: Mental Health Issue; Insomnia; Depression; Anxiety; Daytime Sleepiness; Wellness, Psychological Interventions: Behavioral: Sleep on Schedule; Behavioral: Technology restriction Sponsors: Kristianstad University; Karolinska Institutet; Örebro University, Sweden; Academic Primary Health Care Centre, Region Stockholm Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 12, 2024 Category: Research Source Type: clinical trials
Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa
Conditions: Hidradenitis Suppurativa Interventions: Drug: TIRZEPATIDE Sponsors: Florida Academic Centers Research and Education, LLC Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 8, 2024 Category: Research Source Type: clinical trials
Personalized Innovative Intervention Pathways to Promote EF in Children With CP
Conditions: Executive Functions in Cerebral Palsy Interventions: Other: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities; Other: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills; Other: Game-based tools for the rehabilitation of EF and motor planning Sponsors: IRCCS Fondazione Stella Maris; University of Pisa; University of Florence; Anastasis Societ à Cooperativa Sociale Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 1, 2024 Category: Research Source Type: clinical trials
Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial
This study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Th...
Source: Trials - March 1, 2024 Category: Research Source Type: clinical trials
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
Conditions: Follicular Lymphoma Interventions: Drug: Mosunetuzumab; Drug: Lenalidomide; Drug: Rituximab; Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristin; Drug: Prednisone; Drug: Rituximab; Drug: Obinutuzumab; Drug: Bendamustin Sponsors: The Lymphoma Academic Research Organisation; Lymphoma Study Association; Swiss Group for Clinical Cancer Research; Grupo Espa ñol de Linfomas y Transplante Autólogo de Médula Ósea Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 28, 2024 Category: Research Source Type: clinical trials
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Conditions: Diffuse Large B-cell Lymphoma Refractory; Refractory Primary Mediastinal Large B-Cell Lymphoma; Refractory Transformed B-cell Non-Hodgkin Lymphoma; Refractory High Grade B-Cell Lymphoma Interventions: Drug: golcadomide Sponsors: The Lymphoma Academic Research Organisation; Lymphoma Study Association Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 21, 2024 Category: Research Source Type: clinical trials
LI-TASTE Study: Light for Taste
Conditions: Multiple Myeloma Interventions: Device: LX2.3 Laser and LED Photobiomodulation System; Device: LX2.3 Laser and LED Photobiomodulation System Sham-PBMT Setting Sponsors: Academic Centre for Dentistry in Amsterdam Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 14, 2024 Category: Research Source Type: clinical trials
Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial
This study aims to investigate the benefits of REBOA adjunct to CPR compared with conventional CPR for the clinical management of nontraumatic OHCA.MethodsThis is a parallel-group, randomized, controlled, multinational trial that will be conducted at two urban academic tertiary hospitals in Korea and Taiwan. Patients aged 20 –80 years presenting with witnessed OHCA will be enrolled in this study. Eligible participants must fulfill the inclusion criteria, and written informed consent should be collected from their legal representatives. Patients will be randomly assigned to the intervention (REBOA-CPR) or control (conv en...
Source: Trials - February 13, 2024 Category: Research Source Type: clinical trials
Good Statistical Practice —development of tailored Good Clinical Practice training for statisticians
ConclusionAll research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders. (Source: Trials)
Source: Trials - February 10, 2024 Category: Research Source Type: clinical trials
