Clinical trials: Patient-Reported Outcomes
Anterior Cruciate Ligament Rupture
BFRT in Adolescents After ACL Reconstruction
This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR).
- Trial name
- NCT04390035
- Testing
- Blood Flow Restriction using Delfi Personalized Tourniquet System
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Children's Healthcare of Atlanta
Metatarsus Adductus, Hallux Valgus
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction.
- Trial name
- MTA3D (NCT05587569)
- Testing
- Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
- Where
- 9 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Breast Augmentation
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
- Trial name
- MIRO (NCT05449587)
- Testing
- MRI and PRO
- Where
- 2 sites in Costa Rica
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Periprosthetic Knee Infection
Outcome After Revisions of Infected Knee Arthroplasties
A prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.
- Trial name
- RIKA (NCT04427943)
- Testing
- revision surgery
- Where
- 8 sites in Denmark
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Celiac Disease in Children, Celiac Disease
Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease
A multicentre, prospective observational study to develop the CELIAC-Q KIDS patient reported outcome measure for children and adolescents with celiac disease.
- Conditions
- Celiac Disease in Children, Celiac Disease, Patient-reported Outcome Measures
- Trial name
- NCT05548166
- Testing
- Interview and scale development
- Where
- 2 sites in Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- McMaster University
Congenital Heart Disease
Transition Care Model for Adolescents With Congenital Heart Disease
The primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD).
- Trial name
- TELEMACO (NCT05713591)
- Testing
- Transition care model
- Where
- Italy
- Volunteers
- 964 people, healthy volunteers welcome
- Sponsor
- IRCCS Policlinico S. Donato
Eosinophilic Esophagitis
A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany
This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with…
- Trial name
- ProMEAL (NCT06695897)
- Testing
- Dupilumab
- Where
- 15 sites in Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi
Joint Arthrodesis, Joint Fixation
The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)
Post-market, observational, multicenter, unblinded, ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate™ product.
- Trial name
- SPRINT™ (NCT06548581)
- Testing
- SpeedPlate™ Rapid Compression Implants
- Where
- 5 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Asthma in Children
Personalised Outcomes in Children With Recurrent Wheeze
This project aims to develop a PROM for preschool children with recurrent wheeze. Nearly one third of children will have at least one episode of wheeze in the first five years of life.
- Trial name
- NCT03858010
- Testing
- Wheeze and me questionnaire
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
Pain
Screening Protocol
This study is a screening evaluation for volunteers who are interested in participating in National Center for Complementary and Integrative Health (NCCIH) research studies about pain and related processes, such as emotion, mood…
- Trial name
- NCT07712874
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
Influenza-like Illness, Upper Respiratory Disease
Non-specific Effects of Rabies Vaccine
Vaccines work by stimulating the body to produce a high-quality, rapid and specific immune response upon exposure to infection by a particular disease-causing microorganism - the microorganism targeted by the vaccine.
- Conditions
- Influenza-like Illness, Upper Respiratory Disease, Diarrhea, Fever
- Trial name
- NCT03656198
- Testing
- Rabivax-S, Sterile Water Injection
- Where
- Saint Kitts and Nevis
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Ross University School of Veterinary Medicine
Weight Loss, Bariatric Surgery
Outcomes After Weight Loss Surgery in Low-Risk Patients
The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients.
- Trial name
- NCT05699083
- Testing
- Body Image/Self-Esteem Questionnaires
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Feiz & Associates
Patient Safety
Improving Patient Safety in Spanish Primary Care (PC) Centres
Background: Patient safety has been defined as "the avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the processes of healthcare"[1].
- Trial name
- SinergiAPS (NCT03837912)
- Testing
- Patient reported safety experiences fed back to PC providers
- Where
- Spain
- Volunteers
- 1,248 people, healthy volunteers welcome
- Sponsor
- Fundació d'investigació Sanitària de les Illes Balears
Palliative Care, Wearable Electronic Devices
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care
Non-professional carers (typically family members) play a critical role in providing adequate home care. This research explores the use of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor…
- Conditions
- Palliative Care, Wearable Electronic Devices, Patient Reported Outcome Measures, Cancer
- Trial name
- wePRO-CASA (NCT05273580)
- Testing
- Garmin VivoSmart 4, mema - ilumivu
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Royal North Shore Hospital
Substance Use, Substance-Related Disorders
Clinician Practice Companion to Address Youth Substance Use
Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States.
- Conditions
- Substance Use, Substance-Related Disorders, Adolescent Substance Use, Cannabis Use
- Trial name
- NCT07725289
- Testing
- Practice Companion
- Where
- 5 sites in United States, Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Family Members, Cancer
Evaluation of FROM-16 in ATMP Patients & Families
Poor health, and its treatment, has impact beyond the healthcare system into wider society. A person's productivity, taxable earnings, benefit payments and community contribution may all be adversely affected by poor health.
- Trial name
- NCT05141318
- Testing
- FROM-16 Questionnaire, Semi-structured two-part interview
- Where
- 5 sites in United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Swansea University
Survivorship, Cancer
Patient-Reported Outcome Version of the Common Criteria for Adverse Events
Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death.
- Trial name
- NCT04050072
- Testing
- Childhood Cancer Survivors (CCSS), SJLIFE, Community non-cancer control
- Where
- United States
- Volunteers
- 837 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital
Arthroplasty, Replacement, Knee
The Association of Gait Kinematics, Instability and Patient Reported Outcomes in Patients With Total Knee Replacement
It is unclear why 20% of patients with total knee replacements (TKR) are dissatisfied. Few studies have specifically assessed the way people walk ('gait') with an 'unhappy' or unstable knee or following re-do ('revision') TKR…
- Trial name
- NCT03896191
- Testing
- Revision TKR surgery, No intervention.
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Bath
Patient Comfort, Malocclusion
Comparison of Patient-Reported Comfort Between Two Clear Aligner Trimming-Line Designs: A Split-Mouth Study
The trimming-line design of clear aligners (supragingival versus juxtagingival) is a routine clinical decision whose influence on patient-reported comfort has not been established; available evidence on aligner comfort derives…
- Conditions
- Patient Comfort, Malocclusion, Oral Health
- Trial name
- COMFORT-ALIGN (NCT07660809)
- Testing
- Supragingival trimming-line design, Juxtagingival festooned trimming-line design
- Where
- Romania
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Patient Reported Outcome Measures, Compliance
Motivating Survey Compliance: Game Play Study 1
Self-reports, especially for patients with chronic physical or mental diseases, are critical for disease research and drug development.
- Trial name
- NCT03738254
- Testing
- The Guardians: A smartphone game, Paper Survey, Electronic Survey
- Where
- United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Massachusetts Institute of Technology