Clinical trials: Patient-Reported Outcomes
Thoracic Surgery
Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization…
- Trial name
- NCT04342260
- Testing
- Active Monitoring, Passive Monitoring
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Premature Ejaculation
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with lifelong PE.
- Trial name
- NCT03055806
- Testing
- IX-01 400 mg, IX-01 800 mg, IX-01 1200 mg
- Where
- 29 sites in United States
- Volunteers
- 239 people
- Sponsor
- Ixchelsis Limited
Inflammatory Bowel Disease (IBD)
Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g.
- Trial name
- NCT04345393
- Testing
- Digital Transformation Network (DTN) Program
- Where
- 4 sites in United States
- Volunteers
- 659 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Human Immunodeficiency Virus Type 1 (HIV-1)
Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study
This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the…
- Trial name
- NCT05896748
- Testing
- Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
- Where
- 30 sites in United States, Canada and 4 more
- Volunteers
- 94 people
- Sponsor
- ViiV Healthcare
Leukemia, Chronic Myeloid, Cancer
The EMPATHY Pilot Study
The proposed study, may significantly contribute to improve healthcare delivery in patients with Chronic Myeloid Leukemia (CML) treated with modern tyrosine kinase inhibitors (TKIs) in two ways.
- Trial name
- NCT04384848
- Testing
- EMPATHY Pilot
- Where
- 16 sites in United States, Italy
- Volunteers
- 94 people
- Sponsor
- Northwestern University
Osteoarthritis of the Knee
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than…
- Trial name
- Bioskin (NCT02295020)
- Testing
- Standard treatment only, Standard treatment plus Bioskin Ten-7 knee brace
- Volunteers
- 40 people
- Sponsor
- Cropper Medical
Keratosis, Actinic
Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
The purpose of the study is to evaluate patient reported outcomes (PROs) in terms of health-related quality of life (HRQoL) among subjects with actinic keratosis (AK).
- Trial name
- PROAK (NCT05260073)
- Testing
- Tirbanibulin
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Almirall, S.A.
Excessive Daytime Sleepiness, Narcolepsy
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Trial name
- NCT00228566
- Testing
- Armodafinil
- Where
- 43 sites in United States
- Volunteers
- 247 people
- Sponsor
- Cephalon
Knee Arthroplasty, Patient Engagement
Limited Market Release - MotionSense Clinical Use Evaluation
Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
- Conditions
- Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
- Trial name
- FS5 (NCT05091918)
- Testing
- MotionSense
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Orthosensor, Inc.
Chronic Kidney Disease Requiring Chronic Dialysis
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
Individuals with kidney failure receiving maintenance hemodialysis (HD) have high mortality rates, driven largely by cardiovascular causes.
- Trial name
- NCT04622709
- Testing
- Furosemide (loop diuretic) Tablets
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- University of North Carolina, Chapel Hill
Total Knee Arthroplasty, Arthroplasty of Knee
Navio With Total Knee Arthroplasty
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments.
- Trial name
- NCT03317834
- Testing
- Navio ™ Robotic-assisted Surgical System
- Where
- 6 sites in United States
- Volunteers
- 122 people
- Sponsor
- Smith & Nephew, Inc.
Hearing Loss
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
Lung Cancer, Neoplasms, Lung
Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
The purpose of this study is to demonstrate how Moovcare®, a mobile medical application, can be used to monitor Patient-Reported Outcomes (PROs) related to cancer treatment, cancer complications, and cancer relapse in patients…
- Conditions
- Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer
- Trial name
- LC-PRO (NCT05011890)
- Testing
- Moovcare® use
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Restless Legs Syndrome
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Colorectal Cancer Screening
Promoting Informed Decisions About Cancer Screening in Older Adults
This project aims to examine the impact of different interventions designed to help individualize colorectal cancer (CRC) screening decisions in adults aged 76-85. Clinicians will be assigned by chance to one of two arms.
- Trial name
- PRIMED (NCT03959696)
- Testing
- Notification, Training
- Where
- 5 sites in United States
- Volunteers
- 536 people
- Sponsor
- Massachusetts General Hospital
Arthritis, Rheumatoid
Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions
This study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib or…
- Trial name
- NCT03073109
- Where
- 13 sites in Colombia, Peru
- Volunteers
- 170 people
- Sponsor
- Pfizer
Osteosarcoma, Nephrotoxicity
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with…
- Conditions
- Osteosarcoma, Nephrotoxicity, Ototoxicity
- Trial name
- NCT01848457
- Testing
- Pantoprazole, High-dose methotrexate infusion duration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
Cancer, Lung Cancer
PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
Telemedicine allows clinicians to utilize modern telecommunication technology to provide healthcare services to patients including remote symptom monitoring.
- Conditions
- Cancer, Lung Cancer, Gastro-intestinal
- Trial name
- PROStep (NCT04616768)
- Testing
- PRO questionnaire, Step monitoring, Active nudge text feedback
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Pancreas Transplantation, Kidney Transplantation
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00267150
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS)
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced…
- Trial name
- NCT03104322
- Testing
- patientMpower platform, usual care
- Where
- Ireland
- Volunteers
- 7 people
- Sponsor
- patientMpower Ltd.