Clinical trials: Patient-Reported Outcomes (PRO)
Other Cancer, Gastrointestinal Cancer
Symptom Management Implementation of Patient Reported Outcomes in Oncology
Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize…
- Conditions
- Other Cancer, Gastrointestinal Cancer, Thoracic Cancer, Gynecologic Cancer
- Trial name
- SIMPRO (NCT03850912)
- Testing
- Stakeholder Survey (Control Period), Stakeholder Survey (Intervention Period), Qualitative Interview
- Where
- 6 sites in United States
- Volunteers
- 42,808 people
- Sponsor
- Dana-Farber Cancer Institute
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
Migraine Disorders
An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine
This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.
- Trial name
- NCT01686581
- Testing
- botulinum toxin Type A
- Where
- 77 sites in Germany, Italy and 5 more
- Volunteers
- 641 people
- Sponsor
- Allergan
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer
End Stage Renal Disease
Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to cardiovascular morbidity and mortality among individuals receiving maintenance HD.
- Trial name
- NCT03301740
- Testing
- UF profiling during HD, Conventional HD
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- University of North Carolina, Chapel Hill
Acne Vulgaris
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are…
- Trial name
- PROSES (NCT04820673)
- Testing
- Sarecycline
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Almirall, S.A.
Rheumatoid Arthritis, Ankylosing Spondylitis
Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis
- Trial name
- VALUE (NCT02750800)
- Testing
- Adalimumab, AbbVie Care 2.0
- Volunteers
- 427 people
- Sponsor
- AbbVie
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.
Urinary Bladder, Overactive
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive…
- Trial name
- NCT00613327
- Testing
- Oxybutynin chloride OROS
- Volunteers
- 345 people
- Sponsor
- Janssen Korea, Ltd., Korea
Diabetes Mellitus, Type 2, Patient Education as Topic
Differing Completion Rates of DIABETES Education on Patient Reported Outcomes
The goal of this clinical feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care, diabetes distress…
- Trial name
- DIABETES-PRO (NCT06419907)
- Testing
- Type 2 Live Well (structured diabetes self management education programme)
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- University of Liverpool
Resident Knowledge and Attitudes Regarding Cross-cultural Care, Interpersonal and Communication Skills in Patient-clinician Encounters
The Provider Awareness and Cultural Dexterity Toolkit for Surgeons Trial
This study is designed to test the impact of a new curriculum, called Provider Awareness Cultural Dexterity Toolkit for Surgeons (PACTS), on surgical residents' cross-cultural knowledge, attitudes, and skills surrounding the care…
- Conditions
- Resident Knowledge and Attitudes Regarding Cross-cultural Care, Interpersonal and Communication Skills in Patient-clinician Encounters, Patient-reported Satisfaction With Resident Physicians Involved in Their Care, Patients' Clinical Health Outcomes After Surgery
- Trial name
- PACTS (NCT03576495)
- Testing
- PACTS curriculum, Standard Residency Curriculum
- Where
- 8 sites in United States
- Volunteers
- 2,901 people
- Sponsor
- Brigham and Women's Hospital
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
Hemophilia
Patient Reported Outcomes Burdens and Experiences - Phase 2
The Patient Reported Outcomes, Burdens, and Experiences (PROBE) Study aims to develop a new global tool to enhance the direct patient-voice in health care decision-making.
- Trial name
- PROBE (NCT02439710)
- Testing
- Quality of life measure (survey)
- Where
- Canada
- Volunteers
- 656 people
- Sponsor
- McMaster University
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
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
Pain
EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration…
- Trial name
- TRANSCEND (NCT01919190)
- Testing
- EXPAREL
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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.
Obesity
Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology
This study will assess the feasibility of using patient-centered, commercial off-the-shelf (COTS) health information technology (IT) solutions to collect patient generated health data (PGHD) and patient-reported outcomes (PROs)…
- Trial name
- NCT03386773
- Testing
- 16-week program, Patient generated health data
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Denver Health and Hospital Authority
Plaque Psoriasis
A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults
The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of…
- Trial name
- PRO-SCALP (NCT05811234)
- Testing
- CAL/BDP PAD Cream
- Where
- 37 sites in Germany, Spain and 1 more
- Volunteers
- 291 people
- Sponsor
- Almirall, S.A.
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.