Clinical trials: Patient Reported Outcome
Hemophilia A
Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment
The purpose of the study is to improve the understanding of key patient reported outcomes such as quality of life as well as clinical outcomes in hemophilia A, in a global real world setting.
- Trial name
- ECHO (NCT02396862)
- Testing
- Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222)
- Where
- 10 sites in United States, Japan and 2 more
- Volunteers
- 272 people
- Sponsor
- Bayer
Crohn Disease
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 months following treatment…
- Trial name
- EARLY-CD (NCT04349449)
- Where
- 14 sites in Canada
- Sponsor
- Takeda
Relapsing Remitting Multiple Sclerosis
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates…
- Trial name
- EPOC (NCT01534182)
- Testing
- Fingolimod, Interferon beta - 1a (IFN), Glatiramer acetate (GA)
- Where
- 26 sites in Russia
- Volunteers
- 298 people
- Sponsor
- Novartis Pharmaceuticals
Moderate to Severe Chronic Plaque Psoriasis
Post Marketing Observational Study on Venezuelan Patients With Psoriasis
The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.
- Trial name
- NCT01758705
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Ankle Injuries, Syndesmotic Injuries
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT05190874
- Testing
- Grappler Interference Screw System
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Paragon 28
Hip Arthritis, Osteoarthritis, Hip
Observational Study to Collect Safety Data and PROMs on Primary THA
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis
- Trial name
- NCT06518993
- Testing
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Corin
Ovarian Cancer, Hereditary Ovarian Cancer Syndrome
C-PATROL - Non-interventional Study (NIS) to Collect Clinical and Patient Reported Outcome Data in an Olaparib Treated BRCAm+ PSR Ovarian Cancer Population
The main objective of the proposed non-interventional study is to obtain real-world effectiveness, safety and treatment patterns data of patients with BRCAm+ (Breast Cancer Gene(s) mutation positive) platinum sensitive relapsed…
- Trial name
- C-PATROL (NCT02503436)
- Where
- 68 sites in Germany
- Volunteers
- 276 people
- Sponsor
- AstraZeneca
Friedreich's Ataxia
Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)
This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia.
- Trial name
- PROTI (NCT01303406)
- Testing
- Idebenone
- Where
- 6 sites in Austria, Germany and 2 more
- Volunteers
- 29 people
- Sponsor
- Santhera Pharmaceuticals
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
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.
Open Angle Glaucoma, Ocular Hypertension
Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health
The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle…
- Trial name
- NCT00892762
- Testing
- Travoprost APS 40 micrograms/ml eye drop solution, Latanoprost 50 micrograms/ml eye drop solution
- Volunteers
- 434 people
- Sponsor
- Alcon Research
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.
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
Multiple Sclerosis, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their…
- Trial name
- IMPROVE (NCT02323269)
- Testing
- dimethyl fumarate
- Where
- 10 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Biogen
Knee Arthroplasty, Total
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using…
- Trial name
- NCT05516381
- Testing
- Optetrak Logic CR Knee System
- Where
- Spain
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Exactech
Relapsing Remitting Multiple Sclerosis
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
- Trial name
- ILLUMINATE (NCT05949580)
- Testing
- MS Care Platform (icobrain ms and icompanion ms)
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Nonrestorative Sleep
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument…
- Trial name
- NCT00705601
- Testing
- PSG
- Where
- 13 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Pfizer
Metastatic Pancreatic Cancer, NSCLC, Metastatic
Patient Reported Outcomes Registry in Patient With Cancer Cachexia
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.
- Trial name
- PROXie (NCT02983500)
- Where
- Germany
- Volunteers
- 253 people
- Sponsor
- iOMEDICO AG
Rheumatoid Arthritis
Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting.
- Trial name
- FILOSOPHY (NCT04871919)
- Testing
- Filgotinib
- Where
- 89 sites in Belgium, Germany and 4 more
- Volunteers
- 1,304 people
- Sponsor
- Alfasigma S.p.A.