Clinical trials: Patient Reported Outcome (PRO)
Migraine
Study to Assess Effectiveness of Oral Atogepant in Adult Participants For Prevention of Migraine in the United Kingdom
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound.
- Trial name
- PRACTICE (NCT07690215)
- Volunteers
- 200 people
- Sponsor
- AbbVie
Remote Patient Monitoring in COPD Patients
Compare the Effect of a Remote Monitoring System Using the EXACT Tool to Reduce Hospitalizations Due to Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. EXACT = Exacerbations of Chronic Pulmonary Disease Tool.
The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing hospitalization from Chronic Obstructive…
- Trial name
- PREMIERE (NCT01744028)
- Testing
- Remote Patient Monitoring, Usual care
- Where
- 20 sites in Spain, Sweden
- Volunteers
- 118 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Rhinosinusitis With Nasal Polyps
Tezepelumab CRSwNP Real World Study (CREW Study)
The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)
- Trial name
- CREW (NCT07790198)
- Testing
- Tezepelumab
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Crohn's Disease
Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )
This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).
- Trial name
- PRADA (NCT02896985)
- Where
- 24 sites in Canada
- Volunteers
- 98 people
- Sponsor
- AbbVie
Craniotomy
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months).
- Trial name
- NCT06780852
- Testing
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- RevBio
Psoriasis
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
The objective of this non-interventional, observational study is to assess the effectiveness and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in real world clinical practice in China.
- Trial name
- ADAPT (NCT03236870)
- Where
- 15 sites in China
- Volunteers
- 181 people
- Sponsor
- AbbVie
Hemophilia A
Patient-reported Outcomes in Subjects Treated With ReFacto AF Routine Prophylaxis
This NIS aims to assess the patient-reported outcomes (PROs) in enrolled subjects
- Trial name
- NCT02718677
- Testing
- Refacto AF
- Sponsor
- Pfizer
Kidney Transplantation
Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation
The purpose of this study is to develop and validate a questionnaire to assess the quality of life when the recipients of kidney transplantation switched their medication from tacrolimus twice daily (BID regimen) to Advagraf…
- Trial name
- NCT03623217
- Testing
- Qualitative interviews with participants
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma Korea, Inc.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the…
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life
- Trial name
- STOPGSMP (NCT06962345)
- Testing
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Mucosa Innovations, S.L.
Obstructive Hypertrophic Cardiomyopathy
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.
- Trial name
- COMPASS-HCM (NCT06551129)
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Bristol-Myers Squibb
Primary Sclerosing Cholangitis
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
- Trial name
- NCT02247934
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
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.
Migraine Disorders, Chronic Migraine Headache
EMBRACE-OBS: Single-Site Observational Registry of Patient-Reported Outcomes Following MMA Embolization for Migraine
EMBRACE-OBS is the first phase of the EMBRACE research program. This single-site observational registry accesses and analyzes patient-reported outcome data already collected through routine clinical care from adults with migraine…
- Conditions
- Migraine Disorders, Chronic Migraine Headache, Migraine
- Trial name
- EMBRACE-OBS (NCT07652034)
- Testing
- Middle Meningeal Artery Embolization
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Cortex Neurovascular
Knee Osteoarthritis
Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severely symptomatic osteoarthritis…
- Trial name
- STRIDES-1 (NCT04385303)
- Testing
- Lorecivivint
- Where
- 76 sites in United States
- Volunteers
- 496 people
- Sponsor
- Biosplice Therapeutics, 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
Atopic Dermatitis, Dermatology
A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
The primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting.
- Conditions
- Atopic Dermatitis, Dermatology, Vitiligo, Alopecia Areata
- Trial name
- ClinPRO-DERM (NCT05084417)
- Testing
- N/A This is an observational study
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- OM1, Inc.
Advanced Sarcoma, Metastatic Sarcoma
Study of the Impact of Digital Health Interventions on Symptom & Side-Effect Management in Metastatic Sarcoma Patients
The objective of this prospective study is to capture the quality of life of patients with locally advanced or metastatic sarcoma, and investigate the effectiveness of support provided through a personalized web-based platform.
- Trial name
- SARC-Digital (NCT07642375)
- Testing
- Digital support
- Where
- 11 sites in Greece
- Volunteers
- 108 people
- Sponsor
- CareAcross
Parkinson Disease (PD), Parkinson's Disease
Real-world Patient Experiences With Inbrija®
Parkinson's disease can cause OFF episodes, when medication effects wear off and symptoms return, affecting movement, daily activities, comfort, and wellbeing.
- Conditions
- Parkinson Disease (PD), Parkinson's Disease, Off Episodes of Parkinson Disease
- Trial name
- INHALE-PD (NCT07797790)
- Testing
- Levodopa inhalation powder
- Where
- 2 sites in Austria
- Volunteers
- 120 people
- Sponsor
- Merz Therapeutics GmbH