Clinical trials: Patient-Reported Outcome Measures
Coccidioidomycosis, Disseminated Fungal Infection
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
The purpose of this study is to test measurement tools (questionnaire about symptoms and a questionnaire about quality of life) to assess usability in the assessment of treatment effectiveness for people with disseminated…
- Conditions
- Coccidioidomycosis, Disseminated Fungal Infection, Coccidioides Infection, Coccidioides Immitis Infection
- Trial name
- COCCIMETRICS (NCT07712484)
- Testing
- Olorofim
- Volunteers
- 50 people
- Sponsor
- F2G Ltd
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.
Multiple Myeloma, Refractory Multiple Myeloma
Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data.
- Trial name
- NCT05053607
- Testing
- Digital Health Coaching Program, Fitbit
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Pack Health
Journey II BCS Total Knee System
Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
- Trial name
- JIIPROMS (NCT03903731)
- Testing
- Total knee arthroplasty with Journey II BCS Total Knee System
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 600 people
- Sponsor
- Smith & Nephew, Inc.
Hemophilia A
GAS-Hem Feasibility Study
The purpose of this study is to investigate the feasibility and acceptability of the Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported outcome (PRO) measure to monitor clinical progress in…
- Trial name
- NCT02674997
- Testing
- Factor VIII
- Where
- 4 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Baxalta now part of Shire
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Ovarian Cancer, Breast Cancer
Comprehensive Outcomes for After Cancer Health
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer.
- Conditions
- Ovarian Cancer, Breast Cancer, Lung Cancer, Gastric Cancer
- Trial name
- COACH (NCT05349227)
- Testing
- Digital Health Coaching Program, Fitbit
- Where
- 7 sites in United States
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Pack Health
Chronic Obstructive Pulmonary Disease
Outcomes in Real-life After Initation of Treatment With Trixeo (Budesonide / Glycopyrronium / Formoterol)
The aim of the CHOROS ORION study is to describe patients' clinical and self-reported outcomes of treatment with BGF in Italy through effectiveness, clinical and self-reported measures assessed pre- and post-treatment initiation…
- Trial name
- CHOROS ORION (NCT05862545)
- Testing
- BGF (budesonide/glycopyrrolate/formoterol fumarate)
- Where
- 20 sites in Italy
- Volunteers
- 250 people
- Sponsor
- AstraZeneca
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
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.
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