Clinical trials: Patient Reported Outcome Measures
Total Knee Replacement
Qualitative Interviews With Healthcare Professionals
PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement…
- Trial name
- NCT05597046
- Testing
- Interview
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Invibio Ltd
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
Hallux Valgus
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Trial name
- NCT03846687
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Ipsen
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
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
Vulvodynia
Validation of Patient Reported Outcome Measures for Use in Vulvodynia
The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric…
- Trial name
- NCT03770169
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Growth Hormone Deficiency in Children
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
The aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence").
- Trial name
- NCT03672617
- Testing
- No treatment given
- Where
- Germany
- Volunteers
- 321 people
- Sponsor
- Novo Nordisk A/S
Pulmonary Disease, Chronic Obstructive
Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation…
- Trial name
- NCT01684384
- Testing
- Functional Respiratory Imaging
- Where
- 4 sites in Belgium, Italy and 1 more
- Volunteers
- 53 people
- Sponsor
- FLUIDDA nv
Breast Cancer
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy…
- Trial name
- MAGProm (NCT06610539)
- Where
- 2 sites in United States
- Volunteers
- 184 people
- Sponsor
- Endomagnetics Ltd.
Meniscus Tear
SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single…
- Trial name
- NCT05491564
- Testing
- SoftStitch™
- Volunteers
- 50 people
- Sponsor
- Arthrex, 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
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
Urinary Incontinence
An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT07282860)
- Testing
- PureWick System, UltraFlex Self-Adhering Male External Catheter
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard
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.
Oral Mucositis
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with…
- Trial name
- NCT04595838
- Testing
- Chemo Mouthpiece, Best Supportive Care only
- Where
- 11 sites in United States
- Volunteers
- 176 people
- Sponsor
- Chemo Mouthpiece
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.
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
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.
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