Clinical trials: Patient-Reported Outcomes
Multiple Sclerosis
A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting
This national, open-label study is designed to give complementary efficacy, safety and patient reported outcomes (PROs) data in participants with active relapsing forms of MS.
- Trial name
- PRO-MSACTIVE (NCT03589105)
- Testing
- Ocrelizumab 300 mg, Ocrelizumab 600 mg
- Where
- 46 sites in France
- Volunteers
- 423 people
- Sponsor
- Hoffmann-La Roche
Severe Asthma
Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients
This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia…
- Trial name
- iOUTRUN (NCT05603845)
- Where
- 24 sites in Colombia, Dominican Republic and 6 more
- Volunteers
- 291 people
- Sponsor
- AstraZeneca
Endometriosis
Validation Study for Endometriosis PRO
Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in…
- Trial name
- VALEPRO (NCT01643122)
- Testing
- No drug
- Where
- 21 sites in United States, Germany
- Volunteers
- 275 people
- Sponsor
- Bayer
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
Crohn's Disease, Ulcerative Colitis (UC)
Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient reported outcomes and utilization of health resources over 12 months.
- Conditions
- Crohn's Disease, Ulcerative Colitis (UC), Rheumatoid Arthritis (RA), Psoriatic Arthritis
- Trial name
- IMPROVE (NCT03223012)
- Where
- 15 sites in Portugal
- Volunteers
- 116 people
- Sponsor
- AbbVie
Hypertrophic Cardiomyopathy (HCM)
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice.
- Trial name
- COLLIGO-HCM (NCT06372457)
- Testing
- Approved Hypertrophic Cardiomyopathy drug treatments, Mavacamten
- Where
- United States
- Volunteers
- 331 people
- Sponsor
- Bristol-Myers Squibb
Myelodysplastic Syndrome (MDS)
Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among…
- Trial name
- NCT07008820
- Testing
- Health-related quality of life questionnaires, Qualitative interviews
- Where
- Japan
- Volunteers
- 56 people
- Sponsor
- Bristol-Myers Squibb
Eosinophilic Esophagitis
A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany
This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with…
- Trial name
- ProMEAL (NCT06695897)
- Testing
- Dupilumab
- Where
- 15 sites in Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
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
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
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
Severe Eosinophilic Asthma
Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.
This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.
- Trial name
- POWER (NCT03833141)
- Testing
- Survey Administration
- Where
- 20 sites in Canada
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
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
Pulmonary Disease, Chronic Obstructive, Infections, Bacterial
Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)
The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT00259909
- Testing
- GSK questionnaire, St. George's Respiratory Questionnaire, Acute Short Form 12 version 2
- Where
- 123 sites in United States, Germany and 1 more
- Volunteers
- 259 people
- Sponsor
- GlaxoSmithKline
Kidney Maintenance Transplant
Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are…
- Trial name
- NCT00150007
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 335 people
- Sponsor
- Novartis Pharmaceuticals
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.
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
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
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche