Clinical trials: Patient Reported Outcome (PRO)
Diabetic Peripheral Neuropathy
Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the…
- Trial name
- NCT02056431
- Testing
- IVR Intervention Group
- Where
- United States
- Volunteers
- 1,270 people
- Sponsor
- Kaiser Permanente
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.
Kidney Disease, End-Stage
Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)
People living with end-stage kidney disease (ESKD) need dialysis or transplantation in order to stay alive. This illness and treatment significantly impact peoples' health, emotions, work and relationships.
- Trial name
- NCT03149328
- Testing
- Educational Support
- Where
- 2 sites in Canada
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Colorectal Cancer Screening
Promoting Informed Decisions About Cancer Screening in Older Adults
This project aims to examine the impact of different interventions designed to help individualize colorectal cancer (CRC) screening decisions in adults aged 76-85. Clinicians will be assigned by chance to one of two arms.
- Trial name
- PRIMED (NCT03959696)
- Testing
- Notification, Training
- Where
- 5 sites in United States
- Volunteers
- 536 people
- Sponsor
- Massachusetts General Hospital
Rheumatoid Arthritis, Ankylosing Spondylitis
Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)
The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis
- Trial name
- VALUE (NCT02750800)
- Testing
- Adalimumab, AbbVie Care 2.0
- Volunteers
- 427 people
- Sponsor
- AbbVie
Other Cancer, Gastrointestinal Cancer
Symptom Management Implementation of Patient Reported Outcomes in Oncology
Deficits in the management of common symptoms cause substantial morbidity for cancer patients.Because the health care delivery system is structured to be reactive and not proactive, there are missed opportunities to optimize…
- Conditions
- Other Cancer, Gastrointestinal Cancer, Thoracic Cancer, Gynecologic Cancer
- Trial name
- SIMPRO (NCT03850912)
- Testing
- Stakeholder Survey (Control Period), Stakeholder Survey (Intervention Period), Qualitative Interview
- Where
- 6 sites in United States
- Volunteers
- 42,808 people
- Sponsor
- Dana-Farber Cancer Institute
Fallopian Tube Cancer, Ovarian Cancer
Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life
This study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer, Uterine Cancer
- Trial name
- NCT00870233
- Testing
- online platform WEBCORE
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Chronic Heart Failure With Preserved Ejection Fraction
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after…
- Trial name
- VITALITY-HFpEF (NCT03547583)
- Testing
- Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
- Where
- 177 sites in United States, Argentina and 19 more
- Volunteers
- 789 people
- Sponsor
- Bayer
Cosmetic Techniques
Prospective Evaluation of Facial Cosmetic Procedures
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.
- Trial name
- NCT03460158
- Testing
- Restylane-L®, Restylane-L® Lyft, Restylane Silk®
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Rheumatoid Arthritis
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Primary Objective: To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid…
- Trial name
- SariPRO (NCT03449758)
- Testing
- SARILUMAB, Azathioprine, Chloroquine
- Where
- 33 sites in France
- Volunteers
- 84 people
- Sponsor
- Sanofi
Polycythemia Vera
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically…
- Trial name
- NCT01632904
- Testing
- Ruxolitinib, Hydroxyurea (HU)
- Where
- 70 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- Incyte Corporation
Patient Satisfaction, Sports Injury
Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic
This study will compare patient reported outcomes (PROs) of patients seen at virtual phone visits compared to in-person visits for 6 weeks, 12 weeks, and 6 months post-operative follow up at a sports medicine clinic.
- Conditions
- Patient Satisfaction, Sports Injury, Surgery, Orthopedic Disorder
- Trial name
- NCT05998148
- Testing
- virtual phone appointment visits
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Jonathan Wu
Atopic Dermatitis
ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate…
- Trial name
- NCT03645057
- Testing
- Crisaborole, Tacrolimus 0.03% Ointment
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- University of Rochester
Foot Injury, Foot Deformity
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
The main purpose of this study is to find out if scanning the foot using a 3D scanner influences the effectiveness of custom made insoles, compared to the more traditional approach of taking a foam-box impression cast of the…
- Conditions
- Foot Injury, Foot Deformity, Foot Sprain, Feet, Flat
- Trial name
- NCT05444192
- Testing
- CAD/CAM insoles
- Where
- United Kingdom
- Volunteers
- 114 people
- Sponsor
- NHS Greater Glasgow and Clyde
Idiopathic Pulmonary Fibrosis
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
- Trial name
- NCT05497284
- Testing
- LTP001, Standard of Care (SoC)
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Inflammatory Bowel Disease (IBD)
Translating Scientific Evidence Into Practice Using Digital Medicine and Electronic Patient Reported Outcomes
Delivery of healthcare has been traditionally limited to in-person visits or hospitalizations, while patients spend the majority of their time at home or work. Digital Medicine (e.g.
- Trial name
- NCT04345393
- Testing
- Digital Transformation Network (DTN) Program
- Where
- 4 sites in United States
- Volunteers
- 659 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Breast Cancer
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
- Trial name
- JBCRG-26 (NCT04736576)
- Testing
- Wearable device
- Where
- 20 sites in Japan
- Volunteers
- 99 people
- Sponsor
- Pfizer
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.
Premature Ejaculation
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with lifelong PE.
- Trial name
- NCT03055806
- Testing
- IX-01 400 mg, IX-01 800 mg, IX-01 1200 mg
- Where
- 29 sites in United States
- Volunteers
- 239 people
- Sponsor
- Ixchelsis Limited
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.