Clinical trials: Patient Reported Outcome (PRO)
Erectile Dysfunction
A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation
The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to…
- Trial name
- NCT00210678
- Testing
- No intervention
- Volunteers
- 1,115 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Metatarsus Adductus, Hallux Valgus
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction.
- Trial name
- MTA3D (NCT05587569)
- Testing
- Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure
- Where
- 9 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
COVID-19, Coronavirus Disease 2019
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
The main purpose of this study is to understand: the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses) the potential effects of…
- Conditions
- COVID-19, Coronavirus Disease 2019, Influenza
- Trial name
- NCT05160636
- Testing
- COVID-19 Vaccine
- Where
- United States
- Volunteers
- 999 people
- Sponsor
- Pfizer
Neovascular Age-related Macular Degeneration
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
- Trial name
- Sightspire (NCT06847542)
- Testing
- Susvimo PDS Implant, Ranibizumab
- Where
- 61 sites in Austria, Czechia and 11 more
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
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.
Renal Transplant
Measurement of Patient Reported Outcomes in Korean Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms
This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated…
- Trial name
- NCT00529269
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- 2 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Hemophilia A, Hemophilia B
Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by…
- Trial name
- FORWARD (NCT02392156)
- Testing
- rFVIIIFc, rFIXFc, non-Fc FVIII replacement products
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Bioverativ Therapeutics Inc.
COVID-19
Pilot Test of COVID-19 Related Clinical Outcome Assessment Methodology and Qualitative Evidence of Content Validity
COVID-19 is an acute respiratory disease caused by Severe Acute Respiratory Syndrome coronavirus (SARS-CoV). Synairgen is currently conducting a global Phase III clinical trial of SNG001 to determine efficacy and safety in…
- Trial name
- NCT05207293
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 29 people
- Sponsor
- Synairgen Research Ltd.
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.
- Trial name
- PROTEC (NCT01930708)
- Testing
- dimethyl fumarate
- Where
- 90 sites in Austria, Belgium and 9 more
- Volunteers
- 1,114 people
- Sponsor
- Biogen
Prostate Cancer Patients Treated by Radiotherapy
Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
This study is testing a shorter treatment method for prostate cancer using proton therapy (PT), which is very precise and may cause fewer side effects compared to traditional radiation.
- Trial name
- PT2 (NCT07130682)
- Testing
- Pencil Beam Proton Therapy Treatment Machine
- Where
- Hong Kong
- Volunteers
- 35 people
- Sponsor
- Hong Kong Sanatorium & 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
Severe Asthma
Real-world Study Assessing Efficacy of TezepeLumaB in Patients With Severe Asthma Regardless of Phenotype in Russia
ELBRUS is a 12-month (52-week), multi-centre, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess patient-reported outcomes after tezepelumab…
- Trial name
- ELBRUS (NCT06566885)
- Where
- 15 sites in Russia
- Volunteers
- 125 people
- Sponsor
- AstraZeneca
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
Renal Cell Carcinoma
Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced Renal Cell Carcinoma
Evaluation of patient reported outcomes ( PRO) regarding typical ailments in the REAL LIFE Renal Cell Carcinoma population
- Trial name
- PROKidney (NCT02537743)
- Where
- Germany
- Volunteers
- 98 people
- Sponsor
- iOMEDICO AG
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
Ulcerative Colitis
A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice
The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.
- Trial name
- NCT04963725
- Testing
- Ustekinumab
- Where
- 23 sites in Japan
- Volunteers
- 137 people
- Sponsor
- Janssen Pharmaceutical K.K.
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
Premature Ejaculation
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
This is a Phase 2a, double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and patient-reported outcomes of KH-001 in men with lifelong premature ejaculation (LPE).
- Trial name
- NCT07434271
- Testing
- KH-001 ODT
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Kadence Bio
Hip Disease
ACE Acetabular Cup UK Multi-centre PMCF Study
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket.
- Trial name
- NCT04123431
- Testing
- Total Hip Replacement
- Where
- United Kingdom
- Volunteers
- 225 people
- Sponsor
- JRI Orthopaedics
Nonrestorative Sleep
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncovering problems in instrument…
- Trial name
- NCT00705601
- Testing
- PSG
- Where
- 13 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Pfizer