Clinical trials: Patient-Reported Outcomes (PRO)
Breast Neoplasms, Breast Cancer
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor…
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Trial name
- PROVIDENCE (NCT05573893)
- Where
- 109 sites in Germany
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Hypophosphatasia
Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)
This observational study will evaluate the treatment effect of Strensiq (asfotase alfa) on Patient Reported Outcomes (PROs) in participants diagnosed with pediatric-onset hypophosphatasia (HPP) registered in the patient support…
- Trial name
- NCT04195763
- Testing
- asfotase alfa
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Arthroplasty, Replacement, Knee, Unicompartmental Knee Arthroplasty
Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmental Knee Replacements Versus Conventional Unicompartmental Knee for Subjects With Primary Arthritis of the Knee Joint Involving One (UKA) Compartment (Medial or Lateral)
The overall aim of this trial is to compare functional and patient-reported outcomes and to assess the safety and effectiveness and long-term performance of the Smith+Nephew Robotic Systems for Unicompartmental Knee Replacements…
- Trial name
- NCT06036212
- Testing
- Robotic System, Conventional
- Where
- 5 sites in United Kingdom
- Sponsor
- Smith & Nephew, Inc.
Contraception
Patient Experiences With Contraceptive Care Provided by Community Pharmacists Using the Pharmacist Resource to Implement Services as Modules Platform
Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider.
- Trial name
- PRISM-CS (NCT06819787)
- Testing
- Electronic Heath Record Platform to Support Pharmacists in Delivering Contraceptive Services
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- OvaryIt, LLC
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
Relapsing Remitting Multiple Sclerosis (RRMS)
ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS
The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context…
- Trial name
- ELIOS (NCT06733922)
- Testing
- ETNATM-ProgMS
- Where
- 14 sites in Canada
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer Stage IV
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with…
- Trial name
- NCT02450539
- Testing
- Abemaciclib, Docetaxel
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 159 people
- Sponsor
- Eli Lilly and Company
Carcinoid Syndrome
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
- Trial name
- RELAX (NCT03223428)
- Testing
- Xermelo
- Where
- United States
- Volunteers
- 223 people
- Sponsor
- TerSera Therapeutics LLC
Sickle Cell Disease
A Study to Learn About Sickle Cell Disease In Adult Patients
The purpose of this clinical trial is to evaluate the performance of the sickle cell disease (SCD) electronic diary in people with SCD who are on treatment that will change SCD and those not on such a treatment.
- Trial name
- NCT05407805
- Testing
- Electronic Diary
- Where
- 4 sites in United States
- Volunteers
- 98 people
- Sponsor
- Pfizer
Migraine
Study to Assess Effectiveness of Oral Atogepant in Adult Participants For Prevention of Migraine in the United Kingdom
Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound.
- Trial name
- PRACTICE (NCT07690215)
- Volunteers
- 200 people
- Sponsor
- AbbVie
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
Paroxysmal Nocturnal Hemoglobinuria
Home Reported Outcomes in PNH
The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-Related Quality of Life (HRQoL) experienced by PNH patients.
- Trial name
- NCT06411626
- Testing
- PNH-relevant therapies
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- Novartis Pharmaceuticals
Patient-Reported Outcomes (PRO)
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument
- Trial name
- NCT03536715
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Craniotomy
A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months).
- Trial name
- NCT06095531
- Testing
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- RevBio
Degenerative Osteoarthritis, Rheumatoid Arthritis
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Chronic Instability of Knee
- Trial name
- Pheno4U Pilot (NCT05302934)
- Testing
- Pheno4U
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 600 people
- Sponsor
- Aesculap AG
Ovarian Cancer
Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients…
- Trial name
- SCOUT-1 (NCT04830709)
- Where
- 89 sites in Germany
- Volunteers
- 752 people
- Sponsor
- AstraZeneca
Plaque Psoriasis
A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults
The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of…
- Trial name
- PRO-SCALP (NCT05811234)
- Testing
- CAL/BDP PAD Cream
- Where
- 37 sites in Germany, Spain and 1 more
- Volunteers
- 291 people
- Sponsor
- Almirall, S.A.
Pulmonary Arterial Hypertension
Patient Reported Outcomes in Pulmonary Arterial Hypertension
Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.
- Trial name
- PROPAH (NCT01792622)
- Testing
- Interview, Questionnaire
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Chronic Myelogenous Leukemia - Chronic Phase
A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy
This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for…
- Trial name
- ASC4REAL-2 (NCT07091019)
- Testing
- TKIs
- Where
- 17 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Novartis Pharmaceuticals
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