Clinical trials: Patient Reported Outcome
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.
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.
Chronic Obstructive Pulmonary Disease (COPD)
Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions
Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-world setting over 24 months.
- Trial name
- ANEMO (NCT07052396)
- Testing
- Dupilumab
- Where
- 18 sites in Germany
- Volunteers
- 350 people
- Sponsor
- Sanofi
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
Congenital Thrombotic Thrombocytopenic Purpura
Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]
The purpose of this study is to assess the psychometric properties of a recently developed congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes (PRO) instrument.
- Trial name
- NCT03519672
- Testing
- No intervention
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 41 people
- Sponsor
- Baxalta now part of Shire
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
Premature Ejaculation
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.
- Trial name
- NCT02232425
- Testing
- IX-01
- Where
- 10 sites in United States, Australia
- Volunteers
- 88 people
- Sponsor
- Ixchelsis Limited
Total Hip Arthroplasty
Cemented Acetabular Cups Clinical Study
This clinical study has the aim to evaluate clinical, radiographic, patient-reported outcomes of total hip arthroplasty with the implant of Mueller cemented acetabular cups up to 2 years after surgery, in order to assess the…
- Trial name
- NCT04831918
- Testing
- Mueller cemented cups
- Where
- Italy
- Volunteers
- 45 people
- Sponsor
- Limacorporate S.p.a
Non Small Cell Lung Cancer (NSCLC)
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent.
- Trial name
- ARCHER 1042 (NCT01465802)
- Testing
- Dacomitinib, Doxycycline, Probiotic
- Where
- 81 sites in United States, South Korea
- Volunteers
- 236 people
- Sponsor
- Pfizer
HIV Infections
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies.
- Trial name
- VOLITION (NCT05917509)
- Testing
- DTG/3TC, Cabotegravir (CAB) LA, Rilpivirine (RPV) LA
- Where
- 47 sites in United States, Argentina and 7 more
- Volunteers
- 171 people
- Sponsor
- ViiV Healthcare
History of Myocardial Infarction, Hypertriglyceridemia
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy
- Trial name
- DIAPAsOn (NCT03415152)
- Testing
- Omacor (Omega-3-acid ethyl esters)
- Where
- 93 sites in Russia
- Volunteers
- 3,000 people
- Sponsor
- Abbott
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
Chronic Hepatitis C, Genotype 1 or 4
Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in…
- Trial name
- NCT02581163
- Testing
- Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin
- Volunteers
- 314 people
- Sponsor
- AbbVie
MPN (Myeloproliferative Neoplasms)
Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential…
- Trial name
- NCT02953704
- Where
- 116 sites in United States, Puerto Rico
- Volunteers
- 1,469 people
- Sponsor
- Incyte Corporation
Breast Neoplasm
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin…
- Trial name
- PRECYCLE (NCT03220178)
- Testing
- Palbociclib, Fulvestrant, Anastrozole
- Where
- Germany
- Volunteers
- 532 people
- Sponsor
- Palleos Healthcare GmbH
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
Acromegaly
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical…
- Trial name
- MPOWERED (NCT02685709)
- Testing
- Octreotide capsules
- Where
- 53 sites in United States, Austria and 11 more
- Volunteers
- 146 people
- Sponsor
- Chiasma, Inc.
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.
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
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