Clinical trials: Patient-Reported Outcomes
Excessive Sleepiness
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved…
- Trial name
- NCT01080807
- Testing
- Armodafinil
- Where
- 63 sites in United States
- Volunteers
- 385 people
- Sponsor
- Cephalon
Asthma
PackHealth: Asthma Engagement Tool
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and…
- Trial name
- NCT02413684
- Testing
- Patient engagement toolkit
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Duke University
Metastatic Cancer
Electronic Patient Reporting of Symptoms During Cancer Treatment
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
- Trial name
- PRO-TECT (NCT03249090)
- Testing
- Patient Self-Reporting of Symptoms, Usual Care Delivery
- Where
- 45 sites in United States
- Volunteers
- 1,197 people, healthy volunteers welcome
- Sponsor
- Alliance Foundation Trials, LLC.
Myopia
Patient Reported Outcomes With WaveLight LASIK
This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively.
- Trial name
- NCT06668909
- Testing
- WaveLight® EX500
- Where
- 4 sites in United States
- Volunteers
- 300 people
- Sponsor
- OVO LASIK + Lens
Obstructive Sleep Apnea
DeVilbiss AutoAdjust With SmartFlex Comparative Study
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
- Trial name
- NCT01203956
- Testing
- SmartFlex, Standard
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- DeVilbiss Healthcare LLC
Hearing Loss
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided…
- Trial name
- NCT04041700
- Testing
- Osia 2 system
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 29 people
- Sponsor
- Cochlear
Knee Arthropathy, Allergic Reaction
Nickel Sensitivity
The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants.
- Trial name
- NCT04058743
- Testing
- TKA with nickel free components, TKA with standard cobalt chromium components
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Rush University Medical Center
Autoimmune Disease
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00351377
- Testing
- Enteric-coated Mycophenolate Sodium
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced…
- Trial name
- NCT03104322
- Testing
- patientMpower platform, usual care
- Where
- Ireland
- Volunteers
- 7 people
- Sponsor
- patientMpower Ltd.
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
Restless Legs Syndrome
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Thoracic Surgery
Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization…
- Trial name
- NCT04342260
- Testing
- Active Monitoring, Passive Monitoring
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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.
PROMs, Waitlist
Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures
The utilization of patient reported outcome measures (PROMs) during in-person care allows for on-going assessment of the severity of mental illness and patient outcomes across treatment.
- Conditions
- PROMs, Waitlist, Telemedicine, Mental Health Disorder
- Trial name
- PROMs (NCT05274958)
- Testing
- Patient-rated outcome measures and educational videos
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Carilion Clinic
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
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.
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Multiple Myeloma
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies.
- Trial name
- NCT03525678
- Testing
- Belantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 221 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer
Patient Reported Outcomes
Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients
The aim of this study is to understand and improve the experience of patients after surgery by comparing two methods of following symptoms while the patient recovers at home.
- Trial name
- NCT03178045
- Testing
- Team Monitoring, Enhanced Feedback
- Where
- United States
- Volunteers
- 2,793 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center