Clinical trials: Patient Reported Outcomes
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.
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.
Urinary Bladder, Overactive
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive…
- Trial name
- NCT00613327
- Testing
- Oxybutynin chloride OROS
- Volunteers
- 345 people
- Sponsor
- Janssen Korea, Ltd., Korea
Acne Vulgaris
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are…
- Trial name
- PROSES (NCT04820673)
- Testing
- Sarecycline
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Almirall, S.A.
Rheumatoid Arthritis
App-based Education and GOal-setting in Rheumatoid Arthritis
The purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid…
- Trial name
- AEGORA (NCT05888181)
- Testing
- Mobile app-based self-management intervention
- Where
- 2 sites in Belgium
- Volunteers
- 128 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Hemophilia
Patient Reported Outcomes Burdens and Experiences - Phase 2
The Patient Reported Outcomes, Burdens, and Experiences (PROBE) Study aims to develop a new global tool to enhance the direct patient-voice in health care decision-making.
- Trial name
- PROBE (NCT02439710)
- Testing
- Quality of life measure (survey)
- Where
- Canada
- Volunteers
- 656 people
- Sponsor
- McMaster University
Osteoarthritis of the Knee
Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than…
- Trial name
- Bioskin (NCT02295020)
- Testing
- Standard treatment only, Standard treatment plus Bioskin Ten-7 knee brace
- Volunteers
- 40 people
- Sponsor
- Cropper Medical
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
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
Pulmonary Disease, Chronic Obstructive
Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
- Trial name
- NCT03954132
- Testing
- Spiolto® Respimat®, Triple-Therapy (LAMA/LABA/ICS)
- Where
- 75 sites in Germany
- Volunteers
- 469 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
PORTAL: Patient-reported Outcomes After Routine Treatment of Atypical Lesions
This research study is evaluating how patients feel physically and emotionally after a prior breast biopsy for specific breast conditions (including atypical lesions such as atypical ductal hyperplasia (ADH), atypical lobular…
- Trial name
- NCT03070236
- Testing
- Survey
- Where
- 6 sites in United States
- Volunteers
- 912 people
- Sponsor
- Dana-Farber Cancer Institute
Total Knee Arthroplasty, Arthroplasty of Knee
Navio With Total Knee Arthroplasty
The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments.
- Trial name
- NCT03317834
- Testing
- Navio ™ Robotic-assisted Surgical System
- Where
- 6 sites in United States
- Volunteers
- 122 people
- Sponsor
- Smith & Nephew, 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
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.
Osteosarcoma, Nephrotoxicity
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with…
- Conditions
- Osteosarcoma, Nephrotoxicity, Ototoxicity
- Trial name
- NCT01848457
- Testing
- Pantoprazole, High-dose methotrexate infusion duration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
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
Knee Injuries
Evaluation of Patient Reported Outcomes (PRO) After Total Knee Arthroplasty (TKA) Under Spinal Anesthesia
The purpose of this study will be to evaluate and compare patients undergoing total knee arthroplasty (TKA) with sensor guidance versus that of a standard technique.
- Trial name
- NCT03053453
- Testing
- Spinal Surgery, Verasense Knee System device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- NYU Langone Health