Clinical trials: Outcome Assessment
Heart Failure With Reduced Ejection Fraction (HF-rEF)
Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction
The purpose of this study was to assess the effect of LCZ696 at a target dose of 200 mg b.i.d. compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF) treatment, on delaying time to first occurrence…
- Trial name
- PARALLEL-HF (NCT02468232)
- Testing
- LCZ696, Enalapril
- Where
- 49 sites in Japan
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals
Total Knee Replacement
Qualitative Interviews With Healthcare Professionals
PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement…
- Trial name
- NCT05597046
- Testing
- Interview
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Invibio Ltd
Sepsis
Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at…
- Trial name
- NCT04105699
- Testing
- Blood sampling
- Where
- 5 sites in United States
- Volunteers
- 544 people
- Sponsor
- Abionic SA
Menopause, Menopause Related Conditions
World Digital Detox Program for Enhancing Women's Health & Well-being
The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being.
- Conditions
- Menopause, Menopause Related Conditions, Psychological Stress
- Trial name
- NCT06154798
- Testing
- World Digital Detox Women's Health Program
- Where
- India
- Volunteers
- 73 people
- Sponsor
- Innowage Limited
Parkinson's Disease, Motor Symptoms
Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®
To determine if PT intervention will be improved while in the "on" motor state vs. the "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.
- Trial name
- PERFORM (NCT02549573)
- Testing
- APOKYN, Physical Therapy
- Where
- 12 sites in United States
- Volunteers
- 13 people
- Sponsor
- MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
Ovarian Cancer, Breast Cancer
Comprehensive Outcomes for After Cancer Health
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer.
- Conditions
- Ovarian Cancer, Breast Cancer, Lung Cancer, Gastric Cancer
- Trial name
- COACH (NCT05349227)
- Testing
- Digital Health Coaching Program, Fitbit
- Where
- 7 sites in United States
- Volunteers
- 625 people, healthy volunteers welcome
- Sponsor
- Pack Health
Hypertrophic Scar
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars
The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.
- Trial name
- NCT02246465
- Testing
- RXI-109
- Where
- 6 sites in United States, Honduras
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RXi Pharmaceuticals, Corp.
Primary Sclerosing Cholangitis
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
- Trial name
- NCT02247934
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
Lupus Erythematosus, Systemic
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.
- Trial name
- NCT05141201
- Where
- 47 sites in Japan
- Volunteers
- 1,620 people
- Sponsor
- AstraZeneca
Wet Age-related Macular Degeneration (wAMD)
Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
This is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner.
- Trial name
- NCT03054818
- Where
- 49 sites in China
- Volunteers
- 4,000 people
- Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
Pulmonary Arterial Hypertension
Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)
COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH…
- Trial name
- Compass-2 (NCT00303459)
- Testing
- bosentan
- Volunteers
- 334 people
- Sponsor
- Actelion
Otitis Media
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in middle ear fluid of children with a rapid and severe onset of infection and inflammation of the middle ear who are at high risk for…
- Trial name
- NCT00044473
- Testing
- levofloxacin
- Volunteers
- 206 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Osteoarthritis
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.
- Trial name
- NCT02494544
- Testing
- Off the Shelf Total Knee Replacement, ConforMIS iTotal Knee Replacement
- Where
- 8 sites in United States
- Volunteers
- 215 people
- Sponsor
- Restor3D
Limb-Girdle Muscular Dystrophy ; Subtypes 2A, 2B, and 2I
Limb-Girdle Video Assessment
The purpose of this study is to develop a new remote-based video assessment outcome measure for Limb-Girdle Muscular Dystrophy (LGMD) trials. The overall objectives for this study are: 1.
- Trial name
- NCT05528757
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- The Emmes Company, LLC
Bacterial Infections, Bone Diseases, Infectious
Fosfomycin I.v. for Treatment of Severely Infected Patients
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin…
- Conditions
- Bacterial Infections, Bone Diseases, Infectious, Osteomyelitis, Central Nervous System Bacterial Infections
- Trial name
- FORTRESS (NCT02979951)
- Where
- 50 sites in Austria, Germany and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Infectopharm Arzneimittel GmbH
Neovascular Age-related Macular Degeneration
Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.
The purpose of this study was to identify innovative early imaging parameters as predictors of the long-term clinical response to brolucizumab in terms of fluid resolution in patients with wet Age-related Macular Degeneration…
- Trial name
- IMAGINE (NCT04774926)
- Testing
- Brolucizumab
- Where
- 20 sites in Italy
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals
Life Threatening Bleeding, Factor Xa Inhibitor
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg.
- Trial name
- NCT05454787
- Where
- 54 sites in Japan
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
Hip Osteoarthritis, Hip Necrosis
H1 Hip Resurfacing Arthroplasty
This is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip…
- Conditions
- Hip Osteoarthritis, Hip Necrosis, Hip Dysplasia
- Trial name
- H1HRA (NCT03326804)
- Testing
- H1 Hip Resurfacing Arthroplasty
- Where
- 2 sites in United Kingdom
- Volunteers
- 250 people
- Sponsor
- Embody Orthopaedic Limited
Limb-girdle Muscular Dystrophy
A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical Practice
This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy…
- Trial name
- NCT04475926
- Where
- 26 sites in United States, Belgium and 8 more
- Volunteers
- 205 people
- Sponsor
- Sarepta Therapeutics, Inc.
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with…
- Trial name
- COAPT CAS (NCT07227675)
- Testing
- MitraClip® NT System
- Where
- 32 sites in United States
- Volunteers
- 162 people
- Sponsor
- Abbott Medical Devices