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LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH SPINAL MUSCULAR ATROPHY RECEIVING RISDIPLAM TREATMENT
This study will evaluate the long-term safety and effectiveness of risdiplam (Evrysdi?), prescribed on the basis of the U.S. Package Insert (USPI) and clinician ...Phase
Non-Interventional
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Randomized Controlled Open-Label Parallel Group Multi-Center Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2 3 and 4 Pressure Injuries
This post-marketing study is being performed to assess the effectiveness of Altrazeal® Transforming Powder Dressing (“Altrazeal®” or “TPD”) manufactured by ULURU Inc. in patients with ...Phase
Interventional
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BOLT: A Prospective Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo Aspiration System.
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting ...Phase
Interventional
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A Multicenter Randomized Double-Blind Placebo-Controlled Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients with Systemic Lupus Erythematosus
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the HZ/su vaccine in SLE patients in order to evaluate safety and immunogenicity in patients ...Phase
Interventional
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REBYOTA for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA for the prevention of rCDI in the routine care ...Phase
Non-Interventional
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AFFIRM: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
This is a Phase 4 multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a randomized, double-blind, placebo-controlled, parallel-group study in patients with ...Phase
Interventional
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A Phase 4 Prospective Open label Study of Ozanimod to Explore the Safety Efficacy Quality of Life and Biomarker Response in Participants with Moderate to Severe Ulcerative Colitis in Clinical Practice
Ulcerative colitis (UC) is a chronic inflammatory disorder affecting the gastrointestinal tract. Patients with UC experience symptoms such as diarrhea, rectal bleeding, weight loss, abdominal ...Phase
Interventional
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A Prospective Randomized Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVOTM) Infant Nirsevimab (BEYFORTUSTM) Immunization or Both Products During the First Year of Life
At the NYU Langone Vaccine Center, we are conducting an NIH sponsored clinical trial on two FDA-approved products that protect against RSV (Respiratory Syncytial Virus ...Phase
Interventional
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Treat-to-Target Serum Urate versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial (TRUST trial)
The purpose of this research study is to compare two different treatment strategies and see if they may improve the signs and symptoms of gout ...Phase
Interventional
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The Global Paradise System US Post Approval Study (US GPS)
The objective of the Global GPS Registry is to evaluate the real-world use of the Paradise System as per approved labeling. In addition, US GPS ...Phase
Interventional
