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NCT04552899
This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).
NCT05877066
This is an observational study, meaning participants will not receive any investigational treatment as part of this study. Researchers will collect real-world data (RWD), based on usual care, to gain a more in-depth knowledge of the natural history and the treatment outcomes of Dupuytren's Contracture (DC) to evaluate the management of DC.
NCT02867007
The purpose of this study is to characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to subjects with locally advanced or metastatic solid tumors.
NCT02610231
This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.
NCT02301130
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors
NCT03805308
The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.
NCT04279314
To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls and women with Rett syndrome
NCT05660577
The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis
NCT04414397
The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing
NCT04171765
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
NCT05401565
This study will evaluate the efficacy and safety of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults with PTSD.
NCT01199367
This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.
NCT05489328
The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.
NCT03448692
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.
NCT04861038
The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) therapy.
NCT04593121
The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.
NCT03815695
FT-4202 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of FT-4202 in the context of Phase 1 studies in healthy volunteers and sickle cell disease patients. The effects of food on the absorption of FT-4202 will also be evaluated in healthy volunteers.
NCT02054741
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
NCT04800809
Sickle Cell Anemia (SCA) occurs in 300,000 newborns per year in the world, with 150,000 affected births in Nigeria, alone. With improvement in survival for children with SCA in both high- and low-resource countries, neurological morbidity is an emerging significant public health challenge, particularly in countries with a high rate of sickle cell disease (SCD). Both silent cerebral infarcts (SCI) and overt strokes result in significant neurological morbidity and premature death. Five NIH-funded randomized controlled trials (RCT) demonstrated that regular blood transfusion or hydroxyurea therapy are efficacious treatments for primary and secondary stroke prevention in children with SCA. Despite the observation that at least 99% of children with SCA in high-resource settings reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with SCI and \~10% with overt strokes) and the high disease-burden in Nigeria, the prevalence and incidence rates of new and recurrent stroke (overt and silent strokes)have not been collected systematically in children and young adults (16-25 years old) with SCA. In the last decade, there has been growing use of stroke registries in economically advanced nations, particularly for epidemiological purposes of trend analysis, clinical effectiveness, compliance to guidelines, assessment of implementation, adoption of novel techniques, and quality improvement process. For the first time in clinical centers in Nigeria, the Investigators will conduct an observational epidemiological study to document the prevalence and track the incidence of new and recurrent strokes in children and young adults with SCD. The Investigators will create a stroke registry referred to as the Afolabi Stroke Registry for Children and Young Adults with Sickle Cell Disease in Nigeria. The overall purpose of the stroke registry is to document the natural history of SCD in a low-resource setting and to improve the quality of the care of children and young adults with SCD living in Nigeria.
NCT02908685
Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.