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NCT02305095
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H.
NCT04248868
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
NCT03168867
The purpose of the study is to conduct a multicenter, randomized effectiveness trial of The 3Ms. The proposed study will use an effectiveness-implementation "Hybrid 1" design. In this design, the primary goal is to determine whether an intervention works in a real-world setting, but the design also answers secondary questions such as the relationship between treatment dose and treatment outcome and what factors affect the actual delivery of the intervention in the clinics (staff burden, workflow interference etc).
NCT03278691
To determine is low-dose ketorolac use in the early post-operative period (within 48 hours) provides adequate analgesia without long term adverse effect on spinal fusion rates when compared to post-operative analgesia without the use of NSAIDs.
NCT04001803
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.
NCT03618953
This is a Phase 1/1b open-label dose escalation trial of Ad/MG1-E6E7 and sequential treatment with atezolizumab in patients with HPV associated cancers. This study will consist of two arms. Both arms will dose escalate (MG1-E6E7) using a 3 + 3 design in Phase 1 to establish initial safety and the maximum tolerated dose (MTD) / maximum feasible dose (MFD). * Arm 1 - intravenous (IV) administration of MG1-E6E7 following intramuscular (IM) AD-E6E7 priming and subsequent treatment with IV atezolizumab. * Arm 2 - intratumoral (IT) and IV injection of MG1-E6E7 following (IM) Ad-E6E7 priming and subsequent treatment with IV atezolizumab. In the Phase 1b expansion for each arm, additional patients will be enrolled at the MTD as determined in Phase 1 in order to more thoroughly explore immune response, pharmacokinetics/dynamics, and safety for the patient populations with Cervical cancer, HPV positive (HPV+) Oropharyngeal cancer (Phase 1B, Arm 1, Cohorts A and B respectively) and HPV+ tumors with injectable lesions (Phase 1B, Arm 2, Cohort 3).
NCT03416179
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
NCT04410445
The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
NCT04970212
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events. Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
NCT03745820
The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB104 in participants with CIAS, and to evaluate the efficacy of BIIB104 in participants with CIAS on measures of cognition, functioning, and psychiatric symptomology.
NCT03790111
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin \[cis\] plus gemcitabine \[gem\])
NCT03912233
The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).
NCT04810481
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
NCT03433807
The primary objective of this Expanded Access Program is to provide idebenone as a treatment for eligible participants with Duchenne Muscular Dystrophy before it is commercially available in the United States (U.S.) for the indication of DMD.
NCT02483988
The NUsurface® Meniscus Implant SUN Clinical Trial is a multi-center, single-arm, prospective, open label, non-randomized, observational clinical trial to gather safety and probable clinical benefit data on the NUsurface® Meniscus Implant in treated the target population.
NCT03355755
A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.
NCT04842747
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
NCT02190305
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV. Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.
NCT05363215
The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.
NCT02028884
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.