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NCT02927067
This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir. Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it. After treatment, each participant will be followed up for up to 12 weeks. Participants will visit their study clinic up to 18 times during the study.
NCT02581631
The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).
NCT02219711
MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles. During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.
NCT02016781
This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
NCT03995901
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
NCT01649388
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
NCT02041533
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
NCT03178487
The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
NCT02664558
This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with placebo in patients with pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of II or III.
NCT03824587
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
NCT03759392
The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo
NCT03854721
The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for Instillation (VAX014) in patients with low-grade Non-Muscle Invasive Bladder Cancer (NMIBC). VAX014 is a targeted oncolytic agent designed to kill tumor cells following instillation into the urinary bladder.
NCT03689530
An estimated 86 million adults in the United States have prediabetes, and low-income Latino and African American adults have disproportionately high rates compared to non-Hispanic adults. Structured lifestyle interventions can prevent or delay type 2 diabetes in these at-risk populations and now are widely offered at community organizations and health systems. Yet, uptake of and engagement in available formal programs is very low. Low-income adults in particular face multiple barriers to navigating, engaging in, and sustaining involvement in available programs and lifestyle behaviors found to decrease progression to diabetes. It is critically important to develop and evaluate innovative approaches to increase uptake, engagement, and maintenance of gains in diabetes prevention activities. Peer support has been shown in the investigators' and others' effectiveness trials to be a sustainable, effective approach for positive behavior change and improved outcomes in adults with diabetes and other chronic conditions. The study team's pilot work suggests such approaches are feasible and acceptable among low-income Latino and African American patients with prediabetes to prevent chronic disease and better navigate their health care systems to obtain healthy lifestyle counseling and support. However, such peer support models among Latino, African American, and other low-income adults with prediabetes have not yet been rigorously evaluated. Accordingly, the study will conduct a parallel, two-arm randomized controlled trial in primary care centers in two different health systems that serve multi-ethnic communities with a high concentration of Latinos and African Americans and diverse socio-economic backgrounds. The study will compare enhanced usual care (providing referrals to diabetes prevention programs and resources) with a model of a structured behavioral change intervention supplementing enhanced referral to programs and resources with peer support to help link adults with prediabetes to existing health system and community diabetes prevention programs, to support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes.
NCT04815967
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension safety trial.
NCT02864160
Language barriers continue to impede access to quality care for limited English proficient populations. Recent research has demonstrated that access to language concordant providers increases quality of care. This project evaluates the efficacy and acceptability of a model intervention to improve second language proficiency, patient-centered communication, and clinical competency of nurse practitioner students who care for Spanish-speaking patients with diabetes.
NCT03350035
This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.
NCT04749355
An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who fail to respond or relapsed following first line therapy. Approximately 20 adult patients with relapsed and/or refractory AML and approximately 20 adult patients with relapsed and/or refractory HR MDS, will be enrolled into the study. Patients will be treated with 1-2 induction courses and 2-4 maintenance courses. All patients will be followed for 1 year in the study and additional 1 year post study follow-up.
NCT03882437
This is a non-randomized open-label Phase 1 study to evaluate the safety and toxicity of gene therapy using a recombinant adeno-associated virus serotype 9 (AAV9) containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B) transgene (investigational product (IP), RP-A501) in male patients with Danon Disease (DD).
NCT05747755
This study seeks to link a group of hospitals to measure and share the rates of diagnostic errors, to understand underlying causes of diagnostic errors, and develop ways that hospitals, clinicians, and patients can work together to avoid diagnostic errors and harms due to those errors. The investigators will test how data sharing and collaboration improve diagnostic processes and develop approaches which can be sustained into the future. The approach represents a novel application of rigorous outcome adjudication to the problem of inpatient diagnostic errors using a learning health system model.
NCT04412707
This is a randomized, two-period, cross-over Phase 2 study, comparing PK, and assessing safety and tolerability and efficacy of peripheral and central intravenous administration of melflufen in patients with RRMM. It is an international study, enrolling patients in US and Europe. The study will enroll patients following at least 2 lines of prior therapy.