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Discover 23,476 clinical trials near Baltimore, Maryland. Find research studies in your area.
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NCT02263508
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and overall survival (OS).
NCT04491552
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.
NCT01204905
This is a pilot, open-label study of raltegravir and maraviroc in combination for the treatment of antiretroviral naïve patients. The study will enroll 7 antiretroviral naïve patients with CD4 counts ≥ 350 and viral loads \> 5,000. The subjects will be followed for 48 weeks. The combination of these two agents has the potential to be a potent regimen with minimal metabolic complications. However, they have not been studied in combination previously. This pilot study proposes to evaluate this combination in antiretroviral naïve patients to document the safety and efficacy of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications.
NCT02257567
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.
NCT03544229
The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.
NCT01568866
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.
NCT05032352
Prospective Registrational Trial to Define Real World Outcomes of Patients with Completely Resected Stage I or IIA (tumor \< or = 5cm, node negative) Non-squamous Non-Small Lung Cancer (NSCLC) Identified as High, Intermediate, or Low Risk by a 14-Gene Prognostic Assay DetermaRx being Considered for Adjuvant Platinum-based chemotherapy or other adjuvant therapy versus Observation
NCT03924323
This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.
NCT01380730
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
NCT01905592
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
NCT03373877
This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.
NCT05147389
Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.
NCT04640597
The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.
NCT03548415
The purpose of this study was to assess the safety, tolerability, and efficacy of IONIS-GHR-LRx in up to 60 participants with acromegaly.
NCT04113746
Develop and pilot test four theory-based educational modules that integrate counseling for asthma and obesity to promote greater physical activity among people with asthma.
NCT04974697
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational multifocal toric contact lenses.
NCT03385512
This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess the comparative effectiveness of three interventions in diverse ambulatory care settings and patient populations. Findings will help healthcare systems decide which approach to adopt to empower patients and enable providers to engage in patient centered communication. The specific aims are to: 1. Engage with patients and healthcare providers who have used the tools in the pilot study (ClinicalTrials.gov Identifier NCT02522286) at the Sutter Health Palo Alto Medical Foundation (PAMF), as well as new stakeholders at University of California San Diego Health System and Meyers Primary Care Institute at University of Massachusetts and Reliant Medical Group, to further refine and adapt these patient-centered interventions to be integrated into real world primary care clinics. 2. Conduct a large scale cluster RCT with three arms, to evaluate the comparative effectiveness of three interventions: OPEN with in-person SPI training (High Touch), OPEN with online SPI training (High Tech), and ASK. Primary outcomes will include patient perceptions of how well their PCPs have engaged them in patient centered communication. The investigators will also measure patients' confidence in managing their health, intention to follow through with care plans, and downstream behaviors in following through with care plans, use of services such as phone calls, secure messaging, and additional visits. 3. Identify the strategy that has the most potential for sustained impact and replication within and across healthcare systems. The investigators will analyze the fidelity to the intervention protocols, including consistency of delivery as intended and the time/effort involved in implementing the interventions. The investigators will also assess the extent to which the programs become institutionalized. The investigators anticipate that this multi-level healthcare system intervention will result in significant improvement in: patient satisfaction with how PCP has engaged them in the visit, confidence in selfcare; patients' intention to adhere to care plan, and clinical indicators. Furthermore, more effective communication would lower health service utilization after the visit. The investigators further expect that the intervention will affect physicians', medical assistants' and nurses' experience as well as healthcare system leaders' intention to implement in routine practice.
NCT04095143
Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. The objective of this study is to determine whether ultrasound markers of organ congestion are associated with major adverse kidney events in critically ill patients with severe acute kidney injury.
NCT03515629
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.
NCT03558984
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm.
