University of Maryland, Baltimore

The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025.

Type: Interventional

Start Date: Jan 2024

open study

This study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab. The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells. This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678. This study is looking at several other research questions, including: - What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678? - How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678? - Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?

Type: Interventional

Start Date: Nov 2021

open study

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Type: Interventional

Start Date: May 2019

open study

The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial.

Type: Observational [Patient Registry]

Start Date: Feb 2015

open study

(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.

Type: Interventional

Start Date: Dec 2017

open study

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

Type: Observational

Start Date: Jul 2021

open study

The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.

Type: Interventional

Start Date: Feb 2018

open study

The purpose of this study is to establish autoregulation of retinal blood flow in arterioles and capillaries as a biomarker for early primary open angle glaucoma.

Type: Interventional

Start Date: May 2022

open study

The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.

Type: Observational

Start Date: Jan 2023

open study

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD. The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide. Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Type: Interventional

Start Date: Sep 2024

open study

This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death

Type: Interventional

Start Date: Feb 2024

open study

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 565 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in PPTS with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in PPTS with newly diagnosed treatment-naïve MCL. 8: Oral pirtobrutinib in PPTS with R/R MCL. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Type: Interventional

Start Date: Jun 2022

open study

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.

Type: Interventional

Start Date: Aug 2022

open study

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Type: Interventional

Start Date: Oct 2020

open study

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

Type: Interventional

Start Date: Jun 2017

open study

The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI. The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study. Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).

Type: Interventional

Start Date: Oct 2023

open study

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

Type: Interventional

Start Date: May 2023

open study

The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.

Type: Interventional

Start Date: Apr 2024

open study

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.

Type: Interventional

Start Date: Mar 2024

open study

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.

Type: Observational

Start Date: Dec 2019

open study

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution. The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. This study is seeking participants who are: - male or female infants who are 2 months of age, - infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and, - said to be healthy by the study doctor There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study. The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1. Once 400 participants have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. Once the 100 participants have been assigned to Group 3 then 300 new participants will be assigned to Group 4. Half the participants in Group 4 will receive PG4 in the first solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Group 4 will receive 4 doses of a licensed pneumococcal comparator vaccine at 2, 4, 6, and 12 to 15 months of age. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Type: Interventional

Start Date: Jul 2024

open study

Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Type: Interventional

Start Date: Apr 2019

open study

The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Type: Interventional

Start Date: Nov 2023

open study

This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.

Type: Interventional

Start Date: Jun 2023

open study

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration.

Type: Interventional

Start Date: Jan 2023

open study