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Glucagon-like Peptide-1 in Type 1 Diabetes
University of Maryland, Baltimore
Type1 Diabetes Mellitus
The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial
endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of
repeated hypoglycemia in T1DM. expand
The hypotheses to be tested in this application is: GLP-1 will acutely protect arterial endothelial function and reduce pro-atherothrombotic and pro-coagulant effects of repeated hypoglycemia in T1DM. Type: Interventional Start Date: Jun 2020 |
Differing Levels of Hypoglycemia
University of Maryland, Baltimore
Hypoglycemia
Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes.
To date no studies appear to have investigated the effects of differing levels of
hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in
healthy man. The specific aim of our study... expand
Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. To date no studies appear to have investigated the effects of differing levels of hypoglycemia on the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. The specific aim of our study will be to determine the effects of differing levels of hypoglycemia on in-vivo vascular biologic mechanisms in a healthy population. Type: Interventional Start Date: Jul 2015 |
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus (DM)
University of Maryland, Baltimore
Type 1 Diabetes
Hypoglycemia Associated Autonomic Failure
Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote
weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and
HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced
by diabetic individuals because... expand
Exercise is a cornerstone of diabetes management. It helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and HDL-cholesterol) profiles. Unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). My laboratory has demonstrated that Autonomic nervous system (ANS) counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM. ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia. Furthermore, there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained. Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge. Generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (SSRI's) such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system (SNS) activity. What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise. Therefore, the purpose of this study is to determine if the SSRI fluoxetine (Prozac) can improve SNS responses during exercise. Type: Interventional Start Date: Oct 2012 |
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
Jessica Merlin
Opioid Use Disorder
Chronic Pain
This study seeks to improve the treatment of chronic pain in people who are taking
buprenorphine (also known as Suboxone, Subutex, Zubsolv).
The research study is testing two different interventions along with usual clinical care:
1. Pain Self-Management (PSM): an educational program in which... expand
This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv). The research study is testing two different interventions along with usual clinical care: 1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain. 2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels. The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation. There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention. Type: Interventional Start Date: May 2024 |
Incomplete Cervical SCI Without Instability
AO Foundation, AO Spine
Cervical Spinal Cord Injury
A multicenter, international, prospective, observational case series patient cohort with
incomplete cervical SCI without instability will be enrolled to obtain information and
data that could inform the feasibility of administering a set of additional core and
optional outcome assessments in cervical... expand
A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients. Type: Observational Start Date: Dec 2023 |
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Chimerix
H3 K27M
Glioma
This is a randomized, double-blind, placebo-controlled, parallel-group, international,
Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess
whether treatment with ONC201 following frontline radiotherapy will extend overall
survival and progression-free survival in... expand
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy. Type: Interventional Start Date: Jan 2023 |
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial
Population Health Research Institute
Hip Fractures
Myocardial Injury
The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized
controlled trial to determine whether accelerated surgery for hip fracture in patients
with acute myocardial injury is superior to standard care in reducing death at 90 days
after randomization. The trial will also assess... expand
The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life. Type: Interventional Start Date: Nov 2021 |
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
Atrial Fibrillation
Stroke
Bleeding
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC)
to background antiplatelet therapy in patients who develop new-onset post-operative
atrial fibrillation (POAF) after isolated... expand
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Type: Interventional Start Date: Dec 2019 |
PKD Clinical and Translational Core Study
University of Maryland, Baltimore
Polycystic Kidney Disease
Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney
disease (ADPKD) have opened up possibilities of new therapies to prevent disease
progression. High quality clinical investigations in patients with ADPKD, however, pose
significant challenges to investigators... expand
Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney disease (ADPKD) have opened up possibilities of new therapies to prevent disease progression. High quality clinical investigations in patients with ADPKD, however, pose significant challenges to investigators including limited access to patients with ADPKD,insufficient guidance by experienced investigators and lack of resources to conduct these studies. The Polycystic Kidney Disease Research Clinical and Translational Core (P30) aims to establish an infrastructure that will assist investigators in designing and conducting highest quality clinical and translational research focused on a diverse group of patients with ADPKD. Objective 1: To establish a Mid-Atlantic cohort of ADPKD patients (N=350) with baseline clinical phenotyping performed at the General Clinical Research Unit of the University of Maryland School of Medicine. Objective 2: To establish a state-of-the-art biobank of specimens from the ADPKD cohort including serum, plasma,urine and DNA. Objective 3: To develop a collaborative network of physicians and practices in the Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer patients for future studies and trials. Objective 4: To establish a web-based registry of ADPKD patients in the Mid-Atlantic area. Type: Observational [Patient Registry] Start Date: Mar 2013 |
Emergency Preservation and Resuscitation (EPR) for Cardiac Arrest From Trauma
University of Maryland, Baltimore
Cardiac Arrest From Trauma
The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest
from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable
surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary
bypass. expand
The goal of this study is to rapidly cool trauma victims who have suffered cardiac arrest from bleeding with a flush of ice-cold sodium chloride to preserve the patient to enable surgical control of bleeding, followed by delayed resuscitation with cardiopulmonary bypass. Type: Interventional Start Date: Oct 2016 |
MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
University of Maryland, Baltimore
Task-Specific Focal Dystonia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused
ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a
type of dystonia that affects hand movements during specific tasks such as writing,
playing instruments or typing, often causing... expand
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping. Type: Interventional Start Date: Jun 2024 |
Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone
University of Maryland, Baltimore
Intracerebral Haemorrhage, Intraventricular
This is an exploratory single-center prospective study of 20 subjects with primary basal
ganglia ICH who will receive early MIPS in combination with perioperative pioglitazone
treatment. Outcomes will be compared to matched subjects with basal ganglia ICH who
undergo MIPS alone as part of the ENRICH... expand
This is an exploratory single-center prospective study of 20 subjects with primary basal ganglia ICH who will receive early MIPS in combination with perioperative pioglitazone treatment. Outcomes will be compared to matched subjects with basal ganglia ICH who undergo MIPS alone as part of the ENRICH trial. This study will take approximately two years to complete. Type: Interventional Start Date: May 2023 |
Luteolin for the Treatment of People With Schizophrenia
University of Maryland, Baltimore
Schizophrenia
Schizoaffective Disorder
Luteolin is a natural product found in foods such as celery, green pepper, parsley, and
chamomile tea. It has been found to have anti-cancer, anti-oxidant, and anti-inflammatory
properties. The purpose of this study is to determine if luteolin helps improve symptoms
of schizophrenia. expand
Luteolin is a natural product found in foods such as celery, green pepper, parsley, and chamomile tea. It has been found to have anti-cancer, anti-oxidant, and anti-inflammatory properties. The purpose of this study is to determine if luteolin helps improve symptoms of schizophrenia. Type: Interventional Start Date: Jun 2022 |
LITT Followed by Hypofractionated RT for Recurrent Gliomas
University of Maryland, Baltimore
Glioblastoma
Brain Tumor
Glioma
Neoplasms
The purpose of this study is to evaluate the treatment regimen of using Laser
Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat
patients with recurrent gliomas. expand
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas. Type: Interventional Start Date: Jan 2020 |
The ROle of Compression StocKings in Heart Failure Patients
University of Maryland, Baltimore
Heart Failureļ¼Congestive
Leg Edema
Venous Insufficiency
Venous Ulcers
Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively
pump blood to the body. One of the common manifestations of CHF is fluid overload and
swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid
overload and leg swelling; however, in... expand
Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months. Type: Interventional Start Date: Jan 2024 |
Diaphragm Structure and Function in Children
University of Maryland, Baltimore
Respiratory Muscle Training
The purpose of this research is to study the feasibility of a specific training program
for the breathing muscles (inspiratory muscle training) and the effects on how breathing
is regulated during exercise in typically developing children. expand
The purpose of this research is to study the feasibility of a specific training program for the breathing muscles (inspiratory muscle training) and the effects on how breathing is regulated during exercise in typically developing children. Type: Interventional Start Date: Mar 2024 |
Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial
McMaster University
Pain, Postoperative
Pain, Acute
Pain, Chronic
Fractures, Closed
Fractures, Open
Psychological factors such as stress, distress, anxiety, depression, and poor coping
strategies may be associated with ongoing pain following injuries such as fractures. To
study this relationship, patients will undergo cognitive behavioural therapy (CBT) which
is designed to modify such thoughts... expand
Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton, treated with internal fixation. Type: Interventional Start Date: Jan 2021 |
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Dennis M. McNamara, MD, MS
Peripartum Cardiomyopathy, Postpartum
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5
months postpartum in a randomized placebo controlled trial of bromocriptine therapy to
evaluate its impact on myocardial recovery and clinical outcomes. Given that
bromocriptine prevents breastfeeding, an additional... expand
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort. Type: Interventional Start Date: Jul 2022 |
ICG Fluorescence Imaging in Open Fracture Trauma Patients
Dartmouth-Hitchcock Medical Center
Trauma Injury
This is a prospective observational study that will evaluate the association between bone
and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and
complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to
quantitatively guide operative debridement. expand
This is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (ICG) fluorescence imaging, and complications, in an effort to develop ICG fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement. Type: Observational [Patient Registry] Start Date: Oct 2020 |
Blood Donor CVD 5000
University of Maryland, Baltimore
Risk Reduction
This is an open-label, non-randomized study. Volunteers will be vaccinated with the
typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug
Administration (FDA) for travelers to developing countries. Volunteers will also be asked
to provide blood, saliva, and stool specimens... expand
This is an open-label, non-randomized study. Volunteers will be vaccinated with the typhoid oral vaccine, Vivotif. Vivotif has been licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will also be asked to provide blood, saliva, and stool specimens over a follow-up time period of up to eight years. The specimens obtained in this clinical research study will be used to further the investigator's understanding of the protective immunological mechanisms that can be elicited systemically and may be applicable to other enteric pathogens. Type: Interventional Start Date: Jan 2004 |
APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
Wake Forest University Health Sciences
Kidney Diseases
Kidney Failure
Kidney Disease, Chronic
The APOLLO study is being done in an attempt to improve outcomes after kidney
transplantation and to improve the safety of living kidney donation based upon variation
in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family,
such as eye color or blood type. Variation in... expand
The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes. Type: Observational Start Date: Mar 2019 |
Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
Johns Hopkins University
Multiple Sclerosis, Relapsing-Remitting
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the
relapsing phase of MS but have minimal impact once the progressive phase has begun. It is
unclear if, in the relapsing phase, there is an advantage of early aggressive therapy
with respect to preventing long-term disability.... expand
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability. Type: Interventional Start Date: May 2018 |
CT TAVR Abdomen Study
University of Maryland, Baltimore
Transcatheter Aortic Valve Replacement
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated
contrast. A recent world-wide shortage of iodine based intravenous contrast has
highlighted the need to search for alternative methods or doses. Reducing iodinated IV
contrast dose can mitigate IV contrast supply... expand
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure. Type: Interventional Start Date: Sep 2023 |
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Major Extremity Trauma Research Consortium
Post Operative Surgical Site Infection
The proposed study is a multi-center, prospective randomized controlled trial comparing
current standard of care treatment to the SEXTANT treatment protocol in patients with
Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot. expand
The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot. Type: Interventional Start Date: May 2021 |
Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention
University of Maryland, Baltimore
Respiratory Disease
Inflammation
Insufficient Sleep
Digestive Disease
Skin Conditions
The goal of this randomized controlled trial is to evaluate the impacts of an
attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home
Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood
illnesses, body mass index, and sleep) in low-income Latino... expand
The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group. Type: Interventional Start Date: Oct 2023 |
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