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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 w1 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 |
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 cervic1 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 |
Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation1
University of Maryland, Baltimore
Hemorrhage
Hemodynamic Instability
There is need for a whole blood analog for use when banked blood is unavailable or
undesirable.
In civilian trauma, hemorrhage accounts for ~ 35% of pre-hospital deaths; moreover, ~ 20%
of military casualties are in hemorrhagic shock on arrival to field hospitals and an
additional 5% require urgen1 expand
There is need for a whole blood analog for use when banked blood is unavailable or undesirable. In civilian trauma, hemorrhage accounts for ~ 35% of pre-hospital deaths; moreover, ~ 20% of military casualties are in hemorrhagic shock on arrival to field hospitals and an additional 5% require urgent transfusion. A recent review concluded that hemorrhage accounted for ~ 90% of potentially survivable battlefield deaths - lives that could be saved with better hemorrhage control capabilities and improved, field-ready blood, blood components, or blood substitutes. While study of ideal composition for resuscitative fluids is ongoing, it is evident that for those in hemorrhagic shock, volume replenishment alone (without O2 carrying capacity) is insufficient. Alternatively, with massive blood loss or with ongoing bleeding from non-compressible injuries, resuscitation with an O2 carrier alone may be complicated by acquired coagulopathy (either dilutional or trauma-induced). Development of a balanced resuscitation fluid that treats both shock and coagulopathy (comprising a field-deployable O2 carrier with lyophilized humoral hemostatic components and platelets) is essential to allow on-scene treatment during the critical 'golden-hours' after injury. As such, the whole blood analog described herein could be this product, thus transforming care in both civilian and military settings.The scientific purpose of this study is to develop a combined whole blood substitute from individual artificial prototypes that have been separately developed for each blood component (i.e., combining an artificial oxygen carrier, with an artificial plasma analogue and an artificial platelet analogue). Together, these combined components will recapitulate the composition and performance of natural whole blood. Blending and combination experiments of the individual artificial prototypes will be performed to test compatibility and optimize efficacy. State of the art in vitro (bench top) assays will be performed to assess physicochemical and functional performance (hemodynamics, oxygen delivery, hemostasis), with data being compared to experiments performed on fresh and stored whole blood. Type: Observational Start Date: Apr 2023 |
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 |
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 |
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 st1 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 o1 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 |
2321GCCC: CRD3874-SI in Patients with Relapsed/refractory AML
University of Maryland, Baltimore
Acute Myeloid Leukemia
This clinical research study is being done to answer questions about how to treat cancer.
To clear cancer cells from the body, the immune system needs the action of proteins
called Type 1 interferons. The protein STING (for STimulator of INterferon Genes)
stimulates the body to make Type 1 interfe1 expand
This clinical research study is being done to answer questions about how to treat cancer. To clear cancer cells from the body, the immune system needs the action of proteins called Type 1 interferons. The protein STING (for STimulator of INterferon Genes) stimulates the body to make Type 1 interferons. Type 1 interferons activate key molecules in cancer immunity to kill cancer cells. CRD3874 is a synthetic drug that activates STING, and STING stimulates the immune system to kill cancer cells. In experiments on blood from humans, CRD3874 makes blood cells produce molecules responsible for anti-cancer activity. CRD3874 was tested in mice with cancers including leukemia, head and neck cancer, lung cancer, pancreatic cancer and sarcoma. In these mice, CRD3874 made tumors shrink or disappear, and some mice developed long-lasting immunity against cancer. Also, when CRD3874 was given with other anti-cancer treatments, it increased their anti-cancer effects. Type: Interventional Start Date: Aug 2024 |
A Study of Auxora in Patients with AKI and Injurious Lung "Crosstalk"
CalciMedica, Inc.
Acute Kidney Injury
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic
respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be
randomly assigned to either Auxora or matching placebo. Study drug infusions will occur
every 24 hours for five consecutive day1 expand
Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions. Type: Interventional Start Date: Jun 2024 |
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 i1 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 |
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 c1 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 investigators1 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 ca1 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 |
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 |
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 |
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 additi1 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 deb1 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 o1 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 in1 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 dis1 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 supp1 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 |
ROSE-Longitudinal Assessment With Neuroimaging
University of Cincinnati
Intracerebral Hemorrhage
The investigators will perform follow-up on 250 of 500 cases recruited into the ROSE
study of cases with deep and lobar intracerebral hemorrhage to perform advanced
neuroimaging at 12-24 months post stroke, and evaluations of motor and cognitive function
at baseline, 6 months after baseline, and 121 expand
The investigators will perform follow-up on 250 of 500 cases recruited into the ROSE study of cases with deep and lobar intracerebral hemorrhage to perform advanced neuroimaging at 12-24 months post stroke, and evaluations of motor and cognitive function at baseline, 6 months after baseline, and 12 months after baseline to determine predictors of recovery, progressive cognitive or functional impairment. The investigators propose to leverage the recruitment, DNA, RNA-seq and baseline advanced neuroimaging cohort of ROSE to obtain long-term neuroimaging and identical assessments longitudinally to address critical questions regarding the progressive decline of patients 12 to 24 months post intracerebral hemorrhage (ICH) with long term cognitive follow-up to 36 months on average. This proposal would represent the largest, and longest advanced neuroimaging and RNA-sequencing evaluation after ICH to date. Type: Observational Start Date: Sep 2020 |
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Centinel Spine
Symptomatic Cervical Disc Disease
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and
prodisc C Vivo to the control, a similar, legally marketed total disc replacement device
in subjects with symptomatic cervical disc disease (SCDD). expand
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). Type: Interventional Start Date: Aug 2019 |
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