Search Clinical Trials
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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in... expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Pain Biomarker Study
The University of Texas Health Science Center, Houston
Migraine
Cluster Headache
Trigeminal Autonomic Cephalgia
Hemicrania Continua
Paroxysmal Hemicrania
This study investigates molecular and physical biomarkers of headaches in order to better
understand mechanisms of these diseases.
There are 3 main parts:
1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of
calcitonin gene related peptide - the hypothesis... expand
This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases. There are 3 main parts: 1. Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested. 2. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment. 3. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders. Type: Interventional Start Date: Mar 2018 |
Neurosciences Research Repository
The University of Texas Health Science Center, Houston
Neurological Conditions
In order to expand neuroscience research and move laboratory advances to patients, there
is a need to integrate reliable clinical data with biologic information from patient
tissue specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The
NRR is a prospective database and... expand
In order to expand neuroscience research and move laboratory advances to patients, there is a need to integrate reliable clinical data with biologic information from patient tissue specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The NRR is a prospective database and sample bank created to collect information and samples for current and future neuroscience research. The objective of this NRR is to develop a data and sample repository for study of neurological conditions. A repository utilizing standardized electronic health data and samples collected in a uniform manner serves to foster the ability to perform research on current and future projects. Samples and data for clinical, genomic and proteomic analysis will be provided to optimize their value for neuroscience research. The NRR will enroll patients and collect clinically recorded longitudinal data for as long as they are followed by the Neurosurgery service and up to an additional 5 years after being released from care. Patients will be enrolled on admission to the service and samples will be taken at three time points: Time One, within 24 hours of event (preferably first blood draw); Time Two, within 48 hours of event; and Time Three, time of any residual tissue availability. Family members of select groups of patients will also be approached for enrollment. Samples and data will be labeled with a study code to maintain confidentiality. Samples and data will be maintained in secure, limited access environments with back-up/redundancy procedures in place. Sample inventory will be maintained with a bar-coding system. A duty to warn clause will be included in the consent as will the determination of willingness to be re-contacted for future research. Time of sample acquisition to time of sample processing will be documented for quality control purposes. Freezers will be monitored for temperature stability. Recipient investigators will be requested to provide feedback on sample quality. Samples will be distributed to neuroscience investigators after approval from the Neurosurgery Scientific Review Committee - Dissemination Review Committee and the Committee for the Protection of Human Subjects (CPHS). Type: Observational Start Date: Mar 2009 |
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects...
Pacira Pharmaceuticals, Inc
Postoperative Pain
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is
designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl
for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age
undergoing cardiac surgery, utilizing local... expand
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA). Type: Interventional Start Date: Mar 2024 |
Strategy for Improving Stroke Treatment Response
Translational Sciences, Inc.
Ischemic Stroke
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding
trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal
antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. expand
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. Type: Interventional Start Date: Mar 2024 |
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Johns Hopkins University
Atrial Fibrillation
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE
design), controlled trial comparing the current Standard Of Care (SOC) of continuous
Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an
AF-sensing Smart Watch (AFSW) in participants... expand
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk. Type: Interventional Start Date: Jul 2023 |
TSC Biosample Repository and Natural History Database
National Tuberous Sclerosis Association
Tuberous Sclerosis
Lymphangioleiomyomatosis
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that
scientists can request to use in their research. The samples we collect are all linked to
clinical data in the TSC Natural History Database. The TSC Natural History Database
captures clinical data to document... expand
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively. Type: Observational [Patient Registry] Start Date: Jan 2016 |
Device Global Registry for the IlluminOss Bone Stabilization System
IlluminOss Medical, Inc.
Traumatic Fracture
Pathological Fracture
This is a multi-center, observational patient registry. The primary objective of the
study is to collect safety and performance data on the IlluminOss Device when used to
provide stabilization and alignment for the treatment of traumatic or impending and
pathologic fractures. expand
This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures. Type: Observational [Patient Registry] Start Date: Jun 2021 |
Zenith® Fenestrated+ Clinical Study
Cook Research Incorporated
Aortic Aneurysm, Abdominal
Juxtarenal Aortic Aneurysm
Extent IV Thoracoabdominal
Pararenal Aneurysm
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and
effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with
the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2
for the treatment of patients with... expand
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Type: Interventional Start Date: Dec 2023 |
Trial of eRapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance
Rapamycin Holdings, Inc. dba Emtora Biosciences
Familial Adenomatous Polyposis
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic
surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating
doses/schedules for 12 months with the aim of reducing polyp burden. expand
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp burden. Type: Interventional Start Date: Jan 2021 |
RECOVER-ENERGIZE Platform Protocol
Duke University
Long COVID
Long Covid19
Long Covid-19
This is a platform protocol designed to be flexible so that it is suitable for a range of
interventions and settings within diverse health care systems and community settings with
incorporation into clinical COVID-19 management programs and treatment plans if results
achieve key study outcomes.
This... expand
This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC. Type: Interventional Start Date: Jul 2024 |
Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents
The University of Texas Health Science Center, Houston
Sports-related Concussion
The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to
standard of care in adolescent athletes at risk for delayed recovery from subacute sports
concussion, to substantiate the impact of subacute PBMt over time on functional and
structural connectivity of the brain... expand
The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to standard of care in adolescent athletes at risk for delayed recovery from subacute sports concussion, to substantiate the impact of subacute PBMt over time on functional and structural connectivity of the brain using advanced MRI sequences and to correlate the psychological and behavioral outcomes to neuroimaging findings Type: Interventional Start Date: Apr 2024 |
Reducing Alcohol Exposed Pregnancies
New York University
Alcohol Drinking
The goal of this clinical trial is to compare an active intervention versus a standard of
care control in reducing alcohol use among pregnant women. The main questions it aims to
answer are whether a motivational intervention can:
1. increase the proportion of women detected with a laboratory-confirmed... expand
The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction. Type: Interventional Start Date: Apr 2024 |
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
Weill Medical College of Cornell University
Emphysema
HIV
The purpose of this study is to determine if doxycycline will reduce progression of
emphysema in people living with HIV.
The secondary objectives are to examine the effects of doxycycline on change in quantity
of emphysema, six minute walk distance, patient reported outcomes, ratio of forced
expiratory... expand
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections. Type: Interventional Start Date: Aug 2022 |
DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
ECOG-ACRIN Cancer Research Group
Gliosarcoma
Recurrent Glioblastoma
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic
resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for
early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI
may help evaluate changes in the blood... expand
This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment. Type: Interventional Start Date: Jul 2017 |
Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
The University of Texas Health Science Center, Houston
Smoking Cessation
The purpose of this study is to assess the feasibility and safety of injectable
naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP
administration among individuals with schizophrenia spectrum disorders that smoke
cigarettes and to evaluate change on smoking-related... expand
The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia. Type: Interventional Start Date: May 2024 |
A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches...
The University of Texas Health Science Center, Houston
Post-Lumbar Puncture Headache
The purpose of this study is to o determine whether the modified LP procedure reduces the
incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces
the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population
and to identify factors that may... expand
The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH Type: Interventional Start Date: Nov 2023 |
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
The University of Texas Health Science Center, Houston
Systemic Sclerosis
Constipation
Gastrointestinal Motility Disorder
Autonomic Dysfunction
The purpose of this study is to determine whether transcutaneous electrical
acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal
physiology by enhancing autonomic nervous system (ANS) function. The study will examine
the effects of TEA on slow colonic transit (SCT) and... expand
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways. Type: Interventional Start Date: Feb 2024 |
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NYU Langone Health
Pulmonary Embolism
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare
catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation
alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and
right ventricular dilation. expand
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation. Type: Interventional Start Date: Jul 2023 |
Ferric Citrate and Chronic Kidney Disease in Children
University of California, Los Angeles
Chronic Kidney Diseases
We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess
the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels
(iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged
6-18 years of either sex with chronic kidney... expand
We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 12 core clinical sites. Type: Interventional Start Date: May 2022 |
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Healios K.K.
Trauma
Adult Stem Cells
Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in
severely injured trauma patients within hours of hospitalization who have survived
initial resuscitation. expand
Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation. Type: Interventional Start Date: Nov 2020 |
Perform® Humeral System - Fracture Study (PFX)
Stryker Trauma and Extremities
Traumatic Arthropathy of Shoulder
Fracture Humerus
Traumatic Arthritis
Revision of Other Devices if Sufficient Bone Stock Remains
This study is an international, single arm, multicenter, prospective follow-up,
non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect
safety and performance data on commercially available Perform® Fracture.
Data collected from this study will be used for purposes,... expand
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture. Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development. Type: Observational Start Date: Aug 2023 |
CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following...
The University of Texas Health Science Center, Houston
Chronic Stroke
The purpose of the study is to compare assessments of arm function following a standard
exercise program in chronic stroke patients. expand
The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients. Type: Interventional Start Date: Feb 2023 |
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic...
Ancora Heart, Inc.
Heart Failure With Reduced Ejection Fraction (HFrEF)
Dilated Cardiomyopathy
Prospective, randomized, open-label, international, multi-center clinical study to
evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in
patients with heart failure and reduced ejection fraction (HFrEF). expand
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF). Type: Interventional Start Date: Dec 2020 |
Renal Anhydramnios Fetal Therapy
Johns Hopkins University
Anhydramnios
Potter Syndrome
Lung Hypoplasia
Multicystic Dysplastic Kidney
Multicystic Renal Dysplasia, Bilateral
Early pregnancy renal anhydramnios or EPRA is a condition where a pregnant woman does not
have any amniotic fluid around her fetus because of a problem with the fetus's kidneys.
This condition is thought to be fatal once the fetus is born because of inadequate lung
growth. The Renal Anhydramnios Fetal... expand
Early pregnancy renal anhydramnios or EPRA is a condition where a pregnant woman does not have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This condition is thought to be fatal once the fetus is born because of inadequate lung growth. The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will be carried out by an expert in fetal interventions at a RAFT center. There is a significant risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions, and any potential trial participants will be counseled about these risks before they decide whether to join the trial. Any eligible patients who, after counseling, elect to terminate the pregnancy will not be eligible to participate in the trial. All eligible patients who choose to join the RAFT trial will be able to choose their assignment into one of two arms of the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of patients to study arm will not be random, but will be decided by the participant. Fetuses who do survive after birth will require intensive medical management for kidney failure including placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney transplant. Treatment for lung disease secondary to abnormal lung development may also be required. The study will follow babies and their families until non-survival or transplant. Update: Due to recommendations from the RAFT trial Data and Safety Monitoring Board, the trial is no longer open to enrollment for pregnancies complicated by bilateral renal agenesis as of July 19, 2022. Enrollment for patients with pregnancies complicated by other causes of fetal renal failure remains open. Type: Interventional Start Date: Dec 2018 |
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