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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 |
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 |
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic...
Bayer
Prevention of Ischemic Stroke
Acute Non-cardioembolic Ischemic Stroke
High-risk Transient Ischemic Attack
Researchers are looking for a better way to prevent an ischemic stroke which occurs when
a blood clot travelled to the brain in people who within the last 72 hours had:
- an acute stroke due to a blood clot that formed outside the heart (acute
non-cardioembolic ischemic stroke), or... expand
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study. Type: Interventional Start Date: Jan 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 |
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and...
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without
ibalizumab in a heterogeneous real-world patient... expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric...
Hoffmann-La Roche
Atypical Hemolytic Uremic Syndrome
This study aims to evaluate the efficacy and safety of crovalimab in pediatric
participants with aHUS. expand
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS. Type: Interventional Start Date: Nov 2021 |
Humidity in Incubators for Tiny Infants
The University of Texas Health Science Center, Houston
Extremely Premature Infant
The objective of the study is to assess 2 different initial incubator humidification
protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit
(NICU). The hypothesis is that a higher starting humidity decreases dehydration and
results in no difference in survival or morbidity.... expand
The objective of the study is to assess 2 different initial incubator humidification protocols for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared. Type: Interventional Start Date: Jun 2024 |
Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea...
CinPhloro Pharma, LLC
Irritable Bowel Syndrome With Diarrhea
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help
reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea
(IBS-D) in adult patients. The main questions it aims to answer are:
- To evaluate the efficacy of CIN-103 on symptoms of... expand
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients. The main questions it aims to answer are: - To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with IBS-D compared to a placebo. - To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D compared to a placebo Participants will attend the following visits: - Screening Period (1 Visit) - Baseline Period (1 Visit) - Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued participation. - 12-Week Treatment Period (5 Visits) - Study drug taken twice daily by mouth. - Will complete daily diaries and other PROs as described in the protocol. - Follow- Up Period (1 Visit) Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency along with safety and tolerability. Type: Interventional Start Date: Dec 2023 |
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Yale University
Cesarean Delivery
General Anesthesia
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to
investigate the indications, mode of airway management, predisposing factors, and
obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for
cesarean delivery. expand
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Type: Observational Start Date: Feb 2024 |
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator)...
Merck Sharp & Dohme LLC
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic
obstructive pulmonary disease (COPD). The goal of the study is to learn if people who
take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take
placebo. expand
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo. Type: Interventional Start Date: Mar 2023 |
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic...
Edwards Lifesciences
Aortic Valve Insufficiency
Aortic Valve Stenosis
The objective of this study is to establish the safety and effectiveness of the Edwards
SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk
with a failing aortic bioprosthetic valve. expand
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve. Type: Interventional Start Date: Nov 2023 |
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk of...
Major Extremity Trauma Research Consortium
Post Operative Surgical Site Infection
The overall objective is to compare the effect of Vancomycin and Tobramycin powder
combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation
infections of tibial plateau and tibial pilon fractures at high risk of infection
(collectively considered the "study injuries"). expand
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries"). Type: Interventional Start Date: May 2021 |
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Emalex Biosciences Inc.
Tourette Disorder
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and
tolerability of ecopipam tablets in children, adolescents and adults in the treatment of
Tourette's Disorder (TD). The study includes an open-label period followed by
double-blind, placebo-controlled, randomized withdrawal... expand
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period. Type: Interventional Start Date: Jan 2023 |
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular...
Abiomed Inc.
Left Ventricular Dysfunction
Coronary Artery Disease
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device
during high-risk PCI in patients with reduced left-sided heart function will result in an
improvement in symptoms, heart function and health after a heart procedure compared to
the current standard of care. expand
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Type: Interventional Start Date: Apr 2021 |
Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke
Yale University
Intracerebral Hemorrhage
Ischemic Stroke
Spironolactone
The purpose of this research study is to determine whether blood pressure treatment
regimens with spironolactone are better than blood pressure treatment regimens without
spironolactone at lowering blood pressure in stroke survivors. expand
The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors. Type: Interventional Start Date: Mar 2021 |
A Study of PBFT02 in Patients With Frontotemporal Dementia and Progranulin Mutations (FTD-GRN)
Passage Bio, Inc.
Frontotemporal Dementia
FTD
FTD-GRN
Dementia Frontotemporal
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional
copy of the GRN gene to the brain. This study will assess the safety, tolerability and
efficacy of this treatment in patients with frontotemporal dementia and mutations in the
progranulin gene (FTD-GRN). expand
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the progranulin gene (FTD-GRN). Type: Interventional Start Date: Sep 2021 |
Prenatal Genetic Diagnosis by Genomic Sequencing
Columbia University
Fetal Structural Anomalies
This study is evaluating the impact of prenatal sequencing on the management of fetuses
with ultrasound abnormalities. The hypothesis is that a significant subset of fetal
abnormalities have a genetic cause that can be identified by sequencing and that prenatal
knowledge of this information will improve... expand
This study is evaluating the impact of prenatal sequencing on the management of fetuses with ultrasound abnormalities. The hypothesis is that a significant subset of fetal abnormalities have a genetic cause that can be identified by sequencing and that prenatal knowledge of this information will improve prenatal care, reduce unnecessary diagnostic testing, reduce the cost of care, and improve the quality of life for both the child and the family. Type: Observational Start Date: Jun 2019 |
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 |
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 |
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